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.
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.
* = 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 ‡
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 / Geometric mean/median 148-492 /
167-555
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 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 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.