Modification of the existing maximum residue levels for pyriproxyfen in apricots and peaches

Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe S.A.S. submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for the active substance pyriproxyfen in apricots and peaches. The data submitted in support of the request were found to be sufficient to derive MRL proposal of 0.4 mg/kg for apricots, whereas for peaches an MRL amendment is not necessary. Adequate analytical methods for enforcement are available to control the residues of pyriproxyfen on 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 intended use of pyriproxyfen on apricots and peaches according to the reported agricultural practice is unlikely to present a risk to consumer health.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, Sumitomo Chemical Agro Europe S.A.S. submitted an application to the competent national authority in Greece (evaluating Member State, EMS) to modify the existing maximum residue levels (MRLs) for the active substance pyriproxyfen in apricots and peaches. 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 28 February 2022. To accommodate for the intended southern Europe (SEU) uses of pyriproxyfen, the EMS proposed to raise the existing MRLs for apricots from the limit of quantification (LOQ) of 0.05 mg/kg to 0.4 mg/kg and for peaches to lower the existing MRL set at 0.5 mg/kg to 0.4 mg/kg.

EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified data gaps, which were requested from the EMS. On 21 July 2022 the EMS submitted a revised evaluation report (Greece, 2022), which replaced the previously submitted evaluation report.

Based on the conclusions derived by EFSA in the framework of Regulation (EC) No 1107/2009, 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 pyriproxyfen following foliar application was investigated in crops belonging to the groups of fruit crops and pulses/oilseeds, indicating that parent pyriproxyfen is the relevant residue in these crop groups. As the proposed uses of pyriproxyfen is on permanent crops, investigations on the nature and magnitude of residues in rotational crops are not required. Studies investigating the effect of processing on the nature of pyriproxyfen (hydrolysis studies) demonstrated that the active substance is hydrolytically stable.

The residue definitions for fruit crops and pulses/oilseeds were proposed by the EU pesticides peer review as ‘pyriproxyfen’ for enforcement and risk assessment. These residue definitions are applicable also to rotational crops and processed products.

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

Sufficiently validated analytical methods 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 commodities assessed (LOQ).

The available residue trials are sufficient to derive an MRL proposal of 0.4 mg/kg for apricots and peaches. However, in contrast to the proposal of the EMS and the applicant, the lowering of the existing MRL of 0.5 mg/kg for peaches is not supported by EFSA since it may cover other existing EU authorisations of pyriproxyfen.

The studies investigating the effect of processing on the magnitude of pyriproxyfen residues in processed apricots and/or peaches have not been provided and were requested. The applicant referred to processing studies with citrus fruits and tomatoes from the EU pesticides peer review where a significant reduction of residues is observed in juicing, canning and primary processing, but residues concentrate in tomato puree and citrus pomaces. Only the data on citrus fruit marmalade can be extrapolated to stone fruit marmalade, but as no consumption data of peach/apricot marmalade are available to EFSA, this processing factor is currently not applicable. Overall, considering the low contribution of residues in raw agricultural commodity (RAC) apricots (0.03% acceptable daily intake (ADI)) and peaches (0.12% ADI) to the total consumer exposure, EFSA concludes that the lack of additional processing studies with stone fruits is a minor deficiency not considerably affecting the outcome of the exposure calculation, currently with a wide margin of safety. The need for specific processing studies will be further assessed in the MRL review when information on the authorised pyriproxyfen uses is available.

Residues of pyriproxyfen in commodities of animal origin were not assessed since apricots and peaches are normally not fed to livestock.

The toxicological profile of pyriproxyfen was assessed in the framework of the EU pesticides peer review under Regulation (EC) No 1107/2009 and the data were sufficient to derive an ADI of 0.05 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 1 mg/kg bw.

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 residues in apricots and peaches and did not exceed the ARfD, accounting for a maximum of 0.8% of the ARfD and 2.3% of the ARfD, respectively.

