Peer review of the pesticide risk assessment of the active substance proquinazid

Abstract

The conclusions of the European Food Safety Authority (EFSA) following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State Sweden and co‐rapporteur Member State Lithuania for the pesticide active substance proquinazid are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative uses of proquinazid as a fungicide on powdery mildew diseases on cereals and grapes. The reliable end points, appropriate for use in regulatory risk assessment are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported.

SUMMARY

Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659, lays down the procedure for the renewal of the approval of active substances submitted under Article 14 of Regulation (EC) No 1107/2009. The list of those substances is established in Commission Implementing Regulation (EU) No 686/2012 as amended by Commission Implementing Regulation (EU) No 2016/183. Proquinazid is one of the active substances listed in that Regulation.

In accordance with Article 1 of Regulation (EU) No 844/2012, the rapporteur Member State (RMS), Sweden and co‐rapporteur Member State (co‐RMS), Lithuania, received an application from Corteva Agriscience International Sàrl for the renewal of approval of the active substance proquinazid.

An initial evaluation of the dossier on proquinazid was provided by the RMS in the renewal assessment report (RAR) and, subsequently, a peer review of the pesticide risk assessment on the RMS evaluation was conducted by EFSA in accordance with Article 13 of Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The following conclusions are derived.

The uses of proquinazid as a fungicide on cereals and grapes by foliar spraying in field, as proposed at EU level, result in a sufficient fungicidal efficacy against the target pests (Blumeria graminis and Uncinula necator).

The assessment of the data package revealed no issues that could not be finalised or that need to be included as critical areas of concern with respect to identity, physical and chemical properties and analytical methods.

In the area of mammalian toxicology, data gaps are identified to characterise the toxicological profile of an impurity and some metabolites, leading to issues that could not be finalised.

In the area of residues, due to the multiple data gaps identified – including insufficient characterisation of toxicity of major residue metabolites – the consumer dietary risk assessment for all representative uses could not be finalised. Also, the consumer risk assessment from the consumption of drinking water could not be finalised due to incomplete data.

In the area of environmental fate and behaviour, a data gap remains regarding the effect of water treatment processes on the nature of the identified metabolite residues potentially present in surface water, when surface water is abstracted for the production of drinking water, preventing the finalisation of the consumer risk assessment as indicated above.

In the area of ecotoxicology, a low risk was concluded for birds, mammals (acute), aquatic organisms, bees, soil organisms, non‐target terrestrial plants and organisms involved in biological methods for sewage treatment. A high long‐term risk to mammals and a high in‐field risk to non‐target arthropods other than bees was concluded for several representative uses.

Regarding the assessment of the endocrine disruption (ED) properties, based on the available information, it can be concluded that proquinazid is an endocrine disruptor in humans according to point 3.6.5 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605, leading to a critical area of concern. For non‐target organisms, it could be concluded that the substance does not meet the ED criteria according to point 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605.

BACKGROUND

Commission Implementing Regulation (EU) No 844/2012, ¹ 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, the RMS Sweden and co‐RMS Lithuania received an application from Corteva Agriscience International Sàrl for the renewal of approval of the active substance Proquinazid. Complying with Article 8 of the Regulation, the RMS checked the completeness of the dossier and informed the applicant, the co‐RMS Lithuania, the European Commission and EFSA about the admissibility.

The RMS provided its initial evaluation of the dossier on proquinazid in the RAR, which was received by EFSA on 14 February 2022 (Sweden, 2022).

In accordance with Article 12 of the Regulation, EFSA distributed the RAR to the Member States and the applicant, Corteva Agriscience International Sàrl, for consultation and comments on 5 December 2022. 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 14 February 2023. 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.

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, the RMS and ECHA on 12 May 2023. 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, residues, environmental fate and behaviour, and ecotoxicology.

In addition, following a consultation with Member States in the Pesticides Peer Review Expert meeting TC 131 (March 2024), it was considered necessary to apply an additional clock stop of 3–30 month 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.

In addition, in accordance with the provisions of Commission Implementing Regulation (EU) No 2018/1659, following a consultation with Member States in the Pesticides Peer Review Expert meeting TC 131 (March 2024), the applicant was given the opportunity to submit, within a period of 3 months, additional information to address the approval criteria set out in point 3.6.5 and/or point 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605, and/or documentary evidence demonstrating that Proquinazid may be used such that exposure is negligible, or the conditions for the application of the derogation under Art.4(7) of Regulation (EC) No 1107/2009 are met.

The additional information submitted by the applicant was subsequently evaluated by the RMS. Furthermore, the applicant also requested a derogation under Article 4(7) of Regulation (EC) No 1107/2009, submitting evidence regarding the necessity of proquinazid as fungicide to control a serious danger to plant health. The evaluation of the data regarding this derogation request is presented in Appendices D and E of this conclusion.

A public consultation on the draft Article 4(7) scientific report and the revised RAR on the ED made available after the 3‐month clock stop was conducted between April and June 2025. All comments received, including the ones from the applicant and the Member States, were collated in the format of a commenting table (on the draft Art 4(7) scientific report) and of a reporting table (on the revised RAR on the assessment of the endocrine‐disrupting properties). As a result of the public consultation, the need for an additional experts' consultation in the area of mammalian toxicology and ecotoxicology was identified.

The outcome of the telephone conference, together with EFSA's further consideration of the comments, is reflected in the conclusions set out in column 4 of the reporting table. All points that were identified as unresolved at the end of the comment evaluation phase and which required further consideration, including those issues to be considered in an expert consultation, were compiled by EFSA in the format of an evaluation table.

The conclusions arising from the consideration by EFSA, and as appropriate by the RMS, of the points identified in the evaluation table, together with the outcome of the expert consultation and the written consultation on the assessment of additional information, where these took place, were reported in the final column of the evaluation table.

A final consultation on the conclusions arising from the peer review of the risk assessment took place with Member States via a written procedure in February–March 2026.

This conclusion report summarises the outcome of the peer review of the risk assessment of the active substance and the formulation for representative uses, evaluated on the basis of the representative uses of proquinazid as a fungicide active on powdery mildew diseases on cereals (winter wheat, spring wheat, winter barley, spring barley, winter rye, oats, triticale) and grapes (wine and table), as proposed by the applicant. In accordance with Article 12(2) of Regulation (EC) No 1107/2009, risk mitigation options identified in the RAR and considered during the peer review, if any, are presented in the conclusion.

A list of the relevant end points for the active substance and the formulations provided in Appendix C. In addition, the considerations as regards the cut‐off criteria for Proquinazid according to Annex II of Regulation (EC) No 1107/2009 are summarised in Appendix A.

A key supporting document to this conclusion is the peer review report (EFSA, 2026), which is a compilation of the documentation developed to evaluate and address all issues raised in the peer review, from the initial commenting phase to the conclusion. The peer review report comprises the following documents, in which all views expressed during the course of the peer review, including minority views, where applicable, can be found:

• the comments received on the RAR;

• the reporting Table (12 May 2023);

• the evaluation Table (27 March 2026);

• the report(s) 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 Art 4(7) scientific report;

• the comments received on the draft EFSA conclusion.

Given the importance of the RAR, including its revisions (Sweden, 2025), and the peer review report, both documents are considered as background documents to this conclusion and thus are made publicly available.

It is recommended that this conclusion 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 conclusion report is based.

THE ACTIVE SUBSTANCE AND THE FORMULATION FOR REPRESENTATIVE USES

Proquinazid is an ISO common name for 6‐iodo‐2‐propoxy‐3‐propylquinazolin‐4(3H)‐one (IUPAC). The formulated product for the evaluation was ‘Proquinazid 200 g/L EC’, an emulsifiable concentrate (EC) containing 200 g/L pure proquinazid.

The information on the active substance and the formulation for representative uses, including the co‐formulants in these formulations, was considered in the overall assessment during the peer review. None of the co‐formulants is an unacceptable co‐formulant listed in Annex III of Regulation (EC) No 1107/2009, ⁵ and one co‐formulant, present in significant amount in the formulation for representative uses, is a non‐approved active substance under Regulation (EC) 1107/2009 ^{6 , 7} (not linked to safety concerns).

Details on the composition of the formulations cannot be reported in conclusions because of the provisions in Article 63(2)(d) of Regulation (EC) No 1107/2009, however this information was fully available and evaluated during the peer review. A proposal for classification of the formulation(s) according to Regulation (EC) 1272/2008 was provided by the applicant and assessed by the RMS (please see Volumes 3 CP of the RAR).

The representative uses evaluated were field spray foliar application on cereals (such as winter and spring wheat, winter and spring barley, winter rye oats and triticale) for control of cereals powdery mildew (Blumeria graminis) and on grapes (wine and table) for control of grape powdery mildew (Uncinula necator). Full details of the GAPs can be found in the list of end points in Appendix B.

Data were submitted to conclude that the uses of proquinazid 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).

General aspects

With regard to the mammalian toxicity information available for the formulation for representative uses ‘Proquinazid 200 g/L EC, studies were performed for acute toxicity endpoints. With regard to the co‐formulants contained in ‘A10788A’, sufficient toxicological data were available for all components. The RMS considered that the available toxicological information did sufficiently address genotoxicity, and repeated dose toxicity potential of ‘A10788A’ over the short‐ and long‐term and no concern was identified. ⁸

The availability of ecotoxicity data with the formulation for representative uses was discussed at the Pesticides Peer Review Experts' Teleconference 134. ⁹ Based on the available data (see Section 5), it was noted that the formulation for representative uses was not more toxic than the active substance. Furthermore, the experts discussed the data retrieval search and the available data for the individual components. Considering the available data, the experts could not conclude on the ecotoxicological profile of the representative formulation and agreed that further chronic toxicity considerations to certain non‐target organisms (aquatic organisms) might be necessary to complement these assessments (data gap, see Section 10).

