Statement concerning the assessment of environmental fate and behaviour and ecotoxicology in the context of the pesticides peer review of the active substance dimoxystrobin

Abstract

In August 2022, the European Commission asked EFSA to provide a statement on the available outcomes of the assessment of environmental fate and behaviour and ecotoxicology drawn in the context of the pesticides peer review for the renewal of approval of the active substance dimoxystrobin conducted in accordance with Commission Implementing Regulation (EC) No 844/2012. The current statement contains the conclusions of the assessments related to environmental fate and behaviour and ecotoxicology finalised following the pesticides peer review expert discussions held in January and June 2022. The concerns identified are presented.

Summary

Dimoxystrobin is an active substance covered by the third stage of the renewal programme for pesticides (‘AIR3’) in accordance with Commission Implementing Regulation (EU) No 844/2012.

An application for the renewal of approval of the active substance dimoxystrobin followed by the submission of the supplementary dossiers in July 2015 was made by BASF SE to the rapporteur Member State (RMS), Hungary, and the co‐rapporteur Member State (co‐RMS), Ireland.

An initial evaluation of the dossiers was provided by the RMS in the Renewal Assessment Report (RAR) which was submitted to EFSA in September 2017. Subsequently, EFSA initiated a peer review of the pesticides risk assessment on the RMS evaluation in line with the provisions of Commission Implementing Regulation (EU) No 844/2012.

Following the completion of a commenting period, including a public consultation on the RAR, EFSA requested the applicant to provide certain additional information under the stop the clock procedure in accordance with Article 13(3) of Regulation (EU) No 844/2012, which was evaluated by Hungary and incorporated into an updated RAR. Subsequently, in January 2022, meetings of experts from EFSA and Member States took place to discuss certain elements related to mammalian toxicology, environmental fate and behaviour and ecotoxicology. In addition, in June 2022, follow‐up meetings of experts from EFSA and Member States took place to further discuss elements related to mammalian toxicology and ecotoxicology.

In August 2022, prior to completion of the peer review process, EFSA was mandated by the European Commission to provide a statement on the available outcomes of the assessment of environmental fate and behaviour and ecotoxicology drawn in the context of the peer review of dimoxystrobin.

The present statement contains the finalised conclusions of the assessments related to environmental fate and behaviour and ecotoxicology following the pesticides peer review expert discussions in those areas held in January and June 2022.

The data available on environmental fate and behaviour were sufficient to carry out the required environmental exposure assessments at EU level for the representative uses. A critical area of concern with respect to point 3.10 of Annex II to Regulation (EC) No 1107/2009 was identified in relation to the potential for groundwater contamination by the relevant metabolites.

In the area of ecotoxicology, a high risk was identified for aquatic organisms leading to a critical area of concern. In addition, the risk assessment for honeybee larvae could not be finalised.

1. Introduction

Dimoxystrobin is an active substance covered by the third stage of the renewal programme for pesticides (‘AIR3’) in accordance with Commission Implementing Regulation (EU) No 844/2012 ¹ .

Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659 ² (hereinafter referred to as ‘the Regulation’), lays down the provisions for the procedure of the renewal of the approval of active substances, submitted under Article 14 of Regulation (EC) No 1107/2009 ³ . This regulates for the European Food Safety Authority (EFSA) the procedure for organising the consultation of Member States, the applicant(s) and the public on the initial evaluation provided by the rapporteur Member State (RMS) and/or co‐rapporteur Member State (co‐RMS) in the renewal assessment report (RAR), and the organisation of an expert consultation where appropriate.

In accordance with Article 13 of the Regulation, unless formally informed by the European Commission that a conclusion is not necessary, EFSA is required to adopt a conclusion on whether the active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009 within 5 months from the end of the period provided for the submission of written comments, subject to an extension of an additional 3 months where additional information is required to be submitted by the applicant(s) in accordance with Article 13(3). Furthermore, in accordance with Article 13(3a), where the information available in the dossier is not sufficient to conclude the assessment on whether the approval criteria for endocrine disruption are met, additional information can be requested to be submitted in a period of minimum 3 months, not exceeding 30 months, depending on the type of information requested.

In accordance with Article 1 of the Regulation, an application for the renewal of approval of the active substance dimoxystrobin followed by the submission of the supplementary dossiers in July 2015 was made by BASF SE to the rapporteur Member State (RMS), Hungary, and the co‐rapporteur Member State (co‐RMS), Ireland. The RMS provided its initial evaluation of the dossier on dimoxystrobin in the RAR, which was received by EFSA on 1 September 2017 (Hungary, 2017).

In accordance with Article 12 of the Regulation, EFSA distributed the RAR to the Member States and the applicant, BASF SE, for consultation and comments on 21 February 2019. EFSA also provided comments. In addition, EFSA conducted a public consultation on the RAR. EFSA collated and forwarded all comments received to the European Commission on 26 April 2019. At the same time, the collated comments were forwarded to the RMS for compilation and evaluation in the format of reporting table. In addition, the applicant was invited to respond to the comments received. The comments and the applicant's response were evaluated by the RMS in column 3 of the reporting table.

The need for expert consultation and the necessity for additional information to be submitted by the applicant in accordance with Article 13(3) of the Regulation were considered in a telephone conference between EFSA and the RMS on 17 July 2019. On the basis of the comments received, the applicant's response to the comments and the RMS's evaluation thereof, it was concluded that additional information should be requested from the applicant, and that EFSA should conduct an expert consultation in the areas of mammalian toxicology, environmental fate and behaviour and ecotoxicology, which took place in January 2022.

In addition, in June 2022, follow‐up meetings of experts from EFSA and Member States took place to further discuss elements related to mammalian toxicology and ecotoxicology.

Although the peer review process is not fully completed, with the assessment of the endocrine disruption properties according to point 3.8.2 of Annex II to Regulation (EC) No 1107/2009 remaining pending, all other aspects of the risk assessment are considered finalised. Likewise, the assessment concerning environmental fate and behaviour and ecotoxicology has been completed following the expert discussions in those areas. Subsequently, during the drafting of the EFSA Conclusion, EFSA informed the Commission that critical areas of concern have been identified for dimoxystrobin in those areas.

In this context, on 12 August 2022, prior to completion of the peer review process, EFSA was requested by the European Commission to provide a statement containing the available outcomes of the assessment related to environmental fate and behaviour and ecotoxicology. Given the critical concerns identified, a request in accordance with Commission Implementing Regulation (EU) No 2018/1659, to be able to conclude whether the approval criteria for endocrine disruption in line with the scientific criteria for the determination of endocrine‐disrupting properties, as laid down in Commission Regulation (EU) 2018/605 ⁴ , are met, seems also not justified.

Based on that mandate, EFSA prepared a draft statement in September 2022 summarising the conclusions of the assessment of environmental fate and behaviour and ecotoxicology as finalised following the expert discussions held in January and June 2022 in the context of the peer review of the renewal of the approval of the active substance and the representative formulation, evaluated on the basis of the representative uses of dimoxystrobin as a fungicide on oilseed rape and sunflower, as proposed by the applicant.

The draft statement was circulated to all Member States for commenting via a written procedure. A list of the relevant end points for the active substance and the formulation is provided in Appendix B. In addition, the considerations as regards some of the cut‐off criteria for dimoxystrobin according to Annex II of Regulation (EC) No 1107/2009 are summarised in Appendix A.

A key supporting document to this statement is the peer review report (EFSA, 2022), which is a compilation of the documentation developed to evaluate and address all issues raised in the course of the peer review of the renewal of the active substance dimoxystrobin, from the initial commenting phase to the preparation of this statement. For reasons of completeness and transparency, the peer review report comprises all background documents, which were developed and finalised during the ongoing renewal process up to the production of the present statement and relate to all sections of the risk assessment, as follows:

• the comments received on the RAR;

• the reporting tables (22 July 2019);

• the evaluation tables (September 2022);

• the reports of the scientific consultation with Member State experts (where relevant);

• the comments received on the assessment of the additional information (where relevant);

• the comments received on the draft EFSA statement.

Given the importance of the RAR, including its revisions prepared up to the revision required following the expert consultations (Hungary, 2022), and the peer review report, both documents are considered as background documents to this statement and thus are made publicly available.

It is recommended that this statement and its background documents would not be accepted to support any registration outside the EU for which the applicant has not demonstrated that it has regulatory access to the information on which this statement is based.

1.1. Background and terms of reference as provided by the requestor

EFSA was mandated by the European Commission on 12 August 2022 to provide a statement containing the available outcomes of the assessment related to environmental fate and behaviour and ecotoxicology drawn in the context of the pesticides peer review for the renewal of approval of the active substance dimoxystrobin conducted in accordance with Commission Implementing Regulation (EU) No 844/2012. Given the critical concerns identified during the peer review, a request for additional information in accordance with Article 13(3a) of Regulation (EU) No 844/2012, to obtain information on endocrine disrupting properties, seems also not justified.

Although the peer review process is not yet fully completed, with the assessment of the endocrine disruption properties according to point 3.8.2 of Annex II to Regulation (EC) No 1107/2009 remaining pending, the assessment concerning environmental fate and behaviour and ecotoxicology has been finalised following the expert discussions held in January and June 2022 in those areas. During the drafting of the EFSA Conclusion the Commission was informed by EFSA that critical areas of concern have been identified for dimoxystrobin in those areas. The approval of dimoxystrobin expires on 31 January 2023 following several extensions in accordance with Article 17 of Regulation (EC) No 1107/2009. A further extension should be avoided if it is already clear that the approval criteria laid down in Regulation (EC) No 1107/2009 are not satisfied.

EFSA was requested to complete this mandate by 30 September 2022.

The active substance and the formulated product

Dimoxystrobin is an ISO common name for (2 E)‐2‐{2‐[(2,5‐dimethylphenoxy)methyl]phenyl}‐2‐(methoxyimino)‐N‐methylacetamide (IUPAC).

The representative formulated product for the evaluation was ‘BAS 540 01F’, a suspension concentrate (SC) containing 200 g/L dimoxystrobin and 200 g/L boscalid.

The representative uses evaluated were hydraulic foliar spray application on oilseed rape and sunflower as a fungicide against a broad range of pathogens. Full details of the good agricultural practices (GAPs) can be found in the list of end points in Appendix B.

Data were submitted to conclude that the uses of dimoxystrobin according to the representative uses proposed at EU level result in a sufficient fungicidal efficacy against the target pathogens, following the guidance document SANCO/2012/11251‐rev. 4 (European Commission, 2014b).

2. Assessment

2.1. Mammalian toxicity in relation to groundwater metabolites

The toxicological profile of the active substance dimoxystrobin and its metabolites was discussed at the Pesticides Peer Review Experts' Teleconference 70 in January 2022 and at the Pesticides Peer Review Experts' Teleconference 78 in June 2022. ⁵ The assessment of groundwater metabolites for their relevance was based on the following guidance document: European Commission, 2003.

Dimoxystrobin has harmonised classification according to Regulation (EC) No 1272/2008 ⁶ as Carc. Cat. 2, H351 (‘Suspected of causing cancer’) and Repr. Cat. 2, H361d (‘Suspected of damaging the unborn child’). Metabolites 505M08 and 505M09 are unlikely to be genotoxic. Available data demonstrate that metabolites 505M08 and 505M09 do not share the carcinogenic properties of the parent compound; however, this is not the case for the reproductive toxicity properties of the parent. Consequently, they are considered as toxicologically relevant groundwater metabolites (see also Section 2.2). Metabolite 505M01 is considered unlikely to be mutagenic and clastogenic; however, aneugenicity has not been investigated (outstanding data gap). Data are missing to demonstrate that the metabolite 505M01 does not share the carcinogenicity and reproductive toxicity properties of the parent. Consequently, metabolite 505M01 has to be considered as toxicologically relevant groundwater metabolite (see also Section 2.2).

2.2. Environmental fate and behaviour

Dimoxystrobin was discussed at the Pesticides Peer Review Experts' Teleconference 71 in January 2022.

Dimoxystrobin test substance used in fate and behaviour studies included low amounts of Z‐isomer; however, the Z‐isomer remained at low levels in all environmental compartments. The sum of both isomers (E and Z) was considered for the environmental exposure assessment.

The rates of dissipation and degradation in the environmental matrices investigated were estimated using FOCUS (2006) kinetics guidance. In soil laboratory incubations under aerobic conditions in the dark, dimoxystrobin exhibited high persistence, forming the major (> 10% applied radioactivity (AR)) metabolite 505M09 (max. 13% AR, moderate to high persistence in soil) and metabolite 505M08 (> 10% of the initially measured dimoxystrobin in 0–10 cm soil layer in field studies, moderate to high persistence in soil). Mineralisation to carbon dioxide accounted for 15% AR after 119 days for the benzyl ring ¹⁴C radiolabel and for 25% AR after 122 days for the phenyl ¹⁴C radiolabel. The formation of unextractable residues accounted for 24% AR and 25% AR after 119 and 122 days for the benzyl and the phenyl ¹⁴C radiolabels, respectively. In anaerobic soil incubations, dimoxystrobin was essentially stable. In laboratory soil photolysis studies, dimoxystrobin degraded more rapidly than in the dark control forming the major metabolite 505M01 (max. 11% AR), which exhibited low to moderate persistence under aerobic dark conditions. Dimoxystrobin exhibited medium to low mobility in soil. Metabolites 505M08 and 505M09 exhibited very high to high mobility, and 505M01 exhibited very high soil mobility. It was concluded that the adsorption of dimoxystrobin and metabolite 505M01 was not pH dependent, while the adsorption of metabolites 505M08 and 505M09 was pH dependent, with adsorption decreasing in alkaline soils. In satisfactory field dissipation studies carried out at four sites in Germany, three in Spain, one in Sweden, one in Italy, one in France and one in the UK, dimoxystrobin exhibited medium to high persistence in soil. Sample analyses were carried out for dimoxystrobin, 505M01, 505M08 and 505M09. These three metabolites were only determined sporadically above the limit of quantification precluding the derivation of formation and decline kinetic endpoints. Field study DegT50 values for parent dimoxystrobin were derived following normalisation to FOCUS reference conditions (20°C and pF2 soil moisture) following the EFSA (2014) DegT50 guidance. The field data endpoints were not combined with laboratory values to derive modelling endpoints as following the DegT50 guidance the laboratory and field values were considered to represent different populations.

In a lysimeter study of 2‐year duration, the mean annual concentration of dimoxystrobin was < 0.1 μg/L. Metabolites 505M08 and 505M09 were found to reach a maximum annual average concentration of 2.35 μg/L and 2.0 μg/L, respectively. No other known metabolites were detected in any leachate sample.

In laboratory incubations in dark aerobic natural sediment water systems, dimoxystrobin exhibited high to very high persistence, forming the major metabolite 505M96 (max. 10% AR in water exhibiting moderate persistence). The unextractable sediment fraction (not extracted by acetonitrile/water) accounted for 6–11% AR at study end (100 days) for the phenyl and benzyl ring ¹⁴C radiolabel. Mineralisation of this radiolabel accounted for only 0.8–2.1% AR at the end of the study. The rate of decline of dimoxystrobin in a laboratory sterile aqueous photolysis experiment was faster (low persistence) relative to that which occurred in the aerobic sediment water incubations. No chromatographically resolved component (excluding dimoxystrobin) accounted for > 8% AR.

The necessary surface water and sediment exposure assessments (predicted environmental concentrations (PEC) calculations) were carried out for the metabolites 505M08, 505M09, 505M01 and 505M96, using the FOCUS (FOCUS, 2001) step 1 and step 2 approach (version 3.2 of the Steps 1–2 in FOCUS calculator). For the active substance dimoxystrobin, appropriate step 3 (FOCUS, 2001) and step 4 calculations were available. ⁷ The step 4 calculations appropriately followed the FOCUS (FOCUS, 2007) guidance, with no‐spray drift buffer zones of up to 20 m being implemented for the drainage scenarios (representing a 57–92.5% spray drift reduction), and combined no‐spray buffer zones with vegetative buffer strips of up to 20 m (reducing solute flux in run‐off by 80% and erosion run‐off of mass adsorbed to soil by 95%) being implemented for the run‐off scenarios. The SWAN tool (version 5.0.1) was appropriately used to implement these mitigation measures in the simulations. However, risk managers and others may wish to note that whilst run‐off mitigation is included in the step 4 calculations available, the FOCUS (FOCUS, 2007) report acknowledges that for substances with K_Foc < 2,000 mL/g (i.e. dimoxystrobin), the general applicability and effectiveness of run‐off mitigation measures had been less clearly demonstrated in the available scientific literature, than for more strongly adsorbed compounds.

The necessary groundwater exposure assessments were appropriately carried out using FOCUS (European Commission, 2014a) scenarios and the models PEARL 4.4.4, PELMO 5.5.3 and MACRO 5.5.4 ⁷ for dimoxystrobin and its metabolites. The potential for groundwater exposure from the representative uses by dimoxystrobin above the parametric drinking water limit of 0.1 μg/L was concluded to be low in geoclimatic situations that are represented by all six FOCUS groundwater scenarios.

For the representative use on oilseed rape (early and late triennial applications), the 80th percentile annual average recharge concentrations leaving the 1 m soil layer were estimated to be > 0.1 μg/L at all of the six scenarios for metabolites 505M08 and 505M09 in both acidic and alkaline soils, and in one of six scenarios for metabolite 505M01.

For the representative use on sunflowers (triennial application), the 80th percentile annual average recharge concentrations leaving the 1 m soil layer were estimated to be > 0.1 μg/L at both of the FOCUS sunflower scenarios for metabolite 505M08 in both acidic and alkaline soils and for metabolite 505M09 in alkaline soils, and in one of these two scenarios for metabolite 505M09 in acidic soils, while concentrations leaving the 1 m soil layer were estimated to be < 0.1 μg/L at both of the scenarios for metabolite 505M01.

It should be noted that though concentrations in groundwater were > 0.75 μg/L for metabolites 505M08 and 505M09 as they are concluded as relevant at Step 3 of the applicable guidance (see Sections 2.1 and 2.5), the only concentration that needed to be assessed against was 0.1 μg/L.

A critical area of concern is identified (see Section 3.1.2) as relevant groundwater metabolites (see Sections 2.1 and 2.5) have been indicated to be above the parametric drinking water limit of 0.1 μg/L in annual average recharge concentrations leaving the top 1 m soil layers in geoclimatic conditions represented by all the pertinent FOCUS groundwater scenarios and in a relevant lysimeter, in the context of all the representative uses assessed and the whole range of soil pH conditions.

The applicant provided appropriate information to address the effect of water treatment processes on the nature of the residues that might be present in surface water and groundwater, when surface water or groundwater are abstracted for drinking water, though it should be noted that for groundwater metabolites 505M01, 505M08 and 505M09, concentrations will legally need to be below 0.1 μg/L in groundwater.

The PEC in soil, surface water, sediment and groundwater covering the representative uses assessed can be found in Appendix B of this statement. A key to the wording used to describe the persistence and mobility of the compounds assessed can be found in Appendix C of this statement.

2.3. Ecotoxicology

The risk assessment was based on the following documents: European Commission (2002), SETAC (2001), EFSA (2009, 2013) and EFSA PPR Panel (2013).

The representative formulation, ‘BAS 540 01 F’, contains a second active substance (i.e. boscalid) in the same proportion. In some cases, different formulations than the representative one were used in the ecotoxicity tests (‘BAS 540 00F’; ‘BAS 505 01F’, a solo‐formulation; and ‘BAS 507 00F’, the old representative formulation, which contains epoxiconazole as second active substance in lower proportion). Based on all the available information, bridging between the formulations ‘BAS 540 01 F’ and ‘BAS 540 00 F’ is supported and both formulations can be considered comparable.

Several aspects pertaining to the risk assessment of dimoxystrobin were discussed at the Pesticide Peer Review Experts' Teleconference 72 (January 2022) and at the Pesticides Peer Review Experts' Teleconference 79 in June 2022.

Suitable acute and long‐term ecotoxicity studies were available with dimoxystrobin with birds ⁸ and mammals. ⁹ Acute studies with the representative formulation were also available for both groups. A low acute and long‐term risk to birds and mammals was identified for all representative uses.

An assessment of the major plant metabolites of dimoxystrobin (i.e. 505M01, 505M08, 505M09, 505M93, 505M95, 505M96), to which birds and wild mammals can be exposed, was available in the RAR and the risk was considered as low. In addition, the risk to birds and mammals resulting from the exposure to contaminated water and the risk due to secondary poisoning were also concluded as low for all representative uses.

Acute toxicity data with the active substance were available for fish (three species) and aquatic invertebrates (on the standard species Daphnia magna, on Asellus aquaticus, and with the marine species Americamysis bahia and Crassostrea virginica). The aquatic invertebrate endpoints for A. aquaticus and on A. bahia were discussed at the experts' meeting. ¹⁰

Chronic toxicity data with the active substance were available for fish, aquatic invertebrates and algae. No reliable data were available for macrophytes.

Acute toxicity data with fish and aquatic invertebrates as well as chronic data for algae were available with the representative formulation.

In addition, acute toxicity data with other formulations (‘BAS 505 01 F’ and ‘BAS 507 00 F’) were also available with additional fish species. The reliability of several acute fish studies was discussed during the experts' meeting. ¹¹

The potential use of the fish acute toxicity data with formulations including a second active substance in a refinement at Tier 2 was also discussed at the experts' meeting. ¹² It was agreed that data from formulation with another active substance should not be used in Tier 2 assessment since the presence of another active substance would add uncertainty to the calculation. Therefore, only data on the active substance and the solo‐formulation were considered at Tier 2, using the geomean approach; the species sensitivity distribution (SSD) approach was not considered acceptable for the refined risk assessment, since it includes data from formulation with two active substances.

Endpoints for the two chronic early‐life stage (ELS) fish studies and the two chronic fish modified exposure studies were discussed at the experts' meeting. ¹³ It was agreed that the endpoint of 8 μg/L from a standard ELS study on fathead minnow (revised to cover potential effect on growth) should be used in the risk assessment. Toxicokinetic–Toxicodynamic (TKTD) modelling, using the General Unified Threshold model of Survival (GUTS), was submitted for refining the chronic risk assessment for fish, and was discussed in the follow‐up experts' meeting. ¹⁴ The TKTD model was comprehensively reported and relied on a large experimental data set. However, the calibration and the interpretation of the validation of the model presented some deficiencies which decrease the overall reliability of the model application. In addition, GUTS model addresses lethal effects whereas the Tier 1 risk assessment was driven by sublethal effects; the calibration/validation of the model was carried out for rainbow trout whereas the sublethal effects were observed on the fathead minnow, and interspecies extrapolation is not recommended in the EFSA PPR Panel (2018). Therefore, the experts concluded that this modelling could not be used for refining the chronic fish risk assessment for dimoxystrobin.

For further refinement for aquatic invertebrates, a mesocosm study was also available with the solo formulation. The proposed endpoint from the mesocosm study was also discussed during the experts' meetings. ¹⁵ The experts agreed that an overall endpoint could not be derived for aquatic organisms due to several shortcomings (e.g. few species), especially vulnerable ones, with sufficient abundance; lack of pre‐exposure sampling for some taxa which makes it difficult to assess the effect; an effect class 3A was observed at the lowest concentration which makes it impossible to derive an ETO‐RAC (ecological threshold option – Regulatory Acceptable Concentration). Only a specific provisional ecological recovery option (ERO) – RAC could be derived for Daphnia, and the experts agreed not to use this endpoint in the risk assessment since it has not been demonstrated that the exposure in the mesocosm covers the predicted exposure profiles of the representative uses and that this endpoint might not be protective enough for molluscs (driving the Tier 1 risk assessment), crustaceans with long reproductive cycle and the most sensitive phytoplankton taxa.

Regarding sediment‐dwelling organisms, toxicity data were available with the active substance.

Based on the available Tier 1 data, a high acute risk for fish and aquatic invertebrates was identified at FOCUS Step 3 for all scenarios for the two representative uses.

Considering Tier 2 refinement (geomean), a high acute risk to fish was identified for all scenarios and representative uses using FOCUS Step 3 PECsw, except for scenario D5 on sunflower. At FOCUSsw Step 4, a high acute risk to fish remained for 2/6 scenarios (D2 and D4) for use on oilseed rape. Low acute risk was concluded for the remaining scenarios for the use on oilseed rape when considering risk mitigation measures (RMM) up to 20 m no‐spray buffer zone in combination with 20 m vegetated filter strip. For the use on sunflower, low acute risk to fish was concluded when considering RMM up to 20 m no‐spray buffer zone in combination with a 20 m vegetated filter strip.

An overview of the outcome of the risk assessment for aquatic organisms is presented in Table 1 below.

Table 1.

