HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

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HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

1. BESLUIT Op 6 maart 2018 is van

Globachem N.V.

Lichtenberglaan 2019 Brustem Industriepark B-3800 SINT-TRUIDEN

Belgium

een aanvraag tot wederzijdse erkenning van een gewasbeschermingsmiddel ontvangen voor het middel DIFURE SOLO

op basis van de werkzame stof difenoconazool.

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.

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Part A

National Assessment – The Netherlands

DIFURE SOLO Registration Report – Central Zone Page 2 of 22

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 40 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 2.1 en

de Guidance on semiochemicals

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.

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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, 2 november 2018

Het College voor de toelating van

gewasbeschermingsmiddelen en biociden, voor deze:

de voorzitter,

Ir. J.F. de Leeuw

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Part A

BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING 2.1 Aanvraaginformatie

Aanvraagnummer: 20180590 NLWERGZ

Type aanvraag: aanvraag tot toelating van een

gewasbeschermingsmiddel op basis van wederzijdse erkenning

Middelnaam: DIFURE SOLO

Verzenddatum aanvraag: 5 maart 2018 Formele registratiedatum: * 23 maart 2018 Datum in behandeling name: 10 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

difenoconazool 250 g/L

• De stof difenoconazool is per 1 januari 2009 geplaatst op Annex I 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 2018.

2.3 Toelatingsinformatie

Toelatingsnummer: 15699 N

Expiratiedatum: 31 december 2019

Afgeleide parallel of origineel: Origineel

Biocide, gewasbeschermingsmiddel of toevoegingsstof: Gewasbeschermingsmiddel

Gebruikers: Professioneel

2.4 Verpakkingsinformatie Aard van het preparaat:

Emulgeerbaar concentraat

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HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE II Etikettering van het middel DIFURE SOLO

Professioneel gebruik

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

Difenoconazool

Pictogram GHS07

GHS08 GHS09

Signaalwoord Gevaar

Gevarenaanduidingen H302 Schadelijk bij inslikken.

H304 Kan dodelijk zijn als de stof bij inslikken in de luchtwegen terechtkomt.

H319 Veroorzaakt ernstige oogirritatie.

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

Voorzorgsmaatregelen P273 Voorkom lozing in het milieu.

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

P301 + P310 NA INSLIKKEN: Onmiddellijk een ANTIGIFCENTRUM/arts/... raadplegen.

P305 + P351 + P338 BIJ CONTACT MET DE OGEN: voorzichtig afspoelen met water gedurende een aantal minuten; contactlenzen verwijderen, indien mogelijk. Blijven spoelen.

P331 GEEN braken opwekken.

P337 + P313 Bij aanhoudende oogirritatie: een arts raadplegen.

P501 Inhoud/verpakking afvoeren naar ....

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

Aanvullende etiketelementen

EUH066 Herhaalde blootstelling kan een droge of een gebarsten huid veroorzaken.

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

Kinderveilige sluiting verplicht Nee Voelbare gevaarsaanduiding verplicht Nee

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Part A

REGISTRATION REPORT Part A

Risk Management

Product code: DIFCOR 250 EC Product name: DIFURE SOLO

Active Substance: 250 g/L difenoconazole

Central Zone

Zonal Rapporteur Member State: France

NATIONAL ASSESSMENT

Applicant: Globachem N.V.

Date: October 2018

Evaluator: Ctgb, NL

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PART A – Risk Management

This document describes the acceptable use conditions required for the registration of DIFURE SOLO containing difenoconazole in the Netherlands, as an Mutual Recognition of the authorised product DIFCOR 250 EC in France. This evaluation is required subsequent to the inclusion of difenoconazole on Annex 1.

The risk assessment conclusions are based on the information, data and assessments provided in Registration Report, Part B Sections 1-9 and Part C and where appropriate the addendum for France, for this Mutual Recognition application. The information, data and assessments provided in Registration Report, Parts B includes assessment of further data or information as required at national registration by the EU review. It also includes assessment of data and information relating to DIFURE SOLO which have not been considered in the EU review. Otherwise assessments for the safe use of DIFURE SOLO have been made using endpoints agreed in the EU review of difenoconazole.

This document describes the specific conditions of use and labelling required for the Netherlands for the registration of DIFURE SOLO.

