HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

1. BESLUIT

Op 2 december 2014 is van

Syngenta Crop Protection B.V. Postbus 512

4600 AM BERGEN OP ZOOM

een aanvraag tot toelating ontvangen als bedoeld in artikel 33 Verordening (EG) 1107/2009 (verder te noemen: de Verordening) voor het gewasbeschermingsmiddel

Alibi Flora

op basis van de werkzame stoffen azoxystrobine en difenoconazool. Nederland is in deze een betrokken lidstaat, als bedoeld in artikel 36, tweede lid; de beoordelend lidstaat is het Verenigd Koninkrijk.

HET COLLEGE BESLUIT tot toelating van bovenstaand middel.

Alle bijlagen, waaronder registratierapport deel A en deel B, vormen een onlosmakelijk onderdeel van dit besluit.

1.1 Samenstelling, vorm en verpakking

De toelating geldt uitsluitend voor het middel in de samenstelling, vorm en de verpakking als waarvoor de toelating is verleend.

1.2 Gebruik

Het middel mag slechts worden gebruikt volgens het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in deel A van het registratierapport, Appendix I.

1.3 Classificatie en etikettering

Mede gelet op de onder “wettelijke grondslag” vermelde wetsartikelen, dienen alle volgende aanduidingen en vermeldingen conform de geldende regelgeving op of bij de verpakking te worden vermeld:

▪ De aanduidingen, letterlijk en zonder enige aanvulling, zoals vermeld onder “verpakkingsinformatie” in bijlage I.

▪ Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in deel A van het registratierapport, Appendix I.

▪ Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen.

▪ De classificatie die overeenkomstig het toelatingsbesluit is vastgesteld, moet volgens de voorschriften op de verpakking worden vermeld, zoals beschreven in bijlage II en in hoofdstuk 2 van deel A van het registratierapport.

1.4 Aflever- en opgebruiktermijn (respijtperiode)

Niet van toepassing. Het betreft een nieuwe toelating.

2. WETTELIJKE GRONDSLAG

Besluit

artikel 28 en artikel 36, derde lid, van de Verordening (EG)

1107/2009

Classificatie en etikettering

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

Gebruikt toetsingskader

Bgb en Rgb d.d. 16 december 2011 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.

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, 6 september 2019

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

de voorzitter,

Ir. X.X. xx Xxxxx

BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING

2.1 Aanvraaginformatie

Aanvraagnummer: 20140162 NLTG

Type aanvraag: aanvraag tot nationale toelating gewasbeschermingsmiddel (NL=CMS)

Middelnaam: Xxxxx Xxxxx

Verzenddatum aanvraag: 27 januari 2014

Formele registratiedatum: * 18 december 2014

Datum in behandeling name: 3 mei 2018

Datum compliance check: n.v.t.

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

2.2 Stofinformatie

Werkzame stof Gehalte

azoxystrobine 200 g/L

difenoconazool 125 g/L

• De stof azoxystrobine is per 1 januari 2012 goedgekeurd volgend Verordening (EC) 1107/2009 (Uitvoeringsverordening (EU) 703/2011 d.d. 20 juli 2011). De goedkeuring van deze werkzame stof expireert op 31 december 2024 (Uitvoeringsverordening (EU) 2019/291 d.d. 19 februari 2019).

• De stof difenoconazool is per 1 januari 2009 geplaatst op Xxxxx X van Richtlijn 91/414/EEG (2008/69/EC d.d. 1 juli 2008) en vervolgens bij Uitvoeringsverordening (EU) 540/2011 d.d. 25 mei 2011 goedgekeurd. De voorwaarden voor goedkeuring zijn aangepast bij Uitvoeringsverordening (EU) 1100/2011 d.d. 31 oktober 2011. De goedkeuring van deze werkzame stof expireert op 31 december 2019 (Uitvoeringsverordening (EU) 2018/1796 d.d. 20 november 2018).

2.3 Toelatingsinformatie

Toelatingsnummer: 15909 N

Expiratiedatum: 31 december 2020

Afgeleide parallel of origineel: Origineel

Biocide, gewasbeschermingsmiddel of toevoegingsstof: Gewasbeschermingsmiddel

Gebruikers: Professioneel

2.4 Verpakkingsinformatie

Aard van het preparaat:

Suspensie concentraat

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

BIJLAGE II Etikettering van het middel Alibi Flora

Professioneel gebruik

de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel: 1,2-benzisothiazool-3(2H)-on

Pictogram GHS07

GHS09

Signaalwoord Waarschuwing Gevarenaanduidingen H302 Schadelijk bij inslikken.

H332 Schadelijk bij inademing.

H317 Kan een allergische huidreactie veroorzaken.

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

Voorzorgsmaatregelen P261 Inademing van stof/rook/gas/nevel/damp/spuitnevel vermijden.

P280 Beschermende handschoenen/beschermende kleding/oogbescherming/gelaatsbescherming dragen.

P302 + P352 BIJ CONTACT MET DE HUID: Met veel water/... wassen. P304 + P340 NA INADEMING: de persoon in de frisse lucht brengen en ervoor zorgen dat deze gemakkelijk kan ademen.

P312 Bij onwel voelen een ANTIGIFCENTRUM/arts/... raadplegen. P333 + P313 Bij huidirritatie of uitslag: een arts raadplegen.

P391 Gelekte/gemorste stof opruimen. P501 Inhoud/verpakking afvoeren naar ....

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

Aanvullende etiketelementen

EUH401 Volg de gebruiksaanwijzing om gevaar voor de menselijke gezondheid en het milieu te voorkomen.

Kinderveilige sluiting verplicht Nee Voelbare gevaarsaanduiding verplicht Nee

REGISTRATION REPORT

Part A

Detailed summary of the risk assessment

Alibi Flora (A13703G)

Azoxystrobin : 200 g/L Difenoconazole : 125 g/L

Central Zone

Zonal Rapporteur Member State: UK

NATIONAL ADDENDUM – Netherlands

Applicant: Syngenta Date: August 2019 Evaluator: Ctgb, NL

The summaries and evaluations contained in this registration report may be based on unpublished proprietary data submitted for the purpose of the assessment undertaken by the regulatory authority that prepared it. Other registration authorities should not grant, amend, or renew a registration on the basis of the summaries and evaluation of unpublished proprietary data contained in this registration report unless they have received the data on which the summaries and evaluation are based, either:

From the owner of the data, or

• From a second party that has obtained permission from the owner of the data for this purpose or, alternatively, the applicant has received permission from the data owner that the summaries and evaluation contained in this registration report may be used in lieu of the data, or

• Following expiry of any period of exclusive use, by offering, in certain jurisdictions, mandatory compensation,

unless the period of protection of the proprietary data concerned has expired.

Applicants wishing to avail of information in this registration report should seek advice from the regulatory authority to which application is made concerning the requirements in their country.

PART A - Risk Management

This document describes the acceptable use conditions required for the authorisation in The Netherlands of product Xxxxx Xxxxx, for field and greenhouse use on ornamentals, containing:

• (200 g/L) Azoxystrobin which was included into Annex I of Council Directive 91/414/EEC (Commission Directive 1998/47/EC; 7 July 1998) and for which a renewal of this inclusion was voted by SCoFCAH on 9 July 2010 (Commission Directive 2010/55/EU; 20 August 2010). This active substance is an approved active substance under Regulation (EC) 1107/2009 (repealing Commission Directive 91/414/EEC) as specified in Commission Implementing Regulation (EU) No. 703/2011 of 20 July 2011, amending the Annex to Commission Implementing Regulation (EU) No. 540/2011 of 25 May 2011.

• (125 g/L) Difenoconazole which was included into Annex I of Council Directive 91/414/EEC (Commission Directive 2008/69/EU; 1 July 2008). This active substance is an approved active substance under Regulation (EC) 1107/2009 (repealing Commission Directive 91/414/EEC) as specified in Commission Implementing Regulation (EU) No. 1100/2011 of 31 October 2011, amending the Annex to 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 the Registration Report, Part B Sections 1-7 and Part C (core assessment) as well as in the national addendum of Part B for the Netherlands, where appropriate. The information, data and assessments provided in Registration Report, Part B include assessment of further data or information as required at national level for a new product authorisation. It also includes assessment of data and information relating to Alibi Flora where that data have not been considered in the EU review process. Otherwise assessments for the safe use of Alibi Flora have been made using endpoints agreed in the EU review of azoxystrobin or difenoconazole.

A National Addendum has been prepared to address specific national requirements that differ from standard European approaches, in order to meet the national requirements for product authorisation in The Netherlands. The National addendum also addresses intended use of the formulation Alibi Flora, which differs slightly from the core assessment pattern and can be found in detail in Appendix 2.

This document describes the specific conditions of use and labelling required for the Netherlands for the authorisation of the product Alibi Flora for use on ornamental (lawn and garden uses). The protected uses were addressed in a separated dossier from the field uses ones, both assigned to the UK as Zonal RMS.

Appendix 1 of this document provides a copy of the proposed product label for The Netherlands. Appendix 2 of this document provides a list of data in support of the evaluation.

1 DETAILS OF THE APPLICATION

1.1 Application Background

This application was submitted by Syngenta.

The application was for authorisation of the product Alibi Flora, a suspension concentrate (SC) containing 200 g/L Azoxystrobin and 125 g/L Difenoconazole, for use as a fungicide on ornamentals both on the field and greenhouses (protected uses). Two separated dossiers were submitted by the applicant:

- Central zone core assessment and National Addendum for field uses;

- Interzonal dossier for protected uses.

This formulation was not the representative formulation in the EU review of azoxystrobin or difenoconazole. The product has not been previously evaluated according to Uniform Principles.

This formulation is already authorised in the Netherlands for foliar application on a broad range of edible crops, i.e. different uses than ornamentals (Amistar Top; 13197 N).

1.2 Annex I Inclusion

Azoxystrobin

The EFSA report for the renewal of the inclusion of azoxystrobin (EFSA Journal (2010) 8(4), 1542), and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 9 July 2010, is considered to provide the relevant review information.

The Commission Implementing Regulation (EU) No. 703/2011 of 20 July 2011 provides specific provisions for azoxystrobin which need to be considered by the applicant in the preparation of their submission and by the MS prior to granting an authorisation.

Member States must pay particular attention to:

• the specification of the technical material as commercially manufactured must be confirmed and supported by appropriate analytical data. The test material used in the toxicity dossiers should be compared and verified against this specification of the technical material;

• the potential for groundwater contamination, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

• the protection of aquatic organisms.

Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones.

The submission of further studies should be requested to finalise the risk assessment of groundwater and aquatic organisms. These studies were provided to the Commission and are under evaluation.

These specific concerns are addressed within the current submission.

Difenoconazole

The EFSA report for the inclusion of difenoconazole (EFSA Journal 2011; 9(1): 1967), and in particular Appendices thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 September 2011, is considered to provide the relevant review information.

The Commission Implementing Regulation (EU) No. 1100/2011 of 31 October 2011 provides specific provisions for difenoconazole which need to be considered by the applicant in the preparation of their submission and by the MS prior to granting an authorisation.

Member States must pay particular attention to:

• the protection of aquatic organisms

Conditions of authorisation should include risk mitigation measures, where appropriate, such as buffer zones. These specific concerns are addressed within the current submission.

1.3 Regulatory Approach

To obtain approval the product Alibi Flora must (where appropriate) meet the conditions of EU inclusion and be supported by dossiers satisfying the requirements of Commission Regulation (EU) Nos. 283/2013 and 284/2013, which adopt the requirements of Xxxxx XX and Xxxxx XXX, and the Uniform Principles (Annex VI) to Regulation (EC) 1107/2009.

This application was submitted in order to allow the approval of this product in the Netherlands in accordance with the above.

1.4 Data Protection Claims

Where protection for data is being claimed for information supporting registration of Alibi Flora, it is indicated in the reference lists in Appendix 2.

1.5 Letters of Access

Where Syngenta has provided the supporting data, the ownership of the data is indicated in the reference lists in Appendix 2.

2 DETAILS OF THE AUTHORISATION

2.1 Product Identity

Product Name	Alibi Flora A13703G (product code)
Authorisation Number (for re-registration)	Not applicable (new authorisation)
Function	Fungicide
Applicant	Syngenta Crop Protection B.V.
Composition	200 g/L azoxystrobin 125 g/L difenoconazole
Formulation type	Suspension concentrate [Code: SC]
Packaging	250 ml, 500 ml, 1L, 5L or 10L HDPE canisters or 250ml PET canister

2.2 Classification and labelling according to Regulation (EC) 1272/2008

Based on the profile of the substance, the provided toxicology of the preparation, the characteristics of the co-formulants, the method of application and the risk assessment for the operator, as mentioned above, the following labeling of the preparation is proposed:

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

1,2-benzisothiazol-3(2H)-one

Pictogram: GHS07 Signal word: Warning

GHS09

H-statements: H302 Harmful if swallowed.

H332 Harmful if inhaled.

H317 May cause an allergic skin reaction.

H410 Very toxic to aquatic life with long lasting effects. P-statements: P261 Avoid breathing dust/fume/gas/mist/vapours/spray.

P280 Wear protective gloves/protective clothing/eye protection/face protection.

P302+P352 IF ON SKIN: Wash with plenty of water/...

P304+P340 IF INHALED: Remove person to fresh air and keep comfortable for breathing.

P312 Call a POISON CENTER/doctor/… if you feel unwell.

P333+P313 If skin irritation or rash occurs: Get medical advice/attention.

P391 Collect spillage.

P501 Dispose of contents/container to ....

Supplemental Hazard information:

EUH401 To avoid risks to human health and the environment, comply with the instructions for use.

SP1 Do not contaminate water with the product or its container.

Child-resistant fastening obligatory? not applicable

Tactile warning of danger obligatory? not applicable

Explanation:

Pictogram: -

H-statements: -

P-statements: P280c (gloves and coverall) also required based on risk

assessment. The other P-statements were proposed by the applicant and are accepted.

Other: -

*According to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)

2.3 Product Uses

Use- No.

(e)

Member state(s)

Crop and/ or situation

(crop destination / purpose of crop)

Fn, Fpn G,

Gn, Gpn or

Pests or Group of pests controlled

(additionally: developmental stages of the pest or pest group)

Application

Application rate

PHI

(days)

Remarks:

e.g. g safener/synergist per ha

(f)

Method / Kind

Timing / Growth stage of crop & season

Max. number

a) per use

b) per crop/ season

Min. interval between applications (days)

L A13703G /

a) max. rate per appl.

b) max. total rate per crop/season

g a.s./ha

a) max. rate per appl.

b) max. total rate per crop/season

Water L/ha

min / max

Zonal uses (field or outdoor uses, certain types of protected crops)

Pot plants

Powdery mildew

Foliar

At occurence BBCH 20-39

BBCH 50-92

Apr-Oct

a) 2

b) 2

a) 0.9

b) 1.8/year

a) 180 AZT 112 DFZ

b) 360 AZT 225 DFZ

200 /

900

n/a

Label claim is fixed concentration of 0.1

Cut flowers

Powdery mildew

Foliar

At occurence BBCH 20-39

BBCH 50-92

Apr-Oct

a) 2

b) 2

a) 0.9

b) 1.8/year

a) 180 AZT 112 DFZ

b) 360 AZT 225 DFZ

200 /

900

n/a

Label claim is fixed concentration of 0.1

Tree nurseries

Powdery mildew

Foliar Up and side wards

At occurence BBCH 40-92

Apr-Oct

a) 2

b) 2

a) 0.9

b) 1.8/year

a) 180 AZT 112 DFZ

b) 360 AZT 225 DFZ

200 /

900

n/a

Label claim is fixed concentration of 0.1

Tree nurseries (Shrubs)

Powdery mildew

Foliar Down wards

At occurence BBCH 50-92

Apr-Oct

a) 2

b) 2

a) 1.0

b) 2.0/year

a) 200 AZT 125 DFZ

b) 400 AZT 250 DFZ

200 /

1000

n/a

Label claim is fixed concentration of 0.1

Perennials

Powdery mildew

Foliar

At occurence BBCH 20-39

BBCH 50-92

Apr-Oct

a) 2

b) 2

a) 0.9

b) 1.8/year

a) 180 AZT 112 DFZ

b) 360 AZT 225 DFZ

200 /

900

n/a

Label claim is fixed concentration of 0.1

Flower seed crops

Powdery mildew

Foliar

At occurence

a) 2

a) 0.9

a) 180 AZT

200 /

n/a

Label claim is fixed

Use- No.

(e)

Member state(s)

Crop and/ or situation

(crop destination / purpose of crop)

Fn, Fpn G,

Gn, Gpn or

Pests or Group of pests controlled

(additionally: developmental stages of the pest or pest group)

Application

Application rate

PHI

(days)

Remarks:

e.g. g safener/synergist per ha

(f)

Method / Kind

Timing / Growth stage of crop & season

Max. number

a) per use

b) per crop/ season

Min. interval between applications (days)

L A13703G /

a) max. rate per appl.

b) max. total rate per crop/season

g a.s./ha

a) max. rate per appl.

b) max. total rate per crop/season

Water L/ha

min / max

BBCH 20-39

BBCH 50-92

Apr-Oct

b) 2

b) 1.8/year

112 DFZ

b) 360 AZT 225 DFZ

900

concentration of 0.1

Interzonal uses (use as seed treatment, in greenhouses (or other closed places of plant production), as post-harvest treatment or for treatment of empty storage rooms)

Pot plants

(non-soil bound)

Powdery mildew

Foliar

At occurence BBCH 12-92

Jan-Dec

a) 3 / cycle

b) 15 / year

a) 1.2

b) 3.6/cycle 18/year

a) 240 AZT 150 DFZ

b) 3600 AZT 2250 DFZ per year

200 /

1200

n/a

No emission to the ground.

Label claim is fixed concentration of 0.1

Pot plants (soil-bound)

Powdery mildew

Foliar

At occurence BBCH 20-92

Jan-Dec

a) 2

b) 2

a) 0.9

b) 1.8/year

a) 180 AZT 112 DFZ

b) 360 AZT 225 DFZ

200 /

900

n/a

Label claim is fixed concentration of 0.1

Cut flowers, excluding rose

(non-soil bound)

Powdery mildew

Foliar

At occurence BBCH 12-92

Jan-Dec

a) 3 / block or cycle

b) 15 / year

7 within a block

21 between blocks

a) 1.5

b) 4.5/cycle 22.5/year

a) 300 AZT 187 DFZ

b) 4500 AZT 2812 DFZ

500 /

1500

n/a

Substrate cultivation

Label claim is fixed concentration of 0.1

Cut flowers, rose (non- soil bound )

Powdery mildew Sphaerotheca pannosa (SPHRPA)

Foliar

At occurence BBCH 12-92

Jan-Dec

a) 2 / block Mar- May 3/block Jun-Nov

b) 5 / year

7 within a block 120

between blocks

a) 3.0

b) 15/year

a) 600 AZT 375 DFZ

b) 3000 AZT 1875 DFZ

500 /

3000

n/a

Substrate cultivation

Label claim is fixed concentration of 0.1

Use- No.

