Review of the existing maximum residue levels for etofenprox according to Article 12 of Regulation (EC) No 396/2005

Abstract

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance etofenprox. To assess the occurrence of etofenprox residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.

Summary

Etofenprox was included in Annex I to Directive 91/414/EEC on 1 January 2010 by Commission Directive 2009/77/EC, and has been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011. As the active substance was approved after the entry into force of Regulation (EC) No 396/2005 on 2 September 2008, the European Food Safety Authority (EFSA) is required to provide a reasoned opinion on the review of the existing MRLs for that active substance in compliance with Article 12(1) of the aforementioned regulation. To collect the relevant pesticide residues data, EFSA asked Italy, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile) and to prepare a supporting evaluation report. The PROFile and evaluation report provided by the RMS were made available to the Member States. A request for additional information was addressed to the Member States in the framework of a completeness check period, which was initiated by EFSA on 8 June 2016 and finalised on 8 August 2016. After having considered all the information provided, EFSA prepared a completeness check report which was made available to Member States on 26 September 2016.

Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC the MRLs established by the Codex Alimentarius Commission and the additional information provided by the RMS and Member States, EFSA prepared in April 2017 a draft reasoned opinion, which was circulated to Member States for consultation via a written procedure. Comments received by 5 June 2017 were considered during the finalisation of this reasoned opinion. The following conclusions are derived.

The metabolism of etofenprox was investigated in representatives of three different crop categories: oilseeds (winter rape), fruit crops (vine plants including grapes) and leafy crops (lettuce) following foliar application. Based on all available metabolism studies, etofenprox was the main residue and alpha‐CO represented a significant metabolite. EFSA proposes to simplify the residue definition for enforcement as parent compound only. The residue definition for risk assessment as proposed by the peer review and including the metabolite alpha‐CO is still considered valid. The same residue definitions are applicable for rotational crops and for processed commodities. A validated analytical method for enforcement of the proposed residue definition (etofenprox) in all plant matrices with an limit of quantification (LOQ) of 0.01 mg/kg is available.

Etofenprox is authorised on crops which are non‐permanent and according to soil degradation studies DT₉₀ values of etofenprox ranged between 43 and 580 days and exceeded the trigger of 100 days. Therefore, an investigation of residues in rotational crops was required and provided by growing lettuce, carrots and spring barley on treated soils at rates relevant to the currently authorised uses. Based on the provided data it was concluded the etofenprox will not give rise to residues in rotational crops.

Storage stability of etofenprox and the metabolite alpha‐CO was demonstrated for a period of 24 months at −20°C in commodities with high water, high acid and high oil content; however, it was not investigated in dry commodities.

The available data are considered sufficient to derive MRL proposals as well as risk assessment values for hazelnuts, chestnuts, pine nut kernels, peaches, apples, pears, potatoes, onions, garlic, olives, linseeds, sesame, mustard, borage, gold of pleasure and hemp seeds. Tentative MRL proposals could be derived for citrus fruits, cherries, wine and table grapes, kakis, kiwis, tomatoes, head cabbages, broccoli, cauliflower, lettuces and salad plants, spinaches, chards, fresh herbs, rapeseeds and beans with pods. For all other commodities, the available data were insufficient to derive MRLs and risk assessment values.

For most of the residue trials, residues were analysed according to the enforcement and risk assessment residue definition, therefore enabling to derive proper conversion factors from enforcement to risk assessment. However for cherries, tomatoes, flowering brassicas, head cabbages (northern European Union (NEU)), kiwi, salad plants, spinaches, chards, fresh herbs and rapeseeds (NEU) limited residue data for alpha‐CO or only data for the parent compound were available. For these commodities, the highest conversion factors of 1.2 derived from other fruits crops and leafy vegetables and of 1.1 derived from metabolism studies on rapeseeds were tentatively used for risk assessment.

Robust processing factors could be derived for peach puree, peach juice, peach jam, apple juice, wine grape juice and red wine. For all other processed commodities, only indicative processing factors could be derived due to the limited data sets or residues analysed for the parent compound only.

Etofenprox is authorised for use on several crops that might be fed to livestock. The dietary burdens calculated for all groups of livestock were found to exceed the trigger value of 0.1 mg/kg dry matter (DM). Behaviour of residues was therefore assessed in all commodities of animal origin. It is highlighted that for several feed items, no residue data were available (e.g. maize corn grain and straw, rice grain and straw, sugar beets, vetch). The animal intake of etofenprox residues via these commodities has therefore not been assessed and may have been underestimated.

In animal commodities, a residue definition for monitoring and risk assessment is proposed as etofenprox on a tentative basis only. Validated gas chromatography with mass spectrometric (GC–MS) and/or liquid chromatography with tandem mass spectrometric (LC–MS/MS) methods with an LOQ of 0.01 mg/kg are available for enforcement of the proposed residue definition in meat, fat, eggs and milk. MRLs and risk assessment values derived from cattle feeding study data can be extrapolated to all ruminants (e.g. goats and sheep), and other animals such as horses, pigs and rabbits. However, considering that the residue definition in livestock could be only tentatively derived, the lack of storage stability studies covering tissues others than liver and the lack of fully validated analytical methods for liver and kidney, all the derived MRLs should be considered tentative only.

Chronic and acute consumer exposure resulting from the authorised uses reported in the framework of this review was calculated using revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). According to the results of this calculation, the highest chronic exposure represented 52.2% of the acceptable daily intake (ADI) (UK, toddler) and the highest acute exposure amounted to 15.8% of the acute reference dose (ARfD) (scarole (broad‐leaf endive)).

Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs have also been established for etofenprox. Additional calculations of the consumer exposure, considering these CXLs, were therefore carried out. The highest chronic exposure represented 52.6% of the ADI (UK toddler) and the highest acute exposure amounted to 17% of the ARfD (table grapes).

Background

Regulation (EC) No 396/20051 (hereinafter referred to as ‘the Regulation’) establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. Article 12(1) of that Regulation stipulates that the European Food Safety Authority (EFSA) shall provide, within 12 months from the date of the inclusion or non‐inclusion of an active substance in Annex I to Directive 91/414/EEC2 a reasoned opinion on the review of the existing MRLs for that active substance. As etofenprox was included in Annex I to Council Directive 91/414/EEC on 1 January 2010 by means of Commission Directive 2009/77/EC3, and has been deemed to be approved under Regulation (EC) No 1107/20094, in accordance with Commission Implementing Regulation (EU) No 540/20115, as amended by Commission Implementing Regulation (EU) No 541/20116, EFSA initiated the review of all existing MRLs for that active substance.

According to the legal provisions, EFSA shall base its reasoned opinion in particular on the relevant assessment report prepared under Directive 91/414/EEC. It should be noted, however, that, in the framework of Directive 91/414/EEC, only a few representative uses are evaluated, whereas MRLs set out in Regulation (EC) No 396/2005 should accommodate all uses authorised within the EU, and uses authorised in third countries that have a significant impact on international trade. The information included in the assessment report prepared under Directive 91/414/EEC is therefore insufficient for the assessment of all existing MRLs for a given active substance.

To gain an overview of the pesticide residues data that have been considered for the setting of the existing MRLs, EFSA developed the Pesticide Residues Overview File (PROFile). The PROFile is an inventory of all pesticide residues data relevant to the risk assessment and MRL setting for a given active substance. This includes data on:

• the nature and magnitude of residues in primary crops;

• the nature and magnitude of residues in processed commodities;

• the nature and magnitude of residues in rotational crops;

• the nature and magnitude of residues in livestock commodities;

• the analytical methods for enforcement of the proposed MRLs.

Italy, the designated rapporteur Member State (RMS) in the framework of Directive 91/414/EEC, was asked to complete the PROFile for etofenprox and to prepare a supporting evaluation report (Italy, 2012). The PROFile and the supporting evaluation report were submitted to EFSA on 21 June 2012 and made available to the Member States. A request for additional information was addressed to the Member States in the framework of a completeness check period which was initiated by EFSA on 8 June 2016 and finalised on 8 August 2016. Additional evaluation reports were submitted by the Czech Republic, France, Germany, Greece, Italy, Spain and EU Reference Laboratories (EURLs) (Czech Republic, 2016; EURLs, 2016; France, 2016; Germany, 2016; Greece, 2016; Italy, 2016a,b; Spain, 2016) and after having considered all the information provided by RMS and Member States, EFSA prepared a completeness check report which was made available to all Member States on 26 September 2016. Further clarifications were sought from Member States via a written procedure in September 2016.

Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission (codex maximum residue limit (CXLs)) and the additional information provided by the Member States, EFSA prepared in April 2017 a draft reasoned opinion, which was submitted to Member States for commenting via a written procedure. All comments received by 5 June 2017 were considered by EFSA during the finalisation of the reasoned opinion.

The evaluation report submitted by the RMS (Italy, 2012) and the evaluation reports submitted by the Czech Republic, France, Germany, Greece, Italy, Spain and EURLs (Czech Republic, 2016; EURL, 2016; France, 2016; Germany, 2016; Greece, 2016; Italy, 2016a,b; Spain, 2016) and the evaluation report submitted by the are considered as supporting documents to this reasoned opinion and, thus, are made publicly available.

In addition, key supporting documents to this reasoned opinion are the completeness check report (EFSA, 2016) and the Member States consultation report (EFSA, 2017). These reports are developed to address all issues raised in the course of the review, from the initial completeness check to the reasoned opinion. Also, the chronic and acute exposure calculations for all crops reported in the framework of this review performed using the EFSA Pesticide Residues Intake Model (PRIMo) (excel file) and the PROFile are key supporting documents and made publicly available as background documents to this reasoned opinion. Furthermore, a screenshot of the Report sheet of the PRIMo is presented in Appendix C.

Terms of Reference

According to Article 12 of Regulation (EC) No 396/2005, EFSA shall provide a reasoned opinion on:

• the inclusion of the active substance in Annex IV to the Regulation, when appropriate;

• the necessity of setting new MRLs for the active substance or deleting/modifying existing MRLs set out in Annex II or III of the Regulation;

• the inclusion of the recommended MRLs in Annex II or III to the Regulation;

• the setting of specific processing factors as referred to in Article 20(2) of the Regulation.

The active substance and its use pattern

Etofenprox is the ISO common name for 2‐(4‐ethoxyphenyl)‐2‐methylpropyl 3‐phenoxybenzyl (IUPAC).

Etofenprox belongs to the group of pyrethroid ether compounds which are used as insecticides. It acts on the nervous system of insects disturbing the function of neurons by interaction with the sodium channel. Etofenprox has insecticide activity by contact and ingestion, has a broad spectrum of action on a wide variety of pests, with fast knockdown. Etofenprox is used in agriculture against sucking and biting insects including aphids, thrips, moths, leaf rollers and leafhoppers at adult and larval stage.

The chemical structure of the active substance and its main metabolite are reported in Appendix F.

Etofenprox was evaluated in the framework of Directive 91/414/EEC with Italy designated as RMS. The representative uses supported for the peer review process were foliar spray applications on oilseed rape, head cabbage, grape, peach and apple. Following the peer review, which was carried out by EFSA, a decision on inclusion of the active substance in Annex I to Directive 91/414/EEC was published by means of Commission Directive 2009/77/EC, which entered into force on 1 January 2010. According to Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011, etofenprox is deemed to have been approved under Regulation (EC) No 1107/2009. This approval is restricted to uses as insecticide only.

The EU MRLs for etofenprox are established in Annexes IIIA of Regulation (EC) No 396/2005 and CXLs for etofenprox were also established by the Codex Alimentarius Commission (CAC). An overview of the MRL changes that occurred since the entry into force of the Regulation mentioned above is provided below (Table 1).

Table 1.

Overview of the MRL changes since the entry into force of Regulation (EC) No 396/2005

Procedure	Legal implementation	Remarks
Implementation of CAC 2012	Reg. (EU) No 293/2013a	Modification of MRLs for beans and peaches

^aCommission Regulation (EU) No 293/2013 of 20 March 2013 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for emamectin benzoate, etofenprox, etoxazole, flutriafol, glyphosate, phosmet, pyraclostrobin, spinosad and spirotetramat in or on certain products. OJ L 96, 5.4.2013, p. 1–30.

For the purpose of this MRL review, the critical uses of etofenprox currently authorised within the European Union (EU), have been collected by the RMS and reported in the PROFile. The additional good agricultural practices (GAPs) reported by Member States during the completeness check were also considered. The details of the authorised GAPs for etofenprox are given in Appendix A. The RMS did not report any use authorised in third countries that might have a significant impact on international trade.

Assessment

EFSA has based its assessment on the PROFile submitted by the RMS, the evaluation report accompanying the PROFile (Italy, 2012), the draft assessment report (DAR) and its addenda prepared under Council Directive 91/414/EEC (Italy, 2007, 2008), the conclusion on the peer review of the pesticide risk assessment of the active substance etofenprox (EFSA, 2009), the Joint Meeting on Pesticide residues (JMPR) Evaluation report (FAO, 2011) as well as the evaluation reports submitted during the completeness check (Czech Republic, 2016; EURLs, 2016; France, 2016; Germany, 2016; Greece, 2016; Italy, 2016a,b; Spain, 2016). 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, 1997a, b, c, d, e, f, g, 2000, 2010a, b, 2016; OECD, 2011, 2013).

More detailed information on the available data and on the conclusions derived by EFSA can be retrieved from the list of end points reported in Appendix B.

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 etofenprox was investigated in representatives of three different crop categories: oilseeds (winter rape), fruit crops (vine plants including grapes) and leafy crops (lettuce) following foliar application. In the experimental studies, a 1:1 labelled mixture of [¹⁴C‐benzyl]‐etofenprox and [¹⁴C‐propyl]‐etofenprox was used at representative dose rates and it has to be noted that results regarding metabolites provide qualitative however no quantitative information.

Etofenprox was the major compound in all studies and represented the main radioactive fraction (62–88% total radioactive residue (TRR)). The metabolite alpha‐CO was the only metabolite occurring at more than 1% of the TRR in plant metabolism studies (1–7% TRR). Other minor metabolites remained below 1% TRR. A ratio of etofenprox to the metabolite alpha‐CO from about 27:1 in lettuce to about 7:1 in rape foliage was reported (Italy, 2007). The metabolite alpha‐CO is related in chemical structure to the parent and showed no higher toxicity than the parent. Therefore, the toxicological reference values of etofenprox were proposed to be used for this metabolite (EFSA, 2009).

1.1.2. Nature of residues in rotational crops

Etofenprox is authorised on non‐permanent crops which can be grown in rotation. According to soil degradation studies evaluated in the framework of the peer review, the period required for 90% dissipation (DT₉₀ values) of etofenprox was between 43 and 580 days. This is above the trigger value of 100 days (EFSA, 2009). Therefore, an investigation of residues in rotational crops is required.

