HET COLLEGE VOOR DE TOELATING VAN ... · Besluit artikel 51 Verordening (EG) Nr. 1107/2009 en...

15125 N

HET COLLEGE VOOR DE TOELATING VAN

GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

1 BESLUIT

Op 18 juli 2017 is van

Stichting Trustee Bijzondere Toelatingen

Hogeweg 16

2585 JD Den Haag

een aanvraag tot uitbreiding met kleine toepassing van een gewasbeschermingsmiddeltoelating

ontvangen voor het middel

Reflect

op basis van de werkzame stof isopyrazam.

HET COLLEGE BESLUIT tot uitbreiding van de toelating van bovenstaand middel.

Alle bijlagen vormen een onlosmakelijk onderdeel van dit besluit.

Voor nadere gegevens over deze toelating wordt verwezen naar de bijlagen:

- Bijlage I voor details van de aanvraag en toelating.

- Bijlage II voor de etikettering.

- Bijlage III voor wettelijk gebruik.

- Bijlage IV voor de onderbouwing.

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 met inachtneming van hetgeen in bijlage III bij dit besluit is

voorgeschreven.

1.3 Classificatie en etikettering

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

aanduidingen en vermeldingen op de verpakking te worden vermeld:

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

“verpakkingsinformatie” in bijlage I bij dit besluit.

- Het toelatingsnummer met een cirkel met daarin de aanduiding van de W-codering zoals

vermeld onder “toelatingsinformatie” in bijlage I bij dit besluit.

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- De etikettering zoals opgenomen in bijlage II bij dit besluit.

- Het wettelijk gebruiksvoorschrift, letterlijk en zonder enige aanvulling, zoals opgenomen in

bijlage III bij dit besluit.

- Overige bij wettelijk voorschrift voorgeschreven aanduidingen en vermeldingen.

1.4 Aflever- en opgebruiktermijn (respijtperiode)

Het nieuwe gebruiksvoorschrift en de nieuwe etikettering dienen bij de eerstvolgende aanmaak op

de verpakking te worden aangebracht. Oude verpakkingen mogen worden opgemaakt.

2 WETTELIJKE GRONDSLAG

Besluit artikel 51 Verordening (EG) Nr. 1107/2009 en artikel 2.2 Rgb

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

Gebruikt toetsingskader Conform Bgb en Rgb d.d. 16 december 2011 en Evaluation Manual

Zonaal 2.0.

3 BEOORDELINGEN

3.1 Fysische en chemische eigenschappen

De identiteit en de fysische en chemische eigenschappen van het middel en de werkzame stof

wijzigen niet.

3.2 Analysemethoden

De analysemethoden voor de werkzame stoffen en het middel wijzigen niet. Voor de toegelaten

toepassingen voldoen de vereiste residuanalysemethoden.

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

Gelet op artikel 51 Verordening (EG) 1107/2009 is de aanvraag niet beoordeeld voor het aspect

werkzaamheid (inclusief fytotoxiciteit).

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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, 5 oktober 2018

Het College voor de toelating van

gewasbeschermingsmiddelen en biociden,

voor deze:

de voorzitter,

Ir. J.F. de Leeuw

15125 N

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN

BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING

1 Aanvraaginformatie

Aanvraagnummer: 20171204 NLKUG

Type aanvraag: aanvraag tot uitbreiding met kleine toepassing van een

gewasbeschermingsmiddeltoelating

Middelnaam: Reflect

Formele registratiedatum: * 19 juli 2017

Datum in behandeling name: 27 oktober 2017

Datum compliance check: N.v.t.

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

2 Stofinformatie

Werkzame stof Gehalte

isopyrazam 125 G/L

De stof isopyrazam is per 1 april 2013 goedgekeurd krachtens Verordening (EG) No 1107/2009

(Uitvoeringsverordening (EU) No 1037/2017, d.d. 7 november 2012). De goedkeuringsvoorwaarden

zijn bij Uitvoeringsverordening (EU) No 2015/1106 van 8 juli 2015 gewijzigd (uitstel van de deadline

voor het leveren van confirmatory data). De goedkeuring van deze werkzame stof expireert op 31

maart 2023.

3 Toelatingsinformatie

Toelatingsnummer: 15125 N

Expiratiedatum: 31 maart 2024

Afgeleide of parallel: n.v.t.

Biocide, gewasbeschermingsmiddel of

toevoegingsstof:

Gewas

Gebruikers: Professioneel

W-codering professioneel gebruik: W2

4 Aflever- en opgebruiktermijnen voor oude etiket

Vorige W-codering professioneel gebruik: W1

Aflevertermijn professioneel gebruik: nvt

Opgebruiktermijn professioneel gebruik: nvt

5 Verpakkingsinformatie

Aard van het preparaat:

Emulgeerbaar concentraat

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BIJLAGE II Etikettering van het middel Reflect

Professioneel gebruik

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

isopyrazam

Pictogram GHS07

GHS08

GHS09

Signaalwoord Waarschuwing

Gevarenaanduidingen H302 Schadelijk bij inslikken.

H317 Kan een allergische huidreactie veroorzaken.

H319 Veroorzaakt ernstige oogirritatie.

H332 Schadelijk bij inademing.

H351 Verdacht van het veroorzaken van kanker.

H361d Wordt ervan verdacht het ongeboren kind te schaden.

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

gevolgen.

Voorzorgsmaatregelen P102 Buiten het bereik van kinderen houden.

P201 Alvorens te gebruiken de speciale aanwijzingen raadplegen.

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

P273 Voorkom lozing in het milieu.

P280 Beschermende handschoenen/beschermende

kleding/oogbescherming/gelaatsbescherming dragen.