(e)

Member state(s)

Crop and/ or situation

(crop destination / purpose of crop)

Fn, Fpn G,

Gn, Gpn or

Pests or Group of pests controlled

(additionally: developmental stages of the pest or pest group)

Application

Application rate

PHI

(days)

Remarks:

e.g. g safener/synergist per ha

(f)

Method / Kind

Timing / Growth stage of crop & season

Max. number

a) per use

b) per crop/ season

Min. interval between applications (days)

L A13703G /

a) max. rate per appl.

b) max. total rate per crop/season

g a.s./ha

a) max. rate per appl.

b) max. total rate per crop/season

Water L/ha

min / max

Cut flowers (soil-bound)

Powdery mildew

Foliar

At occurence BBCH 20-92

Jan-Dec

a) 2

b) 2

a) 0.9

b) 1.8/year

a) 180 AZT 112 DFZ

b) 360 AZT 225 DFZ

500 /

900

n/a

Label claim is fixed concentration of 0.1

Tree nurseries (non-soil bound)

Powdery mildew

Foliar Up and side wards

At occurence BBCH 12-92

Jan-Dec

a) 3

b) 3

a) 1.2

b) 3.6/year

a) 240 AZT 150 DFZ

b) 720 AZT 450 DFZ

200 /

1200

n/a

No emission to the ground.

Label claim is fixed concentration of 0.1

Tree nurseries (soil-bound)

Powdery mildew

Foliar Up and side wards

At occurence BBCH 12-92

Jan-Dec

a) 2

b) 2

a) 0.9

b) 1.8/year

a) 180 AZT 112 DFZ

b) 360 AZT 225 DFZ

200 /

900

n/a

Label claim is fixed concentration of 0.1

Tree nurseries (Shrubs) (non-soil bound)

Powdery mildew

Foliar Down wards

At occurence BBCH 12-92

Jan-Dec

a) 3

b) 3

a) 1.2

b) 3.6/year

a) 240 AZT 150 DFZ

b) 720 AZT 450 DFZ

200 /

1200

n/a

No emission to the ground

Label claim is fixed concentration of 0.1

Tree nurseries (Shrubs) (soil-bound)

Powdery mildew

Foliar Down wards

At occurence BBCH 12-92

Jan-Dec

a) 2

b) 2

a) 1.0

b) 2.0/year

a) 200 AZT 125 DFZ

b) 400 AZT 250 DFZ

200 /

1000

n/a

Label claim is fixed concentration of 0.1

Perennials

(non-soil bound)

Powdery mildew

Foliar

At occurence BBCH 12-92

Jan-Dec

a) 3

b) 3

a) 1.0

b) 3.0/year

a) 200 AZT 125 DFZ

b) 600 AZT

200 /

1000

n/a

No emission to the ground.

Label claim is fixed

Use- No.

(e)

Member state(s)

Crop and/ or situation

(crop destination / purpose of crop)

Fn, Fpn G,

Gn, Gpn or

Pests or Group of pests controlled

(additionally: developmental stages of the pest or pest group)

Application

Application rate

PHI

(days)

Remarks:

e.g. g safener/synergist per ha

(f)

Method / Kind

Timing / Growth stage of crop & season

Max. number

a) per use

b) per crop/ season

Min. interval between applications (days)

L A13703G /

a) max. rate per appl.

b) max. total rate per crop/season

g a.s./ha

a) max. rate per appl.

b) max. total rate per crop/season

Water L/ha

min / max

375 DFZ

concentration of 0.1

Flower seed crops

Powdery mildew

Foliar

At occurence BBCH 12-92

Jan-Dec

a) 2

b) 2

a) 0.9

b) 1.8/year

a) 180 AZT 112 DFZ

b) 360 AZT 225 DFZ

200 /

900

n/a

Label claim is fixed concentration of 0.1

3 RISK MANAGEMENT

3.1 Reasoned Statement of the Overall Conclusions taken in accordance with the Uniform Principles

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

The product Alibi Flora is a suspension concentrate (SC). All studies have been performed in accordance with the current requirements and the critical GAP; the results are deemed to be acceptable.

The appearance of the product is that of a yellow, liquid with an aromatic odour. It is not explosive and has no oxidising properties. It is not flammable as the flash-point is >100°C. It is considered not to have self-heating properties as the auto-flammability temperature is 505°C. In aqueous solution, it has a pH value of 6.7 (1% suspension) and the neat formulation has a pH of 7.9. The kinamtic viscosity at 40°C is

88.7 mm2/s, wth no hydrocarbons (H304 classified components) present in the formulation. The surface tension at 1 g/L, 8 g/L, 17 g/L and undiluted is respectively 31.6 mN/m, 28.7 mN/m, 28.4 mN/m and 27.9 mN/m and therefore the formulation is considered to be surface active. The density at 20°C is 1.105 g/mL. The storage stability data at high (14 days at 54°C and 8 weeks at 40°C), ambient ( 2years at ambient temperature) and low temperature (7 days at 0°C) in HDPE and PET packaging were found to be acceptable, as the active substance content did not decrease >5%. The relevant impurity (Z-isomer of azoxystrobin) content did not increase above the maximum content of 25 g/kg (intial and after storage 0.03% or 0.3 g/kg) and the physical, chemical and technical properties did not change significantly after storage. Therefore, a 2 year shelf-life at ambient temperature in HDPE and PET packing can be granted. The technical characteristics of Alibi Flora are acceptable for a suspension concentrate (SC) formulation.

According to Regulation (EC) No 1272/2008 as amended, the physico-chemical properties for Alibi Flora do not require it to be classified.

Compliance with FAO specifications: The product Alibi Flora complies with FAO specifications.

Compatibility of mixtures: No data have been provided regarding the physical and chemical compatibility of tank mixes, as not tank mixtures are proposed on the product label.

Nature and characteristics of the packaging: The core packaging proposed for Alibi Flora is 250 ml, 500 ml, 1L, 5L or 10L HDPE canisters, 5L or 10 L refillable containers, or 250 ml PET. Information/data on this packaging type, dimensions, capacity, size of opening, type of closure, strength, leakproofness, resistance to normal transport and handling, resistance to and compatibility with the contents of the packaging, have been submitted, evaluated and are considered to be acceptable.

Nature and characteristics of the protective clothing and equipment: Information regarding the required protective clothing and equipment for the safe handling of Alibi Flora has been provided and is considered acceptable.

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

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

The analytical method for determination of azoxystrobin and difenoconazole in Alibi Flora has been found to be acceptably validated according to SANCO/3030/99 rev. 4.

Two relevant impurities Z-isomer of azoxystrobin and toluene have been identified in technical azoxystrobin, therefore the analytical methods for the determination of these relevant impurities in Alibi Flora have been provided by the applicant, however not evaluated by the RMS. It was concluded by the RMS that under the data requirements 545/2011, no analytical methods need to be provided if it could be shown that the relevant impurities could not form/increase up on manufacturing or storage of the formulation. Moreover, the applicant has provided data on the content of the relevant impurity Z-isomer of azoxystrobin before and after storage after 14 days at 54°C in the formulation Alibi Flora. The content did not increase (content was stable at .03% before and after storage) and was below the maximum content of 25 g/kg set in the implementing regulation after renewal Reg. (EU) 703/2011. As the application was done in December 2014, therefore the old data requirement (545/2011) still apply and it is justified that the relevant impurities z-isomer of azoxystrobin and toluene would not form/increase after storage no analytical methods are required and don’t have to be evaluated.

CIPAC method 571 for azoxystrobin in SC formulations is, see CIPAC Handbook M, page 10. There are no CIPAC methods available for the determination of difenoconazole.

There are no CIPAC methods available for the determination of azoxystrobin and difenoconazole in mixed SC formulations.

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

Methods for crops and animal products: Analytical methods are active substance data and were evaluated during the EU review of azoxystrobin and difenoconazole. No additional studies were provided for this submission. Moreover, the supported uses of Alibi Flora only include ornamentals, which are plant matrices not intende to be used for human consumption or feed for livestock, therefore no residues data in/on crops and animals are considered necessary.

Methods for soil, water and air: Analytical methods are active substance data and were evaluated during the EU review of azoxystrobin and difenoconazole. Additional data on methods/validation in water for azoxystrobin have been developed and have been provided, however not evaluated by the RMS. This is considered acceptable as sufficient data is available in the active substance dossiers, thereforeall data are considered adequate.

The analytical method for the determination of azoxystrobin residues in surface water is compliant with Dutch national requirements (LOQ ≤ 0.1 µg/L for azoxystrobin).

The analytical method for the determination of difenoconazole residues in surface water is compliant with Dutcgh national requirements (LOQ ≤ 0.1 µg/L for difenoconazole).

Methods for body fluids and tissues:

Azoxystrobin: The EU review (EFSA Journal (2010) 8 (4) 1542) identified a data gap for an adequate analytical method for body fluids and tissues as azoxystrobin is currently classified as Toxic (T). These data have been provided and are considered to be adequate.

Difenoconazole: Difenoconazole is not classified as toxic or very toxic; therefore no analytical method for body fluids or tissues is required.

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

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

Acute toxicity studies for Alibi Flora have not been evaluated as part of the EU review of azoxystrobin or difenoconazole. Therefore, all relevant data are provided and are considered adequate.

Alibi Flora containing 200 g/L azoxystrobin and 125 g/L difenoconazole has a low toxicity in respect to dermal toxicity and is not irritating to the rabbit skin or eye but is harmful if swallowed, a skin sensitiser and is considered harmful by inhalation.

The classification according to Regulation (EC) No 1272/2008, as amended, is given in the table below.

Table 3.1.3-1: Summary of acute toxicological data obtained with A13703G

Parameter [Reference]	Species	Result	Classification according to Regulation (EC) No 1272/2008 as amended
Acute oral LD50	Rat	LD50 >2000 mg/kg	none
Acute oral LD50	Mouse	LD50 1424 mg/kg	H302
Acute dermal LD50	Rat	LD50 >2000 mg/kg	none
Acute inhalation	Rat	LC50 >2.06 mg/L	H332
Acute skin irritation	Rabbit	non-irritant	none
Acute eye irritation	Rabbit	non-irritant	none
Skin sensitisation	Guinea Pigs	sensitising	H317

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

Operator exposure to A13703G has not been evaluated as part of an EU review for proposed critical use rate/crop. Therefore all relevant data and risk assessments are provided and are considered adequate.

According to the model calculations, it can be concluded that the risk for the operator using Alibi Flora for the proposed uses is acceptable with the use of personal protective equipment – gloves during mixing/loading and application, coverall during application for all outdoor and indoor applications. The risk for the operator using Alibi Flora for the proposed uses without the use of personal protective equipment is not considered acceptable.

This conclusion is also valid for the combined exposure to the two active substances.

Given the skin sensitising potential of Alibi Flora impermeable gloves and eye/face protection should be worn when handling the concentrate. Gloves should also be used for the maintenance of the sprayer during application.

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

Bystander and residential exposure to Xxxxx Xxxxx has not been evaluated as part of an EU review for proposed critical use rate/crop. Therefore all relevant data and risk assessments are provided here and are considered adequate.

Bystander and resident exposure was not addressed in the core, therefore, calculations have been made in the National xxxxxxxx.Xx is concluded that there is no undue risk to any bystander and resident after

incidental exposure to Alibi Flora, either to the separate active substances or combined. This has no labelling implications.

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

Worker exposure to A13703G has not been evaluated as part of an EU review for proposed critical use rate/crop. Therefore all relevant data and risk assessments are provided and are considered adequate.

For the field applications the estimated worker exposure without the use of PPE to azoxystrobin accounts for 65% of the established EU-AOEL and for difenoconazole for 88% of the established EU-AOEL. The combined exposure accounts for 153% of the EU-AOEL. The prescription of PPE is therefore required for the worker in the field (combined exposure with PPE 31%).

For the greenhouse applications the estimated worker exposure without the use of PPE to azoxystrobin accounts for 117% of the established EU-AOEL and for difenocanazole for 345% of the established EU- AOEL and therefore not considered acceptable. The prescription of PPE sufficiently reduces the exposure to 23% of the established EU-AOEL and for difenocanazole for 69% of the established EU-AOEL and therefore considered acceptable. Als the combined exposure to the two active substances is considered acceptable (92% of the AOEL).

Based on the current assessment, the following has to be stated in the GAP/legal instructions for use (in Dutch): Draag geschikte handschoenen bij werkzaamheden aan behandeld gewas.

3.1.4 Residues and consumer exposure (Part B, Section 4, Point 8)

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

Since the use of Alibi Flora on ornamental plants does not present any dietary exposure, the assessment of metabolism and residue data is not relevant to this submission.

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

Since the use of Alibi Flora on ornamental plants does not present any dietary exposure, the assessment of metabolism and residue data is not relevant to this submission.

3.1.5 Environmental fate and behaviour (Part B, Section 5, Point 9.1-9.3, 9.9)

Azoxystrobin: The majority of the data presented were reviewed in the EU review. Additional new data are also provided in this submission, and appropriate endpoints were used to calculate PECS for A13703G, azoxystrobin and its metabolites R401553, R402173 and R234886 in soil, surface water, ground water and air for the intended use patterns.

Difenoconazole: The majority of the data presented were reviewed in the EU review. Additional new data are also provided in this submission, and appropriate endpoints were used to calculate PECS for A13703G, difenoconazole and its metabolite CGA205375 and CGA71019 in soil, surface water, ground water and air for the intended use patterns.

3.1.5.1 Predicted Environmental Concentration in soil (PECS) (Part B, Section 5, Points 9.4 and 9.5)

Azoxystrobin: The PEC of A13703G and azoxystrobin in soil (PECS) has been assessed with the FOCUS groundwater crop interception values1 (as a conservative approach it is assumed that all applications occur at the earliest possible growth stage of application), and the longest DT50 value of 262 days established in the EFSA Conclusion on azoxystrobin (EFSA Journal 2010; 8 (4): 1542).

Based on the recommended use rates of azoxystrobin in various crops, the maximum initial Predicted Environmental Concentration in soil (PECS, initial) will be 0.298 mg/kg (use in ornamentals).

Additionally, calculations of the potential accumulation of azoxystrobin in soil (PECS, peak plateau) were required due to DT90f > 365 days. Applications to shrubs generated the worst case PECS, peak plateau and the minimum plateau calculated for shrubs is considered to represent the worst case plateau (when/as ploughing was not considered). Following year-on-year applications to shrubs, azoxystrobin residues are predicted to reach a minimum plateau (PECS, min plateau) of 0.149 mg/kg in year 14 immediately before the first application of the year and the peak accumulated (PECS, peak accum.) of 0.387 mg/kg immediately after applications in the same year.

The PEC of metabolite R234886, R401553 and R402173 in soil (PECS) has been assessed using FOCUS ground water crop interception values, where appropriate, and the worst case DT50 values either established in the EU review or proposed in Annex Point IIIA 9.1 to 9.3 based on new data provided for this assessment. For R234886, R401553 and R402173 the proposed use patterns will lead to maximum initial PECS of 0.080 mg/kg, 0.014 mg/kg and 0.026 mg/kg, respectively, which are acceptable according to the Uniform Principles.

The results for PECS for the active substance and its metabolites were used for the ecotoxicological risk assessment.

Difenoconazole: The PEC in soil of difenoconazole has been assessed with the FOCUS groundwater crop interception values and the longest DT50 of 265 days established in the EFSA conclusion on difenoconazole (EFSA Journal 2011; 9(1): 1967).

Based on the recommended use rates of difenoconazole in various crops, the maximum initial Predicted Environmental Concentration in soil (PECS, initial) will be 0.182 mg/kg (use in ornamentals).

Additionally, calculations of the potential accumulation of difenoconazole in soil (PECS, peak plateau) were required due to DT90f > 365 days. Applications to shrubs generated the worst case PECS, peak plateau and the minimum plateau calculated for shrubs is considered to represent the worst case plateau (when/as ploughing was not considered). Following year-on-year applications to shrubs, difenoconazole residues are predicted to reach a minimum plateau (PECS, min plateau) of 0.095 mg/kg in year 14 immediately before the first application of the year and the peak accumulated (PECS, peak accum) of 0.243 mg/kg immediately after applications in the same year.

The PEC of metabolite CGA205375 and CGA71019 in soil (PECS, initial) has been assessed using FOCUS groundwater crop interception values for the parent, where appropriate, and the worst case DT50 values either established in the EU review or proposed in Annex Point IIIA 9.2 for CGA71019. For CGA205275

1 FOCUS (2012). Generic Guidance for Tier 1 Groundwater Assessments, Version 2.1, FOCUS Version Control Group, European Commission.

and CGA71019 the proposed use patterns will lead to maximum initial PECS of 0.019 mg/kg and 0.007 mg/kg, respectively, which is acceptable according to Uniform Principles.

The results for PECS for the active substance and its metabolites were used for the ecotoxicological risk assessment.

3.1.5.2 Predicted Environmental Concentration in ground water (PECGW) (Part B, Section 5, Point 9.6)

Groundwater modelling performed by applicant in the Core dossier was not considered by zRMS. Therefore, first tier PECgw calculations using the PEARL 4.4.4 Kremsmünster scenario were performed by CMS. Details regarding input parameters for active substances and metabolites and proposed use patterns are reported in the NL Addendum.

Azoxystrobin The estimated peak groundwater concentrations for azoxystrobin and metabolites R402173 and R401553 are not expected to exceed 0.01 µg/L. Values for the metabolite R234886 are above 0.1 µg/L for ornamentals, shrubs and trees. It was concluded in the DAR of the active substance azoxystrobin that there was deemed to be adequate exposure to R234886 in the in vivo genotoxicity studies conducted with parent azoxystrobin. The parent azoxystrobin was concluded to be non-mutagenic/carcinogenic (EFSA Journal 2010; 8(4):1542.

Following the SANCO guidance document, a refined risk assessment considering all the contributions to the diet has been performed since metabolite R234886 concentrations in groundwater were predicted to be higher than the threshold of concern of 0.75 µg/L. The highest estimated exposure via the drinking water is calculated to be 0.12% of the ADI, which is below the allocation factor of 20% set in the WHO Guidance for drinking-water quality and is therefore considered acceptable.