Appendix 1 of this document provides a copy of the approved product label for the Netherlands.

Appendix 2 of this document provides the reference list.

1 Details of the application 1.1 Application background

This application was submitted by Globachem N.V. in February 2018.

The application was for the registration for a mutual recognition of DIFURE SOLO, an EC formulation containing 250 g/L difenoconazole for use as a fungicide in sugar beet in the Netherlands.

1.2 Annex I inclusion

Difenoconazole was included on Annex I of Directive 91/414/EEC on 01/01/2009 under Inclusion Directive 2008/69/EC.

The Annex I Inclusion Directive for difenoconazole (2008/69/EC) provides specific provisions under Part B which need to be considered by the applicant in the preparation of their submission and by the MS prior to granting an authorisation.

For the implementation of the uniform principles of Annex VI, the conclusions of the review report on difenoconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health shall be taken into account. In this overall assessment:

Member States must pay particular attention to the:

• protection of aquatic organisms. Conditions of use shall include adequate risk mitigation measures, where appropriate.

These concerns were all addressed in the submission.

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Part A

1.3 Regulatory approach

To obtain registration of the product, DIFURE SOLO must meet the conditions of Annex I inclusion and be supported by dossiers satisfying the requirements of Annex II and Annex III, with an assessment to Uniform Principles, using Annex I agreed end-points.

1.4 Data protection claims

Data protection is claimed for all Annex II and III studies that are submitted with this evaluation as they have not yet been evaluated before in the Netherlands.

1.5 Letters of Access

The Annex III dossier does not contain letters of access.

2 Details of the authorisation 2.1 Product identity

Product Name DIFURE SOLO

Authorisation Number -

Function Fungicide

Applicant Globachem N.V.

Composition 250 g/L difenoconazole

Formulation type Emulsifiable concentrate [Code: EC]

Packaging 100 mL, 200 mL, 250 mL, 500 mL, 1 or 5 L coex-HDPE/PA 2.2 Classification and labelling under 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 *:

Difenoconazole

Pictogram: GHS07 Signal word: Danger

GHS08 GHS09

H-statements: H302 Harmful if swallowed.

H304 May be fatal if swallowed and enters airways H319 Causes serious eye irritation.

H410 Very toxic to aquatic life with long lasting effects.

P-statements: P273 Avoid release to the environment.

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

P301+P310 IF SWALLOWED: Immediately call a POISON CENTER/doctor/...

P305+P351+P338 IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.

P331 Do NOT induce vomiting.

P337+P313 If eye irritation persists: Get medical advice/attention.

P501 Dispose of contents/container to ....

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Supplemental Hazard information:

EUH066 Repeated exposure may cause skin dryness or cracking.

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: Classification with H373 as proposed by the applicant is not triggered by the available data.

P-statements: Based on the risk assessment, P280a should be assigned for the operator (gloves during mixing/loading and application). P280a is covered by the assignment of P280.

Other: -

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

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Part A

National Assessment - Netherlands

DIFURE SOLO Registration Report – Central Zone

Page 10 of 22

2.3 Product uses

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

Use- No.

(e)

Member state(s)

Crop and/

or situation

(crop destination / purpose of crop)

F, Fn, Fpn G, Gn, Gpn or I

Pests or Group of pests controlled

(additionally:

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 product / ha a) max. rate per appl.

b) max. total rate per crop/season

kg as/ha

a) max. rate per appl.

b) max. total rate per crop/season

Water L/ha

min / max

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

1 NL Sugar beet

(BEAVP)

F Rust

Uromyces betae (UROMBE)

Boom or knapsack sprayer

After BBCH 39, up to PHI (May-Oct.)

a) 2 b) 2

14 a) 0.5

b) 1

a) 0.125 b) 0.250

100- 500

21 /

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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 DIFURE SOLO is an emulsifiable concentrate with a nominal difenoconazole concentration of 250 g/L. All studies have been performed in accordance with the current requirements, the critical GAP and the results are deemed to be acceptable. The appearance of the product is that of a free flowing liquid with dark brown colour with petrol odour. It is not explosive and has no oxidising properties. It has a self ignition temperature of more than 260°C. It is considered not flammable as the flash-point is 75°C.

