Focussed assessment of certain existing MRLs of concern for methoxyfenozide

Abstract

In compliance with Article 43 of Regulation (EC) No 396/2005, the EFSA received from the European Commission a mandate to provide its reasoned opinion on the existing maximum residue levels (MRLs) for methoxyfenozide which might lead to consumers intake concerns on the basis of the new toxicological reference values agreed upon by Member States (MSs) on 13 December 2018. In order to identify the MRLs of potential concern that require a more detailed assessment, EFSA screened the existing MRLs for methoxyfenozide, considering the new toxicological reference values and an acute risk could not be excluded for eight commodities. A fall‐back MRL was proposed for tomatoes and the MRL for citrus fruit could be confirmed considering the use of a peeling factor. No other fall‐back good agricultural practices (GAPs) were received, and thus, a lowering of the MRLs for peaches, apples, pears and broccoli is proposed.

Summary

Methoxyfenozide was firstly included in Annex I to Directive 91/414/EEC on 1 April 2005 by Commission Directive 2005/3/EC. After the first approval, EFSA published three reasoned opinions on the modifications of the existing MRLs, including the assessment of the existing MRLs in compliance with Article 12(2) of Regulation (EC) No 396/2005.

Methoxyfenozide was evaluated for renewal of approval in the framework of Commission Regulation (EC) No 1107/2009 and the toxicological reference value for acute exposure of the substance was lowered and potential exceedances of the threshold value was flagged.

EFSA therefore received on 23 June 2020, a mandate from the European Commission in accordance with Article 43 of Regulation (EC) No 396/2005 to perform a focussed review of the existing maximum residue levels for methoxyfenozide taking into consideration the new toxicological reference value as noted by the Standing Committee on Plants, Animals, Food and Feed and, in case of consumer intake concerns, to derive fall‐back MRLs that would not lead to unacceptable risk for consumers.

Subsequent to the request from the European Commission, EFSA performed a preliminary risk assessment of the existing EU MRLs for methoxyfenozide and for eight plant commodities (grapefruits, oranges, mandarins, apples, pears, peaches, tomatoes, broccoli), an acute consumer intake concern could not be excluded when considering the lower toxicological reference value derived during the renewal. Therefore, EFSA asked Member States to provide fall‐back GAPs with supporting residue data for those commodities for which the existing MRL leads to a potential acute intake concern. In addition, EFSA highlighted during the data call that a peeling factor (PF) for citrus fruits is available that was not considered for the CXLs in the MRL Review. The existing MRLs for citrus fruits correspond to the current CXLs. Member States were requested to express their views on the applicability of the PF.

Considering that Regulation (EU) 2019/158 restricts EU uses to greenhouses, Member States were invited to submit fall‐back GAPs in support of the authorised EU uses in greenhouses and report import tolerances. In the framework of the data call, only for tomatoes, a fall‐back GAP was reported.

The residue data submitted by the MSs in support of the fall‐back GAP for tomatoes were sufficient to derive a fall‐back MRL safe for consumers. The peeling factor for citrus fruits established during the peer review was concluded to be applicable for the corresponding CXLs and should be used in the risk assessment. Accordingly, no risk was identified for the existing MRLs in grapefruits, oranges and mandarins.

For all other commodities (apples, pears, peaches, broccoli), fall‐back MRLs or refined input values could not be derived since less critical GAPs were not provided by MS and no additional data for a possible refinement was available.

Therefore, MSs are recommended to withdraw their national authorisations for broccoli, apples, pears and peaches and to modify the national authorisations for tomatoes in order to comply with the fall‐back MRL derived by EFSA.

Background

Methoxyfenozide was first included in Annex I to Directive 91/414/EEC1 on 1 April 2005 by Commission Directive 2005/03/EC.2 After the first approval, EFSA published several reasoned opinions on the modifications of the existing MRLs, including the assessment of all existing MRLs in compliance with Article 12(2) of Regulation (EC) No 396/20053 (EFSA, 2010, 2012, 2014).