P308 + P313 Na (mogelijke) blootstelling: een arts raadplegen.

P312 Bij onwel voelen een ANTIGIFCENTRUM/arts/... raadplegen.

P391 Gelekte/gemorste stof opruimen.

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.

15125 N


BIJLAGE III WG van het middel

A.

WETTELIJK GEBRUIKSVOORSCHRIFT

Wettelijk Gebruiksvoorschrift Toegestaan is uitsluitend het professionele gebruik als schimmelbestrijdingsmiddel door middel van een gewasbehandeling in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.0, Ctgb juni 2011) onder de vermelde toepassingsvoorwaarden

Toepassingsgebied Te bestrijden organisme Dosering (middel) per toepassing

Maximale dosering (middel) per toepassing

Maximaal aantal toepassingen per 12 maanden

Minimum interval tussen toepassingen in dagen

Veiligheids-termijn in dagen

Augurk (onbedekte teelt)

Echte meeldauw2 1 L/ha 1 L/ha 2 7 1

Courgette (bedekte teelt)

Echte meeldauw2 0,1% (100 ml per 100 liter water)

1 L/ha 2 7 1

Courgette (onbedekte teelt)


Komkommer (bedekte teelt)


1 L/ha 2 7 1

Pompoenachtigen (onbedekte teelt)


Meloen (bedekte teelt)


Watermeloen (bedekte teelt)


Aubergine (bedekte teelt)


1 L/ha 2 7 1

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Tomaat (bedekte teelt)


1 L/ha 2 7 1

Wortelen (onbedekte teelt)

Echte meeldauw3

Loofverbruining4 1 L/ha 1 L/ha 2 14 14

1 Echte meeldauw (Leveillula taurica en Oidium lycopersici) 2 Echte meeldauw (Sphaerotheca fuliginea en Erysiphe cichoracearum) 3 Echte meeldauw (Erysiphe dauci) 4 Loofverbruining (Alternaria dauci)

Het gebruik in de teelt van radijs-achtigen, wortelgewassen m.u.v. wortelen, knolraap, koolraap, aardpeer, Japanse aardappel, rode biet, knolselderij, schorseneer en mierikswortel is beoordeeld conform artikel 51 EG 1107/2009. Er is voor deze toepassingen geen werkzaamheids- en fytotoxiciteitonderzoek uitgevoerd. Er wordt daarom aangeraden een proefbespuiting uit te voeren voordat het middel gebruikt wordt. Het risico voor het gewas bij gebruik van dit middel in deze toepassingsgebieden valt onder verantwoordelijkheid van de gebruiker.






Radijs-achtigen (onbedekte teelt)

Loofverbruining4, Echte meeldauw5, Bladvlekkenziekte6,

Pastinaak kanker7

1 L/ha 1 L/ha 2 14 14

Wortelgewassen m.u.v. wortelen (onbedekte teelt)


Pastinaak kanker7

1 L/ha 1 L/ha 2 14 14

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Knolraap (onbedekte teelt)


Pastinaak kanker7

1 L/ha 1 L/ha 2 14 14

Koolraap (onbedekte teelt)


Pastinaak kanker7

1 L/ha 1 L/ha 2 14 14

Aardpeer (onbedekte teelt)


Pastinaak kanker7

1 L/ha 1 L/ha 2 14 14

Japanse aardappel (onbedekte teelt)


Pastinaak kanker7

1 L/ha 1 L/ha 2 14 14

Rode biet (onbedekte teelt)


Pastinaak kanker7

1 L/ha 1 L/ha 2 14 14

Knolselderij (onbedekte teelt)


Pastinaak kanker7

1 L/ha 1 L/ha 2 14 14

Schorseneer (onbedekte teelt)


Pastinaak kanker7

1 L/ha 1 L/ha 2 14 14

15125 N






Mierikswortel (onbedekte teelt)


Pastinaak kanker7

1 L/ha 1 L/ha 2 14 14

4 Loofverbruining (Alternaria spp.) 5 Echte meeldauw (Erysiphe spp, Microsphaera spp. Oidium spp.) 6 Bladvlekkenziekte (Septoria spp., Cercospora spp, Ramularia spp.) 7 Pastinaak kanker (Itersonilia pastinacae) Toepassingsvoorwaarden In de teelt van radijs-achtigen, knolraap, koolraap, aardpeer, Japanse aardappel, rode biet, knolselderij, schorseneer en mierikswortel het middel toepassen vanaf BBCH 40 (begin verdikking van de wortel/knol) tot BBCH 49 (verdikking van de wortel/knol compleet, typische vorm en grootte van de wortel/knol bereikt). Om in het water levende organismen te beschermen is toepassing in de onbedekte teelt van augurk, courgette, pompoenachtigen, radijsachtigen, wortelgewassen, knolraap, koolraap, aardpeer, Japanse aardappel, rode biet, knolselderij, schorseneer en mierikswortel uitsluitend toegestaan wanneer in percelen die grenzen aan oppervlaktewater gebruik wordt gemaakt van minimaal 90%-driftreducerende spuitdoppen. Let op: dit middel kan schadelijk zijn voor natuurlijke vijanden. Raadpleeg uw leverancier van natuurlijke vijanden over het gebruik van dit middel in combinatie met het gebruik van natuurlijke vijanden. Resistentiemanagement Dit middel bevat de werkzame stof isopyrazam. Isopyrazam behoort tot de pyrazole-4-carboxamides. De FRAC code is 7. Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van resistentiemanagement dient u de adviezen die gegeven worden in de voorlichtingsboodschappen op te volgen.

