Monarch, 20200042 NLKUG 1
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
1 BESLUIT
Op 9 januari 2020 is van
Stichting Trustee Bijzondere Toelatingen Postbus 80523
2508 GM S-GRAVENHAGE Nederland
een aanvraag tot uitbreiding met kleine toepassing van een gewasbeschermingsmiddeltoelating ontvangen voor het middel
Monarch op basis van de werkzame stof flutolanil.
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.
- 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 RGB (Hoofdstuk 2) en de Evaluation Manual 1.1.
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 stof 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).
Monarch, 20200042 NLKUG 3 Bezwaarmogelijkheid.
Degene wiens belang rechtstreeks bij dit besluit is betrokken kan gelet op artikel 4 van Bijlage 2 bij de Algemene wet bestuursrecht en artikel 7:1, eerste lid, van de Algemene wet bestuursrecht, binnen zes weken na de dag waarop dit besluit bekend is gemaakt een bezwaarschrift indienen bij: het College voor de toelating van gewasbeschermingsmiddelen en biociden (Ctgb), Postbus 8030, 6710 AA, EDE.
Het Ctgb heeft niet de mogelijkheid van het elektronisch indienen van een bezwaarschrift opengesteld.
Ede, 6 november 2020
Het College voor de toelating van
gewasbeschermingsmiddelen en biociden, voor deze:
de voorzitter,
Ir. J.F. de Leeuw
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE I DETAILS VAN DE AANVRAAG EN TOELATING
1 Aanvraaginformatie
Aanvraagnummer: 20200042 NLKUG
Type aanvraag: aanvraag tot uitbreiding met kleine toepassing van een gewasbeschermingsmiddeltoelating
Middelnaam: Monarch
Formele registratiedatum: * 30 januari 2020 Datum ontvangst aanvraag: 9 januari 2020 Datum compliance check: N.v.t.
* Datum waarop zowel de aanvraag is ontvangen als de aanvraagkosten zijn voldaan.
2 Stofinformatie
Werkzame stof Gehalte
flutolanil 460 G/L
De stof flutolanil is per 1 maart 2009 geplaatst op Annex I van richtlijn 91/414/EEG (2008/108/EC, d.d. 26 november 2008), welke per 14 Juni 2011 is overgegaan in Uitvoeringsverordening (EU) No 540/2011 d.d. 25 mei 2011 behorende bij Verordening (EG) No 1107/2009, met verlengde expiratiedatum 28 februari 2021.
3 Toelatingsinformatie
Toelatingsnummer: 13144 N
Expiratiedatum: 1 november 2025
Afgeleide of parallel: n.v.t.
Biocide, gewasbeschermingsmiddel of toevoegingsstof:
Gewas
Gebruikers: Professioneel
W-codering professioneel gebruik: W5
4 Aflever- en opgebruiktermijnen voor oude etiket
Vorige W-codering professioneel gebruik: W4 Aflevertermijn professioneel gebruik: nvt Opgebruiktermijn professioneel gebruik: nvt
5 Verpakkingsinformatie Aard van het preparaat:
Suspensie concentraat
Monarch, 20200042 NLKUG 1 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
BIJLAGE II Etikettering van het middel Monarch Professioneel gebruik
de identiteit van alle stoffen in het mengsel die bijdragen tot de indeling van het mengsel:
-
Pictogram -
Signaalwoord -
Gevarenaanduidingen H412 Schadelijk voor in het water levende organismen, met langdurige gevolgen.
Voorzorgsmaatregelen P273 Voorkom lozing in het milieu.
P391 Gelekte/gemorste stof opruimen.
P501 Inhoud/verpakking afvoeren naar ....
SP 1 Zorg ervoor dat u met het product of zijn verpakking geen water verontreinigt.
Aanvullende etiketelementen
EUH208 Bevat 1,2-benzisothiazool-3(2H)-on. Kan een allergische reactie veroorzaken.
EUH401 Volg de gebruiksaanwijzing om gevaar voor de menselijke gezondheid en het milieu te voorkomen.
HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN BIJLAGE III WG van het middel
A.
WETTELIJK GEBRUIKSVOORSCHRIFT
Wettelijk Gebruiksvoorschrift
Het middel is uitsluitend toegelaten als schimmelbestrijdingsmiddel - voor het professionele gebruik in de volgende toepassingsgebieden (volgens Definitielijst toepassingsgebieden versie 2.1 Ctgb juni 2015) onder de hierna vermelde toepassingsvoorwaarden.
Toepassingsvoorwaarden:
Toepassingsgebied Type toepassing Werkzaamheid getoetst op
Dosering*
middel per toepassing
Maximale dosering middel per toepassing
Maximaal aantal toepassingen per teeltcyclus
Maximaal aantal liter middel per ha per teeltcyclus Aardappelen Pootgoedbehandeling Lakschurft1 200 ml per 1000
kg pootgoed, evt. oplossen tot 2 liter water
1 L/ha 1 1 L/ha
Tulp
(onbedekte teelt)
Grondbehandeling**
(voor planten)
Rhizoctonia- ziekte2
6 L/ha 6 L/ha 1 6 L/ha
Voorbehandeling***
(tijdens planten)
3 L/ha 3 L/ha 1
Iris
(onbedekte teelt)
Grondbehandeling**
(voor planten)
Rhizoctonia- ziekte2
6 L/ha 6 L/ha 1 6 L/ha
Voorbehandeling***
(tijdens planten)
3 L/ha 3 L/ha 1
* 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.
** Het middel (volvelds) verspuiten en direct daarna 10-15 cm inwerken met daartoe geëigende apparatuur.
*** Het middel verspuiten over de geplante bollen in de opengetrokken plantregel waarbij ook de dekgrond (opstaande regelwanden) moet worden behandeld.
Monarch, 20200042 NLKUG 2
1 Lakschurft (Rhizoctonia solani)
2 Rhizoctonia-ziekte (Rhizoctonia solani)
Het gebruik in de toepassingsgebieden die in onderstaande tabel genoemd worden, is beoordeeld conform de “vereenvoudigde
uitbreidingsprocedure”. Er is voor deze toepassing geen werkzaamheids- en fytotoxiciteit onderzoek uitgevoerd. Er wordt daarom aangeraden een proefbespuiting uit te voeren voordat het middel gebruikt wordt. Het risico voor het gewas bij gebruik van dit middel in dit toepassingsgebied valt onder verantwoordelijkheid van de gebruiker.