Methoxyfenozide was evaluated for renewal of approval in the framework of Commission Regulation (EC) No 1107/2009.4 On 6 September 2017, EFSA published its conclusion on the peer review of the pesticide risk assessment of the active substance methoxyfenozide (EFSA, 2017) and concluded on a lower acute reference dose (ARfD). The lower toxicological reference value was agreed in the Standing Committee on Plant, Animal, Food and Feed in December 2018 (European Commission, 2018). Potential exceedances of the threshold value considering the lower ARfD was highlighted during the peer review.

EFSA therefore received on 23 June 2020, a mandate from the European Commission in accordance with Article 43 of Regulation (EC) No 396/2005 to perform a focussed review of the existing maximum residue levels for methoxyfenozide taking into consideration the new toxicological reference value and, in case of consumer intake concerns, to derive fall‐back MRLs that would not lead to unacceptable risk for consumers.

Subsequent to the request from the European Commission, EFSA performed a preliminary risk assessment of the existing EU MRLs for methoxyfenozide and for eight plant commodities (grapefruits, oranges, mandarins, apples, pears, peaches, tomatoes, broccoli), an acute consumer intake concern could not be excluded when considering the lower toxicological reference value derived during the renewal. Therefore, EFSA asked Member States to provide fall‐back GAPs with supporting residue data for those commodities for which the existing MRL leads to a potential acute intake concern.

Considering that Regulation (EU) 2019/1585 restricts EU uses to greenhouses, Member States were invited to submit fall‐back GAPs in support of the authorised EU uses in greenhouses and report import tolerances.

All fall‐back data received by 14 August 2020 were evaluated and considered by EFSA during the preparation of the reasoned opinion. In September 2020, the draft reasoned opinion was circulated to Member States for commenting via a written procedure. All comments received by 22 September 2020 were evaluated by EFSA.

Key supporting documents to this reasoned opinion are the Member States consultation reports on the data call (EFSA, 2020a) and on the draft reasoned opinion (EFSA, 2020b), the evaluation report submitted during the data call (Portugal, 2020) and the chronic and acute exposure calculations performed using the EFSA Pesticide Residues Intake Model (PRIMo), revision 3.1 (Appendix C). Therefore, these documents are made publicly available.

The active substance and its use pattern

Methoxyfenozide is the ISO common name for N‐tert‐butyl‐N′‐(3‐methoxy‐o‐toluoyl)‐3,5‐xylohydrazide (IUPAC). The chemical structure of the active substance is reported in Appendix E.

Methoxyfenozide was evaluated in the framework of Directive 91/414/EEC with United Kingdom being the designated rapporteur Member State (RMS). The representative uses supported for the first peer review process were outdoor or indoor foliar spraying applications on fruits (citrus fruits, pome fruits, stone fruits, grapes), fruiting vegetables (tomatoes, peppers) and ornamentals. Methoxyfenozide has been recently peer reviewed by EFSA in the framework of the renewal of the approval of the active substance under Regulation (EC) No 1107/2009 (EFSA, 2017) with United Kingdom as RMS. The representative uses evaluated for the renewal included table and wine grapes, maize and sweet corn, fruiting vegetables (tomato, pepper, aubergine) and leaf vegetables (lettuce and other salad plants, spinach and similar, herbs). Following the peer review under the renewal procedure, a decision on renewal of the approval of the active substance methoxyfenozide in accordance with Regulation (EC) No 1107/2009 was published by Commission Implementing Regulation (EU) 2019/158, which entered into force on 1 April 2019. This approval is restricted to use as insecticide in greenhouses only (European Commission, 2018).

The EU MRLs for methoxyfenozide are established in Annex II of Regulation (EC) No 396/2005. Codex maximum residue limits (CXLs) for this active substance were also established by the Codex Alimentarius Commission (CAC). Following the review of existing MRLs, the legal limits have been modified by Commission Regulation (EU) No 2015/1040.6 The EU MRLs for methoxyfenozide were not modified since the entry into force of the above‐mentioned regulation.

Assessment

For this assessment, EFSA mainly relied on its previous reasoned opinions, its conclusion on the peer review and the additional information provided by the MSs during the Member State consultation (EFSA, 2010, 2012, 2014, 2017, 2020a; Portugal, 2020).