Part A National Assessment

Reflect Art. 51

Extension of authorisation for minor uses Registration Number: 15125 N

Country – The Netherlands

Page 1 of 25

Stichting Trustee Bijzondere Toelatingen Evaluator : Ctgb, NL Date: September 2018

Art. 51

Extension of authorisation for minor uses

REGISTRATION REPORT

Part A

Risk Management

Product code: Reflect

Active Substance:

Isopyrazam 125 g/L

COUNTRY: The Netherlands

NATIONAL ASSESSMENT

Applicant: Stichting Trustee Bijzondere Toelatingen

Date: September 2018


Reflect Art. 51



Page 2 of 25


Table of Contents 1 Details of the application .................................................................................. 4

1.1 Application background .................................................................................................4

1.2 Approval ..........................................................................................................................4

1.3 Regulatory approach ......................................................................................................5

1.3.1 Uses applied for ................................................................................................. 5

1.3.2 Public interest and minor use.............................................................................. 5

1.4 Data protection claims ....................................................................................................5

1.5 Letters of Access ..............................................................................................................5

2 Details of the authorisation ............................................................................................5

2.1 Product identity ...............................................................................................................5

2.2 Classification and labelling ................................................................................. 5

2.2.1 Classification and labelling under Directive 99/45/EC or Regulation (EC) No

1272/2008 ........................................................................................................... 5

2.2.1.1 Specific restrictions linked to the intended uses ................................................... 6

2.3 Product uses for extension (minor uses) ............................................................... 7

3 Risk management ..........................................................................................................12

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

Uniform Principles ........................................................................................................12

3.1.1 Physical and chemical properties ...................................................................... 12

3.1.2 Methods of analysis .......................................................................................... 12

3.1.2.1 Analytical method for the formulation .............................................................. 12

3.1.2.2 Analytical methods for residues ........................................................................ 12

3.1.3 Mammalian Toxicology .................................................................................... 12

3.1.4 Residues and Consumer Exposure .................................................................... 16

3.1.4.1 Residues .......................................................................................................... 16

3.1.5 Environmental fate and behaviour .................................................................... 16

3.1.6 Ecotoxicology ................................................................................................... 17

3.1.7 Efficacy ........................................................................................................... 19

3.2 Conclusions ....................................................................................................................19

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...................................19

Appendix 1 – Copy of the product authorisation ................................................................... 20

Appendix 2 – Copy of the product label ................................................................................ 21

Appendix 3 – Letter of Access .............................................................................................. 25


Reflect Art. 51



Page 3 of 25


PART A – Risk Management

This document describes the acceptable use conditions required for extension of the registration of

Reflect containing isopyrazam in The Netherlands.

The risk assessment conclusions are based on the already existing registration of Reflect in The

Netherlands (risk envelope approach).

Please note that during the risk assessment several uses were withdrawn by the applicant (see 2.3). For

clarity, the risk assessments of the withdrawn uses are not deleted, but they are not relevant for the final

conclusion.

The following sections of Registration Report, Part B were prepared:

• Section 5

• Section 6

• Section 8

Risk envelope overview:

section worst case critical GAP used covered by risk

envelope (decision) remarks

1

Identity, physical and

chemical

not relevant for extension of

authorisation according Article 51. yes n/a

2

analytical methods

formulation: not relevant for extension

of authorisation according Article 51.

Residues (of plant matrices with high

water content) are covered by the main

authorisation.

yes for residues see: 3.1.2.2

3

mammalian toxicology Mechanical upward spraying no See Part A 3.1.3

4

metabolism and

residues

covered by the main authorisation yes n/a

5

environmental fate covered by the main authorisation no n/a

6

ecotoxicological

studies

All field uses. no See Part B 6

7

efficacy data

not relevant for extension of

authorisation according Article 51 n/a n/a

8

relevance of

metabolites in

groundwater

covered by the main authorisation no n/a

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


Reflect Art. 51



Page 4 of 25


1 Details of the application

Application to extend the authorisation of a plant protection product (PPP) already authorised in The

Netherlands to minor uses not yet covered by that authorisation.

The application is intended for use in The Netherlands only.

1.1 Application background

Details on applicant and application

Plant protection product Reflect

Type of application National application according to Article 51

Registration number 15125 N

Applicant Stichting Trustee Bijzondere Toelatingen

Authorisation holder ADAMA Registrations B.V.

Function Fungicide

Type of formulation EC formulation (Emulsifiable Concentrate)

Expiration of authorisation 2024-03-31

1.2 Approval

The active substance included in the plant protection product is approved according to Regulation (EC)

No 1107/2009. The present application is in line with the provisions of the approval.

Active substance

Isopyrazam

Content in PPP 125 g/L

Approval status approved according to Regulation (EC) No 1107/2009

Approval Regulation (EC) No 540/2011

Expiration of approval 2023-03-31


Reflect Art. 51



Page 5 of 25


1.3 Regulatory approach

The PPP is already registered in The Netherlands according to Directive 91/414/EEC or Reg.(EC) No.

1107/2009 taking into account the Uniform Principles of Reg.(EC) No. 546/2011. Therefore the

evaluation of the current application is limited to the points not covered by the existing registration.

1.3.1 Uses applied for

See 2.3

1.3.2 Public interest and minor use

According to Article 51 (2) a and c of the Regulation (EC) No 1107/2009 extensions of authorisation are

only possible if the intended use applied for is minor in nature and in public interest.

In The Netherlands the cultivated area of the extensions asked for fall within the areas that are indicated

to be minor uses (= field use maximum 5.000 ha and indoor use max.1.000 ha).

1.4 Data protection claims

No new studies are submitted, so no extra data protection is granted.