Overview of the outcome of the risk assessment for aquatic organisms

FOCUSsw scenario	Acute fish (geomean)	Chronic fish	Invert acute (C. virginica)	Invert. chronic	Chironomus riparius	Algae
Oilseed rape – 1 or 2 applications
D2	HR	HR	HR	HR	HR	HR
D3	LR step 4 10 m + 10 m	LR	LR step 4 20 m + 20 m	LR	LR step 4 10 m + 10 m	LR
D4	HR	HR	HR	LR	HR	HR
D5	LR step 4 10 m + 10 m	LR	HR	LR	HR	LR
R1	LR step 4 20 m + 20 m	LR step 4 10 m + 10 m	HR	LR step 4 10 m + 10 m	LR step 4 20 m + 20 m	LR step 4 10 m + 10 m
R3	LR step 4 20 m + 20 m	LR step 4 10 m + 10 m	HR	LR step 4 10 m + 10 m	LR step 4 20 m + 20 m	LR step 4 10 m + 10 m
Sunflower
D5	LR	LR	HR	LR	LR step 4 10 m + 10 m	LR
R1	LR step 4 10 m + 10 m	LR step 4 10 m + 10 m	HR	LR	LR step 4 20 m + 20 m	LR step 4 10 m + 10 m
R3	LR step 4 10 m + 10 m	LR step 4 10 m + 10 m	HR	LR	LR step 4 10 m + 10 m	LR step 4 10 m + 10 m
R4	LR step 4 20 m + 20 m	LR step 4 10 m + 10 m	HR	LR step 4 10 m + 10 m	LR step 4 20 m + 20 m	LR step 4 10 m + 10 m

HR: High risk remaining with the RMM; LR: Low risk concluded (FOCUS step 3).

LR step 4 10 m + 10 m: Low risk concluded at FOCUS step 4 with RMM of 10 m no‐spray buffer zone in combination with a 10 m vegetated filter strip.

LR step 4 20 m + 20 m: Low risk concluded at FOCUS step 4 with RMM 20 m no‐spray buffer zone in combination with a 20 m vegetated filter strip.

By using Tier 1 data, high chronic risk for fish was identified at FOCUS Step 3 for 4/6 scenarios for the representative use on oilseed rape and 3/4 scenarios for use on sunflower. At FOCUSsw Step 4, for the use in oilseed rape, a high chronic risk to fish remains with a 20‐m buffer zone combined with a 20‐m vegetated filter strip for 2/6 scenarios; low chronic risk to fish was concluded when considering a 10‐m no‐spray buffer zone in combination with a 10‐m vegetated filter strip for the two remaining scenarios. For the representative use on sunflower, low chronic risk was concluded when considering a 10‐m no‐spray buffer zone in combination with a 10‐m vegetated filter strip for all remaining scenarios.

For acute risk to aquatic invertebrates, based on the most sensitive species (C. Virginica, acute endpoint based on shell deposition), high risk was concluded for all relevant scenarios and uses (except for one scenario (D3) for the use on oilseed rape) at FOCUSsw Step 4 when considering a 20‐m no‐spray buffer zone in combination with a 20‐m vegetated filter strip (critical area of concern, see Section 3.1.2).

High chronic risk to aquatic invertebrates was identified at FOCUS Step 3 for 3/6 scenarios for the use on oilseed rape. By using FOCUSsw Step 4 exposure estimations, a high chronic risk remains for one scenario; low chronic risk to aquatic invertebrates was concluded when considering a 10‐m no‐spray buffer zone in combination with a 10‐m vegetated filter strip for two scenarios. For the use on sunflower, the chronic risk was high at FOCUS step 3 for 1/4 scenarios, for which a low risk was identified at FOCUSsw Step 4, with a 10‐m no‐spray buffer zone in combination with a 10‐m vegetated filter strip.

In addition, high chronic risk to sediment‐dwelling organisms was concluded at FOCUSsw Step 3 for all scenarios for both representative uses. Using the FOCUSsw Step 4 calculations that considered a 20‐m no‐spray buffer zone in combination with a 20‐m vegetated filter strip, high chronic risk to sediment‐dwelling organisms was identified for 3/6 scenarios for the use on oilseed rape. For the use on sunflower, low risk was concluded at FOCUSsw Step 4 for all scenarios when considering RMM up to 20 m no‐spray buffer zone combined with 20 m vegetated filter strip.

By using FOCUSsw Step 3 calculations, 4/6 and 3/4 scenarios showed a high risk to algae for the uses in oilseed rape and sunflower, respectively. At FOCUSsw Step 4, for the use on oilseed rape, the high risk remained for two scenarios (D2 and D4) even after considering a 20‐m no‐spray buffer zone in combination with a 20‐m vegetated filter strip, whereas a low risk was identified for the remaining scenarios when considering a 10‐m no‐spray buffer zone in combination with a 10‐m vegetated filter strip. For the use on sunflower, a low risk to algae could be concluded when considering a 10‐m no‐spray buffer zone in combination with a 10‐m vegetated filter strip.

To conclude on aquatic organisms, 1/6 scenarios show a low risk applying RMM of 20 m no‐spray buffer zone in combination with 20 m vegetated filter strip for the use on oilseed rape, whereas a high risk is identified for the remaining five scenarios; for the use on sunflower, a high risk is identified for all scenarios even considering RMM.

Several pertinent metabolites of dimoxystrobin have been identified in surface water (501 M01, 505M08, 505M09, 505M096). These pertinent aquatic metabolites were tested acutely for fish, invertebrates and algae. Low acute risk was concluded for all the pertinent aquatic metabolites by using FOCUS Step 1 PECsw for fish, aquatic invertebrates and algae for all uses. The metabolites 505M08, 505M09, 505M01, 505M96 were also identified as relevant in the sediment phase. However, no risk assessment for sediment dwellers was submitted (data gap, see Section 3.2).

Oral acute toxicity data on honeybees were available for dimoxystrobin and two formulated products (i.e. ‘BAS 540 01 F’ and ‘BAS 540 00 F’ ¹⁶ ). Acute contact toxicity data were available for the same formulations but not for the active substance (data gap, see Section 3.2). Furthermore, chronic studies for larvae and adults were available. The chronic toxicity study was conducted with the active substance whilst the 8‐day larval toxicity study was conducted with the representative formulation. Since this latest study does not cover the main developmental stages of honeybee larvae in line with the current recommendations, a data gap for a proper study with honeybee larvae was identified (i.e. a test with repeated dosing and longer test duration according to OECD Guidance No 239 is preferable; see also below paragraph for further information). ¹⁷ No information was available on bumblebees and solitary bees.

An acute risk assessment following the SANCO Guidance on Terrestrial ecotoxicology (European Commission, 2002) was available. Low acute risk to honeybees from oral and contact ¹⁸ exposure was concluded for both representative uses. Following the Tier 1 risk assessment according to the EFSA bee guidance (EFSA, 2013), the same conclusion could be reached for the acute scenario as assessed with the SANCO Guidance. Likewise, low chronic risk to adult honeybees could also be concluded for all representative uses, and the acute and chronic risk to adult bees from exposure to contaminated water was considered low as well.

A suitable assessment for sublethal effects (e.g. hypopharyngeal glands (HPGs)) was not available (data gap, see Section 3.2). An assessment to address the potential effects of plant metabolites occurring in pollen and nectar as a result of the representative uses was not available (data gap, see Section 3.2). An assessment of accumulative effects on bees was not available.

In addition to the Tier 1 ecotoxicity data for honeybees, a number of higher tier studies were also available. The available tunnel study considered ecotoxicological parameters related to the honeybee risk assessment (i.e. brood developmental observations) whilst the other two studies, residue studies under semi‐field and field conditions, ¹⁹ aimed at characterising the residue situation in pollen and nectar for oilseed rape and sunflowers. Those studies were discussed at the experts' meeting. ²⁰

The information from the residue studies showed several deficiencies (i.e. the sampling method was not in line with the recommendations of the EFSA bee guidance (EFSA, 2013), the residue trials were not independent from each other, there were adverse environmental conditions that could have affected the residue decline etc.); therefore, it was concluded that the information provided could not be used to refine exposure parameters in the risk assessment equations.

In the tunnel study, high variability on the brood termination rate was observed. In addition, due to several shortcomings in terms of experimental set‐up and conditions, the study was considered unsuitable to fully address the risk to honeybee larvae. As a consequence of the data gap identified for Tier 1 data for honeybee larvae as indicated previously and the unsuitability of a refinement based on the available tunnel study, the risk assessment for honeybee larvae is considered as an issue that could not be finalised (see Section 3.1.1).

Standard and extended laboratory toxicity tests with the formulation ‘BAS 540 00 F’ were available for non‐target arthropods other than bees. By using the available data, low in‐ and off‐field risk could be concluded for all representative uses.

Based on the available laboratory data with dimoxystrobin, high chronic risk was identified for earthworms for all representative uses at Tier 1. Three field studies were available to refine the risk. The studies were discussed at the experts' meeting. ²¹ Two were considered only as supportive information due to several shortcomings identified (e.g. uncertain exposure, limited information in terms of pre‐application sampling and pesticide history, poor performance of the toxic reference), whilst the study conducted in line with the GAPs under assessment was considered reliable and relevant to refine the risk. Considering the information from all the studies, it was possible to conclude low risk for earthworms for both representative uses.

For other soil macro‐ and meso‐fauna (i.e. Folsomia candida and Hypoaspis aculeifer), low chronic risk was concluded for all representative uses at Tier1.

Low risk to soil organisms from the exposure to the soil metabolite 505M09 was concluded for all representative uses. For the other relevant soil metabolites (i.e. 501M01, 505M08), toxicity data were not available for all non‐target soil organism taxa–metabolite combination. However, considering that metabolite 505M09 represents the worst‐case metabolite in soil in terms of formed fraction and degradation time, low chronic risk to soil organisms could be concluded for all the other relevant soil metabolites for the representative uses under assessment.

Suitable ecotoxicity tests were available to conclude a low risk to soil microorganisms for the active substance as well as for all the relevant soil metabolites for all representative uses.

A low chronic risk to non‐target terrestrial plants and organisms involved in biological methods for sewage treatment was concluded for all the representative uses.

2.4. Particular conditions proposed for the representative uses evaluated (Table 2)

Table 2.

Risk mitigation measures proposed for the representative uses assessed

Representative use	Oilseed rape
	Foliar spray
Risk to aquatic organisms	RMM of 20 m no‐spray buffer zone combined with a 20‐m vegetated buffer was sufficient for only 1/6 scenarios (a)

^(a)D3.

2.5. Overview of the risk assessment of compounds listed in residue definitions triggering assessment of effects data for the environmental compartments (Tables 3, 4, 5–3, 4, 5)

Table 3.

Soil

Compound (name and/or code)	Ecotoxicology
Dimoxystrobin	Low risk to soil organisms
505M08	Low risk to soil organisms
505M09	Low risk to soil organisms
505M01	Low risk to soil organisms

Table 4.

Groundwater ^(a)

Compound (name and/or code)	> 0.1 μg/L at 1 m depth for the representative uses (b) Step 2	Biological (pesticidal) activity/relevance Step 3a.	Hazard identified Steps 3b. and 3c.	Consumer RA triggered Steps 4 and 5	Human health relevance
Dimoxystrobin	No	Yes	–	–	Yes
505M08	Yes Winter oilseed rape (early application): 1.253–2.640 μg/L 6/6 FOCUS scenarios (alkaline soils) Winter oilseed rape (late application): 1.283–2.733 μg/L 6/6 FOCUS scenarios (alkaline soils) Sunflower: 0.590–1.050 μg/L 2/2 FOCUS scenarios (alkaline soils)	No	Yes Parent dimoxystrobin is classified Repr. Cat. 2	No Toxicologically relevant groundwater metabolite (see Section 2.1)	Yes
505M09	Yes Winter oilseed rape (early application): 0.927–1.764 μg/L 6/6 FOCUS scenarios (alkaline soils) Winter oilseed rape (late application): 0.929–1.844 μg/L 6/6 FOCUS scenarios (alkaline soils) Sunflower: 0.270–0.684 μg/L 2/2 FOCUS scenarios (alkaline soils)	No	Yes Parent dimoxystrobin is classified Repr. Cat. 2	No Toxicologically relevant groundwater metabolite (see Section 2.1)	Yes
505M01	Yes Winter oilseed rape (late application): 0.111 μg/L 1/6 FOCUS scenarios	No	Yes Parent dimoxystrobin is classified Carc. Cat 2 and Repr. Cat. 2 Aneugenicity not investigated.	No Toxicologically relevant groundwater metabolite (see Section 2.1)	Yes

^(a)Assessment according to European Commission guidance of the relevance of groundwater metabolites (2003).

^(b)FOCUS scenarios or relevant lysimeter.

Table 5.

Surface water and sediment

Compound (name and/or code)	Ecotoxicology
Dimoxystrobin	High acute risk to aquatic invertebrates for 5/6 scenarios for the uses on oilseed rape and all scenarios for the use on sunflower. High chronic risk to sediment‐dwelling organisms for 3/6 scenarios for the uses on oilseed rape. High acute risk and chronic risk to fish for 2/6 scenarios for the uses on oilseed rape. High risk to algae for 2/6 scenarios for the uses on oilseed rape. High chronic risk to aquatic invertebrates for 1/6 scenarios for the uses on oilseed rape.
505M08	Low risk to aquatic organisms, except sediment dwellers (data gap)
505M09	Low risk to aquatic organisms, except sediment dwellers (data gap)
505M01	Low risk to aquatic organisms, except sediment dwellers (data gap)
505M96	Low risk to aquatic organisms, except sediment dwellers (data gap)

3. Conclusions

3.1. Concerns and related data gaps for the representative uses evaluated

3.1.1. Issues that could not be finalised

An issue is listed as ‘could not be finalised’ if there is not enough information available to perform an assessment, even at the lowest tier level, for one or more of the representative uses in line with the uniform principles in accordance with Article 29(6) of Regulation (EC) No 1107/2009 and as set out in Commission Regulation (EU) No 546/2011 ²² and if the issue is of such importance that it could, when finalised, become a concern (which would also be listed as a critical area of concern if it is of relevance to all representative uses).

An issue is also listed as ‘could not be finalised’ if the available information is considered insufficient to conclude on whether the active substance can be expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

The following issues or assessments that could not be finalised have been identified, together with the reasons including the associated data gaps where relevant, which are reported directly under the specific issue to which they are related:

• 1The risk assessment to honeybee larvae could not be finalised due to the lack of reliable information (applicable for all the representative uses, see Section 2.3).

1. A chronic toxicity study with honeybee larvae in line with OECD Guidance No 239 is required (applicable for all the representative uses, see Section 2.3).

3.1.2. Critical areas of concern

An issue is listed as a critical area of concern if there is enough information available to perform an assessment for the representative uses in line with the uniform principles in accordance with Article 29(6) of Regulation (EC) No 1107/2009 and as set out in Commission Regulation (EU) No 546/2011, and if this assessment does not permit the conclusion that, for at least one of the representative uses, it may be expected that a plant protection product containing the active substance will not have any harmful effect on human or animal health or on groundwater, or any unacceptable influence on the environment.

An issue is also listed as a critical area of concern if the assessment at a higher tier level could not be finalised due to lack of information, and if the assessment performed at the lower tier level does not permit the conclusion that, for at least one of the representative uses, it may be expected that a plant protection product containing the active substance will not have any harmful effect on human or animal health or on groundwater, or any unacceptable influence on the environment.

An issue is also listed as a critical area of concern if, in the light of current scientific and technical knowledge using guidance documents available at the time of application, the active substance is not expected to meet the approval criteria provided for in Article 4 of Regulation (EC) No 1107/2009.

The following critical areas of concern are identified, together with any associated data gaps, where relevant, which are reported directly under the specific critical area of concern to which they are related:

• 2High acute risk to aquatic invertebrates for 5/6 scenarios for the use on winter oilseed rape and all scenarios for the use on sunflower (see Section 2.3) when also considering the implementation of the assessed mitigation measures that reduced exposure (20 m no‐spray buffer zone +20 m vegetated filter strip). ²³
• 3High potential for groundwater contamination by groundwater relevant metabolites in geoclimatic conditions represented by all the relevant FOCUS groundwater scenarios for all the representative uses assessed (see Sections 2.1, 2.2 and 2.5).

3.1.3. Overview of the concerns identified for each representative use considered (Table 6)

Table 6.

Overview of concerns reflecting the issues not finalised, critical areas of concerns and the risks identified that may be applicable for some but not for all uses or risk assessment scenarios

Representative use		Oilseed rape	Sunflower
		Foliar spray	Foliar spray
Risk to wild non‐target terrestrial vertebrates	Risk identified
	Assessment not finalised
Risk to wild non‐target terrestrial organisms other than vertebrates	Risk identified
	Assessment not finalised	X1	X1
Risk to aquatic organisms	Risk identified	X2, (b) (5/6)	X2, (c) (4/4)
	Assessment not finalised
Groundwater exposure to active substance	Legal parametric value breached
	Assessment not finalised
Groundwater exposure to metabolites	Legal parametric value breached	X3	X3
	Parametric value of 10 μg/L (a) breached
	Assessment not finalised

The superscript numbers relate to the numbered points indicated in Sections 3.1.1 and 3.1.2.

^(a)Value for non‐relevant metabolites prescribed in SANCO/221/2000‐rev. 10 final, European Commission, 2003.

^(b)High acute risk to aquatic invertebrates (5/6 scenarios); high acute and chronic risk to fish (2/6 scenarios); high risk to algae (2/6 scenarios), high risk to sediment‐dwelling organisms (3/6), high chronic risk to aquatic invertebrates (1/6 scenarios).

^(c)High acute risk to aquatic invertebrates (4/4 scenario).

(If a particular condition proposed to be taken into account to manage an identified risk, as listed in Section 2.4, has been evaluated as being effective, then ‘risk identified’ is not indicated in Table 6).

3.2. List of other outstanding issues

Remaining data gaps not leading to critical areas of concern or issues not finalised but considered necessary to comply with the data requirements, and which are relevant for some or all of the representative uses assessed at EU level. Although not critical, these data gaps may lead to uncertainties in the assessment and are considered relevant.

These data gaps refer only to the representative uses assessed and related to the environmental assessments:

• The aneugenicity potential for metabolite 505M01 was not investigated (relevant for all representative uses, see Section 2.1).

• No aquatic risk assessment for sediment dwellers was provided for the metabolites 505M08, 505M09, 505M01 and 505M96 (relevant for all representative uses, see Section 2.3).

• Acute contact toxicity data with dimoxystrobin for bees were not available (relevant for all representative uses, see Section 2.3).

• Further data were not available to address the risk to honeybees from sublethal effects (e.g. effects on HPG) and via exposure to metabolites formed in pollen and nectar (relevant for all representative uses, see Section 2.3).

Abbreviations

a.s.

active substance

AF

assessment factor

AR

applied radioactivity

BCF

bioconcentration factor

bw

body weight

CAS

Chemical Abstracts Service

CIPAC

Collaborative International Pesticides Analytical Council Limited

cm

centimetre

d

day

DAT

days after treatment

DDD

daily dietary dose

DT₅₀

period required for 50% dissipation (define method of estimation)

DT₉₀

period required for 90% dissipation (define method of estimation)

d.w.

dry weight

EAS

oestrogen, androgen and steroidogenesis modalities

EbC₅₀

effective concentration (biomass)

EC₅₀

effective concentration

ECHA

European Chemicals Agency

EEC

European Economic Community

EINECS

European Inventory of Existing Commercial Chemical Substances

ELINCS

European List of New Chemical Substances

ER₅₀

emergence rate/effective rate, median

ErC₅₀

effective concentration (growth rate)

ERO

ecological recovery option

ETO

ecological threshold option

ETR

exposure toxicity ratio

ETR_acute

exposure toxicity ratio for acute exposure

ETR_larvae

exposure toxicity ratio for chronic exposure

ETR_larvae

exposure toxicity ratio for larvae

FAO

Food and Agriculture Organisation of the United Nations

FOCUS

Forum for the Co‐ordination of Pesticide Fate Models and their Use

g

gram

h

hour(s)

ha

hectare

hL

hectolitre

HQ

hazard quotient

HQ_contact

hazard quotient for contact exposure

HR

hazard rate

ISO

International Organization for Standardization

IUPAC

International Union of Pure and Applied Chemistry

K_doc

organic carbon linear adsorption coefficient

K_Foc

Freundlich organic carbon adsorption coefficient

kg

kilogram

L

litre

LC₅₀

lethal concentration, median

LD₅₀

lethal dose, median; dosis letalis media

LDD₅₀

lethal dietary dose; median

LOQ

limit of quantification

m

metre

M

mol

mg

milligram

mL

millilitre

mm

millimetre (also used for mean measured concentrations)

MWHC

maximum water‐holding capacity

NOAEL

no observed adverse effect level

NOEC

no observed effect concentration

NOEL

no observed effect level

OECD

Organisation for Economic Co‐operation and Development

OM

organic matter content

PEC

predicted environmental concentration

PEC_sed

predicted environmental concentration in sediment

PEC_soil

predicted environmental concentration in soil

PEC_sw

predicted environmental concentration in surface water

pF2

pF value of 2 (suction pressure that defines field capacity soil moisture)

pH

pH‐value

PHI

preharvest interval

P_ow

partition coefficient between n‐octanol and water

RAC

regulatory acceptable concentration

RAR

Renewal Assessment Report

S

svedberg, S (10⁻¹³ s)

SFO

single first‐order

SMILES

simplified molecular‐input line‐entry system

SSD

species sensitivity distribution

TER

toxicity exposure ratio

TWA

time‐weighted average

μg

microgram

Appendix A – Consideration of some cut‐off criteria for dimoxystrobin according to Annex II of Regulation (EC) No 1107/2009 of the European Parliament and of the Council

Properties		Conclusion (a)
CMR	Carcinogenicity (C)	Dimoxystrobin is classified as a Carc. Cat 2 (H351) (ECHA RAC, 2020).
	Mutagenicity (M)	Dimoxystrobin is not classified as Mutag. Cat 1A, B. Dimoxystrobin is not considered to be a mutagen according to point 3.6.2 of Annex II of Regulation (EC) No 1107/2009.
	Toxic for Reproduction (R)	Dimoxystrobin is classified as Repr. Cat 2 (H361d) (ECHA RAC, 2020).
POP	Persistence	Dimoxystrobin is not considered to be a persistent organic pollutant (POP) according to point 3.7.1 of Annex II of Regulation (EC) 1107/2009.
	Bioaccumulation
	Long‐range transport
PBT	Persistence	Dimoxystrobin not considered to be a persistent, bioaccumulative and toxic (PBT) substance according to point 3.7.2 of Annex II of Regulation (EC) 1107/2009.
	Bioaccumulation
	Toxicity
vPvB	Persistence	Dimoxystrobin not considered to be a very persistent, very bioaccumulative substance according to point 3.7.3 of Annex II of Regulation (EC) 1107/2009.
	Bioaccumulation

^(a)Origin of data to be included where applicable (e.g. EFSA, ECHA RAC, Regulation).

Appendix B – List of end points for the active substance and the representative formulations with regard to identity, assessment of mammalian toxicity in relation to groundwater metabolites, environmental fate and behaviour and ecotoxicology

Identity, Physical and Chemical Properties, Details of Uses, Further Information (Regulation (EU) N° 283/2013, Annex Part A, points 1.3 and 3.2)

Identity (Regulation (EU) N° 283/2013, Annex Part A, point 1)

Groundwater metabolites: Screening for biological activity (SANCO/221/2000‐rev.10‐final Step 3 a Stage 1)

Summary of representative uses evaluated, for which all risk assessments needed to be completed (dimoxystrobin)

(Regulation (EU) N° 284/2013, Annex Part A, points 3, 4)

Crop and/or situation(a)	Member State or Country	Product name	F G or I(b)	Pests or Group of pests controlled(c)	Preparation		Application				Application rate per treatment			PHI (days)(m)	Remarks
					Type (d–f)	Conc. a.s.(i)	Method kind (f–h)	Range of growth stages & season(j)	Number min–max(k)	Interval between application (min)	kg a.s/hL min–max(l)	Water L/ha min–max	kg a.s./ha min–max(l)
Oilseed rape Brassica napus BRSNW	EU	BAS 540 01 F	F	Sclerotinia sclerotiorum, Alternaria brassicae, Erysiphe cruciferarum, Pyrenopeziza brassicae, Plenodomus maculans	SC	200 * g/l 200 ** g/l	foliar spraying	BBCH 20–75	2	28	0.025–0.1	100–400	0.1 * 0.1 **	***	no autumn application, spring application not before 1st February Application is restricted to every third year
Sunflower Helianthus annuus HELAN	CEU SEU	BAS 540 01 F	F	Sclerotinia sclerotiorum, Alternaria helianthi, Plenodomus lindquistii, Botrytis cinerea, Diaporthe helianthi	SC	200 * g/l 200 ** g/l	foliar spraying	BBCH 51–75	1	–	0.025–0.1	100–400	0.1 * 0.1 **	30	Application is restricted to every third year

^*dimoxystrobin.