The assessment is performed in accordance with the legal provisions of the uniform principles for evaluation and authorisation of plant protection products as set out in Commission Regulation (EU) No 546/20117 and the currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues (European Commission, 1997b, 1997c, 1997d, 1997e, 1997f, 1997g, 1997a, 2000, 2010a, 2010b, 2017; OECD, 2011, 2013).

In order to identify the potential MRLs of concern, EFSA first performed a preliminary risk assessment (scenario 1), using the risk assessment values derived from the existing EU uses and import tolerances assessed in the Article 12 MRL review, as well as from the CXLs implemented in the EU Legislation (EFSA, 2014). It is noted that during the MRL review, the European uses for oranges and mandarins were not supported by data and the existing MRL was considered for indicative calculation of the consumer exposure. As the MRL finally implemented in the EU legislation for these commodities corresponds to the CXL, risk assessment values as derived by the JMPR were considered for the preliminary assessment of these crops (FAO, 2012).

Chronic and acute exposure calculations were performed using revision 3.1 of the EFSA PRIMo (EFSA, 2018, 2019). The exposures calculated were compared with the toxicological reference values for methoxyfenozide, derived by EFSA in the framework of the renewal for the approval of the active substance (EFSA, 2017).

The highest chronic exposure was calculated for German child, representing 17% of the acceptable daily intake (ADI). Regarding the acute exposure, however, an exceedance of the ARfD was identified for oranges, grapefruits, mandarins, pears, peaches, apples, tomatoes and broccoli (boiled) representing 265%, 133%, 119%, 138%, 133%, 108%, 105% and 126% of the ARfD, respectively.

Regarding all other MRLs that are currently in place for methoxyfenozide, acute intake calculations were below the ARfD. These MRLs are therefore not considered further in the framework of this assessment.

With regard to the commodities where an acute risk was identified a data call was launched to identify potential fall‐back GAPs. Given the approval restriction to indoor applications only, Member States were requested to submit indoor GAPs or report any import tolerance authorised.

In response to the data call, only an indoor GAP on tomatoes was reported. This fall‐back GAP is provided in Appendix A and was already considered in the MRL review (EFSA, 2014). Detailed results of the residue trials and the derived fall‐back MRL and risk assessment values are reported in Appendix B.1.1.

For citrus fruits, as the existing MRL corresponds to the current CXL, the appropriateness of using the peeling factor established for oranges in the framework of the MRL review and confirmed by the peer review for the renewal was considered. The PF of < 0.3 was derived based on three trials on oranges (EFSA, 2017). In the processing studies residue levels ranged between 0.13 and 0.22 mg/kg in fruits, 0.52–0.94 mg/kg in peel and < 0.05 mg/kg in pulp. Although the highest residue (HR) for citrus in the CXL was much higher (1.7 mg/kg) compared to the HR measured in the processing trial, considering that residues were below the limit of quantification (LOQ) of 0.05 mg/kg in pulp, EFSA considers the derived peeling factor sufficiently conservative, and therefore suitable for the use in the consumer exposure calculations.

For all other commodities, since less critical GAPs were not reported by MS and additional data for a possible refinement were not available, fall‐back MRLs or refined input values could not be derived.

A second exposure calculation (scenario 2) was therefore performed considering the peeling factor for citrus fruits and the fall‐back residue data for tomatoes and assuming that the existing CXLs for apples, pears, peaches and broccoli will be withdrawn. According to the results of this second calculation, the highest chronic exposure declined to 3% of the ADI (Dutch toddler) and the highest acute exposure was calculated for lettuces, representing 91% of the ARfD. Table 1 gives an overview of the results of the preliminary and the refined acute risk assessment.

Table 1.