1. IDENTITY, PHYSICAL/CHEMICAL/TECHNICAL PROPERTIES AND METHODS OF ANALYSIS

The following guidance documents were followed in the production of this conclusion: European Commission (2000, 2010a, 2010b, 2019).

The proposed specification for proquinazid is based on batch data from industrial plant production and quality control (QC) data. Based on the data submitted for the renewal procedure it was proposed the minimum purity of 950 g/kg to be maintained, however the maximum level of an impurity to be lowered and an impurity not to be specified. EFSA is of the opinion that based on the data submitted higher minimum purity for the active substance and lower levels for some other impurities could have been set. It should be noted that evaluation of the toxicological relevance of the impurities is open (see Section 2) and as a consequence, new data such as spectral data, content of the impurities before and after the storage of the formulation and methods for analysis of the relevant impurities in the formulation might be required. The batches used in the toxicological assessment are not fully representative of the original and newly proposed reference specification (see Section 2). The available data were insufficient to confirm the compliance of the batches used in the ecotoxicity studies with the current and updated reference specification (see Section 5). There was not FAO specification available for proquinazid.

The main data regarding the identity of proquinazid and its physical and chemical properties are given in Appendix B.

Adequate methods are available for the generation of data required for the risk assessment. A data gap was identified for a summary (description and validation data) of the analytical method used in vapour pressure study (see Section 10). Methods of analysis are available for the determination of the active substance in the technical material and in the representative formulation and for the determination of the respective impurities in the technical material. A data gap for additional validation data for the method for quantification of two impurities in the technical material was identified (see data gap in Section 10). ¹⁰

Proquinazid residue can be monitored in food and feed of plant origin by DFG S19 using liquid chromatography with tandem mass spectrometry (LC–MS/MS) with limit of quantification (LOQ) of 0.01 mg/kg in all commodity groups. For dry, high‐water, high‐acid content commodities, efficiency of the extraction procedure used was demonstrated. Extraction efficiency was not verified for high‐oil content commodities (not needed, considering the representative uses and lack of metabolism studies in these commodities). Proquinazid and metabolite IN‐MU210 residues in food and feed of animal origin can be determined by LC–MS/MS with LOQ of 0.01 mg/kg for each analyte in all animal matrices. Proquinazid and IN‐MW977 can be monitored in honey by LC–MS/MS with LOQs of 0.01 mg/kg.

Proquinazid residue in soil and water can be monitored by LC–MS/MS with LOQs 1.0 μg/kg and 0.1 μg/L, respectively. Appropriate LC–MS/MS method exists for monitoring of proquinazid residue in air with a LOQ of 0.80 μg/m³.

LC–MS/MS can be used for monitoring of proquinazid and IN‐MU210 in body fluids (plasma and urine) with LOQ of 0.01 mg/kg. Proquinazid and IN‐MU210 residues in body tissues can be determined by using the monitoring methods for residue in food of animal origin.

2. MAMMALIAN TOXICITY

Proquinazid was discussed at the Pesticides Peer Review Experts' Teleconference (TC) 131 (4–8 March 2024). The assessment is based on the following guidance documents: European Commission (2003, 2012), EFSA (2014b).

The test material used in toxicity studies is not fully representative of the original and newly proposed reference specification for the active substance and associated impurities. Further data are needed to define the relevance of an impurity and its maximum content ¹¹ (issue not finalised, see Section 1 and 9.1).

The analytical methods used in feed, body fluids and tissues, air and any additional matrices used in support of the key toxicity studies for risk assessment are considered fit‐for‐purpose (see Section 1).

Proquinazid is extensively absorbed (higher than 86%), following oral administration to rats. Metabolism is extensive. No disproportionate or unique human metabolites are identified in vitro (hepatocytes). The residue definition for body fluids and tissues includes proquinazid and IN‐MU210.

Proquinazid is of low acute toxicity to rats following oral, dermal or inhalation exposure; it is not a skin or eye irritant nor a skin sensitiser.

Based on its UV–vis absorption spectra, phototoxicity and photomutagenicity testing is required for proquinazid. Under the conditions of the available studies (OECD TG 432 positive and TG 498, negative with topical application), proquinazid is considered unlikely to be phototoxic. The experts agreed that the requirement to address photomutagenicity was not properly addressed since a rationale for a data waiver was not provided. ¹² Based on the current state of the art and additional considerations as discussed by the expert meeting, EFSA concluded that phototoxicity can be considered as a surrogate for photomutagenicity and a data gap is not set.

After short‐term oral exposure to proquinazid, the relevant no observed adverse effect level (NOAEL) is 1.89 mg/kg bw per day, based on liver and thyroid toxicity in the combined subchronic and neurotoxicity study in rats. In dogs, a lowest observable adverse effect leve (LOAEL) of 17 mg/kg bw per day based on eye and liver toxicity was identified in the 90‐day study (a NOAEL was not identified).

Based on weight‐of‐evidence, proquinazid is unlikely to be genotoxic, in line with the ECHA Risk Assessment Committee (RAC) opinion (ATP05; ECHA, 2023; see Appendix A).

Long‐term toxicity studies in rats and mice indicate liver and thyroid toxicity. The relevant NOAEL for long‐term toxicity is 1.16 mg/kg bw per day from the 2‐year rat study. The relevant NOAEL for carcinogenicity is 12 mg/kg bw per day based on cholangiocarcinomas and hepatocellular adenomas in female rats; and thyroid follicular cell adenomas in male rats. The ECHA RAC proposed to retain the currently legally in place harmonised classification for proquinazid as carcinogenic category 2 (ATP 05; ECHA, 2023, see Appendix A).

No relevant effects related to fertility or sexual function are observed in the available two‐generation studies in rats. The relevant offspring and reproductive NOAELs are 13.7 mg/kg bw per day based on reduced pup weight and 35 mg/kg bw per day (highest dose level tested), respectively. The parental NOAEL is 1.80 mg/kg bw per day based on thyroid toxicity. Proquinazid is not a developmental toxicant. The maternal NOAELs in rat and rabbit are 30 mg/kg bw per day and 2.5 mg/kg bw per day, respectively, based on reduced food consumption and body weight. The developmental NOAELs in rat and rabbits are 30 mg/kg bw per day and 2.5 mg/kg bw per day, respectively, based on reduced body weight and foetal variations.

The ECHA RAC concluded proquinazid warrants no classification for adverse effects on sexual function and fertility and for development (ATP05; ECHA, 2023; see Appendix A).

Acute neurotoxicity studies indicate decreased motor activity at 100 and 500 mg/kg bw in females and males, respectively, but no structural damage to the nervous system. Repeated dose studies, including the combined subchronic and neurotoxicity study in rats, do not show neurotoxic effects up to 135 mg/kg bw per day and 49.7 mg/kg bw per day in males and females respectively. The requirement for information on developmental neurotoxicity (DNT) was discussed at the Pesticides Peer Review TC 131 ¹³ and the experts did not consider a DNT study necessary. While experts agreed that the Uridine 5′‐diphospho‐glucuronosyltransferase(UGT) Mode of action has not been proven to be rodent specific and that observed thyroid effects may be relevant to humans, there was agreement that the young adult rat lacking thyroid binding globulin is likely more sensitive than humans regarding this effect and the intraspecies uncertainty factor of 10 is – in this specific case – expected to cover for the lack of additional investigation in the developing animal.

Immunotoxicity studies do not show impact on immune function.

Health‐based guidance values (HBGVs) were established: the acceptable daily intake (ADI) is 0.012 mg/kg bw per day. This value is based on a NOAEL of 1.16 mg/kg bw per day, identified in a 2‐year rat study, in which histopathological changes in the liver and thyroid along with alterations in thyroid hormone homeostasis were observed at the dose of 12.08 mg/kg bw per day. An uncertainty factor (UF) of 100 was applied. This ADI is the same as in the previous peer review (EFSA, 2009).

The acceptable operator exposure level (AOEL) is 0.02 mg/kg body weight per day. This value is derived from a NOAEL of 1.89 mg/kg bw per day, identified in a combined subchronic and neurotoxicity study in rats, in which morphological changes in the liver and thyroid, alterations in thyroid hormone homeostasis and clinical pathology changes in males were observed at a dose of 6.22 mg/kg bw per day. An uncertainty factor of 100 was applied, with no correction for oral absorption. This AOEL is the same as in the previous peer review (EFSA, 2009).

The acute reference dose (ARfD) is 0.06 mg/kg body weight. This value is based on a LOAEL of 17 mg/kg bw per day, identified in a 90‐day dog study, in which ocular discharge after the initial doses were observed. A standard UF of 100 was applied, along with an additional UF of 3, due to the absence of a NOAEL. This ARfD differs from the value established in the previous peer review (0.2 mg/kg bw; 90‐day dog).

The same basis as the ARfD was applied to derive the acute AOEL (AAOEL), with no correction for oral absorption. An AAOEL was not established during the previous peer review.

Proquinazid meets the criteria for endocrine disruption for T‐modality for humans (Scenario 1b) (see Section 6). The lowest NOAEL for the endocrine disruption endpoint is 1.89 mg/kg bw per day (see Section 6). Consequently, the established HBGVs are considered covering the endocrine effects.

Dermal absorption rates of proquinazid in the formulation for representative uses are 1% for concentrate and 6.5% for a formulation diluted to 0.033 g/L, and 21% (after prorata correction) for a formulation diluted to 0.01 g/L.