The estimated long‐term dietary intake accounted for a maximum of 22% of ADI (NL toddler diet). The contribution of residues expected in apricots and peaches to the overall long‐term exposure accounted for a maximum of 0.03% of the ADI for apricots and 0.12% of the ADI for peaches.

EFSA concluded that the proposed use of pyriproxyfen on apricots and peaches will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers' health.

EFSA notes that the conclusions of this assessment might be subject to modifications when the review of the existing EU MRLs for pyriproxyfen in accordance with the Article 12 of Regulation (EC) No 396/2005 is completed.

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 Appendix B – List of end points, Appendix C – Pesticide Residue Intake Model (PRIMo), Appendix D – Input values for the exposure calculations–Appendix B – List of end points, Appendix C – Pesticide Residue Intake Model (PRIMo), Appendix D – Input values for the exposure calculations.

Code (a)	Commodity	Existing EU MRL (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: Pyriproxyfen (F)
0140010	Apricots	0.05*	0.4	The submitted data are sufficient to derive an MRL proposal for the SEU use. Risk for consumers unlikely.
0140030	Peaches	0.5	No change	The submitted data are sufficient to derive an MRL proposal of 0.4 mg/kg for the SEU use, which is lower than the existing MRL. The proposal of the applicant and the EMS to lower the EU MRL is not supported as the MRL may be required to support other existing EU authorisations of pyriproxyfen. Risk for consumers unlikely.

MRL: maximum residue level; SEU: southern Europe; EMS: evaluating Member State.

^*Indicates that the MRL is set at the limit of analytical quantification (LOQ).

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

^(F)Fat soluble.

Assessment

The European Food Safety Authority (EFSA) received an application to modify the existing maximum residue levels (MRLs) for pyriproxyfen in apricots and peaches. The detailed description of the intended southern Europe (SEU) uses of pyriproxyfen on these fruit crops, which are the basis for the current MRL application, is reported in Appendix A.

Pyriproxyfen is the ISO common name for 4‐phenoxyphenyl (RS)‐2‐(2‐pyridyloxy)propyl ether (IUPAC). The chemical structures of the active substance and its main metabolites are reported in Appendix E.

Pyriproxyfen is an insecticide, which was evaluated in the framework of Regulation (EC) No 1107/20091 with the Netherlands designated as rapporteur Member State (RMS) for the representative uses on citrus fruits, pome fruits (apple, pears), tomatoes, ornamentals (field use) and tomatoes, ornamentals (greenhouse application). The renewal assessment report (RAR) prepared by the RMS has been peer reviewed by EFSA (2019b). The decision on the renewal of pyriproxyfen entered into force on 1 August 20202.

The EU MRLs for pyriproxyfen 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 not yet been completed but is currently ongoing. The representative uses on tomatoes, pome fruits and citrus fruits according to good agricultural practices (GAPs) in the EU were assessed during the approval of pyriproxyfen under Regulation (EC) No 1107/2009; additionally, the MRL application on citrus fruits was assessed (EFSA, 2019b). Prior to the EU pesticides peer review EFSA has issued several reasoned opinions on the modification of MRLs for pyriproxyfen (EFSA, 2013, 2016). The proposals from these reasoned opinions have been considered in the MRL legislation4. Certain Codex maximum residue limits (CXLs) have been taken over in the recent EU MRL legislation (EFSA, 2019c; FAO, 2019).

In accordance with Article 6 of Regulation (EC) No 396/2005, Sumitomo Chemical Agro Europe S.A.S. submitted an application to the competent national authority in Greece (evaluating Member State, EMS) to modify the existing MRLs for the active substance pyriproxyfen in apricots and peaches. 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 EFSA on 28 February 2022. To accommodate for the intended SEU uses of pyriproxyfen, the EMS proposed to raise the existing MRL for apricots from the limit of quantification (LOQ) to 0.4 mg/kg and for peaches to lower the existing MRL from 0.5 mg/kg to 0.4 mg/kg.

EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified data gaps, which were requested from the EMS. On 21 July 2022 the EMS submitted a revised evaluation report (Greece, 2022), which replaced the previously submitted evaluation report.

EFSA based its assessment on the evaluation report submitted by the EMS (Greece, 2022), the RAR and its revision (Netherlands, 2017, 2019) prepared under Regulation (EC) No 1107/2009, the Commission review report on pyriproxyfen (European Commission, 2020a), the conclusion on the peer review of the pesticide risk assessment of the active substance pyriproxyfen (EFSA, 2019b), as well as the conclusions from previous EFSA opinions on pyriproxyfen (EFSA, 2013, 2016), including the EFSA output on the Scientific support for preparing an EU position for the 51st Session of the CCPR (EFSA, 2019c).

For this application, the data requirements established in Commission Regulation (EU) No 283/20135 and the guidance documents applicable at the date of submission of the application to the EMS are applicable (European Commission, 2010, 2017, 2018, 2020b, 2021; OECD, 2007a,b,c,d,e,f, 2008a,b, 2009a,b, 2011, 2013, 2016, 2018). 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 (Greece, 2022) 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 pyriproxyfen in primary crops belonging to the group of fruit crops (apples, tomatoes, cucumbers, oranges) and pulses/oilseeds (cotton) has been investigated in the framework of the EU pesticides peer review (EFSA, 2019b). In the crops tested, following foliar treatment, parent compound was the main residue, representing between 4% (cotton) and 68% (tomato) of the total radioactive residues (TRRs). Other metabolites found above 10% TRR were 4’‐OH‐PYR (in cucumbers), PYPA (in apples and tomatoes), and POPA (in cucumbers), but in low absolute values. These compounds were concluded to be not genotoxic and therefore were not considered further by the EU pesticides peer review (EFSA, 2019b).

For the intended use on apricots and peaches, the metabolic behaviour of pyriproxyfen in primary crops is sufficiently addressed.

1.1.2. Nature of residues in rotational crops

As the proposed use of pyriproxyfen is on permanent crops, investigations on the nature of residues in rotational crops are not required. Confined rotational crops studies were assessed in the EU pesticides peer review (EFSA, 2019b).

1.1.3. Nature of residues in processed commodities

The effect of processing on the nature of pyriproxyfen residues was investigated in the framework of the EU pesticides peer review (EFSA, 2019b). These studies showed that the pyriproxyfen is hydrolytically stable under standard processing conditions.

1.1.4. Analytical methods for enforcement purposes in plant commodities

Analytical enforcement methods for the determination of pyriproxyfen residues in all types of plant matrices were assessed during the EU pesticides peer review (EFSA, 2019b). The methods available are sufficiently validated for the determination of residues of pyriproxyfen at or above the LOQ of 0.01 mg/kg in high‐water content commodities, to which apricots and peaches belong. Extraction efficiency of the analytical method for enforcement was verified in high‐water content commodities.

1.1.5. Storage stability of residues in plants

The stability of pyriproxyfen in plants stored under frozen conditions was investigated in the framework of the EU pesticides peer review (EFSA, 2019b). It was demonstrated that in high water content crop matrices residues were stable for at least 12 months when stored at −18°C.

In addition, a new storage stability study has been submitted and assessed in the framework of this application (Greece, 2022). Samples of apple (whole fruit), soybean (seeds), field bean (dried), wheat (grain) and orange (whole fruit) were spiked with a known amount of pyriproxyfen, stored frozen at −18°C and analysed at five different time intervals up to around 1 year. Residue levels in the samples were determined as pyriproxyfen using the validated analytical method QuEChERS (EN 1562:2008). The results of the study showed that pyriproxyfen residues are stable in apple, soybean, field bean, wheat and orange when stored frozen at −18°C for up to 365–371 days.

