Peer review of the pesticide risk assessment for the active substance difenoconazole in light of confirmatory data submitted

Abstract

The conclusions of the EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, Spain, for the pesticide active substance difenoconazole are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory information with regard to the consumer risk assessment. The conclusions were reached on the basis of the evaluation of the representative uses of difenoconazole as a fungicide on pome fruit, carrot, wheat, barley, triticale, rye and oats. The reliable endpoints concluded as being appropriate for use in regulatory risk assessment, derived from the available studies and/or literature in the dossier peer reviewed, are presented. Concerns were not identified.

SUMMARY

Difenoconazole was included in Annex I to Directive 91/414/EEC on 1 January 2009 by Commission Directive 2008/69/EC and has been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011 and Commission Implementing Regulation (EU) No 1100/2011 as regards the conditions of approval of difenoconazole.

It was a specific provision of the approval that the applicant was required to submit to the European Commission further information as regards:

1. Further data on the specification of the technical material (to be submitted by 31 May 2012);

2. Residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops, processed commodities and products of animal origin (to be submitted by 30 November 2013);

3. The potential for endocrine‐disrupting effects on fish (fish full life cycle study) and the chronic risk to earthworms from the active substance and the metabolite CGA 205375 (to be submitted by 30 November 2013);

4. The possible impact of the variable isomer ratio in the technical material and of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and on the environment (to be submitted within 2 years from the adoption of specific guidance).

The review of confirmatory data related to point (a) was already completed and finalised at the Standing Committee on the Food Chain and Animal Health in December 2013. The Review Report has been updated accordingly (European Commission, 2013a). Confirmatory data required related to point (b) as regards residues for the TDMs have been covered by a separate output for all TDMs (EFSA, 2018) and the Review Report has been updated accordingly (European Commission, 2020). As regards the requirement under point (c) EFSA issued a previous output (EFSA, 2014).

In accordance with the specific provision (d), the applicant, Syngenta Ltd., submitted an updated dossier in December 2022, which was evaluated by the designated rapporteur Member State (RMS), Spain, in the form of an addendum to the draft assessment report. In compliance with guidance document SANCO 5634/2009‐rev.6.1 (European Commission, 2013b), the RMS distributed the addendum to Member States, the applicant and EFSA for comments on 12 June 2023. The RMS collated all comments in the format of a reporting table, which was submitted to EFSA on 13 October 2023.

EFSA added its scientific views on the specific points raised during the commenting phase, leading to the Technical Report finalised on 20 November 2023 (EFSA, 2023). The Technical Report from EFSA on the impact of the variable isomer ratio and preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and on the environment summarised the outcome of the consultation process organised by the RMS, Spain, and presented EFSA's scientific views and conclusions on the individual comments received. In particular, in the residues section, divergent views were expressed by EFSA, the RMS, other Member States and the applicant on whether preferential degradation of diastereoisomers in the aged residues occurred. EFSA recommended to further discuss the point in a peer review expert meeting.

In addition, in the framework of an MRL assessment of difenoconazole in leafy Brassica crops under Article 10 of Regulation 396/2005 (EFSA, 2021), EFSA identified an exceedance of the consumer chronic intake when considering the existing MRLs. Consequently, the Standing Committee on Plants, Animals, Food and Feed agreed to prioritise the review of the existing MRLs for difenoconazole according to Article 12 of Regulation 396/2005. Consequently, the MRL review has been initiated in September 2021 and is currently at an advanced stage. In order to allow the prompt finalisation of the prioritised MRL review, Commission therefore requested EFSA to organise the necessary expert meeting to complete the assessment for difenoconazole with regard to the consumer risk assessment by applying the provisions of Article 13 (3) of Regulation (EC) No 1107/2009. The following conclusions were derived as a result of this mandate:

Based on residue trials submitted in several plant crops on individual stereoisomers, an uncertainty factor of 1.3 was derived to refine the consumer risk assessment, applicable for all plants. For livestock, data were not provided on the behaviour of stereoisomers and a default factor of 2 was proposed for the risk assessment, given that difenoconazole alcohol (CGA205375), which is included in the risk assessment residue definition for animal commodities, has one chiral centre. Conclusively, the preferential degradation and/or conversion of the stereoisomers within formulated product applied on plants have been addressed as well as the potential impact on the consumer risk assessment without any chronic or acute intake concerns identified for the representative uses evaluated. An updated review of the existing MRLs according to Article 12 of Regulation 396/2005 using the derived uncertainty factor is ongoing in a separate output of EFSA (EFSA‐Q‐2009‐00103). It should be noted that difenoconazole is presently undergoing the renewal of the approval process (EFSA‐Q‐2016‐00675).