Non‐dietary exposure estimates, calculated with the EFSA (EFSA, 2014b), showed that operator, worker, resident and bystander exposure to proquinazid was below (A)AOEL values (see Appendix B) considering risk mitigation measures in some scenarios (See Section 8) or using refined input parameters (i.e. measured DFR of 0.53 μg/cm²/kg a.s per hectare in worker hand harvesting grapes).

Toxicological studies and information have been provided for metabolites sulfate conjugate var. 1, Sulfate conjugate var. 2, IN‐MW977 (including its major and minor isomers and their respective glucosides), A1, A4, B3, B4, CRC‐Soy‐01, IN‐MM671, IN‐MU210, IN‐MY340, IN‐MY341, IN‐MY788, IN‐MM986, IN‐MM991, IN‐MU715, IN‐MW397, IN‐MW398, IN‐NA250, IN‐NA251, IN‐NA252, A2 (see Appendix B).

There are no metabolites found in groundwater above 0.1 μg/L (see Section 4 and Table 3).

TABLE 3.

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
Proquinazid	No	Yes	–	–	Yes
IN‐MM671	No	not triggered	Not triggered.	No	Not triggered.
IN‐MM986	No	not triggered	Not triggered.	No	Not triggered.
IN‐MM991	No	not triggered	Not triggered.	No	Not triggered.

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

^b FOCUS scenarios or relevant lysimeter. Ranges indicated for FOCUS scenarios include the result from the model giving the highest concentration at each scenario, as needed to comply with European Commission (2014a) guidance.

With respect to metabolites identified as relevant residues (Section 3), metabolites IN‐MW977 (including its major and minor isomers and their glucosides), IN‐MM671 and IN‐MU210 are unlikely to be genotoxic. Data gaps have been set regarding the genotoxic potential and general toxicity of metabolites CRC‐Soy‐01, IN‐MM986 and IN‐MM991, (see Appendix F, Sections 3 and 9.1).

Data gaps have been set for the general toxicity of metabolites IN‐MW977 (including its isomers major and minor and their glucosides), IN‐MM671 and IN‐MU210 (see Appendix F, Sections 3 and 9.1).

Given that proquinazid is ED for humans, the applicant was given the opportunity to provide additional information, in particular to demonstrate that proquinazid may be used such that exposure is negligible. However, the applicant did not provide a negligible exposure assessment. In addition, the RMS did not include in the revised RAR an assessment addressing non‐dietary negligible exposure (see also Section 6).

3. RESIDUES

3.1. Representative use residues

The assessment in the residue section is based on the following guidance documents: OECD (2009, 2011), European Commission (2011) and JMPR (2004, 2007).

Proquinazid was discussed at the Pesticides Peer Review Experts' TC 133 (12–14 March 2024).

Metabolism studies for the crop categories cereal/grass crops (wheat) and fruit (apple and grape) were available to cover the GAPs of the representative uses. However, major shortcomings were observed, i.e. the fate of proquinazid was not fully elucidated as the studies were performed with only the phenyl ring labelled. Together with the low identification rate it remains unclear whether cleavage can take place and metabolites bearing the pyrimidinyl ring could be expected. Furthermore, the metabolite IN‐MW977, which was quantified in residue field trials with grapes, was not used as standard in the metabolism studies with fruits. The identification in fruit leaves was low despite high total residues and therefore the studies cannot be used to conclude on the metabolic pattern in grape leaves for which a MRL application is reported to be submitted. ¹⁴ A new metabolism study with grape with proquinazid labelled on the pyrimidine ring of the molecule, attempting an identification rate as described in OECD TG 501 (OECD, 2007) and also addressing the metabolism in grape leaves, is requested to confidently conclude on the metabolism of proquinazid in fruit and cereal (data gap leading to an issue not finalised, see Section 9.1). If cleavage of the molecule is observed in this requested study, another metabolism study with the pyrimidine label, performed with a cereal crop, should also be conducted. Based on the considerations above and in the absence of data on the general toxicological profile of IN‐MW977 (see Sections 2 and 9.1), the residue definition for risk assessment in plants is set provisionally as proquinazid and IN‐MW977 (for fruits and cereals including cereal straw). Proquinazid was recovered in all plant parts and is a good marker. Therefore, the residue definition for enforcement is proposed as proquinazid (for fruits and cereals).

A sufficient number of residue field trials is available to cover the representative uses on cereals and grapes analysing for proquinazid and its metabolite IN‐MW977. These trials are considered conditionally valid until the risk assessment residue definition for plants will be confirmed by additional metabolism study(ies) and toxicological data for IN‐MW977 become available (see data gaps above).

The persistence in soil of proquinazid and its soil metabolites IN‐MM671, IN‐MM986 and IN‐MM991 (see Section 4) triggered the investigation of residues also in rotational crops. Two confined rotational crop metabolisms studies were presented. The first study did not allow to fully identify the residues and therefore a second study was submitted to also address the confirmatory data requested in the context of the review of the existing maximum residue levels for proquinazid according to Article 12 of Regulation (EC) No 396/2005 (EFSA, 2020) (see also Section 3.2). Out of the three persistent soil metabolites, only IN‐MM671 and IN‐MM991 were found in low concentrations in soil and some crops, whereas the other soil metabolite IN‐MM986 was not detected. A specific major metabolite, CRC‐Soy‐1, was only found in the rotated soyabean, both in straw and seed. Information on their toxicity (genotoxicity and general toxicity) is not or only partially available (data gap, see Section 2). As both studies were underdosed with respect to the PECplateau for proquinazid, IN‐MM671 and IN‐MM986 and because of the different findings observed among them, a confident decision on the metabolic pattern cannot be established. Therefore, a new confined rotational metabolism study, with proquinazid labelled in the phenyl and pyrimidine rings, investigating parent proquinazid and all relevant metabolites and covering the PECplateau calculated for these compounds is requested (data gap leading to an issue not finalised, see Section 9.1).

Proquinazid is stable under household processing conditions. Processing factors were derived (see Appendix B).

The outcome of the dietary burden calculation for the sum of proquinazid and IN‐MW977 indicates that for all species except swine animal studies are triggered by cereals, the only representative use which results in feed items. The calculation was carried out by using the provisional residue definition, i.e. expressed as proquinazid, and that the potential contribution of residues from rotated crops is not considered in this calculation. The presented metabolism studies with proquinazid in poultry and ruminant were found to be valid. Proquinazid was extensively metabolised in ruminants but it was the major residue in poultry tissues. IN‐MU210 and IN‐MW977 were reported in all ruminant matrices but not found in poultry. For the plant metabolite IN‐MW977, it remains unclear whether it is not formed in poultry or could not be detected because no analytical standard was used. An indicative dietary burden calculation for this metabolite alone exceeded the trigger also for poultry. ¹⁵ Pending the finalisation of the residue definition for risk assessment in primary and rotational crops (see data gaps above), a follow‐up investigation on the behaviour of this metabolite in poultry might become necessary.

A feeding study with dairy cows and analysing for proquinazid, IN‐MU210 and IN‐MW977 was submitted. Proquinazid was recovered only at the highest dose level in liver and fat and IN‐MW977 was reported only in liver at the highest dose level. The residue of IN‐MU210 ranged from 0.011 mg/kg in muscle to 0.53 mg/kg in kidney.

Based on the results presented above from the animal studies, the existing residue definition for enforcement was confirmed as sum of proquinazid and metabolite 3‐[(6‐iodo‐4‐oxo‐3‐propyl‐3,4‐dihydroquinazolin‐2‐yl)oxy]propanoic acid (IN‐MU210), expressed as proquinazid; and the residue definition for risk assessment in livestock as sum of proquinazid, IN‐MU210 and IN‐MW977, expressed as proquinazid. The latter is provisional, pending the toxicity data for the metabolites IN‐MU210 and IN‐MW977 (data gap, see Section 2). Dietary burden calculations in fish indicated that the maximum dietary burden for fish species will be below the threshold of 0.1 mg/kg feed and thus not triggering feeding studies with fish.

Residues of both, proquinazid and IN‐MW977, in honey were below the LOQ of 0.01 mg/kg.

Chronic and acute consumer dietary intake assessment was performed using the revision 3.1 of the EFSA pesticide residue intake model (PRIMo). The consumer exposure corresponds to 8% of the ADI and to 20% (for table grapes, FI child) with the newly derived ARfD (see section 2). However, pending several data gaps, the consumer risk assessment remains provisional (issue not finalised, see Section 9.1). When considering all uses evaluated in the Article 12 MRL review of proquinazid (EFSA, 2020), the consumer exposure corresponds to 29% of the ADI and to 54% of the ARfD (for strawberries, NL child).

The consumer risk assessment from the consumption of drinking water is not finalised considering the lack of appropriate information to address the effect of water treatment processes on the nature of residues, potentially present in surface water, when surface water is abstracted for the production of drinking water (see Sections 4 and 9.1).

Proquinazid meets the criteria for endocrine disruption for T‐modality for humans (see Section 6). An assessment of negligible dietary exposure was requested but not provided. Therefore, it could not be demonstrated that one or more of the representative uses could satisfy the requirements regarding negligible dietary exposure as set out in point 3.6.5 of Annex II to Regulation (EC) No 1107/2009.

3.2. Maximum residue levels and confirmatory data MRL review

Data requirements identified for the MRL requests (residue field trials with barley and oats, pumpkins, grass) were partly addressed, and the additional information was assessed (see data requirement 3.9 and Experts' consultation 3.4 in the evaluation table part 3 residue (EFSA, 2026)).

In the Article 12 MRL review assessment of proquinazid (EFSA, 2020), 8 residue trials on barley and oats in the SEU zone were requested as confirmatory data. A study with 5 GAP compliant and valid residue trials in the SEU zone with barley were submitted and partly addressed the data gap set in the Article 12 MRL review.