^**boscalid.

^***defined by growth stage at latest application timing.

(a): For crops, the EU and Codex classifications (both) should be taken into account; where relevant, the use situation should be described (e.g. fumigation of a structure).

(b): Outdoor or field use (F), greenhouse application (G) or indoor application (I).

(c): e.g. biting and sucking insects, soil born insects, foliar fungi, weeds.

(d): e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR).

(e): CropLife International Technical Monograph no 2, 6th Edition. Revised May 2008. Catalogue of pesticide.

(f): All abbreviations used must be explained.

(g): Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench.

(h): Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plant‐ type of equipment used must be indicated.

(i): g/kg or g/L. Normally the rate should be given for the active substance (according to ISO) and not for the variant in order to compare the rate for same active substances used in different variants (e.g. fluoroxypyr). In certain cases, where only one variant is synthesised, it is more appropriate to give the rate for the variant (e.g. benthiavalicarb‐isopropyl).

(j): Growth stage range from first to last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 3‐8263‐3152‐4), including where relevant, information on season at time of application.

(k): Indicate the minimum and maximum number of applications possible under practical conditions of use.

(l): The values should be given in g or kg whatever gives the more manageable number (e.g. 200 kg/ha instead of 200,000 g/ha or 12.5 g/ha instead of 0.0125 kg/ha).

(m): PHI – minimum preharvest interval.

Impact on Human and Animal Health

Other toxicological studies (Regulation (EU) N°283/2013, Annex Part A, point 5.8)

Environmental fate and behaviour

Route of degradation (aerobic) in soil (Regulation (EU) N° 283/2013, Annex Part A, point 7.1.1.1)

Route of degradation (anaerobic) in soil (Regulation (EU) N° 283/2013, Annex Part A, point 7.1.1.2)

Route of degradation (photolysis) on soil (Regulation (EU) N° 283/2013, Annex Part A, point 7.1.1.3)

Rate of degradation in soil (aerobic) laboratory studies active substance (Regulation (EU) N° 283/2013, Annex Part A, point 7.1.2.1.1 and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.1.1)

Parent	Dark aerobic conditions
Soil type	org. C (%)	pH (CaCl2)	t. oC/% MWHC	Trigger DT50/DT90 (day)	Kinetic parameters	Modelling DT50 (day) 20°C, pF2 (a)	St. (χ2) trigger/modelling	Method of calculation trigger/modelling
Bruch West sandy loam (b)	2.0	7.5	20/40	78.2/423.1	α: 1.869 β: 174.2	138.7 (b)	2.2/ 2.3	FOMC/ DFOP (d)
Bruch West sandy loam (p)	2.0	7.5	20/40	70.9/481.4	α: 1.331 β: 103.8	124.7 (b)	1.2/ 2.4	FOMC/ DFOP (d)
Bruch West sandy loam average	2.0	7.5	20/40	74.5 (c) /451.3 (c)	–	131.5 (c)	–	FOMC/ DFOP (d)
Lufa 2.2 sand/loamy sand (b)	2.5	5.8	20/40	419.9/> 1,000	k1: 0.05724 k2: 0.00148 g: 0.069	331.8	1.2/ 1.5	DFOP/ SFO (d)
Minto loam (b)	3.0	7.7	20/40	363/> 1,000	k: 0.001909	279.5	2.0	SFO (e)
Dinuba sandy loam (b)	0.6	7.0	20/40	265.3/881.3	k: 0.002613	187.8	1.3	SFO (d)
Li 35b sandy loam (b)	1.1	6.8	20/40	411.4/> 1,000	k: 0.00169	325.5	1.6	SFO (d)
Borstel loamy sand (b)	1.2	4.6	20/40	306.2/> 1,000	k: 0.002264	215.7	1.0	SFO (e)
Geometric mean (if not pH dependent)						233.2
pH dependence						No

^(a)Normalised using a Q10 of 2.58 and Walker equation coefficient of 0.7.

^(b)Derived from slow phase of bi‐phasic model (DT50slow = ln2/k2).

^(c)Geometric mean of studies with two labels of Bruch West soil (b), (p) – benzyl‐, phenyl‐label.

^(d)Parent–metabolite pathway fit.

^(e)Parent‐only fit.

Rate of degradation in soil (aerobic) laboratory studies transformation products (Regulation (EU) N° 283/2013, Annex Part A, point 7.1.2.1.2 and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.1.1)

505M08	Dark aerobic conditions
Soil type	org. C (%)	pH (CaCl2)	t. oC/% MWHC	Trigger DT50/DT90 (day)	f. f. kf/kdp trigger/modelling	Kinetic parameters	DT50 (day) 20°C pF2/10kPa (a)	St. (χ2) trigger/modelling	Method of calculation trigger/modelling
Bruch West sandy loam (b)	2.0	7.5	20/40	11.6/38.63	0.2835/ 0.2716	k: 0.0596	11.6	16.5/16.7	SFO (b) / SFO (i)
Bruch West sandy loam (p)	2.0	7.5	20/40	55.8/185.5	0.1222/0.1135	k: 0.01368	52.9	13.2/8.5	SFO (b) / SFO (i)
Bruch West sandy loam average	2.0	7.5	20/40	24.3 (j) /80.7 (j)	0.203 (k) /0.193 (k)	k: 0.0286 (j)	24.7 (j)	–	SFO (b) / SFO (i)
Lufa 2.2 sand/loamy sand (b)	2.5	5.8	20/40	68.1/226.1	0.2226/0.3983	k: 0.01019	26.1	9.1/ 12.4	SFO (i) / SFO (c)
Minto loam (b)	3.0	7.7	20/40	– (d)	(0.042) (e)	– (d)	– (d)	– (d)	SFO (c)
Dinuba sandy loam (b)	0.6	7.0	20/40	27.7/91.92	0.373	k: 0.02505	19.6	14.7	SFO (c)
Li 35b sandy loam (b)	1.1	6.8	20/40	60.7/201.7	0.2288	k: 0.01142	48.0	13.1	SFO (c)
Li 10 loamy sand (b)	0.81	6.3	20/40	179.2/790.4	– (f)	k1: 0.1166 k2: 0.0026 g: 0.1984	247.4 (g)	1.3	DFOP
Lufa 2.2. sandy loam (b)	1.6	5.4	20/40	64.1/294.3	– (f)	k1: 0.2761 k2: 0.007 g: 0.2174	73.5 (g)	2.2	DFOP
Lufa 5 M sandy loam (b)	2.18	7.4	20/40	> 1,000/> 1,000	– (f)	k1: 0.022 k2: 2.26 E‐14 g: 0.4186	133.1 (g)	2.1/ 3.0	DFOP/ HS
Geometric mean (if not pH dependent)							54.72 (h)
Arithmetic mean					0.247 (h)
pH dependence							No

^(a)Normalised using a Q10 of 2.58 and Walker equation coefficient of 0.7.

^(b)FOMC kinetics for parent.

^(c)SFO kinetics for parent.

^(d)No reliable endpoints derived in kinetic evaluation.

^(e)Not taken into consideration for averaging of formation fractions.

^(f)Applied as parent.

^(g)Derived from slow rate of the respective bi‐phasic model (ln2/k2).

^(h)Results from Bruch West soil with two labels were averaged before calculating the overall mean.

⁽ⁱ⁾DFOP kinetics for parent.

^(j)Geometric mean of studies with two labels of Bruch West soil (b), (p) – benzyl‐, phenyl‐label.

^(k)Arithmetic mean of studies with two labels of Bruch West soil (b), (p) – benzyl‐, phenyl‐label.

505M09 (BF 505–8)	Dark aerobic conditions
Soil type	org.C (%)	pH (CaCl2)	t. oC/% MWHC	Trigger DT50/DT90 (day)	f. f. kf/kdp trigger/modelling	Kinetic parameters	DT50 (day) 20°C pF2/10 kPa(a)	St. (χ2) trigger/modelling	Method of calculation trigger/modelling
Bruch West sandy loam (b)	2.0	7.5	20/40	54.6/181.46	0.4286/ 0.428	k: 0.01269	51.8	5.0/ 4.7	SFO(b)/ SFO(i)
Bruch West sandy loam (p)	2.0	7.5	20/40	76.8/255	0.3661/ 0.3537	k: 0.009031	74.9	7.6/ 3.4	SFO(b)/ SFO(i)
Bruch West sandy loam average	2.0	7.5	20/40	64.7(j)/215.1(j)	0.397(k)/0.391(k)	k: 0.0107(j)	62.3(j)	–	SFO(b)/ SFO(i)
Lufa 2.2 sand/loamy sand (b)	2.5	5.8	20/40	29.1/96.61	0.3234/ 0.6017	k: 0.02383	13.4	12.8/ 16.6	SFO(i)/ SFO(c)
Minto loam (b)	3.0	7.7	20/40	–(d)	(0.0722)(e)	–(d)	–(d)	–(d)	SFO(c)
Dinuba sandy loam (b)	0.6	7.0	20/40	69.0/229.12	0.369	k: 0.01005	48.8	9.1	SFO(c)
Li 35b sandy loam (b)	1.1	6.8	20/40	61.9/205.5	0.3033	k: 0.01120	49.0	11.3	SFO(c)
Li 10 loamy sa/nd (b)	0.81	6.3	20/40	122.8/531.8	–(f)	k1: 0.003935 k2: 0.2426 g: 0.811	165.5(g)	1.6	DFOP
Lufa 2.2. sandy loam (b)	1.6	5.4	20/40	65.5/358.8	–(f)	k1: 0.2085 k2: 0.005489 g: 0.284	93.7(g)	2.5	DFOP
Lufa 5 M sandy loam (b)	2.18	7.4	20/40	159.5/592.8	–(f)	k1: 0.4865 k2: 0.003715 g: 0.0958	119.7(g)	2.3/ 3.2	DFOP/ SFO
Geometric mean (if not pH dependent)							62.47(h)
Arithmetic mean					0.347(h)
pH dependence							No

^(a)Normalised using a Q10 of 2.58 and Walker equation coefficient of 0.7.

^(b)FOMC kinetics for parent.

^(c)SFO kinetics for parent.

^(d)No reliable endpoints derived in kinetic evaluation.

^(e)Not taken into consideration for averaging of formation fractions.

^(f)Applied as parent.

^(g)Derived from slow rate of the respective bi‐phasic model (ln2/k2).

^(h)Results from Bruch West soil with two labels were averaged before calculating the overall mean.

⁽ⁱ⁾DFOP kinetics for parent.

^(j)Geometric mean of studies with two labels of Bruch West soil (b), (p) – benzyl‐, phenyl‐label.

^(k)Arithmetic mean of studies with two labels of Bruch West soil (b), (p) – benzyl‐, phenyl‐label.

505M01 (BF 505–4)	Dark aerobic conditions
Soil type	org.C (%)	pH (CaCl2)	t. oC/% MWHC	Trigger DT50/DT90 (day)	f. f. kf/kdp trigger/modelling	Kinetic parameters	DT50 (day) 20°C pF2/10 kPa(a)	St. (χ2) trigger/modelling	Method of calculation trigger/modelling
Li 10 loamy sand (b)	0.81	6.3	20/40	3.1/15.3	–(b)	k1: 0.5452 k2: 0.1195 g: 0.3759	3.4	2.1/ 9.0	DFOP/ SFO
Lufa 2.2. sandy loam (b)	1.6	5.4	20/40	11.6/45.8	–(b)	k1: 0.10.89 k2: 0.04703 g: 0.1379	9.4	5.1/ 8.8	DFOP/ SFO
Lufa 5M sandy loam (b)	2.18	7.4	20/40	1.2/35.07	–(b)	k1: 0.578316 k2: 0.03613 tb: 1.90956	14.4	9.3	HS
Geometric mean (if not pH dependent)							7.75
Arithmetic mean					–
pH dependence							No

^(a)Normalised using a Q10 of 2.58 and Walker equation coefficient of 0.7.

^(b)Applied as parent.

Rate of degradation field soil dissipation studies (Regulation (EU) N° 283/2013, Annex Part A, point 7.1.2.2.1 and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.1.2.1).

Parent	Aerobic conditions
Soil type (indicate if bare or cropped soil was use/d)	Study – Soil	pH(CaCl2)	Org. C (%)	DT50 (day)	DT90 (day)	Kinetic parameters	St. (χ2) (a)	Fast DT50 (dnorm) 20°C/pF2	Slow DT50 (dnorm) 20°C/pF2	Method of calculation (a)
Loamy sand (bare soil)	1999/11287‐ALO/03/98	7.5	0.7	2.4	526.5	k1: 0.2914 k2: 0.00273 tb: 3.005	5.2/ –	– (b)		HS/ –
Sandy loam (bare soil)	1999/11287 ‐ ALO/04/98	7.6	0.9	5.4	793.7	k1: 0.1287 k2:0.00186 tb: 6.527	9.2/ –	– (b)		HS/ –
Loamy sand (bare soil)	1999/11287 ‐HUS/09/98	5.8	1.3	91.5	> 1000	k1: 0.00758 k2: 2.3 E‐14 tb: 118.6	8.8/12.5	79.8		HS/SFO
Loamy sand (bare soil)	2000/1000122 ‐ D05/03/97	6.3	1.08	29.3	> 1000	k1: 0.05682 k2: 0.00029 g: 0.613	1.9/5.9	8.3 (c)	346.2 (d)	DFOP/HS
Loamy sand (bare soil)	2000/1000122 ‐ DU3/04/97	5.3	0.63	63.0	> 1000	k1: 0.01428 k2: 3.07 E‐13 g: 0.843	4.8/7.5	62.0		DFOP/SFO
Silty clay loam (bare soil)	2000/1000122 ‐ DU2/03/97	6.4	1.29	25.1	> 1,000	k1: 0.04073 k2: 0.000619 g: 0.776	6.7/7.0	6.5 (c)	158.7 (d)	DFOP/DFOP
Loam (bare soil, sand cover)	2014/1289366 ‐ 01 (ES)	7.3	0.93	18.5 (f)	611.7 (f)	k1: 0.03753 (f) k2: 0.00178 (f) tb: 3.4 (f)	25.2/33.0	101.9 (e)		HS/FOMC
Sandy loam (bare soil, sand cover)	2014/1289366 ‐ 02 (IT)	7.6	0.45	36.7 (f)	946.6 (f)	k1: 0.04145 (f) k2: 0.001424 (f) g: 0.615 (f)	6.0/6.3	15.3 (c)	279.7 (d)	DFOP/DFOP
Silt loam (bare soil, sand cover)	2014/1289366 ‐ 03 (UK)	6.6	1.64	62.7 (f)	625.1 (f)	k1: 1458 (f) k2: 0.008903 (f) g: 0.241 (f)	15.2/15.8	65.6		DFOP/SFO
Sandy loam (bare soil, sand cover)	2014/1289366 ‐ 04 (DE)	5.9	2.07	184.7 (f)	> 1,000 (f)	k1: 0.02567 (f) k2: 0.001548 (f) g: 0.339 (f)	4.5/6.6	126.6		DFOP/SFO
Silt loam (bare soil, sand cover)	2014/1289366 ‐ 05 (FR)	4.9	0.81	14.0 (f)	283.2 (f)	k1: 0.09157 (f) k2: 0.00427 (f) g: 0.665 (f)	4.5/9.9	47.4 (e)		DFOP/FOMC
Geometric mean (if not pH dependent)								38.0 (n = 9)	113.2 (n = 9)
pH dependence							No

^(a)First value applies to trigger DT₅₀, second value applies to modelling DT₅₀.

^(b)No normalised DT₅₀ derived due to experimental conditions not suitable for normalisation.

^(c)DegT₅₀ calculated from fast rate (ln2/k₁)

^(d)DegT₅₀ calculated from slow rate (ln2/k₁).

^(e)DegT₅₀ was calculated as DT₉₀/3.32.

^(f)Best‐fit endpoints should not be used as triggers for additional work due to exclusion of surface loss processes.

Dimoxystrobin metabolites appeared in amounts > LOQ only sporadically under field conditions

Combined laboratory and field kinetic endpoints for modelling (when not from different populations)*

Soil accumulation (Regulation (EU) N° 283/2013, Annex Part A, point 7.1.2.2.2 and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.1.2.2)

Rate of degradation in soil (anaerobic) laboratory studies active substance (Regulation (EU) N° 283/2013, Annex Part A, point 7.1.2.1.3 and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.1.1)

Parent	Dark anaerobic conditions
Soil type	org. C (%)	pH (a)	t. oC/% MWHC	DT50/DT90 (day)	DT50 (day) 20°C (b)	St. (χ2)	Method of calculation
Bruch West sandy loam (p)	2.0	7.5	20/flooded	not calc. parent stable	not calc.	–	–
Geometric mean (if not pH dependent)					–

^(a)Measured in calcium chloride solution.

^(b)Normalised using a Q10 of 2.58.

Aerobic soil metabolites do not appear in significant amounts under field conditions in soil; data on anaerobic degradation rate of metabolites not considered necessary.

Rate of degradation on soil (photolysis) laboratory active substance (Regulation (EU) N° 283/2013, Annex Part A, point 7.1.1.3)

Parent	Soil photolysis
Soil type	pH (a)	t. oC/% MWHC	DT50/DT90 (d)		St. (χ2)	Method of calculation
Limburgerhof sandy loam	7.5	22/~34	33.8	112.2	3.5	First‐order test system days (cont. irradiation); extrapolated

^(a)Measured in calcium chloride solution.

Soil adsorption active substance (Regulation (EU) N° 283/2013, Annex Part A, point 7.1.3.1.1 and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.2.1)

Parent
Soil Type	OC (%)	pHCaCl2 (pHH2O)	Kd (mL/g)	Kdoc (mL/g)	KF (mL/g)	KFoc (mL/g)	1/n
Indirect method
Silt loam (Nierswalder)	1.85	5.7 (6.5)			9.14	493.8	0.99
Loam (Fiorentino)	1.00	7.4 (8.2)			5.94	593.9	0.95
Loamy sand (Li10)	0.95	6.2 (6.9)			3.33	350.6	0.94
Sand (Lufa 2.1)	0.60	5.6 (6.5)			1.82	303.6	0.93
Sandy loam (Lufa 2.3)	0.99	6.7 (7.4)			3.45	348.1	0.94
Indirect method
Sandy loam (Bruch West)	1.8	7.5 (8.0) (a)			3.52	195.8	0.902
Indirect method
Loamy sand (Borstel)	1.2	4.6 (5.6)			6.76	563	0.940
Geometric mean (if not pH dependent)						382.5
Arithmetic mean (if not pH dependent)							0.942
pH dependence			No

^(a)estimated using pH water = 0.953*pH‐CaCl₂ + 0.853 European Commission ( 2014a ).

Soil adsorption transformation products (Regulation (EU) N° 283/2013, Annex Part A, point 7.1.3.1.2 and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.2.1)

Metabolite 505M08 (BF 505–7)
Soil Type	OC (%)	pHCaCl2 (pHH2O)	Kd (mL/g)	Kdoc (mL/g)	KF (mL/g)	KFoc (mL/g)	1/n
Indirect method
Sand/loamy sand (Lufa 2.2)	2.5	5.8 (6.4)			0.499	20.0	0.95
Loamy sand (Bruch West)	1.5	7.5 (8.0)			0.057	3.8	1.22
Loamy sand (Li35b)	1.1	6.5 (7.0)			0.086	7.8	0.99
Silty loamy sand (USA 538‐31‐2)	0.5	5.2 (5.8)			0.665	133.0	0.95
Indirect (one soil, Niersw. Wild.) and Direct method (four soils)
Silt loam (Niersw. Wild.)	1.9	5.7 (6.5)			0.750	40.6	0.96
Loam (Fiorentino)	1.0	7.4 (8.2)			0.080	8.3	1.00
Loamy sand (Li 10)	1.0	6.2 (6.9)			0.090	9.6	1.00
Sand (Lufa 2.1)	0.6	5.6 (6.5)			0.130	22.0	1.00
Sandy loam (Lufa 2.3)	1.0	6.7 (7.4)			0.060	6.0	0.99
Direct method
Silt loam (Niersw. Wild.)	2.01	5.6 (6.2)			0.49	24.2	0.91
Loam (PioggioRenatico)	0.82	7.5 (8.3)			0.17	20.2	0.96
Loamy sand (Li 10)	0.89	6.1 (6 9)			0.14	15.7	0.93
Sand (Lufa 2.1)	0.72	5.6 (6.2)			0.26	35.6	0.93
Sandy loam (Lufa 2.3)	0.66	5.3 (6 3)			0.12	17.6	0.96

Geometric mean (if not pH dependent) Soils with pH (water) > 6.5 Soils with pH (water) ≤ 6.5		8.92 32.2
Arithmetic mean (if not pH dependent) Soils with pH (water) > 6.5 Soils with pH (water) ≤ 6.5			1.01 0.952

pH dependence

Yes

Metabolite 505M09 (BF 505–8)
Soil Type	OC (%)	pHCaCl2 (pHH2O)	Kd (mL/g)	Kdoc (mL/g)	KF (mL/g)	KFoc (mL/g)	1/n
Indirect method
Sand/loamy sand (Lufa 2.2)	2.5	5.8 (6.4)(a)			1.111	44.4	0.92
Loamy sand (Bruch West)	1.5	7.5 (8)(a)			0.135	9.0	0.81
Loamy sand (Li35b)	1.1	6.5 (7)(a)			0.142	12.9	0.812
Silty loamy sand (USA 538‐31‐2)	0.5	5.2 (5.8)(a)			0.595	119.0	0.892
Direct method
Silt loam (Niersw. Wild.)	1.9	5.7 (6.5)			1.170	63.22	0.95
Loam (Fiorentino)	1.0	7.4 (8.2)			0.200	20.37	0.94
Loamy sand (Li 10)	1.0	6.2 (6.9)			0.180	19.07	0.96
Sand (Lufa 2.1)	0.6	5.6 (6.5)			0.280	45.85	1.00
Sandy loam (Lufa 2.3)	0.99	6.7 (7.4)			0.160	16.56	0.92
Direct method
Sand (Lufa 2.1)	0.72	5.6 (6.2)			0.470	65.217	0.973
Sandy loam (Lufa 2.3)	0.66	5.3 (6.3)			0.165	24.988	0.938
Loamy sand (Li 10)	0.89	6.1 (6.9)			0.235	26.387	0.955
Silt loam (Niersw. Wild.)	2.01	5.6 (6.2)			0.682	33.923	0.943
Loam (PioggioRenatico)	0.82	7.5 (8.3)			0.195	23.750	0.921
Geometric mean (if not pH dependent) Soils with pH (water) > 6.5 Soils with pH (water) ≤ 6.5						17.32 50.58
Arithmetic mean (if not pH dependent) Soils with pH (water) > 6.5 Soils with pH (water) ≤ 6.5							0.903 0.945
pH dependence					Yes

^(a)Estimated as proposed by FOCUS (2000, 2014) pH water = 0.953*pH‐CaCl₂ + 0.85.

