Modification of the existing maximum residue levels for proquinazid in blueberries and cranberries

Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the Federal Public Service (FPS) Health, Food chain Safety and Environment submitted a request on behalf of Belgium (evaluating Member State, EMS) to modify the existing maximum residue levels (MRLs) for the active substance proquinazid in blueberries and cranberries. The data submitted in support of the request were found to be sufficient to derive MRL proposals for blueberries and cranberries. Adequate analytical methods for enforcement are available to control the residues of proquinazid in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of proquinazid according to the reported agricultural practices is unlikely to present a risk to consumer health.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, Federal Public Service (FPS) Health, Food chain Safety and Environment submitted a request on behalf of Belgium (evaluating Member State, EMS) to modify the existing maximum residue levels (MRLs) for the active substance proquinazid in blueberries and cranberries. The EMS drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 3 June 2021. To accommodate for the intended uses in Northern Europe (NEU) of proquinazid, the EMS proposed to raise the existing MRLs in blueberries and cranberries from the limit of quantification (LOQ) of 0.02 to 1.5 mg/kg.

EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation. Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC, the data evaluated under previous MRL assessments and the additional data provided by the EMS in the framework of this application, the following conclusions are derived.

The metabolism of proquinazid following foliar application was investigated in crops belonging to the groups of fruit crops and cereals/grass.

As the proposed uses of proquinazid are on permanent crops, investigations of residues in rotational crops are not required.

Studies investigating the effect of processing on the nature of proquinazid (hydrolysis studies) demonstrated that the active substance is stable.

Sufficiently validated analytical multiresidue methods based on gas chromatography are available to quantify residues in the crops assessed in this application according to the enforcement residue definition. The methods enable quantification of residues at or above 0.01 mg/kg in the crops assessed (limit of quantification – LOQ).

Based on the metabolic pattern identified in metabolism studies, hydrolysis studies and the toxicological significance of metabolites, the residue definitions for fruit crops and cereals were proposed by the MRL review as the ‘sum of proquinazid and metabolite IN‐MW977, expressed as proquinazid’ for risk assessment and as ‘proquinazid’ for enforcement. These residue definitions are applicable to primary crops, rotational crops and processed products.

EFSA concluded that for the crops assessed in this application, metabolism of proquinazid in plants, and the possible degradation in processed products has been sufficiently addressed and that the previously derived residue definitions are applicable.

The available residue trials are sufficient to derive MRL proposals of 1.5 mg/kg for blueberries and cranberries.

Specific studies investigating the magnitude of proquinazid residues in processed blueberries and cranberries have not been submitted and are not relevant, considering the low individual exposure to residues from the intake of these berries. Processing factors for grapes were derived in the framework of the EU pesticides peer review and can be extrapolated to the commodities under assessment, should further exposure refinement be needed.

Residues of proquinazid in commodities of animal origin were not assessed since the commodities under consideration in this MRL application are normally not fed to livestock.

The toxicological profile of proquinazid was assessed in the framework of the EU pesticides peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.01 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 0.2 mg/kg bw. The metabolite included in the risk assessment residue definition is of similar toxicity to the parent active substance.

The consumer risk assessment was performed with revision 3.1 of the EFSA Pesticide Residues Intake Model (PRIMo). The short‐term exposure assessment was performed only for the commodities assessed in this application. The calculations were based on the highest residue (HR) values derived from supervised field trials. The short‐term exposure did not exceed the ARfD for any of the plant commodities assessed (3.4% of the ARfD for blueberries and 1.7% of ARfD for cranberries).

In the framework of the MRL review, a comprehensive long‐term exposure assessment was performed, taking into account the existing uses at EU level. EFSA updated these calculations with the relevant median residue (STMR) values derived from the residue trials submitted in support of the present MRL application for blueberries and cranberries. The estimated long‐term dietary intake accounted for 20% of the ADI (NL toddler diet). The contribution of residues expected in the commodities assessed in this application to the overall long‐term exposure is minimal.

EFSA concluded that the proposed use of proquinazid on blueberries and cranberries will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers’ health.

EFSA proposes to amend the existing MRLs as reported in the summary table below.

Full details of all end points and the consumer risk assessment can be found in Appendices B–D.