1.1.6. Proposed residue definitions

Based on the metabolic pattern identified in metabolism studies, the results of hydrolysis studies, the toxicological significance of metabolites and the capabilities of analytical enforcement method, the following residue definitions were proposed during the EU pesticides peer review:

• residue definition for risk assessment: pyriproxyfen

• residue definition for enforcement: pyriproxyfen.

The residue definitions are also applicable to rotational crops and processed products but are restricted to fruit and pulses/oilseeds crop groups for foliar treatments.

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

EFSA concluded that these residue definitions are appropriate for the crops under assessment and no further information is required.

1.2. Magnitude of residues in plants

1.2.1. Magnitude of residues in primary crops

In support of the MRL application, the applicant submitted GAP‐compliant residue trials performed in France, Spain, Italy and Greece on apricots (four trials) and peaches (six trials). The applicant proposed to derive one MRL proposal for both fruit crops on the basis of a combined residue data set on apricots and peaches. According to the Technical Guidelines SANTE/2019/12752 (European Commission, 2020b), the residue data on apricots and peaches can be combined to derive MRL proposal.

The number of trials is sufficient to derive an MRL proposal of 0.4 mg/kg in support of the intended SEU use of pyriproxyfen on peaches and apricots. It is noted that the existing EU MRL for peaches is higher (0.5 mg/kg) and the applicant and the EMS proposed to lower it to 0.4 mg/kg.

The samples were analysed for the parent compound. According to the assessment of the EMS, the methods used were sufficiently validated and fit for purpose (Greece, 2022). The samples of these residue trials were stored under conditions for which integrity of the samples has been demonstrated.

1.2.2. Magnitude of residues in rotational crops

As the proposed use of pyriproxyfen is on permanent crops investigations on the magnitude of residues in rotational crops are not required.

1.2.3. Magnitude of residues in honey

Apricots and peaches are classified as melliferous crops (European Commission, 2018). However, since the active substance is intended to be applied after the flowering period, further investigation is not required in the framework of the present MRL assessment.

1.2.4. Magnitude of residues in processed commodities

Studies investigating the effect of processing on the magnitude of pyriproxyfen residues in processed commodities of apricots and peaches were not submitted within this application. Considering that residues in unprocessed apricots and peaches (raw agricultural commodity, RAC) occur above 0.1 mg/kg, processing data are required in accordance with Commission Regulation (EU) No 283/2013.

During the assessment of the MRL application, EFSA requested the applicant to provide processing studies with the crops under consideration or to provide a justification on why such studies were not performed. In response to this data requirement the applicant referred to processing studies with citrus fruits and tomatoes as assessed in the EU pesticides peer review demonstrating that significant reduction of residues is observed in citrus and tomato juice, canned citrus fruits and tomato as well as in citrus marmalade; a concentration of residues is observed in tomato puree and processing by products of citrus fruits (wet and dry pomace, press cake) (EFSA, 2019b).

According to the OECD guideline (OECD, 2008a), the extrapolation of results from processing studies performed with citrus fruits to stone fruits is accepted only when processing procedures refer to the preparation of fruit products such as marmalades, jams, jellies, purees/sauces (primary procedures only) but is not supported for processes like juice preparation and canning. Thus, only the data on citrus fruit marmalade can be extrapolated to stone fruit marmalade, with the respective processing factor of 0.16 as derived by the EU pesticides peer review. However, no consumption data of stone fruit marmalade are available in EFSA PRIMo rev. 3.1, therefore this processing factor is currently not applicable.

Considering the low contribution of residues in RAC apricots (0.03% acceptable daily intake (ADI)) and peaches (0.12% ADI) to the overall consumer exposure, EFSA concludes that the lack of additional processing studies with stone fruits is a minor deficiency not considerably affecting the outcome of the exposure calculation, currently with a wide margin of safety. It is also noted that this conclusion might be subject to modifications once the review of existing EU MRLs for pyriproxyfen under Article 12 of Regulation (EC) No 396/2005 is completed.