Difenoconazole Results indicate that the estimated groundwater PEC values for difenoconazole and CGA205375 are below 0.001 µg/L while values for the relevant metabolite CGA71019 are <0.1 µg/L but above the 0.01 µg/L threshold for groundwater protection areas. Consequently, since CGA71019 is a relevant groundwater metabolite, in accordance with the Dutch National Guidelines, the application of Alibi Flora should be prohibited in groundwater protection areas. The following restriction sentence should be applied at the label: Om het grondwater te beschermen mag dit middel niet worden gebruikt in grondwaterbeschermingsgebieden.

Monitoring data groundwater

There are no data available regarding the presence of the substance azoxystrobin and difenoconazole in groundwater (RIVM report 607310001/2007). Also in a more recent report (Grondwaterkwaliteit Nederland 2015-2016, KWR 2017.024, April 2017), azoxystrobin and difenoconazole were not found to exceed the groundwater limit of 0.1 µg/L.

3.1.5.3 Predicted Environmental Concentration in surface water (PECSW) (Part B, Section 5, Points 9.7 and 9.8)

Azoxystrobin: In the Part B Section 5 Addendum for the Netherlands, the PEC of azoxystrobin and its major aquatic metabolite, R234886, in surface water (PECSW and PECSED) due to spray drift has been assessed with the TOXSWA v 1.2 (GUI v1.0) according to Dutch National Guidance (CTGB, 2011, 2014) for field uses (covering the soil-bound greenhouse uses). Additionally PECSW and PECSED simulations using the TOXSWA model v 1.2 covering multiple crop cycles in soil-less applications in greenhouses have been added.

in A13103G on ornamentals and shrubs, while drift rates for ‘high lane trees’, ‘transplanted trees’ and ‘spindle trees’ (CTGB, 2013, 2014) with both standard Dutch spring and autumn scenarios were used to cover all possible growth types relevant for the intended use on trees.

The results for PECSW and PECSED for the active substance and its metabolites were used for the ecotoxicological risk assessment.

Difenoconazole: In the Part B Section 5 Addendum for the Netherlands, the standard PECSW and PECSED of difenoconazole and its aquatic metabolites CGA205375 and CGA71019 in surface water (PECSW and PECSED) due to spray drift has been assessed with the TOXSWA v 1.2 (GUI v1.0) according to Dutch National Guidance (CTGB, 2013, 2014).

The standard Dutch spring water body scenario as implemented in TOXSWA and drift rates for ‘field crops’ and ‘bush and hedge shrubbery’ were used in simulations to cover the intended use of difenoconazole in A13103G on ornamentals and shrubs, while drift rates for ‘high lane trees’, ‘transplanted trees’ and ‘spindle trees’ (CTGB, 2013, 2014) with both standard Dutch spring and autumn scenarios were used to cover all possible growth types relevant for the intended use on trees.

The results for PECSW and PECSED for the active substance and its metabolites were used for the ecotoxicological risk assessment.

Monitoring data surface water

The Pesticide Atlas on internet (xxx.xxxxxxxxxxxxxxx.xx, xxx.xxxxxxxxxxxxxxxxxxxxxxxxx.xx) is used to evaluate measured concentrations of pesticides in Dutch surface water, and to assess whether the observed concentrations exceed threshold values.

Dutch water boards have a well-established programme for monitoring pesticide contamination of surface waters. In the Pesticide Atlas, these monitoring data are processed into a graphic format accessible on- line and aiming to provide an insight into measured pesticide contamination of Dutch surface waters against environmental standards.

Version 3.2 is used for the assessment. This version includes a land use correlation analysis.

Data from the Pesticide Atlas are used to evaluate potential exceeding of the authorisation threshold (RAC).

Regarding a.s. azoxystrobin, 1 locations with 1-5 exceedance of the authorisation threshold was reported. The correlation analysis (land use with exceeding of the RAC) did not show a correlation with the use in ornamentals and nursery tree crops (based on data for the period 2013-2015). Therefore, the observed exceedance of the authorisation threshold does not have consequence for the proposed uses of the product. Regarding a.s. difenoconazole, no exceedance of the authorisation threshold was reported in the Pesticide Atlas.

Drinking water criterion

In the Part B Section 5 Addendum for the Netherlands, the Ctgb drinking water criterion has been assessed for surface water intended for the preparation of drinking water.

Azoxystrobin: Azoxystrobin has been on the Dutch market for >3 years (use in cereals authorised since (at least) 22-11-1996 (Amistar, 11767N). This period is sufficiently long to consider the market share to be established. From the general scientific knowledge collected by the Ctgb about the product and its active substance (azoxystrobin is not on the most recent VEWIN list), the Ctgb concludes that there is no cause for concern about the consequences of this product for surface water from which drinking water is produced, when used in compliance with the directions for use.

Difenoconazole: Difenoconazole has been on the Dutch market for >3 years (used since (at least) 24-02- 1995 (N11544)). This period is sufficiently long to consider the market share to be established. From the general scientific knowledge collected by the Ctgb about the product and its active substance (difenoconazole is not on the most recent VEWIN list), the Ctgb concludes that there is no cause for concern about the consequences of this product for surface water from which drinking water is produced, when used in compliance with the directions for use.

Following this approach, the Ctgb does not expect exceedances of the drinking water criterion because of the intended application of A13703G. The standards for surface water destined for the production of drinking water are met.

3.1.5.4 Predicted Environmental Concentration in air (PECAIR) (Part B, Section 5, Point 9.9)

Azoxystrobin: The fate and behaviour in air of azoxystrobin were evaluated during the EU review. No additional studies have been performed.

Difenoconazole: The fate and behaviour in air of difenoconazole were evaluated during the EU review. No additional studies have been performed.

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

A separated ecotoxicology risk-assessment has been submitted for the non-soil bounded uses in greenhouses (Part B Section 6, interzonal dossier). The soil-bounded uses, field and protected ones, were addressed in the zonal core dossier, and when relevant in the national addendum, as they are considered worst-case scenario for the ecotoxicological assessment, and are here summarised.

3.1.6.1 Effects on terrestrial vertebrates (Part B, Section 6, Points 10.1 and 10.3)

The TER values, calculated for recommended scenarios, all exceeded the trigger value of 10 for acute risk. The long-term TER values for most of the crops exceeded the trigger value of 5 at Tier I scenarios. For those crops that showed long-term TER values below the trigger value, the refined Tier I risk assessment indicated acceptable long-term risk to birds.

Long-term combination toxicity was assessed and was acceptable for small insectivorous/ worm feeding birds (“thrush”) but not for small insectivorous birds (“tit”) for the crop group ornamentals/ nursery. The applicant provided a statement which was not accepted by Ctgb, therefore the applicant is asked to further address the long-term risk for small insectivorous birds.

The main response of the applicant was that the tier 1 risk assessment was too conservative and that the TER of 4.4 was close to the trigger of 5. In response, Ctgb included an uncertainty analyses on this tier 1 risk assessment:

Table 10.1.2 -7 Uncertainty in the tier 1 risk assessment

	Source of uncertainty	Discussion and Conclusion regarding uncertainty	Effect on conservativeness (+ meaning tha the risk assessment is conservative, worst- case)
Crop group	variability	The group of ornamentals and (tree) nurseries is very variable from birds and mammals risk assessment perspective.	-
Focal species	variability	It is unknown which focal species are relevant in the risk assessment. Only insectivorous birds are identified in tier 1; but no information on actual focal species, or species with different feeding guild is available. Tier 1 might both overestimate, but also underestimate the risk.	+/-
Deposition factor	Variability.	Due to the variability in crops (structure) interception is extremely uncertain. However for arthropods only intercepted or non- intercepted RUD values should apply.	-
Combination toxicology	relevance	Both substances have the same effect on birds. It is unknown if the effects are enhanced due to the combination of those actives.	-
DT50	default	Unknown if this is best case of worst- case. In general it is assumed that the default is worst-case	+

PD	100% foliage dwelling insects.	This assumption is worst-case for insects. However if other types of food sources (grasses, seeds) are also consumed, the risk assessment is not worst-case	+/-
PT	100% food from treated area	This is a worst- case assumption, however it is in this application unknown if it is a realistic worst-case, since no information on focal species is available	+
General uncertainties	-Lab vs field -single product risk assessment vs exposure to multiple formulation	Due to uncertainties in -testing two species in the lab, compared to the whole range of species in the field -extrapolating lab results to field exposures -doing a risk assessment for a single product while multiple products are used; an assessment factor of 5 is not extremely high	+/-
Final Conclusion		Tier 1 risk assessment might not be overconservative for birds in ornamentals/nurseries

As no other refinements were submitted, the risk to birds in the outdoor uses is not acceptable.

The risk assessment for secondary poisoning showed that the risk for earthworm-eating and fish-eating birds is acceptable following the use of Alibi Flora. Furthermore, the risk assessment for exposure via drinking water showed acceptable risk. The potential risk to birds feeding on fish containing difenoconazole residues following application of Alibi Flora was assessed using Netherlands PECSW values. The TER value exceeds the trigger value of 5, indicating an acceptable risk to fish-eating birds.

Terrestrial vertebrates (other than birds)

The acute screening TER values, calculated for recommended scenarios, all exceed the trigger values of 10 indicating that acute risk to mammals is acceptable following the use of Alibi Flora according to the

proposed use pattern. The long-term TER values for most of the crops exceeded the trigger value of 5 at Tier I scenario. In the core dRR the zRMS stated that the following needed to be considered by cMS: all reproductive higher tier mammal refinements for azoxystrobin and difenoconazole and the combined reproductive risk to mammals from both a.s’s. Long-term risk and combination toxicity were considered acceptable for all uses, except for:

- the field uses in cut flower, flower seed crops, perrenials and pot plants as a result of the long-term risk fo a small herbivorous mammal for both active substances at BBCH 40-49 and as a result also combination toxicity.

- the field uses in shrubs as a result of the long-term combination risk fo a small herbivorous mammal at BBCH 40-49.

The applicant proposed a restricted GAP and submitted a DT50 refinement for both active substances. The restricted GAP could not be transported to a clear label of use. However in refined risk assessment it was considered that the risk to mammals is acceptable if interception is at least 60%. Thus the risk is acceptable when the following restriction sentence is included on the label:

Om zoogdieren te beschermen is de toepassing in de onbedekte teelt van potplanten, snijbloemen, boomkwekerijgewassen, vaste plantenteelt en bloemzaadteelt uitsluitend toegestaan wanneer de bodembedekking van het gewas meer dan 60% is.

The risk assessment for secondary poisoning showed that the risk for earthworm-eating and fish-eating mammals is acceptable following the use of Alibi Flora. Furthermore, the risk assessment for exposure via drinking water (puddle scenario) showed acceptable risk. The potential risk to mammals feeding on fish containing difenoconazole residues following application of Alibi Flora was assessed using Netherlands PECSW values. The TER value exceeds the trigger value of 5, indicating an acceptable risk to fish-eating mammals.

3.1.6.2 Effects on aquatic species (Part B, Section 6, Point 10.2)

Data on Alibi Flora were evaluated and risk assessments for Alibi Flora with the proposed use pattern were provided using Dutch national PECSW and PECSED values, and are considered adequate.

The TER values for azoxystrobin and its metabolite R234886 exceeded the relevant trigger values for the majority of the risk assessments without the need for refinements, indicating that the risk to aquatic organisms is acceptable following use of Alibi Flora according to the proposed use patterns. Refinement was required for aquatic invertebrates where the worst case PECSW was compared to a RAC derived from a mesocosm study. Refinement was also required for algae. In this case a geomean derived from studies with several species was compared with the worst case PECSW. Furthermore, for some groups and combination toxicity the risk needed to be refined using appropriate drift reduction technology. The TER values for difenoconazole and its metabolites exceeded the relevant trigger values for the majority of the risk assessments without the need for refinements, indicating that the risk to aquatic organisms is acceptable following use of Alibi Flora according to the proposed use patterns. However, for some groups and combination toxicity the risk needed to be refined using appropriate drift reduction technology.

In addition the risk for greenhouse uses is acceptable, except for the use in cut flowers (2 x 3 applications in rose, 21 and 120 d interval) where there is a risk for difenoconazole and combination toxicity.

The applicant did not sumbit a clear statement or refinement, but added the option for 2 x 2 applications. This option results in an acceptable risk.

In conclusion, application of Xxxxx Xxxxx according to the proposed label uses poses acceptable risk to aquatic organisms when consideration is given to drift mitigation techniques:

90% drift reduction for ornamentals/shrubs;

mast sprayer (Venturi ID90015) + 5 m crop free zone only for high lane trees;

standard technique ‘transplanted trees’+ additional 5 m crop-free zone with crops of same height only for transplanted trees;

standard technique ‘spindle trees’+ 50 % drift reducing nozzles for spindle trees.

As of January 1st 2018 the new Activity Decree is effective (See the last version of the Ctgb Evaluation Manual), in which the baseline drift is set at 75% drift reduction. The spray drift deposition values for the techniques for trees are accepted during the transitional period until 2021 as indicated in the activity Decree. This concerns DRT50 + 5 meter crop free for high lane trees, DRT0 (standard equipment) + 5 meter crop for transplanted trees and DRT50 for spindle trees.

Thus the following has to be stated on the WG:

Om in het water levende organismen te beschermen is toepassing in de onbedekte teelt van potplanten, snijbloemen en vaste plantenteelt in percelen die grenzen aan oppervlaktewater uitsluitend toegestaan indien op het gehele perceel gebruik gemaakt wordt van een techniek uit tenminste de klasse DRT90.

Om in het water levende organismen te beschermen is toepassing in de teelt van hoge laanbomen in percelen die grenzen aan oppervlaktewater uitsluitend toegestaan indien op het gehele perceel gebruik gemaakt wordt van een techniek uit tenminste de klasse DRT50 in combinatie met een teeltvrije zone van tenminste 1000 centimeter.

Om in het water levende organismen te beschermen is toepassing in de teelt van opzetters in percelen die grenzen aan oppervlaktewater uitsluitend toegestaan indien op het gehele perceel gebruik gemaakt wordt van een standaard techniek in combinatie met een teeltvrije zone van tenminste 1000 centimeter.

Om in het water levende organismen te beschermen is toepassing in de teelt van spillen in percelen die grenzen aan oppervlaktewater uitsluitend toegestaan indien op het gehele perceel gebruik gemaakt wordt van een techniek uit tenminste de klasse DRT50.

3.1.6.3 Effects on bees and other arthropod species (Part B, Section 6, Points 10.4 and 10.5)

Bees

All the hazard quotients for Alibi Flora are less than 50, indicating that the oral and contact risk to bees is acceptable following use of Alibi Flora according to the proposed use pattern.

Other non-target arthropods

The Tier I and Tier II in-field foliar and soil HQ values for A. rhopalosiphi and T. pyri were below the trigger value of 2 for the worst case use scenario (3 x 1000 mL/ha in leafy and fruiting vegetables and ornamentals), indicating that the risk to in-field non-target arthropods is acceptable following the use of Alibi Flora according to the proposed use pattern.

The risk assessment based on drift rates for the Netherlands indicates acceptable off-field risk to non- target arthropods following application of Alibi Flora according to the proposed use pattern.

3.1.6.4 Effects on earthworms and other soil macro-organisms (Part B, Section 6, Point 10.6)

Earthworms

The acute and long-term risk of Alibi Flora to earthworms was assessed from acute and long-term toxicity exposure ratios (TERs) between the selected toxicity endpoints for Alibi Flora, azoxystrobin and its metabolites and difenoconazole and its metabolites, and the maximum PECsoil. The zRMS commented in the core assessment that the combined risk to soil-macro organisms for the formulated product, Alibi Flora may need further consideration. The acute and long-term risk of Alibi Flora to earthworms was assessed from acute and long-term toxicity exposure ratios (TERs) between the selected toxicity endpoints for Alibi Flora, azoxystrobin and difenoconazole and combination toxicity, and the maximum PECsoil.

The acute and chronic TER values for azoxystrobin are greater than the Regulation (EU) 546/2011 triggers of 10 and 5, respectively. The acute TER values for difenoconazole and combination toxicity are greater than the respective Regulation (EU) 546/2011 triggers whereas the TERLT for difenoconazole and combination toxicity is below the acceptable risk trigger of 5. However, the refined (field study) risk assessment showed that Xxxxx Xxxxx applied according to the proposed use pattern indicated acceptable risk for earthworms.

Other soil non-target macro-organisms

The risk of Alibi Flora to other non-target soil macro-organisms, as represented by Collembola and gamasid mites, was assessed from toxicity exposure ratios (TERs) between the toxicity endpoints for azoxystrobin and its metabolites and difenoconazole and its metabolites and the maximum PECS.

The TERLT values, including combination toxicity, are all much higher than the recommended trigger value of 5, indicating that the risk to soil macro-organisms, as represented by Collembola and gamasid mites, is acceptable following use of Alibi Flora according to the proposed use pattern.

3.1.6.5 Effects on organic matter breakdown (Part B, Section 6, Point 10.6.7)

Litter bag studies are not considered useful anymore for risk assessment, because they have proved to be very insensitive.

3.1.6.6 Effects on soil non-target micro-organisms (Part B, Section 6, Point 10.7)

All no effect levels exceed the relevant PECS values, indicating that Alibi Flora does not pose an unacceptable risk to soil micro-organisms.

3.1.6.7 Assessment of potential for effects on other non-target organisms (Flora and Fauna) (Part B, Section 6, Point 10.8)

Non-target plants - Terrestrial

National specific drift rates are used to calculate exposure to off-field areas (both surface water and land). Based on these national specific exposure calculations, national specific risk calculations for non-target terrestrial plants are performed. The TER values exceed the recommended trigger of 5 for the use in ornamentals and shrubs. For the use in trees, the TER is greater than the recommended trigger of 5 when appropriate mitigation measures are considered as shown in the table above.

In conclusion, application of Xxxxx Xxxxx according to the proposed label uses poses acceptable risk to non target plants when consideration is given to drift mitigation techniques:

75% drift reduction for ornamentals/shrubs;

DRT0 (standard equipment) + 5 m crop free for high lane trees;

DRT0 for transplanted trees;

DRT0 (standard situation) for spindle trees.

As of January 1st 2018 the new Activity Decree is effective (See the last version of the Ctgb Evaluation Manual), in which the baseline drift is set at 75% drift reduction. As a result mitigation measures for ornamentals/shrubs do not have to be stated on the label as these concern DRT75.

The spray drift deposition values for the techniques for trees are accepted during the transitional period until 2021 as indicated in the activity Decree (See the most recent Evaluation Manual of the Ctgb). This concerns all mitigation measures proposed by the applicant for the uses in trees. Please note that for transplanted trees the risk is not acceptable for the mitigation measures according the Activity Decree after the transitional period, when a field borders not adjecent to surface water (upwards and sideways spraying in lane trees).