Assessment of the existing MRLs for which a potential acute risk to European consumers was identified considering the lower toxicological reference value derived during the renewal

Commodity	ExistingEU MRL (mg/kg)	Proposed MRL(mg/kg)	HRa	Acute intake(% ARfD)
				Preliminary risk assessment (scenario 1)	Refined risk assessment (scenario 2)
Oranges	2	2	1.7	265b	63c
Grapefruits	2	2	1.7	133b	37c
Mandarins	2	2	1.7	119b	28c
Pears	2	–	1	138	–
Peaches	2	–	1.4	133	–
Apples	2	–	1	108	–
Tomatoes	2	0.6	1.8/0.46d	105	27d
Broccoli, boiled	3	–	1.6	126	–

RAC: Raw agricultural commodity, MRL: maximum residue level, ARfD: acute reference dose.

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

Results of the acute intake calculations without consideration of the peeling factor.

Results of the calculation considering the peeling factor of < 0.3.

Assessment considering a fall‐back GAP.

Based on these refined calculations, EFSA concludes that no risk to consumers was identified. Therefore, for citrus fruits, the MRLs can be maintained, and for tomatoes, a lower MRL is proposed. However, for apples, pears, peaches and broccoli, no fall‐back GAPs were available to EFSA, and the acute consumer intake could not be refined. As an acute risk to European consumers cannot be excluded for these existing EU MRLs, EFSA therefore recommends lowering the MRLs for these commodities to the appropriate LOQ for enforcement purposes.

Conclusions and recommendations

The residue data submitted by the MSs in support of the fall‐back GAP for tomatoes were sufficient to derive a fall‐back MRL that is safe for consumers. The peeling factor for citrus fruits established during the peer review was concluded to be applicable for the corresponding CXLs and should be used in the risk assessment. Accordingly, no risk was identified for the existing MRLs in grapefruits, oranges and mandarins. For all other commodities (apples, pears, peaches, broccoli), fall‐back MRLs or refined input values could not be derived since less critical GAPs were not provided by MS and no additional data for a possible refinement was available.

Therefore, MSs are recommended to withdraw their national authorisations for broccoli, apples, pears and peaches and to modify the national authorisations for tomatoes in order to comply with the fall‐back MRL derived by EFSA.

In the framework of this assessment, it can be concluded that there is no need to modify the existing EU MRLs for the other commodities of plant or animal origin. Nevertheless, it is noted that some EU MRLs were derived based on outdoor uses and Member States are recommended to review their authorisations considering the restriction to greenhouse uses only.

A summary of the conclusions and recommendations is provided in Table 2.

Table 2.

Summary table

Code number a	Commodity	Existing EU MRL (mg/kg)	Outcome of the assessment
			Proposed MRL (mg/kg)	Comment
Enforcement residue definition: methoxyfenozide
110010	Grapefruits	2	2	Existing MRL can be maintainedb
110020	Oranges	2	2	Existing MRL can be maintainedb
110050	Mandarins	2	2	Existing MRL can be maintainedb
130010	Apples	2	–	A fall‐back MRL could not be proposedc
130020	Pears	2	–	A fall‐back MRL could not be proposedc
140030	Peaches	2	–	A fall‐back MRL could not be proposedc
231010	Tomatoes	2	0.6	Fall‐back MRL is proposedd
241010	Broccoli	3	–	A fall‐back MRL could not be proposedc
–	Other products of plant and animal origin	See Regulation 2015/1040	See Regulation 2015/1040	EU MRLs not identified as MRLs of potential concern for consumers

MRL: maximum residue level.

Commodity code number, as listed in Annex I of Regulation (EC) No 396/2005.

The existing EU MRL is safe, considering a peeling factor.

The existing EU MRL was identified as a potential MRL of concern. No uses are currently authorised in EU that could be considered to derive a fall‐back MRL. EFSA proposes to lower the MRL to the appropriate LOQ and to withdraw the relevant authorisations within the EU.

^aThe existing EU MRL was identified as a MRL of potential concern. Data supporting a fall‐back MRL were submitted by MSs and no risk to consumers is identified for this fall‐back MRL.