1.5 Letters of Access

Authorisation holder agrees to the current application to extend the authorisation.

2 Details of the authorisation

2.1 Product identity

Product name Reflect

Authorisation number 15125 N

Composition Isopyrazam pure 125 g/L

Type of formulation EC formulation (Emulsifiable Concentrate)

Function Fungicide

Authorisation holder ADAMA Registrations B.V.

2.2 Classification and labelling

2.2.1 Classification and labelling under Directive 99/45/EC or Regulation (EC) No

1272/2008

The current classification and labelling of the product can be maintained.


Reflect Art. 51



Page 6 of 25


Restrictions linked to the PPP

The authorisation of the PPP is linked to the conditions (mandatory labelling) as stated on the label of

the already authorized uses.

2.2.1.1 Specific restrictions linked to the intended uses

Some of the authorised uses are linked to the following conditions (mandatory labelling):

See Chapter 3.2 Conclusions and Appendix 2 (copy of the product label).


Reflect Art. 51



Page 7 of 25


2.3 Product uses for extension (minor uses)

The uses that have been crossed out are withdrawn by the applicant during the evaluation, but were already (partially) assessed.

For clarity, they are incorporated in the GAP but are not relevant for the final conclusion.

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

Use-No.

Member state(s)

Crop and/ or situation

(crop destination

/ purpose of crop)

F G or I

Pests or Group of pests controlled

(additionally:

developmental stages of the pest

or pest group)

Application Application rate PHI (days)

Remarks:

Concentration in

g a.s./hL

Method / Kind

Timing / Growth stage of crop & season

Max. number (min. interval between applications)

a) per use

b) per crop/ season

Minimum interval between applications (days)

L product / ha

a) max. rate per appl.

b) max. total rate per crop/season

g isopyrazam /ha a) max. rate per appl.


Water L/ha

min / max

New uses: Minor uses Art 51

1 NL Radishes RAPSR RAPSN

F Erysiphe spp ERYSSP, Microsphaera spp MCRSSP,. Oidium spp. OIDISP, Septoria spp. SEPTSP, Cercospora spp CERCSP, Ramularia spp. RAMUSP, Alternaria spp. ALTESP, Itersonilia pastinacae ITERPA

Foliar spray

BBCH 14 40-49 May - Oct

a) 2 b) 2 / 2

14 a) 1 b) 2 / 2

a) 125 b) 250

200-800 14


Reflect Art. 51



Page 8 of 25


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

Use-No.

Member state(s)


(crop destination

/ purpose of crop)

F G or I


(additionally:


or pest group)


Remarks:

Concentration in

g a.s./hL

Method / Kind



a) per use

b) per crop/ season


L product / ha





Water L/ha

min / max

2 NL Rootvegetables except carrots Skirret SIUSI Turnip PARCT Parsnips PAVSA


Foliar spray


a) 2 b) 2 / 2

14 a) 1 b) 2 / 2

a) 125 b) 250

200-800 14


Reflect Art. 51



Page 9 of 25


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

Use-No.

Member state(s)


(crop destination

/ purpose of crop)

F G or I


(additionally:


or pest group)


Remarks:

Concentration in

g a.s./hL

Method / Kind



a) per use

b) per crop/ season


L product / ha





Water L/ha

min / max

3 NL Other root and tuber vegetables except sweet potato and yam: Turnip cabbage BRSOG Swede BRSNA Jerusalem artichoke HELTU Japanese artichoke STASB Red beet BEAVD Celeriac APUGR Black salsify SCVHI TROPS Hoorseradish ARWLA


Foliar spray


a) 2 b) 2 / 2

14 a) 1 b) 2 / 2

a) 125 b) 250

200-800 14


Reflect Art. 51



Page 10 of 25


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

Use-No.

Member state(s)


(crop destination

/ purpose of crop)

F G or I


(additionally:


or pest group)


Remarks:

Concentration in

g a.s./hL

Method / Kind



a) per use

b) per crop/ season


L product / ha





Water L/ha

min / max

1 NL Root and tuber vegetables except carrots, sweet potato and yam RAPSR RAPSN SIUSI PARCT PAVSA BRSOG BRSNA STASB BEAVD APUGR SCVHI TROPS ARWLA


Foliar spray

BBCH 14-49 May - Oct

a) 2 b) 2 / 2

14 a) 1 b) 2 / 2

a) 125 b) 250

200-800 14

2 NL Bulb flower and tuber flower

G Botrytis spp. 1BOTRG

Foliar spray

BBCH 11 - 89 Jan-Dec

a) 2 b) 2 / 2

7 a) 1 b) 2 / 2

a) 125 b) 250

300-1000 - 12.5 g a.s./hL

3 NL Floricultural crops F Erysiphe spp ERYSSP, Microsphaera spp MCRSSP,. Oidium spp. OIDISP

Foliar spray

BBCH 11-69, May-Oct

a) 2 b) 2 / 2

7 a) 1 b) 2 / 2

a) 125 b) 250

200-1200 -

4 NL Perennial crops G Erysiphe spp ERYSSP, Microsphaera spp MCRSSP,. Oidium spp. OIDISP

Foliar spray


a) 2 b) 2 / 2

7 a) 1 b) 2 / 2

a) 125 b) 250

300-1000 - 12.5 g a.s./hL


Reflect Art. 51



Page 11 of 25


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

Use-No.