A rotational crop study was reported during the peer review (Italy, 2007). Etofenprox was applied onto bare soil as a 1:1 mixture of both labelled forms at a dose rate of 312 g a.s./ha. Lettuce, carrots and spring barley were sown in the treated soil 4 weeks after application and showed only a very small uptake of radioactivity. The highest amount of radioactivity was found in the aerial parts of the crops (0.07 mg/kg in barley straw; 0.02 mg/kg in lettuce leaves), whereas a very small amount was found in carrots (0.007 mg/kg). The parent compound and individual metabolites were not identified (Italy, 2007).

Based on the available data, it can be concluded that the investigated application of etofenprox will not give rise to residues in succeeding crops and additional studies with ageing of the soil for longer plant back intervals of 120 or 365 days would not be needed.

1.1.3. Nature of residues in processed commodities

The effect of processing on the nature of residues was not investigated in the framework of the peer review. The RMS considered waving these studies by assuming that, based on the chemical structure of etofenprox and alpha‐CO, there would be a high probability that hydrolysis studies simulating processing conditions would show that the nature of the residue remains unchanged (Italy, 2007).

In the addendum to the DAR, standard hydrolysis studies were provided by the RMS (Italy, 2008). They were not evaluated during the peer review, however are considered in this review. Based on the results of these studies it is concluded that etofenprox and the metabolite alpha‐CO remain stable during processing.

1.1.4. Methods of analysis in plants

In the framework of the peer review, a gas chromatography method with mass spectrometry (GC–MS) detection and its independent laboratory validation (ILV) were considered suitable for the monitoring of etofenprox and alpha‐CO in high water, high acid and high oil commodities with a limit of quantification (LOQ) of 0.01 mg/kg, respectively (Italy, 2007; EFSA, 2009). An analytical method for enforcement in dry commodities is not available and is in principle still required. Nevertheless, during the completeness check, the EURLs provided a gas chromatography with tandem mass spectrometric (GC–MS/MS) method for etofenprox in all matrices, including dry commodities, with an LOQ of 0.01 mg/kg and a liquid chromatography with tandem mass spectrometric (LC–MS/MS) method for alpha‐CO in all matrices with an LOQ of 0.01 mg/kg (EURL, 2016).

1.1.5. Stability of residues in plants

In the framework of the peer review, storage stability of etofenprox and the metabolite alpha‐CO was demonstrated for a period of 24 months at −20°C in commodities with high water, high acid and high oil content (EFSA, 2009). It has to be noted that storage stability of etofenprox and alpha‐CO was not investigated in dry commodities which represents a data gap.

1.1.6. Proposed residue definitions

Based on all three available metabolism studies, etofenprox was the main residue and alpha‐CO represented a significant metabolite. During the peer review, it was noted that the alpha‐CO metabolite was found in proportions higher than 10% of the etofenprox levels in supervised residue trials on grapes (22%), apples (14%) and peaches (12%). For this reason and considering that the limited residue data available during the peer review did not allow deriving proper conversion factors from enforcement to risk assessment, it was decided to define the residue definition for enforcement and risk assessment as the sum of etofenprox and alpha‐CO (Italy, 2007; EFSA, 2009).

In the framework of this review, based on the metabolism data and the results from the available supervised residue trials (see Section 1.2.1) EFSA proposes to simplify the residue definition for enforcement as parent compound only. The residue definition (parent and metabolite alpha‐CO) which was proposed by the peer review is still considered as appropriate for risk assessment. A validated analytical method for enforcement of the proposed residue definition (etofenprox) in all matrices with an LOQ of 0.01 mg/kg is available.

The same residue definitions are applicable for rotational crops and processed commodities.

1.2. Magnitude of residues in plants

1.2.1. Magnitude of residues in primary crops

To assess the magnitude of etofenprox residues resulting from the reported GAPs, EFSA considered all residue trials reported by the RMS in its evaluation report (Italy, 2012), including residue trials evaluated in the framework of the peer review (EFSA, 2009) and additional data submitted during the completeness check by the Czech Republic, France, Germany, Greece, Italy and Spain (Czech Republic, 2016; France, 2016; Germany, 2016; Greece, 2016; Italy, 2016a,b; Spain, 2016).

Residue trial samples considered in this framework were stored in compliance with the demonstrated storage conditions with the exception of samples for wine grapes and kiwi fruits where storage information was not provided. Considering that storage stability in high water and acidic commodities was demonstrated for 2 years at −20°C, it is assumed that in samples no significant degradation is expected to have had occurred; however further information on the storage conditions is still desirable. Storage stability in dry commodities was not demonstrated but this is not considered relevant since no residue trials on dry matrices were available.

The number of residue trials and extrapolations were evaluated in accordance with the European guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs (European Commission, 2016).

The available residue trials, MRL proposals and proposed conversion factors for risk assessment are summarised in Table B.1.2.1.

Residue trials are not available to support the authorisations on plums, berries, figs, granate apples, aubergines, peppers, cucurbits with inedible peel, Brussels sprouts, beans without pods, lentils, lupins, maize and rice grains, sugar beet and vetch. Therefore, MRLs and risk assessment values for these crops could not be derived by EFSA and the following data gaps were identified:

• Plums: six additional trials on plums compliant with the southern outdoor GAP are required.

• Strawberries: eight trials on strawberries compliant with the southern outdoor GAP are required.

• Black‐ and raspberries: four trials on black‐ and/or raspberries compliant with the southern outdoor GAP are required.

• Blue‐, gooseberries and currants: four trials on currants compliant with the southern outdoor GAPs for blueberries, gooseberries and currants are required.

• Figs: four trials on figs compliant with the southern outdoor GAP are required.

• Granate apple: four trials on granate apples compliant with the southern outdoor GAP are required.

• Aubergines: four trials on aubergines compliant with the southern outdoor GAP are required.

• Peppers: one residue trial analysing parent compound only is available. Therefore, a complete dataset on peppers compliant with the southern outdoor GAP is required.

• Cucurbits with inedible peel: eight trials on melons compliant with the southern outdoor GAP for cucurbits with inedible peel are required.

• Brussels sprouts: four trials on Brussels sprouts compliant with the southern outdoor GAP are required.

• Beans (without pods): four trials on beans without pods compliant with the southern outdoor GAP are required.

• Lentils (fresh): four trials on lentils compliant with the southern outdoor GAP are required.

• Lupins (dry): four trials on lupins compliant with the southern outdoor GAP are required.

• Maize: eight trials on maize compliant with the southern outdoor GAP are required.

• Rice: eight trials on rice compliant with the southern outdoor GAP are required.

• Sugar beet: eight trials on sugar beet compliant with the southern outdoor GAP are required.

• Vetch: four trials on vetch compliant with the southern outdoor GAP are required.

All required trials should be performed analysing simultaneously for the enforcement and risk assessment residue definitions.

For some crops, the available residue trials were not fully compliant with the authorised GAPs or the number of residue trials was not compliant with the data requirements, only tentative MRLs and risk assessment values could be derived by EFSA and the following data gaps were identified:

• Citrus fruits: available residue trials supporting the southern outdoor GAP were all performed with two instead of one application. Although a tentative MRL could be derived from available data, eight additional trials on oranges and eight on lemons or mandarins compliant with the southern outdoor GAP are still required.

• Apricots: no residue trials on apricots are available. Although a tentative extrapolation from peaches is possible, at least 50% additional trials on apricots compliant with the southern outdoor GAP are still required.

• Cherries: available trials were only analysed for the parent and therefore four additional trials compliant with the southern outdoor GAP are still required.

• Table and wine grapes: available residue trials for the northern GAP were all performed with two applications instead of one. Available trials to support the southern GAP were all overdosed (performed at 4 × 150 instead of 1 × 115 g a.i./kg). Although tentative MRLs could be derived from southern data, eight trials supporting the northern outdoor GAP on wine grapes and eight residue trials supporting the southern GAP for table and wine grapes are still required.

• Kaki: one of the four available residue trials to support the southern GAP was overdosed with twice the application rate and only in one trial residues were analysed for the parent and alpha‐CO. While a tentative MRL could be derived from the available data, three additional trials compliant with the southern outdoor GAP are still required.

• Kiwi: available trials on kiwis were all overdosed (210–240 g a.i./ha and one trial with two instead of one application). While a tentative MRL can be derived, eight additional trials on kiwi compliant with the southern outdoor GAP are still required.

• Tomatoes: four of nine available tomato trials were overdosed (performed at 2 × 400 g a.i./ha) and three trials were carried out according to a different GAP (1 × 300 g a.i./ha instead of 2 × 160 g a.i./ha). Moreover, all residues were analysed only for the parent. While a tentative MRL could be derived from the available data, eight additional trials on tomatoes compliant with the southern outdoor GAP are still required.

• Flowering Brassica: eight available combined residue trials on cauliflower (three) and broccoli (five) are all performed with two instead of one application and all residues were analysed only for the parent. While a tentative MRL can be derived, four additional trials on cauliflower and on broccoli, respectively compliant with the northern outdoor GAP are still required.

• Head cabbage: available trials to support the northern GAP were performed with two applications instead of one and all residues were analysed only for the parent. While a tentative MRL can be derived from the available trials, eight additional trials on head cabbage compliant with the northern outdoor GAP are still required.

• Lettuces, lambs lettuce, escaroles, cresses, roman rocket, spinaches, chards and fresh herbs: the number of residue trials is not compliant with the data requirements for this crop (six instead of eight). Moreover, four available trials were performed on head‐forming varieties while two (variety names: Lido, Dimar) could not be assigned to a variety. Only two of the six trials were analysed for parent and alpha‐CO simultaneously. While a tentative MRL could be derived from the available trials, eight additional trials on lettuces (open leaf variety) compliant with the southern outdoor GAP are still required.

• Rapeseeds: the number of residue trials supporting the northern outdoor GAP is not compliant with the data requirements for this crop (seven instead of eight). Moreover, in all available residue trials, samples were analysed for parent compound only. While a tentative MRL can be derived from the available trials, eight additional trials on rapeseed compliant with the northern outdoor GAP are still required.

• Beans (with pods): four additional trials on beans with pods compliant with the southern outdoor GAP are required.

All required trials should be performed analysing simultaneously for enforcement and risk assessment residue definitions.

For all other crops, available residue trials are sufficient to derive MRL and risk assessment values, taking note of the following considerations:

• Hazelnuts, chestnuts, pine nut kernels, potatoes, onions, garlic, olives: the number of residue trials supporting the southern outdoor GAPs is not compliant with the data requirements for these crops. However, the reduced number of residue trials is considered acceptable in these cases because all results were below the LOQ and a no residues situation is expected. Further residue trials are therefore not required.

• Linseeds, sesame, mustard, borage, gold of pleasure and hemp seeds: trials were performed with one instead of two applications. However, this is considered acceptable because the first application done at an early growth stage is not expected to have a significant impact on the final residue.

1.2.2. Magnitude of residues in rotational crops

Based on the results of the confined rotational crop study (Section 1.1.2) performed at 312 g a.i/ha and covering the most critical GAPs considered in this review (maximal application rates for grapes and strawberries of 320 g a.i./ha), it can be concluded that no significant residues of etofenprox and alpha‐CO are expected in rotational crops.

1.2.3. Magnitude of residues in processed commodities

Studies on oilseed rape, grapes, peaches, apples and tomatoes were conducted and reported (Italy, 2007, 2012). Since residues in raw and processed commodities of oilseed rape were always below the LOQ of 0.01 mg/kg, it was not possible to derive processing factors.

An overview of all available processing studies is available in Appendix B.1.2.3. Robust processing factors could be derived for peach puree, peach juice, peach jam, apple juice, wine grape juice and red wine. For all other processed commodities only indicative processing factors could be derived due to the limited data sets or residues analysed for the parent compound only.

If more robust processing factors were to be required by the risk managers, in particular for enforcement purposes, additional processing studies would be needed.

1.2.4. Proposed MRLs

The available data are considered sufficient to derive MRL proposals as well as risk assessment values for hazelnuts, chestnuts, pine nut kernels, peaches, apples, pears, potatoes, onions, garlic, olives, linseeds, sesame, mustard, borage, gold of pleasure and hemp seeds. Tentative MRL proposals could be derived for citrus fruits, cherries, wine and table grapes, kakis, kiwis, tomatoes, head cabbages, broccoli, cauliflower, lettuces and salad plants, spinaches, chards, fresh herbs, rapeseeds and beans with pods. For all other commodities the available data were insufficient to derive MRLs and risk assessment values.

For most of the residue trials, residues were analysed according to the enforcement and risk assessment residue definition, therefore enabling to derive proper conversion factors from enforcement to risk assessment. However for cherries, tomatoes, flowering brassicas, head cabbages (northern European Union (NEU)), kiwi, salad plants, spinaches, chards, fresh herbs and rapeseeds (NEU) limited residue data for alpha‐CO or only data for the parent compound were available. For these commodities, the highest conversion factors of 1.2 derived from other fruits crops and leafy vegetables and the CF of 1.1 derived from the metabolism study on rapeseeds were tentatively proposed for risk assessment.

2. Residues in livestock

Etofenprox is authorised for use on several crops that might be fed to livestock. Livestock dietary burdens were therefore calculated for different groups of livestock according to OECD guidance (OECD, 2013), which has now also been agreed upon at European level. The input values for all relevant commodities are summarised in Appendix D. The dietary burdens calculated for all groups of livestock were found to exceed the trigger value of 0.1 mg/kg DM. Behaviour of residues was therefore assessed in all commodities of animal origin.

It is highlighted that for several feed items, no residue data were available (e.g. maize corn grain and straw, rice grain and straw, sugar beets, vetch forage). The animal intake of etofenprox residues via these commodities has therefore not been assessed and may have been underestimated.

2.1. Nature of residues and methods of analysis in livestock

During the peer review, metabolism studies performed on domestic animals (goat and hen) dosed with etofenprox only, indicate that etofenprox should be defined as the residue of concern in food of animal origin (Italy, 2007). Most of the applied radioactivity (77–92%) was excreted. Transfer to milk and to eggs remained low (less than 1% of the applied dose). Residue levels in edible tissues, organs and blood reached 3.7% and were mostly located in fat (Italy, 2007).

The metabolite alpha‐CO was only formed transiently and did not represent a significant residue. Nevertheless, during the peer review it was noted that additional information on the fate of alpha‐CO would be needed (EFSA, 2009). No further information was received during this review. Metabolism studies performed with the parent and metabolite are therefore still required.

Pending the submission of new metabolism studies, to perform at least a tentative assessment based on the available information, a residue definition for monitoring and risk assessment is proposed as etofenprox only.

A validated GC–MS method for etofenprox and alpha‐CO with an LOQ of 0.01 mg/kg each in meat, fat, eggs and milk is available. The inter‐laboratory validation study conducted for meat, milk, egg and fat demonstrated good reproducibility (Italy, 2007). The EURLs provided a validated LC–MS/MS method for etofenprox for eggs and muscle with LOQs of 0.02 and 0.001 mg/kg, respectively. However, the lack of a validated analytical method for liver and kidney has to be noted.