Toepassingsgebied Type toepassing Werkzaamheid aannemelijk tegen
Dosering*
middel per toepassing
Maximaal aantal toepassingen per 12 maanden
Maximaal aantal liter middel per ha per teeltcyclus
Bloembollen en bloemknollen m.u.v. lelie, tulp en iris (onbedekte teelt)
Grondbehandeling**
(voor planten)
Rhizoctonia-ziekte2 6 L/ha 1 6 L/ha
Voorbehandeling***
(tijdens planten)
3 L/ha 1
Snijbloemen
(grondgebonden teelt)
Gewasbehandeling (kort na planten)
Rhizoctonia-ziekte2 6 L/ha 1 6 L/ha
Trekheesters Gewasbehandeling
(kort na planten)
Rhizoctonia-ziekte2 6 L/ha 1 6 L/ha
Snijgroen Gewasbehandeling
(kort na planten)
Rhizoctonia-ziekte2 6 L/ha 1 6 L/ha
Sierheesters Gewasbehandeling
(kort na planten)
Rhizoctonia-ziekte2 6 L/ha 1 6 L/ha
Vaste plantenteelt Gewasbehandeling (kort na planten)
Rhizoctonia-ziekte2 6 L/ha 1 6 L/ha
Bloemenzaadteelt Gewasbehandeling
(kort na planten)
Rhizoctonia-ziekte2 6 L/ha 1 6 L/ha
* Verlaging van de dosering is toegestaan, maar van het maximaal aantal toepassingen en de andere toepassingsvoorwaarden mag niet worden afgeweken.
** Het middel (volvelds) verspuiten en direct daarna 10-15 cm inwerken met daartoe geëigende apparatuur.
*** Het middel verspuiten over de geplante bollen in de opengetrokken plantregel waarbij ook de dekgrond (opstaande regelwanden) moet worden behandeld
2 Rhizoctonia-ziekte (Rhizoctonia solani) Overige toepassingsvoorwaarden
In de teelt van snijbloemen, trekheesters, snijgroen, sierheesters, vaste planten en bloemenzaad het middel toepassen met 400-1000 liter water per hectare.
Let op: dit middel kan schadelijk zijn voor natuurlijke vijanden. Raadpleeg deskundigen (uw leverancier van natuurlijke vijanden, de producent van dit middel, uw adviseur) over het gebruik van dit middel in combinatie met het gebruik van natuurlijke vijanden.
Monarch, 20200042 NLKUG 1 HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN BIOCIDEN
BIJLAGE IV
RISKMANAGEMENT
Contents
1 Identity of the plant protection product ... 2
2 Physical and chemical properties ... 2
3 Methods of analysis ... 2
4 Mammalian toxicology ... 3
5 Residues ... 2
6 Environmental fate and behaviour ... 2
7 Ecotoxicology ... 12
8 Efficacy ... 24
9 Conclusion ... 24
10 Classification and labelling... 25
1 Identity of the plant protection product 1.1 Applicant
Stichting Trustee Bijzondere Toelatingen 1.2 Identity of the active substance
The identity of the active substance does not change.
Common name Flutolanil Name in Dutch Flutolanil
Chemical name α,α,α,-trifluoro-3’-isopropoxy-o-toluanilide
CAS no 66332-96-5
EC no Not allocated
The active substance was included in Annex I of Directive 91/414/EEC on May 1st, 2009.
From 14 June 2011 forward, according to Reg. (EU) No 540/2011 the substance is approved under Reg. (EC) No 1107/2009, repealing Directive 91/414/EEC.
1.3 Identity of the plant protection product
The identity of the plant protection product does not change.
Name Monarch
Formulation type Suspension concentrate (SC) Content active substance 460 g/L
The formulation is not part of the assessment of the active substance for inclusion in Annex I of Directive 91/414/EEC.
1.4 Function Fungicide
1.5 Uses applied for See GAP (Appendix I).
1.6 Background to the application
It concerns a simplified extension of the authorization with minor uses.
1.7 Packaging details Packaging details do not change.
2 Physical and chemical properties
The physical and chemical properties of the active substance and the formulation do not change.
3 Methods of analysis
3.1 Analytical methods in technical material and plant protection product
Monarch, 20200042 NLKUG 3 The analytical methods for the technical material and the plant protection product do not change.
3.2 Residue analytical methods
The proposed extension for use of Monarch does not include crops intended for human consumption and/or as food/feed for livestock. Therefore, residue analytical methods for food/feed of plant and animal origin are not required.
The residue analytical methods for air, soil and water were accepted during the assessment which led to the original authorization of Monarch. This simplified extension does not give rise to re-assess these residue analytical methods.
3.3 Conclusion
The proposed extension for use does not include crops intended for human consumption and/or as food/feed for livestock. Therefore, assessment of coverage of the risk envelope of the existing authorisation for the section residue analytical methods is not required.
4 Mammalian toxicology
4.1 Acute toxicity of the formulation
For the acute toxicity data, it is referred to the original authorisation.
4.2 Operator risk assessment
The intended minor use in cut flowers (soil-bound), forced shrubs, cut green, ornamental shrubs, perennial crops and flower seed crops is not fully covered by the original authorisation as manual downward spraying in the field and the greenhouse application were not evaluated for the original authorisation. Therefore, a risk assessment has to be conducted for manual downward spraying in the field and for the greenhouse application for these crops. The other uses applied for are applications by mechanical downward broadcast spraying and in furrow applications (max 2.76 kg a.s./ha and minimum water volume of 150 L/ha) and these are covered by the main authorisation.
