HET COLLEGE VOOR DE TOELATING VAN ......Ede, 1 februari 2019 Het College voor de toelating van voor deze: de voorzitter, Ir. J.F. de Leeuw A9459C / Maxim 480 FS Page Part A - Registration

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

1. BESLUIT Op 6 april 2016 is van

Syngenta Crop Protection B.V. Postbus 512 4600 AM BERGEN OP ZOOM

een aanvraag tot wijziging van de toelating van een gewasbeschermingsmiddel met Nederland als Eu-ropees rapporteur ontvangen als bedoeld in artikel 33 Verordening (EG) 1107/2009 (verder te noemen: de Verordening) voor het gewasbeschermingsmiddel

Maxim 480 FS op basis van de werkzame stof fludioxonil. HET COLLEGE BESLUIT tot toelating van de wijziging bovenstaand middel. De wijziging betreft de uitbreiding van de toelating in sla, andijvie, spinazie, witlof, veldsla, courgette, komkommer, vruchtgroenten van cucurbitaceae-niet eetbare schil, aubergine, tomaat en paprika. 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 aandui-dingen en vermeldingen conform de geldende regelgeving op of bij de verpakking te worden vermeld: De aanduidingen, letterlijk en zonder enige aanvulling, zoals vermeld onder “verpakkingsinformatie”

in bijlage I. Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in deel A

van het registratierapport, Appendix I.

A9459C / Maxim 480 FS

Part A - National Assessment

Page 2 /83

Registration report – All zones

Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen. De classificatie die overeenkomstig het toelatingsbesluit is vastgesteld, moet volgens de voorschrif-

ten 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. Het gebruik van het middel wordt niet beperkt en respijttermijnen voor verpakkingen met de oude W-codering zijn niet van toepassing (besluit beleidsregel respijttermij-nen voor gewasbeschermingsmiddelen, Staatscourant d.d. 31 augustus 2016). De te hanteren w-coderingen 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.



Page 3 /83


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, 1 februari 2019

Het College voor de toelating van gewasbeschermingsmiddelen en biociden, voor deze: de voorzitter, Ir. J.F. de Leeuw



Page 4 /83


BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING 2.1 Aanvraaginformatie Aanvraagnummer: 20151623 ZEWTG Type aanvraag: Aanvraag tot wijziging van de toelating van een gewas-

beschermingsmiddel met Nederland als Europees rap-porteur

Middelnaam: Maxim 480 FS Verzenddatum aanvraag: 5 april 2016 Formele registratiedatum: * 27 april 2016 2.2 Stofinformatie Werkzame stof Gehalte

fludioxonil 480 G/L

De stof is per 1 november 2008 geplaatst op Annex I van Richtlijn 91/414/EEG (2007/76/EC) en vervolgens bij Uitvoeringsverordening (EU) 540/2011 d.d. 25 mei 2011 goedgekeurd). De goedkeuring van deze werkzame stof expireert op 31 oktober 2019.

2.3 Toelatingsinformatie Toelatingsnummer: 14184 N Expiratiedatum: 31 oktober 2019 Afgeleide parallel of origineel: Wijziging middel Biocide, gewasbeschermingsmiddel of toevoegingsstof: Gewas Gebruikers: Professioneel W-coderingen en aflever- en opgebruiktermijnen: W-codering professioneel gebruik: W1 Vorige w-codering professioneel gebruik: - Aflevertermijn professioneel gebruik: N.v.t. Opgebruiktermijn professioneel gebruik: N.v.t 2.4 Verpakkingsinformatie Aard van het preparaat: Suspensie concentraat voor zaadbehandeling (FS)

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



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HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE II Etikettering van het middel Maxim 480 FS Professioneel gebruik de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel: Pictogram GHS09

Signaalwoord Waarschuwing

Gevarenaanduidingen H410 Zeer giftig voor in het water levende organismen, met langdurige gevolgen.

Voorzorgsmaatregelen P273 Voorkom lozing in het milieu. P280C Beschermende handschoenen en beschermende kleding dragen. P391 Gelekte/gemorste stof opruimen. SP 1 Zorg ervoor dat u met het product of zijn verpakking geen water verontreinigt.

Aanvullende etiketele-menten

EUH208 Bevat 1,2-benzisothiazol-3-one. Kan een allergische reac-tie veroorzaken. EUH401 Volg de gebruiksaanwijzing om gevaar voor de menselijke gezondheid en het milieu te voorkomen.

Kinderveilige sluiting verplicht Nee Voelbare gevaarsaanduiding verplicht Nee



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REGISTRATION REPORT

Part A

Risk Management

Product code: A9459C

Product name(s): Maxim 480FS

Chemical active substance:

Fludioxonil, 480g/L

Interzonal

Zonal Rapporteur Member State: Netherlands

NATIONAL ASSESSMENT Netherlands

(Article 33 Amendment of authorisation)

Applicant: Syngenta

Submission date: February 2016

MS Finalisation date: January 2019



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Table of Contents

1 Details of the application ............................................................................. 9

1.1 Application background ................................................................................. 9

1.2 Letters of Access ............................................................................................ 9

1.3 Justification for submission of tests and studies .......................................... 10

1.4 Data protection claims ................................................................................. 10

2 Details of the authorization decision ........................................................ 10

2.1 Product identity ............................................................................................ 10

2.2 Conclusion ................................................................................................... 10

2.3 Substances of concern for national monitoring ........................................... 10

2.4 Classification and labelling .......................................................................... 11 2.4.1 Classification and labelling under Regulation (EC) No 1272/2008 ............ 11 2.4.2 Standard phrases under Regulation (EU) No 547/2011 ............................... 11 2.4.3 Other phrases (according to Article 65 (3) of the Regulation (EU) No

1107/2009) ................................................................................................... 11

2.5 Risk management ......................................................................................... 11 2.5.1 Restrictions linked to the PPP ...................................................................... 11

2.5.2 Specific restrictions linked to the intended uses .......................................... 12

2.6 Intended uses (only NATIONAL GAP) ...................................................... 13

3 Background of authorization decision and risk management ............... 16

3.1 Physical and chemical properties (Part B, Section 2) .................................. 16

3.2 Efficacy (Part B, Section 3) ......................................................................... 17

3.3 Efficacy data ................................................................................................ 17 3.3.1 Information on the occurrence or possible occurrence of the development

of resistance ................................................................................................. 19 3.3.2 Adverse effects on treated crops .................................................................. 20

3.3.3 Observations on other undesirable or unintended side-effects .................... 21

3.4 Methods of analysis (Part B, Section 5) ....................................................... 22 3.4.1 Analytical method for the formulation ........................................................ 22 3.4.2 Analytical methods for residues ................................................................... 22

3.5 Mammalian toxicology (Part B, Section 6) ................................................. 23 3.5.1 Acute toxicity ............................................................................................... 23

3.5.2 Operator exposure ........................................................................................ 23 3.5.3 Worker exposure .......................................................................................... 24

3.5.4 Bystander and resident exposure ................................................................. 24

3.6 Residues and consumer exposure (Part B, Section 7) .................................. 25 3.6.1 Residues ....................................................................................................... 25 3.6.2 Consumer exposure ...................................................................................... 25

3.7 Environmental fate and behaviour (Part B, Section 8) ................................ 26 3.7.1 Predicted environmental concentrations in soil (PECsoil) ............................ 26 3.7.2 Predicted environmental concentrations in groundwater (PECgw) .............. 27

3.7.3 Predicted environmental concentrations in surface water (PECsw).............. 27 3.7.4 Predicted environmental concentrations in air (PECair) ............................... 28

3.8 Ecotoxicology (Part B, Section 9) ............................................................... 29

3.8.1 Effects on terrestrial vertebrates .................................................................. 29



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3.8.2 Effects on aquatic species ............................................................................ 29

3.8.3 Effects on bees ............................................................................................. 29 3.8.4 Effects on other arthropod species other than bees ...................................... 29

3.8.5 Effects on soil organisms ............................................................................. 30 3.8.6 Effects on non-target terrestrial plants ......................................................... 30 3.8.7 Effects on other terrestrial organisms (Flora and Fauna) ............................. 30

3.9 Relevance of metabolites (Part B, Section 10) ............................................ 31

4 Conclusion of the national comparative assessment (Art. 50 of

Regulation (EC) No 1107/2009) ................................................................ 32

5 Further information to permit a decision to be made or to support a

review of the conditions and restrictions associated with the

authorization .............................................................................................. 33

Appendix 1 Copy of the product label .......................................................................... 34

Appendix 2 Letter of Access .......................................................................................... 36

Appendix 3 Lists of data considered for national authorization ................................ 37



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PART A

RISK MANAGEMENT

1 Details of the application

This document describes the acceptable use conditions required for the registration extension in The

Netherlands of Maxim 480 FS (A9459C) containing:

480 g/L fludioxonil which was included into Annex I of Council Directive 91/414/EEC (Commission

Directive 2007/76/EC; 20 December 2007). This active substance is approved under Regulation

(EC) No. 1107/2009 (repealing Commission Directive 91/414/EEC); Commission Implementing

Regulation (EU) No. 540/2011 of 25 May 2011.

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

tration Report, Part B Sections 1-10 and Part C and where appropriate the addenda for The Nether-

lands. The information, data and assessments provided in Registration Report, Parts B include assess-

ment of further data or information as required at national re-registration/registration by the EU review. It

also includes assessment of data and information relating to Maxim 480 FS where that data have not been

considered in the EU review process. Otherwise assessments for the safe use of Maxim 480 FS have been

made using endpoints agreed in the EU review of fludioxonil.

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

registration of Maxim 480 FS.

Appendix 1 of this document provides a copy of the final product authorisation for The Netherlands.

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

Appendix 3 of this document contains, if relevant, 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 summarises the national data protection claims including justifications, for

data submitted in support of the evaluation.

1.1 Application background

This application was submitted by Syngenta.

The application was for extending approval of Maxim 480 FS, a flowable concentrate for seed treatment

(FS) containing 480 g/L fludioxonil to a range of vegetable crops to control fungal diseases, in The Neth-

erlands and other countries in the EU.

1.2 Letters of Access

Where Syngenta has provided the supporting data in Document K, the ownership of the data is indicated

in Appendix 4 of this document and also in the reference lists in Appendix 1 of the Registration Re-

port, Part B Sections 1-10.



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1.3 Justification for submission of tests and studies

There is no duplication of vertebrate studies and extrapolation to data of similar formulations is not possi-

ble.

1.4 Data protection claims

Where protection for data is being claimed for information supporting registration of Maxim 480 FS, it is

indicated in Appendix 4 of this document.

2 Details of the authorization decision

2.1 Product identity

Product code A9459C

Product name in MS Maxim 480 FS

Authorization number 14184 N

Function Fungicide (seed treatment)

Applicant Syngenta

Active substance(s)

(incl. content)

Fludioxonil; 480 g/L

Formulation type FS

Packaging 1 L and 20 L HDPE canister

Coformulants of concern for

national authorizations

none

Restrictions related to identiy none

Mandatory tank mixtures none

Recommended tank mixtures none

2.2 Conclusion

The evaluation of the application for product name resulted in the decision to grant the authorization.

2.3 Substances of concern for national monitoring

Not applicable.



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2.4 Classification and labelling

2.4.1 Classification and labelling under Regulation (EC) No 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 mix-

ture *:

-

Pictogram: GHS09 Signal word: Warning

H-statements: H410 Very toxic to aquatic life with long lasting effects.

P-statements: P273 Avoid release to the environment.

P280c Wear protective gloves and coveralls.

P391 Collect spillage.

Supplemental Hazard

information:

EUH208 Contains 1,2-benzisothiazol-3-one. May produce

an allergic reaction.

EUH401 To avoid risks to human health and the environ-

ment, 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

2.4.2 Standard phrases under Regulation (EU) No 547/2011

See 2.4.1

2.4.3 Other phrases (according to Article 65 (3) of the Regulation (EU) No

1107/2009)

-

2.5 Risk management

2.5.1 Restrictions linked to the PPP

The authorization of the PPP is linked to the following conditions (mandatory labelling):

Operator protection:

P280C Seed treatment: Coveralls, gloves during mixing/loading, calibration and cleaning.

Coveralls during bagging.

Worker protection:

No PPE requirements

Integrated pest management (IPM)/sustainable use:

respective code if

available

Product stewardship- sensitivity monitoring and communication of changes to performance.

Do not use phenylamides as a soil treatment where they are used as seed treatments.



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Cultural considerations, good farming practice.