Codea	Commodity	Existing EU MRL (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: Proquinazid
0154010	Blueberries	0.02*	1.5	The submitted data are sufficient to derive MRL proposals for the NEU uses. Risk for consumers unlikely.
0154020	Cranberries	0.02*	1.5

MRL: maximum residue level; NEU: northern Europe.

^*Limit of quantification (LOQ). It is noted that a lower MRL at the LOQ of 0.01 mg/kg is proposed to be implemented according to Draft Regulation SANTE/10034/2020.

^aCommodity code number according to Annex I of Regulation (EC) No 396/2005.

Assessment

The European Food Safety Authority (EFSA) received an application to modify the existing maximum residue level (MRL) for proquinazid in blueberries and cranberries. The detailed description of the intended NEU uses of proquinazid, which are the basis for the current MRL application, is reported in Appendix A.

Proquinazid is the ISO common name for 6‐iodo‐2‐propoxy‐3‐propylquinazolin‐4(3H)‐one (IUPAC). The chemical structures of the active substance and its main metabolites are reported in Appendix E.

Proquinazid was evaluated in the framework of Directive 91/414/EEC1 with the United Kingdom designated as rapporteur Member State (RMS) for the representative uses as a foliar treatment on grapes and cereals (winter and spring wheat and winter and spring barley, oats, triticale, winter rye). The draft assessment report (DAR) prepared by the RMS has been peer reviewed by EFSA (EFSA, 2009). Proquinazid was approved2 for the use as fungicide on 1 August 2010.

The EU MRLs for proquinazid are established in Annex III of Regulation (EC) No 396/20053. The review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (MRL review) has been performed (EFSA, 2020) and the proposed modifications have been voted at the Standing Committee on Plants, Animals, Food and Feed (PAFF committee) but are currently not implemented in Regulation yet (draft Regulation SANTE/10034/2020).4

In accordance with Article 6 of Regulation (EC) No 396/2005, Federal Public Service (FPS) Health, Food chain Safety and Environment submitted a request on behalf of Belgium (evaluating Member State, EMS) to modify the existing maximum residue levels (MRLs) for the active substance proquinazid in blueberries and cranberries. The EMS drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 3 June 2021. To accommodate for the intended uses of proquinazid, the EMS proposed to raise the existing MRLs from the limit of quantification (LOQ) of 0.02 to 1.5 mg/kg.

EFSA based its assessment on the evaluation report submitted by the EMS (Belgium, 2021), the draft assessment report (DAR) and its addendum (United Kingdom, 2006, 2009) prepared under Council Directive 91/414/EEC, the Commission review report on proquinazid (European Commission, 2010a), the conclusion on the peer review of the pesticide risk assessment of the active substance proquinazid (EFSA, 2009), the conclusions from previous EFSA opinions on proquinazid (EFSA, 2015), including the reasoned opinion on the MRL review according to Article 12 of Regulation No 396/2005 (EFSA, 2020).

For this application, the data requirements established in Regulation (EU) No 544/20115 and the guidance documents applicable at the date of submission of the application to the EMS are applicable (European Commission, 1997a, 1997b, 1997c, 1997d, 1997e, 1997f, 1997g, 2000, 2010b, 2010c, 2017; OECD, 2011). The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation of Plant Protection Products adopted by Commission Regulation (EU) No 546/20116.

A selected list of end points of the studies assessed by EFSA in the framework of this MRL application including the end points of relevant studies assessed previously is presented in Appendix B.

The evaluation report submitted by the EMS (Belgium, 2021) and the exposure calculations using the EFSA Pesticide Residues Intake Model (PRIMo) are considered as supporting documents to this reasoned opinion and, thus, are made publicly available as background documents to this reasoned opinion.

1. Residues in plants

1.1. Nature of residues and methods of analysis in plants

1.1.1. Nature of residues in primary crops

The metabolism of proquinazid was investigated using phenyl‐labelled proquinazid after foliar treatment in fruits crops (grapes and apples) and in cereals (wheat). Metabolism studies on grapes and wheat were assessed in the framework of the peer review (EFSA, 2009). The apple study was reported in the final addendum to the DAR (United Kingdom, 2009); however, due to its late submission in the process, it was not peer reviewed but further considered in the framework of the MRL review (EFSA, 2020).