Metabolite 505M01 (BF 505–4)
Soil Type	OC (%)	pHCaCl2 (pHH2O)	Kd (mL/g)	Kdoc (mL/g)	KF (mL/g)	KFoc (mL/g)	1/n
Direct method
Silt loam (Niersw. Wild.)	1.85	5.7 (6.5)			0.150	8.4	0.99
Loam (Fiorentino)	1.0	7.4 (8.2)			0.230	23.4	0.91
Loamy sand (Li 10)	0.95	6.2 (6.9)			0.050	5.5	0.98
Sand (Lufa 2.1)	0.6	5.6 (6.5)			0.040	6.6	0.93
Sandy loam (Lufa 2.3)	0.99	6.7 (7.4)			0.100	10.0	1.00
Direct method
Sand (Lufa 2.1)	0.72	5.6 (6.2)			0.031	4.322	0.973
Sandy loam (Lufa 2.3)	0.66	5.3 (6.3)			0.019	2.862	0.877
Loamy sand (Li 10)	0.89	6.1 (6.9)			0.040	4.525	1.017
Silt loam (Niersw. Wild.)	2.01	5.6 (6.2)			0.156	7.758	0.998
Loam (Fiorentino)	0.82	7.5 (8.3)			0.105	12.784	0.954
Geometric mean (if not pH dependent)						7.24
Arithmetic mean (if not pH dependent)							0.963
pH dependence					No

Mobility in soil column leaching active substance (Regulation (EU) N° 283/2013, Annex Part A, point 7.1.4.1.1 and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.2.1)

Mobility in soil column leaching transformation products (Regulation (EU) N° 283/2013, Annex Part A, point 7.1.4.1.2 and Regulation (EU) N° 284/2013, Annex Part A, point 9.1.2.1)

Lysimeter/field leaching studies (Regulation (EU) N° 283/2013, Annex Part A, points 7.1.4.2/7.1.4.3 and Regulation (EU) N° 284/2013, Annex Part A, points 9.1.2.2/9.1.2.3)

Hydrolytic degradation (Regulation (EU) N° 283/2013, Annex Part A, point 7.2.1.1)

Aqueous photochemical degradation (Regulation (EU) N° 283/2013, Annex Part A, points 7.2.1.2/7.2.1.3)

‘Ready biodegradability’ (Regulation (EU) N° 283/2013, Annex Part A, point 7.2.2.1)

Aerobic mineralisation in surface water (Regulation (EU) N° 283/2013, Annex Part A, point 7.2.2.2 and Regulation (EU) N° 284/2013, Annex Part A, point 9.2.1)

Parent	Compound stable under applied experimental conditions, no significant degradation was observed
System identifier (indicates fresh, estuarine or marine)	pH water phase	pH sed (a)	t. oC (b)	DT50/DT90 whole sys. (suspended sediment test)		St. (χ2)	DT50/DT90 Water (pelagic test)		St. (χ2)	Method of calculation
				At study temp	Normalised to – oC (c)		At study temp	Normalised to – oC (c)
Fresh water (high conc.*)	8.99	7.5	20	n.c.	n.p.	–	n.c.	n.p.	–	–
Fresh water (low conc.*)	8.99	7.5	20	n.c.	n.p.	–	n.c.	n.p.	–	–

n.p.: not performed; n.c.: not calculated.

^*The test was performed in lake water and sediment at two different dimoxystrobin concentrations (10 μg/L and 90 μg/L).

^(a)Measured in calcium chloride solution.

^(b)Temperature of incubation = temperature that the environmental media were collected or std. temperature of 20°C.

^(c)Normalised using a Q₁₀ of 2.58 to the temperature of the environmental media at the point of sampling. (note temp of × should be stated).

Metabolites 505M08 & 09	Max in total system < 1% after 59 days
System identifier (indicates fresh, estuarine or marine)	pH water phase	pH sed(a)	t. oC(b)	DT50/DT90 whole sys. (suspended sediment test)		St. (χ2)	DT50/DT90 Water (pelagic test)		St. (χ2)	Method of calculation
				At study temp	Normalised to – oC(c)		At study temp	Normalised to – oC(c)
Fresh water (high conc.*)	8.99	7.5	20	n.c.	n.p.	–	n.c.	n.p.
Fresh water (low conc.*)	8.99	7.5	20	n.c.	n.p.	–	n.c.	n.p.

n.p.: not performed; n.c.: not calculated.

^*The test was performed in lake water and sediment at two different dimoxystrobin concentrations (10 μg/L and 90 μg/L).

^(a)Measured in calcium chloride solution.

^(b)Temperature of incubation = temperature that the environmental media were collected or std. temperature of 20°C.

^(c)Normalised using a Q10 of 2.58 to the temperature of the environmental media at the point of sampling. (note temp of × should be stated).

Mineralisation and non‐extractable residues (for parent dosed experiments)

System identifier (indicate fresh, estuarine or marine)	pH water phase	pH sed	Mineralisation max % after 35 and 59 days (end of the study)	Non‐extractable residues. Max % after d (suspended sediment test)	Non‐extractable residues. Max % after d (end of the study) (suspended sediment test)
Fresh water (high conc.*)	8.99	7.5	0.1–0.5% (35, 59 d)	–	–
Fresh water (low conc.*)	8.99	7.5	0.7% (59 d)	–	–

^*The test was performed in lake water and sediment at two different dimoxystrobin concentrations (10 μg/L and 90 μg/L).

Water/sediment study (Regulation (EU) N° 283/2013, Annex Part A, point 7.2.2.3 and Regulation (EU) N° 284/2013, Annex Part A, point 9.2.2)

Parent	Distribution max 89–93% in water after 0 d; max. sed. dark: 58–62% after 100 d
Water/sediment system	pH water phase	pH sed (a)	t. oC	DT50/DT90 whole sys.	St. (χ2)	DT50/DT90 water	St. (χ2)	DT50/DT90 sed	St. (χ2)	Method of calculation
Trigger endpoints
Kellmetschweiher (dark, lab.)	8.5	7.5	20	834.5/> 1,000	0.5	25.3/213.9	2.4	n.c.	–	HS/DFOP/−
Bergh. Altrhein (dark, lab.)	8.2	7.6	20	297.6/988.7	1.5	13.6/126.9	3.0	n.c.	–	SFO/DFOP/−
Modelling endpoints
Kellmetschweiher (dark, lab.)	8.5	7.5	20	525.6	1.0	–	–	–	–	SFO/−/−
Bergh. Altrhein (dark, lab.)	8.2	7.6	20	297.6	1.5	–	–	–	–	SFO/−/−
Geometric mean at 20°C				395.5(b)		n.c.		n.c.

n.c.: not calculated; not rep.: not reported.

^(a)Measured in calcium chloride solution.

^(b)Geometric mean of modelling endpoints, laboratory systems, n = 2.

Metabolite 505M08	Distribution: max. water (dark) 2.9%; max. water (irrad.) 3.6% max. sediment (dark) 0%, max. sediment (irrad.) 0.8% no reliable derivation of degradation rates possible
Water/sediment system	pH water phase	pH sed	t. o C	DT50/DT90 whole sys.	St. (χ2)	DT50/DT90 water	St. (χ2)	DT50/DT90 sed	St. (χ2)	Method of calculation
				n.c.		n.c.		n.c.
Geometric mean at 20°C

n.c.: not calculated.

Metabolite 505M09	Distribution: max. water (dark) 5.2%; max. water (irrad.) 5.3% max. sediment (dark) 0%, max. sediment (irrad.) 1.2% no reliable derivation of degradation rates possible
Water/sediment system	pH water phase	pH sed	t. oC	DT50/DT90 whole sys.	St. (χ2)	DT50/DT90 water	St. (χ2)	DT50/DT90 sed	St. (χ2)	Method of calculation
				n.c.		n.c.		n.c.
Geometric mean at 20°C

n.c.: not calculated.

Metabolite 505M01	Distribution: max. water (irrad.) 3.2% max. sediment (irrad.) 0.4%
Water/sediment system	pH water phase	pH sed(a)	t. oC	DT50/DT90 whole sys.	St. (χ2)	DT50/DT90 water	St. (χ2)	DT50/DT90 sed	St. (χ2)	Method of calculation
Kellmetschweiher (irradiated)	8.8	not rep.	(b)	31.2/103.6	4.4	n.c.		n.c.		SFO
Geometric mean at 20oC(b)

not rep.: not reported; n.c.: not calculated.

^(a)Measured in calcium chloride solution.

^(b)Mean water temp. during incub. period 18.1°C (min 8.6°C, max. 28.5°C).

Metabolite 505M96	Distribution:max. water (irrad.) 9.6% max. sediment (irrad.) 0%
Water/sediment system	pH water phase	pH sed(a)	t. oC	DT50/DT90 whole sys.	St. (χ2)	DT50/DT90 water	St. (χ2)	DT50/DT90 sed	St. (χ2)	Method of calculation
Kellmetschweiher (irradiated)	8.8	not rep.	(b)	43.4/144.2	4.2	n.c.		n.c.		SFO
Geometric mean at 20oC(b)

not rep.: not reported; n.c.: not calculated.

^(a)Measured in calcium chloride solution.

^(b)Mean water temp. during incub. period 18.1°C (min 8.6°C, max. 28.5°C).

Mineralisation and non‐extractable residues (from parent dosed experiments)

Water/sediment system	pH water phase	pH sed	Mineralisation % after 100/120 d. (end of the study).	Non‐extractable residues in sed. max % after 100/120 d (end of the study)	Non‐extractable residues in sed. max % after 100/120 d (end of the study)
Kellmetschweiher (dark, lab.)	8.5	7.5	0.8% at 100 d	6% after 100 d	6% after 100 d
Bergh. Altrhein (dark, lab.)	8.2	7.6	2.1% at 100 d	11% after 100 d	11% after 100 d

Fate and behaviour in air (Regulation (EU) N° 283/2013, Annex Part A, point 7.3.1)

Residues requiring further assessment (Regulation (EU) N° 283/2013, Annex Part A, point 7.4.1)

Definition of the residue for monitoring (Regulation (EU) N° 283/2013, Annex Part A, point 7.4.2)

Monitoring data, if available (Regulation (EU) N° 283/2013, Annex Part A, point 7.5

PEC soil (Regulation (EU) N° 284/2013, Annex Part A, points 9.1.3/9.3.1)

Parent – Winter oilseed rape

PEC(s) (mg/kg)	Single application Actual	Single application Time‐weighted average	Multiple application Actual	Multiple application Time‐weighted average
Initial	Not reported (a)		0.048
Short term 24 h	Not reported (a)	Not reported (a)	0.048	0.048
2d	Not reported (a)	Not reported (a)	0.048	0.048
4d	Not reported (a)	Not reported (a)	0.047	0.048
Long term 7d	Not reported (a)	Not reported (a)	0.046	0.047
28d	Not reported (a)	Not reported (a)	0.039	0.044
50d	Not reported (a)	Not reported (a)	0.033	0.040
100d	Not reported (a)	Not reported (a)	0.023	0.034
Plateau concentration	0.006 mg/kg (ESCAPE)

^(a)Only values for the multiple application are reported as worst case.

Parent – Sunflower

PEC(s) (mg/kg)	Single application Actual	Single application Time‐weighted average	Multiple application Actual	Multiple application Time‐weighted average
Initial	0.033		Not applicable
Short term 24 h	0.033	0.033	Not applicable	Not applicable
2d	0.033	0.033	Not applicable	Not applicable
4d	0.032	0.033	Not applicable	Not applicable
Long term 7d	0.032	0.033	Not applicable	Not applicable
28d	0.027	0.030	Not applicable	Not applicable
50d	0.023	0.027	Not applicable	Not applicable
100d	0.016	0.023	Not applicable	Not applicable
Plateau concentration	0.004 mg/kg (ESCAPE)

505M01 – Winter oilseed rape

PEC(s) (mg/kg)	Single application Actual	Single application Time‐weighted average	Multiple application Actual	Multiple application Time‐weighted average
Initial	Not reported (a)		0.005
Short term 24 h	Not reported (a)	Not reported (a)	Not reported (b)	Not reported (b)
2d	Not reported (a)	Not reported (a)	Not reported (b)	Not reported (b)
4d	Not reported (a)	Not reported (a)	Not reported (b)	Not reported (b)
Long term 7d	Not reported (a)	Not reported (a)	Not reported (b)	Not reported (b)
28d	Not reported (a)	Not reported (a)	Not reported (b)	Not reported (b)
50d	Not reported (a)	Not reported (a)	Not reported (b)	Not reported (b)
100d	Not reported (a)	Not reported (a)	Not reported (b)	Not reported (b)
Plateau concentration	Not applicable

^(a)Only values for the multiple application are reported as worst case.

^(b)Only initial values are reported as worst‐case estimates of short‐term and long‐term exposure.

505M01 – Sunflower

PEC(s) (mg/kg)	Single application Actual	Single application Time‐weighted average	Multiple application Actual	Multiple application Time‐weighted average
Initial	0.005		Not applicable
Short term 24 h	Not reported (a)	Not reported (a)	Not applicable	Not applicable
2d	Not reported (a)	Not reported (a)	Not applicable	Not applicable
4d	Not reported (a)	Not reported (a)	Not applicable	Not applicable
Long term 7d	Not reported (a)	Not reported (a)	Not applicable	Not applicable
28d	Not reported (a)	Not reported (a)	Not applicable	Not applicable
50d	Not reported (a)	Not reported (a)	Not applicable	Not applicable
100d	Not reported (a)	Not reported (a)	Not applicable	Not applicable
Plateau concentration	Not applicable

^(a)Only initial values are reported as worst‐case estimates of short‐term and long‐term exposure.

505M08 – Winter oilseed rape

PEC(s) (mg/kg)	Single application Actual	Single application Time‐weighted average	Multiple application Actual	Multiple application Time‐weighted average
Initial	Not reported (a)		0.008
Short term 24 h	Not reported (a)	Not reported (a)	Not reported (b)	Not reported (b)
2d	Not reported (a)	Not reported (a)	Not reported (b)	Not reported (b)
4d	Not reported (a)	Not reported (a)	Not reported (b)	Not reported (b)
Long term 7d	Not reported (a)	Not reported (a)	Not reported (b)	Not reported (b)
28d	Not reported (a)	Not reported (a)	Not reported (b)	Not reported (b)
50d	Not reported (a)	Not reported (a)	Not reported (b)	Not reported (b)
100d	Not reported (a)	Not reported (a)	Not reported (b)	Not reported (b)
Plateau concentration	0.004 mg/kg (ESCAPE)

^(a)Only values for the multiple application are reported as worst case.

^(b)Only initial values are reported as worst‐case estimates of short‐term and long‐term exposure.

505M08 – Sunflower

PEC(s) (mg/kg)	Single application Actual	Single application Time‐weighted average	Multiple application Actual	Multiple application Time‐weighted average
Initial	0.005		Not applicable
Short term 24 h	Not reported (a)	Not reported (a)	Not applicable	Not applicable
2d	Not reported (a)	Not reported (a)	Not applicable	Not applicable
4d	Not reported (a)	Not reported (a)	Not applicable	Not applicable
Long term 7d	Not reported (a)	Not reported (a)	Not applicable	Not applicable
28d	Not reported (a)	Not reported (a)	Not applicable	Not applicable
50d	Not reported (a)	Not reported (a)	Not applicable	Not applicable
100d	Not reported (a)	Not reported (a)	Not applicable	Not applicable
Plateau concentration	0.003 mg/kg (ESCAPE)

^(a)Only initial values are reported as worst‐case estimates of short‐term and long‐term exposure.

505M09 – Winter oilseed rape

PEC(s) (mg/kg)	Single application Actual	Single application Time‐weighted average	Multiple application Actual	Multiple application Time‐weighted average
Initial	Not reported (a)		0.008
Short term 24 h	Not reported (a)	Not reported (a)	Not reported (b)	Not reported (b)
2d	Not reported (a)	Not reported (a)	Not reported (b)	Not reported (b)
4d	Not reported (a)	Not reported (a)	Not reported (b)	Not reported (b)
Long term 7d	Not reported (a)	Not reported (a)	Not reported (b)	Not reported (b)
28d	Not reported (a)	Not reported (a)	Not reported (b)	Not reported (b)
50d	Not reported (a)	Not reported (a)	Not reported (b)	Not reported (b)
100d	Not reported (a)	Not reported (a)	Not reported (b)	Not reported (b)
Plateau concentration	0.001 mg/kg (ESCAPE)

^(a)Only values for the multiple application are reported as worst case.

^(b)Only initial values are reported as worst‐case estimates of short‐term and long‐term exposure.

505M09 – Sunflower

PEC(s) (mg/kg)	Single application Actual	Single application Time‐weighted average	Multiple application Actual	Multiple application Time‐weighted average
Initial	0.005		Not applicable
Short term 24 h	Not reported (a)	Not reported (a)	Not applicable	Not applicable
2d	Not reported (a)	Not reported (a)	Not applicable	Not applicable
4d	Not reported (a)	Not reported (a)	Not applicable	Not applicable
Long term 7d	Not reported (a)	Not reported (a)	Not applicable	Not applicable
28d	Not reported (a)	Not reported (a)	Not applicable	Not applicable
50d	Not reported (a)	Not reported (a)	Not applicable	Not applicable
100d	Not reported (a)	Not reported (a)	Not applicable	Not applicable
Plateau concentration	< 0.001 mg/kg (ESCAPE)

^(a)Only initial values are reported as worst‐case estimates of short‐term and long‐term exposure.

PEC ground water (Regulation (EU) N° 284/2013, Annex Part A, point 9.2.4.1)

PEC(gw) – FOCUS modelling results (80th percentile annual average concentration at 1 m) triennial application

PEARL 4.4.4/Winter oilseed rape 2 × 100 g a.i./ha	Scenario	Parent (μg/L)	Metabolite (μg/L)
			505M01	505M08 (Kfoc = 8.93 ml/g)	505M08 (Kfoc = 32.2 ml/g)	505M09 (Kfoc = 17.32 ml/g)	505M09 (Kfoc = 50.58 ml/g)
	Early application
	Chateaudun	0.001	0.010	2.018	0.621	1.129	0.431
	Hamburg	0.011	0.091	2.640	1.127	1.701	0.823
	Kremsmunster	0.007	0.030	1.760	0.735	1.160	0.533
	Okehampton	0.011	0.054	1.499	0.773	1.097	0.607
	Piacenza	0.004	0.025	0.979	0.496	0.741	0.371
	Porto	0.003	0.044	1.259	0.532	0.849	0.399
	Late application
	Chateaudun	0.001	0.011	2.034	0.640	1.149	0.428
	Hamburg	0.011	0.101	2.727	1.144	1.742	0.849
	Kremsmunster	0.007	0.033	1.774	0.752	1.195	0.549
	Okehampton	0.010	0.056	1.511	0.786	1.107	0.615
	Piacenza	0.003	0.028	1.011	0.497	0.750	0.375
	Porto	0.003	0.051	1.373	0.578	0.920	0.433

PELMO 5.5.3/Winter oilseed rape 2 × 100 g a.i./ha	Scenario	Parent (μg/L)	Metabolite (μg/L)
			505M01	505M08 (Kfoc = 8.93 ml/g)	505M08 (Kfoc = 32.2 ml/g)	505M09 (Kfoc = 17.32 ml/g)	505M09 (Kfoc = 50.58 ml/g)
	Early application
	Chateaudun	0.001	0.013	1.847	0.592	1.089	0.404
	Hamburg	0.009	0.101	2.588	1.169	1.764	0.854
	Kremsmunster	0.007	0.039	1.902	0.834	1.299	0.606
	Okehampton	0.014	0.075	1.630	0.876	1.220	0.694
	Piacenza	0.004	0.045	1.253	0.601	0.927	0.459
	Porto	0.006	0.075	1.302	0.677	0.936	0.514
	Late application
	Chateaudun	< 0.001	0.013	1.822	0.599	1.095	0.403
	Hamburg	0.009	0.111	2.733	1.228	1.844	0.870
	Kremsmunster	0.007	0.043	1.914	0.857	1.312	0.616
	Okehampton	0.013	0.078	1.638	0.890	1.251	0.708
	Piacenza	0.003	0.050	1.283	0.623	0.929	0.460
	Porto	0.005	0.087	1.379	0.689	0.983	0.515

MACRO 5.5.4/Winter oilseed rape 2 × 100 g a.i./ha	Scenario	Parent (μg/L)	Metabolite (μg/L)
			505M01	505M08 (Kfoc = 8.93 ml/g)	505M08 (Kfoc = 32.2 ml/g)	505M09 (Kfoc = 17.32 ml/g)	505M09 (Kfoc = 50.58 ml/g)
	Chateaudun (early appl.)	0.001	0.015	1.480	0.447	0.857	0.299
	Chateaudun (late appl.)	0.001	0.016	1.570	0.458	0.896	0.310

PEARL 4.4.4/Sunflower 100 g a.i./ha	Scenario	Parent (μg/L)	Metabolite (μg/L)
			505M01	505M08 (Kfoc = 8.93 ml/g)	505M08 (Kfoc = 32.2 ml/g)	505M09 (Kfoc = 17.32 ml/g)	505M09 (Kfoc = 50.58 ml/g)
	Piacenza	0.004	0.024	1.050	0.438	0.684	0.340
	Sevilla	< 0.001	0.006	0.541	0.112	0.234	0.069

PELMO 5.5.3/Sunflower 100 g a.i./ha	Scenario	Parent (μg/L)	Metabolite (μg/L)
			505M01	505M08 (Kfoc = 8.93 ml/g)	505M08 (Kfoc = 32.2 ml/g)	505M09 (Kfoc = 17.32 ml/g)	505M09 (Kfoc = 50.58 ml/g)
	Piacenza	0.007	0.031	0.885	0.427	0.604	0.340
	Sevilla	< 0.001	0.009	0.590	0.129	0.270	0.062

MACRO 5.5.4/maize 100 g a.i./ha	Scenario	Parent (μg/L)	Metabolite (μg/L)
			505M01	505M08 (Kfoc = 8.93 ml/g)	505M08 (Kfoc = 32.2 ml/g)	505M09 (Kfoc = 17.32 ml/g)	505M09 (Kfoc = 50.58 ml/g)
	Chateaudun	0.001	0.018	0.813	0.308	0.507	0.205

PEC (gw) From lysimeter/field studies

–

PEC surface water and PEC sediment (Regulation (EU) N° 284/2013, Annex Part A, points 9.2.5/9.3.1)

FOCUS STEP 1 Scenario	Day after overall maximum	PECSW (μg/L)		PECSED (μg/kg)
		Actual	TWA	Actual	TWA
Twofold application to winter oilseed rape	0 h	45.989	–	173.23	–
	24 h	45.289	45.639	Not reported (a)	Not reported (a)
	2 d	45.210	45.444	Not reported (a)	Not reported (a)
	4 d	45.051	45.287	Not reported (a)	Not reported (a)
	7 d	44.815	45.135	Not reported (a)	Not reported (a)
	14 d	44.269	44.838	Not reported (a)	Not reported (a)
	21 d	43.729	44.553	Not reported (a)	Not reported (a)
	28 d	43.196	44.284	Not reported (a)	Not reported (a)
	42 d	42.149	43.746	Not reported (a)	Not reported (a)

^(a)Only initial values are reported as worst‐case estimates of short‐term and long‐term exposure.

FOCUS STEP 2 Scenario	Day after overall maximum	PECSW (μg/L)		PECSED (μg/kg)
		Actual	TWA	Actual	TWA
Northern EU Twofold application to winter oilseed rape, early application (October–February)	0 h	7.141	–	26.76	–
	24 h	6.996	7.069	Not reported (a)	Not reported (a)
	2 d	6.984	7.030	Not reported (a)	Not reported (a)
	4 d	6.960	7.001	Not reported (a)	Not reported (a)
	7 d	6.923	6.975	Not reported (a)	Not reported (a)
	14 d	6.839	6.928	Not reported (a)	Not reported (a)
	21 d	6.755	6.884	Not reported (a)	Not reported (a)
	28 d	6.673	6.842	Not reported (a)	Not reported (a)
	42 d	6.511	6.759	Not reported (a)	Not reported (a)
Southern EU Twofold application to winter oilseed rape, early application (October–February)	0 h	5.948	–	22.21	–
	24 h	5.805	5.877	Not reported (a)	Not reported (a)
	2 d	5.795	5.839	Not reported (a)	Not reported (a)
	4 d	5.775	5.812	Not reported (a)	Not reported (a)
	7 d	5.745	5.790	Not reported (a)	Not reported (a)
	14 d	5.675	5.750	Not reported (a)	Not reported (a)
	21 d	5.605	5.713	Not reported (a)	Not reported (a)
	28 d	5.537	5.678	Not reported (a)	Not reported (a)
	42 d	5.403	5.608	Not reported (a)	Not reported (a)

^(a)Only initial values are reported as worst‐case estimates of short‐term and long‐term exposure.

FOCUS STEP 2 Scenario	Day after overall maximum	PECSW (μg/L)		PECSED (μg/kg)
		Actual	TWA	Actual	TWA
Northern EU Twofold application to winter oilseed rape, late application (March–May)	0 h	3.562	–	13.09	–
	24 h	3.423	3.493	Not reported (a)	Not reported (a)
	2 d	3.417	3.457	Not reported (a)	Not reported (a)
	4 d	3.406	3.434	Not reported (a)	Not reported (a)
	7 d	3.388	3.418	Not reported (a)	Not reported (a)
	14 d	3.346	3.392	Not reported (a)	Not reported (a)
	21 d	3.306	3.370	Not reported (a)	Not reported (a)
	28 d	3.265	3.349	Not reported (a)	Not reported (a)
	42 d	3.186	3.308	Not reported (a)	Not reported (a)
Southern EU Twofold application to winter oilseed rape, late application (March–May)	0 h	5.948	–	22.21	–
	24 h	5.805	5.877	Not reported (a)	Not reported (a)
	2 d	5.795	5.839	Not reported (a)	Not reported (a)
	4 d	5.775	5.812	Not reported (a)	Not reported (a)
	7 d	5.745	5.790	Not reported (a)	Not reported (a)
	14 d	5.675	5.750	Not reported (a)	Not reported (a)
	21 d	5.605	5.713	Not reported (a)	Not reported (a)
	28 d	5.537	5.678	Not reported (a)	Not reported (a)
	42 d	5.403	5.608	Not reported (a)	Not reported (a)

^(a)Only initial values are reported as worst‐case estimates of short‐term and long‐term exposure.