Environmental protection

respective code if

available

No national risk mitigation

Other specific restrictions

respective code if

available

n/a

The authorization of the PPP is linked to the following conditions (voluntary labelling):

Integrated pest management (IPM)/sustainable use:

respective code if

available

n/a

2.5.2 Specific restrictions linked to the intended uses

Some of the authorised uses are linked to the following conditions in addition to those listed under point

2.5.1 (mandatory labelling):

Integrated pest management (IPM)/sustainable use: Relevant for use no.

n/a n/a n/a

Environmental protection: Relevant for use no.

n/a n/a n/a



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2.6 Intended uses (only NATIONAL GAP)

PPP (product name/code): Maxim 480 FS / formulation code A9459C

Active substance(s) (name and content, g/L): 480 g/L fludioxonil

Formulation type: Flowable Suspension concentrate for seed treatment (FS)

1 2 3 4 5 6 7 8 9 10 10b 11 12 13 14



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Use-

No. (e)

Member

state(s)

Crop and/

or situation

(crop destination

/ purpose of

crop)

F,

Fn,

Fpn

G,

Gn,

Gpn

or

I

Pests or Group of

pests controlled

(additionally: develop-

mental stages of the pest or pest group)

Application Application rate PHI (days)

Remarks: e.g. g safen-

er/synergist per ha (f)

Method / Kind Timing /

Growth stage of

crop & season

Max.

number

a) per use b) per crop/

season

Min. interval

between

applications (days)

µg

a.s./seed

g a.s./ha Sowing

density

(number of seeds/ha)

min / max

TGW

(g/1000

seeds) min /

max

Existing uses are not included in the GAP, only changed and new uses

1 NL Melons

[CUMME]

I Didymella bryoniae

[DIDYBR] Fusarium

oxysporum [FUSAOX]

Seed treatment BBCH 00 1 N/A 6.72-28.80 14-60 N/A 100 ml product/100

kg seeds

G Sowing BBCH 00

F

G

Transpl

anting

BBCH 13-17

May-June (F) Jan-Dec (G)

0.03-0.26 4500- 9000

2 NL Watermelon [CITLA]

I Didymella bryoniae [DIDYBR] Fusarium

oxysporum [FUSAOX]

Seed treatment BBCH 00 1 N/A 6.24-55.20 13-115 N/A 100 ml product/100 kg seeds

G Sowing BBCH 00

F

G

Transplanting BBCH 13

May-June (F)

Feb-June (G)

0.01-0.442 2000-8000

3 NL Pumpkins (in-

cluding winter squash) [CUUPE]


[DIDYBR] Fusarium oxysporum [FUSAOX]


kg seeds G Sowing BBCH 00

F G

Transplanting BBCH 13-16 Mar-Nov (F)

May-June (G)

0.46-1.47 10000-13600

4 NL Zucchini (sum-

mer squash,

edible peel) [CUPPE]


[DIDYBR] Fusarium

oxysporum [FUSAOX]


kg seeds

F: 2 crop cy-cles/year

G: 2 crop cy-

cles/year

G Sowing BBCH 00

F

G

Transplanting BBCH 13-16

Mar-Nov (F)

May-June (G)

0.46-1.47 10000-13600

5 NL Cucumbers [CUMSA]

I Didymella bryoniae [DIDYBR] Fusarium

oxysporum [FUSAOX]


3 crop cycles/year G Sowing BBCH 00

G Tra

nsplanting

BBCH 13-14

Nov-Aug (G)

0.13-0.64 15000-35000

6a NL Tomatoes

[LYPES]

I Fusarium oxysporum

[FUSAOX]

Seed treatment BBCH 00 1 N/A 0.43-2.064 0.9-4.3 N/A 100 ml product/100


G Transplanting BBCH 13-14 0.01-0.083 20000-40000



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Jan- Dec

7 NL Aubergines

[SOLME]

I Fusarium oxysporum

[FUSAOX]

Seed treatment BBCH 00 1 N/A 1.92-2.592 4-5.4 N/A 100 ml product/100


G Transplanting BBCH 13-14 Jan-Dec

0.03-0.095 18000-36500

8a NL Sweet peppers [CPSAN]

I Fusarium oxysporum [FUSAOX]


G Sowing BBCH 00

G Transplanting BBCH 13-14

Jan-Dec

0.07-0.13 20000-30000

9 NL Lettuce [LACSS] I Rhizoctonia solani

[RHIZSO]


kg seeds F: 3 crop cy-

cles/year

G: 5 crop cy-cles/year

G Sowing BBCH 00

G F

Transplanting BBCH 14-17 Jan-Dec (F, G)

0.02-0.14 75000-110000

10 NL Lamb’s lettuce [VILLO]

I Rhizoctonia solani [RHIZSO]

Seed treatment BBCH 00 1 N/A 0.82-1,40 1.7-2.9 N/A 100 ml product/100 kg seeds

F: 3 crop cy-

cles/year G: 5 crop cy-

cles/year

G

F

Sowing BBCH 00

Jan-Dec(G) March-Sept (F)

2.45-

9,05

3000000-

6500000

11 NL Endive/Escarole

[CICEN]

I Rhizoctonia solani

[RHIZSO]


kg seeds

F: 3 crop cy-cles/year

G: 5 crop cy-

cles/year

G Sowing BBCH 00

F

G

Transplanting BBCH 14-17

Jan-Dec (F, G)

0.05-0.11 75000-

110000

12 NL Witloof chicory

(Belgian endive)

[CICIF]

I Rhizoctonia solani

[RHIZSO]


kg seeds

F Sowing BBCH 00 March-April

0.09-0.243 150000-220000

13 NL Spinach [SPQOL] I Rhizoctonia solani [RHIZSO]

Colletotrichum demati-

um [COLLDE]

Seed treatment BBCH 00 1 N/A 4.56-6.24 9.5-13 N/A 100 ml product/100 kg seeds

2 crop cycles/year F Sowing BBCH 00

Jan-Sept

9.12-56.16 2000000-

9000000



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3 Background of authorization decision and risk management

3.1 Physical and chemical properties (Part B, Section 2)

The product Maxim 480 FS is a flowable concentrate for seed treatment (FS) formulation. All studies

have been performed in accordance with the current requirements including the critical GAP and the

results are deemed to be acceptable. Physical chemistry studies that involve dilution in water have been

conducted at concentrations (10% and 90%) appropriate to those stated in the GAP document.

The appearance of the product is that of light grey liquid with a sweetish odour. It is not explosive and has

no oxidising properties. Maxim 480 FS does not have a flash point below 101°C and has a self-ignition

temperature of 475 °C. In 1% aqueous solution, it has a pH value of 7.2 at 20°C and the neat formulation

has an pH of 7.7.

The active ingredient contents and physical properties remain unchanged after low, and high and ambient

temperature storage (for 7 days at 0°C, and 14 days at 54°C and 2 year at ambient temperature)

demonstrating no significant effect of low, and high and ambient temperatures.

The stability data indicate a shelf life of at least 2 years at ambient temperature when stored in HDPE

packages.

The technical characteristics of Maxim 480 FS are acceptable for a flowable concentrate for seed

treatment formulation.

Compatibility of mixtures: The product Maxim 480 FS is not proposed to be used in a tank mix with

other products.

Justified Proposals for Classification and Labelling (KCP 12) for physical chemical part only:

According to Regulation (EC) No. 1272/2008, no specific labelling or classification is proposed based on

the measured physico-chemical properties of Maxim 480 FS.

Notifier Proposals for Risk and Safety Phrases (KCP 12):

According to Regulation (EC) No. 1272/2008, no specific labelling or classification is proposed based on

the measured physico-chemical properties of Maxim 480 FS.

Compliance with FAO specifications:

There is no FAO specification for Maxim 480 FS.

Formulation used for tests:

All physico-chemical endpoints were measured using Maxim 480 FS. Thus, no bridging to other

formulations is required.



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3.2 Efficacy (Part B, Section 3)

This registration concerns an amendment for a seed coating fungicide MAXIM 480 FS (A9459C). The

amendment includes several new uses at the same dosage that is currently registered (100ml/100kg seed).

The new uses fall under several family groups:

• the Cucurbitaceae (specifically: Melons, Watermelon, Pumpkins, and Zucchini) for use against both

Didymella bryoniae [DIDYBR] and Fusarium oxysporum [FUSAOX] ;

• the Solanaceae (specifically: Tomatoes, Aubergines, Sweet peppers) for use against Fusarium ox-

ysporum [FUSAOX];

• the leafy vegetables (specifically: Lettuce, Lamb's Lettuce, Endive/Scarole, Witloof/Chicory) for use

against Rhizoctonia solani [RHIZSO]

• For Spinach, use against Fusarium oxysporum [FUSAOX] and Colletotrichum dematium

[COLLDE].

As the registration concerns a seed treatment, for the greenhouse / growth chamber trials no differentia-

tion is made for the EPPO climate zones and this application has an interzonal approach. The registration

concerns a seed treatment and the treated seeds may be sold throughout Europe, regulatory decisions re-

garding seed treatments should be made by the zRMS for all concerned member states. However, for

some uses the ZRMS has left CMS member states open to give feedback on the regulatory decision be-

fore the final RR is set by the ZRMS. Following the first draft of the registration report we received addi-

tional information from the applicant and this is also taken into consideration in the conclusions given

below.

In general the following extrapolation tables were taken into account for minimum effective dose, effica-

cy and phytotoxicity trials:

In EPPO tables for extrapolation to minor uses for effectiveness of fungicides on:

• PP 1/257 FEET 69(1)- damping off, soil and airborn fungal diseases:

○ FUSASP from tomato or cucurbitaceae to all crops where FUSASP appears

○ RHIZSO from Lettuce to other AG4 crops, from Cucurbitaceae to other AG4-AG5 groups

• 14/19578- Diseases of leafy vegetables

○ RHIZSP from Lettuce to spinach, witloof, lambs lettuce, endive…

• 14/19722- Diseases of Cucurbitaceae

○ RHIZSO melon or cucumber to all crops within the group

○ DIDYBR melon or cucumber to all crops within the group

• PP 1/257 FEET 70(1)- Seed borne diseases

○ RHIZSP Tomato or Lettuce or Melon or Cucumber to any crops where seeds can be infected

○ FUSASP from any relevant crops to any crops where seeds can be infected by FUSASP

3.3 Efficacy data

Preliminary tests: Data is not included due to a sufficient number of GEP trials / registration trials.

Products based on the well-known active substance fludioxonil have already been authorised for a con-

siderable time all over Europe in a broad range of crops. In specific, A9459C is already registered in bras-

sicas, onions and carrots across several EU countries. Preliminary screening was therefore not considered

necessary for this registration purpose.

Minimum effective dose tests:



Page 18 /83


Melon and Cucumber were tested in trials as representatives of all Cucurbitaceae,

Tomato was tested to represent the Solanaceae, and

Lettuce was tested to represent all leafy vegetables (apart from spinach).

For minimum effective dose tests the following traits were measured (inoculation rate unclear):

disease incidence (% of seedlings affected),

Disease severity (%leaf area affected)

Emergence failure (#plants that did not emerge)

Plant weight (g)

Doses tested: 0.5N, 0.75N, 1N, 1.5N

Cucurbitaceae (cultivars melon: Sensei, Match; cultivars cucumber: Excalibur (all merged- reason not

clear))

Minimum effective dose against Didymella bryoniae [DIDYBR] was tested in 11 greenhouse trials

from 2013-2014 and against Fusarium oxysporum [FUSAOX] was tested in 12 greenhouse trials from

2013-2014

Although 0.75N appears to be the most optimal based on the majority of parameters measured, due to the

exceptional price and quality expectations of the seeds in question, often a better than usual efficacy is

expected for seed treatments. Since a dose response is evident for efficacy with respect to emergence

failure, the claimed dose of 1N (100ml/100 kg seed) can be justified against DIDYBR and FUSAOX for

the Cucurbitaceae.

Solanaceae (cultivars tomato: Katalina, Supersweet, Delgado)

Minimum effective dose against Fusarium oxysporum [FUSAOX] was tested in 13 greenhouse trials

from 2013-2014

Justification is needed for using 1N as the minimum effective dose in Solanaceae against FUSAOX, giv-

en that 0.75N appears to be the most optimal based on all parameters measured.

Justification has been provided by the applicant highlighting the possible longer lasting control at the

higher dosage. Although this is not supported statistically, the argument that extrapolation can be made

between the Cucurbitaceae (PP 1/257 FEET 69(1) and 70(1) can be considered. The ZRMS therefore

accepts 1N as minimum effective dose in Solanaceae.

Leafy vegetables (cultivars lettuce: Chervita, Funly)

Minimum effective dose against Rhizoctonia solani [RHIZSO] was tested on 10 greenhouse trials from

2013-2015 (except 0.75N not included in 2 trials (not explained) )

Although lower doses appears to be the optimal based on the some of parameters measured, due to the

exceptional price and quality expectations of the seeds in question, often a better than usual efficacy is

expected for seed treatments. Since a dose response is evident in disease incidence and severity, the

claimed dose of 1N (100ml/100 kg seed) can be justified against RHIZSO in leafy vegetables.

Spinach (cultivars: Walibi, Pelican,Emu, Silverwhale) Based on the EPPO extrapolation table 14/19578-

Diseases of leafy vegetables RHIZSP efficacy can be extrapolated from Lettuce to spinach, witloof,

lambs lettuce or endive; while this list is regarding extrapolation to minor uses we can expect that trials

on lettuce will produce comparable results in spinach as well as other leafy vegetables.

Minimum effective dose against Colletotrichum dematium [COLLDE] 10 trials from

2008,2009,2010,2011



Page 19 /83


Only relatively low efficacy was reached at the highest rate. Please refer to the efficacy section for further

evaluation.

Efficacy tests:

The reference product ProSeed (was used at 600 mL/100 kg seed for comparison for all claimed uses.

Cucurbitaceae Efficacy against Didymella bryoniae at 1N (100nL/100kg seed)

From 11 greenhouse trials from 2013-2014: With 47-65% disease incidence, the product generally

showed >90% efficacy against DIDYBR, and better efficacy than the reference product for all measured

parameters.

Efficacy against Fusarium oxysporum 12 greenhouse trials from 2013-2014, For all parameters A9459C

showed good effectiveness against FUSAOX and was comparable to the efficacy of the reference

ProSeed.

Solanaceae

Efficacy against Fusarium oxysporum at 1N (100nL/100kg seed) in Tomato

5 trials at were compared to a reference product, at BBCH 11-12. With disease incidence at 38% ,

A9459C was comparable to the reference product in reduced disease incidence and severity.

For emergence failure and plant weight, only 3 trials were compared to a reference product and for these

ProSeed had a higher Emergence failure reduction (58% in ProSeed vs 57% A9459C); and Proseed lead

to a higher plant weight (117g for ProSeed vs. 77g for A9459C)

Leafy vegetables

Efficacy against Rhizoctonia solani at 1N (100nL/100kg seed) in Lettuce

The product generally showed >90% efficacy against RHIZSO, and similar efficacy as the reference

product for all measured parameters.

Spinach

Efficacy against Colletotrichum dematium at 1N (100nL/100kg seed)

Efficacy was low at the claimed dose. The reference that was used (proseed) is not authorized for this

purpose in NL, raising questions about validity of the trials. Feedback from the commenting round makes

it clear that the product is already authorised in a number of member states for control of COLLDE, and

that in other member states Proseed is authorized and considered to be a relevant reference product. .

Considering that there are currently no products on the market against COLLDE in the Netherlands the-

low efficacy can still provide value and thus the claim can be accepted.

3.3.1 Information on the occurrence or possible occurrence of the development of

resistance

The active compound fludioxonil belongs to the chemical class of the phenylpyrroles, and is based on a

natural antifungal compound isolated from bacteria. Fludioxonil interferes with the transport mechanisms

of the fungal cell by blocking a protein kinase that catalyses the phosphorylation of a regulatory enzyme

of the glycerol synthesis. According to the FRAC document “List of plant pathogenic organisms resistant

to disease control agents” (REVISED January 2013) resistance has been found in Fusarium spp.(and oth-

er pathogens not relevant to this product claim) against fungicides in group E2 such as fludioxonil.

Therefore resistance precautions are required on the label.