Storage stability of etofenprox was demonstrated in liver only at −20°C for 12 months (Italy, 2007). Additional studies covering storage stability in all other tissues, milk and eggs are still required.

2.2. Magnitude of residues in livestock

One feeding study performed on dairy cattle was evaluated by the RMS in the DAR (Italy, 2007). Three dose levels were tested (0.018, 0.054 and 1.82 mg etofenprox/kg body weight (bw) per day), whereby the second dosing level covers the calculated dietary burden for cattle. Samples were stored at −20°C until analysis; however, since the storage period is not specified and because storage stability was only investigated in liver, a decline of residues during storage cannot be excluded.

For poultry, residue data were derived from a hen metabolism study with two dose levels (0.075 and 0.75 mg etofenprox/kg bw per day). The lower dose level covers the calculated dietary burden for poultry. Samples were stored at −20°C for no longer than 12 months and a decline of residues during storage is not expected in liver (Italy, 2007). However, for all the other tissues and for eggs since the storage stability was not investigated, a decline of residues during storage cannot be excluded.

MRLs and risk assessment values for animal products were derived according to the OECD guidance which was agreed upon at the European level (OECD, 2013). The overview of the study results used to derive the risk assessment values and the MRL proposals are summarised in Appendix B.2.2. According to the OECD guidance, MRLs and risk assessment values derived from cattle feeding study data can be extrapolated to all ruminants (e.g. goats and sheep), and other animals such as horses, pigs and rabbits. However, considering that the residue definition in livestock could be only tentatively derived, the lack of storage stability studies covering tissues others than liver and the lack of fully validated analytical methods for liver and kidney, all the derived MRLs should be considered tentative only.

3. Consumer risk assessment

In the framework of this review, only the uses of etofenprox reported by the RMS in Appendix A were considered; however, the use of etofenprox was previously also assessed by the 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 (JMPR)) (FAO, 1993, 2011). The CXLs, resulting from these assessments by JMPR and adopted by the CAC, are now international recommendations that need to be considered by European risk managers when establishing MRLs. To facilitate consideration of these CXLs by risk managers, the consumer exposure was calculated both with and without consideration of the existing CXLs.

3.1. Consumer risk assessment without consideration of the existing CXLs

Chronic and acute exposure calculations for all crops reported in the framework of this review were performed using revision 2 of the EFSA PRIMo (EFSA, 2007). Input values for the exposure calculations were derived in compliance with the decision tree reported in Appendix E. Hence, for those commodities where a (tentative) MRL could be derived by EFSA in the framework of this review, input values were derived according to the internationally agreed methodologies (FAO, 2009).

For those commodities where data were insufficient to derive an MRL in Section 3, EFSA considered the existing EU MRL multiplied by the following highest conversion factors for risk assessment derived from residue trials analysing simultaneously according to the residue definitions for enforcement and risk assessment: 1 for root and tuber vegetables and 1.2 for fruit crops, leafy vegetables and pulses. For maize and rice, in the absence of residue trials on other cereals analysing simultaneously for parent and alpha‐CO, a conversion factor of 2 was considered based on the worst‐case assumption that the metabolite alpha‐CO is present at the same level as the parent compound. All input values included in the exposure calculations are summarised in Appendix D.

The exposures calculated were compared with the toxicological reference values for etofenprox, derived by EFSA (2009) under Directive 91/414/EEC. The highest chronic exposure was calculated for the UK toddler, representing 52.2% of the acceptable daily intake (ADI) with sugar beet root representing 38.1% followed by milk and cream with 3.6% and oranges with 2.6%. The highest acute exposure was calculated for scarole (broad‐leaf endive), representing 15.8% of the acute reference dose (ARfD). Although major uncertainties remain due to the data gaps identified in the previous sections, this indicative exposure calculation did not indicate a risk to consumers.

3.2. Consumer risk assessment with consideration of the existing CXLs

To include the CXLs in the calculations of the consumer exposure, CXLs were compared with the EU MRL proposals in compliance with Appendix E and all data relevant to the consumer exposure assessment have been collected from JMPR evaluations. An overview of the input values used for this exposure calculation is also provided in Appendix D. Residue definition for risk assessment defined by the JMPR is different and does not include the metabolite alpha‐CO. In order to consider the contribution of this metabolite to the dietary intake, the same conversion factors were tentatively applied to the CXLs as outlined in Section 3.1. Therefore, all the existing CXLs should be considered tentative only.

Chronic and acute exposure calculations were also performed using revision 2 of the EFSA PRIMo and the exposures calculated were compared with the toxicological reference values derived for etofenprox. The highest chronic exposure was calculated for UK toddler, representing 52.6% of the ADI, and the highest acute exposure was calculated for table grapes, representing 17% of the ARfD.

Based on these calculations, EFSA concludes that although major uncertainties remain due to the data gaps identified for these CXLs, this indicative exposure calculation did not indicate a risk to consumers.

Conclusions

The metabolism of etofenprox was investigated in representatives of three different crop categories: oilseeds (winter rape), fruit crops (vine plants including grapes) and leafy crops (lettuce) following foliar application. Based on all available metabolism studies, etofenprox was the main residue and alpha‐CO represented a significant metabolite. EFSA proposes to simplify the residue definition for enforcement as parent compound only. The residue definition for risk assessment as proposed by the peer review and including the metabolite alpha‐CO is still considered valid. The same residue definitions are applicable for rotational crops and for processed commodities. A validated analytical method for enforcement of the proposed residue definition (etofenprox) in all plant matrices with an LOQ of 0.01 mg/kg is available.

Etofenprox is authorised on crops which are non‐permanent and according to soil degradation studies DT₉₀ values of etofenprox ranged between 43 and 580 days and exceeded the trigger of 100 days. Therefore, an investigation of residues in rotational crops was required and provided by growing lettuce, carrots and spring barley on treated soils at rates relevant to the currently authorised uses. Based on the provided data it was concluded the etofenprox will not give rise to residues in rotational crops.

Storage stability of etofenprox and the metabolite alpha‐CO was demonstrated for a period of 24 months at −20°C in commodities with high water, high acid and high oil content however it was not investigated in dry commodities.

The available data are considered sufficient to derive MRL proposals as well as risk assessment values for hazelnuts, chestnuts, pine nut kernels, peaches, apples, pears, potatoes, onions, garlic, olives, linseeds, sesame, mustard, borage, gold of pleasure and hemp seeds. Tentative MRL proposals could be derived for citrus fruits, cherries, wine and table grapes, kakis, kiwis, tomatoes, head cabbages, broccoli, cauliflower, lettuces and salad plants, spinaches, chards, fresh herbs, rape seeds and beans with pods. For all other commodities, the available data were insufficient to derive MRLs and risk assessment values (Table 2).

Table 2.

Summary table

Code numbera	Commodity	Existing EU MRL (mg/kg)	Existing CXL (mg/kg)	Outcome of the review
				MRL (mg/kg)	Comment
Enforcement residue definition: EtofenproxF
110010	Grapefruits	1	–	1.5	Further consideration neededb
110020	Oranges	1	–	1.5	Further consideration neededb
110030	Lemons	1	–	1.5	Further consideration neededb
110040	Limes	1	–	1.5	Further consideration neededb
110050	Mandarins	1	–	1.5	Further consideration neededb
120040	Chestnuts	0.5	–	0.01*	Recommendedc
120060	Hazelnuts/cobnuts	0.5	–	0.01*	Recommendedc
120090	Pine nut kernels	0.01*	–	0.01*	Recommendedc
130010	Apples	1	0.6	0.7	Recommendedd
130020	Pears	1	0.6	0.7	Recommendedd
140010	Apricots	1	–	0.6	Further consideration neededb
140020	Cherries (sweet)	1	–	0.8	Further consideration neededb
140030	Peaches	0.6	0.6	0.6	Recommendedd
140040	Plums	1	–	1	Further consideration needede
151010	Table grapes	5	4	4	Further consideration neededf
151020	Wine grapes	5	4	4	Further consideration neededf
152000	Strawberries	1	–	1	Further consideration needede
153010	Blackberries	1	–	1	Further consideration needede
153030	Raspberries (red and yellow)	1	–	1	Further consideration needede
154010	Blueberries	1	–	1	Further consideration needede
154030	Currants (black, red and white)	1	–	1	Further consideration needede
154040	Gooseberries (green, red and yellow)	1	–	1	Further consideration needede
161020	Figs	1	–	1	Further consideration needede
161030	Table olives	0.01*	–	0.01*	Recommendedc
161060	Kaki/Japanese persimmons	1	–	0.8	Further consideration neededb
162010	Kiwi fruits (green, red, yellow)	1	–	1	Further consideration neededb
163050	Granate apples/pomegranates	1	–	1	Further consideration needede
211000	Potatoes	0.5	–	0.01*	Recommendedc
220010	Garlic	0.5	–	0.01*	Recommendedc
220020	Onions	0.5	–	0.01*	Recommendedc
231010	Tomatoes	1	–	0.7	Further consideration neededb
231020	Sweet peppers/bell peppers	2	–	2	Further consideration needede
231030	Aubergines/eggplants	0.5	–	0.5	Further consideration needede
233010	Melons	0.5	–	0.5	Further consideration needede
233020	Pumpkins	0.5	–	0.5	Further consideration needede
233030	Watermelons	0.5	–	0.5	Further consideration needede
241010	Broccoli	0.2	–	0.4	Further consideration neededb
241020	Cauliflowers	0.2	–	0.4	Further consideration neededb
242010	Brussels sprouts	2	–	2	Further consideration needede
242020	Head cabbages	2	–	0.7	Further consideration neededb
251010	Lamb's lettuces/corn salads	3	–	3	Further consideration neededb
251020	Lettuces	3	–	3	Further consideration neededb
251030	Escaroles/broad‐leaved endives	3	–	3	Further consideration neededb
251040	Cresses and other sprouts and shoots	3	–	3	Further consideration neededb
251060	Roman rocket/rucola	3	–	3	Further consideration neededb
252010	Spinaches	3	–	3	Further consideration neededb
252030	Chards/beet leaves	3	–	3	Further consideration neededb
256010	Chervil	3	–	3	Further consideration neededb
256020	Chives	3	–	3	Further consideration neededb
256030	Celery leaves	3	–	3	Further consideration neededb
256040	Parsley	3	–	3	Further consideration neededb
256050	Sage	3	–	3	Further consideration neededb
256060	Rosemary	3	–	3	Further consideration neededb
256070	Thyme	3	–	3	Further consideration neededb
256080	Basil and edible flowers	3	–	3	Further consideration neededb
256090	Laurel/bay leave	3	–	3	Further consideration neededb
256100	Tarragon	3	–	3	Further consideration neededb
260010	Beans (with pods)	0.5	–	0.4	Further consideration neededb
260020	Beans (without pods)	0.5	–	0.5	Further consideration needede
260050	Lentils (fresh)	0.01*	–	0.01*	Further consideration needede
300010	Beans (dry)	0.05	0.05	0.05	Further consideration neededg
300040	Lupins/lupini beans (dry)	0.5	–	0.5	Further consideration needede
401010	Linseeds	0.01*	–	0.01*	Recommendedc
401040	Sesame seeds	0.01*	–	0.01*	Recommendedc
401060	Rapeseeds/canola seeds	0.05	0.01*	0.05	Further consideration neededh
401080	Mustard seeds	0.01*	–	0.01*	Recommendedc
401120	Borage seeds	0.01*	–	0.01*	Recommendedc
401130	Gold of pleasure seeds	0.01*	–	0.01*	Recommendedc
401140	Hemp seeds	0.01*	–	0.01*	Recommendedc
402010	Olives for oil production	0.01*	–	0.01*	Recommendedc
500030	Maize/corn grains	0.5	0.05*	0.5	Further consideration neededi
500060	Rice grains	0.5	0.01*	0.5	Further consideration neededi
900010	Sugar beet roots	0.5	–	0.5	Further consideration needede
1011010	Swine muscle	0.5	0.03*	0.05	Further consideration neededh
1011020	Swine fat tissue	0.5	0.5	1.5	Further consideration neededh
1011030	Swine liver	0.5	0.05	0.05	Further consideration neededh
1011040	Swine kidney	0.5	0.05	0.05	Further consideration neededh
1012010	Bovine muscle	0.5	0.03*	0.06	Further consideration neededh
1012020	Bovine fat tissue	0.5	0.5	2	Further consideration neededh
1012030	Bovine liver	0.5	0.05	0.06	Further consideration neededh
1012040	Bovine kidney	0.5	0.05	0.07	Further consideration neededh
1013010	Sheep muscle	0.5	0.03*	0.05	Further consideration neededh
1013020	Sheep fat tissue	0.5	0.5	1.5	Further consideration neededh
1013030	Sheep liver	0.5	0.05	0.05	Further consideration neededh
1013040	Sheep kidney	0.5	0.05	0.05	Further consideration neededh
1014010	Goat muscle	0.5	0.03*	0.05	Further consideration neededh
1014020	Goat fat tissue	0.5	0.5	1.5	Further consideration neededh
1014030	Goat liver	0.5	0.05	0.05	Further consideration neededh
1014040	Goat kidney	0.5	0.05	0.05	Further consideration neededh
1015010	Equine muscle	0.5	0.03*	0.06	Further consideration neededh
1015020	Equine fat tissue	0.5	0.5	2	Further consideration neededh
1015030	Equine liver	0.5	0.05	0.06	Further consideration neededh
1015040	Equine kidney	0.5	0.05	0.07	Further consideration neededh
1016010	Poultry muscle	0.01*	0.01*	0.01*	Further consideration neededh
1016020	Poultry fat tissue	0.01*	0.01*	0.04	Further consideration neededh
1016030	Poultry liver	0.01*	0.01*	0.01*	Further consideration neededh
1020010	Cattle milk	0.05	0.02	0.07	Further consideration neededh
1020020	Sheep milk	0.05	0.02	0.04	Further consideration neededh
1020030	Goat milk	0.05	0.02	0.04	Further consideration neededh
1020040	Horse milk	0.05	0.02	0.07	Further consideration neededh
1030000	Birds eggs	0.01*	0.01*	0.015	Further consideration neededh
	Other commodities of plant and animal origin	Regulation (EC) No 149/2008k			Further consideration neededj

MRL: maximum residue level; CXL: codex maximum residue limit.

* Indicates that the MRL is set/proposed at the limit of quantification.

F Residue is fat soluble.

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

^bTentative MRL is derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk to consumers was identified (assuming the existing residue definition); no CXL is available (combination E‐I in Appendix E).

^cMRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to consumers is identified; no CXL is available (combination G‐I in Appendix E).

^dMRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to consumers is identified; existing CXL is covered by the recommended MRL (combination G‐III in Appendix E).

^eGAP evaluated at EU level is not supported by data but no risk to consumers was identified for the existing EU MRL (also assuming the existing residue definition); no CXL is available (combination C‐I in Appendix E).

^fMRL is derived from the existing CXL, which is not sufficiently supported by data but for which no risk to consumers is identified (assuming the existing residue definition); GAP evaluated at EU level, which is also not fully supported by data, would lead to a lower tentative MRL (combination E‐V in Appendix E).