Thus the following has to be stated on the WG:

Om niet tot de doelsoorten behorende terrestrische planten te bescherm is toepassing in de teelt van laanbomen in percelen die niet grenzen aan oppervlaktewater uitsluitend toegestaan indien op het gehele perceel gebruik gemaakt wordt van een standaardtechniek in combinatie met een teeltvrije zone van tenminste 1000 centimeter.

This sentence is covered by the sentence for aquatic organisms.

Other non-target species (Flora and Fauna)

Tests on other non-target species are not required.

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

A13703G (Alibi Flora) is a suspension concentrate (SC) formulation containing 200 g/l azoxystrobin and 125 g/l difenoconazole intended for use as an fungicide on protected and unprotected floriculture, tree nursery and perennial crops for the control of powdery mildews.

Justification of co-formulation

This product contains two actives that are well established within Europe. No preliminary data are required, however a justification of the co-formulation of the actives must be included.

Six trials were conducted in NL in 2010/11 in glasshouse grown roses against Sphaerotheca pannosa (SPHRPA). The results show that the combination of actives together (as Alibi Flora/ A13703G) at the recommended concentration of 100 ml/hl gave a mean of 73.1% control which was better control than azoxystrobin alone at 20 g a.s./hl (mean 45.5%), however the combination of actives did not give better control than the difenoconazole alone at 12.5 g a.s./hl (mean 75.6%).

zRMS UK has rejected the product on the basis of the co-formulation. UK considers the added value of the combination Azoxystrobin (AZT) and Difenoconazole (DFZ) not sufficiently proven in relation to DFZ solo, in terms of efficacy. Compared to AZT solo, the added value to add DFZ is clearly present on

efficacy. In this respect we agree with UK and the question can be asked why the applicant has not chosen to apply for a DFZ approval as a solo product. Currently DFZ is an authorized solo product in NL (e.g. Score 250SC, 11453 N) in various crops except in the floriculture crops. And in floricuculture crops AZT solo product is currently authorized (Ortiva 12169 N).

However, the applicant made an explanation with regard to resistance management which zRMS UK follows in outline but ultimately indicates that the added value of the combination of AZT and DFZ in relation to resistance management has not been sufficiently demonstrated (ie efficacy). zRMS UK leaves MS to assess whether they see added value in the AZT & DFZ combination.

MS NL (we) see the added value as resistance development for AZT's solo is classified as high, resistances are already known and efficacy is declining in some cases. By adding DFZ, resistance development of AZT is limited and efficacy is increased. This approach is also mentioned by FRAC as an opportunity to limit resistance development.

From the available results it is possible to ask whether the amount of DFZ that is added should not have been reduced (no improvement in efficacy compared to DFZ solo). However, because also DFZ solo has a risk of resistance development, partly on the basis of FRAC recommendations, it can be stated that in the context of resistance management the combination of AZT & DFZ is a good product for floriculture crops and can therefore be accepted in NL.

Minimum effective dose

Minimum effective dose of A13703G against powdery mildew (Oidium citrulli) in protected gerbera (PODOXA)

The Applicant presented 4 glasshouse trials on protected gerbera conducted in NL in 2011. Three consecutive sprays were applied at 60 ml/hl and 100 ml/hl in 1000l of water. The data showed that in 3 trials there was only a slight difference in mean control 7-14 DAA3 between the 60 and the 100 ml/hl concentrations. In the fourth trial where assessment was at a later timing (22 DAA3) there was a clear difference between the 60 and the 100 ml/hl concentrations. This suggests that the higher rate may possibly give a longer duration of disease control. According to the Dutch and EU extrapolation document, extrapolation is not possible from Gerbera to the rest of the cut flowers.

Minimum effective dose of A13703G against powdery mildew (Sphaerotheca pannosa) in rose (protected and outdoor)

The 7 Maritime trials on protected roses and 4 outdoor trials on tree nursery stock rose show a clear dose response up to the 100 ml/hl concentration. Control at 100 ml product/hl is consistently higher than the lower concentrations. Also there was no obvious benefit of a concentration of 200 ml/hl. These data are considered to support the proposed concentration of 100 ml/hl. Extrapolation is possible from cut rose to other cut flowers, according to the Dutch extrapolation document.

Minimum effective dose of A13703G against powdery mildew (Microsphaera begonia) in protected begonia

In the 6 Maritime trials for protected begonia, the mean control indicates that there is a dose response between the 60 and the 100 ml/hl concentrations, however on examination of the data, two of the trials showed better control at 60 ml/hl than at the 100 ml/hl. These were also the trials with the highest disease level in the untreated. On balance, 4 out of the 6 trials showed a higher dose response at 100 ml/hl and therefore the higher concentration is considered to be acceptable. According tho the Dtuch extrapolation document, extrapolation is possible from pot plant begonia to other pot plants where Microspheara spp occurs.

Minimum effective dose of A13703G against powdery mildew (Microsphaera alphitoides) in oak (Outdoor)

The applicant presented 4 field trials on oak for minimum effective dose. All trials showed a clear dose response between 60 ml/hl and 100 ml/hl with a clear increase in mean control. It was also noted that there was no clear difference between a concentration of 100 ml/hl and 200 ml/ha and so this also supported the 100 ml/hl rate as being the maximum needed. Therefore the proposed concentration of 100 ml/hL is considered justified. Oak is considered an appropriate representative species for ornamental tree production. According to the Dutch extrapolation document, extrapolation is possible from oak to other tree nursery crops and perennials.

Shrubs and perennials

No data were provided for shrubs however it is considered that the MED can be extrapolated from trees. According to the Dutch extrapolation document, extrapolation is possible from oak to perennials.

Conclusion minimum effective dose

Data were provided from both indoor and outdoor situations to justify the proposed concentration of 100 ml/hl in protected gerbera, protected begonia, protected and outdoor rose and oak trees. These species are considered by the zRMS (as well as NL authorities who were consulted as the applicant referenced their national guidance) to be fully representative of the situations proposed in the GAP. Overall, the data supported this as being the minimum effective dose.

Efficacy tests

The applicant stated that efficacy data for powdery mildews are presented from 43 efficacy trials assessed (32 glasshouse trials and 11 field trials). These trials were carried out between 2008 and 2013 in the Maritime EPPO Zone (the Netherlands, France and Germany).

Note that the majority of proposed doses in the GAP do not match up to the doses tested in the effectiveness trials (justified under Minimum Effective dose) in terms of rate in L/ha and amount of active delivered. It is understood that the applicant measured all applications in the trials in terms of ml/hL, i.e, they applied 100ml/hl in all cases. This would mean, for example, that 1L/ha of product in 1000L water would be the equivalent of 0.9 L/ha. As they are both equal to 100ml/hl (0.1% concentration as the GAP states in the remarks section), it is therefore acceptable.

The applicant has sufficiently justified all GAP uses (apart from flowerseed) in terms of effectiveness at 100 ml/hl.

In the Netherlands water volume for unprotected cut flower is 200-1200, for protected cut flower 500- 4000, pot plants (protected and unprotected) 200-1200 L/ha.

Oidium citrulli (PODOXA) in protected gerbera

Dose tested: 100 ml/hl. Water volume tested: 1000 L/ha in all trials

The applicant presented 10 Maritime trials on Oidium citrulli (PODOXA) in protected gerbera. Mean control was 80.4% which was better than the grouped reference producs.

One trial had low disease pressure. All other trials showed sufficient disease pressure and gave between 80 and 95% control.

It is concluded that Alibi flora at claimed dose rate provided useful to high levels of powdery mildew control in gerbera. The Maritime glasshouse data are considered relevant and sufficient to support a claims a claim of control. This use is justified in NL. Extrapolation is not possible from Gerbera to the rest of the cut flowers.

Sphaerotheca pannosa (SPHRPA) in protected rose (cut flower)

Dose tested: 100 ml/hL. Water volume tested: 1500 L/ha in all trials

The applicant presented 16 Maritime trials on Sphaerotheca pannosa (SPHRPA) in protected rose (cut flower). Mean control was 73.1% which was better than the standard, dodemorph.

One trial had low disease disease pressure. All other trials showed sufficient disease pressure and gave between (32-95%) control.

It is concluded that Alibi flora at claimed dose rate provided sufficient to medium levels of control of powdery mildew in cut rose. The majority of results were high, however as there was some variability in the data. This use is justified in NL. Extrapolation is possible from cut rose to other cut flowers, according to the Dutch extrapolation document.

Microsphaera begonia (OIDIBE) in protected begonia

Dose tested: 100 ml/hL. Water volume tested: 1500 L/ha in all trials

The applicant presented 6 trials on Microsphaera begonia (OIDIBE) in protected begonia. Mean control was 88.4% which was better than the reference standards (grouped and separate).

Two trials had low disease pressure. All other trials showed sufficient disease pressure and gave between 87 and 100% control.

It is concluded that that Alibi flora at claimed dose rate provided high levels of control of powdery mildew in begonia. This use is justified in NL. According to the Dutch extrapolation document, extrapolation is possible from pot plant begonia to other pot plants where Microspheara spp occurs.

Microsphaera alphitoides and Microsphaera spp in outdoor grown oak

Dose tested: 100 ml/hL. Water volume tested: 500-1000 L/ha

The applicant presented 7 trials on Microsphaera alphitoides (MCRSAL) and Microsphaera spp (MCRSSP) in outdoor grown oak. Medium to high levels of control is achieved by Xxxxx Xxxxx on the control of pest severity (mean control 70.5%), which is comparable or slightly higher than the results achived by the reference products. This use is justified in NL. According to the Dutch extrapolation document, extrapolation is possible from oak to other tree nursery crops and perennials.

Shrubs and perennials

No data were provided for shrubs however it is considered that the Efficacy can be extrapolated from trees. According to the Dutch extrapolation document, extrapolation is possible from oak to perennials. This use is justified in NL.

Effects on yield and quality

The main indication of quality of the plant species on the label (ornamentals) is visual effects on the plants themselves (leaves/ flowers) i.e. phytotoxicity. Therefore see section Adverse effects.

Effects on the processing procedure is not applicable to horticultural, tree nursery and perennial crops. Yield quantity is not required for ornamental plant production.

Adverse effects:

Greenhouse uses:

A total of 41 selectivity trials have been carried out in the maritime zone (all NL) to EPPO guidelines. Selectivity trials were conducted on 3 different cutflower crops and 9 different potted plant crops in glasshouses at 100 ml/hl. The cutflower crops used were carnation, gerbera and rose, and the potted plant crops used were African violet, begonia, cyclamen, chrysanthemum, exacum, ficus, gerbera, kalanchoe and rose. In all tested crops phytotoxicity symptoms were seen on flowers and /or on plants or leaves.

Field uses:

Assessments on phytotoxic effects, visible residue and crop condition were made on 11 efficacy trials in nursery stock of rose (4) and nursery stock of oak (7). All trials were carried out in the Maritime climatic zone (The Netherlands, France and Germany) between 2011 and 2013.

In all of the trials no adverse effects were seen at the maximum concentration of 100 ml/hl in Rose and Oak (1.5 L/ha and 1L/ha).

According to the Dutch extrapolation document entitled ‘Ctgb Appendix E: Extrapolation possibilities, version 2.0.’, phytotoxicity can be extrapolated from at least three different cut flowers (protected) and three different potplants (protected) to all ornemantal crops, tree nursery crops and perennial plants.

Phytotoxic effects were seen on the majority of flowers tested. In addition, on some species, further phytotoxic effects were seen and require additional label warning. These include:

Carnation- as phytotoxic effects were seen in the plants of half of the trials which was higher than that seen in the reference standard.

Exacum- as out of the two trials, one showed significantly more damage to leaves than the reference and the other showed phytotoxic effects on flowers.

Rose- as 4 of the trials showed some phytotoxic symptoms on the plants themselves (i.e. the other species apart from the above showed no phytotoxic effects on the plants themselves- only the flowers).

Therefore a label warning is required as the applicant has proposed. In the Dutch label the following warning sentence are included:

Gewasveiligheid

Gezien het grote aantal variëteiten en de wisselende teeltomstandigheden van sierteeltgewassen is het onmogelijk de gewasverdraagzaamheid voor alle situaties te onderzoeken. Met name op sommige bloeiende gewassen blijkt er een verhoogd risico te zijn op bloemschade. Als er nog geen ervaring is opgedaan met dit middel wordt aangeraden om eerst een proefbespuiting uit te voeren om de verdraagzaamheid van het gewas te testen.

Adverse effects on parts of plant used for propagating purposes

No data have been presented. Both actives have some level of systemicity although plants will not be grown primarily for seed production.

Impact on succeeding crops

For succeeding crops, extrapolation may be made from the product ‘Amistar Top’ which has an identical formulation to that of ‘Alibi Flora.’

Amistar Top and both active ingredients (azoxystrobin and difenoconazole) are already authorised in the respective crops in many European countries for many years without having any restrictions on the label concerning succeeding and substitution crops. As a consequence, it is not to be expected that applications with Xxxxx Xxxxxxxxx have an impact on succeeding or substitution crop.

Impact on other plants including adjacent crops

For adjacent crops, extrapolation may be made from the product ‘Amistar Top’ which has an identical formulation to that of ‘Alibi Flora.’ Although Amistar Top has not GAP uses on ornamentals, it is considered that direct extrapolation may be made for ornamental plants under 50cm in height as drift values are identical to those used for field crops inclusive of those on the Amistar Top GAP.

AmistarTop and both active ingredients (azoxystrobin and difenoconazole) are already authorised in the respective crops in many European countries for many years without having caused any effects on adjacent crops. In The Netherlands also productbased on azoxystrobin is authorized in high growing crops and ornamental crops. As a consequence, it is not to be expected that applications with Alibi Flora will have an effect on adjacent crops.

Possible development of resistance or cross-resistance Azoxystrobin is a QOI fungicide with a high resistance risk. Difenoconazole is DMI (SBI) fungicide with a medium resistance risk.

Powdery mildew has high resistance risk on wheat/barley (Blumeria graminis), curcurbits (Sphaerotheca fuliginea, Podosphaera xanthii), medium risk on grapevine (Erysiphe necator), Pepper (Leveillula taurica) and strawberry (Sphaerotheca macularis ) and low risk on apples (Podosphaera leucotricha ). However theis resistance risk on ornamentals is not mentioned in the FRAC guideline.

The QoI component (azoxystrobin) is a high risk MOA, therefore overall resistance risk management is required for the QoI component. The applicant proposes that this is implemented by the addition of the azole component of Alibi Flora. Azoles (including difenoconazole) are medium risk. In the Dutch lable the following warning sentences will be included:

Resistentiemanagement

Dit middel bevat de werkzame stoffen azoxystrobin en difenoconazool. Azoxystrobin behoort tot de methoxy-acrylates (QoI-fungiciden). De Frac code is 11. Difenoconazool behoort tot de triazolen (DMI fungiciden). De Frac code is 3. Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van resistentiemanagement dient u de adviezen die gegeven worden in de voorlichtingsboodschappen, op te volgen.

3.2 Conclusions

Regarding combination toxicology for birds, the zRMS concluded: The reproductive risk for both actives was resolved at screening step however it is noted that the TER for difenoconazole is only just above the trigger value (5.03) and the shortcut value used (18.2) would also be used in the first tier assessment.

Despite this it is clear that the risk from difenoconazole is driving the risk assessment and therefore an acceptable combined reproductive risk can be concluded.

Both substances have the same effect on birds and it is unknown if the effects are enhanced due to the combination of the active substances. Furthermore, the approach of the zRMS regarding combination toxicology is not in line with the guidance. Therefore, the Ctgb performed a risk assessment for

combination toxicology for birds which resulted in a TER of 4.4. An additional uncertainty analysis showed that the tier 1 risk assessment might not be over conservative for birds in ornamentals/nurseries.

However, the zRMS did consider the NL comments, other member states did not disagree with the approach of the zRMS regarding combination toxicology for birds and it is not clear whether there is an actual risk based on combination toxicology.

Therefore, the zRMS conclusion, i.e. the risk regarding combination toxicology for birds is acceptable, is followed.

In conclusion, based on the evaluation, an authorisation can be granted for Xxxxx Xxxxx.

3.3 Further Information to Permit a Decision to be made or to support a Review of the Conditions and Restrictions associated with the Authorisation

None.

Appendix 1: Copy of the proposed product label

Wettelijk Gebruiksvoorschrift

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

Toepassingsvoorwaarden:

Toepassingsgebied	Type toepassing	Werkzaamheid getoetst op	Dosering* middel per toepassing	Maximale dosering middel per toepassing	Maximaal aantal toepassingen per teeltcyclus of per 12 maanden	Minimum interval tussen toepassingen in dagen
Potplanten (bedekte, niet-grond gebonden** teelt)	-	Echte meeldauw	0,1% (100 ml / 100 L water)	1,2 L/ha	3 per teeltcyclus, 15 per 12 maanden	7
Potplanten (bedekte, grond gebonden*** teelt)	-	Echte meeldauw	0,1% (100 ml / 100 L water)	0,9 L/ha	2 per 12 maanden	7
Potplanten (onbedekte teelt)	-	Echte meeldauw	0,1% (100 ml / 100 L water)	0,9 L/ha	2 per 12 maanden	7
Snijbloemen (bedekte teelt m.u.v. substraatteelt)	-	Echte meeldauw	0,1% (100 ml / 100 L water)	0,9 L/ha	2 per 12 maanden	7
Snijbloemen m.u.v. roos (bedekte substraatteelt)	-	Echte meeldauw	0,1% (100 ml / 100 L water)	1,5 L/ha	3 per blok of teeltcyclus, 15 per 12 maanden	7 dagen binnen een blok 21 dagen tussen twee blokken
Roos (bedekte substraatteelt)	-	Echte meeldauw1	0,1% (100 ml / 100 L water)	3,0 L/ha	2 per blok 4 per 12 maanden	7 dagen binnen een blok 120 dagen

Toepassingsgebied	Type toepassing	Werkzaamheid getoetst op	Dosering* middel per toepassing	Maximale dosering middel per toepassing	Maximaal aantal toepassingen per teeltcyclus of per 12 maanden	Minimum interval tussen toepassingen in dagen
						tussen twee blokken
Snijbloemen (onbedekte teelt)	-	Echte meeldauw	0,1% (100 ml / 100 L water)	0,9 L/ha	2 per 12 maanden	7
Boomkwekerijgewassen (bedekte, grond gebonden*** (container)teelt)	neerwaarts spuiten	Echte meeldauw	0,1% (100 ml / 100 L water)	1,0 L/ha	2 per 12 maanden	7
Boomkwekerijgewassen (bedekte grond gebonden*** (container)teelt)	zij- en opwaarts spuiten	Echte meeldauw	0,1% (100 ml / 100 L water)	0,9 L/ha	2 per 12 maanden	7
Boomkwekerijgewassen (bedekte, niet-grond gebonden** (container)teelt)	-	Echte meeldauw	0,1% (100 ml / 100 L water)	1,2 L/ha	3 per 12 maanden	7
Boomkwekerijgewassen (onbedekte teelt)	zij-/opwaarts spuiten	Echte meeldauw	0,1% (100 ml / 100 L water)	0,9 L/ha	2 per 12 maanden	7
Boomkwekerijgewassen (onbedekte teelt)	neerwaarts spuiten	Echte meeldauw	0,1% (100 ml / 100 L water)	1,0 L/ha	2 per 12 maanden	7
Vaste plantenteelt (bedekte, niet-grond gebonden** (container)teelt)	-	Echte meeldauw	0,1% (100 ml / 100 L water)	1,0 L/ha	3 per 12 maanden	7
Vaste plantenteelt (onbedekte teelt)	-	Echte meeldauw	0,1% (100 ml / 100 L water)	0,9 L/ha	2 per 12 maanden	7
Bloemenzaadteelt (bedekte teelt)	-	Echte meeldauw	0,1% (100 ml / 100 L water)	0,9 L/ha	2 per 12 maanden	7
Bloemenzaadteelt (onbedekte teelt)	-	Echte meeldauw	0,1% (100 ml / 100 L water)	0,9 L/ha	2 per 12 maanden	7

* Verlaging van de dosering is toegestaan, maar van het maximaal aantal toepassingen en de andere toepassingsvoorwaarden mag niet worden afgeweken. Werkzaamheid is vastgesteld voor de genoemde dosering per toepassing en niet voor verlaagde doseringen.