In a 1% aqueous solution, it has a pH value of 6.5 at 20°C. The kinematic viscosity at 40°C is 2.24 mm²/s and the hydrocarbon content (H304 classified components) is above 10% in the formulation, therefore the formulation is classified as an aspiration hazard and H304 is proposed on the product label. The surface tension of the neat formulation is 36.1 mN/m at 20°C and 39.8 mN/m at 25°C, indicating the formulation is surface active. The density of the formulation is 1.06 g/mL at 20°C.

There is no effect of low and high temperature on the stability of the formulation, since after 7 days at 0

°C and 14 days at 54 °C 8 weeks at 40 °C, neither the active ingredient content nor the technical properties were changed when tested in coex-HDPE/PA packaging. The formulation was found to be stable for 2 years at ambient temperature when stored in coex-HDPE/PA and coex-HDPE/EVOH.

Therefore an 2-year shelf-life for storage in coex-HDPE/PA and coex-HDPE/EVOH can be granted for DIFURE SOLO. Its technical characteristics are acceptable for a EC formulation.

Implications for labelling: H304 classified (aspiration hazard). The kinematic viscosity at 40°C is 2.24 mm²/s and the hydrocarbon content is above 10% in the formulation of DIFURE SOLO.

Compliance with FAO specifications: The investigations of the physical and chemical properties have shown that DIFURE SOLO meets the general requirements for an EC-formulation according to the FAO specifications. This indicates that no particular problems are to be expected if the preparation is used as recommended.

Compatibility of mixtures: No tank mixtures are mentioned on the label.

Nature and characteristics of the packaging: Information with regard to type, dimensions, capacity, size of opening, type of closure, strength, leakproofness, resistance to normal transport & handling, resistance to & compatibility with the contents of the packaging, have been submitted, evaluated and is considered to be acceptable.

Nature and characteristics of the protective clothing and equipment: Information regarding the required protective clothing and equipment for the safe handling of DIFURE SOLO has been provided and is considered to be acceptable.

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

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

Analytical methods for determination of difenoconazole in DIFURE SOLO were not evaluated as part of the EU review of difenoconazole. Therefore all relevant data are provided and are considered adequate. A

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Part A

National Assessment Netherlands

GC-MS method was submitted to analyse the active ingredient content in the formulation. The method was validated in compliance with SANCO/3030/99 rev. 4.

There are no relevant impurities formed and identified in DIFCOR 250 EC therefore no analytical methods are required to determine the relevant impurities in the formulation.

There is no CIPAC method available for the determination of difenoconazole.

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

All analytical methods for the determination of residues in crops and animal products, water, soil and air are active substance data and were provided in the EU review of difenoconazole. Additional data on methods/validation in potatoes, cereal grain and straw for difenoconazole have been provided.

New analytical methods for the determination of difenoconazole residues in milk were provided in the study from Faessel, V. 2013a and Hubbars, S. 2013 with LOQ of 0.01 mg/kg and 0.005 mg/kg, respectively. Analytical method for the determination of difenoconazole residue in tomato and soil were presented in the study from SIMEK I., 2012 and Eberhard Zietz, 2008 with LOQ of 0.01 and 0.001mg/kg, respectively. The methods are considered adequately validated under the requirement of SANCO/825/00 rev. 8.1.

Several additional analytical methods to determine difenoconazole residues in crops were studied in Jonchère F., 2011, Agnès 2008/2011, ERTUS. C. 2013 and SIMEK I. 2013. The methods are considered adequately validated under the requirement of SANCO/3029/99 rev. 4.

An analytical method (Tribolet, 1999) for the determination of difenoconazole residues in surface water has been evaluated in the DAR and was considered not highly specific. A confirmatory method (FAESSEL.V, 2013 - B2299) using LC-MS/MS for the determination of difenoconazole residues in surface water has been provided and validated with LOQ = 0.1 µg/L for surface water. The Dutch specific requirement for the analytical method for the determination of residues in surface water is met for the active substance difenoconazole.

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 DIFURE SOLO were not evaluated as part of the EU review of difenoconazole.

Therefore, all relevant data were provided and are considered adequate.

DIFURE SOLO, containing 250 g/L difenoconazole, has a low toxicity in respect to acute dermal toxicity. It is not a skin sensitiser. It is irritating to the rabbit eye and acutely harmful by the oral route.