The critical GAP for the risk assessment is:
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
Method / Kind
Timing / Growth stage
of crop &
season
Max. number (min. interval
between applications)
product / ha a) max. rate per appl.
b) max. total rate per season
kg, as/ha a) max. rate per appl.
b) max. total rate per crop/season
Water L/ha min / max
Cut flowers (soil- bound), forced shrubs,
cut green, ornamental shrubs,
perennial crops, flower seed crops
F G
Rhizoctonia solani (RHIZSO)
Broadcast application shortly after
planting
BBCH 00-16
March-Dec 1 a) 6
b) 6
a) 2.76
b) 2.76 400 -1000
According to the Dutch Plant Protection Products and Biocides Regulations the risk assessment is performed according to a tiered approach. There are four possible tiers:
Tier 1: Risk assessment using the EU-AOEL without the use of PPE Tier 2: Risk assessment using the NL-AOEL without the use of PPE
Tier 3: Refinement of the risk assessment using new dermal absorption data Tier 4: Prescription of PPE
Monarch, 20200042 NLKUG 1 Tier 1
Calculation of the EU-AOEL / Tolerable Limit Value (TLV)
For flutolanil no TLV has been set. The AOEL will be used for the risk assessment.
Since the formulation is applied once during the period March – December, a semi-chronic exposure duration is applicable for the operator (including contract workers). A semi-chronic AOEL is therefore derived.
Since flutolanil is included in Annex I of 91/414/EEC and subsequently approved according to
Regulation (EC) 1107/2009, the semi-chronic EU-AOEL of 0.56 mg/kg bw/day (= 39.2 mg/day for a 70- kg operator), based on the 90-day study in dog is used for the risk assessment (see List of Endpoints).
Dermal absorption
Refer to the original authorisation (20110408 THG), a value of 0.5% can be used for the concentrate and a value of 5% for the spray dilution.
Exposure/risk
Exposure to flutolanil during mixing and loading and application of Monarch is estimated with models. The exposure is estimated for the unprotected operator. In general, mixing and loading and application is performed by the same person. Therefore, for the total exposure, the inhalation and dermal exposure during mixing/loading and application have to be combined.
In the Table below the estimated internal exposure is compared with the systemic EU-AOEL.
Table T.1 Internal operator exposure to flutolanil and risk assessment for the use of Monarch
Route Estimated internal
exposure a (mg/day)
Systemic EU-AOEL (mg/day)
%EU-AOEL
Manual downward spraying on several crops, 6 L product/ha (uncovered) Mixing/
Loadingb
Respiratory 0.01 39.2 <1
Dermal 1.66 39.2 4
Applicationc Respiratory 0.83 39.2 2
Dermal 35.19 39.2 90
Total 37.69 39.2 96
Manual up- and downward spraying on several crops, 6 L product/ha (covered) Mixing/
Loading and applicationd
Respiratory 2.76 39.2 7
Dermal 27.60 39.2 70
Total 30.36 39.2 77
a Internal exposure was calculated with:
• biological availability via the dermal route: 0.5% (concentrate) and 5% (spray dilution)
• biological availability via the respiratory route: 100% (worst case)
b External exposure is estimated with the NL model (inhalation exposure) and EUROPOEM I (dermal exposure).
c External exposure is estimated with UK POEM.
d External exposure is estimated with the NL greenhouse model.
Since the EU-AOEL is not exceeded without the use of PPE, a higher tier assessment with the use of PPE is not required.
4.3 Bystander / resident risk assessment
The minor uses applied for are covered by the risk envelop of the original authorisation.
4.4 Worker risk assessment
The minor uses applied for are covered by the risk envelop of the original authorisation.
5 Residues Conclusion
The uses requested within this application include not-edible crops only: flower bulbs and flower tubers (except lily, tulip and iris), cut flowers (soil-bound), shrubs, cut green, ornamental shrubs, perennial crops, and flower seed crops. Therefore, risk assessment for the consumer is not required.
Possible residues in rotational crops have been addressed and are covered by the current authorisation, when product is applied according to the requested cGAP.
6 Environmental fate and behaviour
Conclusion for environmental aspects persistence in soil and leaching to groundwater, emission to surface water and sediment, drinking water criterion and monitoring data
The new uses of Monarch applied for in a range of new field and glasshouse uses (except glasshouse use in Cut flowers) 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 new glasshouse use of Monarch applied for in Cut flowers does not have an equal risk for persistence in soil, leaching to groundwater and emission to surface water and sediment as the already authorised uses. For this use, a separate risk assessment is required.
Substance has been on the Dutch market for > 3 years (authorised since December 1993). This period is sufficiently large to consider the market share to be established. The substance was not
mentioned on the latest (2019) VEWIN list with problematic substances. The now proposed extension of the use concerns a minor use with limited acreage. Therefore it is considered that this will not contribute substantially to the use of the active substance. The drinking water criterion is considered to be met.
The available and most recent monitoring data in groundwater and surface water have been reviewed and have no consequences for the proposed uses.
Risk assessment is done in accordance with Chapter 2 of the RGB published in the Government Gazette (Staatscourant) 188 of 28 September 2007, including the updates of 20 October 2009 (which came into effect on 1 January 2010) and 18 April 2011 (which came into effect on 23 April 2011).
Flutolanil was included in Annex I on November 26th, 2008 (entry into force March 2009). The List of Endpoints of the EFSA conclusion is used for the assessment.
In the inclusion directive (PART B) the following is mentioned:
In assessing applications to authorise plant protection products containing flutolanil for uses other than potato tuber treatment, Member States shall pay particular attention to the criteria in Article 4(1)(b), and shall ensure that any necessary data and information is provided before such an authorisation is granted. For the implementation of the uniform principles of Annex VI, the
conclusions of the review report on flutolanil, and in particular Appendices I and II thereof, as finalised
Monarch, 20200042 NLKUG 3 in the Standing Committee on the Food Chain and Animal Health on 20 May 2008 shall be taken into account.
In this overall assessment Member States must pay particular attention to:
— the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions.
Conditions of authorisation should include risk mitigation measures, where appropriate.
An additional study, a kinetic analysis of field trials, was evaluated and summarized by Alterra (Nov 2007, report no. 10579-mil). For the the application for extension of Monarch (20090949), one additional field study was evaluated (Alterra report no. 23495-mil, October 2010). Evaluated endpoints of these studies are added to the List of Endpoints (below the field studies) in italics.
Moreover, for current application a kinetic analysis of a water –sediment study is submitted. A summary of these studies including evaluated endpoints are added in italics below the list of endpoints.