Member state(s)


(crop destination

/ purpose of crop)

F G or I


(additionally:


or pest group)


Remarks:

Concentration in

g a.s./hL

Method / Kind



a) per use

b) per crop/ season


L product / ha





Water L/ha

min / max

5 NL Perennial crops F Erysiphe spp ERYSSP, Microsphaera spp MCRSSP,. Oidium spp. OIDISP

Foliar spray

BBCH 11-69, May-ct

a) 2 b) 2 / 2

7 a) 1 b) 2 / 2

a) 125 b) 250

200-1000 -

6 NL Plant breeding crops and seed production

G Erysiphe spp ERYSSP, Microsphaera spp MCRSSP,. Oidium spp. OIDISP

Foliar spray


a) 2 b) 2 / 2

7 a) 1 b) 2 / 2

a) 125 b) 250

300-1000 - 12.5 g a.s./hL

7 NL Plant breeding crops and , flower seed crops, vegetable seed crops and seed production for herbs, beet, pulses, oilseeds, green manure crops, fibre crops, fodder crops, witloof chicory, large-rooted chicorei, buckwheat and common madder

F Erysiphe spp ERYSSP, Microsphaera spp MCRSSP,. Oidium spp. OIDISP

Foliar spray

BBCH 14-49

May - Oct

a) 2 b) 2 / 2

7 a) 1 b) 2 / 2

a) 125 b) 250

200-1200 -


Reflect Art. 51



Page 12 of 25


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

Not relevant for extension of authorisation according Article 51.

3.1.2 Methods of analysis

3.1.2.1 Analytical method for the formulation

Not relevant for extension of authorisation according Article 51.

3.1.2.2 Analytical methods for residues

The proposed extension for use involves application on crops that can be extrapolated from the current

authorisation based on their crop group (matrix) and their MRL. Therefore, the proposed extension

remains within the existing risk envelope for the section residue analytical methods for food/feed of plant

and animal origin. The proposed extension for use is covered by the risk envelope of the existing

authorisation for the section residue analytical methods.

3.1.3 Mammalian Toxicology



conclusion.

3.1.3.1 Operator exposure

Greenhouse uses

The proposed extension for use involves an application on uses in the greenhouse for which the risk

assessment can be extrapolated from the current authorisation based on the method of application and

dosage (manual up- and downward spraying with a maximum dosage of 1L product/ha). Therefore, the

proposed extension for greenhouse uses remains within the risk envelope.

Field uses

The proposed extension for use involves uses for which the risk assessment can be extrapolated from the

current authorisation based on the method of application and dosage (mechanical and manual downward

spraying with a maximum dosage of 1 L product/ha). Therefore, these uses are within the risk envelope of

the existing authorisation.

The proposed extension for use involves application in ornamentals, perennial crops and plant breeding

crops/seed production for which mechanical and manual upward spray application by operators cannot be

excluded. In the current authorisation, upward spraying in the field was not assessed.


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Based on expert judgement, manual upward spraying in the field is considered to be within the risk

envelope of the greenhouse uses in the current authorisation based on the method of application and

dosage (manual up- and downward spraying with a maximum dosage of 1L product/ha).

For mechanical upward spraying in the field, a risk assessment was performed. For this assessment the

AOEL (0.05 mg/kg bw/day) and dermal absorption value (1% concentrate and dilution) from the current

authorisation were used.


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Table T.3.1.3.1 Internal operator exposure to isopyrazam and risk assessment for the use of Reflect

Route Estimated internal

exposure a (mg /day)

Systemic

EU-AOEL

(mg/day)

% AOEL

Mechanical upward spraying on the intended uses (uncovered, 1L product/ha)

Mixing/

Loadingb

Respiratory <0.01 3.5 0.11

Dermal 0.15 3.5 4.29

Applicationb Respiratory 0.02 3.5 0.64

Dermal 0.32 3.5 9.11

Total 0.50 3.5 14.14

a Internal exposure was calculated with:

• biological availability via the dermal route: 1% (concentrate and spray dilution).

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

b External exposure is estimated with EUROPOEM.

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the

unprotected operator after dermal and respiratory exposure to isopyrazam as a result of the mechanical

upward application of Reflect in the intended uses.

3.1.3.2 Bystander and resident exposure

Greenhouse uses

The proposed extension for use involves an application on uses in the greenhouse for which the risk

assessment can be extrapolated from the current authorisation based on the method of application and

dosage. Therefore, the proposed extension for greenhouse uses remains within the risk envelope.

Field uses

Considering the downward spray applications in the field for this application for minor use extension, the

risk assessment can be extrapolated from the current authorisation based on the method of application

and dosage (mechanical and manual downward spraying with a maximum dosage of 1 L product/ha).

Therefore, these uses are within the risk envelope of the existing authorisation.

The proposed extension for use also involves application in ornamentals, perennial crops and plant

breeding crops/seed production for which upward spray application cannot be excluded. In the current

authorisation, upward spraying in the field was not assessed. Therefore a risk assessment was performed

for the professional bystander, non-professional bystander and residents.

Table T. 3.1.3.2-1 Internal professional bystander exposure to isopyrazam and risk assessment

during application of Reflect Route Estimated internal


Systemic

EU-AOEL

(mg/day)

% AOEL

Bystander exposure during application in ornamentals, perennial crops, plant breeding crops and seed

production (uncovered, 1L product/ha, 200 L water/ha)

Respiratory 0.05 3.5 1.34

Dermal 0.04 3.5 1.09

Total 0.08 3.5 2.43

a External exposure was estimated with EUROPOEM II. Internal exposure was calculated with:

* biological availability via the dermal route: 1% (see 4.2)


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

Table T.3.1.3.2-2 Internal non-professional bystander and resident exposure to isopyrazam and

risk assessment for the application of Reflect

Route Estimated internal


Systemic

AOEL

(mg/day)b

%AOEL

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

Child Total <0.01 0.81 0.28

Adult Total 0.01 3.00 0.34

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

Child Total 0.01 0.81 1.45

Adult Total 0.02 3.00 0.60

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

Adult Total 0.02 3.00 0.77

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

Child Respiratory <0.01 0.75 1.11

Dermal+Oral <0.01 0.75 0.38

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: 1% (see 4.2)

• biological availability via the oral route: 64% (see List of EndPoints)

b From the systemic AOEL of 0.05 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.