Abbreviations

a.i.

active ingredient

a.s.

active substance

ADI

acceptable daily intake

ARfD

acute reference dose

BBCH

growth stages of mono‐ and dicotyledonous plants

bw

body weight

CAC

Codex Alimentarius Commission

CAS

Chemical Abstract Service

CF

conversion factor for enforcement residue definition to risk assessment residue definition

CS

capsule suspension

CV

coefficient of variation (relative standard deviation)

CXL

codex maximum residue limit

DAR

draft assessment report

DAT

days after treatment

DB

dietary burden

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

FAO

Food and Agriculture Organization of the United Nations

FID

flame ionisation detector

GAP

Good Agricultural Practice

GC

Gas chromatography

GC‐FID

gas chromatography with flame ionisation detector

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

ISO

International Organisation for Standardization

IUPAC

International Union of Pure and Applied Chemistry

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)

LOQ

limit of quantification

Mo

Monitoring

MRL

maximum residue level

MS

Member States

MS

mass spectrometry detector

MS/MS

tandem mass spectrometry detector

MW

molecular weight

NEU

northern European Union

OECD

Organisation for Economic Co‐operation and Development

PF

processing factor

PHI

preharvest interval

PRIMo

(EFSA) Pesticide Residues Intake Model

RA

risk assessment

RD

residue definition

RAC

raw agricultural commodity

RD

residue definition

RMS

rapporteur Member State

SANCO

Directorate‐General for Health and Consumers

SC

suspension concentrate

SEU

southern European Union

SMILES

simplified molecular‐input line‐entry system

SL

soluble concentrate

SP

water soluble powder

STMR

supervised trials median residue

TAR

total applied radioactivity

WHO

World Health Organization

Appendix A – Summary of the fall‐back GAPs considered in the assessment

1.

Crop and/or situation	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.	Method kind	Range of growth stages & seasonc	Number min–max	Interval between application (min)	a.s./hL min–max	Water L/ha min–max	Rate and unit
Tomato	PT	G	caterpillars	SC	240 g/L	Spraying	BBCH 30–87	3	14–21 days	0,0096	500–1000	0,048–0,096 kg a.i./ha	1

MS: Member State, a.s.: active substance, SC: suspension concentrate.

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

^bCropLife International Technical Monograph no 2, 6th Edition. Revised May 2008. Catalogue of pesticide.

^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 Endpoints relevant for the assessment

B.1. Magnitude of residues in plants

B.1.1. Summary of residues data from the supervised residue trials – fall‐back

Crop	Region/ indoora	Residue levels observed in the supervised residue trials relevant to the supported GAPs (mg/kg)	Recommendations/comments (OECD calculations)	MRL proposals (mg/kg)	HR (mg/kg)b	STMR (mg/kg)c
Tomatoes	EU	0.08; 0.11; 4 × 0.12; 0.13; 2 × 0.14; 0.16; 0.18; 2 × 0.20; 0.26; 0.29; 0.46	Trials on tomatoes compliant with fall‐back GAP already assessed under MRL review (EFSA, 2014). MRLOECD: 0.55	0.6	0.46	0.14

GAP: Good Agricultural Practice; OECD: Organisation for Economic Co‐operation and Development; MRL: maximum residue level.

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

^bHighest residue.

^cSupervised trials median residue.

B.1.2. Processing factors

Processed commodity	Number of valid studiesa	Processing Factor (PF)		Comment/Source
		Individual values	Median PF
Oranges, peeled	3	< 0.4, < 0.3, < 0.2	< 0.3	Residue levels of methoxyfenozide in pulp < 0.05 mg/kg. PF extrapolated to all citrus fruits. (EFSA, 2014, 2017)

PF: Processing factor (=Residue level in processed commodity expressed according to RD‐Mo/Residue level in raw commodity expressed according to RD‐Mo).

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

B.2. Consumer risk assessment

ADI	0.1 mg/kg bw per day (EFSA, 2017)
Highest IEDI, according to EFSA PRIMo vers.3.1	Scenario 1:preliminary risk assessment 17% ADI (DE, child) Scenario 2:refined risk assessment 3% ADI (NL toddler)
Assumptions made for the calculations	Scenario 1:preliminary risk assessment The calculation is based on the median residue levels in the raw agricultural commodities. Scenario 2:refined risk assessment The calculation is based on the median residue levels in the raw agricultural commodities, except for citrus fruits, where the relevant peeling factor was applied. The median residue level for apples, pears, peaches and broccoli was disregarded (assuming that the existing CXLs of concern will be withdrawn) and the median residue level for tomatoes resulting from the CXL of concern, is replaced by the median residue levels resulting from the fall‐back GAP.