4. ENVIRONMENTAL FATE AND BEHAVIOUR

Proquinazid was discussed at the Pesticides Peer Review Meeting Experts' TC 143 (6–7 March 2024).

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, proquinazid exhibited moderate to high persistence, forming the major (> 10% applied radioactivity (AR)) metabolite IN‐MM671 (max. 65.3% AR) which exhibited high persistence, metabolite IN‐MM986 (max. 8.1% AR), which exhibited moderate to very high persistence, and metabolite IN‐MM991 (max. 6.7% AR), exhibiting moderate to high persistence. Mineralisation of the phenyl ¹⁴C radiolabel to carbon dioxide accounted for 2.4%–9.5% AR after 120 days. The formation of unextractable residues (not extracted by acetonitrile/water) for this radiolabel accounted for 6.4%–12.5% AR after 120 days. In anaerobic soil incubations, proquinazid degraded faster than under aerobic conditions with the route of degradation being the same as in the aerobic investigations. In soil photolysis conditions, proquinazid degradation was faster than in the dark control, but no novel metabolites were formed. Proquinazid exhibited immobility in soil. Metabolite IN‐MM671 exhibited low to slight soil mobility, metabolite IN‐MM986 exhibited low soil mobility to immobility and metabolite IN‐MM991 exhibited high to low soil mobility. It was concluded that the adsorption of proquinazid and its soil metabolites was not pH dependent. In satisfactory field dissipation studies carried out at 8 sites from UK, France, Italy and Germany (spray application to the soil surface on bare soil plots), proquinazid exhibited low to medium persistence. Sample analyses were carried out for the parent proquinazid and metabolites IN‐MM671, IN‐MM986 and IN‐MM991. Field study DegT50 values were derived following normalisation to FOCUS reference conditions (20°C and pF2 soil moisture) following the EFSA (2014a) DegT50 guidance.

In laboratory incubations in dark aerobic natural sediment water systems, proquinazid exhibited moderate to high persistence, forming the major metabolite IN‐MM671 (max. 7% AR in water and max. 32% in sediment, exhibiting high persistence). The unextractable sediment fraction (not extracted by acetonitrile/water) was the major sink for the phenyl ¹⁴C radiolabel, accounting for 7% AR at study end (100 days). Mineralisation of this radiolabel accounted for 0.2%–1.4% AR at the end of the study. In a laboratory sterile aqueous photolysis experiment, the rate of decline of proquinazid was higher compared to the observed rate in the aerobic sediment water incubations. Chromatographically resolved components accounting for > 10% AR were metabolites IN‐MT884 (max. 30.5% AR), IN‐MM671 (max. 19.5% AR), metabolite IN‐MM986 (max. 14.5% AR) and metabolite IN‐MM991 (max. 14.2% AR). The necessary surface water and sediment exposure assessments (predicted environmental concentrations (PEC) calculations) were carried out for proquinazid and metabolites IN‐MT884, IN‐MM671, IN‐MM986 and IN‐MM991 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 proquinazid and metabolites IN‐MT884, IN‐MM671 IN‐MM986 IN‐MM991, appropriate step 3 (FOCUS, 2001) and step 4 calculations were available. ¹⁶ The step 4 calculations appropriately followed the FOCUS (FOCUS, 2007) guidance and applying appropriate mitigation measures, with no‐spray drift buffer zones of up to 20 m being implemented for the drainage scenarios (representing a 60%–93% 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 < 2000 mL/g (i.e. IN‐MM671 and IN‐MM991), 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 5.5.4.¹⁶ The potential for groundwater exposure from the representative uses by proquinazid and its soil metabolites IN‐MM671, IN‐MM986 and IN‐MM991 above the parametric drinking water limit of 0.1 μg/L was concluded to be low in geoclimatic situations that are represented by 9 out of 9 FOCUS groundwater scenarios.

The applicant did not provide appropriate information to address the effect of water treatments processes on the nature of the residues that might be present in surface water, when surface water is abstracted for drinking water. This has led to the identification of a data gap and results in the consumer risk assessment not being finalised (see Sections 3 and 9.1).

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

5. ECOTOXICOLOGY

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

Proquinazid was discussed at the Pesticide Peer Review Experts' TC 134 (11–14 March 2024) and 146 (4–12 July 2024).

The available data were insufficient to confirm the compliance of the batches used in the ecotoxicity studies with the current and updated reference specification.

Acute and long‐term toxicity studies with birds and mammals were available for the active substance. In addition, acute toxicity studies with the formulation for representative uses ‘proquinazid 200 g/L EC’ were also available for both taxonomic groups. Long‐term endpoints for birds and mammals were agreed during the experts' meeting. ¹⁷ An acute toxicity study with rats was also available for the metabolite IN‐MM671.

Based on the available data and the screening‐level risk assessment, a low acute risk to birds and mammals was indicated for all representative uses. A low long‐term risk to birds was indicated at the screening step for the use in grapes at 50 g a.s./ha, whereas a low risk was concluded at Tier 1 for the uses in cereals and in grapes at 75 g a.s./ha. A high long‐term risk to small herbivorous mammals was identified at Tier 1 for all representative uses: in cereals at BBCH ≥ 40 and in grapes at BBCH 10–39. Several refinement options for the long‐term risk to mammals were discussed at the experts meeting. ¹⁸ A refinement of exposure based on crop interception was agreed. In addition, the use of a mixed diet consisting of monocotyledonous and dicotyledonous plants for small herbivorous mammals was considered scientifically justified to refine the dietary composition. Based on the refined risk assessment, a low long‐term risk to mammals was concluded for representative uses in cereals, whereas the high long‐term risk for uses in grapes remained. A low acute risk to birds and mammals could also be concluded for the plant metabolite IN‐MW977 considering the high margins of safety relative to the parent compound. The long‐term risk for IN‐MW977 could not be finalised (data gap; see Section 10). For all representative uses, a low risk to birds and mammals from exposure via consumption of contaminated water was concluded. A low risk from exposure via secondary poisoning for proquinazid and the metabolites IN‐MM671 and IN‐MM986 ¹⁹ was also indicated.

To evaluate the risk for aquatic organisms, toxicity data for fish and aquatic invertebrates (acute and chronic), sediment dwelling organisms and algae were available for proquinazid. In addition, acute studies with fish and aquatic invertebrates and with algae were available with the formulation for representative uses ‘Proquinazid 200 g/L EC’. No chronic data for fish and aquatic invertebrates were available with ‘Proquinazid 200 g/L EC’ (see data gap under General aspects). During the meeting, experts discussed whether a fish full life cycle study was needed to address the data requirements, considering that effects on fecundity and fertility had been observed in the available fish short‐term reproductive assay (see Section 6). The experts agreed that a fish full life cycle test was not required since effects on reproduction in the short‐term assay occurred at a concentration more than 10 times higher than the chronic NOEC proposed for risk assessment, and the substance is not bioaccumulative. ²⁰ For all representative uses, a low risk to aquatic organisms was concluded at FOCUS Step 4, following the application of appropriate risk mitigation measures (Table 6).

TABLE 6.

Risk mitigation measures (RMM) proposed for the representative uses assessed.

Representative use	Cereals a		Grapes
	1 × 50 g a.s./ha	2 × 50 g a.s./ha	1 × 50 g a.s./ha	1 × 75 g a.s./ha	2 × 50 g a.s./ha	2 × 75 g a.s./ha
Operator risk			RMM*	RMM*	RMM*	RMM*
Risk to aquatic organisms	RMM equivalent to 10 m no‐spray buffer zone combined with a 10 m vegetated filter strip for 5/5 scenarios for spring cereals and for 9/9 scenarios for winter cereals b	RMM equivalent to 10 m no‐spray buffer zone combined with a 10 m vegetated filter strip for 4/5 scenarios for spring cereals and for 7/9 scenarios for winter cereals c	RMM equivalent to 20 m no‐spray buffer zone combined with a 20 m vegetated filter strip for 5/5 scenarios d	RMM equivalent to 20 m no‐spray buffer zone combined with a 20 m vegetated filter strip for 5/5 scenarios e	RMM equivalent to 20 m no‐spray buffer zone combined with a 20 m vegetated filter strip for 5/5 scenarios f	RMM equivalent to 20 m no‐spray buffer zone combined with a 20 m vegetated filter strip for 5/5 scenarios g

^a Winter and spring wheat and barley, rye, oats and triticale.

^b D1/ditch, D1/stream, D3/ditch, D4/stream, D5/stream and R4/stream for spring cereals and D1/ditch, D1/stream, D2/ditch, D2/stream, D3/ditch, D4/stream, D5/stream, D6/ditch, R1/stream, R3/stream and R4/stream for winter cereals.

^c D1/ditch, D1/stream, D3/ditch, D4/stream and D5/stream and for spring cereals and D1/ditch, D1/stream, D2/ditch, D2/stream, D3/ditch, D4/stream, D5/stream, D6/ditch and R3/stream for winter cereals.

^d D6/ditch, R1/pond, R1/stream, R2/stream, R3/stream and R4/stream.

^e D6/ditch, R1/stream, R2/stream, R3/stream and R4/stream.

^f D6/ditch, R1/stream, R2/stream, R3/stream and R4/stream.

^g D6/ditch, R1/stream, R2/stream, R3/stream and R4/stream.

^*During treatment of grapes, the acute exposure of an operator requires personal protective equipment (Work wear (arms, body and legs covered)) to be below AAOEL.