1.2.5. Proposed MRLs

The available data are considered sufficient to derive an MRL proposal as well as risk assessment values for the commodities under evaluation (see Appendix B.4). In Section B.3, EFSA assessed whether residues in peaches and apricots resulting from the intended use are likely to pose a consumer health risk.

2. Residues in livestock

Not relevant as apricots and peaches are 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, 2019a). This exposure assessment model contains food consumption data for different sub‐groups 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 pyriproxyfen used in the risk assessment (i.e., ADI and acute reference dose (ARfD) values) were derived in the framework of the EU pesticides peer review (European Commission, 2020a).

Short‐term (acute) dietary risk assessment

The short‐term exposure assessment was performed only for the commodities assessed in this application in accordance with the internationally agreed methodology (FAO, 2016). The calculations were based on the highest residue (HR) value as derived from the submitted supervised field trials for apricots and peaches (see Appendix D.1). The short‐term exposure did not exceed the ARfD for any the crops assessed in this application: 0.8% of the ARfD for apricots (DE child diet) and 2.3% of the ARfD for peaches (NL toddler diet) (see Appendix B.3).

Long‐term (chronic) dietary risk assessment

The long‐term exposure assessment was performed, taking into account the supervised trials median residue (STMR) value as derived for apricots from the residue trials assessed in this application; for peaches a higher STMR value supporting the existing EU MRL and derived in the previous EFSA assessment (EFSA, 2013), was used as an input value. For the remaining commodities covered by the MRL regulation, the existing EU MRLs and STMR values derived in previous MRL applications, including those related to the safe CXLs implemented in the EU legislation, were selected as input values (EFSA, 2013, 2016; FAO, 2019). The complete list of input values is presented in Appendix D.1.

The estimated long‐term dietary intake was up to 22% 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 low and is presented in more detail in Appendix B.3.

EFSA concluded that the long‐term intake of residues of pyriproxyfen resulting from the existing and the intended uses is unlikely to present a risk to consumer health.

EFSA notes that a more realistic long‐term consumer risk assessment will be performed in the framework of the currently ongoing Article 12 MRL review, when full information on authorised uses of pyriproxyfen and additional residue data will be available to EFSA.

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 apricots and peaches.

EFSA concluded that the proposed use of pyriproxyfen on apricots and peaches will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers' health.

EFSA notes that the conclusions of this assessment might be subject to modifications when the review of the existing EU MRLs for pyriproxyfen is performed in accordance with the Article 12 of Regulation (EC) No 396/2005.