In fruit crops, the parent compound was identified as the main residue. In grapes, proquinazid accounted for the majority of the extractable radioactivity (35–39% total radioactive residue (TRR), 0.08–0.09 mg/kg, day 0–29). In apple fruits, parent proquinazid was the major component identified, declining from 61% of the TRR (0.11 mg eq/kg) for the day 0 samples to 22% of the TRR (0.03 mg eq/kg) for the 28‐day samples. Part of the unextracted radioactivity was further extracted with strong alkaline treatment and the majority of this unextractable residue reflected lignin incorporation.

In wheat, parent proquinazid was the main residue in grain (0.12 mg/kg) whereas metabolite IN‐MW977 (isomers of mono‐hydroxy proquinazid) was the main component of the TRR in forage, hay and straw (0.27 mg eq/kg, 0.40 mg eq/kg and 1.5 mg eq/kg, respectively).

For the intended uses on the berries under consideration, the metabolic behaviour in primary crops is sufficiently addressed.

1.1.2. Nature of residues in rotational crops

As the proposed uses of proquinazid are on permanent crops, investigations of residues in rotational crops are not required.

1.1.3. Nature of residues in processed commodities

The effect of processing on the nature of proquinazid was investigated in the framework of the EU pesticides peer review (EFSA, 2009). Studies demonstrated that proquinazid is hydrolytically stable under standard processing conditions representative of pasteurisation, baking/brewing/boiling and sterilisation.

1.1.4. Methods of analysis in plants

Analytical methods for the determination of proquinazid residues were assessed during the EU pesticides peer review (EFSA, 2009) and further discussed in the framework of the MRL review (EFSA, 2020). Residues of proquinazid can be enforced by modified multiresidue method DFG S19, with gas chromatography coupled with mass spectrometry (GC‐MS) with LOQs of 0.01 mg/kg for apples, grapes and wheat grain, 0.02 mg/kg for oilseed rape and 0.1 mg/kg for wheat straw (EFSA, 2009).

Furthermore, in the framework of the MRL review, it was confirmed by the European Union Reference Laboratories (EURLs) that proquinazid can be monitored in high water content, high acid content, high oil content and dry commodities at 0.01 mg/kg by using QuEChERS multiresidue analytical method (EURLs, 2018; EFSA, 2020).

EFSA notes that the extraction efficiency for the analytical methods applied for enforcement and used for the residue trials is not proven as indicated according to the requirements of the extraction efficiency Guidance (European Commission, 2017). Further investigation on this matter would in principle be required. EFSA would therefore recommend reconsidering this point in the framework of the peer review for the renewal of approval of the active substance.

1.1.5. Storage stability of residues in plants

The storage stability of proquinazid in plants stored under frozen conditions was investigated in the framework of the EU pesticides peer review (EFSA, 2009). The storage stability of proquinazid was demonstrated for a period of 18 months at –18°C in plant commodities, including the group to which the crops under assessment belong (high acid content commodities).

1.1.6. Proposed residue definitions

Based on the metabolic pattern identified in primary and rotational crop metabolism studies, the results of hydrolysis studies and the toxicological significance of metabolites, the following residue definitions were proposed during the EU pesticides peer review (EFSA, 2009) and confirmed in the framework of the MRL review (EFSA, 2020):

• residue definition for risk assessment: sum of proquinazid and IN‐MW977, expressed as proquinazid (for fruit crops and cereals).

• residue definition for enforcement: proquinazid (for fruit crops and cereals).

Conversion factors (CF) from enforcement to risk assessment have also been derived considering the metabolism studies and the available residue trials. For fruit crops, a CF of 1 was derived since according to the metabolism studies in apples and grapes, metabolite IN‐MW977 is not expected to be present in fruits.

The same residue definitions are applicable to processed products and rotational crops (plant commodity relevant for human consumption), noting that it was not possible to conclude on the residue definition for feed items from rotational crops (EFSA, 2020).

The residue definition for enforcement set in Regulation (EC) No 396/2005 is identical with the above‐mentioned residue definition.

Taking into account the proposed uses assessed in this application, EFSA concluded that these residue definitions and the CF for fruits are applicable and no further information is required.