^gMRL is derived from the existing CXL, which is not sufficiently supported by data but for which no risk to consumers is identified (assuming the existing residue definition); there are no relevant authorisations or import tolerances reported at EU level (combination A‐V in Appendix E).

^hTentative MRL is derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk to consumers was identified (assuming the existing residue definition); existing CXL is covered by the tentative MRL (combination E‐III in Appendix E).

ⁱGAP evaluated at EU level is not supported by data but no risk to consumers was identified for the existing EU MRL (also assuming the existing residue definition); existing CXL is covered by the existing EU MRL (combination C‐III in Appendix E).

^jThere are no relevant authorisations or import tolerances reported at EU level; no CXL is available. Either a specific LOQ or the default MRL of 0.01 mg/kg may be considered (combination A‐I in Appendix E).

^kCommission Regulation (EC) No 149/2008 of 29 January 2008 amending Regulation (EC) No 396/2005 of the European Parliament and of the Council by establishing Annexes II, III and IV setting maximum residue levels for products covered by Annex I thereto. OJ L 58, 1.3.2008, p. 1–398.

For most of the residue trials, residues were analysed according to the enforcement and risk assessment residue definition, therefore enabling to derive proper conversion factors from enforcement to risk assessment. However for cherries, tomatoes, flowering brassicas, head cabbages (NEU), kiwi, salad plants, spinaches, chards, fresh herbs and rapeseeds (NEU) limited residue data for alpha‐CO or only data for the parent compound were available. For these commodities, the highest conversion factors of 1.2 derived from other fruits crops and leafy vegetables and of 1.1 derived from metabolism studies for rapeseeds were tentatively used for risk assessment.

Robust processing factors could be derived for peach puree, peach juice, peach jam, apple juice, wine grape juice and red wine. For all other processed commodities only indicative processing factors could be derived due to the limited data sets or residues analysed for the parent compound only.

Etofenprox is authorised for use on several crops that might be fed to livestock. The dietary burdens calculated for all groups of livestock were found to exceed the trigger value of 0.1 mg/kg DM. Behaviour of residues was therefore assessed in all commodities of animal origin. It is highlighted that for several feed items, no residue data were available (e.g. maize corn grain and straw, rice grain and straw, sugar beets, vetch). The animal intake of etofenprox residues via these commodities has therefore not been assessed and may have been underestimated.

In animal commodities, a residue definition for monitoring and risk assessment is proposed as etofenprox on a tentative basis only. Validated GC–MS and/or LC–MS/MS methods with an LOQ of 0.01 mg/kg are available for enforcement of the proposed residue definition in meat, fat, eggs and milk. MRLs and risk assessment values derived from cattle feeding study data can be extrapolated to all ruminants (e.g. goats and sheep), and other animals such as horses, pigs and rabbits. However, considering that the residue definition in livestock could be only tentatively derived, the lack of storage stability studies covering tissues others than liver and the lack of fully validated analytical methods for liver and kidney, all the derived MRLs should be considered tentative only.

Chronic and acute consumer exposure resulting from the authorised uses reported in the framework of this review was calculated using revision 2 of the EFSA PRIMo. According to the results of this calculation, the highest chronic exposure represented 52.2% of the ADI (UK, toddler) and the highest acute exposure amounted to 15.8% of the ARfD scarole (broad‐leaf endive).

Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs have also been established for etofenprox. Additional calculations of the consumer exposure, considering these CXLs, were therefore carried out. The highest chronic exposure represented 52.6% of the ADI (UK toddler) and the highest acute exposure amounted to 17% of the ARfD (table grapes).

Recommendations

MRL recommendations were derived in compliance with the decision tree reported in Appendix E of the reasoned opinion (see summary table). All MRL values listed as ‘Recommended’ in the table are sufficiently supported by data and are therefore proposed for inclusion in Annex II to the Regulation. The remaining MRL values listed in the table are not recommended for inclusion in Annex II because they require further consideration by risk managers (see summary table footnotes for details). In particular, some tentative MRLs and existing EU MRLs need to be confirmed by the following data:

• storage stability studies investigating stability of etofenprox and alpha‐CO residues in dry commodities;

• residue trials supporting the authorisation of citrus fruits, cherries, apricots, plums, wine and table grapes, berries, currants, figs, kaki, kiwi, granate apples, tomatoes, aubergines, sweet peppers, melons, pumpkins, watermelons, flowering brassica, Brussels sprout, head cabbages, lettuces, lambs lettuce, escaroles, cresses, roman rocket, spinaches, chards and fresh herbs, beans with and without pods, fresh lentils, dry lupins, rapeseeds, maize grain, rice grain and sugar beet roots analysing simultaneously for the residue definition of monitoring and risk assessment;

• metabolism studies in ruminants and poultry performed with the parent and the metabolite alpha‐CO;

• a fully validated method for enforcement in kidney and liver;

• storage stability studies investigating stability of etofenprox in eggs, milk and animal tissues others than liver.

If the above reported data gaps are not addressed in the future, Member States are recommended to withdraw or modify the relevant authorisations at national level.

Minor deficiencies were also identified but these deficiencies are not expected to impact either on the validity of the MRLs derived or on the national authorisations. The following data are therefore considered desirable but are not essential:

• Information on storage conditions of samples for residue trials on wine grapes (southern European Union (SEU)) and kiwis (SEU).

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

CCPR

Codex Committee on Pesticide Residues

CF

conversion factor for enforcement residue definition to risk assessment residue definition

cGAP

critical GAP

CXL

codex maximum residue limit

DAR

draft assessment report

DAT

days after treatment

DB

dietary burden

DM

dry matter

DS

powder for dry seed treatment

DT₉₀

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

EC

emulsifiable concentrate

EMS

evaluating Member State

EURLs

EU Reference Laboratories (former CRLs)

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 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)

LC

liquid chromatography

LC–MS/MS

liquid chromatography with tandem mass spectrometry

LOQ

limit of quantification

ME

microemulsion

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

NOAEL

no observed adverse effect level

OECD

Organisation for Economic Co‐operation and Development

PBI

plant‐back interval

PF

processing factor

PHI

preharvest interval

PRIMo

(EFSA) Pesticide Residues Intake Model

PROFile

(EFSA) Pesticide Residues Overview File

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 European Union

SMILES

simplified molecular‐input line‐entry system

SP

water soluble powder

STMR

supervised trials median residue

TAR

total applied radioactivity

TRR

total radioactive residue

UV

ultraviolet (detector)