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

CCPR

Codex Committee on Pesticide Residues

CF

conversion factor for enforcement to risk assessment residue definition

CXL

Codex maximum residue limit

DALA

days after last application

DAR

draft assessment report

DAT

days after treatment

EC

emulsifiable concentrate

EMS

evaluating Member State

FAO

Food and Agriculture Organization of the United Nations

GAP

Good Agricultural Practice

HR

highest residue

IEDI

international estimated daily intake

IESTI

international estimated short‐term intake

ISO

International Organisation for Standardisation

IUPAC

International Union of Pure and Applied Chemistry

JMPR

Joint FAO/WHO Meeting on Pesticide Residues

K_oc

organic carbon adsorption coefficient

LC–MS/MS

liquid chromatography with tandem mass spectrometry detector

LOQ

limit of quantification

MRL

maximum residue level

MS

Member States

NEU

northern Europe

OECD

Organisation for Economic Co‐operation and Development

PBI

Plant‐back interval

PeF

peeling 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

SEU

southern Europe

STMR

supervised trials median residue

TRR

total radioactive residue

WHO

World Health Organization

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

Crop and/or situation	NEU, SEU, MS or country	F G or I (a)	Pests or Group of pests controlled	Preparation		Application				Application rate per treatment				PHI (days) (d)	Remarks
				Type (b)	Conc. a.s.	Method kind	Range of growth stages & season (c)	Number min–max	Interval between application (days) min‐max	g a.s./hL min–max	Water (L/ha) min–max	Rate min–max	Unit
Peaches	SEU	F	Scales	EC	100 g/L	Foliar treatment – broadcast spraying	BBCH 75; post flowering	1	n.a.	0.0035–0.0040	600–1,500	0.021–0.060	kg a.s./ha	14	–
Apricots	SEU	F	Scales	EC	100 g/L	Foliar treatment – broadcast spraying	BBCH 75; post flowering	1	n.a.	0.0035–0.0040	600–1,500	0.021–0.060	kg a.s./ha	14	–

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; n.a.: not applicable.

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

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

^(c)Growth stage range from first to last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 3–8,263–3,152–4), including, where relevant, information on season at time of application.

^(d)PHI: minimum preharvest interval.

Appendix B – List of end points

B.1 Residues in plants

B.1.1 Nature of residues and analytical methods for enforcement purposes in plant commodities

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

Primary crops (available studies)	Crop groups	Crops	Applications	Sampling (DALA)	Comment/Source
	Fruit crops	Apples	Foliar, 3 × 148 g a.s./ha	45	Phenoxyphenyl‐14C label and pyridyl‐14C label pyriproxyfen (EFSA, 2019b)
		Tomatoes	Foliar, 3 × 148 g a.s./ha	7
			Foliar, 3 × 593 g a.s./ha	7
		Cucumbers (supportive data)	Spray onto leaf, 1 × 200 μg/leaf	0, 1, 3, 7, 14, 21
			Spray onto fruit, 1 × 30 μg/fruit	0, 3, 7
		Oranges	Foliar, 1 × 225 g a.s./ha	28 (Fruit, leaves)
	Pulses/oilseeds	Cotton	Foliar, 2 × 148 g a.s./ha	28 (Cotton seed, gin trash)
Rotational crops (available studies)	Crop groups	Crops	Applications	PBI (DAT)	Comment/Source
	Root/tuber crops	Radishes	Bare soil, 1 × 198 g a.s./ha	30	Phenoxyphenyl‐14C labelled and pyridyl‐14C labelled pyriproxyfen (EFSA, 2019b)
	Leafy crops	Lettuces	Bare soil, 1 × 198 g a.s./ha	30
	Cereal (small grain)	Wheat	Bare soil, 1 × 198 g a.s./ha	30
	other

Processed commodities (hydrolysis study)	Conditions	Stable?	Comment/Source
	Pasteurisation (20 min, 90°C, pH 4)	Yes	U‐phenoxyphenyl‐14C labelled pyriproxyfen (EFSA, 2019b)
	Baking, brewing and boiling (60 min, 100°C, pH 5)	Yes
	Sterilisation (20 min, 120°C, pH 6)	Yes
	Other processing conditions	–

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	Tomatoes	−18	12	Months	Pyriproxyfen	EFSA, 2019b
		Apples	−18	371	Days	Pyriproxyfen	Greece, 2022
	High oil content	Cotton seed	−20	13	Months	Pyriproxyfen	EFSA, 2019b
		Cotton seed	−20	12.5	Months	PYPAC	EFSA, 2019b
		Soybean seeds	−18	365	Days	Pyriproxyfen	Greece, 2022
	High protein content	Beans (dried)	−18	365	Days	Pyriproxyfen	Greece, 2022
	Dry/High starch content	Wheat grain	−18	365	Days	Pyriproxyfen	Greece, 2022
	High acid content	Oranges	−20	4	Months	Pyriproxyfen	EFSA, 2019b
		Oranges	−18	371	Days	Pyriproxyfen	EFSA, 2019b
	Processed products	Cotton, crude oil	−20	1	Months	Pyriproxyfen	EFSA, 2019b
		Cotton, crude oil	−20	1	Months	PYPAC	EFSA, 2019b
		Cotton, crude oil	−20	1	Months	DPH‐Pyriproxyfen	EFSA, 2019b
	Others	Cotton, gin trash	−20	7.5	Months	Pyriproxyfen	EFSA, 2019b
		Cotton, gin trash	−20	6.5	Months	DPH‐Pyriproxyfen	EFSA, 2019b