Based on the risk assessment, it can be concluded that no adverse health effects are expected for the

unprotected bystander, nor for nearby non-work related bystanders and residents, due to exposure to

isopyrazam during and after upward application of Reflect in the intended uses.

3.1.3.3 Worker exposure

Greenhouse and field uses

The worst case scenario assessed in the current authorisation was harvesting high crop vegetables in the

greenhouse with a maximum dosage of 1L product/ha and using a TC value of 0.45 m2/hr.

Considering the proposed extension for minor use, ornamental crops are also applied for (greenhouse and

field) for which a higher TC value of 0.5 m2/hr is applicable. The maximum dosage applied for in this

minor use extension is the same as the one already authorised (1L product/ha)

Considering the small difference in TC value (0.5 vs 0.45 m2/hr) and the low exposure in the current

authorisation (5.4% of the AOEL), based on expert judgement no unacceptable risk is anticipated for the

unprotected worker.

It can be concluded that no adverse health effects are expected for the unprotected worker after dermal

and respiratory exposure during re-entry activities in the intended uses due to exposure to isopyrazam

after application of Reflect.


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3.1.4 Residues and Consumer Exposure

3.1.4.1 Residues

The proposed extension for use involves an application on edible crops from root and tuber vegetables

group: beetroot, celeriac, horseradish, Jerusalem artichokes, parsnip, parsley root, radishes, salsify,

swedes and turnips, for which the risk assessment can be extrapolated from the current authorisation for

carrots. Therefore, the proposed extension remains within the existing risk envelope for the section

residues and consumer risk assessment. The current EU-MRL in requested uses is covered by the data

available in the existing authorisation.

For requested non-edible crops bulb: flowers and tuber flowers where residues in rotational crops might

be of relevance, the assessment of residues in rotational crops falls within the existing risk envelope.

No risk for the consumer is expected.

3.1.5 Environmental fate and behaviour

Prior to performing the risk assessment, a risk envelope analysis of the applications was held, in which

the following was concluded:

The new field uses of Reflect applied for in Root and tuber vegetables except carrots, sweet potato and

yam, Ornamental crops, Perennial crops, Plant breeding crops and flower seed crops, vegetable seed

crops and seed production for herbs, beet, pulses, oilseeds, green manure crops, fibre crops, fodder crops,

witloof chicory, large-rooted chicorei, buckwheat and common madder have an equal (or lower) risk for

emission to surface water and sediment as the already authorised uses. The drinking water criterion is

met.

The available and most recent monitoring data in groundwater and surface water have been reviewed and

have no consequences for the proposed uses.

The risk of the above mentioned field uses applied for is not included in the risk envelope for the aspects

persistence in soil and leaching to groundwater. For these aspects a separate risk assessment is required.

The new greenhouse uses of Reflect applied for in Bulb flower and tuber flower, Perennial crops and

Plant breeding crops and seed production have an equal (or lower) risk for persistence in soil, leaching to

groundwater and emission to surface water and sediment as the already authorised uses. The drinking

water criterion is met.

The available and most recent monitoring data in groundwater and surface water have been reviewed and

have no consequences for the proposed uses.

No separate risk assessment is required.

Please note that the GAP has been adjusted while working on the risk assessment of the several aspects,

several uses were withdrawn by the applicant (see 2.3). Adjustment of the GAP led to a new conclusion

regarding the new uses: The new uses of Reflect applied for in Radishes, Root vegetables except carrots

and Other root and tuber vegetables except sweet potato and yam have an equal (or lower) risk for

persistence in soil, leaching to groundwater, and emission to surface water and sediment as the already

authorised uses. The drinking water criterion is met. The available and most recent monitoring data in

groundwater and surface water have been reviewed and have no consequences for the proposed uses.

As the uses assessed fall under the risk envelope of the already authorised uses, no additional calculations

based on the new GAP were required (either relevant for the fate & behaviour aspect or the

ecotoxicological risk assessment).


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3.1.6 Ecotoxicology



conclusion.

The risk of the use applied for in the field use of root and tuber vegetables except carrots, sweet potato

and yam is not included in the risk envelope for the aspects depending on exposure to soil (secondary

poisoning of birds and mammals, and soil organisms). For these aspects a separate risk assessment is

required.

The risk of the use applied for in the field use of ornamental crops, perennial crops, plant breeding crops

and , flower seed crops, vegetable seed crops and seed production for herbs, beet, pulses, oilseeds, green

manure crops, fibre crops, fodder crops, witloof chicory, large-rooted chicorei, buckwheat and common

madder is not included in the risk envelope for the aspects birds (secondary poisoning via earthworms),

mammals and soil organisms. For these aspects a separate risk assessment is required.

The risk of the applied greenhouse use in bulb flower and tuber flower, perennial crops, plant breeding

and seed production is equal to or lower than the risk of the authorised uses with regard to the

environment for all aspects addressed above.

Birds

Secondary poisoning via earthworms

The TERearthworm value is greater than the trigger of 5, indicating an acceptable long-term risk to

earthworm-eating birds.

Conclusion birds:

The risk to birds for all the proposed uses is acceptable.