Since there is a chance for resistance development the Dutch label must include the following statement:



Page 20 /83


Dit middel bevat de werkzame stof fludioxonil. Fludioxonil behoort tot de phenylpyrrolen. De FRAC

code-is 12. Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van het resistentiema-

nagement dient u de adviezen die gegeven worden in de voorlichtingsboodschappen op te volgen.

3.3.2 Adverse effects on treated crops

Phytotoxicity:

In the following crops, selectivity trials were carried out (GH= Greenhouse; F= Field) according to table

3.4.-1.

Cucurbitaceae: Melon(GH:8, F:7), cucumber(GH:8) and zucchini(GH:2, F:3)

Minimal phytotoxicity <2% was observed at the requested dose in one cucumber trial

(NLZWZT9312013). No other trials on cucumber melon or zuchini showed harmful effects and therefore

A9459C can be considered safe for use on the tested Cucurbitaceae crops: Melon, cucumber and zuchini.

Extrapolation can be made to watermelon and pumpkins since cucumber is the most sensitive of the

claimed crops.

Yield: assessed in 3 cucumber trials-, no negative effects were found on crop yield in the absence

of the disease at 100mL/100kg seed or 150mL/100kg seed.

Solanaceae: Eggplant (GH:8, F:1), bell pepper(GH:4, F:1), tomato(GH:6, F:4)

Phytotoxicity was recorded in two greenhouse trials in bell pepper (cultivars Benecid and Bily)

that started following a storage period of 7 and 18 days after treatment. In one trial, deformation to the

leaf edges was observed which reached a maximum of 3% at the proposed dose rate and 5% at the 1.5N

dose rate. In one trial, discolouration was observed which reached a maximum of 9% at the proposed dose

rate and 19% at the 1.5N dose rate. The symptoms disappeared later on in the trial and no further adverse

effects were observed either on plant weight or plant height.

No other trials on eggplant or tomato showed harmful effects and therefore A9459C can be con-

sidered safe for use on the tested crops.

Yield: assessed in 4 trials: 2 in tomato, 2 in eggplant-no negative effects were found on crop yield

in the absence of the disease at 100nl/100kg seed or 150ml/100kg seed.

Leafy vegetables: Lettuce (GH:10, F:2), Endive(GH:1), Spinach(GH:15, F:2), lamb's lettuce (GH:3),

Witloof (F:2), leafy endive (F:1)

In the field trail in lamb’s lettuce (FRSTZT0242014), phytotoxicity was recorded which was

preceded by a lower crop vigor and lower score for crop development, and lower plant counts. Phytotoxi-

city was observed at harvest, 140 days after sowing in a trial that was started following a storage period of

80 days after treatment. This also resulted in a lower yield. In the other trials in leafy vegetables, includ-

ing two other lamb’s lettuce trials no crop safety issues were noted, therefore in general the product can

be considered crop safe in leafy vegetables. A label warning may be required for use of the product in

lamb’s lettuce.

The following sentence should be included on the label.

In veldsla kan het product enige gewasschade geven.

Effects on the quality of plants or plant products:

Four taint tests were conducted in 2014 on cucumber (1 trial), fresh tomato (1 trial), tomato puree (1 trial)

and lettuce (1 trial). The four studies conducted no negative impact of A9459C was revealed on quality

of plants or taint.

Impact on treated plants or plant products to be used for propagations:



Page 21 /83


The zRMS agrees with the applicant that A9459C is applied as a seed treatment and that no major adverse

effects were observed in the trial data presented in this dossier, it is highly unlikely that there would be a

negative effect in cases where these crops were grown for seed production, particularly given that the

quantity applied is very low and because fludioxonil has no systemic properties.

3.3.3 Observations on other undesirable or unintended side-effects

Impact on succeeding crops:

3.5.1 Impact on Succeeding crops

Given that fludioxonil is applied as a seed treatment at low rates, soil accumulation is of no concern and

in general fludioxonil is well tolerated by many crops, it is very unlikely that there will be an impact on

succeeding crops.

Impact on other plants including adjacent crops:

The zRMS agrees with the applicant A9459C will be applied to the seeds in a controlled environment

with professional equipment. Treated seeds are directly incorporated into the soil. Taking these points

into consideration and knowing that fludioxonil is non-volatile, it is clear that there will be no impact on

other plants, including adjacent crops.

Other/special studies Loading and adhesion: seeds from cucumber (1), melon(2), lettuce (4), endive(1), tomato(6) and egg-

plant (1) were tested and showed very good adhesion properties in vegetable seeds with A9459C.

Germination after storage: was tested in 2014 and 2014 after storage for 6, 12 and 18 months in tomato

(4), eggplant(2), bell pepper (1), gherkin(1), cucumber(1), melon(3), lettuce(4) and leafy endive(1), wit-

loof(1), endive(1) and lamb's lettuce(1). For all storage periods and for all species tested, the seed quality

of the seeds treated with Maxim 480FS (A9459C) was unaffected.



Page 22 /83


3.4 Methods of analysis (Part B, Section 5)

3.4.1 Analytical method for the formulation

An analytical method for determination of fludioxonil (CGA173506), its impurities and the relevance of

CIPAC methods to Maxim 480 FS has not been evaluated as part of an EU review. Therefore, all rele-

vant data are provided and are considered adequate.

3.4.2 Analytical methods for residues

Methods for crops and animal products: All crop and animal product analytical methods are active

substance data and are required in support of the setting of EU MRLs, MSs are invited to comment as part

of the EU MRL setting process. Adequate EU MRLs for the proposed uses of Maxim 480 FS are in

place.

New studies for the determination of fludioxonil residues in crops (cucumber and leaf lettuce) and animal

products have been provided and were fully validated according SANCO/3029/99 rev 4 for crops and

SANCO/825/00 rev. 8.1 for animal products.

Methods for soil, water and air: All analytical methods are active substance data and were evaluated

during the EU review. However, additional data on analytical methods/validation in water not previously

submitted for EU review of fludioxonil is also provided in support of this dossier. All data are fully vali-

dated according SANCO/825/00 rev. 8.1 for groundwater and river water (i.e. surface water) and accord-

ing SANCO/3029/00 rev. 4 for drinking water. No ILV method for drinking water was provided, there-

fore the analytical method for drinking water was not considered fully adequate according to the data

requirements (EU) No 284/2013. As the primary/confirmatory method is considered adequate, the ful-

fillment of the gap will be addressed during the Renewal.

The analytical method for the determination of fludioxonil, CGA211955 and CGA339833 in surface wa-

ter is compliant with Dutch national requirements (LOQ ≤ 0.1 µg/L for fludioxonil, CGA211955 and

CGA339833).

Methods for body fluids and tissues: This Annex Point is presently considered covered by the method

for analysis of residues in animal matrices, as it includes appropriate matrix types (tissues and whole

blood) and adequate corresponding LOQs. For the pending Renewal however, a dedicated method is ex-

pected to be submitted.



Page 23 /83


3.5 Mammalian toxicology (Part B, Section 6)

3.5.1 Acute toxicity

The acute oral, acute dermal and skin sensitisation studies were performed with A9459A while studies for

skin and eye irritation potential were performed with A9459C (Maxim 480 FS). Acute toxicity studies

for A9459A and A9459C have not been evaluated as part of the EU review of fludioxonil. A comparison

of the formulation is presented (Part C) and it is considered that studies conducted for A9459A were

suitable for A9459C. Therefore, all relevant data are provided and are considered adequate. The conclu-

sions made on classification for A9459A are therefore also applicable to A9459C.

A9459A/C containing 480 g/L fludioxonil have a low toxicity in respect to acute oral and dermal toxicity

and is not irritating to the rabbit skin or eye and is not a skin sensitizer (based on calculation rules as the

study is not acceptable). The classification according to Regulation 1272/2008 is given in the table be-

low.

Parameter

[Reference]

Species Result

Classification (according

to the criteria in reg

1272/2008)

Acute oral LD50 – A9459A

Rat >5050 mg/kg None

Acute dermal LD50 - A9459A

Rabbit >2020 mg/kg None

Acute skin irritation - A9459C

Rabbit Mild-irritant None

Acute eye irritation - A9459C

Rabbit Non-irritant None

Skin sensitisation - A9459A

Guinea Pigs Study not accepted. -

3.5.2 Operator exposure

A summary of the exposure models used for estimation of operator exposure to the active substances dur-

ing application of MAXIM 480 FS according to the critical use(s) (curcubits, max 1L product/tonne) is

presented in Section B.6. Operator exposure is estimated using the “Seed-TReatment OPerator EXpo-

sure” data (Seed-TROPEX). Seed-TROPEX is an exposure data base submitted to UK-PSD in 1996 for

national registrations by an Industry Task Force and contains results from studies performed in the UK

and France.

The Seed-TROPEX data base submitted in 1996 consists of two parts: Exposure values for operators in-

volved in seed treatment activities and exposure values for workers loading and sowing treated seed.

According to the calculations, it can be concluded that no unacceptable risk for operators was identified

when the product is used as intended and provided that the PPE/ risk mitigation measures stated in the

table below.

Result PPE / Risk mitigation measures

Operators (seed

treatment)

Acceptable Coveralls, gloves during mixing/loading, calibration and cleaning.

Coveralls during bagging.



Page 24 /83


3.5.3 Worker exposure

The only intended use of Maxim 480 FS is treatment of seed prior to sowing. Consequently, no re-entry

scenario is given for harvest or crop inspection activities . Exposure may occur during loading and sowing

of seeds. According to the calculations it can be concluded that there is no unacceptable risk for the un-

protected worker.

3.5.4 Bystander and resident exposure

In industrial seed treatment facilities the incidental presence of bystanders can be excluded by technical

management measures. If occurring, exposure of bystanders would be of short duration and normally

lower than that of seed treatment operators who are occupationally exposed all day long. The same ap-

plies for seed loading and sowing activities. Therefore, it is reasonable to assume that there will be no

undue risk to persons being incidentally exposed to seed treatment or seed sowing operations.



Page 25 /83


3.6 Residues and consumer exposure (Part B, Section 7)

For the uses proposed for fludioxonil in 9459C all relevant residue data and assessments are provided.

The following paragraphs summarises the evaluation of 9459C.

3.6.1 Residues

Fludioxonil is a non-systemic compound and when applied to seeds, no residues should normally be

found in plants or plant products and therefore normally no residue trials are necessary (Document SAN-

CO 7525/VI/95 rev. 10.2). Studies from the DAR (Denmark, 2007) prove that there is no translocation of

fludioxonil residues from the treated seed to the final agricultural commodity. Moreover, new studies on

sunflower were submitted and evaluated. In all studies evaluated within this application and on cereal

from the DAR (Denmark, 2007) residues were below LOQ. Foliar spray applications for fludioxonil for

which MRLs are set for all crops uses proposed are considered worst case.

Sufficient trials from three example crop groups (cereals, oilseeds and vegetables) are available to

demonstrate that residues are not expected and to support the proposed uses.

The data submitted show that no exceedance of the MRL will occur. The uses are considered acceptable.

3.6.2 Consumer exposure

Comprehensive chronic consumer risk assessment has been performed by EFSA during the most recent

EFSA Reasoned Opinion: EFSA Journal 2016 14 (3):4445), covering crops requested within this applica-

tion. Since no ARfD is set for fludioxonil, no acute risk assessment is required.

TMDI (% ADI) according to EFSA PRIMo 18 % (based on DE child)

IEDI (% ADI) according to EFSA PRIMo not required

IESTI (% ARfD) according to EFSA PRIMo Not applicable (no ARfD set for fludioxonil)

No chronic risk has been identified, with the highest TMDI of 18.2% of the ADI for German child. The

proposed uses of fludioxonil in A9459C do not represent unacceptable chronic risk for the consumer.



Page 26 /83


3.7 Environmental fate and behaviour (Part B, Section 8)

The rate of degradation in laboratory soil of fludioxonil was evaluated for Annex I Inclusion. The EU

review concluded that no additional laboratory data were required at national re-registration for the rate of

degradation in soils. The fate and behaviour of fludioxonil in soil is discussed in detail in the correspond-

ing document of the EU dossier where the study references can be found. Photolysis can play a major role

for the degradation pathway and degradation rate of fludioxonil in soil. Major metabolites are formed in

light but not in the dark. Although endpoints are given in the EFSA Scientific Report for the metabolites

CGA265378, CGA339833 and CGA192155, it is also stated that the degradation following seed treat-

ment use differs to foliar use as these metabolites are formed primarily through photolysis. Therefore, for

seed treatment use, these metabolites are not considered further.

All studies on aerobic and anaerobic degradation in soil have been reviewed for fludioxonil under Council

Directive 91/414/EEC.

The rate of degradation in soil of fludioxonil was evaluated during the Annex I Inclusion. However, the

DT50 of 43 days is not relevant for seed treatment uses as it includes photolytic degradation. A study on

field dissipation rates performed on fludioxonil has been submitted earlier to The Netherlands and re-

viewed according to FOCUS Degradation Kinetics (authorisation of Beret Gold 025 FS). The study re-

view is also presented and used in the original authorisation of Maxim 480 FS RR (Registration number

14184). This led to a maximum best fit FOMC DT50 of 138 days for the assessment of seed treatment.

All soil accumulation studies on fludioxonil have been evaluated in the EU review. The mobility in soil

of fludioxonil was evaluated during the EU review. No additional studies have been performed. Studies

on column leaching are considered to be data provided in support of the active substance. No lysimeter or

field leaching study has been performed with fludioxonil in view of the results of the soil degradation and

mobility studies and of the predicted extremely low environmental concentrations in soil and groundwa-

ter. The rate of degradation in water/sediment systems of fludioxonil was evaluated during the EU re-

view. No additional studies have been performed.

Please note that the proposed indoor use will not result in an emission to soil and no exposure assessment

to soil is conducted. Only the greenhouse uses were evaluated in the current assessment, which covers

the uses for transplanting.

Please note that multiple crop cycles are possible for zucchini, cucumbers, lettuce, endive and spinach, as

proposed in the current GAP. Multiple crop cycles have been included in the assessment (for fruiting and

leafy vegetables, based on a critical GAP).

3.7.1 Predicted environmental concentrations in soil (PECsoil)

Assessment of the PEC in soil (PECsoil) of fludioxonil for greenhouse applications, was done following a

tiered approach using the worst case laboratory DT50 value of 569 days reported in the EFSA Scientific

Report (2007) (Tier I) and a DT50 value of 137 days (Tier II) derived from field dissipation trials includ-

ing soil incorporation of the substance (Emburey, 2004). This led to a maximum best fit FOMC DT50 of

138 days for the PECsoil calculation of seed treatment.