WHO

World Health Organization

Appendix A – Summary of authorised uses considered for the review of MRLs

Crop		Region	Outdoor/indoor	Member state or country	Pest controlled	Formulation			Application										PHI or waiting period (days)	Comments (max. 250 characters)
Common name	Scientific name					Type	Content		Method	Growth stage		Number		Interval (days)		Rate
							Conc.	Unit		From BBCH	Until BBCH	Min.	Max.	Min.	Max.	Min.	Max.	Unit
Critical outdoor GAPs for Northern Europe
Wine grapes	Vitis vinifera	NEU	Outdoor	FR	Grape berry moths	EC	287.5	g/L	Foliar treatment – spraying	69	89		1				115.00	g a.i./ha	14
Broccoli	Brassica oleracea var. italica	NEU	Outdoor	DE	Eupoecilia ambiguella/Clysia	EC	287.5	g/L	Foliar treatment – spraying	13	81		1				57.50	g a.i./ha	7
Cauliflowers	Brassica oleracea var. botrytis	NEU	Outdoor	DE	Lobesia botrana	EC	287.5	g/L	Foliar treatment – spraying	13	81		1				57.50	g a.i./ha	7
Head cabbages	Brassica oleracea var. capitata	NEU	Outdoor	DE	Blossom beetle, rape stem weevil, cabbage stem weevil	EC	287.5	g/L	Foliar treatment – spraying				1				57.50	g a.i./ha	3
Linseeds	Linum usitatissimum	NEU	Outdoor	FR	Blossom beetle, rape stem weevil, cabbage stem weevil	EC	287.5	g/L	Foliar treatment – spraying	11	61		2		90		57.50	g a.i./ha	n.a.
Rapeseeds	Brassica napus subsp. napus	NEU	Outdoor	CZ, DE,	Flea beetles, stem weevil, Pollen beetles	EC	287.5	g/L	Foliar treatment – spraying		65		2	7			57.50	g a.i./ha	n.a.	Covers also FR GAP with maximum interval of 90 days
Mustard seeds	Brassica juncea; Brassica nigra; Sinapis alba	NEU	Outdoor	FR	Flea beetles, stem weevil, Pollen beetles	EC	287.5	g/L	Foliar treatment – spraying	11	61		2		90		57.50	g a.i./ha	n.a.
Borage seeds	Borago officinalis	NEU	Outdoor	FR	Ceutorhynchus napi, Ceutorhynchus quadridens, Ceutorhynchus obstrictus, Meligethes aeneus	EC	287.5	g/L	Foliar treatment – spraying	11	61		2		90		57.50	g a.i./ha	n.a.
Gold of pleasure seeds	Camelina sativa	NEU	Outdoor	FR	Flea beetles, stem weevil, Pollen beetles	EC	287.5	g/L	Foliar treatment – spraying	11	61		2		90		57.50	g a.i./ha	n.a.
Hemp seeds	Cannabis sativa subsp. sativa; Cannabis sativa subsp. spontanea	NEU	Outdoor	FR	Flea beetles, stem weevil, Pollen beetles	EC	287.5	g/L	Foliar treatment – spraying	11	61		2		90		57.50	g a.i./ha	n.a.
Critical outdoor GAPs for Southern Europe
Grapefruits	Citrus paradisi	SEU	Outdoor	IT	Leaf hoppers, Ceratitis capitata	ME	158.0	g/L	Foliar treatment – spraying		85		1				240	g a.i./ha	7
Oranges	Citrus sinensis	SEU	Outdoor	IT	Leaf hoppers, Ceratitis capitata	ME	158.0	g/L	Foliar treatment – spraying		85		1				240	g a.i./ha	7
Lemons	Citrus limon	SEU	Outdoor	IT	Leaf hoppers, Ceratitis capitata	ME	158.0	g/L	Foliar treatment – spraying		85		1				240	g a.i./ha	7
Limes	Citrus aurantiifolia	SEU	Outdoor	IT	Leaf hoppers, Ceratitis capitata	ME	158.0	g/L	Foliar treatment – spraying		85		1				240	g a.i./ha	7
Mandarins	Citrus reticulata, syn: Citrus deliciosa	SEU	Outdoor	IT	Leaf hoppers, Ceratitis capitata	ME	158.0	g/L	Foliar treatment – spraying		85		1				240	g a.i./ha	7
Chestnuts	Castanea crenata; Castanea dentata; Castanea mollissima; Castanea sativa	SEU	Outdoor	IT	Stink bug Curcculio nucum (Coleoptera beetle)	ME	158.0	g/L	Foliar treatment – spraying		85		1				240	g a.i./ha	14
Hazelnuts	Corylus avellana	SEU	Outdoor	IT	Stink bug Curcculio nucum (Coleoptera beetle)	ME	158.0	g/L	Foliar treatment – spraying		85		1				240	g a.i./ha	14
Pine nut kernels	Pinus pinea	SEU	Outdoor	ES	Processionary caterpillar	EC	300.0	g/L	Foliar treatment – spraying				1				50	g a.i./ha	n.a.
Apples	Malus domestica	SEU	Outdoor	IT	Aphids, Leaf hoppers, Metcalfa pruinosa, Codling moth, Oriental fruit moth, Leaf rollers, Psyllae, Leaf miners spp., Ceratitis capitata	ME	158.0	g/L	Foliar treatment – spraying		85		3	7			240	g a.i./ha	7
Pears	Pyrus communis	SEU	Outdoor	IT	Aphids, Leaf hoppers, Metcalfa pruinosa, Codling moth, Oriental fruit moth, Leaf rollers, Psyllae, Leaf miners spp., Ceratitis capitata	ME	158.0	g/L	Foliar treatment – spraying		85		3	7			240	g a.i./ha	7
Apricots	Armeniaca vulgaris, syn: Prunus armeniaca	SEU	Outdoor	IT	Peach twig borer, Ceratitis capitata	ME	158.0	g/L	Foliar treatment – spraying		85		1				240	g a.i./ha	7
Cherries	Cerasus avium, syn: Prunus avium	SEU	Outdoor	IT	Aphids, Rhagoletis cerasi, Stink bug	ME	158.0	g/L	Foliar treatment – spraying		85		1				240	g a.i./ha	7
Peaches	Persica vulgaris, syn: Prunus persica	SEU	Outdoor	IT	Aphids, Ceratitis capitata, Oriental fruit moth, Peach twig borer, Leaf hoppers, Metcalfa pruinosa, ired bug, fruit tree tortrix, Thrips	ME	158.0	g/L	Foliar treatment – spraying		85	1	2	7			240	g a.i./ha	7
Plums	Prunus domestica	SEU	Outdoor	IT	Cydia funebrana, Aphids, Anarsia lineatella, leaf hopper, fruit tree tortrix, Thrips	ME	158.0	g/L	Foliar treatment – spraying		85		1				240	g a.i./ha	7
Table grapes	Vitis vinifera	SEU	Outdoor	FR	Leaf hoppers, Metcalfa pruinosa, Grape berry moth, Grape fruit moth, Ceratits c., Thrips	EC	287.5	g/L	Foliar treatment – spraying	69	89		1				115	g a.i./ha	14	A more critical GAP is authorised in IT however not supported by data (2 × 320 g a.i./ha)
Wine grapes	Vitis vinifera	SEU	Outdoor	FR	Leaf hoppers, Metcalfa pruinosa, Grape berry moth, Grape fruit moth, Ceratits c., Thrips	EC	287.5	g/L	Foliar treatment – spraying	69	89		1				115	g a.i./ha	14	A more critical GAP is authorised in IT however not supported by data (2 × 320 g a.i./ha)
Strawberries	Fragaria × ananassa	SEU	Outdoor	IT	Aphids, Leaf hoppers Thrips	ME	158.0	g/L	Foliar treatment – spraying		85		1			160	320	g a.i./ha	7
Blackberries	Rubus sect. Rubus	SEU	Outdoor	IT	Aphids, Leaf hoppers, Noctuide, Thrips	EC	280.0	g/L	Foliar treatment – spraying		85		1			140	170	g a.i./ha	7
Raspberries	Rubus idaeus	SEU	Outdoor	IT	Aphids, Leaf hoppers, Noctuide, Thrips	EC	280.0	g/L	Foliar treatment – spraying		85		1			140	170	g a.i./ha	7
Blueberries	Vaccinium angustifolium; Vaccinium corymbosum; Vaccinium formosum; Vaccinium virgatum	SEU	Outdoor	IT	Aphids, Leaf hoppers, Noctuide, Thrips	EC	280.0	g/L	Foliar treatment – spraying		85		1			140	170	g a.i./ha	7
Currants	Ribes nigrum; Ribes rubrum	SEU	Outdoor	IT	Aphids, Leaf hoppers, Noctuide, Thrips	EC	280.0	g/L	Foliar treatment – spraying		85		1			140	170	g a.i./ha	7
Gooseberries	Ribes uva‐crispa	SEU	Outdoor	IT	Aphids, Leaf hoppers, Noctuide, Thrips	EC	280.0	g/L	Foliar treatment – spraying		85		1			140	170	g a.i./ha	7
Figs	Ficus carica	SEU	Outdoor	IT	Metcalfa pruinosa	ME	158.0	g/L	Foliar treatment – spraying		85		1				160	g a.i./ha	7
Table olives	Olea europaea	SEU	Outdoor	ES	Prays olea (antophagous generations)	EC	300.0	g/L	Foliar treatment – spraying	30	65		2	10	60	30	40	g a.i./ha	n.a.
Kaki	Diospyros kaki	SEU	Outdoor	IT	Metcalfa pruinosa	ME	158.0	g/L	Foliar treatment – spraying		85		1				240	g a.i./ha	7
Kiwi fruits	Actinidia deliciosa; Actinidia chinensis	SEU	Outdoor	IT	Metcalfa pruinosa, Ceratitis capitata	ME	158.0	g/L	Foliar treatment – spraying		85		1				160	g a.i./ha	7
Granate apples	Punica granatum	SEU	Outdoor	IT	Metcalfa pruinosa	ME	158.0	g/L	Foliar treatment – spraying		85		1				160	g a.i./ha	7
Potatoes	Solanum tuberosum subsp. tuberosum	SEU	Outdoor	IT	Colorado potato beetle	ME	158.0	g/L	Foliar treatment – spraying		85		1			100	160	g a.i./ha	7
Garlic	Allium sativum	SEU	Outdoor	IT	Aphids, Noctuidae, other Lepidoptera Thrips	ME	158.0	g/L	Foliar treatment – spraying		85		1			160	320	g a.i./ha	7
Onions	Allium cepa Common Onion Group	SEU	Outdoor	IT	Aphids, Noctuidae, other Lepidoptera Thrips	ME	158.0	g/L	Foliar treatment – spraying		85		1			160	320	g a.i./ha	14
Tomatoes	Lycopersicon esculentum	SEU	Outdoor	IT	Aphids, White flies	ME	158.0	g/L	Foliar treatment – spraying		85		2	14			160	g a.i./ha	3	A more critical GAP was notified by ES with 3 applications and not supported by trials
Sweet peppers	Capsicum annuum	SEU	Outdoor	IT	Aphids, White flies, Corn moth Thrips	ME	158.0	g/L	Foliar treatment – spraying		85		1			160	320	g a.i./ha	7
Aubergines	Solanum melongena	SEU	Outdoor	IT, ES	Aphids, Moths, White flies, Noctuidae, other Lepidoptera Thrips	ME	158.0	g/L	Foliar treatment – spraying		85		3	10		160	320	g a.i./ha	3
Melons	Cucumis melo	SEU	Outdoor	IT	Aphids, White flies, Noctuidae, Lepidoptera Aphis gossypii Thrips	EC	280.0	g/L	Foliar treatment – spraying	12	89		2	10		150	210	g a.i./ha	3
Pumpkins	Cucurbita maxima	SEU	Outdoor	IT	Aphids, White flies, Noctuidae, Lepidoptera	EC	280.0	g/L	Foliar treatment – spraying	12	89		2	10		150	210	g a.i./ha	3
Watermelons	Citrullus vulgaris, syn: Citrullus lanatus	SEU	Outdoor	IT	Aphids, White flies, Noctuidae, Lepidoptera	EC	280.0	g/L	Foliar treatment – spraying	12	89		2	10		150	210	g a.i./ha	3
Brussels sprouts	Brassica oleracea var. gemmifera	SEU	Outdoor	IT	Aphids, Noctuidae, other Lepidoptera	EC	280.0	g/L	Foliar treatment – spraying		85		3	7			140	g a.i./ha	7
Head cabbages	Brassica oleracea – capitata	SEU	Outdoor	EL	Pieris Brassicae	EC	287.5	g/L	Foliar treatment – spraying				2	7	14		140	g a.i./ha	7
Lamb's lettuces	Valerianella locusta	SEU	Outdoor	IT	Noctuidae, Mirid bug	ME	158.0	g/L	Foliar treatment – spraying		85		1				160	g a.i./ha	7
Lettuces	Lactuca sativa	SEU	Outdoor	IT	Noctuidae, Mirid bug	ME	158.0	g/L	Foliar treatment – spraying		85		1				160	g a.i./ha	7
Escaroles	Cichorium endivia – latifolia	SEU	Outdoor	IT	Noctuidae, Mirid bug	ME	158.0	g/L	Foliar treatment – spraying		85		1				160	g a.i./ha	7
Cresses	Lepidium sativum – sativum	SEU	Outdoor	IT	Noctuidae, Mirid bug	ME	158.0	g/L	Foliar treatment – spraying		85		1				160	g a.i./ha	7
Roman rocket	Eruca sativa	SEU	Outdoor	IT	Noctuidae, Mirid bug	ME	158.0	g/L	Foliar treatment – spraying		85		1				160	g a.i./ha	7
Spinaches	Spinacia oleracea	SEU	Outdoor	IT	Noctuidae, Mirid bug	ME	158.0	g/L	Foliar treatment – spraying		85		1				160	g a.i./ha	7
Chards	Beta vulgaris – flavescens	SEU	Outdoor	IT	Noctuidae, Mirid bug	ME	158.0	g/L	Foliar treatment – spraying		85		1				160	g a.i./ha	7
Chervil	Anthriscus cerefolium	SEU	Outdoor	IT	Noctuidae, Mirid bug	ME	158.0	g/L	Foliar treatment – spraying		85		1				160	g a.i./ha	7
Chives	Allium schoenoprasum	SEU	Outdoor	IT	Noctuidae, Mirid bug	ME	158.0	g/L	Foliar treatment – spraying		85		1				160	g a.i./ha	7
Celery leaves	Apium g raveolens – secalinum	SEU	Outdoor	IT	Noctuidae, Mirid bug	ME	158.0	g/L	Foliar treatment – spraying		85		1				160	g a.i./ha	7
Parsley	Petroselinum crispum	SEU	Outdoor	IT	Noctuidae, Mirid bug	ME	158.0	g/L	Foliar treatment – spraying		85		1				160	g a.i./ha	7
Sage	Salvia officinalis	SEU	Outdoor	IT	Noctuidae, Mirid bug	ME	158.0	g/L	Foliar treatment – spraying		85		1				160	g a.i./ha	7
Rosemary	Rosmarinus officinalis	SEU	Outdoor	IT	Noctuidae, Mirid bug	ME	158.0	g/L	Foliar treatment – spraying		85		1				160	g a.i./ha	7
Thyme	Thymus vulgaris	SEU	Outdoor	IT	Noctuidae, Mirid bug	ME	158.0	g/L	Foliar treatment – spraying		85		1				160	g a.i./ha	7
Basil	Ocimum basilicum	SEU	Outdoor	IT	Noctuidae, Mirid bug	ME	158.0	g/L	Foliar treatment – spraying		85		1				160	g a.i./ha	7
Laurel	Laurus nobilis	SEU	Outdoor	IT	Noctuidae, Mirid bug	ME	158.0	g/L	Foliar treatment – spraying		85		1				160	g a.i./ha	7
Tarragon	Artemisia dracunculus	SEU	Outdoor	IT	Noctuidae, Mirid bug	ME	158.0	g/L	Foliar treatment – spraying		85		1				160	g a.i./ha	7
Beans (with pods)	Phaseolus vulgaris	SEU	Outdoor	IT	Aphids, White flies, Noctuidae, other Lepidoptera	EC	280.0	g/L	Foliar treatment – spraying		85		3	7			140	g a.i./ha	7
Beans (without pods)	Phaseolus vulgaris	SEU	Outdoor	IT	Aphids, White flies, Noctuidae, other Lepidoptera	ME	158.0	g/L	Foliar treatment – spraying		85		3	7			160	g a.i./ha	7
Lentils (fresh)	Lens culinaris, syn: Lens esculenta	SEU	Outdoor	IT	Aphids, White flies, Noctuidae, other Lepidoptera	ME	158.0	g/L	Foliar treatment – spraying		85		3	7			160	g a.i./ha	7
Lupins (dry)	Lupinus albus subsp. albus; Lupinus angustifolius; Lupinus luteus; Lupinus mutabilis	SEU	Outdoor	IT	Aphids, White flies, Noctuidae, other Lepidoptera	ME	158.0	g/L	Foliar treatment – spraying		85		3	7			160	g a.i./ha	7
Sesame seeds	Sesamum indicum	SEU	Outdoor	FR	Flea beetles, stem weevil, Pollen beetles	EC	287.5	g/L	Foliar treatment – spraying	11	61		2				57.5	g a.i./ha	n.a.
Rapeseeds	Brassica napus subsp. napus	SEU	Outdoor	FR	Flea beetles, stem weevil, Pollen beetles	EC	287.5	g/L	Foliar treatment – spraying	11	61		2		90		57.5	g a.i./ha	n.a.
Borage seeds	Borago officinalis	SEU	Outdoor	FR	Flea beetles, stem weevil, Pollen beetles	EC	287.5	g/L	Foliar treatment – spraying	11	61		2		90		57.5	g a.i./ha	n.a.
Gold of pleasure seeds	Camelina sativa	SEU	Outdoor	FR	Flea beetles, stem weevil, Pollen beetles	EC	287.5	g/L	Foliar treatment – spraying	11	61		2		90		60.0	g a.i./ha	70
Hemp seeds	Cannabis sativa subsp. Sativa; Cannabis sativa subsp. spontanea	SEU	Outdoor	FR	Flea beetles, stem weevil, Pollen beetles	EC	287.5	g/L	Foliar treatment – spraying	11	61		2		90		57.5	g a.i./ha	n.a.
Olives for oil production	Olea europaea var. europaea	SEU	Outdoor	ES	Prays olea (antophagous generations)	EC	300.0	g/L	Foliar treatment – spraying	30	65		2	10	60	30	40	g a.i./ha	n.a.
Maize	Zea mays	SEU	Outdoor	IT	Noctuide, Pyrausta nubilalis	ME	158.0	g/L	Foliar treatment – spraying		85		1				160	g a.i./ha	28
Rice	Oryza sativa	SEU	Outdoor	ES	Eusarcoris sp. Chironomids, Diptera larvae	EC	300.0	g/L	Foliar treatment – spraying	7	58		2	25	60	150	230	g a.i./ha	49
Sugar beets	Beta vulgaris subsp. vulgaris var. altissima	SEU	Outdoor	IT	Flea‐beetles, Mamestra spp.	ME	158.0	g/L	Foliar treatment – spraying		85		1			130	160	g a.i./ha	14
Vetch (for forage)	Vicia spp.	SEU	Outdoor	IT	Aphids, White flies, Noctuidae, other Lepidoptera	EC	280.0	g/L	Foliar treatment – spraying		85		3	7			140	g a.i./ha	7

GAP: Good Agricultural Practice; BBCH: growth stages of mono‐ and dicotyledonous plants; PHI: preharvest interval; NEU: northern European Union; SEU: southern European Union; a.i.: active ingredient; EC: emulsifiable concentrate; ME: microemulsion.

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)
	Fruit crops	Vine plants	Foliar, 1 × 300 g a.s./ha	14, 28
			Foliar, 1 × 3,000 g a.s./ha	14, 28
	Leafy crops	Lettuce	Foliar, 1 × 180 g a.s./ha	8
			Foliar, 1 × 1,800 g a.s./ha	8
	Pulses/oilseeds	Winter rape	Foliar, 1 × 120 g a.s./ha	56
			Foliar, 1 × 1,200 g a.s./ha	56
	Reference: Italy (2007)
Rotational crops (available studies)	Crop groups	Crop(s)	Application(s)	PBI (DAT)
	Root/tuber crops	Carrots	Bare soil, 311.8 g a.s./ha	28
	Leafy crops	Lettuce	Bare soil, 311.8 g a.s./ha	28
	Cereal (small grain)	Barley	Bare soil, 311.8 g a.s./ha	28
	Reference: Italy (2007)
Processed commodities (hydrolysis study)	Conditions			Investigated?
	Pasteurisation (20 min, 90°C, pH 4)			Yes
	Baking, brewing and boiling (60 min, 100°C, pH 5)			Yes
	Sterilisation (20 min, 120°C, pH 6)			Yes
	Available hydrolysis studies cover the stability of both etofenprox and alpha‐CO Reference: Italy (2007)

a.s.: active substance; DAT: days after treatment; PBI: plant‐back interval; GC–MS/MS: gas chromatography with tandem mass spectrometry; LC–MS/MS: liquid chromatography with tandem mass spectrometry; LOQ: limit of quantification; ILV: independent laboratory validation.