1.2. Magnitude of residues in plants

1.2.1. Magnitude of residues in primary crops

Blueberries, cranberries GAP (NEU, outdoor): 2 × 75 g a.s./ha; interval between applications: 7 days; PHI: 7 days

In support of the current MRL application, the applicant refers to residue trials conducted on currants that were previously assessed by EFSA (EFSA, 2015, 2020). Samples were analysed for proquinazid only, which is acceptable since the metabolite IN‐MW977 included in the residue definition for risk assessment is not expected to be present in fruits (see Section 1.1.6). Data on five good agricultural practice (GAP) compliant residue trials performed with currants in Northern Europe were resubmitted (Belgium, 2021). These studies have been previously assessed by EFSA and concluded to be sufficient to derive MRL proposals of 1.5 mg/kg for currants and by extrapolation for gooseberries in support of identical GAPs (EFSA, 2015). Storage integrity of the samples has been demonstrated, and the analytical method used to quantify the residues has been sufficiently validated and was proven to be fit for purpose (Belgium, 2021).

Applicant requested to extrapolate residue data from currants to blueberries and cranberries. Such an extrapolation is applicable according to the Technical Guidelines on extrapolation (European Commission, 2020).

EFSA confirms the previous conclusions as valid for the present MRL request in blueberries and cranberries and an MRL of 1.5 mg/kg is proposed for both commodities.

1.2.2. Magnitude of residues in rotational crops

As the proposed uses of proquinazid are on permanent crops, investigations of residues in rotational crops are not required.

1.2.3. Magnitude of residues in processed commodities

Specific processing studies for the crops under assessment were not submitted and are not required, since the contribution of the commodities under consideration to the theoretical maximum daily intake (TMDI) is < 10% of the acceptable daily intake (ADI) and the estimated daily intake is < 10% of the acute reference dose (ARfD) for any European consumer group diet (see Appendix B.3).

Moreover, the effect of industrial processing and/or household preparation was assessed during the pesticides peer review in studies conducted with grapes (EFSA, 2009) deriving various processing factors (PF). PF for juice making (i.e. < 0.25) could be extrapolated to small berries in case a refinement in consumer risk assessment is necessary (OECD, 2008).

1.2.4. Proposed MRLs

The available data are considered sufficient to derive MRL proposals as well as risk assessment values for blueberries and cranberries. In Section 3, EFSA assessed whether residues on these crops resulting from the intended uses are likely to pose a consumer health risk.

2. Residues in livestock

Not relevant as blueberries and cranberries are generally not used for feed purposes.

3. Consumer risk assessment

EFSA performed a dietary risk assessment using revision 3.1 of the EFSA PRIMo (EFSA, 2018, 2019). This exposure assessment model contains food consumption data for different subgroups of the EU population and allows the acute and chronic exposure assessment to be performed in accordance with the internationally agreed methodology for pesticide residues (FAO, 2016).

The toxicological reference values for proquinazid used in the risk assessment (i.e. ADI of 0.01 mg/kg bw per day and ARfD value of 0.2 mg/kg bw) were derived in the framework of the EU pesticides peer review (European Commission, 2010a). The toxicological reference values of proquinazid were considered applicable for metabolite IN‐MW977 included in the residue definition for risk assessment (EFSA, 2009).

Short‐term (acute) dietary risk assessment

The short‐term exposure assessment was performed only for the commodities assessed in this application. The calculations were based on the highest residue (HR) values derived from supervised field trials and the complete list of input values can be found in Appendix D.1. The short‐term exposure did not exceed the ARfD for any of the plant commodities assessed in this application (3.4% of the ARfD for blueberries and 1.7% of ARfD for cranberries) (see Appendix B.3).

Long‐term (chronic) dietary risk assessment

In the framework of the MRL review, a comprehensive long‐term exposure assessment was performed, taking into account the existing uses at EU level (EFSA, 2020). EFSA updated the calculations with the relevant median residue (STMR) values derived from the residue trials submitted in support of the present MRL application for blueberries and cranberries. The crops, on which no uses were reported in the MRL review, were excluded from the exposure calculation, as it was assumed that proquinazid is not authorised on those crops. The input values used in the exposure calculations are summarised in Appendix D.1.

Provided that the existing EU MRLs will be amended as proposed by the MRL review, the estimated long‐term dietary intake accounted for 20% of the ADI (NL toddler diet). The contribution of residues expected in the commodities assessed in this application to the overall long‐term exposure is minimal (see Appendix B.3).

For further details on the exposure calculations, a screenshot of the Report sheet of the PRIMo is presented in Appendix C.