The PEC of fludioxonil in soil (PECS) has been determined based on the proposed field DT50 value for

seed treatment of 137 days. The maximum GAP for seed treatment use rates, taking crop cycles into ac-

count, is equivalent to 2 x 1.47 g a.s./ha (zucchini for fruiting vegetables) and 2 x 56.16 g a.s./ha (spinach

for leafy vegetables), which result in maximum initial predicted environmental concentration in soil

(PECS) of respectively 0.003 and 0.141 mg/kg fludioxonil. Assuming the same application regime is

used year after year, it is predicted that a plateau concentration of fludioxonil in the soil will be 0.0002

and 0.008 mg/kg, respectively, for applications to fruiting vegetables and leafy vegetables for a 20 cm soil



Page 27 /83


layer, after 10 years. PECaccumulation (PECact (5 cm) +PECsoil plateau (20 cm)) are 0.004 and 0.149 mg/kg for

fruiting and leafy vegetables respectively, based on a field DT50 of 137 days.

For fludioxonil seed treatment uses, there are no relevant metabolites in soil. The results for PECS for the

active substance were used for the ecotoxicological risk assessment.

3.7.2 Predicted environmental concentrations in groundwater (PECgw)

For estimation of the PEC in groundwater (PECgw) of fludioxonil for greenhouse applications, no new

endpoints were defined. PECgw has been assessed with FOCUS PEARL v4.4.4 groundwater model and

the endpoints proposed in accordance with the EFSA Scientific Report (2007). Major metabolites of flu-

dioxonil are formed through photolysis. Although endpoints are given in the EFSA Conclusion for the

metabolites CGA265378, CGA339833 and CGA192155, it is also stated that the degradation following

seed treatment use differs to foliar use as these metabolites are formed primarily through photolysis, thus

in the light rather than in the dark. Therefore, for seed treatment use, these metabolites are not considered

further.

All scenarios including the Dutch relevant Kremsmünster scenario indicate groundwater PEC values

<0.001 µg/L. Based on the assessment, the use of fludioxonil is not expected to lead to leaching into

groundwater at levels that would be unacceptable when applied according to the recommended use pat-

tern.

Monitoring data groundwater

There are no data available regarding the presence of the substance fludioxonil in groundwater.

3.7.3 Predicted environmental concentrations in surface water (PECsw)

For the assessment of the PEC in surface water (PECsw) and sediment (PECsed) of fludioxonil no new

endpoints were defined. The PECsw and PECsed have been assessed with the TOXSWA NL model and the

end-points proposed in accordance with the EFSA Scientific Report (2007). An emission rate of 0.1% for

greenhouse was taken into account. Major metabolites of fludioxonil are formed through photolysis. Alt-

hough endpoints are given in the EFSA Conclusion for the metabolites CGA265378, CGA339833 and

CGA192155, it is also stated that the degradation following seed treatment use differs to foliar use as

these metabolites are formed primarily through photolysis, thus in the light rather than in the dark. There-

fore, for seed treatment use, these metabolites are not considered further. The maximum PECsw and

PECsed for fludioxonil were 0.032 µg/L and 13.98 µg/kg following indoor spring application, respective-

ly (based on 0.1% emission from greenhouses and taking into account most conservative possible crop

cycles).

Since spray drift is not a relevant entry path for seed treatments, the PECsw for the formulation was not

assessed.

The results for PECSW and PECSED for the active substance were used for the ecotoxicological risk as-

sessment.

Monitoring data surface water

Data from the Pesticide Atlas are used to evaluate potential exceedances of the authorisation threshold

and environmental quality standards. As there are no exceedances of thresholds, the monitoring data have

no consequences for the proposed use of the product.

Drinking water criterion

Fludioxonil has been on the Dutch market for more than 3 years (authorised since 23-10-1998). This



Page 28 /83


period is sufficiently large to consider the market share to be established. From the general scientific

knowledge collected by the Ctgb about the active substance fludioxonil, the Ctgb concludes that there are

in this case no concrete indications for concern about the consequences of fludioxonil for surface water

from which drinking water is produced, when used in compliance with the directions for use. The Ctgb

does under this approach expect no exceeding of the drinking water criterion. The standards for surface

water destined for the production of drinking water are met.

3.7.4 Predicted environmental concentrations in air (PECair)

The fate and behaviour in air of fludioxonil was evaluated during the EU review. No additional studies

have been performed.

The vapour pressure at 25 °C of the active substance fludioxonil is < 10-5

Pa. Hence, the active substance

fludioxonil is regarded as non-volatile. The same low volatility can be expected for the major degradates

as they have low vapour pressures, too. Therefore, exposure of adjacent surface waters and terrestrial

ecosystems by the active substance fludioxonil due to volatilization with subsequent deposition should

not be considered.

According to Regulation 1272/2008 as amended, the proposed environmental classification for

A19188A is: None based on the ready biodegradability properties of fludioxonil. As a plant protection

product, the instructions for use should be followed to avoid risks to man and the environment.



Page 29 /83


3.8 Ecotoxicology (Part B, Section 9)

The core also covers the national specific aspects so no B9 NL-addendum is produced and summaries

below are from the core only.

3.8.1 Effects on terrestrial vertebrates

Effects on birds

The TER values, calculated for recommended scenarios, all exceed the trigger values of 10 for acute risk.

The long-term TER value was below the trigger value of 5 indicating a potential long term risk to birds.

Further evaluation of the long term risk considering multiply refinements including measured seed dissi-

pation data, foraging area, attractiveness and palatability of treated seeds, and a grit risk assessment.

These were all indicative that the use of A9459C as a seed treatment would pose an acceptable long term

risk to medium granivorous birds, and seedling eating birds. For small granivorous birds, data collected in

the UK indicate that the risk is low. However information is lacking for the northern or the southern zone,

acceptation of the studies it is up to the memberstates . The risk from secondary poisoning was above the

trigger value of 5 demonstrating acceptable use following use of A9459C according to the proposed use

pattern.

Effects on vertebrates other than birds

The TER values, calculated for recommended scenarios, all exceed the trigger values of 10 for acute risk.

For the long term, an acceptable risk is expected for seedling eating mammals and for secondary poison-

ing.

For omnivorous/granivorous mammals, higher tier risk assessments included refinements of TWA based

on measured seed dissipation data and foraging area. However as the relevant focal species could not be

determined, and factors like body weight and diet are essential for the risk assessment, more information

was requested for seed eating mammals in the use of Lamb’s lettuce and Spinach. For Belgian endive, the

risk is acceptable. The applicant submitted a justification, supported by studies to demonstrate that the

woodmouse was the most likely focal species and the risk to mammals is considered acceptable.

Effects on other terrestrial vertebrate wildlife (reptiles and amphibians)

No risk assessment was conducted, as the risk assessment provided above for birds and mammals is con-

sidered to be protective of terrestrial amphibian and reptile species.

3.8.2 Effects on aquatic species

The PEC/RAC ratios, using worst-case PECSW values for fludioxonil are less than the trigger value of 1,

indicating that the risk to aquatic organisms is acceptable following use of A9459C according to the pro-

posed use pattern.

3.8.3 Effects on bees

All the acute hazard quotients are less than 50, indicating that the acute risk to bees is acceptable follow-

ing use of A9459C according to the proposed use pattern.

3.8.4 Effects on other arthropod species other than bees

The Tier II, extended laboratory study showed acceptable in-field effects from seed treatments of A9459C

for Aleochara bilineata for the worst case use scenario (1 x 116.9 mL A9459C/ha in leafy vegetables).

Although no first Tier studies were conducted with standard species Typhlodromus pyri, Aphidius



Page 30 /83


rhopalosiphi it can be concluded that there is a low risk for non-target arthropods. There is a appropriate

margin of safety based on Tier II and higher Tier studies conducted with the formulation on the standard

species and with the active substance on additional species, hence uncertainties coincided with this risk

assessment are considered to be covered.

3.8.5 Effects on soil organisms

The acute and long-term risk of A9459C and fludioxonil was evaluated where relevant for earthworms,

Collembola and Hypoaspis. The risk assessment demonstrated that the risk to non-target soil meso- and

macrofauna is acceptable following use of A9459C according to the proposed use pattern.

The no effect level for fludioxonil exceeded the relevant PECsoil value indicating that the risk to organic

matter breakdown is acceptable following use of A9459C according to the proposed use pattern.

All the effect levels for A9459C and fludioxonil and relevant metabolites exceeded the relevant PECsoil

values, indicating that the risk to soil micro-organisms is acceptable following use of A9459C according

to the proposed use pattern.

3.8.6 Effects on non-target terrestrial plants

According to the Terrestrial Guidance Document, the definition of non-target plants are non-crop plants

located outside the treatment area. Since A9459C is a seed treatment there will be negligible exposure to

the off-field environment.. According to the Terrestrial Guidance Document1, the definition of non-target

plants are non-crop plants located outside the treatment area. Exposure of non-target terrestrial plants is

possible by dust drift at drilling. There are no data available for A9459C regarding the effects on non-

target plants. Effects of fludioxonil (products Switch 62.5 WG and Celest 025 FS) on non-target plants

were evaluated as part of an EU review. At relevant application rates there were no significant effects on

non-target plants. Hence, it can be concluded that A9459C presents no unacceptable risk to non-target

plants.

3.8.7 Effects on other terrestrial organisms (Flora and Fauna)

The formulation A9459C is a fungicide seed treatment and as such tests on other non-target species are

not required.

According to Regulation 1272/2008 as amended, the proposed environmental classification for

A19188A is: H400 and H410 based on the aquatic toxicity data for A9459C. As a plant protection prod-

uct, the instructions for use should be followed to avoid risks to man and the environment.

1 Anonymous (2002b). Guidance Document on terrestrial ecotoxicology under council directive 91/414/EEC. SAN-

CO/10329/2002. 17 October 2002.



Page 31 /83


3.9 Relevance of metabolites (Part B, Section 10)

Major metabolites of fludioxonil are formed through photolysis. Although endpoints are given in the EF-

SA Conclusion for the metabolites CGA265378, CGA339833 and CGA192155, it is also stated that the

degradation following seed treatment use differs to foliar use as these metabolites are formed primarily

through photolysis. Since the present use is a seed treatment, exposure to light and thus formation of the

metabolites is not relevant. Therefore, no risk assessment (Steps 1 to 5) was done for these metabolites.



Page 32 /83


4 Conclusion of the national comparative assessment (Art. 50 of

Regulation (EC) No 1107/2009)

Not applicable. Time of application was before the start of the Comparative Assessment in The Nether-

lands.



Page 33 /83


5 Further information to permit a decision to be made or to support

a review of the conditions and restrictions associated with the au-

thorization

None.

Copy of the product authorization

Please find a copy of the product authorisation above this document.



Page 34 /83


Appendix 1 Copy of the product label

Wettelijk Gebruiksvoorschrift

Het middel is uitsluitend toegelaten als schimmelbestrijdingsmiddel voor het professionele gebruik door

middel van een zaadbehandeling (zaadcoating) 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

Sla Rhizoctonia1

100 ml per 100 kg zaad

Andijvie Rhizoctonia1


Spinazie Rhizoctonia1

Bladvlekkenziekte2


Witlof Rhizoctonia1


Veldsla Rhizoctonia1


Courgette Stengelrot3

Fusarium4


Komkommer Stengelrot3

Fusarium4


Vruchtgroenten van

Cucurbitaceae - niet-eetbare schil

Stengelrot3

Fusarium4


Aubergine Fusarium4


Tomaat Fusarium4


Paprika Fusarium4


Koolgewassen Kankerstronken5


Rammenas Kankerstronken5


Wortelen Bladvlekkenziekte6 100 ml per 100 kg zaad

Wortelpeterselie Bladvlekkenziekte6 100 ml per 100 kg zaad

Knolselderij Bladvlekkenziekte6 100 ml per 100 kg zaad

Uien m.u.v. tweedejaars plantui Nekrot7 100 ml per 100 kg zaad

Zaaisjalot Nekrot7 100 ml per 100 kg zaad

Bosuien Nekrot7 100 ml per 100 kg zaad

Peterselie Bladvlekkenziekte6 100 ml per 100 kg zaad

Venkel Bladvlekkenziekte6 100 ml per 100 kg zaad

Bladselderij Bladvlekkenziekte6 100 ml per 100 kg zaad

* Verlaging van de dosering is toegestaan, maar van het maximaal aantal toepassingen en de andere toepas-

singsvoorwaarden mag niet worden afgeweken. Werkzaamheid is vastgesteld voor de genoemde dosering

per toepassing en niet voor verlaagde doseringen.

1 Rhizoctonia

(Rhizoctonia solani)

2 Bladvlekkenziekte (Colletotrichum dematium)

3 Stengelrot (Didymella bryoniae)

4 Fusarium (Fusarium oxysporum)

5 Kankerstronken (Leptosphaeria maculans (Phoma lingam))



Page 35 /83


6 Bladvlekkenziekte (Alternaria spp)

7 Nekrot (Botrytis allii (Botrytis aclada))

Overige Toepassingsvoorwaarden

In veldsla kan het product enige gewasschade geven.

Dit middel bevat de werkzame stof fludioxonil. Fludioxonil behoort tot de phenylpyrroles. De Frac code

is 12. 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.



Page 36 /83


Appendix 2 Letter of Access

Not applicable.



Page 37 /83


Appendix 3 Lists of data considered for national authorization

List of data submitted by the applicant and relied on Data point Author(s)

Year Title

Company Report No.

Source (where different from company)

GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N

Justification if data

protection is claimed

Data protec-

tion granted

Owner Application

number / date of

submission

Part B, Sections B1, B2, B4 (Identity, Physical and Chemical Properties, Other Information)

KCP

2.7.5

Kalt, R. 2013 A9459C – Storage stability and shelf life statement (2

years 20oC) in packaging made of HDPE

Syngenta document A9459C_10289

Syngenta Crop Protection Münchwilen AG, CH-4333

Münchwilen

GLP

Unpublished

N Y Data/study report never

submitted before to

Netherlands

Y Syngenta -

Part B, Sections B3 (Efficacy)

KCP

6.0/01

Paul De Boer, and

Tamsin Knight

2016 Biological Assessment Dossier A9459C

Syngenta

-,-

non GEP

Unpublished

Syngenta File No. A9459C_10786


submitted before to

Netherlands

N (it con-

cerns a

BAD, data

protection

can be

granted for

underlying

reports but

not BAD

itself)

Syngenta -

KCP

6.2/1

KCP

6.4/1

Folini, T. 2013 Maxim 480 FS (A9459C) & Mertect 500 SC

(A10466G) efficacy against Didymella bryoniae in

melons (controlled conditions)

IT39ZT5582013

Agri 2000 Soc. Coop.