List of Endpoints Fate/behaviour (in line with EFSA conclusion) Route of degradation (aerobic) in soil (Annex IIA, point 7.1.1.1.1) (The percentages quoted are referred to the % of the applied radioactivity) MineralizaNon aOer 100 days ‡
([aniline ring-U-14C]-label)
- European soils: 2.9-9.9 % after 105 d (n1= 4), 20 oC - US soil: 13.4 % after 116 d (27.5 % after 365 d) (n=1), 25 oC
Non-extractable residues aOer 100 days ‡ ([aniline ring-U-14C]-label)
- European soils: 9.4-27.9 % after 105 d (n=4), 20 oC - US soil: 15.9 % after 116 d (26.7 % after 365 d) (n=1), 25 oC
Metabolites requiring further consideraNon ‡ - name and/or code, % of applied (range and maximum) ([aniline ring-U-14C]-label)
No (the only metabolite appearing over 5 % was CO2)
Route of degradation in soil - Supplemental studies (Annex IIA, point 7.1.1.1.2) Anaerobic degradaNon ‡
Mineralization after 100 days days ([aniline ring-U-14C]-label)
0.2 % / 120 d (0.4 % / 365 d) (n=1) Sterile conditions: no data available Non-extractable residues after 100 days
([aniline ring-U-14C]-label)
4.6 % / 120 d (7.4 % / 365 d) (n=1)
Metabolites that may require further consideration for risk assessment - name and/or code, % of applied (range and maximum)
No (after 365 days total amount of flutolanil 86 %)
Soil photolysis ‡
Metabolites that may require further consideration for risk assessment - name and/or code, % of applied (range and maximum)
The study is not relied upon (PRAPeR 22, May 2007), but it is not required for the representative use evaluated (seed treatment for potatoes prior planting)
1 n corresponds to the number of soils.
Rate of degradation in soil (Annex IIA, point 7.1.1.2, Annex IIIA, point 9.1.1) Laboratory studies ‡
Parent Aerobic conditions Soil type Org.
carbon2
pH t. oC / moisture (%)
DT50 /DT90
(d)
DT50 (d) 20 °C pF2/10kPa
St.
Min χ2
Method of calculation
Loamy sand 2.3 6.0 (KCl) 20 oC/100 % FC 115/3823 115 1.8 SFO Sandy loam 2.4 7.1 (KCl) 20 oC/100 % FC 380/12623 380 1.1 SFO
Loam 1.0 7.2 (KCl) 20 oC/100 % FC 151/5013 151 0.9 SFO
Sand 0.6 7.4 (KCl) 20 oC/100 % FC 397/13183 397 2.1 SFO Sandy loam 3.2 7.41 25 oC/75 % FC 110/3653 133 4.5 SFO
Loamy sand 2.2 5.7 (CaCl2)
10 oC/40 % MWH
295/9793 135 1.7 SFO
Geometric mean/median 190/143 (n = 6) SFO
1 = based on average determinations on soil samples taken from the same location five years before the test started, no information on the measurement method
2 = calculated by the RMS
3 = calculated by the RMS by the equation DT90 = 3.32 x DT50
No metabolites requiring further consideration
Field studies ‡ field studies available, revised DT50 values not peer reviewed. *, **
pH dependence ‡
(yes / no) (if yes type of dependence)
No
Soil accumulaNon and plateau concentraNon ‡ No field accumulation studies
The plateau concentration (0.1301 mg/kg) was calculated to be achieved after 16 years (a 2-year rotation, 276 g as/ha) 1
1 = based on the worst case laboratory DT50 value of 412 days, as calculated in the original DAR; agreed by PRAPeR 22 as worst case
* Ctgb added from EFSA conclusion: The view of the experts was that as the study design of the treated seed potato trials represents the intended use applied for flutolanil, the derived DT50s can be considered appropriate for PECsoil calculations (see section 4.1.3). However, no agreement could be reached on the suitability of the use of the field DT50 derived from the available field trials for FOCUS modelling.
** Ctgb: study submitted for the Dutch application for authorisation evaluated by Alterra (report no. 10579-mil, November 2007). During evaluation, some values were rejected and the data set was improved by first
averaging DT50 values from the same soils). Individual values are: 152, 153, 171 (geomean of 140 and 208 d), 175 d (overall geomean normalised DT50 162 days, used for assessment of potato tuber treatment)
For the application for extension in the use of flower bulbs (spray application) another study (Ginzburg, 2007, only spray application) was submitted and evaluated (report no. 23495-mil, October 2010) resulting in two new values of 52 days (Amstenrade trial) and 49 days (Ubachsberg trial). Applicant submitted a new kinetic analysis (also summarized in Alterra 23495-mil) using only the spray applications, so combining the newly fitted results (Ottersum 114 days, Manningtree 64 days) for the spray applications from the studies evaluated in report no.
Monarch, 20200042 NLKUG 5 10579-mil (November 2007) with the newly submitted studies. This leads to a geomean normalised DT50 of 66 days (49, 52, 64 and 114 days) to be used for persistence and modelling assessment of spray applications.
Laboratory studies ‡
Parent Anaerobic conditions
Soil type Org.
matte r (%)3
pH t. oC / % MWHC
DT50 / DT90 (d) DT50 (d) 20 °C pF2/10kPa
St.
(r2)
Method of calculation
Sandy loam 1.8 6.1 25 o/* 4917**/- 6378***/-
N.a.**** N.a.**** ****
Geometric mean/median
* = Water saturated soil
** = Test concentration 5 mg/kg
*** = Test concentration 50 mg/kg
**** = The first order decline curve was calculated based on the concentrations of flutolanil as a percentage of recovered radioactivity. However, very little degradation was detected over the course of the study (after 365 days total amount of flutolanil 86 %) and the substance can be classified as stable in anaerobic conditions.