BACKGROUND

Difenoconazole was included in Annex I to Directive 91/414/EEC ¹ on 1 January 2009 by Commission Directive 2008/69/EC ² and has been deemed to be approved under Regulation (EC) No 1107/2009, ³ in accordance with Commission Implementing Regulation (EU) No 540/2011, ⁴ as amended by Commission Implementing Regulation (EU) No 541/2011 ⁵ and Commission Implementing Regulation (EU) No 1100/2011 ⁶ as regards the conditions of approval of difenoconazole.

EFSA previously finalised a Conclusion on 7 January 2011 (EFSA, 2011) and a Technical Report on the outcome of the consultation with Member States, applicant and EFSA on the pesticide risk assessment of confirmatory data (EFSA, 2014) for this active substance.

It was a specific provision of the approval that the applicant was required to submit to the European Commission further information as regards:

1. Further data on the specification of the technical material (to be submitted by 31 May 2012);

2. Residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops, processed commodities and products of animal origin (to be submitted by 30 November 2013);

3. The potential for endocrine‐disrupting effects on fish (fish full life cycle study) and the chronic risk to earthworms from the active substance and the metabolite CGA 205375 (to be submitted by 30 November 2013);

4. The possible impact of the variable isomer ratio in the technical material and of the preferential degradation and/or conversion of the mixture of isomers on the worker risk assessment, the consumer risk assessment and on the environment (to be submitted within 2 years from the adoption of specific guidance).

The review of confirmatory data related to point (a) was already completed and finalised at the Standing Committee on the Food Chain and Animal Health in December 2013. The Review Report has been updated accordingly (European Commission, 2013a). Confirmatory data required related to point (b) as regards residues for the TDMs have been covered by a separate output for all TDMs (EFSA, 2018) and the Review Report has been updated accordingly (European Commission, 2020). As regards the requirement under point (c) EFSA issued a previous output (EFSA, 2014).

In accordance with the specific provision (d), the applicant, Syngenta Ltd., submitted an updated dossier in December 2022, which was evaluated by the designated rapporteur Member State (RMS), Spain, in the form of an addendum to the draft assessment report. In compliance with guidance document SANCO 5634/2009‐rev.6.1 (European Commission, 2013b), the RMS distributed the addendum to Member States, the applicant and EFSA for comments on 12 June 2023 (Spain, 2023). The RMS collated all comments in the format of a reporting table, which was submitted to EFSA on 13 October 2023. EFSA added its scientific views on the specific points raised during the commenting phase, leading to the Technical Report finalised on 20 November 2023 (EFSA, 2023). The Technical Report from EFSA summarised the outcome of the consultation process organised by the RMS, Spain, and presented EFSA's scientific views and conclusions on the individual comments received. In particular, in the residues section, divergent views were expressed by EFSA, the RMS, other Member States and the applicant on whether preferential degradation of diastereoisomers in the aged residues occurred. EFSA recommended to further discuss this issue at a peer review expert meeting given its implications on the consumer risk assessment. The confirmatory data provided and the present peer review should be taken into account in the renewal peer review process which is currently undergoing (renewal dossier submitted on 30 June 2016). Moreover, additional data were submitted on 22 January 2024 for the determination of the endocrine‐disrupting properties of difenoconazole in the context of the renewal of approval process. Consequently, the TRVs are subject to potential revision and may change in the future.

In 2021, in the framework of an MRL assessment of difenoconazole in leafy Brassica crops under Article 10 of Regulation 396/2005 (EFSA, 2021), EFSA identified an exceedance of the consumer chronic intake when considering the existing MRLs. Consequently, the Standing Committee on Plants, Animals, Food and Feed ⁷ agreed to prioritise the review of the existing MRLs for difenoconazole according to Article 12 of Regulation 396/2005. Consequently, the MRL review has been initiated in September 2021 and is currently at an advanced stage (EFSA‐Q‐2009‐00103). In order to allow the prompt finalisation of the prioritised MRL review, in January 2024, the European Commission requested EFSA to organise the necessary expert discussion to complete the assessment for difenoconazole with regard to the consumer risk assessment by applying the provisions of Article 13(3) of Regulation (EC) No 1107/2009.

Following the expert discussions conducted in March 2024, a final consultation on the conclusions arising from the peer review of the confirmatory data under the present mandate took place with Member States via a written procedure in May 2024.