B.1.1.2. Stability of residues in plants

Plant products (available studies)	Category	Commodity	T (°C)	Stability (Months)
	High water content	Head cabbage	−20	24
		Peach, apple	−20	24
	High oil content	Oil seed rape	−20	24
	Dry/high starch	–	–	–
	High acid content	Grape	−20	24
	Reference: Italy (2007) Stability was investigated for etofenprox and alpha‐CO in the indicated commodities. A storage stability study in dry matrices is not available and is required

B.1.2. Magnitude of residues in plants

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

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)	HRMo (mg/kg)b	STMRMo (mg/kg)c	CFd
Citrus fruits	SEU	Mo: 0.249; 0.431; 0.276; 0.254; 0.492; 0.521 RA: 0.285; 0.524; 0.326; 0.277; 0.531; 0.543	Trials on oranges performed with 2 applications instead of 1 (Italy, 2016b). Grapefruits, lemons, limes, mandarins are extrapolated from oranges. Tentative extrapolation to citrus fruits is proposed	1.5e , f (tentative)	0.52	0.35	1.1
Hazelnuts/cobnuts, chestnuts and pine nut kernels	SEU	Mo: < 0.01; < 0.01 RA: < 0,02; < 0,02	Trials on hazelnuts compliant with GAP (Italy, 2012). Extrapolation to chestnuts and pine nut kernel (less critical GAP and residues < LOQ)	0.01*	0.01	0.01	1.0g
Apples, pears	SEU	Mo: 0.13; 0.27; 0.10; 0.34; 0.25; 0.20; 0.18; 0.22; 0.14; 0.37 RA: 0.15; 0.30; 0.11; 0.36; 0.29; 0.23; 0.21; 0.26; 0.16; 0.39	Trials on apples performed with dose rates within 25% deviation (Italy, 2016b). Extrapolation to pears possible	0.7	0.37	0.21	1.2
Cherries (sweet)	SEU	Mo: 0.22; 0.20; 0.31; 0.33 RA: –	Trials on cherries compliant with GAP (Italy, 2016b)	0.8 (tentative)f	0.33	0.27	1.2h
Peaches	SEU	Mo: 0.01; 0.08; 0.08; 0.14; 0.18; 0.18; 0.20; 0.23; 0.23; 0.37 RA: 0.03; 0.08; 0.08; 0.16; 0.20; 0.20; 0.22; 0.26; 0.28; 0.41	Trials on peaches according to GAP (Italy, 2007)	0.6	0.37	0.18	1.1
Apricots	SEU	Mo: 0.01; 0.08; 0.08; 0.14; 0.18; 0.18; 0.20; 0.23; 0.23; 0.37 RA: 0.03; 0.08; 0.08; 0.16; 0.20; 0.20; 0.22; 0.26; 0.28; 0.41	Trials on peaches according to GAP (Italy, 2007). Tentatively extrapolated to apricots	0.6f (tentative)	0.37	0.18	1.1
Plums	SEU	Mo: 0.03; 0.07 RA: 0.04; 0.08	Trials on plums compliant with GAP (Italy, 2012). Number of trials insufficient	–	–	–	–
Wine and table grapes	NEU	Mo: 0.20; 0.21; 0.26; 0.28; 0.32; 0.32; 0.35; 0.36 RA: 0.28; 0.26; 0.29; 0.33; 0.35; 0.36; 0.42; 0.38	Trials on grapes according to a more critical GAP with 2 applications instead of 1 (Italy, 2007). Not authorised for use on table grapes in NEU	0.9e (tentative)	0.36	0.30	1.2
	SEU	Mo: 0.29; 0.35; 0.38; 0.39; 0.39; 0.53; 0.96; 1.37 RA: 0.37; 0.38; 0.44; 0.53; 0.57; 0.59; 1.04; 1.68	Trials on grapes performed according to a more critical GAP (4 × 150 g a.i./ha instead of 1 × 150 g a.i./ha). Information on the sample storage conditions was not available and is still desirable (Italy, 2007)	3e (tentative)	1.37	0.39	1.2
Strawberries	SEU	–	No GAP‐compliant trials available	–	–	–	–
Blackberries	SEU	–	No trials available	–	–	–	–
Raspberries (red and yellow)	SEU	–	No trials available	–	–	–	–
Blueberries	SEU	–	No trials available	–	–	–	–
Currants (black, red and white)	SEU	–	No trials available	–	–	–	–
Gooseberries (green, red and yellow)	SEU	–	No trials available	–	–	–	–
Figs	SEU	–	No trials available	–	–	–	–
Kaki/Japanese persimmons	SEU	Mo: 0.17; 0.05; 0.31; 0.135 RA: –; –; –; 0.145	Trials on kaki compliant with GAP (3) (Italy, 2016b). Last trial performed with 2x application rate (Spain, 2016)	0.8e , f (tentative)	0.31	0.15	1.2i
Kiwi fruits (green, red, yellow)	SEU	Mo: 0.14; 0.15; 0.21; 0.36; 0.16; 0.58 RA: 0.15; 0.16; 0.22; 0.37; 0.17; 0.61	Trials on kiwi with an exaggerated application rate (210–240 g a.i./ha); last 2 trials with 2 applications instead of 1. Information on the sample storage conditions was not available (Italy, 2016b)	1e , f (tentative)	0.58	0.19	1.1
Granate apples/pomegranates	SEU	–	No trials available	–	–	–	–
Potatoes	SEU	Mo: < 0.01; < 0.01 RA: < 0.02; < 0.02	Trials on potatoes compliant with GAP (Italy, 2012)	0.01*	0.01	0.01	1.0g
Onions, garlic	SEU	Mo: < 0.01; < 0.01 RA: < 0.02; < 0.02	Trials on onions compliant with GAP (Italy, 2012). Extrapolation to garlic	0.01*	0.01	0.01	1.0g
Tomatoes	SEU	Mo: 0.13; 0.14; 0.20; 0.26; 0.4; 0.25; 0.14; 0.14; 0.24 RA: –	Combined data set on tomatoes compliant with GAP (2); overdosed 2 × 400 g a.i./ha (4); with 1 × 300 g a.i./ha (3) (Italy, 2016b)	0.7e (tentative)	0.40	0.20	1.2h
Aubergines/eggplants	SEU	–	No GAP compliant trials available	–	–	–	–
Sweet peppers/bell peppers	SEU	Mo: 0.71 RA: –	Trial on peppers compliant with GAP (Italy, 2016b). Number of trials insufficient	–	–	–	–
Melons	SEU	–	No GAP compliant trials available	–	–	–	–
Pumpkins	SEU	–	No trials available	–	–	–	–
Watermelons	SEU	–	No trials available	–	–	–	–
Broccoli, cauliflowers	NEU	Mo: < 0.005; < 0.01; 0.05; 0.028; 0.10; 0.11; 0.12; 0.20 RA: –	Combined data set on cauliflower (3) and broccoli (5) with 2 applications instead of 1 (Germany, 2016). Tentative extrapolation to flowering Brassica	0.4e (tentative)	0.20	0.08	1.2i
Brussels sprouts	SEU	–	No trials available	–	–	–	–
Head cabbages	NEU	Mo: < 0.005; 0.01; 0.02; 0.02; 0.14; 0.19; 0.37 RA: –	Trials on head cabbage with 2 applications instead of 1 (Germany, 2016)	0.7e , f (tentative)	0.37	0.08	1.2i
	SEU	Mo: < 0.01; < 0.01; < 0.01; < 0.01; 0.01; 0.01; < 0.04; 0.12 RA: < 0.01; < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; < 0.05; 0.14	Trials on head cabbage compliant with GAP (Italy, 2007; Greece, 2016). Information on the sample storage conditions was provided (6–12 months at −20°C) (Greece, 2016)	0.2	0.12	0.01	1.2
Lamb's lettuce, lettuces, escaroles, cresses, roman rockets, spinaches, chards, fresh herbs	SEU	No info on varieties: Mo: 1.06; 1.51 RA: –; – Head forming varieties: Mo: 0.27; 0.18; 0.47; 1.03 RA: –; –; 0.48; 1.05	Trials on lettuce compliant with GAP (Italy, 2016a). Tentatively extrapolated to other salad plants, spinaches, chards and fresh herbs	3e , f (tentative)	1.51	0.75	1.2i
Beans (with pods)	SEU	Mo: 0.028; 0.057; 0.15; 0.12 RA: 0.038; 0.067; 0.17; 0.13	GAP–compliant trials (only on whole pod) (Italy, 2016b)	0.4f (tentative)	0.15	0.09	1.2i
Beans (without pods)	SEU	–	No GAP‐compliant trials available	–	–	–	–
Lentils (fresh)	SEU	–	No trials available	–	–	–	–
Lupins/lupini beans (dry)	SEU	–	No trials available	–	–	–	–
Rapeseeds/canola seeds	NEU	Mo: < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; 0.02; 0.03 RA: –	GAP‐compliant trials on oilseed rape analysed for etofenprox only (7) (Czech Republic, 2016; Germany, 2016). A tentative MRL can be derived	0.04	0.03	0.01	1.1j
	SEU	Mo: < 0.01; < 0.01 RA: < 0.02; < 0.02	Trials on rapeseeds performed with 1 application instead of 2. This is acceptable since first application done at an early growth stage is not expected to have impact on final residue (France, 2016)	0.01*	0.01	0.01	1.0g
Borage seeds, gold of pleasure seeds, hemp seeds	NEU	Mo: < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; < 0.01 RA: < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; < 0.02	Trials on rapeseeds performed with 1 instead of 2 applications (Italy, 2007; France, 2016). This is acceptable since first application done at an early growth stage is not expected to have impact on final residue (France, 2016). Extrapolation to other oilseeds possible	0.01*	0.01	0.01	1.0g
	SEU	Mo: < 0.01; < 0.01 RA: < 0.02; < 0.02	Trials on rapeseeds performed with 1 application instead of 2. This is acceptable since first application done at an early growth stage is not expected to have impact on final residue (France, 2016). Extrapolation to other oilseeds possible	0.01*	0.01	0.01	1.0g
Olives for oil production, table olives	SEU	Mo: < 0.01; < 0.01 RA: < 0.02; < 0.02	Trials on olive compliant with GAP (Spain, 2016). Extrapolation to table olives possible	0.01*	0.01	0.01	1.0g
Maize/corn grains	SEU	–	No GAP‐compliant trials available	–	–	–	–
Rice grains	SEU	–	No GAP‐compliant trials available	–	–	–	–
Sugar beet roots	SEU	–	No trials available	–	–	–	–
Vetch forage	SEU	–	No GAP‐compliant trials available	–	–	–	–
Maize/corn stover	SEU	–	No trials available	–	–	–	–
Rice straw	SEU	–	No trials available	–	–	–	–
Sugar beet tops	SEU	–	No trials available	–	–	–	–

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

* Indicates that the MRL is proposed at the limit of quantification.

^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 according to the residue definition for monitoring.

^cSupervised trials median residue according to the residue definition for monitoring.

^dConversion factor for risk assessment; median of the individual conversion factors at the supported PHI for each residues trial.

^eTentative MRL derived from trials according to a more critical GAP.

^fTentative MRL derived from a reduced number of trials.

^gSince both parent and metabolite alpha‐CO were below the LOQ, a conversion factor of 1 is proposed for risk assessment.

^hIn absence of residue trials analysing simultaneously according to the residue definitions for enforcement and risk assessment, the highest conversion factor of 1.2 derived from other fruit crops is tentatively proposed for risk assessment.

ⁱIn absence of residue trials analysing simultaneously according to the residue definitions for enforcement and risk assessment, the highest conversion factor of 1.2 derived from other leafy crops is tentatively proposed for risk assessment.

^jIn absence of residue trials analysing simultaneously according to the residue definitions for enforcement and risk assessment, the conversion factor of 1.1 derived from the metabolism study on rapeseeds is tentatively proposed for risk assessment.

B.1.2.2. Residues in succeeding crops

B.1.2.3. Processing factors

Processed commodity	Number of studiesa	Processing factor (PF)		CFP b
		Individual values	Median PF
Robust processing factors (sufficiently supported by data)
Peach, puree	4	0.33; 0.68; 1.57; 9	1.13	1.2
Peach, juice	3	0.04; 0.04; 0.33	0.04c	1.7
Peach, jam	4	0.04; 0.4; 0.1; 4	0.07c	1.3
Apples, juice	3	0.05; 0.06; 0.08	0.06c	1
Wine grapes, juice	5	0.05; 0.07; 0.07; 0.08; 0.08	0.07c	1
Wine grapes, red wine (unheated)	3	0.05; 0.07; 0.08	0.07c	1
Indicative processing factors (limited dataset and/or residue analysed for parent only)
Peach, canned	1	0.1	0.1c	1
Peach, wet pomace	1	3.3	3.3	1.3
Peach, dry pomace	1	20	20	1.1
Tomato, juice	3	0.14; 0.21; 0.21	0.21c	1.2d
Tomato, puree	3	0.21; 0.25; 0.57	0.25c	1.2d
Tomato, preserve	3	0.07 0.21; 0.36	0.21c	1.2d
Apples, dry pomace	1	12.1	12.1	1.1
Apples, wet pomace	1	3.21	3.21	1.1
Table grapes, dried (raisins)	2	1.6; 2.5	2	1.1

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

^bConversion factor for risk assessment in the processed commodity; median of the individual conversion factors for each residues trial.

^cResidues were < LOQ in this processed item; therefore, the calculated processing factor (considering the LOQ of 0.01 mg/kg in processed items) may be overestimated.

^dIn the absence of residue trials analysing simultaneously according to the residue definitions for enforcement and risk assessment, the highest conversion factor of 1.2 derived from other raw fruit crops is tentatively proposed for risk assessment.

B.2. Residues in livestock

Relevant groups	Dietary burden expressed in				Most critical dieta	Most critical commoditya	Trigger exceeded (Y/N)
	mg/kg bw per day		mg/kg DM
	Med.	Max.	Med.	Max.
Cattle (all diets)	0.039	0.057	1.01	1.48	Cattle (dairy)	Grapefruits, dried pulp	Yes
Cattle (dairy only)	0.039	0.057	1.01	1.48	Cattle (dairy)	Grapefruits, dried pulp	Yes
Sheep (all diets)	0.011	0.021	0.26	0.50	Sheep (ram/ewe)	Cabbage, heads, leaves	Yes
Sheep (ewe only)	0.009	0.017	0.26	0.50	Sheep (ram/ewe)	Cabbage, heads, leaves	Yes
Swine (all diets)	0.017	0.022	0.74	0.97	Swine (breeding)	Grapefruits, dried pulp	Yes
Poultry (all diets)	0.003	0.011	0.04	0.16	Poultry (layer)	Cabbage, heads, leaves	Yes
Poultry (layer only)	0.003	0.011	0.04	0.16	Poultry (layer)	Cabbage, heads, leaves	Yes

bw: body weight; DM: dry matter.

^aCalculated for the maximum dietary burden.

B.2.1. Nature of residues and methods of analysis in livestock

B.2.1.1. Metabolism studies, methods of analysis and residue definitions in livestock

Livestock (available studies)	Animal	Dose (mg/kg bw per day)	Duration (days)	N rate/comment
	Laying hen	0.075; 0.75	14	6.8N; 68N; compared to poultry maximum dietary burden
	Lactating goat	0.075; 0.675	7	1.3N; 11.9N; compared to cattle all maximum dietary burden
	Reference: Italy (2007)

B.2.1.2. Stability of residues in livestock

Animal products (available studies)	Animal	Commodity	T (°C)	Stability (Months/years)
		Muscle	–	–
	Laying hena	Liver	−20	12
		Kidney	–	–
		Milk	–	–
		Egg	–	–
	Reference: Italy (2007) Storage stability studies on muscle, kidney, milk and egg are not available and required

^aIndirect evidence from laying hen metabolism study.