** Grond afgedekt: een afdekking met een ondoorlatende laag (bijv. beton), zodat er geen emissie is naar de ondergrond.

*** Grond niet afgedekt. Een grondbedekking met een doorlatende laag (bijv. geperforeerde folie) wordt gelijkgesteld met grond niet afgedekt.

1 Echte meeldauw (Sphaerotheca pannosa).

Overige toepassingsvoorwaarden

Draag geschikte handschoenen bij werkzaamheden aan het behandeld gewas.

Om het grondwater te beschermen mag dit middel niet worden gebruikt in grondwaterbeschermingsgebieden.

Om in het water levende organismen en niet tot de doelsoort behorende terrestrische planten te beschermen is toepassing in de teelt van hoge laanbomen in percelen die grenzen aan oppervlaktewater uitsluitend toegestaan indien op het gehele perceel gebruik gemaakt wordt van een techniek uit tenminste de klasse DRT50 in combinatie met een teeltvrije zone van tenminste 1000 centimeter.

Gewasveiligheid

Resistentiemanagement

Dit middel bevat de werkzame stoffen azoxystrobine en difenoconazool. Azoxystrobine behoort tot de methoxy-acrylaten (QoI fungicide). FRAC code is 11. Difenoconazool behoort tot de triazolen. De FRAC code is 3. Bij dit product bestaat de kans op resistentieontwikkeling. In het kader van resistentiemanagement dient u de adviezen die gegeven worden in de voorlichtingsboodschappen op te volgen.

Appendix 2: Summary of the national data protection claims including justifications, for data submitted and used in support of the evaluation