The result of the skin irritation study does not trigger CLP classification. Taking into account all submitted data, DIFURE SOLO should be classified with the H phrases H302 and H319.

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

Operator exposure to DIFURE SOLO was not evaluated as part of the EU review of difenoconazole for the intended uses. Therefore all relevant data and risk assessments are provided here and are considered adequate.

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Operator exposure was assessed against the AOEL agreed in the EU review (0.16 mg a.i./kg bw/d). No dermal absorption study on the formulation DIFCOR 250 EC is available and therefore the default dermal absorption values of 25% for concentrate and 75% for dilution were used. Operator exposure was modelled using UK-POEM and the German model.

According to UK-POEM, the systemic exposure for an operator without PPE is above the AOEL for difenoconazole, it is estimated to be 0.346 mg a.i./kg bw, which represents approximately 216% of the AOEL. The systemic exposure for an operator using personal protective equipment represents 33% of the AOEL, i.e., gloves during mixing/loading and application.

According to the German model calculations, the systemic exposure for an operator without PPE is 0.076 mg a.i./kg bw, this represents approximately 48% of the AOEL for difenoconazole.

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

Bystander exposure to DIFURE SOLO was not evaluated as part of the EU review of difenoconazole.

Therefore, all relevant data and risk assessments have been provided and are considered adequate for the intended uses.

In the Core only a risk assessment using EUROPOEM II has been performed. For the Netherlands, a calculation with the DE and UK model is needed.

Internal bystander and resident exposure to difenoconazole and risk assessment for the use of DIFURE SOLO

Route Estimated internal

exposure ^a (mg/day)

Systemic AEL (mg/day)^b

% AEL ^c

Bystander exposure during application in representative uses according to the German model

Child Total 0.05 2.58 2

Adult Total 0.26 9.60 3

Resident exposure during application in all representative uses according to the German model

Child Total 0.02 2.58 1

Bystander exposure during application in representative uses according to the UK method

Resident exposure during application in representative uses according to the UK method

Child Respiratory 0.01 2.40 <1

Dermal+Oral 0.01 2.40 <1

a External exposure was estimated according to 1) the German guidance paper for exposure and risk assessment for

bystanders and residents (Martin et al. 2008, J. Verbr. Lebensm. 3: 272-281), and 2) the UK method. Internal exposure was calculated with:

• biological availability via the respiratory route: 100% (worst case)

• biological availability via the dermal route: 75% (see 4.2)

• biological availability via the oral route: 100% (see List of Endpoints)

b From the systemic AOEL of 0.16 mg/kg bw/day a specific AEL is derived assuming a body weight of 16.15 or 15 kg for children in the German model or UK method, respectively, and of 60 kg for adults.

c The % AEL is calculated by dividing the internal exposure by the systemic AEL and multiplying this by 100%.

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Part A

It is concluded that there is no undue risk to any bystander or resident after accidental short-term exposure to DIFURE SOLO.

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

Worker exposure to DIFURE SOLO was not evaluated as part of the EU review of difenoconazole.

Therefore, all relevant data and risk assessments have been provided and are considered adequate for the intended uses.

According to the EUROPOEM re-entry model presented in the Core section, the exposure covers 29% of the AOEL without the use of PPE. It is concluded that there is no unacceptable risk anticipated for the worker wearing adequate work clothing (but no PPE), when using DIFURE SOLO in accordance with the intended uses.

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

For the aspect ‘Residues’ and risk for consumers we refer to the member state of the original authorisation (France). The Guidelines for the generation of data concerning residue data Appendix C 7524/VI/95 rev.2 require that the residue situation in rotational crops must always be considered if, after the treated crop has been harvested (or in the event of early ploughing), it is possible to sow or plant a crop which can be used as a foodstuff and/or feed. Since the product was assessed according to the Uniform Principles by the member state of the original authorisation, residues in succeeding crops need no further consideration.

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

No new studies are presented; all data were reviewed in the EU review of difenoconazole. Appropriate endpoints from the EU review were used to calculate PECs for difenoconazole and the relevant metabolites in soil, surface water, ground water and air for the intended use patterns.