GEP, Unpublished

Syngenta File No : A9459C_10448


submitted before to

Netherlands

Y Syngenta -

KCP

6.2/2

KCP

6.4/2




IT39ZT5592013



submitted before to

Netherlands

Y Syngenta -



Page 38 /83


Data point Author(s)

Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

GEP, Unpublished


KCP

6.2/3

KCP

6.4/3




IT39ZT6272014


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/4

KCP

6.4/4




IT39ZT6282014


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/5

KCP

6.4/5



cucumber (controlled conditions)

IT39ZT6542014


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/6

KCP

6.4/6

Pinardi, L. 2014 Maxim 480 FS (A9459C) & Mertect 500 SC


cucumber (controlled conditions)

IT39ZT6552014


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/7

KCP

6.4/7

Janssen, E. 2014 Maxim 480FS (A9459C) and Mertect 500SC

(A10466G): efficacy in melon against Didymella

bryoniae (controlled conditions)

NLBTZT9132014

De Bredelaar

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/8


(A10466G): efficacy in melon against Didymella


submitted before to

Y Syngenta -



Page 39 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

KCP

6.4/8


NLBTZT9142014

De Bredelaar

GEP, Unpublished


Netherlands

KCP

6.2/9

KCP

6.4/9


(A10466G): efficacy in cucumber against Didymella


NLBTZT9152014

De Bredelaar

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/10

KCP

6.4/10




NLBTZT9162014

De Bredelaar

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/11

KCP

6.4/11




NLBTZT9172014

De Bredelaar

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/12

KCP

6.4/12

Castaño Muñoz,

R.

2014 Maxim 480FS (A9459C) and Mertect 500SC

(A10466G): efficacy in tomato against Fusarium

oxysporum fsp. lycopersici (controlled conditions)

ESAYZT0072014

Agricultura y Ensayo S.L.

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/13

KCP

6.4/13

Castaño Muñoz,

R.




ESAYZT0082014


GEP, Unpublished


submitted before to

Netherlands

Y Syngenta -



Page 40 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission


KCP

6.2/14

KCP

6.4/14

Castaño Muñoz,

R.




ESAYZT0092014


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/15

KCP

6.4/15

Castaño Muñoz,

R.

2015 Maxim 480FS (A9459C): efficacy in tomato against

Fusarium oxysporum lycopersici

ESAYZT0162015


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/16

KCP

6.4/16

Castaño Muñoz,

R.



ESAYZT0172015


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/17

KCP

6.4/17

Castaño Muñoz,

R.



ESAYZT0182015


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/18

KCP

6.4/18

Pilano, R. 2015 Maxim 480FS (A9459C): efficacy in tomato against


IT39ZT5092015


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/19

KCP

6.4/19

Folini, T. 2014 Maxim 480FS (A9459C) and Mertect 500SC



IT39ZT6092014


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -



Page 41 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

KCP

6.2/20

KCP

6.4/20




IT39ZT6102014


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/21

KCP

6.4/21




IT39ZT6112014


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/22



oxysporum fsp lycopersici (controlled conditions)

NLBTZT9102014

Aegisto

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/23



oxysporum fsp lycopersici (controlled conditions)

NLBTZT9122014

Aegisto

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/24

Oostingh, C. 2013 Maxim 480FS (A9459C) and Mertect 500SC

(A10466G) efficay against Fusarium oxysporum

lycopersici in tomatoes (controlled conditions)

NLZWZT9292013

Proeftuin Zwaagdijk

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/22

KCP

6.4/25

Sobolewski, J. 2015 Maxim 480FS (A9459C): efficacy in tomato against


PLIWZT1082015

Institute of Horticulture, Skierniewice


submitted before to

Netherlands

Y Syngenta -



Page 42 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

GEP, Unpublished


KCP

6.2/23

KCP

6.4/26

Sobolewski, J. 2014 Maxim 480FS (A9459C) and Mertect 500SC



PLIWZT1092014


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/24

Szymanska, B. 2014 Maxim 480FS (A9459C) and Mertect 500SC



PLUPZT1222014

ZDD Gorzyn UP, Poznan

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/25

KCP

6.4/27


(A10466G): efficacy in melon against Fusarium

oxysporum fsp. melonis (controlled conditions)

IT39ZT6292014


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/26

KCP

6.4/28

Martín, C. 2015 Maxim 480FS (A9459C): efficacy in melon against

Fusarium oxysporum melonis (controlled conditions)

ESACZT0022015

Agrocolor

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/27

KCP

6.4/29

Pilani, R. 2015 Maxim 480FS (A9459C): efficacy in melon against

Fusarium oxysporum melonis (controlled conditions)

IT39ZT5192015


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/28

KCP

6.4/30


(A10466G) efficacy against Fusarium oxysporum

melonis in melons (controlled conditions)

IT39ZT5382013


submitted before to

Netherlands

Y Syngenta -



Page 43 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission


GEP, Unpublished


KCP

6.2/29

KCP

6.4/31



melonis in melons (controlled conditions)

IT39ZT5392013


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/30

KCP

6.4/32


(A10466G): efficacy in melon against Fusarium

oxysporum fsp. melonis (controlled conditions)

IT39ZT6302014


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/31

KCP

6.4/33

Geuijen, M. 2013 Maxim 480FS (A9459C) and Mertect 500SC


radicis-cucumerinum in cucumber (controlled

conditions)

NLBTZT9012013

De Bredelaar

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/32

KCP

6.4/34




conditions)

NLZWZT9272013

Proeftuin Zwaagdijk

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/33

KCP

6.4/35

Robak, J. 2013 Maxim 480FS (A9459C) and Mertect 500SC



conditions)

PLIWZT1062013



submitted before to

Netherlands

Y Syngenta -



Page 44 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

GEP, Unpublished


KCP

6.2/34

KCP

6.4/36

Sobolewski, J. 2015 Maxim 480FS (A9459C): efficacy in cucumber against

Fusarium oxysporum radicus cucumerinum (controlled

conditions)

PLIWZT1072015


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/35

KCP

6.4/37

Janssen, E. 2015 Maxim 480FS (A9459C): efficacy in cucumber against


conditions)

NLBTZT9052015

De Bredelaar

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/36

KCP

6.4/38

Janssen, E. 2015 Maxim 480FS (A9459C): efficacy in cucumber against


conditions)

NLBTZT9062015

De Bredelaar

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/37

KCP

6.4/39

Arnoux, I. 2009 Maxim 480 FS; efficacy against seed borne diseases

(Colletotrichum dematium, Fusarium) in spinach

(greenhouse trials)

FRAIZT0302009

Syngenta Agro

GEP, Unpublished


N Y Data protection started

with

authorization number

14184 N

Y Syngenta 20110742 ZETG;

2-11-2011

KCP

6.2/38

KCP

6.4/40

Arnoux, I. 2011 Maxim 480 FS (A9459C); efficacy against seed borne

Colletotrichum dematium in spinach (greenhouse trials).

FRAIZT0612011

Syngenta Agro

GEP, Unpublished



with


14184 N


2-11-2011

KCP

6.2/39

KCP

Arnoux, I. 2011 Maxim 480 FS (A9459C); efficacy against seed borne

Colletotrichum dematium in spinach (greenhouse trials)

FRAIZT0622011


with



2-11-2011



Page 45 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

6.4/41 Syngenta Agro

GEP, Unpublished


14184 N

KCP

6.2/40

KCP

6.4/42

Lambourne, C. 2011 Maxim 480 FS (A9459C); efficacy against seed borne

Colletotrichum dematium in spinach (greenhouse trials)

GBSTZT9032011

STC

GEP, Unpublished



with


14184 N


2-11-2011

KCP

6.2/41

KCP

6.4/43

Janssen, E. 2008 Maxim 480 FS, Tecto 500 SC and A 16148 A: evaluate

efficacy against Colletotrichum dematium f.sp.

spinaciae in spinach

NLSNZT7902008

De Bredelaar

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/42

KCP

6.4/44

Janssen, E. 2008 Maxim 480 FS, Tecto 500 SC and A 16148 A: evaluate

efficacy against Colletotrichum dematium f.sp.

spinaciae in spinach

NLSNZT7912008

De Bredelaar

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/43

KCP

6.4/45

Pszczola, J. 2009 Maxim 480 FS; efficacy against seed borne diseases


(greenhouse trials)

PLFPZT0432009

Jan Pszczola

GEP, Unpublished



with


14184 N


2-11-2011

KCP

6.2/44

KCP

6.4/46

Robak, J. 2009 Maxim 480 FS; efficacy against seed borne diseases


(greenhouse trials)

PLIWZT0022009

Research institute of vegetable crops

GEP, Unpublished



with


14184 N


2-11-2011

KCP

6.2/45

Robak, J. 2011 Maxim 480 FS; efficacy against seed borne diseases



with


2-11-2011



Page 46 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

KCP

6.4/47

(greenhouse trials)

PLIWZT0022011

Instytut Ogrodnictwa

GEP, Unpublished



14184 N

KCP

6.2/46

KCP

6.4/48

Ratajkiewicz, H. 2011 Maxim 480 FS; efficacy against seed borne diseases


(greenhouse trials)

PLUPZT0102011

Poznan University of Life Sciences

GEP, Unpublished



with


14184 N


2-11-2011

KCP

6.2/47

KCP

6.4/49

Pollet, S. 2015 Maxim 480FS (A9459C): efficacy in lettuce against

Rhizoctonia solani (controlled conditions)

BEINZT9102015

Inagro

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/48

KCP

6.4/50

Pilani, R. 2015 Maxim 480FS (A9459C): efficacy in lettuce against


IT39ZT5152015


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/49

KCP

6.4/51

Pilani, R. 2015 Maxim 480FS (A9459C): efficacy in lettuce against


IT39ZT5162015


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/50

KCP

6.4/52


(A10466G) efficacy against Rhizoctonia solani in

lettuce (controlled conditions)

IT39ZT5632013


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/51

Folini, T. 2014 Maxim 480FS (A9459C): efficacy in lettuce against



submitted before to

Y Syngenta -



Page 47 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

KCP

6.4/53

IT39ZT6162014


GEP, Unpublished


Netherlands

KCP

6.2/52

KCP

6.4/54



IT39ZT6172014


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/53

KCP

6.4/55



IT39ZT6182014


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/54

KCP

6.4/56



IT39ZT6192014


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/55

KCP

6.4/57

Sobolewski, J. 2014 Maxim 480FS (A9459C): efficacy in lettuce against


PLIWZT1072014

Research Institute of Horticulture

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.2/56

KCP

6.4/58

Sobolewski, J. 2014 Maxim 480FS (A9459C): efficacy in lettuce against


PLIWZT1082013

Research Institute of Horticulture

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/59

Martín, C. 2014 Maxim 480FS (A9459C) and Mertect 500SC

(A10466G): crop safety in melons (protected

conditions)

ESACZT0072014

Agrocolor, S.L.


submitted before to

Netherlands

Y Syngenta -



Page 48 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

GEP, Unpublished


KCP

6.4/60



conditions)

ESACZT0082014

Agrocolor, S.L.

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/61



conditions)

ESACZT0092014

Agrocolor, S.L.

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/62



conditions)

ESACZT0112013

Agrocolor, S.L.

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/63

Soto, F. 2013 Maxim 480FS (A9459C) and Mertect 500SC

(A10466G): crop safety in squash

ESFSZT0032012

Agrocolor, S.L.

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/64

Espinosa, F. 2014 Maxim 480FS (A9459C) and Mertect 500SC

(A10466G): crop safety in melons (field conditions)

ESFSZT0102014

Sistemas de Control de Producción S.L.

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/65

Mar López García,

M. del

2012 Maxim 480 FS (A9459C) and Mertect 500SC

(A10466G): crop safety in watermelons

ESSCZT0092012



submitted before to

Netherlands

Y Syngenta -



Page 49 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

GEP, Unpublished


KCP

6.4/66

Angel Piedra, M. 2014 Maxim 480FS (A9459C) and Mertect 500SC

(A10466G): crop safety in squash (protected conditions)

ESSEZT2262014

Syngenta España S.A.

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/67

Jollivet, B. 2012 Maxim 480 FS (A9459C) and Mertect 500SC

(A10466G): crop safety in melons

FRJBZT0312012

Syngenta France

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/68

Speyer, M. 2012 Maxim 480 FS (A9459C) and Mertect 500SC

(A10466G): crop safety in melons

FRSMZT0252012

Syngenta France

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/69

Lunzenfichter, D. 2013 Maxim 480FS (A9459C) and Mertect 500SC


conditions)

FRSYZT0562013

SynTech Research France

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/70

D'Andrea, D. 2014 Maxim 480FS (A9459C) and Mertect 500SC


IT32ZT6532014

Res Agraria srl

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/71

Pasini, M 2014 Maxim 480FS (A9459C) and Mertect 500SC

(A10466G): crop safety in watermelon (protected

conditions)

IT33ZT6542014

AGREA srl

GEP, Unpublished


submitted before to

Netherlands

Y Syngenta -



Page 50 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission


KCP

6.4/72

Bellingeri, G. 2014 Maxim 480FS (A9459C) and Mertect 500SC

(A10466G): safety in gherkin (protected conditions)

IT37ZT6372014

ANADIAG ITALIA SRL

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/73



IT37ZT6522014

ANADIAG ITALIA SRL

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/74

Emmolo, S. 2014 Maxim 480FS (A9459C) and Mertect 500SC

(A10466G): crop safety in cucumber (protected

conditions, to yield)

IT51ZT6352014

Centro Ricerche Agrobiocontrol srl

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/75

Emmolo, S. 2014 Maxim 480FS (A9459C) and Mertect 500SC


conditions)

IT51ZT6382014

Centro Ricerche AgroBioControl Srl

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/76

Serra, L. 2012 Maxim 480 FS (A9459C) and Mertect 500SC

(A10466G): crop safety in watermelons

ITNEZT3192012

SYNGENTA CP ITALIA

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/77

Serra, L. 2012 Maxim 480 FS (A9459C) and Mertect 500 SC

(A10466G): crop safety in squash

ITNEZT3202012

SYNGENTA CP ITALIA

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -



Page 51 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

KCP

6.4/78

Aversa, A. 2014 Maxim 480FS (A9459C) and Mertect 500SC


conditions)

ITSOZT1432014

Syngenta Italia Spa

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/79


(A10466G): crop safety in squash (protected conditions)

ITSOZT1442014

Syngenta Italia Spa

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/80




NLBTZT9182014

Aegisto

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/81




NLBTZT9192014

Aegisto

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/82



NLBTZT9202014

Aegisto

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/83

Sobolewski, J. 2014 Maxim 480FS (A9459C) and Mertect 500SC


PLIWZT0012014

Institute of Horticulture Skierniewice

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -



Page 52 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

KCP

6.4/84

Robak, J. 2013 Maxim 480 FS (A9459C) and Mertect 500SC


conditions)

PLIWZT1072013

Instytut Ogrodnictwa Skierniewice

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/85

Oostingh, C. 2013 Maxim 480 FS (A9459C) and Mertect 500SC


conditions)

NLZWZT9312013

Proeftuin Zwaagdijk

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/86

Prats Martín, C. 2014 Maxim 480FS (A9459C) and Mertect 500SC

(A10466G): crop safety in tomato (protected

conditions)

ESACZT0122014

Agrocolor, S.L.