FOCUS STEP 1 Scenario	Day after overall maximum	PECSW (μg/L)		PECSED (μg/kg)
		Actual	TWA	Actual	TWA
Single application to sunflowers	0 h	22.995	–	86.61	–
	24 h	22.644	22.820	Not reported (a)	Not reported (a)
	2 d	22.605	22.722	Not reported (a)	Not reported (a)
	4 d	22.526	22.644	Not reported (a)	Not reported (a)
	7 d	22.408	22.568	Not reported (a)	Not reported (a)
	14 d	22.134	22.419	Not reported (a)	Not reported (a)
	21 d	21.864	22.279	Not reported (a)	Not reported (a)
	28 d	21.598	22.142	Not reported (a)	Not reported (a)
	42 d	21.074	21.873	Not reported (a)	Not reported (a)

^(a)Only initial values are reported as worst‐case estimates of short‐term and long‐term exposure.

FOCUS STEP 2 Scenario	Day after overall maximum	PECSW (μg/L)		PECSED (μg/kg)
		Actual	TWA	Actual	TWA
Northern EU Single application to sunflowers (March–May)	0 h	1.759	–	6.42	–
	24 h	1.679	1.719	Not reported (a)	Not reported (a)
	2 d	1.677	1.699	Not reported (a)	Not reported (a)
	4 d	1.671	1.686	Not reported (a)	Not reported (a)
	7 d	1.662	1.678	Not reported (a)	Not reported (a)
	14 d	1.642	1.665	Not reported (a)	Not reported (a)
	21 d	1.622	1.654	Not reported (a)	Not reported (a)
	28 d	1.602	1.643	Not reported (a)	Not reported (a)
	42 d	1.563	1.623	Not reported (a)	Not reported (a)
Southern EU Single application to sunflowers (March–May)	0 h	2.837	–	10.54	–
	24 h	2.755	2.796	Not reported (a)	Not reported (a)
	2 d	2.750	2.774	Not reported (a)	Not reported (a)
	4 d	2.741	2.760	Not reported (a)	Not reported (a)
	7 d	2.726	2.749	Not reported (a)	Not reported (a)
	14 d	2.693	2.729	Not reported (a)	Not reported (a)
	21 d	2.660	2.712	Not reported (a)	Not reported (a)
	28 d	2.628	2.695	Not reported (a)	Not reported (a)
	42 d	2.564	2.662	Not reported (a)	Not reported (a)

^(a)Only initial values are reported as worst‐case estimates of short‐term and long‐term exposure.

FOCUS STEP 2 Scenario	Day after overall maximum	PECSW (μg/L)		PECSED (μg/kg)
		Actual	TWA	Actual	TWA
Northern EU Single application to sunflowers (June–September)	0 h	1.759	–	6.42	–
	24 h	1.679	1.719	Not reported (a)	Not reported (a)
	2 d	1.677	1.699	Not reported (a)	Not reported (a)
	4 d	1.671	1.686	Not reported (a)	Not reported (a)
	7 d	1.662	1.678	Not reported (a)	Not reported (a)
	14 d	1.642	1.665	Not reported (a)	Not reported (a)
	21 d	1.622	1.654	Not reported (a)	Not reported (a)
	28 d	1.602	1.643	Not reported (a)	Not reported (a)
	42 d	1.563	1.623	Not reported (a)	Not reported (a)
Southern EU Single application to sunflowers (June–September)	0 h	2.298	–	8.48	–
	24 h	2.217	2.258	Not reported (a)	Not reported (a)
	2 d	2.213	2.237	Not reported (a)	Not reported (a)
	4 d	2.206	2.223	Not reported (a)	Not reported (a)
	7 d	2.194	2.213	Not reported (a)	Not reported (a)
	14 d	2.167	2.197	Not reported (a)	Not reported (a)
	21 d	2.141	2.183	Not reported (a)	Not reported (a)
	28 d	2.115	2.169	Not reported (a)	Not reported (a)
	42 d	2.064	2.142	Not reported (a)	Not reported (a)

^(a)Only initial values are reported as worst‐case estimates of short‐term and long‐term exposure.

FOCUS STEP 3 and STEP 4 Scenario	Water body	Day after overall maximum	PECSW (μg/L) STEP 3		PECSW (μg/kg) STEP 4 10 m buffer (Drift + Runoff mitigation)		PECSW (μg/kg) STEP 4 20 m buffer (Drift + Runoff mitigation)
			Actual	TWA	Actual	TWA	Actual	TWA
Single application to winter oilseed rape (early application)	D2, ditch	0 h	3.805	–	3.805	–	3.805	–
		24 h	0.641	3.376	0.641	3.376	0.641	3.376
		2 d	0.483	3.118	0.483	3.118	0.483	3.118
		4 d	0.417	2.743	0.417	2.743	0.417	2.743
		7 d	0.388	2.576	0.387	2.576	0.387	2.576
		14 d	0.335	2.291	0.334	2.291	0.334	2.291
		21d	0.301	2.204	0.300	2.203	0.299	2.203
		28 d	0.275	2.131	0.273	2.130	0.273	2.130
		42 d	0.238	2.069	0.235	2.068	0.235	2.068
Single application to winter oilseed rape (early application)	D2, stream	0 h	2.671	–	2.671	–	2.671	–
		24 h	0.221	2.106	0.221	2.106	0.221	2.106
		2 d	0.199	1.833	0.199	1.833	0.199	1.833
		4 d	0.186	1.498	0.186	1.498	0.186	1.498
		7 d	0.184	1.292	0.184	1.292	0.184	1.292
		14 d	0.178	1.112	0.178	1.112	0.178	1.112
		21 d	0.174	1.052	0.174	1.051	0.174	1.051
		28 d	0.164	1.034	0.164	1.034	0.163	1.034
		42 d	0.132	0.982	0.131	0.982	0.131	0.982
Single application to winter oilseed rape (early application)	D3, ditch	0 h	0.631	–	0.091	–	0.047	–
		24 h	0.114	0.391	0.016	0.056	0.008	0.029
		2 d	0.006	0.213	0.001	0.031	0.000	0.016
		4 d	0.001	0.107	0.000	0.015	0.000	0.008
		7 d	0.000	0.062	0.000	0.009	0.000	0.005
		14 d	0.000	0.031	0.000	0.004	0.000	0.002
		21 d	0.000	0.021	0.000	0.003	0.000	0.002
		28 d	0.000	0.015	0.000	0.002	0.000	0.001
		42 d	0.000	0.010	0.000	0.001	0.000	0.001
Single application to winter oilseed rape (early application)	D4, pond	0 h	0.444	–	0.443	–	0.442	–
		24 h	0.444	0.444	0.443	0.443	0.442	0.442
		2 d	0.442	0.444	0.441	0.443	0.441	0.442
		4 d	0.438	0.443	0.437	0.442	0.437	0.442
		7 d	0.431	0.442	0.430	0.441	0.429	0.441
		14 d	0.411	0.438	0.410	0.437	0.409	0.436
		21d	0.391	0.431	0.390	0.430	0.390	0.430
		28 d	0.366	0.424	0.366	0.423	0.365	0.422
		42 d	0.326	0.407	0.325	0.406	0.325	0.406
Single application to winter oilseed rape (early application)	D4, stream	0 h	0.494	–	0.455	–	0.455	–
		24 h	0.002	0.407	0.364	0.407	0.364	0.407
		2 d	0.002	0.376	0.322	0.376	0.322	0.376
		4 d	0.002	0.362	0.270	0.362	0.270	0.362
		7 d	0.002	0.341	0.309	0.341	0.309	0.341
		14 d	0.002	0.325	0.216	0.325	0.216	0.325
		21 d	0.002	0.293	0.112	0.293	0.112	0.293
		28 d	0.002	0.250	0.064	0.250	0.064	0.250
		42 d	0.003	0.186	0.040	0.186	0.040	0.186
Single application to winter oilseed rape (early application)	D5, pond	0 h	0.244	–	0.243	–	0.242	–
		24 h	0.243	0.243	0.242	0.243	0.242	0.242
		2 d	0.242	0.243	0.242	0.243	0.241	0.242
		4 d	0.240	0.243	0.239	0.242	0.239	0.242
		7 d	0.236	0.242	0.235	0.241	0.235	0.241
		14 d	0.227	0.238	0.226	0.238	0.226	0.237
		21 d	0.219	0.234	0.218	0.234	0.217	0.233
		28 d	0.211	0.230	0.211	0.230	0.210	0.229
		42 d	0.197	0.223	0.196	0.222	0.196	0.222
Single application to winter oilseed rape (early application)	D5, stream	0 h	0.505	–	0.189	–	0.189	–
		24 h	0.044	0.153	0.146	0.153	0.146	0.153
		2 d	0.042	0.149	0.103	0.149	0.103	0.149
		4 d	0.038	0.142	0.124	0.142	0.124	0.142
		7 d	0.034	0.129	0.072	0.129	0.072	0.129
		14 d	0.037	0.104	0.055	0.104	0.055	0.104
		21d	0.033	0.083	0.038	0.083	0.038	0.083
		28 d	0.031	0.070	0.042	0.070	0.042	0.070
		42 d	0.026	0.058	0.032	0.058	0.032	0.058
Single application to winter oilseed rape (early application)	R1, pond	0 h	0.040	–	0.019	–	0.011	–
		24 h	0.039	0.039	0.018	0.019	0.010	0.011
		2 d	0.039	0.039	0.018	0.018	0.010	0.010
		4 d	0.038	0.039	0.018	0.018	0.010	0.010
		7 d	0.037	0.038	0.017	0.018	0.010	0.010
		14 d	0.034	0.037	0.016	0.017	0.009	0.010
		21 d	0.032	0.036	0.015	0.017	0.009	0.010
		28 d	0.030	0.034	0.014	0.016	0.008	0.009
		42 d	0.027	0.032	0.013	0.015	0.007	0.009
Single application to winter oilseed rape (early application)	R1 stream	0 h	0.892	–	0.390	–	0.201	–
		24 h	0.001	0.285	0.000	0.124	0.000	0.063
		2 d	0.000	0.143	0.000	0.062	0.000	0.032
		4 d	0.000	0.072	0.000	0.031	0.000	0.016
		7 d	0.000	0.041	0.000	0.018	0.000	0.009
		14 d	0.000	0.023	0.000	0.009	0.000	0.005
		21 d	0.000	0.015	0.000	0.006	0.000	0.003
		28 d	0.000	0.012	0.000	0.005	0.000	0.002
		42 d	0.000	0.008	0.000	0.003	0.000	0.002
Single application to winter oilseed rape (early application)	R3, stream	0 h	0.989	–	0.437	–	0.227	–
		24 h	0.005	0.475	0.002	0.207	0.001	0.107
		2 d	0.001	0.240	0.001	0.105	0.000	0.054
		4 d	0.000	0.120	0.000	0.052	0.000	0.027
		7 d	0.000	0.069	0.000	0.030	0.000	0.015
		14 d	0.000	0.050	0.000	0.018	0.000	0.009
		21d	0.000	0.033	0.000	0.012	0.000	0.006
		28 d	0.000	0.025	0.000	0.009	0.000	0.005
		42 d	0.000	0.017	0.000	0.006	0.000	0.003

FOCUS STEP 3 and STEP 4 Scenario	Water body	Day after overall maximum	PECSW (μg/L) STEP 3		PECSW (μg/kg) STEP 4 10 m buffer (Drift + Run‐off mitigation)		PECSW (μg/kg) STEP 4 20 m buffer (Drift + Run‐off mitigation)
			Actual	TWA	Actual	TWA	Actual	TWA
Twofold application to winter oilseed rape (early application)	D2, ditch	0 h	8.174	–	8.174	–	8.174	–
		24 h	5.914	7.138	5.914	7.138	5.914	7.138
		2 d	4.271	6.157	4.271	6.157	4.271	6.157
		4 d	3.491	4.979	3.491	4.979	3.491	4.979
		7 d	3.216	4.287	3.216	4.287	3.216	4.287
		14 d	2.772	3.838	2.771	3.837	2.771	3.837
		21d	4.397	3.554	4.397	3.554	4.397	3.554
		28 d	3.504	3.616	3.503	3.616	3.503	3.616
		42 d	2.724	3.475	2.723	3.474	2.723	3.474
Twofold application to winter oilseed rape (early application)	D2, stream	0 h	5.129	–	5.129	–	5.129	–
		24 h	3.445	4.385	3.445	4.385	3.445	4.385
		2 d	2.388	3.475	2.388	3.475	2.388	3.475
		4 d	1.363	2.607	1.363	2.607	1.363	2.607
		7 d	1.341	2.177	1.341	2.177	1.341	2.177
		14 d	1.265	2.071	1.264	2.071	1.264	2.071
		21 d	1.533	1.914	1.533	1.914	1.533	1.914
		28 d	1.478	1.820	1.478	1.820	1.478	1.820
		42 d	1.241	1.657	1.241	1.657	1.241	1.657
Twofold application to winter oilseed rape (early application)	D3, ditch	0 h	0.552	–	0.074	–	0.038	–
		24 h	0.172	0.388	0.023	0.052	0.012	0.027
		2 d	0.013	0.225	0.002	0.030	0.001	0.015
		4 d	0.001	0.114	0.000	0.015	0.000	0.008
		7 d	0.000	0.066	0.000	0.009	0.000	0.004
		14 d	0.000	0.033	0.000	0.004	0.000	0.002
		21 d	0.000	0.022	0.000	0.003	0.000	0.002
		28 d	0.000	0.016	0.000	0.002	0.000	0.001
		42 d	0.000	0.020	0.000	0.003	0.000	0.001
Twofold application to winter oilseed rape (early application)	D4, pond	0 h	0.917	–	0.915	–	0.914	–
		24 h	0.916	0.916	0.914	0.915	0.913	0.914
		2 d	0.913	0.916	0.911	0.914	0.911	0.914
		4 d	0.905	0.915	0.903	0.914	0.903	0.913
		7 d	0.889	0.914	0.888	0.912	0.887	0.911
		14 d	0.848	0.905	0.847	0.903	0.846	0.902
		21d	0.807	0.891	0.806	0.889	0.805	0.888
		28 d	0.757	0.875	0.755	0.874	0.755	0.873
		42 d	0.673	0.841	0.672	0.839	0.671	0.839
Twofold application to winter oilseed rape (early application)	D4, stream	0 h	0.947	–	0.947	–	0.947	–
		24 h	0.766	0.851	0.766	0.851	0.766	0.851
		2 d	0.682	0.790	0.682	0.790	0.682	0.790
		4 d	0.575	0.759	0.575	0.759	0.575	0.759
		7 d	0.642	0.718	0.642	0.718	0.642	0.718
		14 d	0.427	0.678	0.427	0.678	0.427	0.678
		21 d	0.223	0.605	0.223	0.605	0.223	0.605
		28 d	0.131	0.514	0.131	0.514	0.131	0.514
		42 d	0.080	0.382	0.080	0.382	0.080	0.382
Twofold application to winter oilseed rape (early application)	D5, pond	0 h	0.513	–	0.512	–	0.511	–
		24 h	0.512	0.513	0.511	0.512	0.510	0.511
		2 d	0.510	0.513	0.509	0.511	0.508	0.511
		4 d	0.506	0.512	0.504	0.510	0.503	0.510
		7 d	0.497	0.509	0.496	0.508	0.495	0.507
		14 d	0.478	0.502	0.477	0.501	0.476	0.500
		21 d	0.461	0.494	0.460	0.493	0.459	0.492
		28 d	0.446	0.486	0.445	0.485	0.443	0.484
		42 d	0.416	0.470	0.415	0.469	0.414	0.468

Twofold application to winter oilseed rape (early application)	D5, stream	0 h	0.512	–	0.397	–	0.397	–
		24 h	0.067	0.320	0.321	0.320	0.321	0.320
		2 d	0.065	0.313	0.241	0.313	0.241	0.313
		4 d	0.061	0.298	0.180	0.298	0.180	0.298
		7 d	0.054	0.270	0.118	0.270	0.118	0.270
		14 d	0.058	0.218	0.072	0.218	0.072	0.218
		21d	0.072	0.176	0.051	0.176	0.051	0.176
		28 d	0.069	0.148	0.038	0.148	0.038	0.148
		42 d	0.038	0.123	0.067	0.123	0.067	0.123
Twofold application to winter oilseed rape (early application)	R1, pond	0 h	0.083	–	0.037	–	0.020	–
		24 h	0.081	0.082	0.037	0.037	0.020	0.020
		2 d	0.081	0.082	0.036	0.037	0.020	0.020
		4 d	0.079	0.081	0.036	0.036	0.019	0.020
		7 d	0.077	0.079	0.035	0.036	0.019	0.020
		14 d	0.072	0.077	0.032	0.035	0.018	0.019
		21 d	0.068	0.075	0.031	0.034	0.017	0.018
		28 d	0.064	0.072	0.029	0.033	0.016	0.018
		42 d	0.057	0.068	0.026	0.031	0.014	0.017
Twofold application to winter oilseed rape (early application)	R1 stream	0 h	1.634	–	0.715	–	0.369	–
		24 h	0.001	0.523	0.000	0.226	0.000	0.116
		2 d	0.000	0.262	0.000	0.113	0.000	0.058
		4 d	0.000	0.131	0.000	0.057	0.000	0.029
		7 d	0.000	0.077	0.000	0.034	0.000	0.017
		14 d	0.000	0.053	0.000	0.023	0.000	0.012
		21 d	0.000	0.035	0.000	0.015	0.000	0.008
		28 d	0.000	0.033	0.000	0.014	0.000	0.007
		42 d	0.000	0.031	0.000	0.013	0.000	0.007
Twofold application to winter oilseed rape (early application)	R3, stream	0 h	0.989	–	0.437	–	0.227	–
		24 h	0.005	0.569	0.002	0.262	0.001	0.137
		2 d	0.001	0.294	0.001	0.135	0.000	0.071
		4 d	0.000	0.148	0.000	0.068	0.000	0.036
		7 d	0.000	0.085	0.000	0.039	0.000	0.020
		14 d	0.000	0.048	0.000	0.021	0.000	0.011
		21d	0.000	0.032	0.000	0.014	0.000	0.007
		28 d	0.000	0.024	0.000	0.011	0.000	0.006
		42 d	0.000	0.026	0.000	0.012	0.000	0.006

FOCUS STEP 3 and STEP 4 Scenario	Water body	Day after overall maximum	PECSW (μg/L) STEP 3		PECSW (μg/kg) STEP 4 10 m buffer (Drift + Run‐off mitigation)		PECSW (μg/kg) STEP 4 20 m buffer (Drift + Run‐off mitigation)
			Actual	TWA	Actual	TWA	Actual	TWA
Single application to winter oilseed rape (late application)	D2, ditch	0 h	2.060	–	2.060	–	2.060	–
		24 h	0.501	1.440	0.500	1.440	0.500	1.440
		2 d	1.516	1.297	1.516	1.297	1.516	1.297
		4 d	0.390	1.142	0.389	1.142	0.389	1.142
		7 d	0.347	1.156	0.346	1.155	0.346	1.155
		14 d	0.905	1.120	0.904	1.120	0.904	1.120
		21d	1.369	1.051	1.369	1.051	1.369	1.051
		28 d	0.971	1.009	0.971	1.009	0.971	1.009
		42 d	0.755	0.918	0.754	0.918	0.754	0.918
Single application to winter oilseed rape (late application)	D2, stream	0 h	1.289	–	1.289	–	1.289	–
		24 h	0.143	0.828	0.143	0.828	0.143	0.828
		2 d	0.834	0.759	0.834	0.759	0.834	0.759
		4 d	0.146	0.675	0.146	0.675	0.146	0.675
		7 d	0.224	0.662	0.224	0.662	0.224	0.662
		14 d	0.454	0.656	0.454	0.656	0.454	0.656
		21 d	0.782	0.615	0.782	0.615	0.782	0.615
		28 d	0.616	0.585	0.616	0.585	0.616	0.585
		42 d	0.456	0.536	0.456	0.536	0.456	0.536
Single application to winter oilseed rape (late application)	D3, ditch	0 h	0.635	–	0.091	–	0.047	–
		24 h	0.394	0.527	0.057	0.076	0.029	0.039
		2 d	0.101	0.377	0.015	0.054	0.008	0.028
		4 d	0.006	0.204	0.001	0.029	0.000	0.015
		7 d	0.001	0.118	0.000	0.017	0.000	0.009
		14 d	0.000	0.059	0.000	0.009	0.000	0.004
		21 d	0.000	0.040	0.000	0.006	0.000	0.003
		28 d	0.000	0.030	0.000	0.004	0.000	0.002
		42 d	0.000	0.020	0.000	0.003	0.000	0.001
Single application to winter oilseed rape (late application)	D4, pond	0 h	0.309	–	0.307	–	0.306	–
		24 h	0.309	0.309	0.307	0.307	0.306	0.306
		2 d	0.308	0.309	0.306	0.307	0.305	0.306
		4 d	0.305	0.309	0.303	0.307	0.302	0.306
		7 d	0.299	0.308	0.298	0.306	0.297	0.305
		14 d	0.285	0.305	0.284	0.303	0.283	0.302
		21d	0.272	0.300	0.270	0.299	0.269	0.298
		28 d	0.255	0.295	0.253	0.293	0.253	0.292
		42 d	0.227	0.283	0.226	0.282	0.225	0.281
Single application to winter oilseed rape (late application)	D4, stream	0 h	0.534	–	0.309	–	0.309	–
		24 h	0.001	0.275	0.245	0.275	0.245	0.275
		2 d	0.000	0.254	0.216	0.254	0.216	0.254
		4 d	0.000	0.244	0.180	0.244	0.180	0.244
		7 d	0.000	0.229	0.213	0.229	0.213	0.229
		14 d	0.000	0.222	0.155	0.222	0.155	0.222
		21 d	0.000	0.202	0.079	0.202	0.079	0.202
		28 d	0.000	0.173	0.045	0.173	0.045	0.173
		42 d	0.000	0.129	0.029	0.129	0.029	0.129
Single application to winter oilseed rape (late application)	D5, pond	0 h	0.201	–	0.200	–	0.199	–
		24 h	0.201	0.201	0.200	0.200	0.199	0.199
		2 d	0.200	0.201	0.199	0.200	0.198	0.199
		4 d	0.199	0.201	0.198	0.199	0.197	0.199
		7 d	0.197	0.200	0.196	0.199	0.195	0.198
		14 d	0.191	0.198	0.190	0.197	0.189	0.196
		21 d	0.186	0.196	0.184	0.195	0.184	0.194
		28 d	0.180	0.193	0.179	0.192	0.179	0.192
		42 d	0.177	0.189	0.176	0.188	0.176	0.187

Single application to winter oilseed rape (late application)	D5, stream	0 h	0.591	–	0.198	–	0.198	–
		24 h	0.005	0.226	0.163	0.164	0.163	0.164
		2 d	0.001	0.158	0.125	0.158	0.125	0.158
		4 d	0.000	0.142	0.141	0.142	0.141	0.142
		7 d	0.000	0.–35	0.095	0.135	0.095	0.135
		14 d	0.000	0.112	0.077	0.112	0.077	0.112
		21d	0.000	0.098	0.059	0.098	0.059	0.098
		28 d	0.000	0.089	0.066	0.089	0.066	0.089
		42 d	0.000	0.080	0.052	0.080	0.052	0.080
Single application to winter oilseed rape (late application)	R1, pond	0 h	0.129	–	0.055	–	0.029	–
		24 h	0.127	0.128	0.055	0.055	0.029	0.029
		2 d	0.126	0.127	0.054	0.055	0.029	0.029
		4 d	0.123	0.126	0.053	0.054	0.028	0.029
		7 d	0.120	0.124	0.051	0.053	0.027	0.028
		14 d	0.112	0.120	0.048	0.052	0.025	0.027
		21 d	0.105	0.116	0.045	0.050	0.024	0.026
		28 d	0.101	0.113	0.043	0.049	0.023	0.026
		42 d	0.091	0.113	0.039	0.049	0.021	0.026
Single application to winter oilseed rape (late application)	R1 stream	0 h	1.247	–	0.566	–	0.296	–
		24 h	0.002	0.668	0.001	0.303	0.001	0.159
		2 d	0.001	0.335	0.000	0.152	0.000	0.080
		4 d	0.005	0.168	0.000	0.076	0.000	0.040
		7 d	0.001	0.142	0.001	0.064	0.000	0.033
		14 d	0.105	0.097	0.004	0.044	0.002	0.023
		21 d	0.000	0.078	0.000	0.035	0.000	0.018
		28 d	0.000	0.060	0.000	0.026	0.000	0.014
		42 d	0.000	0.045	0.000	0.020	0.000	0.011
Single application to winter oilseed rape (late application)	R3, stream	0 h	0.589	–	0.191	–	0.100	–
		24 h	0.002	0.341	0.072	0.157	0.039	0.083
		2 d	0.000	0.276	0.032	0.127	0.017	0.067
		4 d	0.000	0.171	0.000	0.079	0.000	0.042
		7 d	0.000	0.098	0.000	0.045	0.000	0.024
		14 d	0.000	0.058	0.000	0.027	0.000	0.014
		21d	0.000	0.038	0.000	0.018	0.000	0.009
		28 d	0.000	0.029	0.000	0.013	0.000	0.007
		42 d	0.000	0.019	0.003	0.009	0.002	0.005