ARfD	0.1 mg/kg bw (EFSA, 2017)
Highest IESTI, according to EFSA PRIMo	Scenario 1:preliminary risk assessment 265% ARfD (oranges) 133% ARfD (grapefruits) 119% ARfD (mandarins) 138% ARfD (pears) 133% ARfD (peaches) 108% ARfD (apples) 105% ARfD (tomatoes) 126% ARfD (broccoli, boiled) Scenario 2:refined risk assessment 91% ARfD (lettuce)
Assumptions made for the calculations	Scenario 1:preliminary risk assessment The calculation is based on the highest residue levels in the raw agricultural commodities. Scenario 2:refined risk assessment The calculation is based on the highest residue levels in the raw agricultural commodities, except for citrus fruits, where the relevant peeling factor was applied. The highest residue level for apples, pears, peaches and broccoli was disregarded (assuming that the existing CXLs of concern will be withdrawn) and the highest residue levels for tomatoes resulting from the CXL of concern, is replaced by the highest residue levels resulting from the fall‐back GAP.

ADI: acceptable daily intake; bw: body weight; IEDI: international estimated daily intake; PRIMo: (EFSA) Pesticide Residues Intake Model; WHO: World Health Organization; ARfD: acute reference dose; IESTI: international estimated short‐term intake, CXL: codex maximum residue limit.

B.3. Proposed MRLs

Code numbera	Commodity	Existing EU MRL (mg/kg)	Outcome of the assessment
			Proposed MRL (mg/kg)	Comment
Enforcement residue definition: methoxyfenozide
110010	Grapefruits	2	2	Existing MRL can be maintainedb
110020	Oranges	2	2	Existing MRL can be maintainedb
110050	Mandarins	2	2	Existing MRL can be maintainedb
130010	Apples	2	–	A fall‐back MRL could not be proposedc
130020	Pears	2	–	A fall‐back MRL could not be proposedc
140030	Peaches	2	–	A fall‐back MRL could not be proposedc
231010	Tomatoes	2	0.6	Fall‐back MRL is proposedd
241010	Broccoli	3	–	A fall‐back MRL could not be proposedc
–	Other products of plant and animal origin	See Regulation 2015/1040	See Regulation 2015/1040	EU MRLs not identified as MRLs of potential concern for consumers

MRL: maximum residue level.

^aCommodity code number, as listed in Annex I of Regulation (EC) No 396/2005.

^bThe existing EU MRL is safe, considering a peeling factor.

^cThe existing EU MRL was identified as a potential MRL of concern. No uses are currently authorised in EU that could be considered to derive a fall‐back MRL. EFSA proposes to lower the MRL to the appropriate LOQ and to withdraw the relevant authorisations within the EU.

^dThe existing EU MRL was identified as a MRL of potential concern. Data supporting a fall‐back MRL were submitted by MSs and no risk to consumers is identified for this fall‐back MRL.

Appendix C – Pesticide Residue Intake Model (PRIMo)

1.

• PRIMo (scenario 1)

• PRIMo (scenario 2)