B.2.2. Magnitude of residues in livestock

B.2.2.1. Summary of the residue data from livestock feeding studies

Animal commodity	Residues at the closest feeding level (mg/kg)		Estimated value at 1N		MRL proposal (mg/kg)
	Mean	Highest	STMRa (mg/kg)	HRb (mg/kg)
Cattle (all diets) Closest feeding level (0.054 mg/kg bw; 0.95N rate)c
Muscle	< 0.05	< 0.05	0.05	0.05	0.06f , h (tentative)
Fat	0.743	1.89	0.55	1.91	2f , h (tentative)
Liver	< 0.05	< 0.05	0.05	0.057	0.06f , g (tentative)
Kidney	0.05	0.05	0.05	0.063	0.07f , g , h (tentative)
Cattle (dairy only) Closest feeding level (0.054 mg/kg bw; 0.95N rate)c
Milkd	0.05	n.a.	0.05	0.07	0.07f , h (tentative)
Sheep (all diets) e Closest feeding level (0.018 mg/kg bw; 0.9N rate)c
Muscle	< 0.05	< 0.05	0.05	0.05	0.05f , h (tentative)
Fat	0.74	1.89	0.17	1.10	1.5f , h (tentative)
Liver	< 0.05	< 0.05	0.05	0.05	0.05f , g (tentative)
Kidney	0.05	0.05	0.05	0.05	0.05f , g , h (tentative)
Sheep (dairy only) e Closest feeding level (0.018 mg/kg bw; 1.06N rate)c
Milkd	< 0.05	< 0.05	0.05*	0.05*	0.04f , h (tentative)
Swine e Closest feeding level (0.022 mg/kg bw; 0.8N rate)c
Muscle	< 0.05	< 0.05	0.05	0.05	0.05f , h (tentative)
Fat	0.743	1.89	0.45	1.11	1.5f , h (tentative)
Liver	< 0.05	< 0.05	0.05	0.05	0.05f , g (tentative)
kidney	0.05	0.05	0.05	0.05	0.05f , g , h (tentative)
Poultry (all diets) Closest feeding level (0.0675 mg/kg bw; 6.1N rate)c
Muscle	0.004	0.004	< 0.001	0.001	0.01*, f , h (tentative)
Fat	0.217	0.217	0.009	0.034	0.04f , h (tentative)
Liver	0.035	0.035	0.001	0.005	0.01*, f , g (tentative)
Poultry (layer only) Closest feeding level (0.0675 mg/kg bw; 6.1N rate)c
Egg	0.09	0.09	0.004	0.014	0.015f , g , h (tentative)

MRL: maximum residue level; STMR: supervised trials median residue; HR: highest residue; bw: body weight; n.a: not applicable.

* Indicates that the MRL is proposed at the limit of quantification.

^aAs the mean residue levels were not reported for tissues and eggs (minor deficiency), the mean residue level for milk and the highest residue levels for eggs and tissues were recalculated at the 1N rate for the median dietary burden.

^bThe mean residue level in milk and the highest residue levels in eggs and tissues were recalculated at the 1N rate for the maximum dietary burden.

^cClosest feeding level and N dose rate related to the maximum dietary burden.

^dHighest residue level from day 1 to day 28 (daily mean of 3 cows).

^eSince extrapolation from cattle to other ruminants and swine is acceptable, results of the livestock feeding study on ruminants were relied upon to derive the MRL and risk assessment values in sheep and swine.

^fIn the absence of metabolism studies investigating etofenprox and alpha‐CO only tentative MRLs can be derived.

^gMRL proposal is tentative because a validated analytical method for enforcement is not available.

^hMRL proposal is tentative because a storage stability study is not available.

B.3. Consumer risk assessment

B.3.1. Consumer risk assessment without consideration of the existing CXLs

B.3.2. Consumer risk assessment with consideration of the existing CXLs

B.4. Proposed MRLs

Code numbera	Commodity	Existing EU MRL (mg/kg)	Existing CXL (mg/kg)	Outcome of the review
				MRL (mg/kg)	Comment
Enforcement residue definition: EtofenproxF
110010	Grapefruits	1	–	1.5	Further consideration neededb
110020	Oranges	1	–	1.5	Further consideration neededb
110030	Lemons	1	–	1.5	Further consideration neededb
110040	Limes	1	–	1.5	Further consideration neededb
110050	Mandarins	1	–	1.5	Further consideration neededb
120040	Chestnuts	0.5	–	0.01*	Recommendedc
120060	Hazelnuts/cobnuts	0.5	–	0.01*	Recommendedc
120090	Pine nut kernels	0.01*	–	0.01*	Recommendedc
130010	Apples	1	0.6	0.7	Recommendedd
130020	Pears	1	0.6	0.7	Recommendedd
140010	Apricots	1	–	0.6	Further consideration neededb
140020	Cherries (sweet)	1	–	0.8	Further consideration neededb
140030	Peaches	0.6	0.6	0.6	Recommendedd
140040	Plums	1	–	1	Further consideration needede
151010	Table grapes	5	4	4	Further consideration neededf
151020	Wine grapes	5	4	4	Further consideration neededf
152000	Strawberries	1	–	1	Further consideration needede
153010	Blackberries	1	–	1	Further consideration needede
153030	Raspberries (red and yellow)	1	–	1	Further consideration needede
154010	Blueberries	1	–	1	Further consideration needede
154030	Currants (black, red and white)	1	–	1	Further consideration needede
154040	Gooseberries (green, red and yellow)	1	–	1	Further consideration needede
161020	Figs	1	–	1	Further consideration needede
161030	Table olives	0.01*	–	0.01*	Recommendedc
161060	Kaki/Japanese persimmons	1	–	0.8	Further consideration neededb
162010	Kiwi fruits (green, red, yellow)	1	–	1	Further consideration neededb
163050	Granate apples/pomegranates	1	–	1	Further consideration needede
211000	Potatoes	0.5	–	0.01*	Recommendedc
220010	Garlic	0.5	–	0.01*	Recommendedc
220020	Onions	0.5	–	0.01*	Recommendedc
231010	Tomatoes	1	–	0.7	Further consideration neededb
231020	Sweet peppers/bell peppers	2	–	2	Further consideration needede
231030	Aubergines/eggplants	0.5	–	0.5	Further consideration needede
233010	Melons	0.5	–	0.5	Further consideration needede
233020	Pumpkins	0.5	–	0.5	Further consideration needede
233030	Watermelons	0.5	–	0.5	Further consideration needede
241010	Broccoli	0.2	–	0.4	Further consideration neededb
241020	Cauliflowers	0.2	–	0.4	Further consideration neededb
242010	Brussels sprouts	2	–	2	Further consideration needede
242020	Head cabbages	2	–	0.7	Further consideration neededb
251010	Lamb's lettuces/corn salads	3	–	3	Further consideration neededb
251020	Lettuces	3	–	3	Further consideration neededb
251030	Escaroles/broad‐leaved endives	3	–	3	Further consideration neededb
251040	Cresses and other sprouts and shoots	3	–	3	Further consideration neededb
251060	Roman rocket/rucola	3	–	3	Further consideration neededb
252010	Spinaches	3	–	3	Further consideration neededb
252030	Chards/beet leaves	3	–	3	Further consideration neededb
256010	Chervil	3	–	3	Further consideration neededb
256020	Chives	3	–	3	Further consideration neededb
256030	Celery leaves	3	–	3	Further consideration neededb
256040	Parsley	3	–	3	Further consideration neededb
256050	Sage	3	–	3	Further consideration neededb
256060	Rosemary	3	–	3	Further consideration neededb
256070	Thyme	3	–	3	Further consideration neededb
256080	Basil and edible flowers	3	–	3	Further consideration neededb
256090	Laurel/bay leave	3	–	3	Further consideration neededb
256100	Tarragon	3	–	3	Further consideration neededb
260010	Beans (with pods)	0.5	–	0.4	Further consideration neededb
260020	Beans (without pods)	0.5	–	0.5	Further consideration needede
260050	Lentils (fresh)	0.01*	–	0.01*	Further consideration needede
300010	Beans (dry)	0.05	0.05	0.05	Further consideration neededg
300040	Lupins/lupini beans (dry)	0.5		0.5	Further consideration needede
401010	Linseeds	0.01*	–	0.01*	Recommendedc
401040	Sesame seeds	0.01*	–	0.01*	Recommendedc
401060	Rapeseeds/canola seeds	0.05	0.01*	0.05	Further consideration neededh
401080	Mustard seeds	0.01*	–	0.01*	Recommendedc
401120	Borage seeds	0.01*	–	0.01*	Recommendedc
401130	Gold of pleasure seeds	0.01*	–	0.01*	Recommendedc
401140	Hemp seeds	0.01*	–	0.01*	Recommendedc
402010	Olives for oil production	0.01*	–	0.01*	Recommendedc
500030	Maize/corn grains	0.5	0.05*	0.5	Further consideration neededi
500060	Rice grains	0.5	0.01*	0.5	Further consideration neededi
900010	Sugar beet roots	0.5	–	0.5	Further consideration needede
1011010	Swine muscle	0.5	0.03*	0.05	Further consideration neededh
1011020	Swine fat tissue	0.5	0.5	1.5	Further consideration neededh
1011030	Swine liver	0.5	0.05	0.05	Further consideration neededh
1011040	Swine kidney	0.5	0.05	0.05	Further consideration neededh
1012010	Bovine muscle	0.5	0.03*	0.06	Further consideration neededh
1012020	Bovine fat tissue	0.5	0.5	2	Further consideration neededh
1012030	Bovine liver	0.5	0.05	0.06	Further consideration neededh
1012040	Bovine kidney	0.5	0.05	0.07	Further consideration neededh
1013010	Sheep muscle	0.5	0.03*	0.05	Further consideration neededh
1013020	Sheep fat tissue	0.5	0.5	1.5	Further consideration neededh
1013030	Sheep liver	0.5	0.05	0.05	Further consideration neededh
1013040	Sheep kidney	0.5	0.05	0.05	Further consideration neededh
1014010	Goat muscle	0.5	0.03*	0.05	Further consideration neededh
1014020	Goat fat tissue	0.5	0.5	1.5	Further consideration neededh
1014030	Goat liver	0.5	0.05	0.05	Further consideration neededh
1014040	Goat kidney	0.5	0.05	0.05	Further consideration neededh
1015010	Equine muscle	0.5	0.03*	0.06	Further consideration neededh
1015020	Equine fat tissue	0.5	0.5	2	Further consideration neededh
1015030	Equine liver	0.5	0.05	0.06	Further consideration neededh
1015040	Equine kidney	0.5	0.05	0.07	Further consideration neededh
1016010	Poultry muscle	0.01*	0.01*	0.01*	Further consideration neededh
1016020	Poultry fat tissue	0.01*	0.01*	0.04	Further consideration neededh
1016030	Poultry liver	0.01*	0.01*	0.01*	Further consideration neededh
1020010	Cattle milk	0.05	0.02	0.07	Further consideration neededh
1020020	Sheep milk	0.05	0.02	0.04	Further consideration neededh
1020030	Goat milk	0.05	0.02	0.04	Further consideration neededh
1020040	Horse milk	0.05	0.02	0.07	Further consideration neededh
1030000	Birds eggs	0.01*	0.01*	0.015	Further consideration neededh
	Other commodities of plant and animal origin	Regulation (EC) No 149/2008			Further consideration neededj

MRL: maximum residue level; CXL: codex maximum residue limit.

* Indicates that the MRL is set/proposed at the limit of quantification.

F Residue is fat soluble.

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

^bTentative MRL is derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk to consumers was identified (assuming the existing residue definition); no CXL is available (combination E‐I in Appendix E).

^cMRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to consumers is identified; no CXL is available (combination G‐I in Appendix E).

^dMRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to consumers is identified; existing CXL is covered by the recommended MRL (combination G‐III in Appendix E).

^eGAP evaluated at EU level is not supported by data but no risk to consumers was identified for the existing EU MRL (also assuming the existing residue definition); no CXL is available (combination C‐I in Appendix E).

^fMRL is derived from the existing CXL, which is not sufficiently supported by data but for which no risk to consumers is identified (assuming the existing residue definition); GAP evaluated at EU level, which is also not fully supported by data, would lead to a lower tentative MRL (combination E‐V in Appendix E).

^gMRL is derived from the existing CXL, which is not sufficiently supported by data but for which no risk to consumers is identified (assuming the existing residue definition); there are no relevant authorisations or import tolerances reported at EU level (combination A‐V in Appendix E).

^hTentative MRL is derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk to consumers was identified (assuming the existing residue definition); existing CXL is covered by the tentative MRL (combination E‐III in Appendix E).

ⁱGAP evaluated at EU level is not supported by data but no risk to consumers was identified for the existing EU MRL (also assuming the existing residue definition); existing CXL is covered by the existing EU MRL (combination C‐III in Appendix E).

^jThere are no relevant authorisations or import tolerances reported at EU level; no CXL is available. Either a specific LOQ or the default MRL of 0.01 mg/kg may be considered (combination A‐I in Appendix E).

Appendix C – Pesticide Residue Intake Model (PRIMo)

C.1. PRIMo (EU)

C.2. PRIMo (CXL)

Appendix D – Input values for the exposure calculations

D.1. Livestock dietary burden calculations

Feed commodity	Median dietary burden		Maximum dietary burden
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Risk assessment residue definition: sum of etofenprox and alpha‐CO, expressed as etofenprox
Grapefruits, dried pulp	3.95	STMR × CF × 10 (tentative)	3.95	STMR × CF × 10 (tentative)
Oranges, dried pulp	3.95	STMR × CF × 10 (tentative)	3.95	STMR × CF × 10 (tentative)
Lemons, dried pulp	3.95	STMR × CF × 10 (tentative)	3.95	STMR × CF × 10 (tentative)
Limes, dried pulp	3.95	STMR × CF × 10 (tentative)	3.95	STMR × CF × 10 (tentative)
Mandarins, dried pulp	3.95	STMR × CF × 10 (tentative)	3.95	STMR × CF × 10 (tentative)
Apple, pomace, wet	0.74	STMR × CF × PF (tentative)	0.74	STMR × CF × PF (tentative)
Potato, culls	0.01*	STMR × CF	0.01*	HR × CF
Potato, process waste	0.01*	STMRa × CF	0.01*	STMRa × CF
Potato, dried pulp	0.01*	STMRa × CF	0.01*	STMRa × CF
Cabbage, heads, leaves	0.10	STMR × CF (tentative)	0.44	HR × CF (tentative)
Flaxseed/Linseed, meal	0.01*	STMRa	0.01*	STMRa
Canola (Rapeseed), meal	0.02	STMRb × CF	0.02	STMRb × CF
Rape, meal	0.02	STMRb × CF	0.02	STMRb × CF

STMR: supervised trials median residue; HR: highest residue; PF: processing factor.

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

^aFor potatoes by‐products and linseed meal, no default processing factor was applied because etofenprox is applied early in the growing season and residues are expected to be below the LOQ in the raw commodities. Concentration of residues in these commodities is therefore not expected.

^bFor canola and rape meal, in the absence of processing factors supported by data, a default processing factor of 2 was included in the calculation to consider the potential concentration of residues in these commodities.