No metabolites requiring further consideration
Soil adsorption/desorption (Annex IIA, point 7.1.2) Parent ‡
Soil Type Org.
matter %
Soil pH Kd (mL/g)
Koc (mL/g)
Kf (mL/g)
Kfoc (mL/g)
1/n
Sand 0.2 6.5 - - 1.34 13401,3 1.164
Clay 2.4 6.7 - - 10.6 8831 0.909
Mississippi sediment 3.9 7.5 - - 10.3 5281 0.943
Clay loam 4.9 7.8 - - 16.0 6531 0.943
Sandy loam 6.2 6.1 - - 35.5 11501 0.980
Sand 0.3 8.0 (w) - - 0.996 5712,3 0.962
Loam 0.8 8.0 (w) - - 2.76 5942 0.855
Clay loam 4.9 7.4 (w) - - 13.0 4572 0.714
Clay loam 1.1 6.2 (w) - - 4.02 6282 0.901
Loamy sand 2.7 4.8 (w) - - 15.8 10052 0.926
Arithmetic mean/median/geometric mean 7814/641/735 0.93/0.935
/0.924
pH dependence, Yes or No No
1 = assuming organic matter (%) = 2.0 x organic carbon (%) 2 = assuming organic matter (%)= 1.72 x organic carbon (%)
3 = these values were omitted in PECgw modelling due to their low organic matter content
4 = the arithmetic mean value used in PECgw modelling (683, n = 8) was calculated assuming organic matter = 1.724 x organic carbon
3 X This column is reserved for any other property that is considered to have a particular impact on the degradation rate.
No metabolites requiring further consideration
Mobility in soil (Annex IIA, point 7.1.3, Annex IIIA, point 9.1.2)
Column leaching ‡ Eluation (mm): 200 mm
Time period (d): 2 d
Leachate: less than 0.24 % total residues/radioactivity in leachate
The radioactivity of soil column was not analyzed.
Aged residues leaching ‡ After 8 months of aging flutolanil still accounted for 84
% of the extracted radioactivity. Thus it was considered inappropriate to continue the experiment and the study was found unnecessary.
Lysimeter/ field leaching studies ‡ Not considered necessary
Route and rate of degradation in water (Annex IIA, point 7.2.1) Hydrolytic degradation of the active substance and
metabolites > 10 % ‡
Photolytic degradation of active substance and metabolites above 10 % ‡
Stable to hydrolysis (pH 5-9: at the end of a 30-day study recovery of applied radioactivity 103-108 %, flutolanil accounted for 98.3-99.5 %, no hydrolysis products were observed)
DT50: 277 d (SFO, r2 = 0.812) No relevant metabolites Xenon arc lamp, 30 d Quantum yield of direct phototransformation in
water at Σ > 290 nm
N.a.
Readily biodegradable ‡ (yes/no)
No (the change of BOD/28 days was 0 %)
Degradation in water / sediment
Parent Distribution (max in water 96.8-97.8 % after 0.25 d. Max. sed 34.0-68.7 % after 30 d) Water /
sediment system
pH water phase
pH sed
t. oC DT50-DT90
whole sys.
St.
(r2)
DT50- DT90
water St.
(r2)
DT50- DT90
sed St.
(r2)
Method of calculation
Pond, NL 8.31- 7.02
7.3 20 90-299 0.987 53-176 0.878 n.a. n.a. SFO
n.a. n.a. 25-274 0.984 n.a. n.a. SQRT 1. order Ditch, NL 7.21-
6.52
6.7 20 244-811 0.956 33-110 0.623 n.a. n.a. SFO
543-5992 0.952 n.a. n.a. n.a. n.a. SQRT 1. order n.a. n.a. 3.4-92 0.911 n.a. n.a. SQRT 1.5 order Geometric mean/median 148-492 /
167-555 (n=2)
42-139 / 43-143 (n=2)
SFO
1 = before study start
Monarch, 20200042 NLKUG 7 2 = study end
No metabolites requiring further consideration
Mineralization and non extractable residues Water /
sediment system
pH water pH sed Mineralization
x % after n d. (end of the study)
Non-extractable residues in sed. max x % after n d (end of the study) Pond, NL 8.31-7.02 7.3 5.2 % after 105 d 26.3 % after 105 d
Ditch, NL 7.21-6.52 6.7 3.7 % after 105 d 15.1 % after 105 d 1 = before study start
2 = study end
PEC (ground water) (Annex IIIA, point 9.2.1) Method of calculation and type of study (e.g.
modelling, field leaching, lysimeter )
For FOCUS gw modelling, values used – Model(s) used:
FOCUS PRZM V2.4.1 and FOCUS PEARL V3.3.3:
Scenarios: Chateaudun, Hamburg, Jokioinen,
Kremsmünster, Okehampton, Piacenza, Porto, Sevilla, Thiva
Crop: Potatoes
DT50, parent: 190 d (geometric mean, n=6, ModelMaker optimization and normalisation to pF2, 20 oC with Q10 of 2.2) *
Kfoc, parent: 683 L/kg (arithmetic mean, n=8, the sand soils were omitted from the calculations due their low organic matter content) 1/n= 0.896
Metabolites: No metabolites requiring further consideration
Lysimeter or field leaching studies were not carried out.
Application rate Application rate: 276 g/ha (potato seed planting rate 3000 kg/ha, incorporation depth 20 cm)
No. of applications: 1 application/2 years (a 2-year crop rotation period)
Time of application: the date of planting for PEARL, 15 days pre-emergence for PRZM (January-May)
* Ctgb: for spray application (extension to flower bulbs, 20090949 UG) a geomean normalised field DT50 of 66 days was derived (Ginzburg, 2007, evaluated in Alterra 23495-mil) and used for groundwater modelling
Fate and behaviour in air (Annex IIA, point 7.2.2, Annex III, point 9.3)
Direct photolysis in air ‡ No data available (flutolanil has a low vapour pressure, 4.7 x 10-8, and as such its concentration in the
atmosphere is likely to be negligible)
Quantum yield of direct phototransformation No data available (flutolanil is not susceptible to direct phototransformation and therefore it is not possible to determine the quantum yield)
Photochemical oxidaNve degradaNon in air ‡ Half-life: 0.114 days (a day:12 hours of sunlight), 0.057 days (a day: 24 hours of sunlight)
(The concentration of OH radicals 9.5 x 105)
(These estimations were carried out with respect to the OH-radical reaction, only.)
VolaNlisaNon ‡ Not available
Metabolites None
Residues requiring further assessment Environmental occurring metabolite requiring further assessment by other disciplines (toxicology and ecotoxicology).