B.1.2 Magnitude of residues in plants

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

Commodity	Region (a)	Residue levels observed in the supervised residue trials (mg/kg)	Comments/Source	Calculated MRL (mg/kg)	HR (b) (mg/kg)	STMR (c) (mg/kg)	CF (d)
Apricots, peaches	SEU	2 × 0.02, 2 × 0.02, 0.03, 0.04, 0.04, 0.11, 0.17, 0.24	Residue trials on apricots and peaches compliant with GAP. Combination of residue data on apricots and peaches possible to derive an MRL in both crops. Values in italics correspond to the results in apricots. The underlined value corresponds to higher residue at a longer PHI of 21 days.	0.4	0.24	0.035	N/A

MRL: maximum residue level; GAP: Good Agricultural Practice; PHI: pre‐harvest interval; N/A: not applicable.

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

^(b)Highest residue. The highest residue for risk assessment refers to the whole commodity and not to the edible portion.

^(c)Supervised trials median residue. The median residue for risk assessment refers to the whole commodity and not to the edible portion.

^(d)Conversion factor to recalculate residues according to the residue definition for monitoring to the residue definition for risk assessment.

B.1.2.2 Residues in rotational crops

B.1.2.3 Processing factors

No processing studies were submitted in the framework of the present MRL application therefore no processing factors are reported. Even though processing data are required in accordance with Commission Regulation (EU) No 283/2013, EFSA concluded that the lack of additional processing studies for peaches and apricots is a minor deficiency not considerably affecting the residue level calculation.

B.2 Residues in livestock

Not relevant.

B.3 Consumer risk assessment

B.4 Recommended MRLs

Code (a)	Commodity	Existing EU MRL (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: Pyriproxyfen (F)
0140010	Apricots	0.05*	0.4	The submitted data are sufficient to derive an MRL proposal for the SEU use. Risk for consumers unlikely.
0140030	Peaches	0.5	No change	The submitted data are sufficient to derive an MRL proposal of 0.4 mg/kg for the SEU use, which is lower than the existing MRL. The proposal of the applicant and the EMS to lower the EU MRL is not supported as the MRL may be required to support other existing EU authorisations of pyriproxyfen. Risk for consumers unlikely.

MRL: maximum residue level; SEU: southern Europe; EMS: evaluating Member State.

^*Indicates that the MRL is set at the limit of analytical quantification (LOQ).

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

^(F)Fat soluble.

Appendix C – Pesticide Residue Intake Model (PRIMo)

Appendix D – Input values for the exposure calculations

D.1 Consumer risk assessment

Commodity	Existing/Proposed MRL (mg/kg)	Source	Chronic risk assessment		Acute risk assessment
			Input value (mg/kg)	Comment	Input value (mg/kg)	Comment (a)
Risk assessment residue definition: Pyriproxyfen (F)
Apricots	0.4	Intended use	0.035	STMR‐RAC	0.24	HR‐RAC
Cherries (sweet)	1	EFSA, 2013	0.26	STMR‐RAC	0.62	HR‐RAC
Peaches	0.5	Intended use (Greece, 2022) and the existing use as assessed by EFSA, 2013	0.16	STMR‐RAC (EFSA, 2013)	0.24	HR‐RAC
Plums	0.3	EFSA, 2013	0.045	STMR‐RAC	0.20	HR‐RAC
Bananas	0.7	EFSA, 2016	0.011	STMR‐RAC (0.22) × PeF	0.012	HR‐RAC (0.24) × PeF
Papayas	0.3	FAO, 2019	0.07	STMR‐RAC	0.15	HR‐RAC
Melons	0.07	FAO, 2019	0.016	STMR‐RAC	0.035	HR‐RAC
Other commodities of plant origin	MRL/LOQ	According to Reg. (EU) No 2020/856 7			MRL/LOQ
Other commodities of animal origin	MRL/LOQ	According to Reg. (EU) No 2020/856 7			MRL/LOQ
Risk assessment residue definition: Sum of pyriproxyfen and 4‐OH‐pyriproxyfen, expressed as pyriproxyfen (c)
Tea (dried leaves of Camellia sinensis)	15	EFSA, 2013	4.06	STMR‐RAC (2.9) × CF (1.4) (b)	4.06	STMR‐RAC (2.9) × CF (1.4) (b)