Toxicity data for several aquatic taxa were available for the pertinent metabolites IN‐MM671, IN‐MM986, IN‐MM991 and IN‐MT884. In the absence of toxicity data, a screening‐level risk assessment was conducted in line with EFSA PPR Panel (2013). The risk assessment outcome for these metabolites is summarised in Table 2. As a low risk could not always be demonstrated for these metabolites, even with FOCUS Step 4 calculations (when available) with application of appropriate risk mitigation measures, a data gap was identified to further address the risk to aquatic organisms from metabolites IN‐MM671, IN‐MM986 and IN‐MM991 (see Section 10) (Table 1).

TABLE 2.

Soil.

Compound (name and/or code)	Ecotoxicology
Proquinazid	Low risk
IN‐MM671	Low risk
IN‐MM986	Low risk
IN‐MM991	Low risk

TABLE 1.

Outcome of the aquatic screening risk assessment for the relevant metabolites of proquinazid.

Metabolite	Cereals 1 × 50 g a.s./ha a	Cereals 2 × 50 g a.s./ha a	Grapes 1 × 50 g a.s./ha	Grapes 1 × 75 g a.s./ha	Grapes 2 × 50 g a.s./ha	Grapes 2 × 75 g a.s./ha
IN‐MM671	Spring cereals	Spring cereals	Early applications	Early applications	Early applications	Early applications
	Low risk not demonstrated at FOCUS Step 3 for fish (chronic) for 2/5 scenarios	Low risk not demonstrated at FOCUS Step 3 for fish (chronic) for 3/5 scenarios	Low risk at FOCUS Step 4 considering risk mitigation measures (20 m NSZ zone +20 m VFS)	Low risk at FOCUS Step 4 considering risk mitigation measures (20 m NSZ zone +20 m VFS)	Low risk not demonstrated at FOCUS Step 3 for fish (chronic) for 5/5 scenarios	Low risk not demonstrated at FOCUS Step 3 for fish (chronic) for 5/5 scenarios
	FOCUS Step 4 calculations did not demonstrate a low risk either	FOCUS Step 4 calculations did not demonstrate a low risk either	Late applications Low risk at FOCUS Step 4 considering risk mitigation measures (20 m NSZ zone +20 m VFS)	Late applications Low risk at FOCUS Step 4 considering risk mitigation measures (20 m NSZ zone +20 m VFS)	FOCUS Step 4 calculations did not demonstrate a low risk either	FOCUS Step 4 calculations did not demonstrate a low risk either
	Winter cereals	Winter cereals			Late applications	Late applications
	Low risk not demonstrated at FOCUS Step 3 for fish (chronic) for 6/9 scenarios	Low risk not demonstrated at FOCUS Step 3 for fish (chronic) for 7/9 scenarios			Low risk at FOCUSsw Step 4 considering risk mitigation measures (20 m NSZ zone +20 m VFS)	Low risk not demonstrated at FOCUS Step 3 for fish (chronic) for 4/5 scenarios
	FOCUS Step 4 calculations did not demonstrate a low risk either	FOCUS Step 4 calculations did not demonstrate a low risk either				FOCUS Step 4 calculations did not demonstrate a low risk either
IN‐MM986	Spring cereals	Spring cereals	Early applications	Early applications	Early applications	Early applications
	Low risk not demonstrated at FOCUS Step 3 for aquatic invertebrates (chronic) for 1/5 scenarios	Low risk not demonstrated at FOCUS Step 3 for aquatic invertebrates (chronic) for 2/5 scenarios	Low risk at FOCUSsw Step 4 considering risk mitigation measures (20 m NSZ zone +20 m VFS)	Low risk not demonstrated at FOCUS Step 3 for aquatic invertebrates (chronic) for 3/5 scenarios	Low risk not demonstrated at FOCUS Step 3 for aquatic invertebrates (chronic) for 4/5 scenarios	Low risk not demonstrated at FOCUS Step 3 for aquatic invertebrates (chronic) for 5/5 scenarios
	FOCUS Step 4 calculations did not demonstrate a low risk either	FOCUS Step 4 calculations did not demonstrate a low risk either	Late applications Low risk at FOCUS Step 4 considering risk mitigation measures (20 m NSZ zone +20 m VFS)	FOCUS Step 4 calculations did not demonstrate a low risk either	FOCUS Step 4 calculations did not demonstrate a low risk either	FOCUS Step 4 calculations did not demonstrate a low risk either
	Winter cereals	Winter cereals		Late applications	Late applications	Late applications
	Low risk not demonstrated at FOCUS Step 3 for aquatic invertebrates (chronic) for 4/9 scenarios	Low risk not demonstrated at FOCUS Step 3 for aquatic invertebrates (chronic) for 5/9 scenarios		Low risk not demonstrated at FOCUS Step 3 for aquatic invertebrates (chronic) for 2/5 scenarios	Low risk not demonstrated at FOCUS Step 3 for aquatic invertebrates (chronic) for 3/5 scenarios	Low risk not demonstrated at FOCUS Step 3 for aquatic invertebrates (chronic) for 5/5 scenarios
	FOCUS Step 4 calculations did not demonstrate a low risk either	FOCUS Step 4 calculations did not demonstrate a low risk either		FOCUS Step 4 calculations did not demonstrate a low risk either	FOCUS Step 4 calculations did not demonstrate a low risk either	FOCUS Step 4 calculations did not demonstrate a low risk either
IN‐MM991	Spring cereals	Spring cereals	Low risk at FOCUS Step 3	Low risk at FOCUS Step 3	Early applications	Early applications
	Low risk at FOCUS Step 3	Low risk not demonstrated at FOCUS Step 3 for aquatic invertebrates (chronic) for 1/5 scenarios			Low risk at FOCUS Step 3	Low risk at FOCUS Step 4 considering risk mitigation measures (10 m NSZ zone +10 m VFS)
	Winter cereals Low risk at FOCUS Step 3	FOCUS Step 4 calculations did not demonstrate a low risk either			Late applications Low risk at FOCUS Step 3	Late applications Low risk at FOCUS Step 4 considering risk mitigation measures (20 m NSZ zone +20 m VFS)
		Winter cereals
		Low risk not demonstrated at FOCUS Step 3 for aquatic invertebrates (chronic) for 3/9 scenarios
		FOCUS Step 4 calculations did not demonstrate a low risk either
IN‐MT884	Spring cereals	Spring cereals	Low risk at FOCUS Step 3	Low risk at FOCUS Step 3	Early applications	Early applications
	Low risk at FOCUS Step 4 considering risk mitigation measures (10 m NSZ zone +10 m VFS)	Low risk at FOCUS Step 4 considering risk mitigation measures (10 m NSZ zone +10 m VFS)			Low risk at FOCUS Step 3	Low risk at FOCUS Step 3
	Winter cereals	Winter cereals			Late applications	Late applications
	Low risk at FOCUS Step 3	Low risk at FOCUS Step 3			Low risk at FOCUS Step 3	Low risk at FOCUS Step 4 considering risk mitigation measures (10 m NSZ zone +10 m VFS)

Abbreviations: NSZ, no‐spray buffer zone; VFS, vegetated filter strip.

^a Winter and spring wheat and barley, rye, oats and triticale.

Acute oral and contact and adult oral chronic toxicity studies with honey bees were available with both proquinazid and the formulation for representative uses Proquinazid 200 g/L EC. Additionally, a larval repeated‐exposure study with Proquinazid 200 g/L EC was available. The risk assessment performed in line with the SANCO guidance on terrestrial ecotoxicology (European Commission, 2002) indicated a low acute risk to honey bees from contact and oral exposure for all representative uses. The same conclusion was reached by applying the EFSA bee guidance document (EFSA, 2013) at the screening step. Likewise, low chronic risk to larvae and adults was concluded at the screening step for all uses. A suitable assessment of accumulative and sublethal effects was not available (data gap for sublethal effects, see Section 10). The risk to the relevant plant metabolite IN‐MW977 was covered by the risk to the parent.

Acute oral and contact studies with bumble bees were available with the formulation for the representative uses. Low acute risk from oral and contact exposure was concluded for all uses. ²¹ Toxicity data and risk assessment were not available for solitary bees.

For non‐target arthropods other than bees, glass plate studies were available with the standard sensitive species, i.e. the cereal aphid parasitoid Aphidius rhopalosiphi and the predatory mite Typhlodromus pyri, using the formulation for the representative uses. In addition, extended laboratory studies with freshly dried and aged residues were available for A. rhopalosiphi and the green lacewing Chrysoperla carnea. A low risk was concluded for grape use at 1 × 75 g a.s./ha and for all uses in cereals. However, a low in‐field risk could not be concluded at Tier 1 for the uses in grapes at 2 × 75 g a.s/ha. The in‐field risk for these uses was not refined. ²² Low off‐field risk was concluded for all representative uses of proquinazid at Tier 1.

The risk to earthworms and other soil macro‐organisms (i.e. the Collembola Folsomia candida and the soil mite Hypoaspis aculeifer) was evaluated using chronic toxicity studies with proquinazid (except for earthworms), Proquinazid 200 g/L EC and the soil metabolites IN‐MM671, IN‐MM986 (except for H. aculeifer ²³ ) and IN‐MM991. Based on the available data and risk assessment outcome, a low risk was concluded for proquinazid and the soil metabolites for all representative uses. Nitrogen transformation studies with proquinazid, the representative formulation and all relevant soil metabolites were available to address the risk to soil microorganisms. A low risk was indicated for all representative uses.

A screening study with the formulation for the representative uses was available to assess the risk to non‐target terrestrial plants and was discussed at the experts' meeting. The experts acknowledged that, although the study presented several limitations, these were regarded as minor and the study was deemed adequate for use in the risk assessment. ²⁴ Furthermore, a seedling emergence and vegetative vigour study with a formulation different from that of the representative uses was provided and regarded by the experts as supporting information. A low risk to non‐target terrestrial plants was indicated for all representative uses.A low risk to organisms involved in biological methods for sewage treatment could be concluded for all representative uses.