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 1.4.4 / 01	2014	Please refer to Part C A13703G - Material Safety Data Sheets Syngenta Crop Protection AG, Basel, CH, Not GLP, not published Syngenta File No A13703G_10887 This is confidential Data	N	N	N/A	N/A	SYN
KIIIA1 2 / 01	2011	A13703G - Chemical Characterization before storage of batch GRA1A241D Syngenta Crop Protection AG, Basel, CH, Syngenta Biosciences Pvt. Ltd., Ilhas Goa, India, 10464719 GLP, not published Syngenta File No A13703G_10939	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 2 / 02	2003	A13703 G – Report on chemical composition (batch: J6129/117) (incl. Appendix) Syngenta Crop Protection AG, Basel, CH Syngenta Crop Protection Münchwilen AG, Münchwilen, Switzerland, 110760 GLP, not published Syngenta File No ICI5504/2115	N	N	N	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 2.1 / 01 KIIIA1 2.8.2 / 01 KIIIA1 2.8.3.1 / 01 KIIIA1 2.8.3.2 / 01l KIIIA1 2.8.5.2 / 01 KIIIA1 2.8.8.2 / 01	2011	A13703G - Technical properties of batch GRA1A241D Syngenta Crop Protection AG, Basel, CH Syngenta Biosciences Pvt. Ltd., Ilhas Goa, India, SMN10578 Not GLP, not published Syngenta File No A13703G_10429	N	N	N	N/A	SYN
KIIIA1 2.2.1 / 01	2003	A13703 G - Report on explosive properties Syngenta Crop Protection AG, Basel, CH, Syngenta - Process Hazards Section, Huddersfield, UK, HT03/312 GLP, not published Syngenta File No ICI5504/2101	N	N	N	Submitted with application 20080302 TG	SYN
KIIIA1 2.2.2 / 01	2003a	A13703G - Report on oxidising properties Syngenta Crop Protection AG, Basel, CH Syngenta - Process Hazards Section, Huddersfield, UK, HT03/314 GLP, not published Syngenta File No ICI5504/2102	N	N	N	Submitted with application 20080302 TG	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 2.3.1 / 01	2003b	A13703G - Report on flash point Syngenta Crop Protection AG, Basel, CH Syngenta - Process Hazards Section, Huddersfield, United Kingdom, HT03/311 GLP, not published Syngenta File No ICI5504/2103	N	N	N	Submitted with application 20080302 TG	SYN
KIIIA1 2.3.3 / 01	2003c	A13703G - Report on auto-ignition temperature Syngenta Crop Protection AG, Basel, CH Syngenta - Process Hazards Section, Huddersfield, UK, HT03/313 GLP, not published Syngenta File No ICI5504/2104	N	N	N	Submitted with application 20080302 TG	SYN
KIIIA1 2.4.1 / 01	2003	A13703G - Report on colour, odour, physical state, pH 1%, pH undiluted, density Syngenta Crop Protection, Guildford, UK Syngenta Crop Protection Münchwilen AG, Münchwilen, Switzerland, 110720 GLP, not published Syngenta File No ICI5504/2100	N	N	N	Submitted with application 20080302 TG	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 2.4.2 / 01	2003a	A13703G - Report on acidity/alkalinity Syngenta Crop Protection, Guildford, UK Syngenta Crop Protection Münchwilen AG, Münchwilen, Switzerland, 110721 GLP, not published Syngenta File No ICI5504/2106	N	N	N	Submitted with application 20080302 TG	SYN
KIIIA1 2.5.2 / 01	2003	-13703G - Report on viscosity Syngenta Crop Protection AG, Basel, CH Solvias AG, Basel, Switzerland, L03-005580 GLP, not published Syngenta File No ICI5504/2105	N	N	N	Submitted with application 20080302 TG	SYN
KIIIA1 2.5.3 / 01	2003b	A13703G - Report on surface tension (100%, 1.7%, 0.8%, 0.1%) Syngenta Crop Protection, Guildford, UK Syngenta Crop Protection Münchwilen AG, Münchwilen, Switzerland, 110727 GLP, not published Syngenta File No ICI5504/2107	N	N	N	Submitted with application 20080302 TG	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 2.6.1 / 01	2013	A13703G - Chemical characterization before storage of batch GRA1A241D Syngenta Crop Protection AG, Basel, CH Syngenta Biosciences Pvt. Ltd., Ilhas Goa, India, SMG10886 GLP, not published Syngenta File No A13703G_10425	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 2.7.2 / 01 KIIIA1 4.1.3 / 03	2003c	A13703G - Report on storage stability and shelf life statement (8 weeks 40°C, packaging made of HDPE) Syngenta Crop Protection, Guildford, UK Syngenta Crop Protection Münchwilen AG, Münchwilen, Switzerland, 10024343 Not GLP, not published Syngenta File No ICI5504/2126	N	N	N	Submitted with application 20080302 TG	SYN
KIIIA1 2.7.2 / 02 KIIIA1 4.1.3 / 04	2003d	A13703G - Report on storage stability and shelf life statement (8 weeks 40°C, packaging made of PET) Syngenta Crop Protection, Guildford, UK Syngenta Crop Protection Münchwilen AG, Münchwilen, Switzerland, 10024346 Not GLP, not published Syngenta File No ICI5504/2127	N	N	N	Submitted with application 20080302 TG	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 2.7.2 / 03	2013a	A13703G - Content of active ingredient(s) of batch GRA1A241D after storage in packaging made of HDPE for 2 weeks at 54°C Syngenta Crop Protection AG, Basel, CH Syngenta Biosciences Pvt. Ltd., Ilhas Goa, India, SMG10887 GLP, not published Syngenta File No A13703G_10426	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 2.7.2 / 04	2011a	A13703G - Content of R230310 of batch GRA1A241D after storage in packaging made of HDPE for 2 weeks at 54°C Syngenta Crop Protection AG, Basel, CH Syngenta Biosciences Pvt. Ltd., Ilhas Goa, India, SMG10891 GLP, not published Syngenta File No A13703G_10427	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 2.7.4 / 01	2003	A13703G - Report on low temperature stability Syngenta Crop Protection, Guildford, UK Syngenta Crop Protection Münchwilen AG, Münchwilen, Switzerland, 110725 Not GLP, not published Syngenta File No ICI5504/2109	N	N	N	Submitted with application 20080302 TG	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 2.7.5 / 01 KIIIA1 4.1.3 / 01	2006	A13703G - Storage stability and shelf life statement (2 years 20°C) in packaging made of HDPE Syngenta Crop Protection AG, Basel, CH Syngenta Crop Protection Münchwilen AG, Münchwilen, Switzerland, 10089672 Not GLP, not published Syngenta File No ICI5504/3124	N	N	N	Submitted with application 20080302 TG	SYN
KIIIA1 2.7.5 / 02 KIIIA1 4.1.3 / 02	2006a	A-13703 G - Storage stability and shelf life statement (2 years 20°C) in packaging made of PET Syngenta Crop Protection AG, Basel, CH Syngenta Crop Protection Münchwilen AG, Münchwilen, Switzerland, 10089970 Not GLP, not published Syngenta File No ICI5504/3128	N	N	N	Submitted with application 20080302 TG	SYN
KIIIA1 4.2.2 / 01	2011	A13703G - The Effectiveness of the Spray Tank Cleaning Procedure Syngenta Crop Protection AG, Basel, CH Syngenta Crop Protection, Münchwilen, Switzerland, 10467096 Not GLP, not published Syngenta File No A13703G_11029	N	N	N	Not submitted before	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
N/A	N/A	No references submitted.	N	N	N/A	N/A	N/A
KIIIA1 5.2.2 / 01	2004	A13703G - Analytical method the simultaneous determination of Azoxystrobin and Difenoconazole in formulated materials by capillary gas chromatography Syngenta Crop Protection, Guildford, UK Syngenta - Jealott’s Hill, Bracknell, UK, SF-26/1 Not GLP, not published Syngenta File No ICI5504/2323	N	N	N	Submitted with application 20080302 TG	SYN
KIIIA1 5.2.2 / 02	2004a	A13703G - Validation of Analytical Method - SF-26/1 Syngenta Crop Protection AG, Basel, CH Syngenta - Jealott’s Hill, Bracknell, UK, TMJ4910A GLP, not published Syngenta File No ICI5504/2325	N	Y	N	Study already submitted with application 20080302 TG Submission date: 31 March 2008	SYN
KIIIA1 5.2.4 / 01	2011	Determination of toluene in formulation by headspace gas chromatography Syngenta Crop Protection AG, Basel, CH Syngenta Crop Protection, Münchwilen, Switzerland, SD-1540/1 Not GLP, not published Syngenta File No A16283D_10108	N	N	N	Study submitted in support of application number 20110957WSG).	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 5.2.4 / 02	2012	Statement on validation of the Analytical Method SD-1540/1 for the determination of toluene in A13703G Azoxystrobin / Difenoconazole SC (200/125) Syngenta Crop Protection AG, Basel, CH Syngenta Crop Protection, Münchwilen, Switzerland, Not GLP, not published Syngenta File No A13703G_10542	N	N	N	Study already submitted in support of application 20120010 THG) but no decision regarding this submission	SYN
KIIIA1 5.2.4 / 03	2011	A16283D - Validation of analytical method SD-1540/1 - toluene in A16283D Syngenta Crop Protection AG, Basel, CH Syngenta Crop Protection, Münchwilen, Switzerland, 123787 GLP, not published Syngenta File No A16283D_10107	N	Y	Y	Study submitted in support of 20131583 NLTHG / 20131580 NLTHG/ 20131577 VAG but no decision yet.	SYN
KIIIA1 5.2.4 / 04	2011	Determination of R230310 in formulation by HPLC (A17961A) Syngenta Crop Protection AG, Basel, CH Syngenta Crop Protection, Münchwilen, Switzerland, SD-1464/1 Not GLP, not published Syngenta File No A17961A_10048	N	N	N	Study submitted in support of 20131583 NLTHG / 20131580 NLTHG/ 20131577 VAG but no decision yet.	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 5.2.4 / 05	2012	Statement on validation of analytical method SD-1464/1 - Specificity for formulation A13703G (azoxystrobin/difenoconazole SC (200/125)) Syngenta Crop Protection AG, Basel, CH Syngenta Crop Protection, Münchwilen, Switzerland, 10506369 Not GLP, not published Syngenta File No A13703G_10546	N	N	N	Study submitted in support of 20131583 NLTHG / 20131580 NLTHG / 20131577 VAG.	SYN
KIIIA1 5.2.4 / 06	2011a	R230310 - Validation of analytical method SD-1464/1 (A17961A) Syngenta Crop Protection AG, Basel, CH Syngenta Crop Protection, Münchwilen, Switzerland, 123137 GLP, not published Syngenta File No A17961A_10049	N	Y	Y	Study submitted in support of 20131583 NLTHG / 20131580 NLTHG / 20131577 VAG.	SYN
KIIIA1 5.6 / 01	2012	Azoxystrobin - Residue Method for the Determination of Azoxystrobin and its Metabolite R234886 in Water Syngenta Crop Protection AG, Basel, CH Eurofins - ADME Bioanalyses, Vergeze, France, GRM057.01A Not GLP, not published Syngenta File No ICI5504_11505	N	N	N	Study submitted in support of applications 20131583 NLTHG / 20131580 NLTHG/ 20131577 VAG.	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 5.6 / 02	2012a	Azoxystrobin - Validation of Analytical Method for the Determination of Azoxystrobin and its Metabolite R234886 in Water. Syngenta Crop Protection AG, Basel, CH Eurofins - ADME Bioanalyses, Vergeze, France, S11-03538 GLP, not published Syngenta File No ICI5504_11490	N	Y	Y	Study submitted in support of other applications 20131583 NLTHG / 20131580 NLTHG/ 20131577 VAG.	SYN
KIIIA1 5.6 / 03	2006	Residue Analytical Method for the Determination of Residues of Difenoconazole (CGA169374) in Water. Syngenta - Jealott’s Hill, Bracknell, UK Syngenta - Jealott’s Hill, Bracknell, UK, RAM485-01 Not GLP, not published Syngenta File No CGA169374_10381	N	N	N	Study already submitted in support of application 20120010 THG) but no decision regarding this submission	SYN
KIIIA1 5.6 / 04	2006	Difenoconazole - Validation of an Analytical Method for the Determination of Residues of Difenoconazole (CGA169374) in Water Syngenta Crop Protection AG, Basel, CH Syngenta - Jealott’s Hill, Bracknell, UK, T022437-04-REG 05-S613 GLP, not published Syngenta File No CGA169374/3060	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 5.8 / 01	2011	Azoxystrobin - Validation of analytical method RAM 399/01 for the determination of azoxystrobin, R230310 and R234886 in human whole blood. Syngenta Crop Protection AG, Basel, CH Eurofins - ADME Bioanalyses, Vergeze, France, S10-03815 GLP, not published Syngenta File No ICI5504_11467	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
N/A	N/A	No references submitted.	N	N	N/A	N/A	N/A
KIIIA1 6/01	2014	Please refer to Part C A13703G Alibi Flora BAD - Field Use Syngenta Crop Protection AG, Basel, CH, A13703G_11077 Not GLP, not published Syngenta File No A13703G_11077 This is CONFIDENTIAL Data	N	N	N/A	N/A	SYN
KIIIA1 6.1.2 / 01 KIIIA1 6.1.3 / 01 KIIIA1 6.2.1 / 01	2014	Evaluate the efficacy of A17358A and A16609D on powdery mildew in Gerbera Syngenta Crop Protection AG, Basel, CH, Syngenta, NLOM0F7132010 GEP, not published Syngenta File No A13703G_11157	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 6.1.2 / 02 KIIIA1 6.1.3 / 02 KIIIA1 6.2.1 / 02	2014a	Evaluate the efficacy of A17358A and A16609D on powdery mildew in Gerbera Syngenta Crop Protection AG, Basel, CH, Syngenta, NLOM0F7142010 GEP, not published Syngenta File No A13703G_11181	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 03 KIIIA1 6.1.3 / 03 KIIIA1 6.2.1 / 03	2014b	Evaluate the efficacy of A17358A and A16609D on powdery mildew in Gerbera Syngenta Crop Protection AG, Basel, CH, Syngenta, NLOM0F7412010 GEP, not published Syngenta File No A13703G_11159	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 04 KIIIA1 6.1.3 / 04 KIIIA1 6.2.1 / 04	2014	Evaluate the efficacy of A17358A and A16609D on powdery mildew in Gerbera Syngenta Crop Protection AG, Basel, CH, Aegisto BV, Xxxxx Xxxxxxx, Netherlands, NLOMZF2012011 GEP, not published Syngenta File No A13703G_11233	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 05 KIIIA1 6.1.3 / 05 KIIIA1 6.2.1 / 05	2014a	Evaluate the efficacy of A17358A and A16609D on powdery mildew in Gerbera Syngenta Crop Protection AG, Basel, CH, Aegisto BV, Xxxxx Xxxxxxx, Netherlands, NLOMZF2022011 GEP, not published Syngenta File No A13703G_11235	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 6.1.2 / 06 KIIIA1 6.1.3 / 06 KIIIA1 6.2.1 / 06	2014c	Evaluation of several fungicide mixtures on Powdery Mildew in Gerbera Oidium citrulli Syngenta Crop Protection AG, Basel, CH, Syngenta, NLOM0F2342011 GEP, not published Syngenta File No A13703G_11161	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 07 KIIIA1 6.1.3 / 07 KIIIA1 6.2.1 / 07	2014d	Evaluation of several fungicide mixtures on Powdery Mildew in Gerbera Oidium citrulli Syngenta Crop Protection AG, Basel, CH, Syngenta, NLOM0F2352011 GEP, not published Syngenta File No A13703G_11147	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 08 KIIIA1 6.1.3 / 08 KIIIA1 6.2.1 / 08	2014e	Evaluation of several fungicide mixtures on Powdery Mildew in Gerbera Oidium citrulli Syngenta Crop Protection AG, Basel, CH, Syngenta, NLOM0F2362011 GEP, not published Syngenta File No A13703G_11167	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 09 KIIIA1 6.1.3 / 09 KIIIA1 6.2.1 / 09	2014b	Evaluation of several fungicide mixtures on Powdery Mildew in Gerbera Oidium citrulli Syngenta Crop Protection AG, Basel, CH, Aegisto BV, Xxxxx Xxxxxxx, Netherlands, NLOM0F2372011 GLP, not published Syngenta File No A13703G_11149	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 6.1.2 / 10 KIIIA1 6.1.3 / 10 KIIIA1 6.2.1 / 10	2014c	Evaluation of several fungicide mixtures on Powdery Mildew in Gerbera Oidium citrulli Syngenta Crop Protection AG, Basel, CH, Aegisto BV, Xxxxx Xxxxxxx, Netherlands, NLOM0F2382011 GEP, not published Syngenta File No A13703G_11169	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 11 KIIIA1 6.1.3 / 11 KIIIA1 6.2.1 / 11	2014	Development of a new mildewicide Syngenta Crop Protection AG, Basel, CH, NLOMZF1192008 GEP, not published Syngenta File No A13703G_11119	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 12 KIIIA1 6.1.3 / 12 KIIIA1 6.2.1 / 12	2014a	Development of a new mildewicide Syngenta Crop Protection AG, Basel, CH, NLOMZF1882008 GEP, not published Syngenta File No A13703G_11133	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 13 KIIIA1 6.1.3 / 13 KIIIA1 6.2.1 / 13	2014	Development of a new mildewicide Syngenta Crop Protection AG, Basel, CH, NLOMZF6602008 GEP, not published Syngenta File No A13703G_11137	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 6.1.2 / 14 KIIIA1 6.1.3 / 14 KIIIA1 6.2.1 / 14	2014b	Screen XXX000000 solo and in combination on powdery mildew in covered roses Syngenta Crop Protection AG, Basel, CH, NLOM0F1042009 GEP, not published Syngenta File No A13703G_11197	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 15 KIIIA1 6.1.3 / 15 KIIIA1 6.2.1 / 15	2014c	Screen XXX000000 solo and in combination on powdery mildew in covered roses Syngenta Crop Protection AG, Basel, CH, NLOM0F1052009 GEP, not published Syngenta File No A13703G_11105	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 16 KIIIA1 6.1.3 / 16 KIIIA1 6.2.1 / 16	2014d	Evaluate the efficacy of A13703G on Sphaerotheca pannosa in covered roses Syngenta Crop Protection AG, Basel, CH, NLOMZF1382009 GEP, not published Syngenta File No A13703G_11231	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 17 KIIIA1 6.1.3 / 17 KIIIA1 6.2.1 / 17	2014f	Evaluate the efficacy of A13703G on Sphaerotheca pannosa in covered roses Syngenta Crop Protection AG, Basel, CH NLOMZF6772009 GEP, not published Syngenta File No A13703G_11129	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 6.1.2 / 18 KIIIA1 6.1.3 / 18 KIIIA1 6.2.1 / 18	2014g	Evaluate the efficacy of A13703G on Sphaerotheca pannosa in covered roses Syngenta Crop Protection AG, Basel, CH NLOMZF6782009 GEP, not published Syngenta File No A13703G_11141	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 19 KIIIA1 6.1.3 / 19 KIIIA1 6.2.1 / 19	2014a	Evaluate the efficacy of A13703G on Rose Powdery Mildew Sphaerotheca pannosa Syngenta Crop Protection AG, Basel, CH NLOM0F7442010 GEP, not published Syngenta File No A13703G_11183	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 20 KIIIA1 6.1.3 / 20 KIIIA1 6.2.1 / 20	2014b	Evaluate the efficacy of A13703G on Rose Powdery Mildew Sphaerotheca pannosa Syngenta Crop Protection AG, Basel, CH, NLOM0F7452010 GLP, not published Syngenta File No A13703G_11163	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 21 KIIIA1 6.1.3 / 21 KIIIA1 6.2.1 / 21	2014c	Evaluate the efficacy of A13703G on Rose Powdery Mildew Sphaerotheca pannosa Syngenta Crop Protection AG, Basel, CH NLOM0F7462010 GEP, not published Syngenta File No A13703G_11123	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 6.1.2 / 22 KIIIA1 6.1.3 / 22 KIIIA1 6.2.1 / 22	2014h	Evaluate the efficacy of A13703G on Sphaerotheca pannosa in covered roses Syngenta Crop Protection AG, Basel, CH NLOMZF6982010 GLP, not published Syngenta File No A13703G_11139	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 23 KIIIA1 6.1.3 / 23 KIIIA1 6.2.1 / 23	2014i	Evaluate the efficacy of A13703G on Sphaerotheca pannosa in covered roses Syngenta Crop Protection AG, Basel, CH NLOMZF6992010 GEP, not published Syngenta File No A13703G_11143	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 24 KIIIA1 6.1.3 / 24 KIIIA1 6.2.1 / 24	2014e	Evaluate the efficacy of A13703G on Sphaerotheca pannosa in covered roses Syngenta Crop Protection AG, Basel, CH NLOMZF1102011 GEP, not published Syngenta File No A13703G_11131	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 25 KIIIA1 6.1.3 / 25 KIIIA1 6.2.1 / 25	2014d	Evaluate the efficacy of A13703G on Sphaerotheca pannosa in covered roses Syngenta Crop Protection AG, Basel, CH Aegisto BV, Xxxxx Xxxxxxx, Netherlands, NLOMZF2092011 GLP, not published Syngenta File No A13703G_11135	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 6.1.2 / 26 KIIIA1 6.1.3 / 26 KIIIA1 6.2.1 / 26	2014e	Evaluate the efficacy of A13703G on Sphaerotheca pannosa in covered roses Syngenta Crop Protection AG, Basel, CH Aegisto BV, Xxxxx Xxxxxxx, Netherlands, NLOMZF2102011 GEP, not published Syngenta File No A13703G_11121	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 27 KIIIA1 6.1.3 / 28 KIIIA1 6.2.1 / 28	2014f	Efficacy of Alibi Flora and Sunjet Flora on Sphaerotheca pannosa in Roses Syngenta Crop Protection AG, Basel, CH NLOM0F2212013 GEP, not published Syngenta File No A13703G_11189	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 29 KIIIA1 6.1.3 / 29 KIIIA1 6.2.1 / 29	2014g	Efficacy of Alibi Flora and Sunjet Flora on Sphaerotheca pannosa in Roses Syngenta Crop Protection AG, Basel, CH Xxxxxxxxx Laboratorium BV, Wijster, Netherlands, NLOM0F2232013 GEP, not published Syngenta File No A13703G_11155	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 30 KIIIA1 6.1.3 / 30 KIIIA1 6.2.1 / 30	2014	Efficacy of Alibi Flora and Sunjet Flora on Sphaerotheca pannosa on Roses Syngenta Crop Protection AG, Basel, CH Anadiag France, Ruy, France, FROM0F2172013 GEP, not published Syngenta File No A13703G_11103	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 6.1.2 / 31 KIIIA1 6.1.3 / 31 KIIIA1 6.2.1 / 31	2014h	Efficacy of Alibi Flora and Sunjet Flora on Sphaerotheca pannosa on Roses Syngenta Crop Protection AG, Basel, CH DEOM0F2152013 GEP, not published Syngenta File No A13703G_11101	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 32 KIIIA1 6.1.3 / 32 KIIIA1 6.2.1 / 32	2014i	Evaluate the efficacy of several fungicide mixtures in Begonia Syngenta Crop Protection AG, Basel, CH NLOM0F2582011 GEP, not published Syngenta File No A13703G_11153	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 33 KIIIA1 6.1.3 / 33 KIIIA1 6.2.1 / 33	2014	Efficacy of several fungicide mixtures on Microsphaera in Begonia Syngenta Crop Protection AG, Basel, CH Aegisto BV, Horst Meterik, Netherlands, NLOM0F2032012 GEP, not published Syngenta File No A13703G_11087	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 34 KIIIA1 6.1.3 / 34 KIIIA1 6.2.1 / 34	2014a	Efficacy of A13703G and several A16609 formulations against Microsphaera begoniae in Begonia Syngenta Crop Protection AG, Basel, CH Aegisto BV, Xxxxx Xxxxxxx, Netherlands, NLOM0F2122012 GEP, not published Syngenta File No A13703G_11095	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 6.1.2 / 35 KIIIA1 6.1.3 / 35 KIIIA1 6.2.1 / 35	2014b	Efficacy of A13703G and several A16609 formulations against Microsphaera begoniae in Begonia Syngenta Crop Protection AG, Basel, CH Aegisto BV, Xxxxx Xxxxxxx, Netherlands, NLOM0F2132012 GEP, not published Syngenta File No A13703G_11219	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 36 KIIIA1 6.1.3 / 36 KIIIA1 6.2.1 / 36	2014j	Bridge two different A16609 variants and test A13703G on Powdery Mildew in Begonia Syngenta Crop Protection AG, Basel, CH NLOM0F2472012 GEP, not published Syngenta File No A13703G_11151	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 37 KIIIA1 6.1.3 / 37 KIIIA1 6.2.1 / 37	2014k	Bridge two different A16609 variants and test A13703G on Powdery Mildew in Begonia Syngenta Crop Protection AG, Basel, CH NLOM0F2482012 GEP, not published Syngenta File No A13703G_11171	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 6.1.2 / 38 KIIIA1 6.1.3 / 38 KIIIA1 6.2.1 / 38	2014j	Profile the efficacy of A18905A and several fungicides on fungal diseases in Nursery Stock Syngenta Crop Protection AG, Basel, CH Aegisto BV, Xxxxx Xxxxxxx, Netherlands, NLOM0F2202011 GEP, not published Syngenta File No A13703G_11097	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 39 KIIIA1 6.1.3 / 39 KIIIA1 6.2.1 / 39	2014k	Profile the efficacy of A18905A and several fungicides on fungal diseases in Nursery Stock Syngenta Crop Protection AG, Basel, CH Aegisto BV, Xxxxx Xxxxxxx, Netherlands, NLOM0F2212011 GEP, not published Syngenta File No A13703G_11221	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 40 KIIIA1 6.1.3 / 40 KIIIA1 6.2.1 / 40	2014l	Profile the efficacy of A18905A and several fungicides on fungal diseases in Nursery Stock Syngenta Crop Protection AG, Basel, CH De Bredelaar B.V., Elst, Netherlands, NLOM0F2222011 GEP, not published Syngenta File No A13703G_11099	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 6.1.2 / 41 KIIIA1 6.1.3 / 41 KIIIA1 6.2.1 / 41	2014m	Efficacy of Alibi Flora and Sunjet Flora on Microsphaera alphidoides on Quercus Syngenta Crop Protection AG, Basel, CH NLOM0F2222013 GEP, not published Syngenta File No A13703G_11223	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 42 KIIIA1 6.1.3 / 42 KIIIA1 6.2.1 / 42	2014n	Efficacy of Alibi Flora and Sunjet Flora on Microsphaera alphidoides on Quercus Syngenta Crop Protection AG, Basel, CH Xxxxxxxxx Laboratorium BV, Wijster, NL, NLOM0F2242013 GEP, not published Syngenta File No A13703G_11145	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 43 KIIIA1 6.1.3 / 43 KIIIA1 6.2.1 / 43	2014o	Efficacy of Alibi Flora and Sunjet Flora on Microsphaera alphitoides in Quercus Syngenta Crop Protection AG, Basel, CH DEOM0F2162013 GEP, not published Syngenta File No A13703G_11193	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.1.2 / 44 KIIIA1 6.1.3 / 44 KIIIA1 6.2.1 / 44	2014a	Efficacy of Alibi Flora and Sunjet Flora on Microsphaera alphitoides on Quercus Syngenta Crop Protection AG, Basel, CH Anadiag France, Ruy, France, FROM0F2202013 GEP, not published Syngenta File No A13703G_11195	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 6.2.1 / 45	2014f	Evaluate selectivity of several new products for the control of powdery mildew in Cut Gerbera Syngenta Crop Protection AG, Basel, CH NLOM0F1132011 GEP, not published Syngenta File No A13703G_11201	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.2.1 / 46	2014g	Evaluate selectivity of several new products for the control of powdery mildew in Cut Gerbera Syngenta Crop Protection AG, Basel, CH NLOM0F1142011 GEP, not published Syngenta File No A13703G_11113	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.2.1 / 47	2014h	Evaluate selectivity of several new products for the control of powdery mildew in Cut Gerbera Syngenta Crop Protection AG, Basel, CH NLOM0F1152011 GEP, not published Syngenta File No A13703G_11115	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 6.2.1 / 48	2014i	Evaluate selectivity of several new products for the control of powdery mildew in Cut Gerbera Syngenta Crop Protection AG, Basel, CH NLOM0F1162011 GEP, not published Syngenta File No A13703G_11117	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.2.1 / 49	2014j	Evaluate selectivity of several new products for the control of powdery mildew in Cut Gerbera Syngenta Crop Protection AG, Basel, CH NLOM0F1172011 GEP, not published Syngenta File No A13703G_11085	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.2.1 / 50	2014k	Selectivity of XXX000000, XXX000000 and Amistar Top in covered roses Syngenta Crop Protection AG, Basel, CH NLOM0F1162009 GEP, not published Syngenta File No A13703G_11229	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.2.1 / 51	2014l	Selectivity of XXX000000, XXX000000 and Amistar Top in covered roses Syngenta Crop Protection AG, Basel, CH NLOM0F1172009 GEP, not published Syngenta File No A13703G_11203	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 6.2.1 / 52	2014m	Selectivity of new powdery mildew products in cutroses Syngenta Crop Protection AG, Basel, CH NLOMZF1062010 GEP, not published Syngenta File No A13703G_11165	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.2.1 / 52iz KIIIA1 6.2.1 / 58	2014n	Selectivity of new powdery mildew products in cutroses Syngenta Crop Protection AG, Basel, CH NLOM0F1062011 GEP, not published Syngenta File No A13703G_11107	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.2.1 / 53	2014o	Selectivity of new powdery mildew products in cutroses Syngenta Crop Protection AG, Basel, CH NLOMZF1072010 GEP, not published Syngenta File No A13703G_11175	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.2.1 / 54	2014p	Selectivity of new powdery mildew products in cutroses Syngenta Crop Protection AG, Basel, CH NLOMZF1082010 GEP, not published Syngenta File No A13703G_11125	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 6.2.1 / 55	2014q	Selectivity of new powdery mildew products in cutroses Syngenta Crop Protection AG, Basel, CH NLOMZF1092010 GEP, not published Syngenta File No A13703G_11127	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.2.1 / 56	2014r	Selectivity of new powdery mildew products in cutroses Syngenta Crop Protection AG, Basel, CH NLOMZF1102010 GEP, not published Syngenta File No A13703G_11177	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.2.1 / 57	2014s	Selectivity of new powdery mildew products in cutroses Syngenta Crop Protection AG, Basel, CH NLOM0F1052011 GEP, not published Syngenta File No A13703G_11191	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.2.1 / 59	2014t	Selectivity of new powdery mildew products in cutroses Syngenta Crop Protection AG, Basel, CH NLOM0F1072011 GEP, not published Syngenta File No A13703G_11185	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 6.2.1 / 60	2014u	Selectivity of new powdery mildew products in cutroses Syngenta Crop Protection AG, Basel, CH NLOM0F1082011 GEP, not published Syngenta File No A13703G_11109	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.2.1 / 61	2014v	Selectivity of new powdery mildew products in cutroses Syngenta Crop Protection AG, Basel, CH NLOM0F1092011 GEP, not published Syngenta File No A13703G_11187	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.2.1 / 62	2014w	Crop safety of A13703G and several A16609 formulation variants in cutflower production Syngenta Crop Protection AG, Basel, CH NLOM0F1122012 GEP, not published Syngenta File No A13703G_11111	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.2.1 / 63	2014x	Crop safety of A13703G and several A16609 formulation variants in cutflower production Syngenta Crop Protection AG, Basel, CH NLOM0F1132012 GEP, not published Syngenta File No A13703G_11199	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 6.2.1 / 64	2014y	Crop safety of fungicide products of A13703G and A16609 formulation variants in carnation Syngenta Crop Protection AG, Basel, CH NLOM0F1142012 GEP, not published Syngenta File No A13703G_11225	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.2.1 / 65	2014z	Crop safety of fungicide products of A13703G and A16609 formulation variants in carnation Syngenta Crop Protection AG, Basel, CH NLOM0F1152012 GEP, not published Syngenta File No A13703G_11227	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.2.1 / 66	2014d	Selectivity of XXX000000 and other AI’s on covered ornamentals Syngenta Crop Protection AG, Basel, CH NLOM0F6012009 GEP, not published Syngenta File No A13703G_11173	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.2.1 / 67	2014e	Selectivity of XXX000000 and other AI’s on covered ornamentals Syngenta Crop Protection AG, Basel, CH NLOM0F6032009 GEP, not published Syngenta File No A13703G_11179	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 6.2.1 / 68	2014p	Evaluate selectivity of A13703G, A16609D and MBI-106020 in ornamental crops Syngenta Crop Protection AG, Basel, CH Aegisto BV, Xxxxx Xxxxxxx, Netherlands, NLOM0F2032011 GEP, not published Syngenta File No A13703G_11205	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.2.1 / 69	2014q	Evaluate selectivity of A13703G, A16609D and MBI-106020 in ornamental crops Syngenta Crop Protection AG, Basel, CH Aegisto BV, Xxxxx Xxxxxxx, Netherlands, NLOM0F2042011 GEP, not published Syngenta File No A13703G_11207	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.2.1 / 70	2014r	Evaluate selectivity of A13703G, A16609D and MBI-106020 in ornamental crops Syngenta Crop Protection AG, Basel, CH Aegisto BV, Xxxxx Xxxxxxx, Netherlands, NLOM0F2052011 GEP, not published Syngenta File No A13703G_11089	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 6.2.1 / 71	2014s	Evaluate selectivity of A13703G, A16609D and MBI-106020 in ornamental crops Syngenta Crop Protection AG, Basel, CH Aegisto BV, Xxxxx Xxxxxxx, Netherlands, NLOM0F2062011 GEP, not published Syngenta File No A13703G_11091	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.2.1 / 72	2014c	Crop safety: A13703G and A16609 formulations variants in potplants Syngenta Crop Protection AG, Basel, CH Aegisto BV, Xxxxx Xxxxxxx, Netherlands, NLOM0F2042012 GEP, not published Syngenta File No A13703G_11209	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.2.1 / 73	2014d	Crop safety: A13703G and A16609 formulations variants in potplants Syngenta Crop Protection AG, Basel, CH Aegisto BV, Xxxxx Xxxxxxx, Netherlands, NLOM0F2052012 GEP, not published Syngenta File No A13703G_11211	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 6.2.1 / 74	2014e	Crop safety: A13703G and A16609 formulations variants in potplants Syngenta Crop Protection AG, Basel, CH Aegisto BV, Xxxxx Xxxxxxx, Netherlands, NLOM0F2062012 GEP, not published Syngenta File No A13703G_11213	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.2.1 / 75	2014f	Crop safety: A13703G and A16609 formulations variants in potplants Syngenta Crop Protection AG, Basel, CH Aegisto BV, Xxxxx Xxxxxxx, Netherlands, NLOM0F2072012 GEP, not published Syngenta File No A13703G_11093	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6.2.1 / 76	2014g	Crop safety: A13703G and A16609 formulations variants in potplants Syngenta Crop Protection AG, Basel, CH Aegisto BV, Xxxxx Xxxxxxx, Netherlands, NLOM0F2082012 GEP, not published Syngenta File No A13703G_11215	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 6.2.1 / 77	2014h	Crop safety: A13703G and A16609 formulations variants in potplants Syngenta Crop Protection AG, Basel, CH Aegisto BV, Xxxxx Xxxxxxx, Netherlands, NLOM0F2092012 GEP, not published Syngenta File No A13703G_11217	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 6/01	2014a	Please refer to Part C A13703G - Alibi Flora BAD - Greenhouse Syngenta Crop Protection AG, Basel, CH, A13703G_11083 Not GLP, not published Syngenta File No A13703G_11083 This is CONFIDENTIAL Data	N	N	N/A	N/A	SYN
N/A	N/A	No NL addendum for Section 7	N	N	N/A	N/A	N/A
KIIIA1 7.1.1 / 01l	2003	Azoxystrobin/Difenoconazole 200/125G/L SC Formulation (A13703G) - Acute Oral Toxicity Study in the Rat - Up and Down Procedure GLP, not published Syngenta File No ICI5504/2140	Y	Y	N	Submitted with application 20080302 TG	SYN
KIIIA1 7.1.2 / 01	2003a	Azoxystrobin/Difenoconazole 200/125g/l SC Formulation (A13703G): Acute Dermal Toxicity Study in the Rat GLP, not published Syngenta File No ICI5504/2138	Y	Y	N	Submitted with application 20080302 TG	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 7.1.3 / 01	2006	CGA169374/Azoxystrobin SC (125/200) (A13703G) - 4-Hour Acute Inhalation Toxicity Study In Rats GLP, not published Syngenta File No ICI5504/3131	Y	Y	N	Submitted with application 20080302 TG	SYN
KIIIA1 7.1.4 / 01	2003b	Azoxystrobin/Difenoconazole 200/125G/L SC Formulation (A13703G) - Skin Irritation Study in the Rabbit GLP not published Syngenta File No ICI5504/2139	Y	Y	N	Submitted with application 20080302 TG	SYN
KIIIA1 7.1.5 / 01	2003c	Azoxystrobin/Difenoconazole 200/125g/l SC Formulation (A13703G): Eye Irritation Study in the Rabbit GLP, not published Syngenta File No ICI5504/2137	Y	Y	N	Submitted with application 20080302 TG	SYN
KIIIA1 7.1.6 / 01	2003	Azoxystrobin/Difenoconazole 200/125g/l SC Formulation (A13703G): Contact Hypersensitivity in Albino Guinea Pigs, Buhler Test GLP, not published Syngenta File No ICI5504/2156	Y	Y	N	Submitted with application 20080302 TG	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 7.6.1 / 01	2006	Azoxystrobin 250 g/l SC Formulation (A12705B) - In Vivo Dermal Absorption Study GLP, not published Syngenta File No ICI5504/3674	Y	Y	N	Submitted with application 20080302 TG	SYN
KIIIA1 7.6.2 / 01	2006	Azoxystrobin 250g/l SC formulation (A12705B):In Vitro Absorption Of Azoxystrobin Through Rat Epidermis Syngenta Crop Protection AG, Basel, CH JV1903-REG GLP, not published Syngenta File No ICI5504/3263	N	Y	N	Submitted with application 20080302 TG	SYN
KIIIA1 7.6.2 / 02	2006a	Azoxystrobin 250 g/l SC formulation (A12705B):In Vitro Absorption Of Azoxystrobin Through Human Epidermis JV1904-REG GLP, not published Syngenta File No ICI5504/3307	N	Y	N	Submitted with application 20080302 TG	SYN
KIIIA1 7.6.2 / 03	2013	Difenoconazole/Azoxystrobin SC (A18253A) - The In Vitro Percutaneous Absorption of Radiolabelled Difenoconazole in Concentrate Formulation and Two In-Use Dilutions Through Human Split-Thickness Skin 34702 GLP, not published Syngenta File No A18253A_10052	N	Y	N	Study submitted in support of the authorisation renewal of A13703G but no decision yet	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 7.3.3 / 01iz	1996	Operator Exposure in Greenhouses during Practical Use of Plant Protection Products Novartis Crop Protection AG, Basel, CH ECON Forschung und Bewertungskonzepte, Ingelheim, Germany, EF 94-02-03 Not GLP, not published Syngenta File No N/0688	N	N	N	Study already submitted with application 20060753 THG. Submission date: 18 December 2008	SYN
KIIIA1 7.5.3 / 01 iz	2013	Difenoconazole - Residue study on Protected Lettuce in the United Kingdom, Germany and Northern France in 2012. , Report No. S12- 01409 Eurofins Agrosciences services GLP, not published Syngenta File No. A7402T_10608	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 7.5.3 / 02 iz	2013a	Difenoconazole - Residue study on Protected Lettuce in the Southern France and Italy in 2012, Report No. S12-01410 Eurofins Agrosciences services GLP, not published Syngenta File No. A7402T_10607	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
N/A	N/A	No references submitted.	N	N	N/A	N/A	N/A
N/A	N/A	No references submitted.	N	N	N/A	N/A	N/A