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/87


(A10466G): crop safety in tomato (field conditions)

ESACZT0132014

Agrocolor, S.L.

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/88


(A10466G) safety in eggplant (protected conditions)

ESACZT0142014

Agrocolor, S.L.

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/89

Soto, F. 2013 Maxim 480 FS (A9459C) and Mertect 500SC


conditions)

ESFSZT0162013

F.S.TRIALS

GEP, Unpublished


submitted before to

Netherlands

Y Syngenta -



Page 53 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission


KCP

6.4/90

Abellán Martínez,

G.


(A10466G) safety in bell pepper (protected conditions)

ESMSZT0102014

Métodos Servicios Agrícolas S.L.

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/91

Mar López García,

M.del



conditions)

ESSCZT0182013


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/92

Pasini, M. 2013 Maxim 480 FS (A9459C) and Mertect 500SC


conditions)

IT33ZT5642013

AGREA srl

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/93

Pasini, M. 2013 Maxim 480 FS (A9459C) and Mertect 500SC

(A10466G): crop safety in eggplant (protected

conditions)

IT33ZT5652013

AGREA

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/94


(A10466G): safety in eggplant (protected conditions)

IT37ZT6362014

ANADIAG ITALIA SRL

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/95

Derrico, M. 2014 Maxim 480FS (A9459C) and Mertect 500SC

(A10466G): crop safety in field tomato (nursery stage)

ITFGZT1462014

Syngenta Italia S.p.A.

GEP, Unpublished


submitted before to

Netherlands

Y Syngenta -



Page 54 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission


KCP

6.4/96

Derrico, M. 2014 Maxim 480FS (A9459C) and Mertect 500SC

(A10466G): crop safety in field tomato (transplanted

into field, to yield)

ITFGZT9462014

Syngenta Italia

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/97

Serra, L. 2013 Maxim 480 FS (A9459C) and Mertect 500SC


conditions)

ITNEZT3192013

SYNGENTA C.P. ITALIA

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/98

Antonio, A. 2014 Maxim 480FS (A9459C) and Mertect 500SC

(A10466G): crop safety in glasshouse tomato (nursery

stage)

ITS0ZT9452014

Singenta Italia Spa

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/99

Asero, G. 2015 Maxim 480FS (A9459C): crop safety in bell pepper

(protected conditions)

ITSOZT0312015

Syngenta Italia Spa

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/100


(A10466G): crop safety in glasshouse tomato (nursery

stage)

ITSOZT1452014

Syngenta Italia SPA

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/101

Asero, G. 2014 Maxim 480FS (A9459C) and Mertect 500SC


ITSOZT1542014

Syngenta Italia SpA


submitted before to

Netherlands

Y Syngenta -



Page 55 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

GEP, Unpublished


KCP

6.4/102

Janssen, E. 2015 Maxim 480FS (A9459C): safety in eggplant under

winter conditions (protected)

NLBTZT9012015

Aegisto

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/103



NLBTZT9022015

Aegisto

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/104



NLBTZT9032015

Aegisto

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/105

Janssen, E. 2015 Maxim 480FS (A9459C): crop safety in bell pepper


NLBTZT9042015

Aegisto

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/106



conditions)

NLZWZT9232014

Proeftuin Zwaagdijk

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/107


(A10466G) safety in eggplant (protected conditions)

NLZWZT9242014

Proeftuin Zwaagdijk

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -



Page 56 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

KCP

6.4/108


(A10466G): crop safety in eggplant (protected

conditions)

NLZWZT9322013

Proeftuin Zwaagdijk

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/109

Angel Piedra, M. 2015 Maxim 480FS (A9459C): crop safety in bell pepper


ESSEZT2272015

Syngenta España S.A.

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/110



NLZWZT9252014

Proeftuin Zwaagdijk

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/111

Lambourne, C. 2010 Apron XL 350 ES (A9642C); crop tolerance in various

vegetable crops for A1 renewal and PA1 BAD

GBSTZT9202010

STC

GEP, Unpublished



with


14184 N


2-11-2011

KCP

6.4/112



GBSTZT9212010

STC

GEP, Unpublished



with


14184 N


2-11-2011

KCP

6.4/113



GBSTZT9402010

STC

GEP, Unpublished



with


14184 N


2-11-2011

KCP

6.4/114




with


2-11-2011



Page 57 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

GBSTZT9412010

STC

GEP, Unpublished



14184 N

KCP

6.4/115

Jansen, E. 2008 Crop tolerance of Maxim 480 FS, Tecto 500 FS and

SYN 524464 500 FS in spinach.

NLSNZT7732008

De Bredelaar

GEP, Unpublished



with


14184 N


2-11-2011

KCP

6.4/116



NLSNZT7742008

De Bredelaar

GEP, Unpublished



with


14184 N


2-11-2011

KCP

6.4/117



NLSNZT7762008

De Bredelaar

GEP, Unpublished



with


14184 N


2-11-2011

KCP

6.4/118



NLSNZT7772008

De Bredelaar B.V.

GEP, Unpublished



with


14184 N


2-11-2011

KCP

6.4/119



NLSNZT7782008

De Bredelaar B.V.

GEP, Unpublished



with


14184 N


2-11-2011

KCP

6.4/120



NLSNZT7792008

De Bredelaar B.V.

GEP, Unpublished


with


14184 N


2-11-2011



Page 58 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission


KCP

6.4/121



NLSNZT7802008

De Bredelaar B.V.

GEP, Unpublished



with


14184 N


2-11-2011

KCP

6.4/122



NLSNZT7812008

De Bredelaar B.V.

GEP, Unpublished



with


14184 N


2-11-2011

KCP

6.4/123



NLSNZT7822008

De Bredelaar B.V.

GEP, Unpublished



with


14184 N


2-11-2011

KCP

6.4/124



NLSNZT7832008

De Bredelaar B.V.

GEP, Unpublished



with


14184 N


2-11-2011

KCP

6.4/125



NLSNZT7842008

De Bredelaar B.V.

GEP, Unpublished



with


14184 N


2-11-2011

KCP

6.4/126

Pszczola, J. 2010 Apron XL 350 ES (A9642C); crop tolerance in various


PLFPZT0342010

Field Research Support

GEP, Unpublished



with


14184 N


2-11-2011

KCP

6.4/127

Pszczola, J. 2010 Apron XL 350 ES (A9642C); crop tolerance in various



with


2-11-2011



Page 59 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

PLFPZT0402010

Field Research Support

GEP, Unpublished



14184 N

KCP

6.4/128

Bogaert, A. 2014 Maxim 480FS (A9459C): safety in lettuce (protected

conditions)

BEKHZT9182014

PCG

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/129

Bogaert, A. 2014 Maxim 480FS (A9459C): safety in lettuce (under

nursery conditions and transplanted into field)

BEKHZT9192014

PCG

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/130

Soto, F. 2014 Maxim 480FS (A9459C): safety in lettuce (protected

conditions)

ESFSZT0092014

FS TRIALS

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/131

Soto, F. 2013 Maxim 480 FS (A9459C) and Mertect 500SC

(A10466G): crop safety in lettuce (protected conditions)

ESFSZT0152013

F.S.TRIALS

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/132

Abellán Martínez,

G.



ESMSZT0092013


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/133

Abellán Martínez,

G.

2014 Maxim 480FS (A9459C): safety in lettuce (protected

conditions)

ESMSZT0092014


GEP, Unpublished


submitted before to

Netherlands

Y Syngenta -



Page 60 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission


KCP

6.4/134

Rivet, J-P. 2014 Maxim 480FS (A9459C): safety in belgian (witloof)

endive (direct drilling in field)

FREPZT0272014

Essais Plus

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/135

Rivet, J-P. 2014 Maxim 480FS (A9459C): safety in leafy endive (under

nursery conditions, transplanted into field)

FREPZT0312014

ESSAIS +

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/136

Pasini, M. 2014 Maxim 480FS (A9459C): safety in lettuce (protected

conditions)

IT33ZT6202014

AGREA srl

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/137

Emmolo, S. 2014 Maxim 480FS (A9459C): safety in lettuce (protected

conditions)

IT51ZT6212014

Centro Ricerche AgroBioControl srl

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/138

D'Asero, R. 2014 Maxim 480FS (A9459C): safety in lettuce (under

nursery conditions and transplanted into field)

ITSOZT3112014

Syngenta Italia Spa

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/139

Lange, J. de 2014 Maxim 480FS (A9459C): safety in belgian (witloof)

endive (direct drilling in field)

NLZWZT9222014

Proeftuin Zwaagdijk

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/140


(A10466G): crop safety in endive (controlled


submitted before to

Y Syngenta -



Page 61 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

conditions)

NLZWZT9282013

Proeftuin Zwaagdijk

GEP, Unpublished


Netherlands

KCP

6.4/141

Oostingh, C. 2014 Maxim 480FS (A9459C): safety in lambs lettuce (direct

drilling under glass)

NLZWZT9302014

Proeftuin Zwaagdijk

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/142

Oostingh, C. 2014 Maxim 480FS (A9459C): safety in lambs lettuce

(nursery propagation)

NLZWZT9312014

Proeftuin Zwaagdijk

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/143



NLZWZT9332013

Proeftuin Zwaagdijk

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/144

Branchereau, S. 2014 Maxim 480FS (A9459C): safety in lambs lettuce (direct

drilliing, in field)

FRSTZT0242014

STAPHYT

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/145

Pasqualini, E 2015 Quality testing and taint testing of processed tomato, to

support the

registration of seedcare products Maxim 480 FS and

Mertect 500 SC

ITA 14144 BA1

Anadiag Italia S.R.L.

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/146


support the


submitted before to

Y Syngenta -



Page 62 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission


Mertect 500 SC

ITA 14145 BA1


GEP, Unpublished


Netherlands

KCP

6.4/147


support the


Mertect 500 SC

ITA 14146 BA1


GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.4/148

Buysens, S. 2014 Taint studiy on lettuce Maxim 480 FS (A9459C).

SM14SLGB01

PCG vzw

GEP, unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.6/1

Van Diepen, L. 2015 Loading and adhesion results tested at INCOTEC -

Treated seeds Batches of Cucumber and Melon T16

INCOTEC Europe BV

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.6/2

Stahl M. and

Wittich T.

2014 Loading and adhesion results tested at SUET via HPLC

T15

SUET Saat- und Erntetechnik GmbH , NL

GEP, Unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.6/3

Maile, L. 2013 Maxim 480FS and Mertect 500SC on a range of

vegetable crops, Time zero (T0)

NIAB UK

P111 V20.13 T0

GEP, unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.6/4


vegetable crops, After 6 months storage (T+6)

NIAB UK

P111 V20.13 T6


submitted before to

Netherlands

Y Syngenta -



Page 63 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

GEP, unpublished


KCP

6.6/5



NIAB UK

P111 V20.13 T12

GEP, unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.6/6



NIAB UK

P111 V20.13 T18

GEP, unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.6/7


vegetable crops, Time zero (T0)

NIAB UK

P140 V13.14 T0

GEP, unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.6/8



NIAB UK

P140 V13.14 T6

GEP, unpublished



submitted before to

Netherlands

Y Syngenta -

KCP

6.6/9



NIAB UK

P140 V13.14 T12

GEP, unpublished



submitted before to

Netherlands

Y Syngenta -

Part B, Sections B5 (Analytical Methods)

KCA

4.1.2/03

Sole C 2008 GRM025.03A: Fludioxonil – Analytical Method for the

Determination of Residues of Total Fludioxonil

(CGA173506) and Metabolites as CGA192155 in

Animal Matrices (Milk, Eggs, Muscle, Fat, Liver,

Kidney and Whole Blood).


with


14184 N


2-11-2011



Page 64 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

Syngenta Method No. GRM025.03A

Syngenta File No. CGA173506/11402

KCA

4.1.2/04

Sole C 2008a Fludioxonil: Validation of Residue Method

GRM025.03A for Total Fludioxonil (CGA173506) and

Metabolites as CGA192155 in Animal Matrices (Milk,

Eggs, Muscle, Fat, Liver, Kidney and Whole Blood).

Report No. T001341-08-REG , Syngenta File No.

CGA173506/11403

Unpublished

GLP


with


14184 N


2-11-2011

KCA

4.1.2/05

2009 Fludioxonil - Magnitude of residues in animal tissues

following repeated oral administration to the laying hen.

Study No. 1983/108-D2149, Syngenta Report No.