The conclusions laid down in this report were reached on the basis of the peer review of the RMS's evaluation of the confirmatory data submitted in relation to point to the possible impact of the variable isomer ratio in the technical material and of the preferential degradation and/or conversion of the mixture of isomers on the consumer risk assessment. A key supporting document to this conclusion is the peer review report, which is a compilation of the documentation developed to evaluate and address all issues raised in the peer review, from the compilation of comments in the reporting table to the conclusion. The peer review report (EFSA, 2024) comprises the following documents, in which all views expressed during the course of the peer review, including minority views, can be found:

• the report of the scientific consultation with Member State experts;

• the comments received on the draft EFSA conclusion.

Given the importance of the addendum to the assessment report on difenoconazole, confirmatory data (Spain, 2023) and the peer review report, these documents are considered as background documents to this conclusion.

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

THE ACTIVE SUBSTANCE AND THE FORMULATIONS FOR REPRESENTATIVE USES

Difenoconazole is the ISO common name for 3‐chloro‐4‐[(2RS,4RS;2RS,4SR)‐4‐methyl‐2‐(1H‐1,2,4‐triazol‐1‐ylmethyl)‐1,3‐dioxolan‐2‐yl]phenyl 4‐chlorophenyl ether (IUPAC). The formulations for the representative uses were ‘Score’ an emulsifiable concentrate (EC) containing 250 g/L difenoconazole and ‘Dividend 030 FS’, a flowable concentrate for seed treatment (FS) containing 30 g/L difenoconazole.

The representative uses as a fungicide evaluated for the formulation ‘Score’ are outdoor foliar spraying of pome fruit and carrots. The representative uses evaluated for the formulation ‘Dividend 030 FS’ are as a seed treatment for cereals (wheat, barley, triticale, rye, oat).

1. CONCLUSIONS OF THE EVALUATION

The assessment of the information submitted by the applicant in December 2022 to address the confirmatory data under point (d) was presented in confirmatory data addendum (Spain, 2023). The current conclusions address the confirmatory data requirement on the consideration of the impact of the isomeric composition of the substance pertaining only to the dietary risk assessment, as requested in the mandate.

The assessment of confirmatory data on difenoconazole pertaining to the impact on the consumer risk assessment was discussed at the Pesticides Peer Review Experts' Teleconference (TC) 133 (12–14 March 2024).

During the original peer review (EFSA, 2011), EFSA concluded that additional data on stereoisomeric changes are needed since difenoconazole is composed of an enantiomeric pair of diastereomers. To fulfil the confirmatory data requirements pertaining to the dietary risk assessment, the applicant submitted a total of 13 field trials as following: for apples and lettuce one trial per zone, South Europe (SEU) and North Europe (NEU), for beans, carrots and wheat two trials each for the NEU zone and one each for the SEU zone. These trials were analysed for difenoconazole enantiomers CGA201275 (2S,4R‐difenoconazole/cis1), CGA201276 (2R,4S‐difenoconazole/cis2), CGA201277 (2R,4R‐difenoconazole/trans1) and CGA201278 (2S,4S‐difenoconazole/trans2) by using a fully validated analytical method. Storage stability data were submitted for five crops, lettuce, orange, wheat, dried beans and oilseed rape, demonstrating the stability of each individual isomer for 12 months when the samples are stored at temperature below −18°C. The study design of the trials covered the representative GAP assessed under the peer review and the most critical GAPs assessed under Art. 12 MRL review.

In accordance with the EFSA guidance (EFSA, 2019), a threshold of a 10% change in stereoisomeric excess in the residues, relative to the substance as manufactured is used for evaluating the potential impact of such change on dietary risk assessment. The approved specification for the stereoisomeric cis/trans ratio is broad, ranging from 0.8 to 1.6 and is included in the ‘finalisation of the reference specification for technical active substances’ after the peer review (Sweden, 2012). No information was provided regarding the isomeric ratio of the formulated product applied in the residue trials. Consequently, the isomeric ratio at the time of application was considered for the initial analysis to calculate the enantiomeric/diastereoisomeric excess. This isomeric ratio served as a baseline for comparison with the isomeric composition determined in samples collected in subsequent harvesting points to determine the proportion of individual isomers in the final residue content. Data on the isomeric ratio were available on the date of application for all crops under investigation, except for wheat. In the case of wheat, the baseline for isomeric ratio calculations was established by using the initial analysis conducted at 21 days.