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
N/A	N/A	No references submitted.	N	N	N/A	N/A	N/A
KIIIA1 9.1.1 / 01	2011	Azoxystrobin - Rate of Degradation of [14C]- R234886, a Soil Metabolite, in Nine Soils under Aerobic Laboratory Conditions at 20°C Syngenta Crop Protection AG, Basel, CH Battelle UK Ltd., Ongar, UK, NC/10/030 GLP, not published Syngenta File No R234886_10002	N	Y	Y	Study submitted in support of other applications 20131583 NLTHG / 20131580 NLTHG/ 20131577 VAG	SYN
KIIIA1 9.1.1 / 02	2011	Azoxystrobin - Calculation of Kinetic Endpoints for Soil Metabolite R234886 from Laboratory Study Data according to FOCUS Kinetics Guidelines Syngenta Crop Protection AG, Basel, CH, Syngenta - Jealott’s Hill, Bracknell, UK, RAJ0866B Not GLP, not published Syngenta File No R234886_10003 This is CONFIDENTIAL INFORMATION	N	N	N	Study submitted in support of applications 20131583 NLTHG / 20131580 NLTHG/ 20131577 VAG.	SYN
KIIIA1 9.3 /	2011	Azoxystrobin - Adsorption and Desorption Properties of 14C-R234886 in Nine Soils Syngenta Crop Protection AG, Basel Battelle UK Ltd., Ongar, UK, NC/10/055 GLP, not published Syngenta File No R234886_10004	N	Y	Y	Study submitted in support of applications 20131583 NLTHG / 20131580 NLTHG/ 20131577 VAG.	SYN

Data point

Year

Title

Company Report No.

Source (where different from company) GLP or GEP status

Published or not

Vertebrat e study Y/N

Data protection claimed Y/N

Data protection granted Y/N

Justification if data protection (DP) is claimed

(Paragraph number refers to SANCO/12576/2012-

rev. 1.1; 1 February

2013)

Owner

SYN =

Syngenta

KIIIA1 9.6.1

/ 01

KIIIA1 10.3.3/03

nl add

2011

Azoxystrobin - A Leaching Assessment for Parent and Soil Metabolites R234886, R402173 and R401553 using the FOCUS Groundwater Scenarios Following Spray Application to Leafy Vegetables in the EU Syngenta Crop Protection AG, Basel, CH Xx Xxxxxx Consult GmbH, Mannheim, DE, 102225-18

Not GLP, not published

Syngenta File No ICI5504_11471

This is CONFIDENTIAL INFORMATION

Study submitted in support of applications 20131583 NLTHG /

20131580 NLTHG/

20131577 VAG.

SYN

KIIIA1 9.6.1

/ 02

2011a

Azoxystrobin - A Leaching Assessment for Parent and Soil Metabolites R234886, R402173 and R401553 using the FOCUS Groundwater Scenarios Following Spray Application to Vines in the EU

Syngenta Crop Protection AG, Basel, CH, Xx Xxxxxx Consult GmbH, Mannheim, DE, 102225-21

Not GLP, not published

Syngenta File No ICI5504_11474

This is CONFIDENTIAL INFORMATION

Study submitted in support of applications 20131583 NLTHG /

20131580 NLTHG/

20131577 VAG.

SYN

Data point

Year

Title

Company Report No.

Source (where different from company) GLP or GEP status

Published or not

Vertebrat e study Y/N

Data protection claimed Y/N

Data protection granted Y/N

Justification if data protection (DP) is claimed

(Paragraph number refers to SANCO/12576/2012-

rev. 1.1; 1 February

2013)

Owner

SYN =

Syngenta

KIIIA1 9.6.1

/ 03

2013

Azoxystrobin - A Leaching Assessment for Parent and Soil Metabolites R234886, R402173 and R401553 using the FOCUS Groundwater Scenarios with FOCUS PEARL

4.4.4 and FOCUS PELMO 4.4.3 Following Spray Application to Trees in the EU Syngenta Crop Protection AG, Basel, CH Xx Xxxxxx Consult GmbH, Mannheim, DE, 420603-10

Not GLP, not published

Syngenta File No ICI5504_11579

This is CONFIDENTIAL INFORMATION

Study submitted in support of applications 20131583 NLTHG /

20131580 NLTHG/

20131577 VAG.

SYN

KIIIA1 9.6.1

/ 04

2014

Difenoconazole - A Leaching Assessment for Difenoconazole and Its Soil Metabolites CGA205375 and CGA71019 Using the FOCUS-PEARL 4.4.4 and PELMO 5.5.3

Groundwater Models Following Spray Application of Difenoconazole to Leafy Vegetables

Syngenta Crop Protection AG, Basel, CH RIFCON GmbH, Hirschberg, DE, R1420182-1

Not GLP, not published

Syngenta File No CGA169374_10840

This is CONFIDENTIAL INFORMATION

Study not submitted before

SYN

Data point

Year

Title

Company Report No.

Source (where different from company) GLP or GEP status

Published or not

Vertebrat e study Y/N

Data protection claimed Y/N

Data protection granted Y/N

Justification if data protection (DP) is claimed

(Paragraph number refers to SANCO/12576/2012-

rev. 1.1; 1 February

2013)

Owner

SYN =

Syngenta

KIIIA1 9.6.1

/ 05

2012a

Difenoconazole - A Leaching Assessment for Parent and Soil Metabolites CGA205375 and CGA71019 using the FOCUS Groundwater Scenarios Following Spray Application to Vines in the EU

Syngenta Crop Protection AG, Basel, CH Xx Xxxxxx Consult GmbH, Mannheim, DE, 102267-3

Not GLP, not published

Syngenta File No CGA169374_10527

This is CONFIDENTIAL INFORMATION

Study submitted in support of application 20120010 THG: under

evaluation.

SYN

KIIIA1 9.6.1

/ 06

2012b

Difenoconazole - A Leaching Assessment for Parent and Soil Metabolites CGA205375 and CGA71019 using the FOCUS Groundwater Scenarios Following Spray Application to Orchards in the EU

Syngenta Crop Protection AG, Basel, CH Xx Xxxxxx Consult GmbH, Mannheim, DE, 102267-8

Not GLP, not published

Syngenta File No CGA169374_10534

This is CONFIDENTIAL INFORMATION

Study already submitted in support of application 20120007 THG): under evaluation. Submission date 24 September

2013

SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 9.6.2 / 01	2013	Document Syngenta Crop Protection AG, Basel, CH, ICI5504_11562 Not GLP, not published Syngenta File No ICI5504_11562 This is CONFIDENTIAL INFORMATION	N	N	N	Study submitted in support of application 20120010 THG: under evaluation.	SYN
KIIIA1 9.7.1 / 01	2014c	Azoxystrobin - A European Fate Assessment using the FOCUS Surface Water Scenarios at Step 3 and Step 4 Following Application to Leafy Vegetables Syngenta Crop Protection AG, Basel, CH Xx Xxxxxx Consult GmbH, Mannheim, DE, 101522-1 Not GLP, not published Syngenta File No ICI5504_11639 This is CONFIDENTIAL INFORMATION	N	N	N	Study not submitted before	SYN
KIIIA1 9.7.1 / 02	2014e	Azoxystrobin - A European Fate Assessment using the FOCUS Surface Water Scenarios at Step 3 and Step 4 Following Application to Vines Syngenta Crop Protection AG, Basel, CH Xx Xxxxxx Consult GmbH, Mannheim, DE, 101522-2 Not GLP, not published Syngenta File No ICI5504_11640 This is CONFIDENTIAL INFORMATION	N	N	N	Study not submitted before	SYN

Data point

Year

Title

Company Report No.

Source (where different from company) GLP or GEP status

Published or not

Vertebrat e study Y/N

Data protection claimed Y/N

Data protection granted Y/N

Justification if data protection (DP) is claimed

(Paragraph number refers to SANCO/12576/2012-

rev. 1.1; 1 February

2013)

Owner

SYN =

Syngenta

KIIIA1 9.7.1

/ 03

2014g

Azoxystrobin - A European Fate Assessment using the FOCUS Surface Water Scenarios at Step 3 and Step 4 Following Application to Trees

Syngenta Crop Protection AG, Basel, CH Xx Xxxxxx Consult GmbH, Mannheim, DE, 101522-3

Not GLP, not published

Syngenta File No ICI5504_11641

This is CONFIDENTIAL INFORMATION

Study not submitted before

SYN

KIIIA1 9.7.1

/ 04

2012

Difenoconazole - A European Fate Assessment using the FOCUS Surface Water Scenarios at Step 3 and Step 4 Following Application to Leafy Vegetables

Syngenta Crop Protection AG, Basel, CH Xx Xxxxxx Consult GmbH, Mannheim, DE, 104002-2

Not GLP, not published

Syngenta File No CGA169374_10552

This is CONFIDENTIAL INFORMATION

Study submitted in support of application 20120010 THG: under

evaluation.

SYN

Data point

Year

Title

Company Report No.

Source (where different from company) GLP or GEP status

Published or not

Vertebrat e study Y/N

Data protection claimed Y/N

Data protection granted Y/N

Justification if data protection (DP) is claimed

(Paragraph number refers to SANCO/12576/2012-

rev. 1.1; 1 February

2013)

Owner

SYN =

Syngenta

KIIIA1 9.7.1

/ 05

2012a

Difenoconazole - A European Fate Assessment using the FOCUS Surface Water Scenarios at Step 3 and Step 4 Following Application to Vines

Syngenta Crop Protection AG, Basel, CH Xx Xxxxxx Consult GmbH, Mannheim, DE, 104002-9

Not GLP, not published

Syngenta File No CGA169374_10560

This is CONFIDENTIAL INFORMATION

Study submitted in support of application 20120010 THG: under

evaluation

SYN

KIIIA1 9.7.1

/ 06

2012b

Difenoconazole - A European Fate Assessment using the FOCUS Surface Water Scenarios at Step 3 and Step 4 Following Application to Pome and Stone Fruit Syngenta Crop Protection AG, Basel,CH,

Xx Xxxxxx Consult GmbH, Mannheim, DE, 104002-7

Not GLP, not published

Syngenta File No CGA169374_10558

This is CONFIDENTIAL INFORMATION

Study already submitted in support of application 20120007 THG: under evaluation. Submission date 24 September

2013

SYN

Data point

Year

Title

Company Report No.

Source (where different from company) GLP or GEP status

Published or not

Vertebrat e study Y/N

Data protection claimed Y/N

Data protection granted Y/N

Justification if data protection (DP) is claimed

(Paragraph number refers to SANCO/12576/2012-

rev. 1.1; 1 February

2013)

Owner

SYN =

Syngenta

KIIIA1 9.7.1

/ 01iz

2014d

Azoxystrobin - An Environmental Fate Assessment using the Surface Water Model TOXSWA 1.2 Following Spray Application to Plants in Greenhouses in The Netherlands Syngenta Crop Protection AG, Basel, CH

Xx Xxxxxx Consult GmbH, Mannheim, DE, 101522-4

Not GLP, not published

Syngenta File No ICI5504_11647

This is CONFIDENTIAL INFORMATION

Study not submitted before

SYN

KIIIA1 9.7.1

/ 02iz

2014f

Azoxystrobin - An Environmental Fate Assessment using the Surface Water Model TOXSWA 1.2 Following Spray Application to Trees in The Netherlands

Syngenta Crop Protection AG, Basel, CH Xx Xxxxxx Consult GmbH, Mannheim, DE, 101522-5

Not GLP, not published

Syngenta File No ICI5504_11645

This is CONFIDENTIAL INFORMATION

Study not submitted before

SYN

Data point

Year

Title

Company Report No.

Source (where different from company) GLP or GEP status

Published or not

Vertebrat e study Y/N

Data protection claimed Y/N

Data protection granted Y/N

Justification if data protection (DP) is claimed

(Paragraph number refers to SANCO/12576/2012-

rev. 1.1; 1 February

2013)

Owner

SYN =

Syngenta

KIIIA1 9.7.1

/ 03iz

2014g

Difenoconazole - An Environmental Fate Assessment Using the TOXSWA 1.2 Model Following Applications to Ornamentals in Greenhouses in the Netherlands

Syngenta Crop Protection AG, Basel, CH RIFCON GmbH, Hirschberg, DE, R1420255-1

Not GLP, not published

Syngenta File No CGA169374_10856

This is CONFIDENTIAL INFORMATION

Study not submitted before

SYN

KIIIA1 9.7.1

/ 01add

2011b

Azoxystrobin - An Environmental Fate Assessment using the Surface Water Model TOXSWA 1.2 Following Spray Application to Field Crops in The Netherlands

Syngenta Crop Protection AG,Basel, CH, Xx Xxxxxx Consult GmbH, Mannheim, DE, 102222-2

Not GLP, not published

Syngenta File No ICI5504_11485

This is CONFIDENTIAL INFORMATION

Study submitted in support of application 20120010 THG: under

evaluation.