Mammals

Acute and long-term risk to mammals

The results of the screening step indicated that the acute and long-term TER values for isopyrazam

following applications to ornamentals and vegetables are below the relevant trigger. A Tier I assessment

was subsequently performed. In the core dossier, the risk was acceptable for short-cut values of 45.2 and

below. This means that only vole scenarios were considered in the Tier I assessment.

The Tier 1 assessment resulted in TERA value for small herbivorous mammals below the trigger of 10. A

refinement or further information should be submitted by the applicant on acute risk to mammals.

Similarly, for long-term risk to small herbivorous mammals, the Tier I assessment resulted in TER values

below the trigger. The TERLT values for the most sensitive scenario (small herbivorous mammal “vole”

BBCH 10-49) are within 2.61 and 8.89, depending on the endpoint used. In the core dossier, the use of a

NOEL of 20 mg a.s./kg bw/day was considered extreme worst-case situation and consequently, uses with

TER’s below the trigger of 5 (4 and 4.6) were considered acceptable. However, for the proposed uses in

this application, the TERLT (using the endpoint from the refinement in the core dossier) is 1.53 times

lower than the TER values accepted in the core dossier. Thus, the long-term risk to mammals is

considered to be non-acceptable. As the formulation is 10 times more toxic (acute toxicity) than the active

substance, it is considered that the use of the lowest NOEL is preferable.

Concluding, the risk to small herbivorous mammals “vole” in the scenarios ornamentals and vegetables

BBCH ≥ 50 is higher than the trigger of 5 and considered acceptable. However, for voles (BBCH 10-49),

the risk is not acceptable. A refinement for this aspect is required.

Secondary poisoning via earthworms


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The TERearthworm value exceeds the long-term trigger value of 5. Therefore, it can be considered that

isopyrazam poses an acceptable risk to earthworm-eating mammals.

Conclusion mammals:

It can be concluded that there is an acceptable risk to mammals following proposed applications of the

formulated product for uses in the field: for root and tuber vegetables (except carrots, sweet potato and

yam), ornamental crops and perennial crops and in greenhouses: in bulb flower and tuber flower,

perennial crops and plant breeding crops and seed production.

For the proposed field uses in plant breeding crops and flower seed crops, vegetable seed crops and seed

production for herbs, beet, pulses, oilseeds, green manure crops, fibre crops, fodder crops, witloof

chicory, large-rooted chicorei, buckwheat and common madder, acute and long-term risk to mammals is

not acceptable. For this aspect, a further refinement is required.

The applicant has withdrawn these uses from the label.

Soil organisms

For the use in root and tuber vegetables, the applicant wants to restrict the use for application after BBCH

40 onward, and proposes the following restriction on the label:

In de teelt van radijs-achtigen, knolraap, koolraap, aardpeer, Japanse aardappel, rode biet, knolselderij,

schorseneer en mierikswortel het middel toepassen vanaf BBCH 40 (begin verdikking van de wortel/knol)

tot BBCH 49 (verdikking van de wortel/knol compleet, typische vorm en grootte van de wortel/knol

bereikt).

When application is only from BBCH 40 onwards, the interception to soil increases and environmental

fate concludes that when the application is from BBCH 40 onwards, the proposed uses fall within the

existing risk envelope. No further assessment is required.

Effects on organic matter breakdown

For the use in root and tuber vegetables, the applicant wants to restrict the use for application after BBCH

40 onward, and proposes the following restriction on the label:




bereikt).

When application is only from BBCH 40 onwards, the interception to soil increases and environmental

fate concludes that when the application is from BBCH 40 onwards, the proposed uses fall within the

existing risk envelope. No further assessment is required.

Effects on soil microbial activity

Isopyrazam had no significant effect (< 25% reduction in respiration or nitrate formation) on soil micro-

organisms at 1.67 mg/kg. This is 3.3 times higher than the maximum PECS of 0.425 mg isopyrazam/kg

following the worst-case application to vegetables. This indicates that the risk to non-target soil micro-

organisms is acceptable following use of Reflect according to the proposed use pattern. Furthermore, the

NOECs for CSCD459488 and CSCD465008 are at least 3.6 times higher than the maximum PECS

values.

Conclusion on soil microbial activity


Reflect Art. 51



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When applied in accordance with the uses supported in this submission Reflect poses an acceptable risk

to soil microorganisms.

3.1.7 Efficacy

According to Article 51 of the Regulation (EC) No 1107/2009 the requirements for approval concerning

the sufficient effect and any unacceptable effects on plants and plant products does not need to be

checked.

3.2 Conclusions

During the assessment the applicant has withdrawn the following uses:

- Bulb flower and tuber flower

- Ornamental crops

- Perennial crops

- Plant breeding crops and seed production

- Plant breeding crops and , flower seed crops, vegetable seed crops and seed production for herbs, beet,

pulses, oilseeds, green manure crops, fibre crops, fodder crops, witloof chicory, large-rooted chicorei,

buckwheat and common madder

PPP Reflect is already registered in The Netherlands according to Directive 91/414/EEC or Reg. (EC)

No. 1107/2009 taking into account the Uniform Principles of Reg. (EC) No. 546/2011.

The intended use is minor in nature and the extension of authorisation is in public interest.

For the uses applied for in this minor use extension, no unacceptable risks are anticipated for the

unprotected operator, worker or bystander, nor for non-work related bystanders and residents.

The intended uses will not result in residues above the MRLs set in or proposed for isopyrazam.

Regulation (EC) No 396/2005. A risk for consumers through the consumption of food with these residues

of isopyrazam is not expected. Considering an application in accordance with the evaluated use pattern

and good agricultural practise as well as strict observance of the conditions of use no harmful effects on

groundwater are to be apprehended.