FOCUS STEP 3 and STEP 4 Scenario	Water body	Day after overall maximum	PECSW (μg/L) STEP 3		PECSW (μg/kg) STEP 4 10 m buffer (Drift + Runoff mitigation)		PECSW (μg/kg) STEP 4 20 m buffer (Drift + Runoff mitigation)
			Actual	TWA	Actual	TWA	Actual	TWA
Twofold application to winter oilseed rape (late application)	D2, ditch	0 h	6.392	–	6.392	–	6.392	–
		24 h	1.690	4.102	1.689	4.102	1.689	4.102
		2 d	1.459	3.309	1.457	3.309	1.457	3.309
		4 d	1.236	3.257	1.233	3.257	1.232	3.257
		7 d	1.121	3.022	1.115	3.022	1.115	3.022
		14 d	0.947	2.855	0.938	2.855	0.937	2.855
		21d	0.833	2.718	0.821	2.718	0.820	2.718
		28 d	0.750	2.688	0.736	2.687	0.735	2.687
		42 d	2.169	2.496	2.168	2.496	2.168	2.496
Twofold application to winter oilseed rape (late application)	D2, stream	0 h	3.995	–	3.995	–	3.995	–
		24 h	0.328	2.237	0.328	2.237	0.328	2.237
		2 d	0.299	1.980	0.299	1.980	0.299	1.980
		4 d	0.296	1.784	0.296	1.784	0.296	1.784
		7 d	0.300	1.760	0.299	1.760	0.299	1.760
		14 d	0.296	1.601	0.293	1.601	0.293	1.601
		21 d	0.279	1.562	0.275	1.562	0.274	1.562
		28 d	0.253	1.518	0.248	1.518	0.247	1.518
		42 d	0.969	1.430	0.969	1.430	0.969	1.430
Twofold application to winter oilseed rape (late application)	D3, ditch	0 h	0.555	–	0.075	–	0.038	–
		24 h	0.344	0.461	0.046	0.062	0.024	0.032
		2 d	0.089	0.330	0.012	0.044	0.006	0.023
		4 d	0.005	0.178	0.001	0.024	0.000	0.012
		7 d	0.001	0.103	0.000	0.014	0.000	0.007
		14 d	0.000	0.052	0.000	0.007	0.000	0.004
		21 d	0.000	0.035	0.000	0.005	0.000	0.002
		28 d	0.000	0.026	0.000	0.003	0.000	0.002
		42 d	0.000	0.031	0.000	0.004	0.000	0.002
Twofold application to winter oilseed rape (late application)	D4, pond	0 h	0.705	–	0.702	–	0.701	–
		24 h	0.704	0.705	0.701	0.702	0.700	0.701
		2 d	0.702	0.704	0.699	0.702	0.698	0.700
		4 d	0.696	0.704	0.693	0.701	0.692	0.700
		7 d	0.684	0.702	0.681	0.700	0.680	0.698
		14 d	0.652	0.695	0.649	0.693	0.648	0.691
		21d	0.621	0.685	0.618	0.682	0.617	0.681
		28 d	0.582	0.673	0.580	0.670	0.579	0.669
		42 d	0.518	0.646	0.516	0.644	0.515	0.643
Twofold application to winter oilseed rape (late application)	D4, stream	0 h	0.714	–	0.714	–	0.714	–
		24 h	0.572	0.639	0.572	0.639	0.572	0.639
		2 d	0.507	0.591	0.507	0.591	0.507	0.591
		4 d	0.427	0.567	0.427	0.567	0.427	0.567
		7 d	0.498	0.536	0.498	0.536	0.498	0.536
		14 d	0.338	0.515	0.338	0.515	0.338	0.515
		21 d	0.173	0.463	0.173	0.463	0.173	0.463
		28 d	0.101	0.394	0.101	0.394	0.101	0.394
		42 d	0.064	0.293	0.064	0.293	0.064	0.293
Twofold application to winter oilseed rape (late application)	D5, pond	0 h	0.434	–	0.432	–	0.431	–
		24 h	0.433	0.434	0.431	0.432	0.430	0.431
		2 d	0.432	0.434	0.430	0.432	0.429	0.431
		4 d	0.429	0.433	0.427	0.431	0.426	0.430
		7 d	0.423	0.432	0.421	0.430	0.420	0.429
		14 d	0.409	0.427	0.407	0.425	0.406	0.424
		21 d	0.396	0.421	0.394	0.419	0.393	0.418
		28 d	0.384	0.415	0.382	0.413	0.381	0.412
		42 d	0.369	0.404	0.368	0.402	0.367	0.401
Twofold application to winter oilseed rape (late application)	D5, stream	0 h	0.530	–	0.356	–	0.356	–
		24 h	0.037	0.291	0.289	0.291	0.289	0.291
		2 d	0.030	0.279	0.220	0.279	0.220	0.279
		4 d	0.011	0.251	0.248	0.251	0.248	0.251
		7 d	0.001	0.236	0.165	0.236	0.165	0.236
		14 d	0.000	0.196	0.131	0.196	0.131	0.196
		21d	0.000	0.170	0.101	0.170	0.101	0.170
		28 d	0.000	0.154	0.111	0.154	0.111	0.154
		42 d	0.000	0.137	0.090	0.137	0.090	0.137
Twofold application to winter oilseed rape (late application)	R1, pond	0 h	0.203	–	0.087	–	0.046	–
		24 h	0.199	0.201	0.085	0.086	0.045	0.046
		2 d	0.196	0.199	0.084	0.086	0.044	0.045
		4 d	0.192	0.197	0.082	0.084	0.043	0.045
		7 d	0.185	0.193	0.080	0.083	0.042	0.044
		14 d	0.173	0.186	0.074	0.080	0.039	0.042
		21 d	0.161	0.180	0.069	0.077	0.037	0.041
		28 d	0.162	0.176	0.070	0.076	0.037	0.040
		42 d	0.156	0.169	0.067	0.072	0.035	0.038
Twofold application to winter oilseed rape (late application)	R1 stream	0 h	1.259	–	0.573	–	0.300	–
		24 h	0.003	1.024	0.001	0.467	0.001	0.245
		2 d	0.001	0.516	0.001	0.236	0.000	0.124
		4 d	0.000	0.259	0.000	0.118	0.000	0.062
		7 d	0.000	0.148	0.000	0.068	0.000	0.035
		14 d	0.000	0.074	0.000	0.034	0.000	0.018
		21 d	0.000	0.057	0.000	0.026	0.000	0.013
		28 d	0.000	0.057	0.000	0.025	0.000	0.013
		42 d	0.000	0.051	0.000	0.022	0.000	0.012
Twofold application to winter oilseed rape (late application)	R3, stream	0 h	1.510	–	0.688	–	0.361	–
		24 h	0.016	1.013	0.007	0.466	0.004	0.245
		2 d	0.003	0.520	0.002	0.239	0.001	0.126
		4 d	0.001	0.261	0.000	0.120	0.000	0.063
		7 d	0.000	0.173	0.000	0.077	0.000	0.040
		14 d	0.000	0.097	0.000	0.040	0.000	0.021
		21d	0.000	0.065	0.000	0.028	0.000	0.015
		28 d	0.000	0.050	0.000	0.021	0.000	0.011
		42 d	0.000	0.044	0.000	0.017	0.000	0.009

FOCUS STEP 3 and STEP 4 Scenario	Water body	Day after overall maximum	PECSW (μg/L) STEP 3		PECSW (μg/kg) STEP 4 10 m buffer (Drift + Runoff mitigation)		PECSW (μg/kg) STEP 4 20 m buffer (Drift + Runoff mitigation)
			Actual	TWA	Actual	TWA	Actual	TWA
Single application to sunflower	D5, pond	0 h	0.193	–	0.191	–	0.190	–
		24 h	0.192	0.193	0.191	0.191	0.190	0.190
		2 d	0.192	0.193	0.190	0.191	0.189	0.190
		4 d	0.189	0.192	0.188	0.191	0.187	0.190
		7 d	0.186	0.191	0.184	0.189	0.183	0.189
		14 d	0.178	0.188	0.177	0.186	0.176	0.185
		21 d	0.171	0.184	0.170	0.183	0.169	0.182
		28 d	0.166	0.181	0.164	0.180	0.163	0.179
		42 d	0.155	0.175	0.154	0.174	0.153	0.173
Single application to sunflower	D5, stream	0 h	0.513	–	0.229	–	0.229	–
		24 h	0.004	0.196	0.185	0.187	0.185	0.187
		2 d	0.001	0.181	0.131	0.181	0.131	0.181
		4 d	0.000	0.157	0.149	0.157	0.149	0.157
		7 d	0.000	0.144	0.080	0.144	0.080	0.144
		14 d	0.000	0.107	0.048	0.107	0.048	0.107
		21d	0.000	0.084	0.027	0.084	0.027	0.084
		28 d	0.000	0.071	0.029	0.071	0.029	0.071
		42 d	0.000	0.056	0.020	0.056	0.020	0.056
Single application to sunflower	R1, pond	0 h	0.278	–	0.117	–	0.061	–
		24 h	0.274	0.276	0.116	0.116	0.060	0.060
		2 d	0.271	0.274	0.114	0.116	0.059	0.060
		4 d	0.265	0.271	0.112	0.114	0.058	0.059
		7 d	0.256	0.267	0.108	0.113	0.056	0.058
		14 d	0.239	0.261	0.101	0.110	0.052	0.057
		21 d	0.223	0.258	0.094	0.109	0.049	0.056
		28 d	0.210	0.252	0.088	0.106	0.046	0.055
		42 d	0.185	0.239	0.078	0.101	0.040	0.052
Single application to sunflower	R1 stream	0 h	1.167	–	0.528	–	0.276	–
		24 h	0.002	0.836	0.001	0.382	0.001	0.201
		2 d	0.001	0.512	0.000	0.231	0.000	0.120
		4 d	0.780	0.345	0.306	0.154	0.151	0.080
		7 d	0.006	0.279	0.003	0.125	0.001	0.065
		14 d	0.000	0.145	0.000	0.064	0.000	0.033
		21 d	0.000	0.116	0.000	0.051	0.000	0.027
		28 d	0.000	0.087	0.000	0.038	0.000	0.020
		42 d	0.000	0.058	0.000	0.026	0.000	0.013
Single application to sunflower	R3, stream	0 h	0.865	–	0.394	–	0.207	–
		24 h	0.010	0.716	0.005	0.329	0.002	0.173
		2 d	0.003	0.383	0.001	0.176	0.001	0.093
		4 d	0.001	0.192	0.000	0.088	0.000	0.047
		7 d	0.628	0.110	0.286	0.051	0.150	0.027
		14 d	0.000	0.095	0.000	0.044	0.000	0.023
		21d	0.001	0.080	0.000	0.037	0.000	0.019
		28 d	0.001	0.068	0.000	0.031	0.000	0.017
		42 d	0.000	0.050	0.000	0.023	0.000	0.012
Single application to sunflower	R4, stream	0 h	1.283	–	0.584	–	0.306	–
		24 h	0.003	1.009	0.009	0.460	0.005	0.241
		2 d	0.001	0.508	0.001	0.231	0.000	0.121
		4 d	0.000	0.255	0.000	0.116	0.000	0.061
		7 d	0.000	0.146	0.000	0.066	0.000	0.035
		14 d	0.000	0.112	0.000	0.051	0.000	0.027
		21d	0.187	0.089	0.085	0.040	0.045	0.021
		28 d	0.000	0.075	0.001	0.034	0.000	0.018
		42 d	0.000	0.051	0.000	0.023	0.000	0.012

FOCUS STEP 3 Scenario	Waterbody	Maximum PECSED (μg/kg) STEP 3 (a)
Single application to winter oilseed rape (early application)	D2, ditch	9.626
	D2, stream	5.288
	D3, ditch	0.183
	D4, pond	1.895
	D4, stream	0.712
	D5, pond	1.515
	D5, stream	0.336
	R1, pond	0.162
	R1, stream	0.185
	R3, stream	0.271

^(a)Only maximum values at STEP 3 are reported as worst‐case estimates of short‐term and long‐term exposure.

FOCUS STEP 3 Scenario	Waterbody	Maximum PECSED (μg/kg) STEP 3 (a)
Twofold application to winter oilseed rape (early application)	D2, ditch	17.850
	D2, stream	9.660
	D3, ditch	0.203
	D4, pond	3.818
	D4, stream	1.437
	D5, pond	3.132
	D5, stream	0.698
	R1, pond	0.390
	R1, stream	0.509
	R3, stream	0.310

^(a)Only maximum values at STEP 3 are reported as worst‐case estimates of short‐term and long‐term exposure.

FOCUS STEP 3 Scenario	Waterbody	Maximum PECSED (μg/kg) STEP 3 (a)
Single application to winter oilseed rape (late application)	D2, ditch	5.623
	D2, stream	3.067
	D3, ditch	0.267
	D4, pond	1.352
	D4, stream	0.501
	D5, pond	1.597
	D5, stream	0.345
	R1, pond	0.519
	R1, stream	0.481
	R3, stream	0.273

^(a)Only maximum values at STEP 3 are reported as worst‐case estimates of short‐term and long‐term exposure.

FOCUS STEP 3 Scenario	Waterbody	Maximum PECSED (μg/kg) STEP 3 (a)
Twofold application to winter oilseed rape (late application)	D2, ditch	12.550
	D2, stream	7.234
	D3, ditch	0.268
	D4, pond	2.984
	D4, stream	1.119
	D5, pond	3.016
	D5, stream	0.657
	R1, pond	0.776
	R1, stream	0.758
	R3, stream	0.617

^(a)Only maximum values at STEP 3 are reported as worst‐case estimates of short‐term and long‐term exposure.

FOCUS STEP 3 Scenario	Waterbody	Maximum PECSED (μg/kg) STEP 3 (a)
Single application to sunflower	D5, pond	1.298
	D5, stream	0.271
	R1, pond	0.965
	R1, stream	0.972
	R3, stream	0.553
	R4, stream	0.511

^(a)Only maximum values at STEP 3 are reported as worst‐case estimates of short‐term and long‐term exposure.

FOCUS STEP 1	Single application		Twofold application
	Max. PECSW (μg/L) (a)	Max. PECSED (μg/kg) (a)	Max. PECSW (μg/L) (a)	Max. PECSED (μg/kg) (a)
Winter oilseed rape	5.69	0.41	11.38	0.82
Sunflowers	5.69	0.41	Not applicable	Not applicable

^(a): Only initial values are reported as worst‐case estimates of short‐term and long‐term exposure.

FOCUS STEP 2	Single application		Twofold application
	Max. PECSW (μg/L) (a)	Max. PECSED (μg/kg) (a)	Max. PECSW (μg/L) (a)	Max. PECSED (μg/kg) (a)
Northern EU
Winter oilseed rape, early application (October–February)	0.65	0.05	0.81	0.06
Winter oilseed rape, late application (March–May)	0.27	0.02	0.35	0.03
Sunflowers (March–May)	0.23	0.02	Not applicable	Not applicable
Sunflowers (June–September)	0.23	0.02	Not applicable	Not applicable
Southern EU
Winter oilseed rape, early application (October–February)	0.52	0.04	0.65	0.05
Winter oilseed rape, late application (March–May)	0.52	0.04	0.65	0.05
Sunflowers (March–May)	0.44	0.03	Not applicable	Not applicable
Sunflowers (June–September)	0.34	0.02	Not applicable	Not applicable

^(a): Only initial values are reported as worst‐case estimates of short‐term and long‐term exposure.

FOCUS STEP 1	Single application		Twofold application
	Max. PECSW (μg/L) (a)	Max. PECSED (μg/kg) (a)	Max. PECSW (μg/L) (a)	Max. PECSED (μg/kg) (a)
Winter oilseed rape	6.84	0.61	13.68	1.22
Sunflowers	6.84	0.61	Not applicable	Not applicable

^(a)Only initial values are reported as worst‐case estimates of short‐term and long‐term exposure.

FOCUS STEP 2	Single application		Twofold application
	Max. PECSW (μg/L) (a)	Max. PECSED (μg/kg) (a)	Max. PECSW (μg/L) (a)	Max. PECSED (μg/kg) (a)
Northern EU
Winter oilseed rape, early application (October–February)	1.02	0.09	1.77	0.16
Winter oilseed rape, late application (March–May)	0.43	0.04	0.75	0.07
Sunflowers (March–May)	0.37	0.03	Not applicable	Not applicable
Sunflowers (June–September)	0.37	0.03	Not applicable	Not applicable
Southern EU
Winter oilseed rape, early application (October–February)	0.82	0.07	1.43	0.13
Winter oilseed rape, late application (March–May)	0.82	0.07	1.43	0.13
Sunflowers (March–May)	0.69	0.06	Not applicable	Not applicable
Sunflowers (June–September)	0.53	0.05	Not applicable	Not applicable

^(a)Only initial values are reported as worst‐case estimates of short‐term and long‐term exposure.

FOCUS STEP 1	Single application		Twofold application
	Max. PECSW (μg/L) (a)	Max. PECSED (μg/kg) (a)	Max. PECSW (μg/L) (a)	Max. PECSED (μg/kg) (a)
Winter oilseed rape	7.46	1.29	14.93	2.58
Sunflowers	7.46	1.29	Not applicable	Not applicable

^(a)Only initial values are reported as worst‐case estimates of short‐term and long‐term exposure.

FOCUS STEP 2	Single application		Twofold application
	Max. PECSW (μg/L) (a)	Max. PECSED (μg/kg) (a)	Max. PECSW (μg/L) (a)	Max. PECSED (μg/kg) (a)
Northern EU
Winter oilseed rape, early application (October–February)	1.13	0.20	2.00	0.35
Winter oilseed rape, late application (March–May)	0.49	0.08	0.87	0.15
Sunflowers (March–May)	0.42	0.07	Not applicable	Not applicable
Sunflowers (June–September)	0.42	0.07	Not applicable	Not applicable
Southern EU
Winter oilseed rape, early application (October–February)	0.92	0.16	1.62	0.28
Winter oilseed rape, late application (March–May)	0.92	0.16	1.62	0.28
Sunflowers (March–May)	0.78	0.13	Not applicable	Not applicable
Sunflowers (June–September)	0.60	0.10	Not applicable	Not applicable

^(a)Only initial values are reported as worst‐case estimates of short‐term and long‐term exposure.

FOCUS STEP 1	Single application		Twofold application
	Max. PECSW (μg/L) (a)	Max. PECSED (μg/kg) (a)	Max. PECSW (μg/L) (a)	Max. PECSED (μg/kg) (a)
Winter oilseed rape	2.22	0.00	4.44	0.00
Sunflowers	2.22	0.00	Not applicable	Not applicable

^(a)Only initial values are reported as worst‐case estimates of short‐term and long‐term exposure.

FOCUS STEP 2	Single application		Twofold application
	Max. PECSW (μg/L) (a)	Max. PECSED (μg/kg) (a)	Max. PECSW (μg/L) (a)	Max. PECSED (μg/kg) (a)
Northern EU
Winter oilseed rape, early application (October–February)	0.38	0.00	0.69	0.00
Winter oilseed rape, late application (March–May)	0.19	0.00	0.34	0.00
Sunflowers (March–May)	0.16	0.00	Not applicable	Not applicable
Sunflowers (June–September)	0.16	0.00	Not applicable	Not applicable
Southern EU
Winter oilseed rape, early application (October–February)	0.31	0.00	0.57	0.00
Winter oilseed rape, late application (March–May)	0.31	0.00	0.57	0.00
Sunflowers (March–May)	0.27	0.00	Not applicable	Not applicable
Sunflowers (June–September)	0.22	0.00	Not applicable	Not applicable

^(a)Only initial values are reported as worst‐case estimates of short‐term and long‐term exposure.

Estimation of concentrations from other routes of exposure (Regulation (EU) N° 284/2013, Annex Part A, point 9.4)

Ecotoxicology

Effects on birds and other terrestrial vertebrates (Regulation (EU) N° 283/2013, Annex Part A, point 8.1 and Regulation (EU) N° 284/2013, Annex Part A, point 10.1)

Species	Test substance	Timescale	End point	Toxicity (mg/kg bw per day)
Birds
Colinus virginianus	Dimoxystrobin	Acute	LD50	> 2,000
			LD50 extrapolated	3,776
Colinus virginianus	BAS 540 01 F	Acute	LD50	> 2,000
Colinus virginianus	Dimoxystrobin	Short term	LC50	> 1,043
Anas platyrhynchos	Dimoxystrobin	Short term	LC50	> 232
Colinus virginianus	Dimoxystrobin	Long term	NOAEL	77
Anas platyrhynchos	Dimoxystrobin	Long term	NOAEL	36
Mammals
Rattus	Dimoxystrobin	Acute	LD50	> 5,000
Rattus	BAS 540 01 F	Acute	LD50	> 300
Rattus	Dimoxystrobin	Long term (two generation)	NOAEL	12

Endocrine‐disrupting properties (Annex Part A, points 8.1.5). Specific information on the ED properties of dimoxystrobin for non‐target organisms is not available. A preliminary assessment of the available XETA test in line with OECD TG 248 was available. For details, please refer to the ED assessment in Vol 1. Additional higher tier studies (Annex Part A, points 10.1.1.2): A number of residue decline studies were submitted for the refinement of the birds & mammals section. Further information can be found in Vol 3 B9 CP (Section B.9.2.2.1). Terrestrial vertebrate wildlife (birds, mammals, reptile and amphibians) (Annex Part A, points 8.1.4, 10.1.3): See information in Vol 3 B9 CA, B.9.1.4.

Toxicity/exposure ratios for terrestrial vertebrates (Regulation (EU) N° 284/2013, Part A, Annex point 10.1)

Oilseed rape at 100 g a.s./ha × 2 applications; interval of 28 d

Sunflower at 100 g a.s./ha × 1 application

Growth stage	Indicator or focal species	Timescale	DDD (mg/kg bw per day)	TER	Trigger
Screening Step (Birds)
Oilseed rape	Small omnivorous bird	Acute	17.47	216.2	10
Oilseed rape	Small omnivorous bird	Long term	3.78	9.5	5
Sunflower	Small omnivorous bird	Acute	15.88	237.8	10
Sunflower	Small omnivorous bird	Long term	3.43	10.5	5
Screening Step (Birds) 0.56 kg formulation/ha using a measured LD50 for BAS 540 01 F
Oilseed rape	Small omnivorous bird	Acute	97.82	> 20.4	10
Sunflower	Small omnivorous bird	Acute	88.93	> 22.5	10
Screening Step (Mammals)
Oilseed rape	Small herbivorous mammal	Acute	13.02	> 383.9	10
Oilseed rape	Small herbivorous mammal	Long term	2.82	4.26	5
Sunflower	Small herbivorous mammal	Acute	11.84	> 422.3	10
Sunflower	Small herbivorous mammal	Long term	2.56	4.69	5
Tier 1 (Mammals) – long term
Oilseed rape BBCH 10–29	Small omnivorous mammal ‘mouse’	Long term	0.46	26.09	5
Oilseed rape BBCH ≥20	Small insectivorous mammal ‘shrew’	Long term	0.11	109.1	5
Oilseed rape BBCH 30–39	Small omnivorous mammal ‘mouse’	Long term	0.13	92.31	5
Oilseed rape BBCH ≥40	Small herbivorous mammal ‘vole’	Long term	1.06	11.32	5
Oilseed rape BBCH ≥40	Small omnivorous mammal ‘mouse’	Long term	0.11	109.1	5
Oilseed rape All season	Large herbivorous mammal ‘lagomorph’	Long term	0.83	14.46	5
Sunflower BBCH ≥20	Small insectivorous mammal ‘shrew’	Long term	0.1	120	5
Sunflower BBCH ≥40	Large herbivorous mammal ‘lagomorph’	Long term	0.19	63.16	5
Sunflower BBCH ≥40	Small herbivorous mammal ‘vole’	Long term	0.96	12.5	5
Sunflower BBCH ≥40	Small omnivorous mammal ‘mouse’	Long term	0.1	120	5

Higher tier (Mammals): Not required.