Soil: flutolanil
Surface water: flutolanil Sediment: flutolanil Ground water: flutolanil Air: flutolanil
Monitoring data, if available (Annex IIA, point 7.4)
Soil (indicate location and type of study) No data provided - none requested Surface water (indicate location and type of study) No data provided - none requested Ground water (indicate location and type of study) No data provided - none requested Air (indicate location and type of study) No data provided - none requested
Points pertinent to the classification and proposed labelling with regard to fate and behaviour data Not readily biodegradable, R53
Also an additional kinetic evaluation [Hardy and Patterson, 2010] of the water/sediment study [Wyss-Benz, 1993] was submitted. This water/sediment study was according to GLP, and accepted by the RMS. The kinetic analysis was performed according to FOCUS kinetics, statistics and visual fits were good/excellent. Ctgb agrees on the evaluation. DT50 value for modelling is 146 days (geomean, n=2).
Appendix A: Metabolite names, codes and other relevant information of the pesticide Monarch with a.s. flutolanil.
The compounds shown below were found in one or more studies involving the metabolism and/or environmental fate of flutolanil. The parent compound structure of flutolanil is shown first in this list and followed by degradate or related compounds.
Compound name
IUPAC name Structural formula
Structure Mole-
cular mass [g/mol]
Observed in study (% of occurrence/
formation) Flutolanil α,α,α-
trifluoro-3’- isopropoxy- o-toluanilide
C17H16F3NO2 323.3 parent
No major metabolites identified
CONH
CF3 OCH(CH3)2
Monarch, 20200042 NLKUG 9
6.1 Fate and behaviour in soil 6.1.1 Persistence in soil
Article 2.8 of the Plant Protection Products and Biocides Regulations (RGB) describes the
authorisation criterion persistence. If for the evaluation of the product a higher tier risk assessment is necessary, a standard is to be set according to the MPC-INS4 method. Currently this method equals the method described in the Technical Guidance Document (TGD). Additional guidance is presented in RIVM5-report 601782001/20076.
Preceding the harmonisation of the persistence assessment in The Netherlands with regulation 1107/EG, the EU approach for persistence assessment is followed.
For the current application this means the following:
Active substance flutolanil:
The following laboratory DT50 values are available for the active substance flutolanil: 115, 380, 151, 397, 133, 135 days (geomean 190 days, n=6).
There are no major soil metabolites.
Due to the exceeding of the threshold value of 60 days for the mean DT50 (lab) for flutolanil, it must be demonstrated by means of field dissipation studies that the field DT50 is < 90 days. The DT50 values derived from field data in the DAR were under discussion in PRAPeR 22. The new values (not yet in updated List of Endpoints) are not EU peer reviewed. However, for the Dutch application for authorisation, a report of Hardy & Pattel7 was submitted. This report is evaluated by Alterra and (after evaluation, some values were rejected and the data set was improved by first averaging DT50
values from the same soils) yields a geomean normalised (to 20 °C assuming a Q10 of 2.2) field DT50
value for use in tuber treatment of 171 days (geomean of: 152, 153, 208, 175 d).
Based on the above, the proposed application of the pesticide Monarch as tuber treatment does not meet the standards for persistence as laid down in the RGB. Therefore an additional ecotoxicological assessment is needed based on the PECplateau summed up with the PIEC from one season.
For the previous application for extension of the authorisation of Monarch (13144N, 12-08-2011), new studies were submitted consisting solely of spray applications. These were evaluated in report Alterra-23495 (October 2010) and yielded two new representative normalised half-lives of 52 days (Amstenrade trial) and 49 days (Ubachsberg trial). This report also recalculated the earlier derived values for Ottersum (114 days) and Manningtree (64 days) trials. Alterra recommended to use only the endpoints derived from trials with spray applications (hence leaving out the earlier endpoints for trials with tuber treatment). Non-normalised values are not available. Therefore, for the current spray applications, the geometric mean of the four field-spray DT50 values is 66 days.
4 INS: international and national quality standards for substances in the Netherlands.
5 RIVM: National institute of public health and the environment.
6 601782001/2007: P.L.A. van Vlaardingen and E.M.J. Verbruggen, Guidance for the derivation of environmental risk limits within the framework of 'International and national environmental quality standards for substances in the Netherlands' (INS). Revision 2007’.
7 I.A.J. Hardy & M. Patel. XG/06/002B “Flutolanil: kinetic modelling analysis of data from a field soil dissipation study at four locations in Europe”
From the results it is shown that the mean field DT50 is < 90 days when flutolanil is applied as a spray.
Hence the substance meets the standards for persistence and no higher tier assessment is deemed necessary.
Based on the above, the proposed spray applications of the pesticide Monarch meet the standards for persistence as laid down in the RGB and the applications as tuber treatment do not meet the standards for persistence as laid down in the RGB.
PECsoil
The concentration of the active substance flutolanil in soil is needed to assess the risk for soil
organisms (earthworms, micro-organisms). The PECsoil is calculated for the upper 5 cm of soil using a soil bulk density of 1500 kg/m3.
For the glasshouse use in cutflowers exposure of soil organisms is not relevant. Greenhouse soils are not considered as natural soils therefore the a soil assessment is not required. Additionally, since flutalonil is not persistent a PECplateau is not required.
6.1.2 Leaching to shallow groundwater
Article 2.9 of the Plant Protection Products and Biocides Regulations (RGB) describes the authorisation criterion leaching to groundwater.
The leaching potential of the active substance flutolanil is calculated in the first tier using Pearl 4.4.4 and the FOCUS Kremsmünster scenario. Input variables are the actual worst-case application rate 2.76 kg/ha, the crop winter cereals (wost case surrogate for cut flowers), seven crop cycles (approximately every 1,5 month) and no interception. The initial date of yearly application is May 25th for greenhouse applications. The other applications were on 11 July, 27 August, 13 October, 30 November, 15 January and 03 March. The application type applied was to the soil surface.
PEARL:
Geometric mean field DT50 for degradation in soil (20C): 66 days Arithmetic mean Kom (pH-independent): 396.2 L/kg
Arithmetic mean 1/n: 0.896
Saturated vapour pressure: 4.1x10-7 Pa (20 °C) Solubility in water: 8.01 mg/L (20 °C)
Molecular weight: 323.3 g/mol
Plant uptake factor: 0.5 (systemic substance) Q10: 2.2
Other parameters: standard settings of PEARL 4.4.4
The following concentrations are predicted for the active substance flutolanil following the realistic worst case GAP, see Table M.2.