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

The PEC of difenoconazole, CGA71019 and CGA205375 in soil has been assessed with the FOCUS model and the DT50 values established in the EU review. Based on the critical use “leafy vegetables 2 early”), the maximum initial predicted environmental concentration in soil (PECs, ini) and the maximum plateau predicted environmental concentration in soil (PECs, plateau) of difenoconazole will be 0.146 and 0.238 mg/kg, respectively. The maximum PEC accumulation is 0.384 mg/kg.

For the metabolites CGA205375, the use “leafy vegetables 2 early will lead to PECs, ini and PECs, plateau of 0.024 mg/kg and 0.030 mg/kg respectively. The maximum PEC accumulation is 0.054 mg/kg.

For the metabolites CGA71019, the use “leafy vegetables 2 early will lead to PECs, ini and PECs, plateau of 0.009 mg/kg and 0.012 mg/kg respectively. The maximum PEC accumulation is 0.021 mg/kg.

The results for PEC soil for the active substance and its metabolites were used for the eco-toxicological risk assessment.

3.1.5.2 Predicted Environmental Concentration in Ground Water (PECGW) (Part B, Section 5, Point 9.6)

The PEC of difenoconazole, CGA205375 and CGA71019 in ground water has been assessed with standard Kremsmünster FOCUS scenario to obtain outputs from the FOCUS-PEARL 4.4.4 model and the

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Koc values established in the EU review. The PECgw was calculated for the use of Difenoconazole 250 EC in sugar beets.

The predicted environmental concentration (PECGW) at 1m depth for difenoconazole and metabolite CGA205375 following use on sugar beet was less than 0.001 µg/L for the Kremsmünster scenario in the core assessment. This value is below the Dutch specific threshold of 0.01 µg/L for groundwater protection areas. The 80^th percentiles PECgw of the difenoconazole metabolite CGA71019 at 1 m soil depth exceeded the Dutch specific threshold of 0.01 µg/L. In the second tier, the leaching in the potential area of use is evaluated using the spatial distribution model GeoPEARL 3.3.3.

GeoPEARL calculations show that the predicted leachate concentrations for CGA71019 are smaller than 0.1 µg/L. However, as the predicted concentrations for CGA71019 are larger than 0.01 µg/L, a restriction on the use in groundwater protection areas should be placed on the label.

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

Monitoring data groundwater

Recent data are presented in RIVM Rapport 607310001/2007. Monitoring data were collected in 2006 in the framework of groundwater monitoring for the WFD starting situation (so-called nulmeting) in the Dutch provinces Drenthe, Flevoland, Friesland, Gelderland, Groningen, Noord-Holland, Overijssel, Utrecht and Zeeland. The indicates that P90 concentration for the monitoring data for difenoconazole in Dutch groundwater (2006) is <0.03 µg/L. It must be noted that (page 19 of the report, translated by Ctgb)

“no check was performed on the measurements as is required for use of the data in registration assessment, as this was not included in the current project remit. Presented values can therefore not be used as such in registration procedures.”

Regarding the presence of metabolites of difenoconazole no monitoring data are available.

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

The PEC of difenoconazole, CGA205375 and CGA71019 in surface water (PECsw) has been assessed with the TOXSWA 1.2 model (GUI version 1.0), Dutch specific drift values and the DT50 water/sediment values established in the EU review. The maximum PECsw values have been calculated for the parent difenoconazole and metabolite CGA205375 to be 0.474 µg/L and 0.045 µg/L respectively.

The results for PEC surface water for the active substance and its metabolite were used for the eco- toxicological risk assessment.

Monitoring data surface water

Data from the Pesticide Atlas are used to evaluate potential exceedances of the authorisation threshold and environmental quality standards. As there is no exceedance of thresholds, the monitoring data have no consequences for the proposed use of the product.

Drinking water criterion

Difenoconazole has been on the Dutch market for > 3 years (authorised since 02-08-2004). This period is sufficiently large to consider the market share to be established. From the general scientific knowledge collected by the Ctgb about the product and its active substance, the Ctgb concludes that there are in this case no concrete indications for concern about the consequences of this product for surface water from which drinking water is produced, when used in compliance with the directions for use. The Ctgb does

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under this approach expect no exceeding of the drinking water criterion. The standards for surface water destined for the production of drinking water as laid down in the BGB are met.

3.1.5.4 Predicted Environmental Concentration in Air (PECAir) (Part B, Section 5, Point 9.9)

The fate and behaviour in air of difenoconazole was evaluated during the EU review of difenoconazole.