D.2. Consumer risk assessment without consideration of the existing CXLs

Commodity	Chronic risk assessment		Acute risk assessment
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Risk assessment residue definition for plant commodities: Sum of etofenprox plus alpha‐CO, expressed as etofenprox
Citrus fruits	0.40	STMR × CF (tentative)	0.58	HR × CF (tentative)
Chestnuts Hazelnuts/cobnuts Pine nut kernels	0.01*	STMR × CF	0.01*	HR × CF
Apples, pears	0.24	STMR × CF	0.42	HR × CF
Apricots	0.20	STMR × CF (tentative)	0.41	HR × CF (tentative)
Cherries (sweet)	0.32	STMR × CF (tentative)	0.40	HR × CF (tentative)
Peaches	0.20	STMR × CF	0.41	HR × CF
Plums	1.20	EU MRL × CF (tentative)	1.20	EU MRL × CF (tentative)
Table grapes, wine grapes	0.46	STMR × CF (tentative)	1.63	HR × CF (tentative)
Strawberries Blackberries Raspberries Blueberries Currants Gooseberries	1.20	EU MRL × CF (tentative)	1.20	EU MRL × CF (tentative)
Figs	1.20	EU MRL × CF (tentative)	1.20	EU MRL × CF (tentative)
Table olives	0.01*	STMR × CF	0.01*	HR × CF
Kaki/Japanese persimmons	0.18	STMR × CF (tentative)	0.37	HR × CF (tentative)
Kiwi fruits (green, red, yellow)	0.20	STMR × CF (tentative)	0.61	HR × CF (tentative)
Granate apples/pomegranates	1.20	EU MRL × CF (tentative)	1.20	EU MRL × CF (tentative)
Potatoes	0.01*	STMR × CF	0.01*	HR × CF
Garlic	0.01*	STMR × CF	0.01*	HR × CF
Onions	0.01*	STMR × CF	0.01*	HR × CF
Tomatoes	0.24	STMR × CF (tentative)	0.48	HR × CF (tentative)
Sweet peppers/bell peppers	2.40	EU MRL × CF (tentative)	2.40	EU MRL × CF (tentative)
Aubergines/eggplants	0.6	EU MRL × CF (tentative)	0.6	EU MRL × CF (tentative)
Melons	0.60	EU MRL × CF (tentative)	0.60	EU MRL × CF (tentative)
Pumpkins	0.60	EU MRL × CF (tentative)	0.60	EU MRL × CF (tentative)
Watermelons	0.60	EU MRL × CF (tentative)	0.60	EU MRL × CF (tentative)
Broccoli	0.09	STMR × CF (tentative)	0.24	HR × CF (tentative)
Cauliflowers	0.09	STMR × CF (tentative)	0.24	HR × CF (tentative)
Brussels sprouts	2.40	EU MRL × CF (tentative)	2.40	EU MRL × CF (tentative)
Head cabbages	0.10	STMR × CF (tentative)	0.44	HR × CF (tentative)
Lettuces, lambs lettuce, escaroles, cresses, roman rocket, spinaches, chards, fresh herbs	0.90	STMR × CF (tentative)	1.81	HR × CF (tentative)
Beans (with pods)	0.1	STMR × CF (tentative)	0.17	HR × CF (tentative)
Beans (without pods) Lentils fresh Lupins	0.06	EU MRL × CF (tentative)	0.06	EU MRL × CF (tentative)
Linseeds	0.01*	STMR × CF	0.01*	HR × CF
Sesame seeds	0.01*	STMR × CF	0.01*	HR × CF
Rapeseeds/canola seeds	0.01	STMR × CF (tentative)	0.03	HR × CF (tentative)
Mustard seeds	0.01*	STMR × CF	0.01*	HR × CF
Borage seeds	0.01*	STMR × CF	0.01*	HR × CF
Gold of pleasure seeds	0.01*	STMR × CF	0.01*	HR × CF
Hemp seeds	0.01*	STMR × CF	0.01*	HR × CF
Olives for oil production	0.01*	STMR × CF	0.01*	HR × CF
Maize corn grains, rice grains	1.00	EU MRL × CF (tentative)	1.00	EU MRL × CF (tentative)
Sugar beet roots	0.5	EU MRL × CF (tentative)	0.5	EU MRL × CF (tentative)
Risk assessment residue definition for animal commodities: etofenprox
Swine meat	0.13	0.8 × STMR muscle + 0.2 × STMR fat (tentative)	0.26	0.8 × HR muscle + 0.2 × STMR fat (tentative)
Swine fat tissue	0.45	STMR (tentative)	1.11	HR (tentative)
Swine liver	0.05	STMR (tentative)	0.05	HR (tentative)
Swine kidney	0.05	STMR (tentative)	0.05	HR (tentative)
Bovine meat	0.15	0.8 × STMR muscle + 0.2 × STMR fat (tentative)	0.43	0.8 × HR muscle + 0.2 × HR fat (tentative)
Bovine fat tissue	0.55	STMR (tentative)	1.91	HR (tentative)
Bovine liver	0.05	STMR (tentative)	0.06	HR (tentative)
Bovine kidney	0.05	STMR (tentative)	0.06	HR (tentative)
Sheep meat	0.07	0.8 × STMR muscle + 0.2 × STMR fat (tentative)	0.26	0.8 × HR muscle + 0.2 × HR fat (tentative)
Sheep fat tissue	0.17	STMR (tentative)	1.10	HR (tentative)
Sheep liver	0.05	STMR (tentative)	0.05	HR (tentative)
Sheep kidney	0.05	STMR (tentative)	0.05	HR (tentative)
Goat meat	0.07	0.8 × STMR muscle + 0.2 × STMR fat	0.26	0.8 × HR muscle + 0.2 × HR fat
Goat fat tissue	0.17	STMR (tentative)	1.10	HR (tentative)
Goat liver	0.05	STMR (tentative)	0.05	HR (tentative)
Goat kidney	0.05	STMR (tentative)	0.05	HR (tentative)
Equine meat	0.15	0.8 × STMR muscle + 0.2 × STMR fat (tentative)	0.43	0.8 × HR muscle + 0.2 × HR fat (tentative)
Equine fat tissue	0.55	STMR (tentative)	1.91	HR (tentative)
Equine liver	0.05	STMR (tentative)	0.06	HR (tentative)
Equine kidney	0.05	STMR (tentative)	0.06	HR (tentative)
Poultry meat	0.001	0.9 × STMR muscle + 0.1 × STMR fat (tentative)	0.004	0.9 × HR muscle + 0.1 × HR fat (tentative)
Poultry fat tissue	0.009	STMR (tentative)	0.03	HR (tentative)
Poultry liver	0.001	STMR (tentative)	0.005	HR (tentative)
Cattle milk	0.05	STMR (tentative)	0.07	HR (tentative)
Sheep milk	0.05	STMR (tentative)	0.04	HR (tentative)
Goat milk	0.05	STMR (tentative)	0.04	HR (tentative)
Horse milk	0.05	STMR (tentative)	0.07	HR (tentative)
Birds eggs	0.004	STMR (tentative)	0.014	HR (tentative)

STMR: supervised trials median residue; HR: highest residue; CF: conversion factor for enforcement residue definition to risk assessment residue definition; MRL: maximum residue level.

* Indicates that the input value is proposed at the limit of quantification. HR (tentative).

D.3. Consumer risk assessment with consideration of the existing CXLs

Commodity	Chronic risk assessment		Acute risk assessment
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Risk assessment residue definition for plant commodities: Sum of etofenprox plus alpha‐CO, expressed as etofenprox
Citrus fruits	0.40	STMR × CF (tentative)	0.58	HR × CF (tentative)
Chestnuts, Hazelnuts, cobnuts, Pine nut kernels	0.01*	STMR × CF	0.01*	HR × CF
Apples, pears	0.24	STMR × CF	0.42	HR × CF
Apricots	0.20	STMR × CF (tentative)	0.41	HR × CF (tentative)
Cherries (sweet)	0.32	STMR × CF (tentative)	0.40	HR × CF (tentative)
Peaches	0.20	STMR × CF	0.41	HR × CF
Plums	1.20	EU MRL × CF (tentative)	1.20	EU MRL × CF (tentative)
Table grapes, wine grapes	0.88	STMR × CF (CXL, tentative)	3.12	HR × CF (CXL, tentative)
Strawberries Blackberries Raspberries Blueberries Currants Gooseberries	1.20	EU MRL × CF (tentative)	1.20	EU MRL × CF (tentative)
Figs	1.20	EU MRL × CF (tentative)	1.20	EU MRL × CF (tentative)
Table olives	0.01*	STMR × CF	0.01*	HR × CF
Kaki/Japanese persimmons	0.18	STMR × CF (tentative)	0.37	HR × CF (tentative)
Kiwi fruits (green, red, yellow)	0.20	STMR × CF (tentative)	0.61	HR × CF (tentative)
Granate apples/pomegranates	1.20	EU MRL × CF (tentative)	1.20	EU MRL × CF (tentative)
Potatoes	0.01*	STMR × CF	0.01*	HR × CF
Garlic	0.01*	STMR × CF	0.01*	HR × CF
Onions	0.01*	STMR × CF	0.01*	HR × CF
Tomatoes	0.24	STMR × CF (tentative)	0.48	HR × CF (tentative)
Sweet peppers/bell peppers	2.40	EU MRL × CF (tentative)	2.40	EU MRL × CF (tentative)
Aubergines/eggplants	0.60	EU MRL × CF (tentative)	0.60	EU MRL × CF (tentative)
Melons	0.60	EU MRL × CF (tentative)	0.60	EU MRL × CF (tentative)
Pumpkins	0.60	EU MRL × CF (tentative)	0.60	EU MRL × CF (tentative)
Watermelons	0.60	EU MRL × CF (tentative)	0.60	EU MRL × CF (tentative)
Broccoli	0.09	STMR × CF (tentative)	0.24	HR × CF (tentative)
Cauliflowers	0.09	STMR × CF (tentative)	0.24	HR × CF (tentative)
Brussels sprouts	2.40	EU MRL × CF (tentative)	2.40	EU MRL × CF (tentative)
Head cabbages	0.10	STMR × CF (tentative)	0.44	HR × CF (tentative)
Lettuces, lambs lettuce, escaroles, cresses, roman rocket, spinaches, chards, fresh herbs	0.9	STMR × CF (tentative)	1.81	HR × CF (tentative)
Beans (with pods)	0.10	STMR × CF (tentative)	0.17	HR × CF (tentative)
Beans (without pods) Lentils (fresh) Lupins (dry)	0.06	EU MRL × CF (tentative)	0.06	EU MRL × CF (tentative)
Beans (dry)	0.06	STMR × CF (CXL, tentative)	0.06	HR × CF (CXL, tentative)
Linseeds	0.01*	STMR × CF	0.01*	HR × CF
Sesame seeds	0.01*	STMR × CF	0.01*	HR × CF
Rapeseeds/canola seeds	0.01	STMR × CF (tentative)	0.03	HR × CF (tentative)
Mustard seeds	0.01*	STMR × CF	0.01*	HR × CF
Borage seeds	0.01*	STMR × CF	0.01*	HR × CF
Gold of pleasure seeds	0.01*	STMR × CF	0.01*	HR × CF
Hemp seeds	0.01*	STMR × CF	0.01*	HR × CF
Olives for oil production	0.01*	STMR × CF	0.01*	HR × CF
Maize corn grains, rice grains	1.00	EU MRL × CF (tentative)	1.00	EU MRL × CF (tentative)
Sugar beet roots	0.5	EU MRL × CF (tentative)	0.5	EU MRL × CF (tentative)
Risk assessment residue definition for animal commodities: etofenprox
Swine meat	0.13	0.8 × STMR muscle + 0.2 × STMR fat (tentative)	0.26	0.8 × HR muscle + 0.2 × STMR fat (tentative)
Swine fat tissue	0.45	STMR (tentative)	1.11	HR (tentative)
Swine liver	0.05	STMR (tentative)	0.05	HR (tentative)
Swine kidney	0.05	STMR (tentative)	0.05	HR (tentative)
Bovine meat	0.15	0.8 × STMR muscle + 0.2 × STMR fat (tentative)	0.43	0.8 × HR muscle + 0.2 × HR fat (tentative)
Bovine fat tissue	0.55	STMR (tentative)	1.91	HR (tentative)
Bovine liver	0.05	STMR (tentative)	0.06	HR (tentative)
Bovine kidney	0.05	STMR (tentative)	0.06	HR (tentative)
Sheep meat	0.07	0.8 × STMR muscle + 0.2 × STMR fat (tentative)	0.26	0.8 × HR muscle + 0.2 × HR fat (tentative)
Sheep fat tissue	0.17	STMR (tentative)	1.10	HR (tentative)
Sheep liver	0.05	STMR (tentative)	0.05	HR (tentative)
Sheep kidney	0.05	STMR (tentative)	0.05	HR (tentative)
Goat meat	0.07	0.8 × STMR muscle + 0.2 × STMR fat (tentative)	0.26	0.8 × HR muscle + 0.2 × HR fat (tentative)
Goat fat tissue	0.17	STMR (tentative)	1.10	HR (tentative)
Goat liver	0.05	STMR (tentative)	0.05	HR (tentative)
Goat kidney	0.05	STMR (tentative)	0.05	HR (tentative)
Equine meat	0.15	0.8 × STMR muscle + 0.2 × STMR fat (tentative)	0.43	0.8 × HR muscle + 0.2 × HR fat (tentative)
Equine fat tissue	0.55	STMR (tentative)	1.91	HR (tentative)
Equine liver	0.05	STMR (tentative)	0.06	HR (tentative)
Equine kidney	0.05	STMR (tentative)	0.06	HR (tentative)
Poultry meat	0.001	0.9 × STMR muscle + 0.1 × STMR fat (tentative)	0.004	0.9 × HR muscle + 0.1 × HR fat (tentative)
Poultry fat tissue	0.009	STMR (tentative)	0.03	HR (tentative)
Poultry liver	0.001	STMR (tentative)	0.005	HR (tentative)
Cattle milk	0.05	STMR (tentative)	0.07	HR (tentative)
Sheep milk	0.05	STMR (tentative)	0.04	HR (tentative)
Goat milk	0.05	STMR (tentative)	0.04	HR (tentative)
Horse milk	0.05	STMR (tentative)	0.07	HR (tentative)
Birds eggs	0.004	STMR (tentative)	0.014	HR (tentative)

STMR: supervised trials median residue; HR: highest residue; CF: conversion factor for enforcement residue definition to risk assessment residue definition; MRL: maximum residue level.

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

Appendix E – Decision tree for deriving MRL recommendations

Appendix F – Used compound codes

Code/trivial name	Chemical name/SMILES notation	Structural formula
Etofenprox	2‐(4‐ethoxyphenyl)‐2‐methylpropyl 3‐phenoxybenzyl ether CCOc1ccc(cc1)C(C)(C)COCc3cc(Oc2ccccc2)ccc3
alpha‐CO	2‐(4‐ethoxyphenyl)‐2‐methylpropyl 3‐phenoxybenzoate CCOc1ccc(cc1)C(C)(C)COC(=O)c3cc(Oc2ccccc2)ccc3

SMILES: simplified molecular‐input line‐entry system.

Suggested citation: EFSA (European Food Safety Authority) , Brancato A, Brocca D, De Lentdecker C, Erdos Z, Ferreira L, Greco L, Jarrah S, Kardassi D, Leuschner R, Lythgo C, Medina P, Miron I, Molnar T, Nougadere A, Pedersen R, Reich H, Sacchi A, Santos M, Stanek A, Sturma J, Tarazona J, Theobald A, Vagenende B, Verani A and Villamar‐Bouza L, 2017. Reasoned opinion on the review of the existing maximum residue levels for etofenprox according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2017;15(8):4964, 57 pp. 10.2903/j.efsa.2017.4964