Monarch, 20200042 NLKUG 11 Table M.2 Leaching of active substance flutolanil as predicted by PEARL 4.4.4
Use Substance Rate
substance [kg/ha]
Frequency/
Interval [days]
Fraction Intercepted
*
PEC
groundwater [µg/L]
spring
Cut flowers (G) (7 crop cycli, interval 1,5 month, broadcast application)
Flutolanil 2.76 1/- 0 0.006
* as a worst case no interception was applied for the PECgw calculations
Results of Pearl 4.4.4 using the Kremsmünster scenario are examined against the standard of 0.01 µg/L. This is the standard of 0.1 µg/L with an additional safety factor of 10 for vulnerable
groundwater protection areas (NL-specific situation).
From Table M.2 it reads that the expected leaching based on the PEARL-model calculations for the active substance flutolanil is small than 0.01 µg/L.
The application meets the standards for leaching. Therefore, no further study into the leaching behaviour is necessary. Hence, the active substance meets the standards laid down in the RGB for the proposed application.
Conclusions
The active substance flutolanil (when used as spray application) complies with the requirements laid down in the RGB concerning persistence in soil.
The proposed application of the product complies with the requirements laid down in the RGB concerning leaching in soil.
6.2 Fate and behaviour in water
6.2.1 Rate and route of degradation in surface water
Article 2.10c of the Plant Protection Products and Biocides Regulations (RGB) prescribes the use of Dutch specific drift percentages.
The exposure concentrations of the active substance flutolanil in surface water have been estimated for the various proposed uses using calculations of surface water concentrations (in a ditch of 30 cm depth), which originate from spray drift during application of the active substance. The spray drift percentage depends on the use. For greenhouse uses 0.1% emission percentage is applied as pseudo drift percentage. The seven crop cycli were evaluated in TOXSWA by every 50 days an application.
Concentrations in surface water are calculated using the model TOXSWA. The following input data are used for the calculation:
TOXSWA:
Active substance flutolanil:
Geometric mean DT50 for degradation in water at 20°C: 146 days (geomean (n=2), kinetic analysis (see LoEP))
DT50 for degradation in sediment at 20°C: 1000 days (default).
Arithmetic mean Kom for suspended organic matter: 396.2 L/kg Arithmetic mean Kom for sediment: 396.2 L/kg
Arithmetic mean 1/n: 0.896
Saturated vapour pressure: 4.1*10-7 Pa (20 °C) Solubility in water: 0.00801 g/L (20 °C)
Molecular weight: 323.3 g/mol Q10: 2.2
Other parameters: standard settings TOXSWA
When no separate degradation half-lives (DegT50 values) are available for the water and sediment compartment (accepted level P-II values), the system degradation half-life (DegT50-system, level P-I) is used as input for the degrading compartment and a default value of 1000 days is to be used for the compartment in which no degradation is assumed. This is in line with the recommendations in the FOCUS Guidance Document on Degradation Kinetics.
Table M.3. Overview of surface water concentrations for active substance flutolanil and in the edge- of-field ditch following spring and autumn application
Use Substance Rate
a.s.
[kg/ha]
Freq./
Interval
Drift [%]
PIEC [µg/L] *
PEC21 [µg/L] *
PEC28 [µg/L] *
spring spring spring
Cut flowers (G) (7 crop cycli, interval 50 days, broadcast application)
Flutolanil 2.76 1/- 0.1% 1.327 1.001 0.932
* calculated according to TOXSWA
The exposure concentrations in surface water are compared to the ecotoxicological threshold values in section 7.2.
6.5 Data requirements none
The following restriction sentences were proposed by the applicant:
-
Based on the current assessment, the following has to be stated in the GAP/legal instructions for use (WG):
-
6.6 Overall conclusions fate and behaviour It can be concluded that:
1. the active substance flutolanil meets the standards for persistence in soil as laid down in the RGB, when used as spray application.
2. all proposed application of the active substance flutolanil meets the standards for leaching to the shallow groundwater as laid down in the RGB.
7 Ecotoxicology
Conclusion with respect to comparability
The risk of the applied use in field in flower bulbs and flower tubers, Cut flowers (soil-bound), forced shrubs, cut green, ornamental shrubs, perennial crops, flower seed crops is equal to or lower than the risk of the authorised uses with regard to the environment for all aspects (aquatic organisms,
Monarch, 20200042 NLKUG 13 birds and mammals, bees and bumblebees, non-target arthropods, earthworms, soil micro-
organisms, activated sludge and non-target plants).
The risk of the use applied for in greenhouse uses in Cut flowers (soil-bound), forced shrubs, cut green, ornamental shrubs, perennial crops, flower seed crops is not included in the risk envelope for the aspects Non-target arthropods ( all uses need a check on IPM warning sentence), and all soil and water related aspects (soil bound use in cut flowers, see conclusion fate). For these aspects a separate risk assessment is required.
Risk assessment is done in accordance with Chapter 2 of the RGB published in the Government Gazette (Staatscourant) 188 of 28 September 2007, including the updates of 20 October 2009 (which came into effect on 1 January 2010) and 18 April 2011 (which came into effect on 23 April 2011).
For the current risk assessment, the final List of Endpoints from the EFSA-conclusion for flutolanil is used (EFSA Scientific report on flutolanil (2008) 126; 1-63 (d.d. 3 March 2008)). In addition, a study on toxicity to sediment organisms evaluated by CTGB has been used in the previous assessment for Monarch.