T001339-08 , Syngenta File No. CGA173506_11440

Unpublished

GLP

Y Y Data protection started

with


14184 N


2-11-2011

KCP

5.2.5/01

Robinson N. 2007 Fludioxonil - Residue Analytical Method for the

Determination of Residues of Fludioxonil and its

Metabolites CGA192155 and CGA339833 in Water

Syngenta Crop Protection AG, Basel, Switzerland

Syngenta - Jealott’s Hill, Bracknell, United Kingdom,

GRM 025.01A

Unpublished

Not GLP

not published

Syngenta File No CGA173506/7219


with


14184 N


2-11-2011

KCA

5.2.5/02

Nagra B. 2007 Fludioxonil (CGA173506) - Validation of a Residue

Analytical Method (GRM025.01A) for the

Determination of Residues of Fludioxonil and its

Metabolites CGA192155 and CGA339833 in Water

Syngenta Crop Protection AG, Basel, Switzerland

Syngenta - Jealott’s Hill, Bracknell, United Kingdom,

T003490-06-REG

GLP

not published

Syngenta File No CGA173506/7220


with


14184 N


2-11-2011

Part B, Sections B7 (Metabolism & Residues)



Page 65 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

K-CA1

6.3.1/01 Solé C. 2003 Residue Study with Fludioxonil (CGA 173506) in or on

Sunflowers in France (North)

Syngenta

ADME Bioanalyses, Residue Analysis, F-30310 Ver-

gèze. France

Report No. 02-4009



submitted before to

Netherlands

Y Syngenta -

K-CA1


Sunflowers in France (North)

Syngenta


gèze. France

Report No. 02-4008



submitted before to

Netherlands

Y Syngenta -

K-CA1


Sunflowers in France (South)

Syngenta


gèze. France

Report No. 02-4010



submitted before to

Netherlands

Y Syngenta -

K-CA1

6.3.1/04 K Van Geluwe 2003 Residue Study with Fludioxonil (CGA 173506) in or on

Sunflowers in France (South)

Syngenta


gèze. France

Report No. 02-4011



submitted before to

Netherlands

Y Syngenta -

K-CA1

6.3.1/05 Robert Williams 1998 CGA 173506, Maxim 4FS, Lettuce, USA.

Novartis Crop Protection, Greensboro, NC 27419

Syngenta Report No. ABR-97096


with


14184 N

N Syngenta 20110742 ZETG;

2-11-2011



Page 66 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission


K-CA1

6.3.1/06 K Van Geluwe 1998 CGA 173506, MAXIM 4 FS, Cucumber (seed), United

States.

Novartis Crop Protection, Greensboro, NC 27419

Report No. ABR-97098



with


14184 N


2-11-2011

Part B, Sections B6 (Toxicology)

KCP

7.1.1

(=KCP

10.1.2.1)

1993 Acute Oral Toxicity Study in Rats.

CGA173506/0396

GLP

Unpublished


with


14184 N

N* Syngenta 20110742 ZETG;

2-11-2011

KCP

7.1.2

1993a Acute Dermal Toxicity Study in Rabbits

CGA173506/0397

GLP

Unpublished


with


14184 N


2-11-2011

KCP

7.1.4

2010 Fludioxonil FS (A9459C) – Primary Skin Irritation

Study in Rabbits (4-Hour Semi-Occlusive Application).

A9459C_10000

GLP

Unpublished


with


14184 N


2-11-2011

KCP

7.1.5

2010a Fludioxonil FS (A9459C) – Primary Eye Irritation

Study in Rabbits.

A9459C_10001

GLP

Unpublished


with


14184 N


2-11-2011

Part B, Sections B8 (Environmental behaviour)

KCP Emburey S. 2004 Fludioxonil: Field Study Comparing Seed Treatment N Y Data protection started N Syngenta 20110742 ZETG;



Page 67 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

9.1.1.2.1 /

01

Dissipation Against Field Dissipation in Switzerland

During 2003.

Syngenta, Environmental Sciences, Jealott’s Hill, Inter-

national Research Centre, Bracknell, Berkshire, RG42

6EY, UK. Laboratory Project ID 03-S60, 25 August

2004,

Syngenta file No. CGA173506/5993

GLP: Yes

Not published

with


14184 N

2-11-2011

KCP

9.2.4 / 01

Reichert M. 2015 Fludioxonil - A Leaching Assessment Using the FO-

CUS Groundwater Scenarios in PEARL (v 4.4.4),

PELMO (v 5.5.3) and MACRO (v 5.5.4) Following

Seed Treatment Applications to Tomatoes and Cabbage

in the EU

Syngenta File No. CGA173506_11835

RIFCON GmbH, Hirschberg, Germany, Report No.

R1520347-2

GLP: No (not applicable)

Not published


submitted before to

Netherlands

N Syngenta -

KCP

9.2.5 / 01

Reichert M. 2015a A European Environmental Fate Assessment Using the

FOCUS Surface Water Model at Steps 1 & 2 Following

Applications as a Seed Treatment to Fruiting Vegetables

and Leafy Vegetables in the EU

Syngenta File No. CGA173506_11834

RIFCON GmbH, Hirschberg, Germany, Report No.

R1520347-1

GLP: No (not applicable)

Not published


submitted before to

Netherlands

N Syngenta -

Part B, Sections B9 (Ecotoxicology)

KCP

10.1.1.1

2012 Fludioxonil FS (A9459C) – Avian Oral Acute Toxicity

Study (Coturnix coturnix japonica)

Report Number RL6771/2012 – 12.0AVO-B. Syngenta

File No. A9459C_10275

l.

GLP

Unpublished

Y Y Data/study report never

submitted before to

Netherlands

Y Syngenta -



Page 68 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

KCP

10.1.1.2/0

2

2015 Fludioxonil - A Reproduction Study with the Northern

Bobwhite

Report Number 528B-457. Syngenta File No.

CGA173506_11828

GLP/non

GLP

Unpublished


submitted before to

Netherlands

Y Syngenta -

KCP

10.1.1.2

/ 04 &

KCP

10.1.2.2

/ 02

Render K. 2012 Fludioxonil, Thiabendazole, Azoxystrobin and

Metalaxyl-M - Dissipation of residues on treated

maize seed and shoots

Syngenta

The Food and Environment Research Agency

(Fera), Sand Hutton, UK, V7YG 1000

GLP

not published

Syngenta File No A14918E_10216


submitted before to

Netherlands

Y Syngenta

KCP

10.1.1.2 /

05

Prosser P. 2014 Investigating potential exposure of birds to treated

vegetable seeds using video in the field

Syngenta

The Food and Environment Research Agency (Fera),

Sand Hutton, UK, W8MH 1001

GLP

not published

Syngenta File No NA_13465


submitted before to

Netherlands

Y Syngenta -

KCP

10.1.1.2 /

06

2004 Untreated seeds: Seed selection by the house sparrow

(Passer domesticus)

Not GLP

not published

Syngenta File No MK936/1043


submitted before to

Netherlands

MS: study was also

submitted for earlier

authorization of Maxim

480

N Syngenta -

KCP

10.1.1.2 /

07

. 2004a Untreated seeds: Seed selection by the grey partridge

(Perdix perdix)


submitted before to

Netherlands

MS: study was also

N Syngenta -



Page 69 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

Not GLP

not published

Syngenta File No MK936/1044

submitted for earlier

authorization of Maxim

480

KCP

10.1.2.1

(=KCP

7.1.1)

1993 Acute Oral Toxicity Study in Rats.

Laboratory

Report No. 9965-93 issue date 19 April 1993.

Unpublished. (Syngenta File No. CGA173506/0396

GLP

Unpublished


with:


14184 N


2-11-2011

KCP

10.3.1.1.1

Minei C.C

2012 Fludioxonil FS (A9459C) – Honeybees (Apis mellifera),

Acute Oral Toxicity Test

Report Number RL6771/2012 – 5.0 ABO-B. Syngenta

file No. A9459C_10276

TECAM Tecnologia Ambiental Ltda. Rua Fábia, 59 –

CEP: 05051-030, São Paulo, SP - Brasil.

GLP

Unpublished


submitted before to

Netherlands

Y Syngenta -

KCP

10.3.1.1.2

Minei C.C

2012a Fludioxonil FS (A9459C) – Honeybees (Apis mellifera),

Acute Contact Toxicity Test

Report Number RL6771/2012 – 4.0 AB-B. Syngenta

file No. A9459C_10283

TECAM Tecnologia Ambiental Ltda. Rua Fábia, 59 –

CEP: 05051-030, São Paulo, SP - Brasil.

GLP

Unpublished


submitted before to

Netherlands

Y Syngenta -

KCP

10.3.2.2/0

1

Fallowfield L. 2014 Fludioxonil FS (A9459C) – A rate-response extended

laboratory bioassay of the effects of fresh residues on

the predatory mite Typhlodromus pyri (Acari:

Phytoseiidae)

Report Number SYN-14-55. Syngenta file No.

A9459C_10346

Mambo-Tox Ltd. 2 Venture Road, Chilworth Science

Park, Southampton SO16 7NP, United Kingdom

GLP

Unpublished


submitted before to

Netherlands

Y Syngenta -

KCP

10.3.2.2/0

2

Röhlig, U 2010 Fludioxonil FS (A9459C) - Chronic Toxicity to the

Rove Beetle Aleochara bilineata GYLL. Under

Extended Laboratory Conditions.

Report Number S10-10 48 032A. Syngenta file No.


with:


14184 N


2-11-2011



Page 70 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

A9459C_10007

BioChem agrar, Labor für biologische und chemische,

Analytik GmbH, Kupferstraße 6, 04827 Gerichshain.

Germany.

GLP

Unpublished

KCP

10.3.2.2/0

3

Stevens J 2014 Fludioxonil FS (A9459C) – A rate-response extended

laboratory bioassay of the effects of fresh residues on

the parasitic wasp Aphidius rhopalosiphi (Hymenoptera,

Braconidae)


A9459C_10341

Mambo-Tox Ltd., 2 Venture Road, Chilworth Science

Park, Southampton SO16 7NP, United Kingdom.

GLP

Unpublished


submitted before to

Netherlands

Y Syngenta -

KCP

10.4.1

Minei C.C 2012b Fludioxonil FS (A9459C) - Earthworm (Eisenia fetida),

Acute Toxicity Test

Report Number RL149113MI-B. Syngenta file No.

A9459C_10274

TECAM Tecnologia Ambiental Ltda. Rua Fábia, 59-

CEP:05051-030 São Paulo, SP, Brasil.

GLP

Unpublished


submitted before to

Netherlands

Y Syngenta -

KCP

10.4.1.1

Friedrich S 2010 Fludioxonil FS (A9459C) - Sublethal Toxicity to the

Earthworm Eisenia fetida in Artificial Soil with 5%

Peat

Report Number 10 10 48 063 S. Syngenta file No.

A9459C_10004


Analytik GmbH, Kupferstraße 6, 04827 Gerichshain,

Germany.

GLP

Unpublished


with:


14184 N


2-11-2011

KCP

10.4.2.1/0

1

Friedrich S 2010a Fludioxonil FS (A9459C) – Effects on the reproduction

of the Collembolans Folsomia candida, Report Number

10 10 48 064 S, Syngenta file No. A9459C_10005




with:


14184 N


2-11-2011



Page 71 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protec-

tion

claimed

Y/N



Data protec-

tion granted

Owner Application

number / date of

submission

Germany.

GLP

Unpublished

KCP

10.4.2.1/0

2

Vinall S. 2015 Fludioxonil FS (A9459C) – A laboratory test to

determine the effects of fresh residues on the predatory

soil mite Hypoaspis aculeifer (Acari, Laelapidae),


A9459C_10494

Mambo-Tox Ltd. 2 Venture Road, University Science

Park, Southampton SO16 7NP, United Kingdom.

GLP

Unpublished


submitted before to

Netherlands

Y Syngenta -

KCP

10.4.2.1/0

3

Riches M. 2005 Fludioxonil (CGA173506) / Cyprodinil (CGA219417)

WG 62.5 (A9219B): Effects on the decomposition of

organic straw in litter bags by soil macro and micro

organisms in the field.

Report No. CEMR-226704, Syngenta File No.

CGA173506/6176

CEM Analytical Services Limited (CEMAS), North

Ascot, Berkshire, UK.

GLP

Unpublished


with:


14184 N


2-11-2011

KCP

10.5/01

Schulz L 2010 Fludioxonil FS (A9459C) - Effects on the Activity of

Soil Microflora (Nitrogen and Carbon Transformation

Tests)

Report Number: 10 10 48 042 C/N. Syngenta file No.

A9459C_10002



Germany

GLP

Unpublished


with:


14184 N


2-11-2011

*Data protection was already granted for the original authorization.



Page 72 /83


List of data submitted or referred to by the applicant and relied on, but already evaluated at EU peer review Data point Author(s)

Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protection

claimed

Y/N

Justification if data protection is

claimed

Owner

KCP 2.1 /

01 &

KCP 2.4 /

01 &

KCP 2.5 /

01

Khot Sunil B. 2010 A9459C - Physical properties of batch SMU9LP001

Syngenta

Syngenta Biosciences Pvt. Ltd., Ilhas Goa, India,

SMG10460

GLP

not published

Syngenta File No A9459C_10010

N N - Syngenta

KCP 2.2 /

01 &

KCP 2.3 /

01

Jackson W. 2010 A9459C - Safety study

Syngenta

Syngenta Technology & Projects, Huddersfield, United

Kingdom, HT10/270

GLP

not published


N N - Syngenta

KCP 2.6 /

01

Khot Sunil B. 2010a A9459C - Chemical characterization before storage of

batch SMU9LP001

Syngenta


SMG10456

GLP

not published


N N - Syngenta

KCP 2.7 /

01

Naegele M. 2011 A9459C - Storage stability and shelf life statement (2

weeks 54°C) in packaging made of HDPE

Syngenta

Syngenta Crop Protection, Münchwilen, Switzerland,

Not GLP

not published


N N - Syngenta

KCP 2.7 /

02 &

KCP

2.8.2 / 01

&

Khot Sunil B. 2010b A9459C - Technical properties of batch SMU9LP001

Syngenta


SMN10325

Not GLP

N N - Syngenta



Page 73 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protection

claimed

Y/N


claimed

Owner

KCP

2.8.3 / 01

&

KCP

2.8.5.1 /

01 &

KCP

2.8.7 / 01

not published


KCP 2.10

/ 01 &

KCP 2.11

/ 01

Kalt R. 2011 A9459C - Technical properties on treated seed of batch

SMU9LP001

Syngenta

Syngenta Crop Protection, Münchwilen, Switzerland,

122507

Not GLP

not published


N N - Syngenta

KCP 2.1 /

01 &

KCP 2.4 /

01 &

KCP 2.5 /

01

Khot Sunil B. 2010 A9459C - Physical properties of batch SMU9LP001

Syngenta


SMG10460

GLP

not published


N N - Syngenta

KCP 2.2 /

01 &

KCP 2.3 /

01

Jackson W. 2010 A9459C - Safety study

Syngenta

Syngenta Technology & Projects, Huddersfield, United

Kingdom, HT10/270

GLP

not published


N N - Syngenta

Mair, P. 1993 Determination of CGA 173506 in Plant material, Wine and Soil

by HPLC Including Validation Data.