4. Conclusion and Recommendations

The data submitted in support of this MRL application were found to be sufficient to derive an MRL proposal for blueberries and cranberries. EFSA concluded that the proposed use of proquinazid on blueberries and cranberries will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers’ health.

The MRL recommendations are summarised in Appendix B.4.

Abbreviations

a.s.

active substance

ADI

acceptable daily intake

ARfD

acute reference dose

BBCH

growth stages of mono‐ and dicotyledonous plants

bw

body weight

CF

conversion factor for enforcement to risk assessment residue definition

CS

capsule suspension

CV

coefficient of variation (relative standard deviation)

DALA

days after last application

DAR

draft assessment report

DAT

days after treatment

DM

dry matter

DP

dustable powder

DS

powder for dry seed treatment

EC

emulsifiable concentrate

EDI

estimated daily intake

EMS

evaluating Member State

eq

residue expressed as a.s. equivalent

EURL

EU Reference Laboratory (former Community Reference Laboratory (CRL))

FAO

Food and Agriculture Organization of the United Nations

GAP

Good Agricultural Practice

GC

gas chromatography

GC‐MS

gas chromatography with mass spectrometry

GC‐MS/MS

gas chromatography with tandem mass spectrometry

GS

growth stage

HR

highest residue

IEDI

international estimated daily intake

IESTI

international estimated short‐term intake

ILV

independent laboratory validation

ISO

International Organisation for Standardisation

IUPAC

International Union of Pure and Applied Chemistry

LC

liquid chromatography

LOD

limit of detection

LOQ

limit of quantification

MRL

maximum residue level

MS

Member States

MS

mass spectrometry detector

MS/MS

tandem mass spectrometry detector

MW

molecular weight

NEU

northern Europe

OECD

Organisation for Economic Co‐operation and Development

PAFF

Standing Committee on Plants, Animals, Food and Feed

PBI

plant back interval

PF

processing factor

PHI

preharvest interval

PRIMo

(EFSA) Pesticide Residues Intake Model

QuEChERS

Quick, Easy, Cheap, Effective, Rugged, and Safe (analytical method)

RA

risk assessment

RAC

raw agricultural commodity

RD

residue definition

RMS

rapporteur Member State

SANCO

Directorate‐General for Health and Consumers

SC

suspension concentrate

SEU

southern Europe

SL

soluble concentrate

SP

water‐soluble powder

STMR

supervised trials median residue

TAR

total applied radioactivity

TMDI

theoretical maximum daily intake

TRR

total radioactive residue

UV

ultraviolet (detector)

WHO

World Health Organization

Appendix A – Summary of intended GAP triggering the amendment of existing EU MRLs

1.

Crop and/or situation	NEU, SEU, MS or country	F G or Ia	Pests or group of pests controlled	Preparation		Application				Application rate per treatment				PHI (days)d	Remarks
				Typeb	Conc. a.s. (g/L)	Method kind	Range of growth stages and seasonc	Number min–max	Interval between application (days) min	g a.s./hL min–max	Water (L/ha) min–max	Rate max	Unit
Blueberries	NEU	F	Powdery mildew – Sphaerotheca mors‐uvae	EC	200	Foliar treatment – broadcast spraying	–	1–2	7	7.5–18.7	400–1,000	75	g a.i./ha	7	BE expresses rate as a.s/ha leaf wall area with a CF = 2. Hence, BE will authorise a rate of 35 g a.s./ha leaf wall area.
Cranberries	NEU	F	Powdery mildew – Sphaerotheca mors‐uvae	EC	200	Foliar treatment – broadcast spraying	–	1–2	7	7.5–18.7	400–1,000	75	g a.i./ha	7

MRL: maximum residue level; GAP: Good Agricultural Practice; NEU: northern European Union; SEU: southern European Union; MS: Member State; a.s.: active substance; EC: emulsifiable concentrate.

^aOutdoor or field use (F), greenhouse application (G) or indoor application (I).

^bCropLife International Technical Monograph no 2, 7th Edition. Revised March 2017. Catalogue of pesticide formulation types and international coding system.

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

^dPHI: minimum preharvest interval.