Risk from bioaccumulation and food chain behaviour
Indicator or focal species	Time scale	DDD (mg/kg bw per day)	TER	Trigger
Earthworm‐eating birds	Long‐term	0.394	91.4	5
Earthworm‐eating mammals	Long‐term	0.481	25.0	5
Fish‐eating birds	Long‐term	0.116	310.3	5
Fish‐eating mammals	Long‐term	0.104	115.4	5

Risk from consumption of contaminated water Puddle scenario, Screening step TER calculations are not needed, since the ratio ‘application rate (g a.s./ha)/relevant endpoint’ is below the trigger of 50 (Koc = 382.5) Birds (oilseed rape): ratio acute = 0.05, ratio (long term) = 5.11 Mammals (oilseed rape): ratio acute = < 0.04, ratio (long term) = 15.3

Scenario	Indicator or focal species	Timescale	DDD (mg/kg bw per day)	TER	Trigger
Puddle scenario	Birds	Acute	–	–	10
Puddle scenario	Mammals	Acute	–	–	10
Puddle scenario	Birds	Long term	–	–	5
Puddle scenario	Mammals	Long term	–	–	5

Toxicity data for all aquatic tested species (Regulation (EU) N° 283/2013, Annex Part A, points 8.2 and Regulation (EU) N° 284/2013 Annex Part A, point 10.2)

Group	Test substance	Timescale (test type)	End point	Toxicity1 (mg/L)
Laboratory tests
Fish
Oncorhynchus mykiss	dimoxystrobin	Acute 96 h (static)	Mortality, LC50	0.0434 (mm)
O. mykiss	dimoxystrobin	Acute 96 h (flow‐through)	Mortality, LC50	0.0465 (nom)
O. mykiss	BAS 540 01 F2	Acute 96 h (static)	Mortality, LC50	0.0512(nom, as) 0.288(nom, pr)
O. mykiss	BAS 540 00 F3,7	Acute 96 h (static)	Mortality, LC50	0.0402(nom, as) 0.220(nom, pr)
O. mykiss	505M01	Acute 96 h (static)	Mortality, LC50	> 100 (nom)
O. mykiss	505M08	Acute 96 h (static)	Mortality, LC50	> 100 (nom)
O. mykiss	505M09	Acute 96 h (static)	Mortality, LC50	> 100 (nom)
O. mykiss	505M96	Acute 96 h (static)	Mortality, LC50	> 100 (nom)
O. mykiss	Dimoxystrobin	Chronic 28 d (flow‐through)	Mortality and sub‐lethal effects (toxic symptoms), NOEC	0.010(nom)
Pimephales promelas (ELS study)	Dimoxystrobin	Chronic 36 d (flow‐through)	Mortality, and sublethal effects (wet weight), NOEC	0.008 (nom)
Cyprinodon variegatus	Dimoxystrobin	Acute 96 h (flow‐through)	Mortality, LC50	0.167 (mm)
Cyprinus carpio	BAS 507 00 F4	Acute 96 h (static)	Mortality, LC50	0.0392 (mm, as)
Danio rerio	BAS 507 00 F	Acute 96 h (static)	Mortality, LC50	0.0259(nom, as) 0.210(nom, pr)
Lepomis macrochirus	Dimoxystrobin	Acute 96 h (flow‐through)	Mortality, LC50	0.0546 (nom)
L. macrochirus	BAS 507 00 F	Acute 96 h (static)	Mortality, LC50	0.0646(mm, as)
Leuciscus idus melanotus	BAS 505 01 F5	Acute 96 h (static)	Mortality, LC50	0.0238 (nom, as) 0.147(nom, pr)
O. mykiss	BAS 507 00 F	Acute 96 h (static)	Mortality, LC50	> 0.0181 < 0.0264 0.02196 (nom, as) > 0.147 < 0.215 0.1786 (nom, pr)
O. mykiss	BAS 505 01 F	Acute 96 h (static)	Mortality, LC50	> 0.0238 < 0.0347 0.02886 (nom, as) > 0.147 < 0.215 0.1786 (nom, pr)
Pimephales promelas	BAS 507 00 F	Acute 96 h (static)	Mortality, LC50	0.0185(nom, as) 0.15(nom, pr)
O. mykiss (modified ELS with variable exposure)	Dimoxystrobin	Chronic 69 d (flow‐through) Pulsed exposure study	Mortality, NOEC	0.012(nom) (based on peak conc.)
L. idus melanotus (ELS study in outdoor microcosms, including sediment)	BAS 505 01 F	66 d (flow‐through)	Mortality, NOEC	0.015(nom, as) 0.092(nom, pr)
Aquatic invertebrates
Daphnia magna	Dimoxystrobin	Acute 48 h (static)	Immobility, EC50	0.0394 (nom)
D. magna	505M01	Acute 48 h (static)	Immobility, EC50	> 100 (nom)
D. magna	505M08	Acute 48 h (static)	Immobility, EC50	> 100 (nom)
D. magna	505M09	Acute 48 h (static)	Immobility, EC50	> 100 (nom)
D. magna	505M96	Acute 48 h (static)	Immobility, EC50	> 100 (nom)
D. magna	BAS 540 01 F	Acute 48 h (static)	Immobility, EC50	0.044(nom, as) 0.243 (nom, pr)
D. magna	BAS 540 00 F	Acute 48 h (static)	Immobility, EC50	0.038(nom, as) 0.21 (nom, pr)
D. magna	Dimoxystrobin	Chronic 21 d (semi‐static)	Reproduction, NOEC	0.0125 (nom)
Asellus aquaticus	Dimoxystrobin	Acute 96 h (static)	Mortality, LC50	0.269 (nom)
Americamysis bahia (former name: Mysidopsis bahia)	Dimoxystrobin	Acute 96 h (flow‐through)	Mortality, LC50	0.0272 (nom)
Crassostrea virginica	Dimoxystrobin	Acute 96 h (flow‐through)	Shell growth and toxic symptoms, EC50 Mortality, LC50	0.00892 (nom) > 0.025 (nom)
Sediment‐dwelling organisms
Chironomus riparius (spiked water study)	Dimoxystrobin	Chronic 28 d (flow‐through)	Emergence rate, NOEC	0.0044 (mm)
Algae
Pseudokirchneriella subcapitata	Dimoxystrobin	96 h (static)	Growth rate, ErC50 ErC10 Biomass, EbC50 EbC10	0.153(nom) 0.0133(nom) 0.017(nom) 0.0035(nom)
P. subcapitata	505M01	72 h (static)	Growth rate, ErC50 Biomass, EbC50	> 100 (nom) > 100(nom)
P. subcapitata	505M08	72 h (static)	Growth rate, ErC50 ErC10 Biomass, EbC50 EbC10	> 100 (nom) > 100(nom) > 100(nom) 47.5(nom)
P. subcapitata	505M09	72 h (static)	Growth rate, ErC50 ErC10 Biomass, EbC50 EbC10	> 100 (nom) > 100(nom) > 100(nom) > 100(nom)
P. subcapitata	505M96	72 h (static)	Growth rate, ErC50 ErC10 Biomass, EbC50 EbC10	43.6 (nom) 14.5(nom) 21.5(nom) 12.4(nom)
P. subcapitata	BAS 540 01 F	72 h (static)	Growth rate, ErC50 Biomass, EyC50	0.093(nom, as) (0.519(nom, pr)) 0.019(nom, as) (0.106(nom, pr))
P. subcapitata	BAS 540 00 F	72 h (static)	Growth rate, ErC50 Biomass, EbC50	0.047(nom, as) (0.264(nom, pr)) 0.013(nom, as) (0.07(nom, pr))
Navicula pelliculosa	Dimoxystrobin	72 h (static)	Growth rate, ErC50 ErC10 Biomass, EbC50	0.0078 (mm) 0.0008(nom) 0.0025(mm)
Anabaena flos‐aquae	Dimoxystrobin	72 h (static)	Growth rate, ErC50 ErC10 Biomass, EbC50	> 2.06(mm) 0.543(mm) 0.96(mm)
Skeletonema costatum	Dimoxystrobin	120 h (static)	Growth rate, ErC50 Biomass, EbC50	> 4.31(mm) > 4.31(mm)
Macrophytes
Lemna gibba	Dimoxystrobin	14 d (static)	EC50	No reliable data available, not required
Mesocosm
Outdoor mesocosm	BAS 505 01 F9	approx. 5 months, single application	NOEAEC (D. Longispina)	0.0017(nom, as) 0.01(nom, pr)
			NOEC	n.d.
Bioconcentration
O. mykiss (bioconcentration study)	Dimoxystrobin	35 d exposure and 14 d depuration period (flow‐through)	BCFSSL (wholefish)	106
Further testing on aquatic organisms Potential endocrine‐disrupting properties (Annex Part A, point 8.2.3) The available information in the data set provided very limited information for the EAS‐modalities since ED‐mediated parameters were not investigated in those studies but only sensitive parameters. Further information is required to finalise the ED assessment. For the T‐modality only preliminary results of the XETA (OECD TG 248) were available. The results of this test were negative for thyroid activity. Therefore, dimoxystrobin does not meet the ED criteria for the T‐modality for non‐target organisms since the T‐mediated endocrine activity was sufficiently investigated and was negative. For details, please refer to the ED assessment in Vol 1.

⁽¹⁾(_nom) nominal concentration; (_mm) mean measured concentration; n.d.: not determined

⁽²⁾Study was conducted with the formulated product BAS 540 01 F (suspension concentrate formulation containing 200 g dimoxystrobin/L and 200 g boscalid/L, nominally; new representative formulated product).

⁽³⁾Study was conducted with the formulation BAS 540 00 F (a minor change formulation of BAS 540 01 F, which differs only in the preservative used).

⁽⁴⁾Study was conducted with the formulated product BAS 507 00 F (suspension concentrate formulation containing 133 g dimoxystrobin/L and 50 g epoxiconazole/L, nominally; former representative formulated product during Annex I inclusion process for dimoxystrobin). Epoxiconazole does not have significant influence on toxicity (dimoxystrobin being the single driver with > 99.5% TU) within the formulation BAS 507 00 F.

⁽⁵⁾Study was conducted with the solo‐formulation BAS 505 01 F (containing 167 g dimoxystrobin/L, nominally).

⁽⁶⁾Interpolated value (geometric mean) with corresponding LC₀ (>) and LC₁₀₀ (<)

⁽⁷⁾Study is not considered fully reliable due to some deviations with respect to the recommendations of the test guideline.

⁽⁸⁾Study is not considered fully reliable because it cannot be excluded that the sensitive life stages were not exposed adequately.

⁽⁹⁾This endpoint is not considered protective of species with a longer reproductive cycle.

Bioconcentration in fish (Annex Part A, point 8.2.2.3)

	Active substance	Metabolite 505M01	Metabolite 505M08	Metabolite 505M09	Metabolite 505M96
logPO/W	3.59	0.79	0.64 (pH 7)	0.87 (pH 7)	No data available
Steady‐state bioconcentration factor (BCF) 1 (total wet weight/normalised to 6% lipid content)	106	No BCF study required	No BCF study required	No BCF study required	No BCF study required
Uptake/depuration kinetics BCF (total wet weight/normalised to 5% lipid content)
Annex VI Trigger for the bioconcentration factor
Clearance time (days) (CT50)	0.5
(CT90)	1.6
Level and nature of residues (%) in organisms after the 14 day depuration phase	< 2.5%
Higher tier study Not provided, not required

⁽¹⁾Based on total ¹⁴C or on specific compounds.

PEC/RAC ratios for the most sensitive aquatic organisms (Regulation (EU) N° 284/2013, Annex Part A, point 10.2)

FOCUS _sw steps 1–3 – PEC/RAC ratios for dimoxystrobin – winter oilseed rape at 100 g a.s./ha one or two applications

Scenario	PECsw global max (μg/L)3	Fish acute	Fish chronic	Aquatic invertebrates acute	Aquatic invertebrates chronic	Algae	Higher plant	Sed. dweller chronic	Higher tier, Geomean	Higher tier, pulse exposure test	Microcosm/Mesocosm
		O. mykiss	P. promelas	C. virginica	D. magna	N. pelliculosa	L. gibba	C. riparius	Fish, acute (4 species)	Fish, chronic, O. mykiss	D. longispina
		LC50	NOEC	EC50	NOEC	ErC50	ErC50	NOEC	geomean LC50	NOEC	NOEAEC
		46.5 μg/L	8 μg/L	8.92 μg/L	12.5 μg/L	7.8 μg/L	No reliable data available	4.42 μg/L	56.4 μg/L	12 μg/L1	1.7 μg/L2
AF		100	10	100	10	10	10	10	100	–	–
RAC (μg/L)		0.465	0.8	0.0892	1.25	0.78	–	0.442	0.564	–	–
FOCUS Step 1	45.99	98.903	57.488	515.583	36.792	58.962		104.050	81.543
FOCUS Step 2
North/South Europe	7.14	15.355	8.925	80.045	5.712	9.154		16.154	12.660
FOCUS Step 3
D2/ditch	8.174	17.578	10.218	91.637	6.539	10.479		18.493	14.493
D2/stream	5.129	11.030	6.411	57.500	4.103	6.576		11.604	9.094
D3/ditch	0.635	1.366	0.794	7.119	0.508	0.814		1.437	1.126
D4/pond	0.917	1.972	1.146	10.280	0.734	1.176		2.075	1.626
D4/stream	0.947	2.037	1.184	10.617	0.758	1.214		2.143	1.679
D5/pond	0.513	1.103	0.641	5.751	0.410	0.658		1.161	0.910
D5/stream	0.591	1.271	0.739	6.625	0.473	0.758		1. 337	1.048
R1/pond	0.203	0.437	0.254	2.276	0.162	0.260		0.459	0.360
R1/stream	1.634	3.514	2.043	18.318	1.307	2.095		3.697	2.897
R3/stream	1.510	3.247	1.888	16.928	1.208	1.936		3.416	2.677

AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold.

⁽¹⁾Study is not considered fully reliable because it cannot be excluded that the sensitive life stages were not exposed adequately.

⁽²⁾As this endpoint may not provide a suitable protection level for species with a longer reproductive cycle it is not considered further; no overall ETO‐NOEC is available.

⁽³⁾For winter oilseed rape, only the worst‐case PEC values are presented, either resulting from calculations for single or multiple, early or late applications.

FOCUSsw Steps 1–3 – PEC/RAC ratios for dimoxystrobin – sunflower at 100 g a.s./ha with one application

Scenario	PECsw global max (μg/L)3	Fish acute	Fish chronic	Aquatic invertebrates acute	Aquatic invertebrates chronic	Algae	Higher plant	Sed. dweller chronic	Higher tier, Geomean	Higher tier, pulse exposure test	Microcosm/Mesocosm
		O. mykiss	P. promelas	C. virginica	D. magna	N. pelliculosa	L. gibba	C. riparius	Fish, acute (4 species)	Fish, chronic, O. mykiss	D. longispina
		LC50	NOEC	EC50	NOEC	ErC50	ErC50	NOEC	geomean LC50	NOEC	NOEAEC
		46.5 μg/L	8 μg/L	8.92 μg/L	12.5 μg/L	7.8 μg/L	No reliable data available	4.42 μg/L	56.4 μg/L	12 μg/L1	1.7 μg/L2
AF		100	10	100	10	10	10	10	100	–	–
RAC (μg/L)		0.465	0.8	0.0892	1.25	0.78	–	0.442	0.564	–	–
FOCUS Step 1	22.99	49.441	28.738	257.735	18.392	29.474		52.014	40.762
FOCUS Step 2
North/South Europe	2.84	6.108	3.550	31.839	2.272	3.641		6.425	5.035
FOCUS Step 3
D5/pond	0.193	0.415	0.241	2.164	0.154	0.247		0.437	0.342
D5/stream	0.513	1.103	0.641	5.751	0.410	0.658		1.161	0.910
R1/pond	0.278	0.598	0.348	3.117	0.222	0.356		0.629	0.493
R1/stream	1.167	2.510	1.459	13.083	0.934	1.496		2.640	2.069
R3/stream	0.865	1.860	1.081	9.697	0.692	1.109		1.957	1.534
R4/stream	1.283	2.759	1.604	14.383	1.026	1.645		2.903	2.275

AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold.

⁽¹⁾Study is not considered fully reliable because it cannot be excluded that the sensitive life stages were not exposed adequately.

⁽²⁾As this endpoint may not provide a suitable protection level for species with a longer reproductive cycle it is not considered further; no overall ETO‐NOEC is available.

FOCUS _sw Step 4 – PEC/RAC ratios for dimoxystrobin – winter oilseed rape at 100 g a.s./ha with one or two applications

Scenario	PECsw global max (μg/L)3	Fish acute	Fish chronic	Aquatic invertebrates acute	Aquatic invertebrates chronic	Algae	Higher plant	Sed. dweller chronic	Higher tier, Geomean	Higher tier, pulse exposure test	Microcosm/Mesocosm
		O. mykiss	P. promelas	C. virginica	D. magna	N. pelliculosa	L. gibba	C. riparius	Fish, acute (4 species)	Fish, chronic, O. mykiss	D. longispina
		LC50	NOEC	EC50	NOEC	ErC50	ErC50	NOEC	geomean LC50	NOEC	NOEAEC
		46.5 μg/L	8 μg/L	8.92 μg/L	12.5 μg/L	7.8 μg/L	No reliable data available	4.42 μg/L	56.4 μg/L	12 μg/L1	1.7 μg/L2
AF		100	10	100	10	10	10	10	100	–	–
RAC (μg/L)		0.465	0.8	0.0892	1.25	0.78	–	0.442	0.564	–	–
Nozzle reduction	FOCUS Step 4	risk mitigation 10 m buffer zone and 10 m vegetated filter strip
None	D2/ditch	8.174	17.578	10.218	91.637	6.539	10.479	18.493	14.493
	D2/stream	5.129	11.030	6.411	57.500	4.103	6.576	11.604	9.094
	D3/ditch	0.091	0.196	0.114	1.020	0.073	0.117	0.206	0.161
	D4/pond	0.915	1.968	1.144	10.258	0.732	1.173	2.070	1.622
	D4/stream	0.947	2.037	1.184	10.617	0.758	1.214	2.143	1.679
	D5/pond	0.512	1.101	0.640	5.740	0.410	0.656	1.158	0.908
	D5/stream	0.397	0.854	0.496	4.451	0.318	0.509	0.898	0.704
	R1/pond	0.087	0.187	0.109	0.975	0.070	0.112	0.197	0.154
	R1/stream	0.715	1.538	0.894	8.016	0.572	0.917	1.618	1.268
	R3/stream	0.688	1.480	0.860	7.713	0.550	0.882	1.557	1.220
Nozzle reduction	FOCUS Step 4	risk mitigation 20 m buffer zone and 20 m vegetated filter strip
None	D2/ditch	8.174	17.578	10.218	91.637	6.539	10.479	18.493	14.493
	D2/stream	5.129	11.030	6.411	57.500	4.103	6.576	11.604	9.094
	D3/ditch	0.047	0.101	0.059	0.527	0.038	0.060	0.106	0.083
	D4/pond	0.914	1.966	1.143	10.247	0.731	1.172	2.068	1.621
	D4/stream	0.947	2.037	1.184	10.617	0.758	1.214	2.143	1.679
	D5/pond	0.511	1.099	0.639	5.729	0.409	0.655	1.156	0.906
	D5/stream	0.397	0.854	0.496	4.451	0.318	0.509	0.898	0.704
	R1/pond	0.046	0.099	0.058	0.516	0.037	0.059	0.104	0.082
	R1/stream	0.369	0.794	0.461	4.137	0.295	0.473	0.835	0.654
	R3/stream	0.361	0.776	0.451	4.047	0.289	0.463	0.817	0.640

AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold.

⁽¹⁾Study is not considered fully reliable because it cannot be excluded that the sensitive life stages were not exposed adequately.

⁽²⁾As this endpoint may not provide a suitable protection level for species with a longer reproductive cycle it is not considered further; no overall ETO‐NOEC is available.

⁽³⁾For winter oilseed rape, only the worst‐case PEC values are presented, either resulting from calculations for single or multiple, early or late applications.

FOCUSsw Step 4 – PEC/RAC ratios for dimoxystrobin – sunflower at 100 g a.s./ha with one application

Scenario		PECsw global max (μg/L)3	Fish acute	Fish chronic	Aquatic invertebrates acute	Aquatic invertebrates chronic	Algae	Higher plant	Sed. dweller chronic	Higher tier, Geomean	Higher tier, pulse exposure test	Microcosm/Mesocosm
			O. mykiss	P. promelas	C. virginica	D. magna	N. pelliculosa	L. gibba	C. riparius	Fish, acute (4 species)	Fish, chronic, O. mykiss	D. longispina
			LC50	NOEC	EC50	NOEC	ErC50	ErC50	NOEC	geomean LC50	NOEC	NOEAEC
			46.5 μg/L	8 μg/L	8.92 μg/L	12.5 μg/L	7.8 μg/L	No reliable data available	4.42 μg/L	56.4 μg/L	12 μg/L1	1.7 μg/L2
AF			100	10	100	10	10	10	10	100	–	–
RAC (μg/L)			0.465	0.8	0.0892	1.25	0.78	–	0.442	0.564	–	–
Nozzle reduction	FOCUS Step 4	risk mitigation 10 m buffer zone and 10 m vegetated filter strip
None	D5/pond	0.191	0.411	0.239	2.141	0.153	0.245		0.432	0.339
	D5/stream	0.229	0.492	0.286	2.567	0.183	0.294		0.518	0.406
	R1/pond	0,117	0.252	0.146	1.312	0.094	0.150		0.265	0.207
	R1/stream	0.528	1.135	0.660	5.919	0.422	0.677		1.195	0.936
	R3/stream	0.394	0.847	0.493	4.417	0.315	0.505		0.891	0.699
	R4/stream	0.584	1.256	0.730	6.547	0.467	0.749		1.321	1.035
Nozzle reduction	FOCUS Step 4	risk mitigation 20 m buffer zone and 20 m vegetated filter strip
None	D5/pond	0.190	0.409	0.238	2.130	0.152	0.244		0.430	0.337
	D5/stream	0.229	0.492	0.286	2.567	0.183	0.294		0.518	0.406
	R1/pond	0.061	0.131	0.076	0.684	0.049	0.078		0.138	0.108
	R1/stream	0.276	0.594	0.345	3.094	0.221	0.354		0.624	0.489
	R3/stream	0.207	0.445	0.259	2.321	0.166	0.265		0.468	0.367
	R4/stream	0.306	0.658	0.382	3.430	0.245	0.392		0.692	0.542

AF: Assessment factor; PEC: Predicted environmental concentration; RAC: Regulatory acceptable concentration; PEC/RAC ratios above the relevant trigger of 1 are shown in bold.

⁽¹⁾Study is not considered fully reliable because it cannot be excluded that the sensitive life stages were not exposed adequately.

⁽²⁾As this endpoint may not provide a suitable protection level for species with a longer reproductive cycle it is not considered further; no overall ETO‐NOEC is available.

FOCUS sw Steps 1–2 – PEC/RAC ratios for 505M01 – winter oilseed rape at 100 g a.s./ha with one or two applications

Scenario	PECsw global max (μg/L)1	Fish acute	Fish chronic	Aquatic invertebrates acute	Aquatic invertebrates chronic	Algae	Higher plant	Sed. dweller chronic
		O. mykiss	O. mykiss	D. magna	D. magna	P. subcapitata	L. gibba	C. riparius
		LC50	NOEC	EC50	NOEC	ErC50	ErC50	NOEC
		> 100,000 μg/L	–	> 100,000 μg/L	–	> 100,000 μg/L	–	–
AF		100		100		10
RAC		> 1,000		> 1,000		> 10,000
FOCUS Step 1	11.38	< 0.011		< 0.011		< 0.001
FOCUS Step 2
North/South Europe	–	–		–		–

⁽¹⁾For winter oilseed rape, only the worst‐case PEC values are presented, either resulting from calculations for single or multiple, early or late applications.