No additional studies have been performed.

The vapour pressure of difenoconazole was determined to be 3.32 x 10^-8 Pa at 25°C. The Henry’s Law Constant was determined as 9.0 x 10^-7 Pa.m³/mol (25°C). Both values indicate a low potential for volatility. No volatilization of difenoconazole from moist soil surface was observed in experiment with measurement of volatile radioactivity over 24 hours. In study with measurement of volatility as percentage loss of radioactivity from plant and soil only a small loss (<9% of initial radioactivity) was observed over 24 hours. Based on the presented data, no significant volatilisation of difenoconazole is expected. Photochemical oxidative degradation was rapid with a calculated half-life of 5 hours and any residue that may occur in the atmosphere are therefore expected to be rapidly degraded.

CGA71019 has a relatively high vapour pressure of 0.34 Pa at 25°C. The value of Henry’s Law Constant is 3 x 10^-5 Pa m³/mol. No volatile products were observed in soil degradation study on CGA71019.

Therefore no significant volatilisation of CGA71019 formed in soil is expected.

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

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

Birds

Effects on birds for DIFURE SOLO were not evaluated as part of the EU review of difenoconazole.

Therefore all relevant data and risk assessments are provided here and are considered adequate.

The risk assessment for effects on birds is carried out according to the ‘Guidance of EFSA – Risk assessment for Birds and Mammals’(EFSA 2009)¹.

The acute and long-term risks of DIFURE SOLO to birds were assessed from toxicity exposure ratios between toxicity endpoints, estimated from studies with difenoconazole and the metabolite CGA131013, and maximum residues occurring on food items following applications according to the proposed use pattern. Risk of secondary poisoning has also been assessed, as difenoconazole has log POW >3.0. When needed, tier 1 risk assessment was performed for the focal species. Furthermore, interception values based on the FOCUSGW guidance document, appropriate residue data or new PT (proportion of food from the treated area) were used as refinement.

The TER values, calculated for recommended scenarios, all exceed the trigger values of 10 for acute risk and 5 for long-term risk (including secondary poisoning), thus indicating no unacceptable risk to birds from the proposed uses.

Terrestrial vertebrates (other than birds)

Effects on terrestrial vertebrates other than birds for DIFURE SOLO were not evaluated as part of the EU review of difenoconazole. Therefore all relevant data and risk assessments are provided here and are considered adequate.

1EFSA (2009). Guidance of EFSA – Risk assessment for Birds and Mammals. EFSA Journal 2009; 7(12):1438.

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The acute and long-term risks of DIFURE SOLO to wild mammals were assessed using the ‘Guidance of EFSA – Risk assessment for Birds and Mammals’(EFSA 2009) by calculating the toxicity exposure ratios between toxicity endpoints, estimated from studies with difenoconazole and CGA131013, and maximum residues occurring on food items following applications according to the use pattern. If needed, tier 1 risk assessment was performed for the focal species. Furthermore, interception values based on the FOCUSGW

guidance document or appropriate residue data (to refine the half-life of difenoconazole in plants and the multiple application factor) were used as refinement. and interception values based on the FOCUSGW

guidance document were used as refinement. Risk of secondary poisoning has also been assessed, as difenoconazole has log POW >3.0.

The TER values, calculated for recommended scenarios, all exceed the trigger values of 10 for acute risk and 5 for long-term risk (including secondary poisoning), thus indicating no unacceptable risk to mammals from the proposed use.

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

Effects on aquatic organisms for DIFURE SOLO were not evaluated as part of the EU review of difenoconazole. During the EU review of difenoconazole, it was quoted that Member States must pay particular attention to the protection of aquatic organisms. Conditions of use shall include adequate risk mitigation measures, where appropriate. A new risk assessment was performed for the intended uses using the toxicity data of the DIFURE SOLO, the active substance as well as the metabolite CGA205375.

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

The TER using PEC values for the active substance and the metabolites exceed the relevant triggers when using a standard 75% drift reducing technique, indicating that neither difenoconazole nor the metabolites pose an unacceptable risk to aquatic organisms following the use of DIFURE SOLO according to the recommended use pattern.