List of Endpoints Ecotoxicology
Explanation of codes: EXP10066A = Monarch = Flutolanil 40SC = 460 g flutolanil/L
Effects on terrestrial vertebrates (Annex IIA, point 8.1, Annex IIIA, points 10.1 and 10.3)
Species Test substance Time scale End point
(mg/kg bw/day)
End point (mg/kg feed)
Birds ‡
Bobwhite quail a.s. Acute LD50 > 2000
Mallard duck a.s. Acute LD50 > 2000
Preparation Acute - -
Metabolite 1 Acute - -
Bobwhite quail a.s. Short-term LD50 > 961 LC50 > 5243 Mallard duck a.s. Short-term LD50 = 1249 LC50 > 5243
Bobwhite quail a.s. Long-term NOEL = 247 NOEC = 1920
Mallard duck a.s. Long-term NOEL = 267 NOEC = 1920
Mammals ‡
Rat a.s. Acute LD50 > 10000
Preparation Acute -
Metabolite 1 Acute -
Rat a.s. Long-term NOEL = 157 NOEC = 2000
AddiNonal higher Ner studies ‡: Not required
Toxicity data for aquatic species (most sensitive species of each group) (Annex IIA, point 8.2, Annex IIIA, point 10.2)
Group Test substance Time-scale
(Test type)
End point Toxicity1 (mg/L) Laboratory tests ‡
Fish
Salmo gairdneri Technical flutolanil
96 h (static) Mortality, LC50 5.4 (mm) Lepomis macrochirus 96 h (static) Mortality LC50 > 5.4 (mm)
Pimephales promelas 96 h (static) Mortality LC50 4.8 (mm)
Pimephales promelas 30 d (flow-
through)
Growth NOEC 0.233 (mm) Aquatic invertebrate
Daphnia magna Technical flutolanil
48 hr (static)
Mortality EC50 > 6.8 (mm)
Daphnia magna 21 d
(semistatic)
Reproduction NOEC
0.53 (mm) Sediment dwelling organisms
Not conducted, not required
Algae Selenastrum capricornuntum
Technical flutolanil
72 h (static) Biomass: EbC50
Growth rate: ErC50
NOEC
0.97 (mm)
>3.2 (mm) 0.18 Pseudokirchneriella
subcapitata (formerly Selenastrum
capricornuntum)
Flutolanil 40SC 72 h (static) Growth rate: ErC50
NOEC
12.3 (a.s., nom)
<0.41 (a.s., nom) Higher plant
Not conducted, not required Microcosm or mesocosm tests Not required
1 indicate whether based on nominal (nom) or mean measured concentrations (mm). In the case of preparations indicate whether end points are presented as units of preparation or a.s.
No studies on the toxicity of the product EX10066 or metabolites to aquatic organisms.
Study submitted with application 20110408 THG of Monarch:
Group Test substance Time-scale
(Test type)
End point Toxicity1 (mg/L) Sediment dwelling organisms
Chironomus riparius Technical flutolanil
28 d (static) Reproduction NOEC 1 (nom)
Monarch, 20200042 NLKUG 15 Bioconcentration
Active substance Metabolites2
logPO/W 3.17 _
Bioconcentration factor (BCF)1 ‡ 100* -
Annex VI Trigger for the bioconcentration factor
100 (for not readily biodegradable substances)
-
Clearance time (days) (CT50) 0.46 d -
(CT90) - -
Level and nature of residues (%) in organisms after the 14 day depuration phase
None detected -
1 only required if log PO/W >3.
2 no studies on metabolites, not required
* based on 14C-flutolanil
Effects on honeybees (Annex IIA, point 8.3.1, Annex IIIA, point 10.4)
Test substance Acute oral toxicity
(LD50 µg/bee)
Acute contact toxicity (LD50 µg/bee)
a.s. ‡ > 208.7 > 200
Preparation1 - -
Metabolite1 - -
Field or semi-field tests
No data is submitted nor required, because the laboratory toxicity of flutolanil to honey bees is low and no risk is anticipated.
1 No studies on the effects of the product EX10066 or metabolites on honey bees, not required Effects on other arthropod species (Annex IIA, point 8.3.2, Annex IIIA, point 10.5)
Laboratory tests with standard sensitive species
The tests were performed using two dose rates (according to ESCORT 1). Thus the results could not be used to derive the LR50 or HQ values. Besides, HQ approach is validated for spray application, not seed treatment.
Species Test
Substance
End point Effect (LR50 g/ha1)
Typhlodromus pyri ‡ Mortality -
Aphidius rhopalosiphi ‡ Mortality -
1 for preparations indicate whether end point is expressed in units of a.s. or preparation
Further laboratory and extended laboratory studies ‡ Species Life stage Test
substance, substrate and duration
1
Dose (g a.s/ha)
End point % Adver- se effect2
TRigger value
Aphidius Rhopalosiphi
Adult
females, < 48 h
EXP10066A (464 g/L), Glass plate
450 (initial residues)
Mortality Reproduction
2.5 0
50 %
Aphidius Rhopalosiphi
Adult
females, < 48 h
EXP10066A (464 g/L), Glass plate
4500 (initial residues)
Mortality Reproduction
2.5 +31
50 %
Typhlodromu s pyri
Protonymph to adult
EXP10066A (464 g/L), Glass plate
450 (initial residues)
Mortality Reproduction
-2.1 +6
50 %
Typhlodromu s pyri
Protonymph to adult
EXP10066A (464 g/L), Glass plate
4500 (initial residues)
Mortality Reproduction
1.1 +5
50 %
Poecilus cupreus
Adult (approx. 6 week old)
EXP10066A (464 g/L), Quartz sand
450 4500 (initial residues)
Mortality 0 6.7
50 %
Pardosa sp. EXP10066A
(464 g/L), Quartz sand
450 4500 (initial residues)
Mortality 0 6.7
50 %
Aleochara bilineata
Adult
(1-3 days old)
EXP10066A (454 g/L), Quartz sand
600 4500
Reproduction 2.2 42.7
50 %
Aleochara bilineata
Adult
(1-4 days old)
EXP10066A (458 g/L), (natural soil)
4500 7800 11200
Reproduction 20.3 15.2 21.9
50 %
Field or semi-field tests
No data submitted nor required
1 Test substance EXP10066A = Monarch
2 Adverse effect means:
x % effect on mortality = x % increase of mortality compared to control
y % effect on a sublethal parameter = y % decrease of sublethal paramether compared to control (sublethal parameters are e.g. reproduction, parasitism, food consumption)
When effects are favourable for the test organisms, a + sign is used for the sublethal effect percentages (i.e. increase of e.g. reproduction) and a – sign for mortality effect percentages (i.e.
decrease of mortality).
Effects on earthworms, other soil macro-organisms and soil micro-organisms (Annex IIA points 8.4 and 8.5. Annex IIIA, points, 10.6 and 10.7)
Test organism Test substance Time scale End point Earthworms
a.s. ‡ Acute 14 days LC50, corr >500 mg a.s./kg d.w.soil