6. ENDOCRINE DISRUPTION PROPERTIES

The endocrine disruption properties (ED) of proquinazid for human and non‐target organisms were discussed at the Pesticides Peer Review Experts' TC 131 (4–8 March 2024). ²⁵

With regard to the assessment of the endocrine disruption (ED) potential of proquinazid for humans according to the ECHA and EFSA guidance (2018), in determining whether proquinazid interacts with the oestrogen, androgen and steroidogenesis‐ (EAS) and thyroid‐ (T) mediated pathways, the number and type of effects induced; and the magnitude and pattern of responses observed across studies were considered. Additionally, the conditions under which effects occur were considered, in particular, whether or not endocrine‐related responses occurred at dose(s) that also resulted in overt toxicity. The assessment is therefore providing a weight‐of‐evidence analysis of the potential interaction of proquinazid with the EAS and T signalling pathways using the available evidence in the dataset.

The T‐modality has been sufficiently investigated and a pattern of T‐mediated adversity i.e. changes in thyroid weight and thyroid histopathology (including increased incidence of follicular cell hypertrophy/hyperplasia and adenomas), and T‐mediated endocrine activity (changes in THs and TSH) has been observed in studies of varying duration and conducted with different species (i.e. rat and mouse). The postulated mode of action (MoA) indicated CAR/PXR induction as a plausible molecular initiating event (MIE) (not experimentally proven) and Phase I/II enzymes induction as plausible downstream intermediate key events (KEs), supported by in vitro (human and rats) and in vivo (rats) evidence. An in vitro comparative liver enzyme induction study, using human and rat hepatocytes, was submitted to explore species‐specific induction of phase II enzymes (namely T4‐UGT). However, due to the number of uncertainties regarding the reliability and relevance of the method used, the available information does not allow the dismissal of human relevance of the MoA. In line with the criteria established in the ECHA/EFSA guidance on ED, ‘relevance to humans should be assumed by default in the absence of appropriate scientific data demonstrating non‐relevance’.

In addition, although the hepatic mediated MoA is plausible, it was concluded that a concomitant MoA dealing with hepatic deiodinase (DIO1) inhibition observed in rats could not be excluded. Proquinazid was shown not to inhibit NIS or TPO activity, and not to act as a TR agonist in vitro.

Upon request for further information in accordance with Article 13(3a) of Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659, related to the implementation of the scientific criteria for the determination of endocrine‐disrupting properties introduced by Regulation (EU) No 2018/605, ²⁶ no additional data were submitted by the applicant to support the ED assessment. The applicant did submit some information after the legal deadline established in the Commission Implementing Regulation (EU) No 2018/1659; consequently, this information could not be considered within the peer review process. Nevertheless, for completeness, EFSA reviewed the late submitted information and concluded that it would not impact the conclusion reached by the experts during TC 131.

Overall, based on the available and sufficient data set and on the MoA analysis, it was concluded that the ED criteria for the T‐modality are met for proquinazid (Scenario 1b of the ECHA and EFSA (2018)).

In the studies conducted with proquinazid, the LOAEL where T‐mediated adversity (i.e. increased incidence of thyroid follicular cell hypertrophy) and endocrine activity (i.e. changes in THs and TSH) were observed in male rats, is 6.22 mg/kg bw per day from an oral 90‐day combined subchronic oral and neurotoxicity study. A NOAEL of 1.89 mg/kg bw per day is derived based on these effects (see Section 2). This NOAEL is supported from the 2‐year combined chronic toxicity and carcinogenicity study in rats in which the NOAELs of 1.16 and 1.39 mg/kg bw per day, for males and females respectively, were established based on thyroid altered colloid and follicular cell hypertrophy at the LOAEL 12.08 and 15.66 mg/kg bw per day, for males and females respectively (see Section 2).

With regard to the EAS‐modalities, the dataset was considered complete, and a pattern of EAS‐mediated adversity was not observed. Therefore, based on the available and sufficient dataset, it was concluded that the ED criteria are not met for the EAS‐modalities (Scenario 1a of the ECHA/EFSA (2018)).

For the EAS‐modalities, the outcome of the assessment reported above for humans also applies to wild mammals as non‐target organisms. ²⁷ For the T‐modality, the outcome of the assessment for humans (ED criteria met) does not apply to wild mammals as non‐target organisms since the relevance of the T‐mediated adversity observed in mammals could not be confirmed at population level.

For non‐mammalian species, an amphibian metamorphosis assay (AMA, OECD TG 231) and a Fish short‐term reproduction assay (FSTRA, OECD TG 229) were available. Although some effects suggested a possible degree of adversity (e.g. accelerated amphibian development and impairment on fish reproduction), a clear pattern of EATS‐mediated endocrine activity/adversity could not be identified.

As consequence of the above‐assessment for non‐target organisms, it is concluded that proquinazid does not meet the ED criteria for EATS‐modalities as laid down in point 3.8.2 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605.

In view of the fact that ED is an approval criterion, the applicant should have provided further information aimed at demonstrating that the exposure of humans to proquinazid was negligible under realistic conditions of use. However, the applicant did not provide a negligible exposure assessment. In addition, the RMS did not include in the revised RAR an assessment addressing non‐dietary negligible exposure (see also Section 2).

7. OVERVIEW OF THE RISK ASSESSMENT OF COMPOUNDS LISTED IN RESIDUE DEFINITIONS TRIGGERING ASSESSMENT OF EFFECTS DATA FOR THE ENVIRONMENTAL COMPARTMENTS (TABLES 2, 3, 4, 5)

TABLE 4.

Surface water and sediment.

Compound (name and/or code)	Ecotoxicology
Proquinazid	Low risk to aquatic organisms considering risk mitigation measures
IN‐MM671	Data gap a
IN‐MM986	Data gap a
IN‐MM991	Data gap a
IN‐MT884	Low risk to aquatic organisms

^a See Sections 5 and 10.

TABLE 5.

Air.

Compound (name and/or code)	Toxicology
Proquinazid	> 5.2 mg/L/4 h (dust aerosol)

8. PARTICULAR CONDITIONS PROPOSED TO BE TAKEN INTO ACCOUNT BY RISK MANAGERS

Risk mitigation measures (RMMs) identified following consideration of Member State (MS) and/or applicant's proposal(s) during the peer review, if any, are presented in this section. These measures applicable for human health and/or the environment leading to a reduction of exposure levels of operators, workers, bystanders/residents, environmental compartments and/or non‐target organisms for the representative uses are listed below. The list may also cover any RMMs as appropriate, leading to an acceptable level of risks for the respective non‐target organisms.

It is noted that final decisions on the need of RMMs to ensure the safe use of the plant protection product containing the concerned active substance will be taken by risk managers during the decision‐making phase. Consideration of the validity and appropriateness of the RMMs remains the responsibility of MSs at product authorisation, taking into account their specific agricultural, plant health and environmental conditions at national level.

9. CONCERNS AND RELATED DATA GAPS

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

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 ²⁸ 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:

1. The test material used in toxicity studies is not fully representative of the original and newly proposed reference specification for the active substance and associated impurities (see Sections 2 and 3).

   1. The relevance of an impurity and its maximum content should be further substantiated to support the reference specification (relevant for all uses, see Sections 1 and 2, See data requirement 2.18 of the evaluation table (EFSA, 2026)).
2. The consumer dietary risk assessment could not be concluded since the risk assessment residue definition for fruit and cereal crops could not be finalised, residue definitions for rotational crops remain open and the livestock exposure assessment cannot be conducted (see Section 3).

   1. The repeated dose toxicity profile of IN‐MW977 (including its isomers major and minor and their glucosides), IN‐MM671 and IN‐MU210 should be further substantiated (relevant for all uses, see Sections 2 and 3).
   2. The genotoxicity and repeated dose toxicity profile of CRC‐Soy‐01, IN‐MM986 and IN‐MM991 should be further addressed (relevant for all uses, see Sections 2 and 3).
   3. A new metabolism study with grape labelled on the pyrimidine ring of the molecule, attempting an identification rate as described in OECD TG 501 and also addressing the metabolism in grape leaves (relevant for all uses, see Section 3).
   4. A new confined rotational metabolism study, with proquinazid labelled in the phenyl and pyrimidine rings, investigating parent proquinazid and all relevant metabolites and covering the PECplateau calculated for these compounds
3. The consumer risk assessment is not finalised with regard to the unknown nature of residues that might be present in drinking water, consequent to water treatment following abstraction of surface water that might contain the active substance and its metabolites (see Sections 3 and 4).

   1. Further data and information were not available to demonstrate that residues of proquinazid will have no immediate or delayed harmful effects on human health, including that of vulnerable groups or animal health, …through drinking water (taking into account substances resulting from water treatment) (relevant to comply with the conditions of approval, not dependent of any specific use, see Section 4).

9.2. 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:

• 4Based on the available data set and on the MoA analysis, it was concluded that the ED criteria for humans for the T‐modality are met for proquinazid according to point 3.6.5 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605. (Scenario 1b of the ECHA and EFSA Guidance (2018)) (relevant to comply with the conditions of approval, not dependent of any specific use, see Section 6).

9.3. Overview of the concerns identified for each representative use considered (Table 7)

TABLE 7.