3.1.6.3 Effects on Bees and Other Arthropod Species (Part B, Section 6, Points 10.4 and 10.5)

Bees

Effects on bees for DIFURE SOLO were not evaluated as part of the EU review of difenoconazole. A study with the formulation was provided showing 48h oral and contact LD50 of >97.9 and >100 µg a.i./bee respectively. A risk assessment for the intended uses was performed. This data has been reviewed and the resulting risk assessments are considered adequate.

The risks of DIFURE SOLO to honey-bees was assessed from hazard quotients between toxicity endpoints, estimated from the acute oral study with active ingredient only, and the maximum single application rate of 1 L formulation/ha (maximum dose rate of the formulation in the EU = 250 g a.i./ha).

All the hazard quotients are considerably less than 50, indicating that the difenoconazole poses a low risk to bees. Therefore a low risk to bees is expected from the application of DIFURE SOLO according to the recommended use pattern.

No risk mitigation measure is necessary.

Other non-target arthropods

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Effects on non-target arthropods for DIFURE SOLO were not evaluated as part of the EU review of difenoconazole. A risk assessment for the critical GAP of 4 x 125 g a.i./ha every 7-14 days in field crops was performed in the core assessment. These data has been reviewed and the resulting risk assessments are considered adequate.

Tier II in-field assessments indicated no potential risk to non-target arthropods (based on Aphidius rhopalosiphi, Typhlodromus pyri, Orius laevigatus and Chrysoperla carnea).

The off-field HQ values for T. pyri , A. rhopalosiphi, C. carnea and O. laevigatus fall below the trigger values, indicating that DIFURE SOLO does not pose an unacceptable risk to non-target arthropods in off- field areas using the standard 75% drift reducing techniques.

3.1.6.4 Effects on Earthworms and Other Soil Marco-organisms (Part B, Section 6, Point 10.6)

Effects on earthworms and other soil macro-organisms for DIFURE SOLO were not evaluated as part of the EU review of difenoconazole. A risk assessment was performed for the crop groups “oilseed rape”

and “leafy vegetables 2 early or 3 late”. All relevant data were assessed and are considered adequate.

Earthworms

The acute and long-term risk of DIFURE SOLO to earthworms was assessed from acute and long-term toxicity exposure ratios (TERs) between the selected toxicity endpoints for the active ingredient and relevant metabolites, and the maximum soil PECs.

Except for the chronic toxicity of difenoconazole to earthworms in “leafy vegetables 2 early or 3 late” and based on the plateau PECs, the acute and chronic TER values for difenoconazole and metabolites CGA205375 and CGA71019 are greater than the Annex IV triggers of 10 and 5, respectively, indicating an acceptable risk to earthworms following application of DIFURE SOLO for these uses.

Effects on other soil non-target macro-organisms

The risk of DIFURE SOLO to other non-target soil macro-organisms, as represented by Collembola, was assessed from toxicity exposure ratios (TERs) between the toxicity endpoints and the maximum soil PECs.

The TER values for difenoconazole and the relevant metabolites are greater than the recommended trigger of 5, indicating no unacceptable risk to soil macro-organisms as represented by Folsomia candida following application of DIFURE SOLO for the proposed uses.

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

The risk of difenoconazole to organic matter decomposition was evaluated by comparison of the soil PEC with no-effect concentrations from a litter-bag test with DIFURE SOLO (corresponding to an application of 500 g a.i./ha on bare soil).

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The NOEC value for difenoconazole is greater than the corresponding soil PEC values, indicating that difenoconazole in DIFURE SOLO does not pose an unacceptable risk to organic matter breakdown.

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

Effects on soil microbial activity of DIFURE SOLO were not evaluated as part of the EU review of difenoconazole. Therefore all relevant data and assessments were provided and are considered adequate.

The risk to soil micro-organisms was evaluated by comparison of no-effect concentrations, derived from laboratory tests on DIFURE SOLO, CGA205375 and CGA71019, with respective soil PECs based on oilseed rape, roses and the crop group “Others” including celeriac, celery and asparagus as a surrogate for any other intended use.

All no effect levels exceed the relevant PEC values for difenoconazole, CGA71019 and CGA205375, indicating that DIFURE SOLO 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

Effects on non-target plants for DIFURE SOLO were not evaluated as part of the EU review of difenoconazole. As required for fungicides, vegetative vigour data on DIFURE SOLO were provided.