Appendix D – Input values for the exposure calculations

D.1. Consumer risk assessment

Commodity	Chronic risk assessment		Acute risk assessment
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Risk assessment residue definition: methoxyfenozide
Grapefruit, lemons, limes	0.28	STMR (CXL) (EFSA, 2014)	1.7	HR (CXL) (EFSA, 2014)
	0.08	STMR (CXL) × PF (0.3)	0.48	HR (CXL) × PF (0.3)
Oranges, Mandarins	0.28	STMR (CXL) (FAO, 2012)	1.7	HR (CXL) (FAO, 2012)
	0.08	STMR (CXL) × PF (0.3)	0.48	HR (CXL) × PF (0.3)
Tree nuts	0.021	STMR (CXL) (EFSA, 2014)	0.07	HR (CXL) (EFSA, 2014)
Apples	0.43	STMR (CXL) (EFSA, 2014)	1	HR (CXL) (EFSA, 2014)
	–	No fall‐back available	–	No fall‐back available
Pears	0.43	STMR (CXL) (EFSA, 2014)	1	HR (CXL) (EFSA, 2014)
	–	No fall‐back available	–	No fall‐back available
Quinces	0.43	STMR (CXL) (EFSA, 2014)	1	HR (CXL) (EFSA, 2014)
Medlar	0.43	STMR (CXL) (EFSA, 2014)	1	HR (CXL) (EFSA, 2014)
Loquat	0.43	STMR (CXL) (EFSA, 2014)	1	HR (CXL) (EFSA, 2014)
Apricots	0.34	STMR (CXL) (EFSA, 2014)	1.4	HR (CXL) (EFSA, 2014)
Cherries	0.34	STMR (CXL) (EFSA, 2014)	1.4	HR (CXL) (EFSA, 2014)
Peaches	0.34	STMR (CXL) (EFSA, 2014)	1.4	HR (CXL) (EFSA, 2014)
	–	No fall‐back available	–	No fall‐back available
Plums	0.340	STMR (CXL) (EFSA, 2014)	1.40	HR (CXL) (EFSA, 2014)
Table grapes	0.260	STMR (EFSA, 2014)	0.57	HR (EFSA, 2014)
Wine grapes	0.330	STMR (CXL) (EFSA, 2014)	0.84	HR (CXL) (EFSA, 2014)
Strawberries	0.240	STMR (CXL) (EFSA, 2014)	1.20	HR (CXL) (EFSA, 2014)
Blueberries	0.130	STMR (CXL) (EFSA, 2014)	2.00	HR (CXL) (EFSA, 2014)
Cranberries	0.085	STMR (CXL) (EFSA, 2014)	0.39	HR (CXL) (EFSA, 2014)
Avocados	0.130	STMR (CXL) (EFSA, 2014)	0.41	HR (CXL) (EFSA, 2014)
Papaya	0.310	STMR (CXL) (EFSA, 2014)	0.33	HR (CXL) (EFSA, 2014)
Granate apples/pomegranates	0.125	STMR (EFSA, 2014)	0.36	HR (CXL) (EFSA, 2014)
Sweet potatoes	0.010	STMR (CXL) (EFSA, 2014)	0.01	HR (CXL) (EFSA, 2014)
Carrots	0.130	STMR (CXL) (EFSA, 2014)	0.31	HR (CXL) (EFSA, 2014)
Radishes	0.080	STMR (CXL) (EFSA, 2014)	0.12	HR (CXL) (EFSA, 2014)
Tomatoes	0.2	STMR (CXL) (EFSA, 2014)	1.8	HR (CXL) (EFSA, 2014)
	0.14	STMR (Fall‐back)	0.46	HR (Fall‐back)
Sweet peppers/bell peppers	0.16	STMR (CXL) (EFSA, 2014)	0.94	HR (CXL) (EFSA, 2014)
Aubergines/eggplants	0.14	STMR (EFSA, 2014)	0.46	HR (CXL) (EFSA, 2014)
Cucurbits with edible peel	0.09	STMR (CXL) (EFSA, 2014)	0.15	HR (CXL) (EFSA, 2014)
Melons	0.09	STMR (CXL) (EFSA, 2014)	0.15	HR (CXL) (EFSA, 2014)
Pumpkins	0.09	STMR (CXL) (EFSA, 2014)	0.15	HR (CXL) (EFSA, 2014)
Sweet corn	0.02	STMR (CXL) (EFSA, 2014)	0.02	HR (CXL) (EFSA, 2014)
Broccoli	0.94	STMR (CXL) (EFSA, 2014)	1.60	HR (CXL) (EFSA, 2014)
	–	No fall‐back available	–	No fall‐back available
Lettuces and salad plants	1.13	STMR (EFSA, 2014)	2.39	HR (EFSA, 2014)
Spinaches and similar Leaves	1.13	STMR (CXL) (EFSA, 2014)	2.39	HR (CXL) (EFSA, 2014)
Herbs and edible flowers	1.13	STMR (EFSA, 2014)	2.39	HR (EFSA, 2014)
Beans (with pods)	0.07	STMR (CXL) (EFSA, 2014)	0.99	HR (CXL) (EFSA, 2014)
Beans, peas (without pods)	0.05	STMR (CXL) (EFSA, 2014)	0.18	HR (CXL) (EFSA, 2014)
Peas (with pods)	0.1	STMR (CXL) (EFSA, 2014)	0.81	HR (CXL) (EFSA, 2014)
Beans (dry)	0.05	STMR (CXL) (EFSA, 2014)	0.22	HR (CXL) (EFSA, 2014)
Peas (dry)	0.17	STMR (CXL) (EFSA, 2014)	3.40	HR (CXL) (EFSA, 2014)
Peanuts/groundnuts	0.01	STMR (CXL) (EFSA, 2014)	0.02	HR (CXL) (EFSA, 2014)
Cotton seeds	0.46	STMR (CXL) (EFSA, 2014)	4.90	HR (CXL) (EFSA, 2014)
Sugar beet roots	0.11	STMR (CXL) (EFSA, 2014)	0.18	HR (CXL) (EFSA, 2014)
Swine and ruminant meat	0.01	STMR (CXL) (EFSA, 2014)	0.053	HR (CXL) (EFSA, 2014)
Swine and ruminant fat tissue	0.036	STMR (CXL) (EFSA, 2014)	0.24	HR (CXL) (EFSA, 2014)
Swine and ruminant liver	0.025	STMR (CXL) (EFSA, 2014)	0.096	HR (CXL) (EFSA, 2014)
Swine and ruminant kidney	0.025	STMR (CXL) (EFSA, 2014)	0.096	HR (CXL) (EFSA, 2014)
Poultry meat, liver, fat	0.01*	STMR (CXL) (EFSA, 2014)	0.01*	HR (CXL) (EFSA, 2014)
Cattle, sheep, goat and horse milk	0.004	STMR (CXL) (EFSA, 2014)	0.004	STMR (CXL) (EFSA, 2014)
Birds eggs	0.003	STMR (CXL) (EFSA, 2014)	0.003	HR (CXL) (EFSA, 2014)