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		Wheat (winter and spring) 1–2 × 50 g a.s./ha	Barley (winter and spring), rye, oats, triticale 1–2 × 50 g a.s./ha	Grapes (wine and table)	Grapes (wine and table) at 2 × 75 g a.s/ha
Proquinazid 200 g/L EC		Hydraulic sprayer overall	Hydraulic sprayer overall	Air‐blast atomizer or hydraulic sprayer with air assistance	Hydraulic sprayer with or without air assistance
		Field	Field	Field	Field
		BBCH 25–65	BBCH 25‐49 (spring)	BBCH 13–83 (spring/summer)	BBCH 13–83 (spring/summer)
Operator risk	Risk identified
	Assessment not finalised
Worker risk	Risk identified
	Assessment not finalised
Resident/bystander risk	Risk identified
	Assessment not finalised
Consumer risk	Risk identified
	Assessment not finalised	X2,3	X2,3	X2,3	X2,3
Risk to wild non‐target terrestrial vertebrates	Risk identified			X	X
	Assessment not finalised
Risk to wild non‐target terrestrial organisms other than vertebrates	Risk identified				X a
	Assessment not finalised
Risk to aquatic organisms	Risk identified
	Assessment not finalised
Groundwater exposure to active substance	Legal parametric value breached
	Assessment not finalised
Groundwater exposure to metabolites	Legal parametric value breached a
	Parametric value of 10 μg/L b breached
	Assessment not finalised

Note: The superscript numbers relate to the numbered points indicated in Sections 9.1 and 9.2. Where there is no superscript number, see Sections 2, 7 for further information.

^a High in‐field risk to non‐target arthropods other than bees for the uses at 2 × 75 g a.s./ha (low risk concluded for the remaining uses).

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

(If a particular condition proposed to be taken into account to manage an identified risk, as listed in Section 8, has been evaluated as being effective, then ‘risk identified’ is not indicated in Table 7).

In addition to the issues indicated in Table 8:

• −the test material used in toxicity studies is not fully representative of the original and newly proposed reference specification for the active substance and associated impurities.
• −the substance was considered to meet the criteria for endocrine disruption for humans as laid down in point 3.6.5 of Annex II to Regulation (EC) No 1107/2009, as amended by Commission Regulation (EU) 2018/605.

10. 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:

• Information on the chronic toxicity for aquatic organisms of the formulation for representative uses, for a comprehensive hazard and (chronic) risk characterisation (relevant for all the representative uses, see ‘General aspects’ Section).

• A summary (description and validation data) of the analytical method used in vapour pressure study (relevant for all representative uses evaluated; see Section 1).

• Additional validation data for the method for quantification of two impurities in the technical material (relevant for all representative uses evaluated; see Section 1 and data requirement 0.2 in the confidential evaluation table (EFSA, 2026)).

• No valid degradation rate endpoints could be derived for metabolite IN‐MM991 in aqueous photolysis (relevant for all representative uses evaluated; see data requirement 4.7 in the evaluation table of Section 4).

• Further data are needed to assess the long‐term risk of the plant metabolite IN‐MW977 to birds and mammals (relevant for all representative uses evaluated; see Section 5).

• Further data are needed to address the risk to aquatic organisms from metabolites IN‐MM671, IN‐MM986 and IN‐MM991 (relevant for all representative uses, see Section 5).

• Further data were not available to address the risk to honey bees from sublethal effects (relevant for all representative uses, see Section 5).

ABBREVIATIONS

1/n

slope of Freundlich isotherm

AAOEL

acute acceptable operator exposure level

ADI

acceptable daily intake

AF

assessment factor

AhR

aryl hydrocarbon receptor

AMA

Amphibian Metamorphosis Assay

AOEL

acceptable operator exposure level

AP

alkaline phosphatase

AR

applied radioactivity

ARfD

acute reference dose

a.s.

active substance

bw

body weight

C&L

classification and labelling

CAS

Chemical Abstracts Service

CI

confidence interval

CL

confidence limits

co‐RMS

co‐rapporteur Member State

DAR

draft assessment report

DAT

days after treatment

DM

dry matter

DNT

developmental neurotoxicity

DT₅₀

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

DT₉₀

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

dw

dry weight

EAS

oestrogen, androgen and steroidogenesis modalities

EC₅₀

effective concentration

ECHA

European Chemicals Agency

ED

endocrine disruption

EEC

European Economic Community

EINECS

European Inventory of Existing Commercial Chemical Substances

ELINCS

European List of New Chemical Substances

FAO

Food and Agriculture Organization of the United Nations

FOCUS

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

FSTRA

Fish short‐term reproduction assay

GAP

Good Agricultural Practice

ISO

International Organization for Standardization

IUPAC

International Union of Pure and Applied Chemistry

iv

intravenous

JMPR

Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Expert Group on Pesticide Residues (Joint Meeting on Pesticide Residues)

K _doc

organic carbon linear adsorption coefficient

KEs

key eventsK _Foc

Freundlich organic carbon adsorption coefficient

LC–MS/MS

liquid chromatography with tandem mass spectrometry

LOAEL

lowest observable adverse effect level

LOD

limit of detection

LOQ

limit of quantification

MIE

molecular initiating event

MOA

mode of action

MRL

maximum residue level

NOAEL

no observed adverse effect level

OECD

Organisation for Economic Co‐operation and Development

PEC

predicted environmental concentration

QSAR

quantitative structure–activity relationship

r ²

coefficient of determination

RAC

regulatory acceptable concentration

RAR

renewal assessment report

RMS

rapporteur Member State

RUD

residue per unit dose

SC

suspension concentrate

SD

standard deviation

SFO

single first‐order

SMILES

simplified molecular‐input line‐entry system

STMR

supervised trials median residue

t _1/2

half‐life (define method of estimation)

TRR

total radioactive residue

TSH

thyroid‐stimulating hormone (thyrotropin)

TWA

time‐weighted average

UDS

unscheduled DNA synthesis

UF

uncertainty factor

UGT

uridine 5′‐diphospho‐glucuronosyltransferase

WG

water‐dispersible granule

WHO

World Health Organization

ε

decadic molar extinction coefficient

λ

wavelength

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2018‐00520

COPYRIGHT FOR NON‐EFSA CONTENT

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NOTE/UPDATE

This scientific output, approved on 30 March 2026, supersedes the previous output published on 29 October 2009 (EFSA, 2009).

Supporting information

APPENDIX B: List of end points for the active substance and the formulation(s) for representative uses

APPENDIX C: Evaluation of data concerning the necessity of proquinazid as a fungicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

APPENDIX D: Data collection set

APPENDIX A. Consideration of cut‐off criteria for Proquinazid according to Annex II of Regulation (EC) No 1107/2009 of the European Parliament and of the Council

Properties		Conclusion a
CMR	Carcinogenicity (C)	Proquinazid is not considered to be a carcinogen (category 1A or 1B) according to point 3.6.3 of Annex II of Regulation (EC) No 1107/2009, based on: Harmonised classification according to Regulation (EC)No 1272/2008 and its Adaptations to Technical Process [Table 3.1 of Annex VI of Regulation (EC) No1272/2008 as amended]: ATP05, Carcinogen category 2
	Germ cell Mutagenicity (M)	Proquinazid is not considered to be a germ cell mutagen according to point 3.6.2 of Annex II of Regulation (EC) No1107/2009, based on: Harmonised classification according to Regulation (EC) No 1272/2008 and its Adaptations to Technical Process [Table 3.1 of Annex VI of Regulation (EC) No 1272/2008 as amended]: ATP05, no entry for germ cell mutagenicity.
	Toxic for Reproduction (R)	Proquinazid is not considered to be toxic for reproduction according to point 3.6.4 of Annex II of Regulation (EC) No 1107/2009, based on: Harmonised classification according to Regulation (EC) No 1272/2008 and its Adaptations to Technical Process [Table 3.1 of Annex VI of Regulation (EC) No 1272/2008 as amended]: ATP05, no entry for adverse effects on sexual function and fertility and for development.
Endocrine‐disrupting properties		Proquinazid is considered to meet the criteria for endocrine disruption for human health according to point 3.6.5 of Annex II of Regulation No 1107/2009, as amended by Commission Regulation (EU) 2018/605. Proquinazid is not considered to meet the criteria for endocrine disruption for non‐target organisms according to points 3.6.5 and 3.8.2 of Annex II of Regulation No 1107/2009, as amended by Commission Regulation (EU) 2018/605.
POP	Persistence	Proquinazid 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	Proquinazid 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	Proquinazid 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 formulation(s) for representative uses

Appendix B can be found in the online version of this output (‘Supporting information’ section): https://doi.org/10.2903/j.efsa.2026.10063.

APPENDIX C. Evaluation of data concerning the necessity of proquinazid as a fungicide to control a serious danger to plant health which cannot be contained by other available means, including non‐chemical methods

Appendix C can be found in the online version of this output (‘Supporting information’ section): https://doi.org/10.2903/j.efsa.2026.10063.

APPENDIX D. Data collection set

Validated Excel files submitted by 11 MS (Austria, Belgium, Croatia, Czech Republic, Denmark, France, Irland, Estonia, Greece, Poland and Sweden) and evaluated by EFSA in the context of the assessment of the evaluation of data under Art 4(7) of Regulation (EC) No 1107/2009 concerning the necessity of proquinazid as herbicide to control a serious danger to plant health which cannot be contained by other available means.

Appendix D can be found in the online version of this output (‘Supporting information’ section): https://doi.org/10.2903/j.efsa.2026.10063.

APPENDIX E. Wording EFSA used in Section 4 of this conclusion, in relation to DT and K _oc ‘classes’ exhibited by each compound assessed

Wording	DT50 normalised to 20°C for laboratory incubations 29 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–< 10 days
Moderate persistence	10–< 60 days
Medium persistence	60–< 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	K oc (either K Foc or K doc) mL/g
Very high mobility	0–50
High mobility	51–150
Medium mobility	151–500
Low mobility	501–2000
Slight mobility	2001–5000
Immobile	> 5000

Note: Based on McCall et al. (1980).