Syngenta Method No. REM 133.04


GLP

N N - Syngenta

Mair, P. 1996 Validation of Method REM 133.04. Determination of Efficiency N N - Syngenta



Page 74 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protection

claimed

Y/N


claimed

Owner

of Extraction and Accountability from 14C-Fludioxonil Treated

Specimen (Tomato).

Syngenta Report No. 110/96


GLP

Tribolet, R. 2001 Validation of Method REM 133.04 by Analysis of Fortified

Specimens (Plant Materials and Soil) for Fludioxonil (CGA

173506) and Evaluation of Recoveries.

Syngenta Report No. 210/01


GLP

N N - Syngenta

KCP 5.2.1 Das, R. 2010 Analytical method ST-16/1 Determination of Fludioxonil

in Formulation FS (480) by HPLC

Syngenta Crop Protection Münchwilen AG, Switzerland

Report No. 10419932, Syngenta File No. A9459C_10788

Unpublished

GLP

N N - Syngenta

KCP 5.2.1 Das, R. 2011 Fludioxonil – A9459C Validation of analytical method. ST-16/1

Syngenta Crop Protection Münchwilen AG, Switzerland.

Report No. 12293, Syngenta File No. A9459C_10047

Unpublished

GLP

N N - Syngenta

KCP

5.2.4/01

Robinson, N.J. and

Tummon, O.J.

2004 Residue Analytical Method for the Determination of Fludioxonil

in Soil.

Syngenta Method No. RAM 423/01 , Syngenta File No.

CGA173506/5941

Unpublished

GLP

N N - Syngenta

KCP

5.2.4/02

Tummon O.J 2004 Long Term Study with Fludioxonil (CGA173506) in or on

Grapes and Soil in Switzerland.

Syngenta Method No. RJ3493B. Syngenta File No.

CGA173506/5940

Unpublished

GLP

N N - Syngenta

KCA 6.1 Tribolet, R. 2000 Stability of residues of CGA 173506 (fludioxonil) in tomatoes

under freezer storage conditions.

Syngenta AG, CH-4002 Basel, Switzerland.

Report No. 222/98

N N n/a Syngenta



Page 75 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protection

claimed

Y/N


claimed

Owner

GLP, not published

Syngenta File No. 173506/5348

KCA 6.1 Tribolet, R. 2000 Stability of residues of CGA 173506 (fludioxonil) in apples under

freezer storage conditions.

Syngenta AG, CH-4002 Basel, Switzerland.

Report No. 221/98

GLP, not published

Syngenta File No. CGA 173506/5349

N N n/a Syngenta

KCA 6.1 Tribolet, R. 2002 Residue stability study for fludioxonil (CGA 173506) in peas and

rapeseed under freezer storage conditions.

Syngenta AG, CH 4002 Basel, Switzerland.

Report No. 210/00

GLP, not published

Syngenta File No. 173506/5508

N N n/a Syngenta

KCA 6.2.1 Close C. 1998 14C-CGA-173506 uptake and distribution in cotton following

seed treatment at 2.5 g ai/100 kg seed.

Novartis Crop Protection Inc., Greensboro, North Carolina,

USA.


GLP, not published


N N n/a Syngenta

KCA 6.2.1 Close C. 1998 14C-CGA-173506 uptake and distribution in cotton following

seed treatment at 5 g ai/100 kg seed.


USA.


GLP, not published


N N n/a Syngenta

KCA 6.2.1 Close C. 1998 14C-CGA-173506 uptake and distribution in soybeans following

seed treatment at 5 g ai/100 kg seed.


USA


GLP, not published


N N n/a Syngenta

KCA 6.2.1 1997 Stability of CGA-173506 fortified into meat, milk and egg

samples under freezer storage conditions.


Y N n/a Syngenta



Page 76 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protection

claimed

Y/N


claimed

Owner

GLP, not published


KCA 6.2.1 Kennedy, E. 1999 [Phenyl-U-14C]-CGA-173506: Nature of the residue in green

onions.

Novartis Crop Protection, Inc., Greensboro, North Carolina,

USA.

Report No. 153-97

GLP, not published


N N n/a Syngenta

KCA 6.2.2 1992 Metabolism of [pyrrole-14C-pyrrole]-CGA-173506 in chickens.

Report No. F-00089 (plus amendment 1, 18.11.1994 and

amendment 2, 11.06.1996)

GLP, not published


Y N n/a Syngenta

KCA 6.2.3 1992 Metabolism of [pyrrole-14C]-CGA-173506 in goats.

Report No. F-00088 (plus amendment 1)

GLP, not published


Y N n/a Syngenta

KCA 6.6.1 Gentile, B. 1992 Outdoor confined accumulation study on rotational crops after

bareground application of [4-14C-pyrrole] CGA 173506.

Ciba-Geigy Ltd, Basle, Switzerland.

Report No. 89BG03PR1

GLP, not published


N N n/a Syngenta

KCA 6.6.1 Close, C. 1997 14C-CGA 173506: Uptake and distribution of residues in confined

rotational crops following treatment at 25 g ai/Acre

Ciba-Geigy Corp., Greensboro, USA.


GLP, not published

Syngenta File No. No CGA173506/0967

N N n/a Syngenta

KCA 6.6.1 Thalacker, F.W. 1996 14C-CGA-173506: Uptake and distribution of residues in

confined rotational crops following treatment at 50 g ai/Acre.

Ciba Crop Protection.

Ciba-Geigy Corporation, Vero Beach, FL 32967

Report No. CHW 6117-329

N N n/a Syngenta



Page 77 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protection

claimed

Y/N


claimed

Owner

GLP, not published

Syngenta File No. GCA173506/0731

KCA 6.6.2 Joseph, T.A. 1999 CGA-219417 and CGA 173506 – Field accumulation in

rotational crops.

Novartis Crop Protection Inc., Greensboro, NC 27419

Report No. 174-97

GLP, not published


N N n/a Syngenta

KCA 6.3 E Altenburger 1991 CGA 173506, wheat, Switzerland Syngenta File No.

CGA173506/0075, Syngenta Report No. 2028/89

N N n/a Syngenta

KCA 6.3 E Altenburger 1991 CGA 173506, FS 025, A-8207 B, Wheat, Switzerland Syngenta

File No. CGA173506/1171, Syngenta Report No. 2030/89

N N n/a Syngenta

KCA 6.3 F Brandl 1993 CGA 173506, Atlas FS, A-8207 A, Summer wheat, Germany

Syngenta File No. CGA173506/0676, Syngenta Report No. gr

10191

N N n/a Syngenta



40191

N N n/a Syngenta



70191

N N n/a Syngenta

KCA 6.3 Brandl, F 1993 CGA 173506, Atlas FS, A-8207, Summer wheat, Germany

Ciba-Geigy GmbH, Frankfurt a.Main, Germany

gr 30192, 02.04.1993

GLP, not published

Syngenta File N° CGA173506/0680

N N n/a Syngenta

KCA 6.3 Brandl, F 1993 CGA 173506, Atlas FS, A-8207, Winter wheat, Germany


gr 40292, 02.04.1993

GLP, not published


N N n/a Syngenta

KCA 6.3 Brandl, F 1993 CGA 173506, Atlas FS, A-8207, Summer wheat, Germany


gr 60192, 02.04.1993

GLP, not published


N N n/a Syngenta

KCA 6.3 Brandl, F 1993 CGA 173506, Atlas FS, A-8207, Winter wheat, Germany


gr 70292, 02.04.1993

N N n/a Syngenta



Page 78 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protection

claimed

Y/N


claimed

Owner

GLP, not published


KCA 6.3 Brandl, F 1993 CGA 173506, Atlas FS, A-8207 A, Summer wheat, Germany


gr 20192, 02.04.1993

GLP, not published


N N n/a Syngenta

KCA 6.3 Brandl, F 1993 CGA 169374 + CGA 173506, Landor C, A-8532 A, FS, Summer

Wheat, Germany


gr 20292, 13.04.1993

GLP, not published


N N n/a Syngenta

KCA 6.3 Brandl, F 1993 CGA 169374 + CGA 173506, Landor C, A- 8532 A, FS, Summer

Wheat, Germany


gr 30292, 13.04.1993

GLP, not published


N N n/a Syngenta

KCA 6.3 Brandl, F 1993 CGA 169374 + CGA 173506, LANDOR C, A-8532 A, FS, Win-

ter wheat, Germany

Ciba-Geigy GmbH, Frankfurt a. Main, Germany

gr 40392, 13.04.1993

GLP, not published


N N n/a Syngenta

KCA 6.3 Brandl, F 1993 CGA 169374 + CGA 173506, LANDOR C, A-8532 A, FS,

Summer wheat, Germany


gr 60292, 13.04.1993

GLP, not published


N N n/a Syngenta

KCA 6.3 Brandl, F 1993 CGA 169374 + CGA 173506, LANDOR C, A-8532 A, FS, Win-

ter wheat, Germany


gr 70392, 02.04.1993

GLP, not published


N N n/a Syngenta


wheat, Germany

N N n/a Syngenta



Page 79 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protection

claimed

Y/N


claimed

Owner


gr 10291, 13.04.1994

GLP, not published



Wheat, Germany


gr 40291, 02.04.1993

GLP, not published


N N n/a Syngenta


Wheat, Germany


gr 70291, 02.04.1993

GLP, not published


N N n/a Syngenta

KCA 6.3 A Kühl 1994 Feldversuche zur Bestimmung der Ruckstande von CGD 20400 F

in Weizen


Report No. gr 6893

N N n/a Syngenta

KCA 6.3 M Maffezzoni 1994 CGA 173506 + Tefluthrine + Anthraquinone, Wheat (grain,

straw), France


Report No. OS94402

N N n/a Syngenta

KCA 6.3 J C Argento 1995 Determination of Residues of CGA 173506 and CGA 169374 in

Wheat (Grains and Straw)


Report No. OS94405

N N n/a Syngenta

KCA 6.3 R Pointurier 1998 Magnitude of Residues of CGA 173506, CGA 169374 and

Tefluthrin in Wheat Grains and Straw after Application of

Formulation ES 0428 FS 320 on Seed


Report No. OS97401/AC99

N N n/a Syngenta

KCA 6.3 R Pointurier 1998 Magnitude of Residues of CGA 173506, CGA 169374 and




Report No. OS97401/KJ99

N N n/a Syngenta

KCA 6.3 R Pointurier 1998 Magnitude of Residues of CGA173506, CGA 169374 and N N n/a Syngenta



Page 80 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protection

claimed

Y/N


claimed

Owner




Report No. OS97401/SJ99

KCA 6.3 R Pointurier 1999 Residue Study with CGA 293343 + CGA 173506 + CGA 169374

in or on Winter Wheat in North of France


Report No. 9840301

N N n/a Syngenta


in or on Winter Wheat in North of France


Report No. 9840302

N N n/a Syngenta


+ Tefluthrin in or on Winter Wheat in North of France


Report No. 9840401

N N n/a Syngenta


+ Tefluthrin in or on Winter Wheat in North of France


Report No. 9840402

N N n/a Syngenta


+ Tefluthrin in or on Winter Wheat in South of France


Report No. 9840403

N N n/a Syngenta


+ Tefluthrin in or on Winter Wheat in South of France


Report No. 9840404

N N n/a Syngenta

KCA 6.3 R Pointurier 2000 Residue Study with CGA 293343 + Fludioxonil in or on Wheat in

North of France


Report No. 9940201

N N n/a Syngenta

KCA 6.3 R Pointurier 2000 Residue study with CGA 293343 + Fludioxonil + Difenoconazole

+ Tefluthrine in or on Wheat in North of France


Report No. 9940301

N N n/a Syngenta

KCA 6.3 R Pointurier 2000 Residue study with CGA 293343 + fludioxonil + difenoconazole

+ teflutrine in or on wheat in north of France


N N n/a Syngenta



Page 81 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protection

claimed

Y/N


claimed

Owner

Report No. 9940302

KCA 6.3 R Pointurier 2000 Residue study with CGA 293343 + fludioxonil + difenoconazole

+ teflutrine in or on wheat in south of France


Report No. 9940304

N N n/a Syngenta

KCA 6.3 R Pointurier 2000 Residue Study with CGA 293343 + Fludioxonil +

Difenoconazole in or on Wheat in South of France Syngenta File

No. CGA169374/2033

Report No. 9940401

N N n/a Syngenta

KCA 6.3 R Pointurier 2000 Residue Study with CGA 293343 + Fludioxonil +

Difenoconazole in or on Wheat in South of France Syngenta File

No. CGA169374/2034

Report No. 9940402

N N n/a Syngenta

KCA 6.3 R Pointurier 2000 Residue Study with CGA 293343+CGA 173506+CGA

169374+Tefluthrin in or on Spring Wheat in North of France


Report No. 9840501

N N n/a Syngenta

KCA 6.3 R Pointurier 2000 Residue Study with CGA 293343+CGA 173506+CGA

169374+Tefluthrin in or on Spring Wheat in North of France


Report No. 9840502

N N n/a Syngenta


in or on Spring Wheat in North of France


Report No. 9840601

N N n/a Syngenta


in or on Spring Wheat in North of France


Report No. 9840602

N N n/a Syngenta

KCA 6.3 R Pointurier 2000 Residue Study with CGA 293343+CGA 173506+CGA 169374+

Tefluthrin in or on Spring Wheat in South of France


Report No. 9840503

N N n/a Syngenta


+ Tefluthrin in or on Spring Wheat in South of France


Report No. 9840504

N N n/a Syngenta


in or on Spring Wheat in South of France

N N n/a Syngenta



Page 82 /83



Year Title

Company Report No.


GLP or GEP status

Published or not

Verte-

brate

study

Y/N

Data

protection

claimed

Y/N


claimed

Owner


Report No. 9840603


in or on Spring Wheat in South of France


Report No. 9840604

N N n/a Syngenta



Page 83 /83


List of data submitted by the applicant and not relied on

Documents

HET COLLEGE VOOR DE TOELATING VAN ......Ede, 1 februari 2019 Het College voor de toelating van voor deze: de voorzitter, Ir. J.F. de Leeuw A9459C / Maxim 480 FS Page Part A - Registration