STMR‐RAC: supervised trials median residue in raw agricultural commodity; HR‐RAC: highest residue in raw agricultural commodity; PeF: peeling factor; MRL: maximum residue level; LOQ: limit of quantification; CF: conversion factor for enforcement to risk assessment.

^(a)Input values for the commodities which are not under consideration for the acute risk assessment are reported in grey.

^(b)A conversion factor of 1.4 from enforcement to risk assessment as derived from the metabolism studies on orange leaves (EFSA, 2013).

^(c)Residue definition for risk assessment was used for tea on provisional basis (EFSA, 2013).

Appendix E – Used compound codes

Code/trivial name a	IUPAC name/SMILES notation/InChiKey b	Structural formula c
Pyriproxyfen	4‐phenoxyphenyl (RS)‐2‐(2‐pyridyloxy)propyl ether CC(COc1ccc(Oc2ccccc2)cc1)Oc1ccccn1 NHDHVHZZCFYRSB‐UHFFFAOYSA‐N
PYPAC	2‐[(pyridin‐2‐yl)oxy]propanoic acid CC(Oc1ccccn1)C(=O)O INLOHHUITHYIOO‐UHFFFAOYSA‐N
4’‐OH‐PYR	4‐(4‐(2‐(pyridin‐2‐yloxy)propoxy)phenoxy)phenol Oc1ccc(cc1)Oc1ccc(cc1)OCC(C)Oc1ccccn1 LRAGDWMWQOLALS‐UHFFFAOYSA‐N
POPA	1‐(4‐phenoxyphenoxy)propan‐2‐ol CC(O)COc1ccc(cc1)Oc1ccccc1 RVAHBQKJLFMRFE‐UHFFFAOYSA‐N
PYPA	2‐(pyridin‐2‐yloxy)propan‐1‐ol CC(CO)Oc1ccccn1 XYMSWYULCWBKHX‐UHFFFAOYSA‐N
DPH‐Pyr	4‐(2‐(pyridin‐2‐yloxy)propoxy)phenol Oc1ccc(cc1)OCC(C)Oc1ccccn1 OEEXMCPZWLJVDE‐UHFFFAOYSA‐N

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

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

^(b)ACD/Name 2021.1.3 ACD/Labs 2021.1.3 (File Version N15E41, Build 123,232, 07 July 2021).

^(c)ACD/ChemSketch 2021.1.3 ACD/Labs 2021.1.3 (File Version C25H41, Build 123,835, 28 August 2021).

Suggested citation EFSA (European Food Safety Authority) , Bellisai G, Bernasconi G, Brancato A, Cabrera LC, Castellan I, Ferreira L, Giner G, Greco L, Jarrah S, Leuschner R, Magrans JO, Miron I, Nave S, Pedersen R, Reich H, Robinson T, Ruocco S, Santos M, Scarlato AP, Theobald A and Verani A, 2022. Reasoned Opinion on the modification of the existing maximum residue levels for pyriproxyfen in apricots and peaches. EFSA Journal 2022;20(9):7567, 22 pp. 10.2903/j.efsa.2022.7567