The EU agreed endpoint for the effect of difenoconazole on the seedling emergence was also used. This data has been reviewed and the resulting risk assessments are considered adequate.

Effects on non-target plants are of concern in the off-field environment, where they may be exposed to spray drift. The risk assessment for non-target plants is based on an off-crop situation with a national drift percentage which depends on the type of use and application.

The potential effect of DIFURE SOLO on vegetative vigour has been tested through studies performed on six non-target terrestrial plants. The ER50 was higher than 250 g a.i./ha for all species. For the application rate of 2 x 125 g a.s./ha, the TER was found to be above the trigger value when using a standard 75% drift reducing technique.

DIFCOR poses no unacceptable risk to terrestrial non-target plants in off-crop areas following the proposed uses.

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)

The product is authorised in France for the use in sugar beet. Climatological and environmental

circumstances relevant for the aspect efficacy in the claimed uses in The Netherlands are comparable to those in Northern France. The cultivation method in sugar beet is similar in both countries and there are no country-specific situations for the use of Difure Solo in the claimed uses.

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dose is the minimum effective dose. Application of the product caused no negative effect on yield or quality (sugar content) at harvest.

On the original label an instruction of use regarding spray volume is given. The recommended spray volume of 100 to 500 liter water per hectare differs from the commonly used spray volumes in sugar beet cultivation in NL (150-400 L water/ha). Therefore the following instruction of use will be placed on the Dutch label:

In de teelt van suikerbiet het middel toepassen in 100 tot 500 L water/ha.

For the evaluation of the aspect ‘Efficacy’ we refer to the evaluation of the member state of the original authorisation France. 1 additional trial was submitted for the NL-Addendum. In this trial the product Difure Solo (as Difcor 250 EC) was applied at the target dose of 0,5 L/ha and 2 lower doses. The trial showed that Difure Solo is equal or better than the reference product at controlling rust and that the target.

The authorisation from France is based on bridging trials of the product DIFCOR 250 EC with approved products Score 250 EC, SPYRALE and ARMURE. Score 250 EC is authorised in NL ( 11453) for use against Ramularia and Cercospora in beets. SPYRALE is authorised in NL (12975) for use against Cercospora, Ramularia, rust and mildew in beets. Active substance and products have been authorised>

10 years and are out of data protection.

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

Please refer to FR evaluation and conclusions of the core dossier. Difenoconazole is a fungicide from the group of DMI-fungicides (DeMethylation Inhibitors). T he FRAC has classified the group of DMI fungicides with moderate risk of resistance. The pathogen, Puccinia and related rust spp. : are classified as a low risk pathogen,. FRAC recommends management strategy to prevent development of resistance.

Because there is a risk for resistance occurring in the field for Difenoconazole the following sentence is written on the Dutch label:

Resistentiemanagement

Dit middel bevat de werkzame stof difenoconazool. Difenoconazool behoort tot de triazool 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.

Adverse effects on treated crops or other undesirable or unintended side-effects

Please refer to the FR evaluation and conclusions. No phytotoxicity, effects on neighboring or following crops were observed.

3.2 Conclusions

The assessment conducted for DIFURE SOLO was in accordance with Uniform Principles and demonstrates an acceptable risk to human health and the environment.

3.3 Further information to permit a decision to be made or to support a review of the conditions and restrictions associated with the authorisation

None.

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Appendix 1 – Copy of the proposed product label

Wettelijk Gebruiksvoorschrift

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

toepassingsvoorwaarden.

Toepassingsvoorwaarden:

Toepassingsgebied Werkzaamheid getoetst op

Dosering*

middel per toepassing

Maximaal aantal toepassingen per teeltcyclus

Minimum interval tussen

toepassingen in dagen

Veiligheidstermijn in dagen

Suikerbiet Roest¹ 0,5 L/ha 2 14 21

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

1 Roest (Uromyces betae).

Overige toepassingsvoorwaarden

In de teelt van suikerbiet het middel toepassen in 100 tot 500 L water per ha.

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

Resistentiemanagement

Dit middel bevat de werkzame stof difenoconazool. Difenoconazool behoort tot de triazool 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.

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DIFURE SOLO Registration Report – Central Zone

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Appendix 2 Reference list No new studies have been submitted.