FOCUS sw Steps 1–2 – PEC/RAC ratios for 505M08 – winter oilseed rape at 100 g a.s./ha with one or two applications

Scenario	PECsw global max (μg/L)1	Fish acute	Fish chronic	Aquatic invertebrates acute	Aquatic invertebrates chronic	Algae	Higher plant	Sed. dweller chronic
		O. mykiss	O. mykiss	D. magna	D. magna	P. subcapitata	L. gibba	C. riparius
		LC50	NOEC	EC50	NOEC	ErC50	ErC50	NOEC
		> 100,000 μg/L	–	> 100,000 μg/L	–	> 100,000 μg/L	–	–
AF		100		100		10
RAC		> 1,000		> 1,000		> 10,000
FOCUS Step 1	13.68	< 0.014		< 0.014		< 0.001
FOCUS Step 2
North/South EU	–	–		–		–

⁽¹⁾For winter oilseed rape, only the worst‐case PEC values are presented, either resulting from calculations for single or multiple, early or late applications.

FOCUS sw Steps 1–2 – PEC/RAC ratios for 505M09 – winter oilseed rape at 100 g a.s./ha with one or two applications

Scenario	PECsw global max (μg/L)1	Fish acute	Fish chronic	Aquatic invertebrates acute	Aquatic invertebrates chronic	Algae	Higher plant	Sed. dweller chronic
		O. mykiss	O. mykiss	D. magna	D. magna	P. subcapitata	L. gibba	C. riparius
		LC50	NOEC	EC50	NOEC	ErC50	ErC50	NOEC
		> 100,000 μg/L	–	> 100,000 μg/L	–	> 100,000 μg/L	–	–
AF		100		100		10
RAC		> 1,000		> 1,000		> 10,000
FOCUS Step 1	14.93	< 0.015		< 0.015		< 0.002
FOCUS Step 2
North/South Europe	–	–		–		–

⁽¹⁾For winter oilseed rape, only the worst‐case PEC values are presented, either resulting from calculations for single or multiple, early or late applications.

FOCUS sw Steps 1–2 – PEC/RAC ratios for 505M096 – winter oilseed rape at 100 g a.s./ha one or two applications

Scenario	PECsw global max (μg/L)1	Fish acute	Fish chronic	Aquatic invertebrates acute	Aquatic invertebrates chronic	Algae	Higher plant	Sed. dweller chronic
		O. mykiss	O. mykiss	D. magna	D. magna	P. subcapitata	L. gibba	C. riparius
		LC50	NOEC	EC50	NOEC	ErC50	ErC50	NOEC
		> 100,000 μg/L	–	> 100,000 μg/L	–	43,600 μg/L	–	–
AF		100		100		10
RAC		> 1,000		> 1,000		4,360
FOCUS Step 1	4.44	< 0.004		< 0.004		0.001
FOCUS Step 2
North/South Europe	–	–		–		–

⁽¹⁾For winter oilseed rape, only the worst‐case PEC values are presented, either resulting from calculations for single or multiple, early or late applications.

FOCUS sw Steps 1–2 – PEC/RAC ratios for 505M01 – sunflower at 100 g a.s./ha with one application

Scenario	PECsw global max (μg/L)	Fish acute	Fish chronic	Aquatic invertebrates acute	Aquatic invertebrates chronic	Algae	Higher plant	Sed. dweller chronic
		O. mykiss	O. mykiss	D. magna	D. magna	P. subcapitata	L. gibba	C. riparius
		LC50	NOEC	EC50	NOEC	ErC50	ErC50	NOEC
		> 100,000 μg/L	–	> 100,000 μg/L	–	> 100,000 μg/L	–	–
AF		100		100		10
RAC		> 1,000		> 1,000		> 10,000
FOCUS Step 1	5.69	< 0.006		< 0.006		< 0.001
FOCUS Step 2
North/South Europe	–	–		–		–

FOCUS sw Steps 1–2 – PEC/RAC for 505M08 – sunflower at 100 g a.s./ha one application

Scenario	PECsw global max (μg/L)	Fish acute	Fish chronic	Aquatic invertebrates acute	Aquatic invertebrates chronic	Algae	Higher plant	Sed. dweller chronic
		O. mykiss	O. mykiss	D. magna	D. magna	P. subcapitata	L. gibba	C. riparius
		LC50	NOEC	EC50	NOEC	ErC50	ErC50	NOEC
		> 100,000 μg/L	–	> 100,000 μg/L	–	> 100,000 μg/L	–	–
AF		100		100		10
RAC		> 1,000		> 1,000		> 10,000
FOCUS Step 1	6.84	< 0.007		< 0.007		< 0.001
FOCUS Step 2
North/South Europe	–	–		–		–

FOCUS sw Steps 1–2 – PEC/RAC for 505M09 – sunflower at 100 g a.s./ha with one application

Scenario	PECsw global max (μg/L)	Fish acute	Fish chronic	Aquatic invertebrates acute	Aquatic invertebrates chronic	Algae	Higher plant	Sed. dweller chronic
		O. mykiss	O. mykiss	D. magna	D. magna	P. subcapitata	L. gibba	C. riparius
		LC50	NOEC	EC50	NOEC	ErC50	ErC50	NOEC
		> 100,000 μg/L	–	> 100,000 μg/L	–	> 100,000 μg/L	–	–
AF		100		100		10
RAC		> 1,000		> 1,000		> 10,000
FOCUS Step 1	7.46	< 0.007		< 0.007		< 0.001
FOCUS Step 2
North/South Europe	–	–		–		–

FOCUS sw Steps 1–2 – PEC/RAC ratios for 505M096 – sunflower at 100 g a.s./ha with one application

Scenario	PECsw global max (μg/L)	Fish acute	Fish chronic	Aquatic invertebrates acute	Aquatic invertebrates chronic	Algae	Higher plant	Sed. dweller chronic
		O. mykiss	O. mykiss	D. magna	D. magna	P. subcapitata	L. gibba	C. riparius
		LC50	NOEC	EC50	NOEC	ErC50	ErC50	NOEC
		> 100,000 μg/L	–	> 100,000 μg/L	–	43,600 μg/L	–	–
AF		100		100		10
RAC		> 1,000		> 1,000		> 4,360
FOCUS Step 1	2.22	< 0.002		< 0.002		0.001
FOCUS Step 2
North/South Europe	–	–		–		–

Effects on bees (Regulation (EU) N° 283/2013, Annex Part A, point 8.3.1 and Regulation (EU) N° 284/2013 Annex Part A, point 10.3.1)

Species	Test substance	Timescale/type of endpoint	End point	Toxicity
Apis mellifera L.	Dimoxystrobin	Acute	Oral toxicity 48 h (LD50)	> 79.4 μg/bee
			Contact toxicity 48 h (LD50)	no data available, required
	BAS 540 00 F	Acute	Oral toxicity 48 h (LD50)	> 342.28 μg product/bee (> 61.23 μg dimoxystrobin/bee)
			Contact toxicity 72 h (LD50)	> 279.5 μg product/bee (> 50 μg dimoxystrobin/bee)
	BAS 540 01 F	Acute	Oral toxicity 48 h (LD50)	> 333.1 μg product/bee (> 59.75 μg dimoxystrobin/bee)
			Contact toxicity 48 h (LD50)	> 278.5 μg product/bee (> 50 μg dimoxystrobin/bee)
	Dimoxystrobin	Chronic	10 d‐LDD50 1	83.3 μg/bee/day
			NOEL for HPG	no data, required
	BAS 540 01 F	Semichronic	8 d‐NOED 2 larvae (with dietary exposure on day 4)	33.48 μg product/larvae (6 μg dimoxystrobin/larvae)
	Dimoxystrobin	Semichronic	22 d‐NOED larvae (repeated dietary exposure)	no data available, required

⁽¹⁾Study is considered reliable although some deviations were noted with respect to the recommendations of the current test guidelines.

⁽²⁾Study is a short‐term study with single exposure.

Potential for accumulative toxicity: no data

Higher tier data with honeybees

A semifield tunnel study conducted with BAS 540 01 F and two residue field studies were available. For further information, please see RAR Vol 3 CP 9, Sections B.9.5.1.6 and B.9.5.1.7.

Risk assessment for dimoxystrobin includes application in winter oilseed rape (2 × 0.5 L BAS 540 01 F/ha, with an application interval of 28 d) and sunflower (1 × 0.5 L BAS 540 01 F/ha)

(The risk assessment was performed according to SANCO/10329/2002 rev 2 final)

Species	Test substance	Risk quotient	HQ/ETR	Trigger
Honeybees	Dimoxystrobin	HQoral	< 1.26	50
Honeybees	BAS 540 01 F	HQoral	< 1.68 1	50
Honeybees	dimoxystrobin	HQcontact	no data available, required	50
Honeybees	BAS 540 01 F	HQcontact	< 2.00 1	50

⁽¹⁾For the calculation of the HQ values, the maximum single application rate of 500 mL/ha was multiplied by the product density of 1.118 g/cm³. For acute contact, the endpoint obtained in the study with the product was considered for risk assessment purposes as it was expressed in terms of a.s. equivalent.

The following risk assessment was carried out according to EFSA Bee GD (2013).

Risk assessment for bees from contact and oral dietary exposure – winter oilseed rape (2 × 0.5 L BAS 540 01 F/ha, with an application interval of 28 d) and sunflower (1 × 0.5 L BAS 540 01 F/ha)

Species	Test substance	Scenario	Risk quotient	HQ/ETR	Trigger
Screening level assessment
Apis mellifera	Dimoxystrobin	Not relevant	ETRacute adult oral	< 0.01	0.2
Apis mellifera	Dimoxystrobin	Not relevant	HQcontact	No data available, required	42
Apis mellifera	BAS 540 01 F	Not relevant	ETRacute adult oral	< 0.01	0.2
Apis mellifera	BAS 540 01 F	Not relevant	HQcontact	< 2	42
Apis mellifera	Dimoxystrobin	Not relevant	ETRchronic adult oral	0.009	0.03
Apis mellifera	BAS 540 01 F	Not relevant	ETRlarvae	No study on repeated exposure is available, required	0.2

Risk assessment for honeybees from consumption of contaminated water

Species	Test substance	Risk quotient	ETR	Trigger
Screening level risk assessment from exposure to residues in guttation fluid (water solubility = 0.003 μg/μL 1 )
Apis mellifera	Dimoxystrobin	ETRacute adult oral	< 0.0004	0.2
Apis mellifera	Dimoxystrobin	ETRchronic adult oral	0.0004	0.03
Apis mellifera	Dimoxystrobin	ETRlarvae	No data available, required	0.2
Risk assessment from exposure to residues in surface water (FOCUS Step 3; D2 ditch PECsw of 8.174 μg/L 2 )
Apis mellifera	Dimoxystrobin	ETRacute adult oral	< 0.0001	0.2
Apis mellifera	Dimoxystrobin	ETRchronic adult oral	< 0.0001	0.03
Apis mellifera	Dimoxystrobin	ETRlarvae	No data available, required	0.2

⁽¹⁾Water solubility: 3.324 mg dimoxystrobin/L (20°C)

⁽²⁾Worst‐case PEC_sw (FOCUS_sw Step 3; D2 ditch) resulting from calculations for application with 100 g a.s./ha in oilseed rape.

Effects on other arthropod species (Regulation (EU) N° 283/2013, Annex Part A, point 8.3.2 and Regulation (EU) N° 284/2013 Annex Part A, point 10.3.2)

Laboratory tests with standard sensitive species

Species	Test Substance	End point	Toxicity
Typhlodromus pyri	Preparation (BAS 540 00 F)	Mortality, LR50 Reproduction, ER50	> 1.0 L/ha > 1.0 L/ha
Aphidius rhopalosiphi	Preparation (BAS 540 00 F)	Mortality, LR50 Reproduction, ER50	> 1.0 L/ha > 0.03 L/ha
Additional species
Chrysoperla carnea	Preparation (BAS 540 00 F)	Mortality, LR50 Reproduction, ER50	> 1.0 L/ha > 1.0 L/ha
Poecilus cupreus	Preparation (BAS 540 00 F)	Mortality, LR50 Food consumption, ER50	> 1.0 L/ha > 1.0 L/ha

First‐tier risk assessment for BAS 540 01 F – winter oilseed rape at 0.5 L product/ha with two applications (covers intended use of BAS 540 01 F in sunflower)

Test substance	Species	Effect (LR50 g/ha)	HQ in‐field	HQ off‐field 1	Trigger
BAS 540 00 F	Typhlodromus pyri	> 1.0	< 0.85	< 0.02	2
BAS 540 00 F	Aphidius rhopalosiphi	> 1.0	< 0.85	< 0.02	2

⁽¹⁾indicates distance assumed to calculate the drift rate: 1 m

Extended laboratory tests, aged residue tests

Species	Life stage	Test substance, substrate	Time scale	Dose (g/ha)1,2	End point	% effect3	ER50
Aphidius rhopalosiphi	Adults	BAS 540 00 F, natural substrate, 3‐D	13 d	0.07 0.5 1.0 (ini)	Mortality, reproduction	8.28 −10.56 17.16	> 1.0 > 1.0

n.d.: not determined; DAT: days after treatment.

⁽¹⁾indicates whether initial or aged residues.

⁽²⁾for preparations indicate whether dose is expressed in units of a.s. or preparation.

⁽³⁾adverse effects; positive values indicate a decrease; negative values indicate an increase.

Risk assessment for BAS 540 01 F – winter oilseed rape at 0.5 L product/ha with two applications (covers intended use of BAS 540 01 F in sunflower) based on extended lab test or aged residue tests

Species	L/ER50 (g/ha)	In‐field rate	Off‐field rate1	Trigger
A. rhopalosiphi, 3D	LR50 > 1.0 ER50 > 1.0	0.85 L/ha	0.1 L/ha	Endpoint > PER acceptable risk

⁽¹⁾At 1 m distance.

Semi‐field tests: Not provided, not required

Field studies: Not provided, not required

Additional specific test: Not provided, not required

Effects on non‐target soil meso‐ and macro fauna; effects on soil nitrogen transformation (Regulation (EU) N° 283/2013, Annex Part A, points 8.4, 8.5, and Regulation (EU) N° 284/2013 Annex Part A, points 10.4, 10.5)

Test organism	Test substance	Application method of test a.s./OM	Timescale	End point	Toxicity
Earthworms
Eisenia fetida	Dimoxystrobin	Mixed into soil 10% peat	Chronic	Growth, reproduction, behaviour	NOEC 0.05 mg/kg d.w. soil (reproduction) EC10 0.048 mg/kg d.w. soil (reproduction) NOECCORR 0.025 mg/kg d.w. soil (reproduction)
Eisenia fetida	BAS 540 01 F	Mixed into soil	Chronic	Growth, reproduction, behaviour	no data available, required
Eisenia fetida	505M01	Mixed into soil 5% peat	Chronic	Growth, reproduction, behaviour	NOEC < 15.625 mg/kg d.w. soil 1
Eisenia fetida	505M08	Mixed into soil 10% peat	Chronic	Growth, reproduction, behaviour	NOEC 250 mg/kg d.w. soil (reproduction)
Eisenia fetida	505M09	Mixed into soil 10% peat	Chronic	Growth, reproduction, behaviour	NOEC 250 mg/kg d.w. soil (reproduction)
Other soil macroorganisms
Folsomia candida	Dimoxystrobin	Mixed into soil 5% peat	Chronic	Mortality, reproduction	NOEC 1,000 mg/kg d.w. soil (reproduction) NOECCORR 500 mg/kg d.w. soil (reproduction)
Folsomia candida	BAS 540 00 F	Mixed into soil 10% peat	Chronic	Mortality, reproduction	NOEC 250 mg product/kg d.w. soil (mortality) NOEC 44.8 mg dimoxystrobin/kg d.w. soil (mortality) NOECCORR 22.4 mg dimoxystrobin/kg d.w. soil
Folsomia candida	505M09	Mixed into soil 5% peat	Chronic	Mortality, reproduction	NOEC 1,000 mg/kg d.w. soil (reproduction)
Hypoaspis aculeifer	dimoxystrobin	Mixed into soil 5% peat	Chronic	Mortality, reproduction	NOEC 1,000 mg/kg d.w. soil (reproduction) NOECCORR 500 mg/kg d.w. soil (reproduction)
Hypoaspis aculeifer	BAS 540 01 F	Mixed into soil 5% peat	Chronic	Mortality, reproduction	NOEC 1,000 mg product/kg d.w. soil (reproduction) NOEC 179 mg dimoxystrobin/kg/kg d.w. soil (reproduction) NOECCORR 89.5 mg dimoxystrobin/kg/kg d.w. soil (reproduction)
Hypoaspis aculeifer	505M09	Mixed into soil 5% peat	Chronic	Mortality, reproduction	NOEC 1,000 mg/kg d.w. soil (reproduction)

⁽¹⁾The study is valid since all validity criteria are met; however, effects on reproduction were seen at the lowest tested concentration; therefore, a proper NOEC from this study could not be derived and the risk assessment to earthworms is considered only illustrative related to this metabolite.

Higher tier testing (e.g. modelling or field studies)

Several field studies with earthworms were available. For further information, please see RAR Vol 3 CP 9, Section B.9.7.1.2.

Nitrogen transformation	dimoxystrobin	< 25% effects after 28 days at 0.72 mg/kg dry soil
	505M01	< 25% effects after 28 days at 100 g/ha, corresponding to 0.133 mg/kg dry soil
	505M08	< 25% effects after 28 days at 40 g/ha, corresponding to 0.053 mg/kg dry soil
	505M09	< 25% effects after 28 days at 200 g/ha, corresponding to 0.266 mg/kg dry soil1
	BAS 540 01 F	< 25% effects after 70 days at 37.2 mg/kg dry soil, 6.7 mg dimoxystrobin/kg dry soil1

⁽¹⁾Study is considered reliable although some deviations were noted with respect to the recommendations of the current test guidelines.

Toxicity/exposure ratios for soil organisms

Test organism	Test substance	Time scale	Soil PEC1	TER	Trigger
In winter oilseed rape 2 × 100 g a.s./ha/year; in sunflower 1 × 100 g a.s./ha/year2
Eisenia fetida	dimoxystrobin	chronic	0.054	0.46 3	5
Eisenia fetida	505M01	chronic	0.0049	< 3,1894	5
Eisenia fetida	505M08	chronic	0.0118	21,186	5
Eisenia fetida	505M09	chronic	0.0082	30,488	5
Folsomia candida	dimoxystrobin	chronic	0.054	9,2593	5
Folsomia candida	505M09	chronic	0.0082	121951	5
Folsomia candida	dimoxystrobin in BAS 540 00 F	chronic	0.054	4153	5
Hypoaspis aculeifer	dimoxystrobin	chronic	0.054	9,2593	5
Hypoaspis aculeifer	505M09	chronic	0.0082	12,1951	5
Hypoaspis aculeifer	dimoxystrobin in BAS 540 01 F	chronic	0.054	1,6573	5

Values in bold fall below the trigger value.

⁽¹⁾PEC_soil,accu was used.

⁽²⁾Worst‐case use pattern of BAS 540 01 F; only the worst‐case PEC_soil values are presented and used for TER calculations.

⁽³⁾Toxicity endpoints of the a.s. are re‐adjusted by a soil factor of 2, since the log P_ow for the substance is > 2.

⁽⁴⁾Risk assessment considered only orientative since a proper NOEC could not be derived from the study.

Effects on terrestrial non‐target higher plants (Regulation (EU) N° 283/2013, Annex Part A, point 8.6 and Regulation (EU) N° 284/2013 Annex Part A, point 10.6)

Screening data

Species	Test substance	ER50 vegetative vigour	ER50 seedling emergence	Exposure1	Risk acceptable	Trigger
Cabbage, carrot, oat, onion, pea, sunflower	BAS 540 00 F	> 1.0 L/ha	No data available	0.5 L/ha	Yes	< 50% effect at highest application rate

Laboratory dose–response tests

Species	Test substance	ER50 (g/ha) vegetative vigour	ER50 (g/ha) emergence	Exposure1 (g/ha)	TER	Trigger
Buckwheat, carrot, corn, cucumber, lettuce, oat, onion, ryegrass, soybean, tomato	BAS 540 01 F	> 2.0 L/ha	> 1.0 L/ha	0.5 L/ha	Yes	< 50% effect at highest application rate

⁽¹⁾maximum single application rate

.

Extended laboratory studies: not provided, not required.

Semi‐field and field test: not provided, not required.

Effects on biological methods for sewage treatment (Regulation (EU) N° 283/2013, Annex Part A, point 8.8)

Test type/organism	End point
Activated sludge	No significant inhibition of respiration was measured. EC50 was determined to be > 1,000 mg a.s./L (nominal)

Monitoring data (Regulation (EU) N° 283/2013, Annex Part A, point 8.9 and Regulation (EU) N° 284/2013, Annex Part A, point 10.8)

Available monitoring data concerning adverse effect of the a.s. No data available

Available monitoring data concerning effect of the PPP. No data available

Definition of the residue for monitoring (Regulation (EU) N° 283/2013, Annex Part A, point 7.4.2) Ecotoxicologically relevant compounds ¹

Compartment
Soil	Dimoxystrobin
Water	Dimoxystrobin
Sediment	Dimoxystrobin

⁽¹⁾Metabolites are considered relevant when, based on the risk assessment, they pose a risk comparable or higher than the parent

Classification and labelling with regard to ecotoxicological data (Regulation (EU) N° 283/2013, Annex Part A, Section 10)

Appendix C – Wording EFSA used in Section 2.2 of this statement, in relation to DT and Koc ‘classes’ exhibited by each compound assessed ²⁴

Wording	DT50 normalised to 20°C for laboratory incubations or not normalised DT50 for field studies (SFO equivalent, when biphasic, the DT90 was divided by 3.32 to estimate the DT50 when deciding on the wording to use)
Very low persistence	< 1 day
Low persistence	1 to < 10 days
Moderate persistence	10 to < 60 days
Medium persistence	60 to < 100 days
High persistence	100 days to < 1 year
Very high persistence	A year or more

Note these classes and descriptions are unrelated to any persistence class associated with the active substance cut‐off criteria in Annex II of Regulation (EC) No 1107/2009. For consideration made in relation to Annex II, see Appendix A.

Wording	Koc (either KFoc or Kdoc) mL/g
Very high mobility	0–50
High mobility	51–150
Medium mobility	151–500
Low mobility	501–2,000
Slight mobility	2,001–5,000
Immobile	> 5,000

Based on McCall et al. (1980).

Appendix D – Used compound codes

Code/trivial name (a)	IUPAC name/SMILES notation/InChiKey (b)	Structural formula (c)
dimoxystrobin	(2E)‐2‐{2‐[(2,5‐dimethylphenoxy)methyl]phenyl}‐2‐(methoxyimino)‐N‐methylacetamide CNC(=O)\C(=N\OC)c1ccccc1COc1cc(C)ccc1C WXUZAHCNPWONDH‐DYTRJAOYSA‐N
505M01 BF 505‐4 M505F001	(2E)‐2‐[2‐(hydroxymethyl)phenyl]‐2‐(methoxyimino)‐N‐methylacetamide OCc1ccccc1/C(=N\OC)C(=O)NC XJIRPXWWLNGHSS‐JLHYYAGUSA‐N
505M08 BF 505‐7 M505F008	2‐({2‐[(1 E)‐N‐methoxy‐2‐(methylamino)‐2‐oxoethanimidoyl]phenyl}methoxy)‐4‐methylbenzoic acid CNC(=O)\C(=N\OC)c1ccccc1COc1cc(C)ccc1C(=O)O VVBFFEYXSJKVET‐HEHNFIMWSA‐N
505M09 BF 505‐8 M505F009	3‐({2‐[(1 E)‐N‐methoxy‐2‐(methylamino)‐2‐oxoethanimidoyl]phenyl}methoxy)‐4‐methylbenzoic acid CNC(=O)\C(=N\OC)c1ccccc1COc1cc(ccc1C)C(=O)O RKECPZYSBKSRJM‐HEHNFIMWSA‐N
505M93	Structure undefined, a unique name/SMILES/InChiKey cannot be allocated
505M95	Structure undefined, a unique name/SMILES/InChiKey cannot be allocated
505M96 M505F096	(4 E)‐1‐hydroxy‐4‐(methoxyimino)‐2‐methyl‐1,4‐dihydroisoquinolin‐3(2H)‐one O=C1\C(=N\OC)c2ccccc2C(O)N1C RVPXDOSJHGHSKY‐FMIVXFBMSA‐N

^(a)The metabolite name in bold is the name used in the conclusion.

^(b)ACD/Name 2021.1.3 ACD/Labs 2021.1.3 (File Version N15E41, Build 123232, 07 Jul 2021).

^(c)ACD/ChemSketch 2021.1.3 ACD/Labs 2021.1.3 (File Version C25H41, Build 123835, 28 Aug 2021).

Suggested citation: EFSA (European Food Safety Authority) 2022. Statement concerning the assessment of environmental fate and behaviour and ecotoxicology in the context of the pesticides peer review of the active substance dimoxystrobin. EFSA Journal 2022;20(11):7634, 90 pp. 10.2903/j.efsa.2022.7634