SYN

Data point

Year

Title

Company Report No.

Source (where different from company) GLP or GEP status

Published or not

Vertebrat e study Y/N

Data protection claimed Y/N

Data protection granted Y/N

Justification if data protection (DP) is claimed

(Paragraph number refers to SANCO/12576/2012-

rev. 1.1; 1 February

2013)

Owner

SYN =

Syngenta

KIIIA1 9.7.1

/ 02add

2014f

Azoxystrobin – An Environmental Fate Assessment using the Surface Water Model TOXSWA 1.2 Following Spray Application to Trees in The Netherlands.

Syngenta Crop Protection AG,Basel, CH, Xx. Xxxxxx Consult GmbH, Mannheim, DE, 101522-5

Not GLP, not published

Syngenta File No ICI5504_11645

This is CONFIDENTIAL INFORMATION

Study not submitted before

SYN

KIIIA1 9.7.1

/ 03add

2013

Difenoconazole - An Environmental Fate Assessment Using the TOXSWA 1.2 Model Following Applications to Field Crops in the Netherlands.

Syngenta Crop Protection AG,Basel, CH, RIFCON GmbH, Hirschberg, DE, R13182-2

Not GLP, not published

Syngenta File No CGA169374_10788

This is CONFIDENTIAL INFORMATION

Study submitted in support of application 20120010 THG: under

evaluation.

SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 9.7.1 / 04add	2014h	Difenoconazole - An Environmental Fate Assessment Using the TOXSWA 1.2 Model Following Applications to Shrubs in the Netherlands. Syngenta Crop Protection AG,Basel, CH, RIFCON GmbH, Hirschberg, DE, R1420182-8, Not GLP, not published Syngenta File No. CGA169374_10846 This is CONFIDENTIAL INFORMATION	N	N	N	Study not submitted before	SYN
KIIIA1 9.7.1 / 05add	2014i	Difenoconazole - An Environmental Fate Assessment Using the TOXSWA 1.2 Model Following Applications to Ornamental Trees in the Netherlands. Syngenta Crop Protection AG, Basel, CH, RIFCON GmbH, Hirschberg, DE, R1420182-9, Not GLP, not published Syngenta File No. CGA169374_10847 This is CONFIDENTIAL INFORMATION	N	N	N	Study not submitted before	SYN
KIIIA1 10.2.2.1 / 01	2003	Difenoconazole / Azoxystrobin 125/200 g/L SC formulation (A13703G): Acute toxicity to rainbow trout (Oncorhynchus mykiss) GLP, not published Syngenta File No ICI5504/2152	Y	Y	N	Submitted with application 20080302 TG	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 10.2.2.2 / 01	2003a	Difenoconazole / Azoxystrobin 125/200 g/L SC formulation (A13703G): Acute toxicity to Daphnia magna Syngenta Crop Protection AG, Basel, CH Brixham Environmental Laboratory, Brixham, United Kingdom, BL7739/B GLP, not published Syngenta File No ICI5504/2150	N	Y	N	Submitted with application 20080302 TG	SYN
KIIIA1 10.2.2.3 / 01	2003	Difenoconazole / Azoxystrobin 125/200 g/L SC formulation (A13703G): Toxicity to the green alga Selenastrum capricornutum Syngenta Crop Protection AG, Basel, CH Brixham Environmental Laboratory, Brixham, United Kingdom, BL7740/B GLP, not published Syngenta File No ICI5504/2146	N	Y	N	Submitted with application 20080302 TG	SYN
KIIIA1 10.2.2.4 / 01	2009	Difenoconazole endpoints - Estuarine and marine data Syngenta - Jealott’s Hill, Bracknell, UK Syngenta - Jealott’s Hill, Bracknell, UK, Not GLP, not published Syngenta File No CGA169374_10433	N	N	N	Study already submitted in support of application 20120010 THG but still under evaluation.	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 10.2.2.4 / 02	2009	Difenoconazole Endpoints - Chronic toxicity to mysids (Americamysis bahia) Syngenta - Jealott’s Hill, Bracknell, UK Syngenta - Jealott’s Hill, Bracknell, UK, Not GLP, not published Syngenta File No CGA169374_10434	N	N	N	Study already submitted in support of application 20120010 THG but still under evaluation.	SYN
KIIIA1 10.2.2.4 / 03	2006	Difenoconazole (CGA169374) - Life-cycle toxicity test with mysids (Americamysis bahia) Syngenta Crop Protection AG, Basel, CH Springborn Xxxxxxxx Laboratories, Wareham, USA, 1781.6653, 2034050 GLP, not published Syngenta File No CGA169374/3251	N	Y	N Not relied upon	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 10.2.2.4 / 04	2009	Difenoconazole (CGA169374):- Life-cycle toxicity test with mysids (Americamysis bahia) following Draft OPPTS Guideline 850.1350 and FIFRA Guideline 72-4 Syngenta Crop Protection AG, Basel, CH Springborn Laboratories Inc., Wareham, USA, 1781.6693 GLP, not published Syngenta File No CGA169374_10393	N	Y	N Not relied upon	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 10.2.5.3 / 01	2009	Difenoconazole - Life cycle test with the fathead minnow (Pimephales promelas) Syngenta Crop Protection AG, Basel, CH GLP, not published Syngenta File No CGA169374_10441	Y	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 10.2.5.3 / 02	2007	Difenoconazole - Fish screening assay for endocrine activity in zebrafish (Danio rerio) Syngenta Crop Protection AG, Basel, CH SYN-003/4-68 GLP, not published Syngenta File No CGA169374/3191	Y	Y	N Not relied upon	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 10.2.5.3 / 03	2007	Difenoconazole - Fish Screening Assay For Endocrine Activity In Zebrafish (Danio Rerio) - Histopathology Phase Syngenta Crop Protection AG, Basel, CH GLP, not published Syngenta File No CGA169374/3166	Y	Y	N Not relied upon	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 10.3 / 01	2004	Toxicological Relevance of Plant Metabolite CGA 131013 (Triazole Alanine or TA), a Crop Metabolite of Triazole Derivatives Syngenta Crop Protection AG, Basel, CH , NA. Not GLP, not published Syngenta File No CGA131013/0046	N	N	N	Study submitted in support of application 20120010 THG: under evaluation.	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 10.3.1.3 / 01c&s	2008	Review of effect of lower bodyweight upon wild mammal population dynamics Syngenta - Jealott’s Hill UK, Syngenta - Jealott’s Hill UK, TMJ5073 Not GLP, not published Syngenta File No N/1184	N	N	N	Study submitted in support of applications 20131583 NLTHG/ 20131580 NLTHG / 20131577 VAG.	SYN
KIIIA1 10.4.2.1 / 01	2003	ZA5504 / CGA169374 (azoxystrobin / difenconazole): Acute toxicity of a 200 / 125 g/L SC formulation (A13703G) to the honeybee, Apis mellifera L. in the laboratory Syngenta Crop Protection AG, Basel, CH GAB Biotechnologie GmbH, Niefern, Germany, 20031268/01-BLEU GLP, not published Syngenta File No ICI5504/2072	N	Y	N	Submitted with application 20080302 TG	SYN
KIIIA1 10.5.1 / 01	2003	CGA169374 (difenconazole) / ZA5504 (azoxystrobin): Tier I standard laboratory bioassay of the effects of fresh residues of a 125/200 g/L SC formulation (A13703G) on the parasitic wasp Aphidius rhopalosiphi Syngenta Crop Protection AG, Basel, CH Syngenta, Jealott’s Hill, UK, RJ3438B GLP, not published Syngenta File No ICI5504/2162	N	Y	N	Submitted with application 20080302 TG	SYN

Data point

Year

Title

Company Report No.

Source (where different from company) GLP or GEP status

Published or not

Vertebrat e study Y/N

Data protection claimed Y/N

Data protection granted Y/N

Justification if data protection (DP) is claimed

(Paragraph number refers to SANCO/12576/2012-

rev. 1.1; 1 February

2013)

Owner

SYN =

Syngenta

KIIIA1

10.5.1 / 02

2003

CGA169374 (difenoconazole) / ZA5504 (azoxystrobin): Tier1 standard laboratory bioassay of the effects of fresh residues of a 125/200 g/L SC formulation (A13703G) on the predatory mite Typhlodromus pyri (Acari, Phytoseiidae)

Syngenta Crop Protection AG, Basel, CH Syngenta, Jealott’s Hill, UK,

RJ3444B

GLP, not published

Syngenta File No ICI5504/2098

Submitted with application 20080302 TG

SYN

KIIIA1

10.5.2 / 01

2011

Azoxystrobin/difenoconazole SC (A13703G)

- A rate response extended laboratory bioassay of the effects of fresh residues on the parasitic wasp Aphidius rhopalosiphi (Hymenoptera, Braconidae)

Syngenta Crop Protection AG, Basel, CH Mambo-Tox Ltd., Southampton, UK, SYN-11-30

GLP, not published

Syngenta File No A13703G_10490

Not relied upon

New DP under paragraph 18 of SANCO/12576/2012

SYN

Data point

Year

Title

Company Report No.

Source (where different from company) GLP or GEP status

Published or not

Vertebrat e study Y/N

Data protection claimed Y/N

Data protection granted Y/N

Justification if data protection (DP) is claimed

(Paragraph number refers to SANCO/12576/2012-

rev. 1.1; 1 February

2013)

Owner

SYN =

Syngenta

KIIIA1

10.5.2 / 02

2011

Azoxystrobin/difenoconazole SC (A13703G)

- A rate response extended laboratory bioassay of the effects of fresh residues on the predatory mite Typhlodromus pyri (Acari: Phytoseiidae)

Syngenta Crop Protection AG, Basel, CH Mambo-Tox Ltd., Southampton, UK, SYN-11-29

GLP, not published

Syngenta File No A13703G_10491

Not relied upon

New DP under paragraph 18 of SANCO/12576/2012

SYN

KIIIA1

10.6.2 / 01

2003

CGA169374 (difenconazole) / ZA5504 (azoxystrobin): Acute toxicity of a 125 / 200 g/L SC formulation (A13703G) to the earthworm Eisenia fetida in a 14-day test in artificial soil

Syngenta Crop Protection AG, Basel, CH RCC Ltd., Itingen, Switzerland,

850140

GLP, not published

Syngenta File No ICI5504/2145

Submitted with application 20080302 TG

SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 10.6.3 / 01	2010	Azoxystrobin/difenoconazole SC (A13703G) - Sublethal Toxicity to the Earthworm Eisenia fetida in Artificial Soil with 5 % Peat Syngenta Crop Protection AG, Basel, CH BioChem Agrar, Gerichshain, Germany, 10 10 48 062 S GLP, not published Syngenta File No A13703G_10368	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 10.6.3 / 02	2011	Difenoconazole tech. - Sublethal Toxicity to the Earthworm Eisenia fetida in Artificial Soil with 5 % Peat Syngenta Crop Protection AG, Basel, CH BioChem Agrar, Gerichshain, Germany, 11 10 48 072 S GLP, not published Syngenta File No CGA169374_10511	N	Y	N (used before)	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 10.6.3 / 03	2010	R234886 - Sublethal Toxicity to the Earthworm Eisenia fetida in Artificial Soil with 5 % Peat Syngenta - Jealott’s Hill, Bracknell, UK BioChem Agrar, Gerichshain, Germany, 10 10 48 078 S GLP, not published Syngenta File No R234886_10001	N	Y	N	Study submitted in support of applications 20131583 NLTHG/ 20131580 NLTHG / 20131577 VAG.	SYN

Data point	Year	Title Company Report No. Source (where different from company) GLP or GEP status Published or not	Vertebrat e study Y/N	Data protection claimed Y/N	Data protection granted Y/N	Justification if data protection (DP) is claimed (Paragraph number refers to SANCO/12576/2012- rev. 1.1; 1 February 2013)	Owner SYN = Syngenta
KIIIA1 10.6.3 / 04	2006	CGA211391 (Difenoconazole metabolite): Sublethal toxicity to the earthworm Eisenia fetida Syngenta Crop Protection AG, Basel, CH BioChem agrar, Gerichshain, Germany, 06 10 48 058 GLP, not published Syngenta File No CGA205375/0030	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 10.6.6 / 01	2006a	CGA211391 (Difenoconazole metabolite): Effects on the reproduction of the collembolans Folsomia candida Syngenta Crop Protection AG, Basel, CH BioChem agrar, Gerichshain, Germany, 06 10 48 059 GLP, not published Syngenta File No CGA205375/0029	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN
KIIIA1 10.6.6 / 02	2014	CGA71019 – Effects on reproduction of the predatory mite Hypoaspis aculeifer Syngenta Crop Protection AG, Basel, CH BioChem Agrar, Gerichshain, Germany, 13 10 48 202 S GLP, not published Syngenta File No CGA071019_10008	N	Y	Y	New DP under paragraph 18 of SANCO/12576/2012	SYN

Data point

Year

Title

Company Report No.

Source (where different from company) GLP or GEP status

Published or not

Vertebrat e study Y/N

Data protection claimed Y/N

Data protection granted Y/N

Justification if data protection (DP) is claimed

(Paragraph number refers to SANCO/12576/2012-

rev. 1.1; 1 February

2013)

Owner

SYN =

Syngenta

KIIIA1

10.6.7 / 01

2002

Effects of A7402G on the Decomposition of Organic Material enclosed in Litter Bags in the field

Syngenta Crop Protection AG, Basel, CH IBACON GmbH, Rossdorf, Germany, 8381081

GLP, not published

Syngenta File No CGA169374/2228

Study already submitted in support other applications 20010382 UG/

20020447 UG.

Submission date: 07

March 2003

SYN

KIIIA1

10.6.7 / 02

2007

Difenoconazole (A7402T) and its metabolite CGA205375: Effects on the decomposition of organic matter in the field

Syngenta Crop Protection AG, Basel, CH GAB Biotechnologie GmbH, Niefern, DE, 20061274/G1-NFLb

GLP, not published

Syngenta File No CGA169374/3334

New DP under paragraph 18 of SANCO/12576/2012

SYN

Data point

Year

Title

Company Report No.

Source (where different from company) GLP or GEP status

Published or not

Vertebrat e study Y/N

Data protection claimed Y/N

Data protection granted Y/N

Justification if data protection (DP) is claimed

(Paragraph number refers to SANCO/12576/2012-

rev. 1.1; 1 February

2013)

Owner

SYN =

Syngenta

KIIIA1

10.7.1 / 01

2010

Azoxystrobin/Difenoconazole SC (A13703G)

- Effects on the activity of soil microflora (Nitrogen and Carbon Transformation Tests) Syngenta Crop Protection AG, Basel, CH BioChem Agrar, Gerichshain, Germany,

10 10 48 007 C/N

GLP, not published

Syngenta File No A13703G_10329

New DP under paragraph 18 of SANCO/12576/2012

SYN

KIIIA1

10.8.1.2 / 01

2010

Azoxystrobin/Difenoconazole SC (A13703G)

- Evaluation of Phytotoxicity to non-target terrestrial plants

Syngenta Crop Protection AG, Basel, CH Agrochemex, Lawford, UK,

ACE-09-383

Not GLP, not published

Syngenta File No A13703G_10328

New DP under paragraph 18 of SANCO/12576/2012

SYN

Data point

Year

Title

Company Report No.

Source (where different from company) GLP or GEP status

Published or not

Vertebrat e study Y/N

Data protection claimed Y/N

Data protection granted Y/N

Justification if data protection (DP) is claimed

(Paragraph number refers to SANCO/12576/2012-

rev. 1.1; 1 February

2013)

Owner

SYN =

Syngenta

KIIIA1

10.3.3.3 / 01 nl add

2018

Azoxystrobin – Foliage Residue Decline Study on Winter Barley in Northern Europe in 2017. Syngenta Crop Protection AG, Basel, Switzerland

Report Number B7306.

Anadiag, 00 xxx Xxxxxx, 00000 Xxxxxxxx, Xxxxxx

GLP, not published

(Syngenta file No. A12705B_14098).

New DP under paragraph 18 of SANCO/12576/2012

SYN

Data point

Year

Title

Company Report No.

Source (where different from company) GLP or GEP status

Published or not

Vertebrat e study Y/N

Data protection claimed Y/N

Data protection granted Y/N

Justification if data protection (DP) is claimed

(Paragraph number refers to SANCO/12576/2012-

rev. 1.1; 1 February

2013)

Owner

SYN =

Syngenta

KIIIA1

10.3.3.3 / 02 nl add

2018a

Difenoconazole – Foliage Decline Study on Winter Barley in Germany, Northern France and United Kingdom in 2017. Syngenta Crop Protection AG, Basel, Switzerland

Report Number B7305.

Anadiag, 00 xxx Xxxxxx, 00000 Xxxxxxxx, Xxxxxx

GLP, not published

(Syngenta file No. (A7402T_11129).

New DP under paragraph 18 of SANCO/12576/2012

SYN

Data point

Year

Title

Company Report No.

Source (where different from company) GLP or GEP status

Published or not

Vertebrat e study Y/N

Data protection claimed Y/N

Data protection granted Y/N

Justification if data protection (DP) is claimed

(Paragraph number refers to SANCO/12576/2012-

rev. 1.1; 1 February

2013)

Owner

SYN =

Syngenta

KIIIA1

10.3.3.3 / 03 nl add

2018

IIIA10.3.3/03 Ford S., (2018), Azoxystrobin – Total foliage decline kinetics including foliage metabolite R230310..

Syngenta Crop Protection AG, Basel, Switzerland

Report Number 0416036-Kin01

ERM, The Exchange Station Parade Harrogate Yorkshire, HG1 1TS United Kingdom

Not GLP, not published

(Syngenta file No. ICI5504_12231).

Not submitted before

SYN

KIIIA1

10.6.4 / 01 nl add

2015

Difenoconazole EC (A7402T) - A Field Study to Investigate Effects on the Earthworm Fauna in Southern Germany.

Syngenta Crop Protection AG, Basel, Switzerland

Eurofins Agroscience Services EcoChem GmbH, Germany, S14-01431

GLP, not published

Syngenta file No. A7402T_10880

New DP under paragraph 18 of SANCO/12576/2012

SYN

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HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

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