The following restriction should be included on the label:




bereikt).

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

of the conditions and restrictions associated with the authorisation

None.


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Appendix 1 – Copy of the product authorisation

The final product authorisation in The Netherlands can be found on the Ctgb website:

www.ctgb.nl > choose English > “pesticide database “> Filter by name > Reflect


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Appendix 2 – Copy of the product label

Wettelijk Gebruiksvoorschrift Toegestaan is uitsluitend het professionele gebruik als schimmelbestrijdingsmiddel door middel van een gewasbehandeling in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.0, Ctgb juni 2011) onder de vermelde toepassingsvoorwaarden

Toepassingsgebied Te bestrijden organisme

Dosering (middel) per toepassing





Augurk (onbedekte teelt)


Courgette (bedekte teelt)


1 L/ha 2 7 1

Courgette (onbedekte teelt)


Komkommer (bedekte teelt)


1 L/ha 2 7 1

Pompoenachtigen (onbedekte teelt)


Meloen (bedekte teelt)


Watermeloen (bedekte teelt)


Aubergine (bedekte teelt)


1 L/ha 2 7 1

Tomaat (bedekte teelt)


1 L/ha 2 7 1


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Wortelen (onbedekte teelt)

Echte meeldauw3

Loofverbruining4 1 L/ha 1 L/ha 2 14 14

1 Echte meeldauw (Leveillula taurica en Oidium lycopersici) 2 Echte meeldauw (Sphaerotheca fuliginea en Erysiphe cichoracearum) 3 Echte meeldauw (Erysiphe dauci) 4 Loofverbruining (Alternaria dauci)

Het gebruik in de teelt van radijs-achtigen, wortelgewassen m.u.v. wortelen, knolraap, koolraap, aardpeer, Japanse aardappel, rode biet, knolselderij, schorseneer en mierikswortel is beoordeeld conform artikel 51 EG 1107/2009. Er is voor deze toepassingen geen werkzaamheids- en fytotoxiciteitonderzoek uitgevoerd. Er wordt daarom aangeraden een proefbespuiting uit te voeren voordat het middel gebruikt wordt. Het risico voor het gewas bij gebruik van dit middel in deze toepassingsgebieden valt onder verantwoordelijkheid van de gebruiker.







Radijs-achtigen (onbedekte teelt)


Pastinaak kanker7

1 L/ha 1 L/ha 2 14 14

Wortelgewassen m.u.v. wortelen (onbedekte teelt)


Pastinaak kanker7

1 L/ha 1 L/ha 2 14 14


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Knolraap (onbedekte teelt)


Pastinaak kanker7

1 L/ha 1 L/ha 2 14 14

Koolraap (onbedekte teelt)


Pastinaak kanker7

1 L/ha 1 L/ha 2 14 14

Aardpeer (onbedekte teelt)


Pastinaak kanker7

1 L/ha 1 L/ha 2 14 14

Japanse aardappel (onbedekte teelt)


Pastinaak kanker7

1 L/ha 1 L/ha 2 14 14

Rode biet (onbedekte teelt)


Pastinaak kanker7

1 L/ha 1 L/ha 2 14 14

Knolselderij (onbedekte teelt)


Pastinaak kanker7

1 L/ha 1 L/ha 2 14 14

Schorseneer (onbedekte teelt)


Pastinaak kanker7

1 L/ha 1 L/ha 2 14 14


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Mierikswortel (onbedekte teelt)


Pastinaak kanker7

1 L/ha 1 L/ha 2 14 14

4 Loofverbruining (Alternaria spp.) 5 Echte meeldauw (Erysiphe spp, Microsphaera spp. Oidium spp.) 6 Bladvlekkenziekte (Septoria spp., Cercospora spp, Ramularia spp.) 7 Pastinaak kanker (Itersonilia pastinacae) Toepassingsvoorwaarden In de teelt van radijs-achtigen, knolraap, koolraap, aardpeer, Japanse aardappel, rode biet, knolselderij, schorseneer en mierikswortel het middel toepassen vanaf BBCH 40 (begin verdikking van de wortel/knol) tot BBCH 49 (verdikking van de wortel/knol compleet, typische vorm en grootte van de wortel/knol bereikt). Om in het water levende organismen te beschermen is toepassing in de onbedekte teelt van augurk, courgette, pompoenachtigen, wortelen knolgewassen, bloemisterijgewassen, vaste planten en Veredeling en bloemenzaadteelt, groentenzaadteelt en zaadteelt van kruiden, bieten, peulvruchten, oliehoudende zaden, vezelgewassen, groenbemesters gewassen, voedergewassen en witlof, cichorei, boekweit en meekrap uitsluitend toegestaan wanneer in percelen die grenzen aan oppervlaktewater gebruik wordt gemaakt van minimaal 90%-driftreducerende spuitdoppen. Let op: dit middel kan schadelijk zijn voor natuurlijke vijanden. Raadpleeg uw leverancier van natuurlijke vijanden over het gebruik van dit middel in combinatie met het gebruik van natuurlijke vijanden. Resistentiemanagement Dit middel bevat de werkzame stof isopyrazam. Isopyrazam behoort tot de pyrazole-4-carboxamides. De FRAC code is 7. Bij dit product bestaat er kans op resistentieontwikkeling. In het kader van resistentiemanagement dient u de adviezen die gegeven worden in de voorlichtingsboodschappen op te volgen.


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Appendix 3 – Letter of Access

No letter of access necessary. Authorisation holder agrees to the current application to extend the authorisation.

HET COLLEGE VOOR DE TOELATING VAN ... · Besluit artikel 51 Verordening (EG) Nr. 1107/2009 en...

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