Appendix B – List of end points

B.1. Residues in plants

B.1.1. Nature of residues and methods of analysis in plants

B.1.1.1. Metabolism studies, methods of analysis and residue definitions in plants

Primary crops (available studies)	Crop groups	Crop(s)	Application(s)	Sampling (DAT)	Comment/Source
	Fruit crops	Grapes	Foliar: 3 × 200 g a.s./ha	0, 14, 29	Radiolabelled active substance: phenyl‐14C (U) proquinazid (United Kingdom, 2006; EFSA, 2009)
		Apples	Foliar: 2 × 225 g a.s./ha	0, 15, 28	Radiolabelled active substance: phenyl‐14C (U) proquinazid (United Kingdom, 2009; EFSA, 2020)
	Cereals/grass	Wheat	Foliar: 3 × 100 g a.s./ha (grain, straw); 2 × 100 g a.s./ha (hay); 1 × 100 g a.s./ha (forage)	26; 16; 13	Radiolabelled active substance: phenyl‐14C (U) proquinazid (United Kingdom, 2006; EFSA, 2009)

Rotational crops (available studies)	Crop groups	Crop(s)	Application(s)	PBI (DAT)	Comment/Source
	Root/tuber crops	Sugar beet	Bare soil: 2 × 150 g a.s./ha (interval 30 days)	45, 210 DALA	Radiolabelled active substance: phenyl‐14C (U) proquinazid (United Kingdom, 2006; EFSA, 2009)
	Pulses/oilseeds	Oilseed rape, Soybean	Bare soil: 2 × 150 g a.s./ha (interval 30 days)	45, 210 DALA	Radiolabelled active substance: phenyl‐14C (U) proquinazid (United Kingdom, 2006; EFSA, 2009)
	Cereal (small grain)	Wheat	Bare soil: 2 × 150 g a.s./ha (interval 30 days)	45, 210 DALA	Radiolabelled active substance: phenyl‐14C (U) proquinazid (United Kingdom, 2006; EFSA, 2009)

Processed commodities (hydrolysis study)	Conditions	Stable?	Comment/Source
	Pasteurisation (20 min, 90°C, pH 4)	Yes	Radiolabelled active substance: phenyl‐14C (U) proquinazid (United Kingdom, 2006; EFSA, 2009)
	Baking, brewing and boiling (60 min, 100°C, pH 5)	Yes	Radiolabelled active substance: phenyl‐14C (U) proquinazid (United Kingdom, 2006; EFSA, 2009)
	Sterilisation (20 min, 120°C, pH 6)	Yes	Radiolabelled active substance: phenyl‐14C (U) proquinazid (United Kingdom, 2006; EFSA, 2009)

B.1.1.2. Stability of residues in plants

Plant products (available studies)	Category	Commodity	T (°C)	Stability period		Compounds covered	Comment/Source
				Value	Unit
	High water content	Wheat forage	–18	18	Months	Proquinazid and IN‐MW977	United Kingdom (2006), EFSA (2009)
	High acid content	Grapes	–18	19	Months	Proquinazid and IN‐MW671	United Kingdom (2006), EFSA (2009)
	Dry	Wheat grains	–18	18	Months	Proquinazid and IN‐MW977	United Kingdom (2006), EFSA (2009)
	Others	Wheat straw	–18	18	Months	Proquinazid and IN‐MW977	United Kingdom (2006), EFSA (2009)

B.1.2. Magnitude of residues in plants

B.1.2.1. Summary of residues data from the supervised residue trials

Commodity	Regiona	Residue levels observed in the supervised residue trials (mg/kg)	Comments/Source	Calculated MRL (mg/kg)	HRb (mg/kg)	STMRc (mg/kg)	CFd
RD‐Mo: Proquinazid RD‐RA: Sum of Proquinazid and metabolite IN‐MW977, expressed as proquinazid
Blueberries and cranberries	NEU	Mo: 0.29; 0.31; 0.43e; 0.49e; 0.74 RA: –	Trials on currants compliant with intended GAPs. Extrapolation to blueberries and cranberries is applicable.	1.5	0.74	0.43	1f

MRL: maximum residue level; RD‐Mo: residue definition for monitoring; RD‐RA: residue definition for risk assessment; GAP: Good Agricultural Practice.

^aNEU: Outdoor trials conducted in northern Europe, SEU: Outdoor trials conducted in southern Europe, EU: indoor EU trials or Country code: if non‐EU trials.

^bHighest residue. The highest residue for risk assessment refers to the whole commodity and not to the edible portion.

^cSupervised trials median residue. The median residue for risk assessment refers to the whole commodity and not to the edible portion.