Consistent with EFSA guidance, calculations were performed for both enantiomeric (ee) and diastereoisomeric (se) excess. The assessment of the submitted field residue trials revealed no change in the enantiomeric ratio, but a significant change in the diastereoisomeric ratio (degradation of trans isomers and relative enrichment of cis isomers) was particularly observed in carrot (tops/leaves), lettuce and fresh beans with pods. Although the available data set was limited, based on the weight of evidence, an uncertainty factor (UF) of 1.3 could be proposed for refining the consumer risk assessment in the absence of toxicological data on individual isomers. The derived UF is applicable for all plant crops.

Data on the behaviour of stereoisomers in livestock were not provided. However, since the risk assessment residue definition for livestock was established as difenoconazole alcohol (CGA205375), which contains only one chiral centre, a default UF of 2 could be applied provisionally for animal commodities.

An update of the consumer risk assessment by using the acceptable daily intake (ADI) of 0.01 mg/kg body weight (bw) per day and the acute reference dose (ARfD) of 0.16 mg/kg bw was conducted for all the representative uses evaluated under the peer review by using EFSA PRIMO rev. 3.1 and PRIMO rev.2 and by applying the proposed UF of 1.3 for plants and 2 for animal commodities. For all the evaluated European consumer groups, both the chronic and acute dietary intakes were consistently below the established safety thresholds. Specifically, the ADI and the ARfD were not exceeded in any group. The highest theoretical maximum daily intake (TMDI) observed was in the Netherlands (toddlers), reaching 63% of the ADI (PRIMO 3.1) and 57% of the ADI (PRIMO 2) for German (child). Moreover, the highest International Estimated Short‐Term Intake (IESTI) constituted 32% of the ARfD in pears (PRIMO 3.1) and 22%of the ARfD in apples (PRIMO 2).

It should be noted that difenoconazole is presently undergoing the renewal of the approval process (EFSA‐Q‐2016‐00675). An update review of the MRLs using the derived UF is ongoing in a separate output of EFSA (EFSA‐Q‐2009‐00103).

2. CONCERNS AND RELATED DATA GAPS FOR THE REPRESENTATIVE USES EVALUATED

2.1. 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 ⁸ 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:

This peer review process of the confirmatory data assessment in the context of the present peer review did not identify any issue that could not be finalised.

2.2. 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:

This peer review process of the confirmatory data assessment in the context of the present peer review did not identify any critical areas of concern.

3. OVERVIEW OF THE CONCERNS IDENTIFIED FOR EACH REPRESENTATIVE USE CONSIDERED (TABLE 1)

TABLE 1.

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		Pome fruit	Carrot	Cereals (wheat, barley, triticale, rye, oat)
		Foliar spray	Foliar spray	Seed treatment
Consumer risk	Risk identified
	Assessment not finalised

4. 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 are listed in the order of the sections:

None identified in the present peer review process of confirmatory data assessment.

ABBREVIATIONS

ADI

Acceptable daily intake

AOEL

Acceptable operator exposure level

APPL

Applicant

AR

Applied radioactivity

a.s.

Active substance

DALA

Days after last application

DAR

Draft assessment report

DFOP

Double first order in parallel

DFR

Dislodgeable foliar residue

DG SANCO

European Commission Directorate General Health and Consumers

DT50

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

EC

Emulsifiable concentrate

EE

Enantiomeric excess

EF

Enantiomeric fraction

FOMC

First order multi compartment

FS

Flowable concentrate for seed treatment

IESTI

international estimated short‐term intake

LC50

Lethal concentration, median

LD50

Lethal dose, median; dosis letalis media

LOQ

Limit of quantification

MRL

Maximum residue level

MS

Member State

PEC

Predicted environmental concentration

PECsoil

Predicted environmental concentration in soil

PECgw

Predicted environmental concentration in groundwater

PHI

Preharvest interval

RMS

Rapporteur Member State

SE

Stereoisomer excess

SFO

Single first order

TDMI

theoretical maximum daily intake

TER

Toxicity exposure ratios

UF

Uncertainty factor

ACKNOWLEDGMENTS

EFSA wishes to thank the rapporteur Member State Spain for the preparatory work on this scientific output.

CONFLICT OF INTEREST

If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact interestmanagement@efsa.europa.eu.

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2024‐00064

COPYRIGHT FOR NON‐EFSA CONTENT

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APPENDIX A. List of end points for the active substance and the representative formulation relevant for the confirmatory data assessed

A.1.