APPENDIX F. Overview table of the toxicological profile of metabolites found as residues in plants and/or livestock triggering toxicological assessment for the representative uses under evaluation

Compound (name and/or code)	Genotoxicity‐Hazard identified	General toxicity‐reference values of parent apply
IN‐MW977 (including its isomers and their respective glucosides)	No Based on an in vitro test battery, not including the vitro mammalian gene mutation assay.	Open Read‐across not sufficiently substantiated (data gap).
CRC‐Soy‐01	Open In silico analysis not robust enough (data gap).	Open Read‐across not sufficiently substantiated (data gap).
IN‐MM671	No Based on experimental data.	Open No assessment done (data gap)
IN‐MU210	No Based on experimental data.	Open Read‐across not sufficiently substantiated (data gap).
IN‐MM986	Open In silico analysis not sufficiently robust (data gap).	Open No assessment done (data gap).
IN‐MM991	Open In silico analysis not sufficiently robust (data gap).	Open No assessment done (data gap).

APPENDIX G. Used compound codes

Code/trivial name a	IUPAC name/SMILES notation/InChiKey b	Structural formula c
proquinazid	6‐iodo‐2‐propoxy‐3‐propylquinazolin‐4(3H)‐one CCCOC1=Nc2ccc(I)cc2C(=O)N1CCC FLVBXVXXXMLMOX‐UHFFFAOYSA‐N
IN‐MU210	3‐[(6‐iodo‐4‐oxo‐3‐propyl‐3,4‐dihydroquinazolin‐2‐yl)oxy]propanoic acid O=C1N(CCC)C(OCCC(O)=O)=Nc2ccc(I)cc12 YYROMWCBRUXFBR‐UHFFFAOYSA‐N
IN‐MW977 (major)	2‐(2‐hydroxypropoxy)‐6‐iodo‐3‐propylquinazolin‐4(3H)‐one CC(O)COC1=Nc2ccc(I)cc2C(=O)N1CCC YCGUJJXFKHHIEK‐UHFFFAOYSA‐N
IN‐MW977 (minor)	2‐[(1‐hydroxypropan‐2‐yl)oxy]‐6‐iodo‐3‐propylquinazolin‐4(3H)‐one CC(CO)OC1=Nc2ccc(I)cc2C(=O)N1CCC ZTOVSVTUXAKRNR‐UHFFFAOYSA‐N
IN‐MW977 (major) glucoside	1‐[(6‐iodo‐4‐oxo‐3‐propyl‐3,4‐dihydroquinazolin‐2‐yl)oxy]propan‐2‐yl D‐glucopyranoside O=C1N(CCC)C(OCC(C)OC2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)=Nc2ccc(I)cc12 HQAFFBXKRWQYDG‐NXTZZEMHSA‐N
MW977 (minor) glucoside	2‐[(6‐iodo‐4‐oxo‐3‐propyl‐3,4‐dihydroquinazolin‐2‐yl)oxy]propyl D‐glucopyranoside O=C1N(CCC)C(OC(C)COC2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)=Nc2ccc(I)cc12 YVGUSIUSBNAHIZ‐NXTZZEMHSA‐N
CRC‐Soy‐01	6‐oxo‐2‐propoxy‐1‐propyl‐1,6‐dihydropyrimidine‐4,5‐dicarboxylic acid CCCOC1=NC(=C(C(=O)N1CCC)C(O)=O)C(O)=O UPOUZAOUSJIEJS‐UHFFFAOYSA‐N
IN‐MM671	2‐propoxy‐3‐propylquinazolin‐4(3H)‐one CCCOC1=Nc2ccccc2C(=O)N1CCC UQWLSCVKSAZQLB‐UHFFFAOYSA‐N
IN‐MM986	6‐iodo‐3‐propylquinazoline‐2,4(1H,3H)‐dione O=C1Nc2ccc(I)cc2C(=O)N1CCC JBMGEIBGOVWTLH‐UHFFFAOYSA‐N
IN‐MM991	3‐propylquinazoline‐2,4(1H,3H)‐dione O=C1Nc2ccccc2C(=O)N1CCC CUFPYJFLBNZMOA‐UHFFFAOYSA‐N
A1	2‐(2,3‐dihydroxypropoxy)‐3‐(2‐hydroxypropyl)‐6‐iodoquinazolin‐4(3H)‐one O=C1N(CC(O)C)C(OCC(O)CO)=Nc2ccc(I)cc12 HTPRXICQPPVMDS‐UHFFFAOYSA‐N
A2	3‐[2‐(2,3‐dihydroxypropoxy)‐6‐iodo‐4‐oxoquinazolin‐3(4H)‐yl]propanoic acid O=C1N(CCC(O)=O)C(OCC(O)CO)=Nc2ccc(I)cc12 QJOQDGOQFJQPHS‐UHFFFAOYSA‐N
A4	2‐hydroxy‐3‐{[3‐(2‐hydroxypropyl)‐6‐iodo‐4‐oxo‐3,4‐dihydroquinazolin‐2‐yl]oxy}propanoic acid OC(=O)C(O)COC1=Nc2ccc(I)cc2C(=O)N1CC(O)C NQXHTNUFOBGXAS‐UHFFFAOYSA‐N
B3	3‐(2,3‐dihydroxypropyl)‐2‐(2‐hydroxypropoxy)‐6‐iodoquinazolin‐4(3H)‐one O=C1N(CC(O)CO)C(OCC(O)C)=Nc2ccc(I)cc12 WZBDBORMZKMBFO‐UHFFFAOYSA‐N
B4	2‐hydroxy‐3‐[2‐(2‐hydroxypropoxy)‐6‐iodo‐4‐oxoquinazolin‐3(4H)‐yl]propanoic acid OC(=O)C(O)CN1C(OCC(O)C)=Nc2ccc(I)cc2C1=O DYYPTFQXBOMSRN‐UHFFFAOYSA‐N
IN‐MY340	2‐(2,3‐dihydroxypropoxy)‐6‐iodo‐3‐propylquinazolin‐4(3H)‐one O=C1N(CCC)C(OCC(O)CO)=Nc2ccc(I)cc12 UAOFRZPQAFNPRQ‐UHFFFAOYSA‐N
IN‐MY341	2‐(2‐hydroxypropoxy)‐3‐(2‐hydroxypropyl)‐6‐iodoquinazolin‐4(3H)‐one O=C1N(CC(O)C)C(OCC(C)O)=Nc2ccc(I)cc12 KRYUXZHJZRGWHX‐UHFFFAOYSA‐N
IN‐MY788	3‐[2‐(2‐hydroxypropoxy)‐6‐iodo‐4‐oxoquinazolin‐3(4H)‐yl]propanoic acid O=C1N(CCC(O)=O)C(OCC(O)C)=Nc2ccc(I)cc12 KDJRRBBOWZAHLE‐UHFFFAOYSA‐N
IN‐MU715	3‐(6‐iodo‐2,4‐dioxo‐1,4‐dihydroquinazolin‐3(2H)‐yl)propanoic acid O=C1Nc2ccc(I)cc2C(=O)N1CCC(O)=O HNFSNUWQKHGEDU‐UHFFFAOYSA‐N
IN‐MW397	3‐(2‐hydroxypropyl)‐6‐iodoquinazoline‐2,4(1H,3H)‐dione O=C1Nc2ccc(I)cc2C(=O)N1CC(O)C SUSPXXSHMBJREC‐UHFFFAOYSA‐N
IN‐MW398	6‐iodoquinazoline‐2,4(1H,3H)‐dione Ic1cc2C(=O)NC(=O)Nc2cc1 NBSMJLABFCDYFQ‐UHFFFAOYSA‐N
IN‐NA250	6‐iodo‐3‐(2‐oxopropyl)quinazoline‐2,4(1H,3H)‐dione O=C1Nc2ccc(I)cc2C(=O)N1CC(=O)C SPHAZIUXJBDPAW‐UHFFFAOYSA‐N
IN‐NA251	3‐(2,3‐dihydroxypropyl)‐6‐iodoquinazoline‐2,4(1H,3H)‐dione O=C1Nc2ccc(I)cc2C(=O)N1CC(O)CO ZCZRNFUXTANSKS‐UHFFFAOYSA‐N
IN‐NA252	2‐hydroxy‐3‐(6‐iodo‐2,4‐dioxo‐1,4‐dihydroquinazolin‐3(2H)‐yl)propanoic acid O=C1Nc2ccc(I)cc2C(=O)N1CC(O)C(O)=O LQKYPMPAVOULGT‐UHFFFAOYSA‐N
IN‐MT884	4‐(2‐carboxyethyl)‐6‐oxo‐2‐propoxy‐1‐propyl‐1,6‐dihydropyrimidine‐5‐carboxylic acid OC(=O)C1=C(CCC(O)=O)N=C(OCCC)N(CCC)C1=O LTAVCFVHNSIACX‐UHFFFAOYSA‐N

^a The name in bold is the name used in the conclusion.

^b ACD/Name 2024.2.3 ACD/Labs 2024.2.3 (File Version N25E41, Build 142837, 21 January 2025).

^c ACD/ChemSketch 2024.2.3 ACD/Labs 2024.2.3 (File Version C45H41, Build 142855, 23 January 2025).

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. , Ippolito, A. , … Villamar‐Bouza, L. (2026). Peer review of the pesticide risk assessment of the active substance proquinazid. EFSA Journal, 24(5), e10063. 10.2903/j.efsa.2026.10063