^dConversion factor to recalculate residues according to the residue definition for monitoring to the residue definition for risk assessment.

^eResidue trial value higher at a longer preharvest interval of 14 days.

^fThe residue trial samples have not been analysed according to the risk assessment residue definition. However, metabolism studies confirm that metabolite IN‐MW977 is not expected to be present in fruit crops. Therefore, a CF of 1 is applicable.

B.1.2.2. Residues in rotational crops

The crops under consideration are perennial. Therefore, the assessment on succeeding crops is not relevant in the framework of this MRL application.

B.1.2.3. Processing factors

Processed commodity	Number of valid studiesa	Processing Factor (PF)		CFP b	Comment/Source
		Individual values	Median PF
Wine grapes, juice	3	< 0.17; < 0.25; < 0.71	< 0.25	1	Residues in juice were always below LOD (United Kingdom, 2006; EFSA, 2009)

PF: processing factor; CF_p: Conversion factor for risk assessment in processed commodity (= Residue level in processed commodity expressed according to RD‐RA/Residue level in processed commodity expressed according to RD‐Mo); LOD: limit of detection.

^aStudies with residues in the RAC at or close to the LOQ were disregarded (unless concentration may occur).

^bFor fruit commodities, a Conversion Factor of 1 can be derived.

B.2. Residues in livestock

Not relevant.

B.3. Consumer risk assessment

B.4. Recommended MRLs

Codea	Commodity	Existing EU MRL (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: Proquinazid
0154010	Blueberries	0.02*	1.5	The submitted data are sufficient to derive MRL proposals for the NEU uses. Risk for consumers unlikely.
0154020	Cranberries	0.02*	1.5

MRL: maximum residue level; NEU: northern Europe.

^*A lower MRL at the LOQ of 0.01 mg/kg to be implemented according to Draft Regulation SANTE/10034/2020.

^aCommodity code number according to Annex I of Regulation (EC) No 396/2005.

Appendix C – Pesticide Residue Intake Model (PRIMo)

1.

Appendix D – Input values for the exposure calculations

D.1. Consumer risk assessment

Commodity	MRLs in SANTE/10034/2020/Proposed MRL (mg/kg)	Source	Chronic risk assessment		Acute risk assessment
			Input value (mg/kg)	Comment	Input value (mg/kg)	Commenta
Risk assessment residue definition 1: Sum of proquinazid and IN‐MW977, expressed as proquinazid.
Apples	0.08	EFSA (2020)	0.024	STMR‐RAC × CF	0.047	HR‐RAC × CF
Pears	0.08	EFSA (2020)	0.024	STMR‐RAC × CF	0.047	HR‐RAC × CF
Table grapes	0.5	EFSA (2020)	0.085	STMR‐RAC × CF	0.34	HR‐RAC × CF
Wine grapes	0.5	EFSA (2020)	0.085	STMR‐RAC × CF	0.34	HR‐RAC × CF
Strawberries	2	EFSA (2020)	0.06	STMR‐RAC × CF	1.2	HR‐RAC × CF
Blueberries	1.5	Intended use	0.43	STMR‐RAC × CF	0.74	HR‐RAC × CF
Cranberries	1.5	Intended use	0.43	STMR‐RAC × CF	0.74	HR‐RAC × CF
Currants (red, black and white)	1.5	EFSA (2020)	0.43	STMR‐RAC × CF	0.74	HR‐RAC × CF
Gooseberries (green, red and yellow)	1.5	EFSA (2020)	0.43	STMR‐RAC × CF	0.74	HR‐RAC × CF
Tomatoes	0.15	EFSA (2020)	0.0375	STMR‐RAC × CF	0.078	HR‐RAC × CF
Aubergines/egg plants	0.15	EFSA (2020)	0.0375	STMR‐RAC × CF	0.078	HR‐RAC × CF
Cucumbers	0.05	EFSA (2020)	0.017	STMR‐RAC × CF	0.024	HR‐RAC × CF
Gherkins	0.05	EFSA (2020)	0.017	STMR‐RAC × CF	0.024	HR‐RAC × CF
Courgettes	0.05	EFSA (2020)	0.017	STMR‐RAC × CF	0.024	HR‐RAC × CF
Barley	0.04	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	STMR‐RAC × CF
Oat	0.04	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	STMR‐RAC × CF
Rye	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	STMR‐RAC × CF
Wheat	0.02	EFSA (2020)	0.01	STMR‐RAC × CF	0.01	STMR‐RAC × CF
Risk assessment residue definition 2: Sum of proquinazid and metabolites IN‐MU210 and IN‐MW977 expressed as proquinazid.
Bovine: Muscle/meat	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	HR‐RAC × CF
Bovine: Fat tissue	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	HR‐RAC × CF
Bovine: Liver	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	HR‐RAC × CF
Bovine: Kidney	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	HR‐RAC × CF
Sheep: Muscle/meat	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	HR‐RAC × CF
Sheep: Fat tissue	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	HR‐RAC × CF
Sheep: Liver	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	HR‐RAC × CF
Sheep: Kidney	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	HR‐RAC × CF
Goat: Muscle/meat	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	HR‐RAC × CF
Goat: Fat tissue	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	HR‐RAC × CF
Goat: Liver	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	HR‐RAC × CF
Goat: Kidney	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	HR‐RAC × CF
Equine: Muscle/meat	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	HR‐RAC × CF
Equine: Fat tissue	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	HR‐RAC × CF
Equine: Liver	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	HR‐RAC × CF
Equine: Kidney	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	HR‐RAC × CF
Poultry: Muscle/meat	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	HR‐RAC × CF
Poultry: Fat tissue	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	HR‐RAC × CF
Poultry: Liver	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	HR‐RAC × CF
Milk: Cattle	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	STMR‐RAC × CF
Milk: Sheep	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	STMR‐RAC × CF
Milk: Goat	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	STMR‐RAC × CF
Milk: Horse	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	STMR‐RAC × CF
Eggs: Chicken	0.02	EFSA (2020)	0.02	STMR‐RAC × CF	0.02	HR‐RAC × CF