STMR: supervised trials median residue, CXL: codex maximum residue limit, HR: highest residue.

^*Indicates that the input value is proposed at the limit of quantification.

Crops in bold indicate the commodities of relevance in the assessment (for which an acute intake concern was identified under scenario 1).

Appendix E – Used compound codes

1.

Code/trivial namea	Chemical name/SMILES notationb	Structural formulac
methoxyfenozide	N′‐tert‐butyl‐N′‐(3,5‐dimethylbenzoyl)‐3‐methoxy‐2‐methylbenzohydrazide QCAWEPFNJXQPAN‐UHFFFAOYSA‐N Cc1c(cccc1OC)C(=O)NN(C(=O)c1 cc(C)cc(C)c1)C(C)(C)C

SMILES: simplified molecular‐input line‐entry system.

^aThe metabolite name in bold is the name used in the conclusion.

^bACD/Name 2019.1.3 ACD/Labs 2019 Release (File version N05E41, Build 111418, 03 Sep 2019).

^cACD/ChemSketch 2019.1.3 ACD/Labs 2019 Release (File version C05H41, Build 111302, 27 Aug 2019).

Suggested citation: EFSA (European Food Safety Authority) , Anastassiadou M, Bernasconi G, Brancato A, Carrasco Cabrera L, Ferreira L, Greco L, Jarrah S, Kazocina A, Leuschner R, Magrans JO, Miron I, Nave S, Pedersen R, Reich H, Rojas A, Sacchi A, Santos M, Scarlato AP, Theobald A, Vagenende B and Verani A, 2020. Reasoned opinion on the focussed assessment of certain existing MRLs of concern for methoxyfenozide. EFSA Journal 2020;18(12):6330, 22 pp. 10.2903/j.efsa.2020.6330