Identity, Physical and Chemical Properties, Details of Uses, Further Information

Identity (Annex IIA, point 1)

Consumer risk assessment (Annex IIA, point 6.9, Annex IIIA, point 8.8)

Uncertainty factor of 1.3 derived at TC 133, March 2024, Peer Review Confirmatory data were used in the EFSA PRIMo 2 and PRIMo 3.1 updated calculations.

APPENDIX B. Used compound codes

B.1.

Code/trivial name a	IUPAC name/SMILES notation/InChiKey b	Structural formula c
Difenoconazole	3‐chloro‐4‐[(2RS,4RS;2RS,4SR)‐4‐methyl‐2‐(1H‐1,2,4‐triazol‐1‐ylmethyl)‐1,3‐dioxolan‐2‐yl]phenyl 4‐chlorophenyl ether Clc1ccc(cc1)Oc1ccc(c(Cl)c1)C1(Cn2ncnc2)OCC(C)O1 BQYJATMQXGBDHF‐UHFFFAOYSA‐N
CGA201278	1‐({(2S,4S)‐2‐[2‐chloro‐4‐(4‐chlorophenoxy)phenyl]‐4‐methyl‐1,3‐dioxolan‐2‐yl}methyl)‐1H‐1,2,4‐triazole Clc1ccc(cc1)Oc1ccc(c(Cl)c1)[C@]1(Cn2ncnc2)OC[C@H](C)O1 BQYJATMQXGBDHF‐ORAYPTAESA‐N
CGA201275	1‐({(2S,4R)‐2‐[2‐chloro‐4‐(4‐chlorophenoxy)phenyl]‐4‐methyl‐1,3‐dioxolan‐2‐yl}methyl)‐1H‐1,2,4‐triazole Clc1ccc(cc1)Oc1ccc(c(Cl)c1)[C@]1(Cn2ncnc2)OC[C@@H](C)O1 BQYJATMQXGBDHF‐BFUOFWGJSA‐N
CGA201276	1‐({(2R,4S)‐2‐[2‐chloro‐4‐(4‐chlorophenoxy)phenyl]‐4‐methyl‐1,3‐dioxolan‐2‐yl}methyl)‐1H‐1,2,4‐triazole Clc1ccc(cc1)Oc1ccc(c(Cl)c1)[C@@]1(Cn2ncnc2)OC[C@H](C)O1 BQYJATMQXGBDHF‐DJJJIMSYSA‐N
CGA201277	1‐({(2R,4R)‐2‐[2‐chloro‐4‐(4‐chlorophenoxy)phenyl]‐4‐methyl‐1,3‐dioxolan‐2‐yl}methyl)‐1H‐1,2,4‐triazole Clc1ccc(cc1)Oc1ccc(c(Cl)c1)[C@@]1(Cn2ncnc2)OC[C@@H](C)O1 BQYJATMQXGBDHF‐YJYMSZOUSA‐N
Difenoconazole alcohol	(1R)‐1‐[2‐chloro‐4‐(4‐chlorophenoxy)phenyl]‐2‐(1H‐1,2,4‐triazol‐1‐yl)ethanol O[C@@H](Cn1cncn1)c1ccc(Oc2ccc(Cl)cc2)cc1Cl NBYSKMWDHCZSIP‐INIZCTEOSA‐N
CGA205375	(1S)‐1‐[2‐chloro‐4‐(4‐chlorophenoxy)phenyl]‐2‐(1H‐1,2,4‐triazol‐1‐yl)ethanol O[C@H](Cn1cncn1)c1ccc(Oc2ccc(Cl)cc2)cc1Cl NBYSKMWDHCZSIP‐MRXNPFEDSA‐N

^a The compound 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, 7 July 2021).

^c ACD/ChemSketch 2021.1.3 ACD/Labs 2021.1.3 (File Version C25H41, Build 123835, 29 August 2021).

EFSA (European Food Safety Authority) , Álvarez, F. , Arena, M. , Auteri, D. , Leite, S. B. , Binaglia, M. , Castoldi, A. F. , Chiusolo, A. , Colagiorgi, A. , Colas, M. , Crivellente, F. , De Lentdecker, C. , De Magistris, I. , Egsmose, M. , Fait, G. , Ferilli, F. , Santonja, G. G. , Gouliarmou, V. , Halling, K. , … Villamar‐Bouza, L. (2024). Peer review of the pesticide risk assessment for the active substance difenoconazole in light of confirmatory data submitted. EFSA Journal, 22(7), e8921. 10.2903/j.efsa.2024.8921