STMR‐RAC: supervised trials median residue in raw agricultural commodity; HR‐RAC: highest residue in raw agricultural commodity; CF: conversion factor.

^aInput values for the commodities which are not under consideration for the acute risk assessment are reported in grey.

Appendix E – Used compound codes

1.

Code/trivial name	IUPAC name/SMILES notation/InChiKeya	Structural formulab
Proquinazid	6‐iodo‐2‐propoxy‐3‐propylquinazolin‐4(3H)‐one Ic1ccc2N=C(OCCC)N(CCC)C(=O)c2c1 FLVBXVXXXMLMOX‐UHFFFAOYSA‐N
IN‐MU210	3‐[(6‐iodo‐4‐oxo‐3‐propyl‐3,4‐dihydroquinazolin‐2‐yl)oxy]propanoic acid O=C(O)CCOC1=Nc2ccc(I)cc2C(=O)N1CCC YYROMWCBRUXFBR‐UHFFFAOYSA‐N
IN‐MW977	2‐(2‐hydroxypropoxy)‐6‐iodo‐3‐propylquinazolin‐4(3H)‐one CC(O)COC1=Nc2ccc(I)cc2C(=O)N1CCC YCGUJJXFKHHIEK‐UHFFFAOYSA‐N
IN‐MM671	2‐propoxy‐3‐propylquinazolin‐4(3H)‐one CCCOC1=Nc2ccccc2C(=O)N1CCC UQWLSCVKSAZQLB‐UHFFFAOYSA‐N

IUPAC: International Union of Pure and Applied Chemistry; SMILES: simplified molecular‐input line‐entry system; InChiKey: International Chemical Identifier Key.

^aACD/Name 2020.2.1 ACD/Labs 2020 Release (File version N15E41, Build 116563, 15 June 2020).

^bACD/ChemSketch 2020.2.1 ACD/Labs 2020 Release (File version C25H41, Build 121153, 22 March 2021).

Suggested citation:EFSA (European Food Safety Authority) , Bellisai G, Bernasconi G, Brancato A, Carrasco Cabrera L, Ferreira L, Giner G, Greco L, Jarrah S, Kazocina A, Leuschner R, Magrans JO, Miron I, Nave S, Pedersen R, Reich H, Ruocco S, Santos M, Scarlato AP, Theobald A, Vagenende B and Verani A, 2021. Reasoned Opinion on the modification of the existing maximum residue levels for proquinazid in blueberries and cranberries. EFSA Journal 2021;19(9):6835, 23 pp. 10.2903/j.efsa.2021.6835