Modification of the existing maximum residue level for methoxyfenozide in aubergines

Abstract

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

SUMMARY

In accordance with Article 6 of Regulation (EC) No 396/2005, the Federal PublicService (FPS) Health, Food chain Safety and Environment submitted a request on behalf of Belgium (evaluating Member State, EMS) to modify the existing maximum residue level (MRL) for the active substance methoxyfenozide in aubergines/eggplants.

The application, alongside the dossier containing the supporting data in IUCLID format, was submitted through the European Food Safety Authority (EFSA) Central Submission System on 13 December 2023. The EMS Belgium assessed the dossier and declared its admissibility on 29 February 2024. Subsequently, following the implementation of the EFSA's confidentiality decision, the non-confidential version of the dossier was published by EFSA, and a public consultation launched on the dossier. The consultation aimed to consult stakeholders and the public on the scientific data, studies and other information part of, or supporting, the submitted application, in order to identify whether other relevant scientific data or studies are available. The consultation run from 21 March 2024 to 11 April 2024. No additional data nor comments were submitted in the framework of the consultation.

At the end of the commenting period, the EMS proceeded drafting the evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and to EFSA on 12 April 2024. To accommodate for the intended use of methoxyfenozide, the EMS proposed to lower the existing (tentative) MRL from 0.6 mg/kg to 0.3 mg/kg.

On 22 April 2024, the European Commission sent a mandate to EFSA to assess the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified points which needed further clarification and requested the EMS to address them. The applicant provided the requested information in an updated IUCLID dossier. The additional information was duly considered by the EMS who submitted a revised evaluation report to EFSA on 3 June 2024, which replaced the previously submitted evaluation report.

Based on the conclusions derived by EFSA in the framework of Regulation (EC) No 1107/2009, the data evaluated under previous MRL assessments and the additional data provided by the EMS in the framework of this application, the following conclusions are derived.

The metabolism of methoxyfenozide following foliar applications was investigated in primary crops belonging to the groups of fruit crops, cereals/grass, pulses/oilseeds. The metabolism of methoxyfenozide in rotational crops was investigated in leafy crops, root/tuber crops and cereals after bare soil applications. Studies investigating the effect of processing on the nature of methoxyfenozide (hydrolysis studies) demonstrated that the active substance is stable under standard hydrolysis conditions.

Based on the metabolic pattern identified in metabolism studies, hydrolysis studies and the toxicological relevance of metabolites, the residue definitions for plant products were proposed as ‘methoxyfenozide’ for enforcement and risk assessment. These residue definitions are applicable to primary crops and processed products. For rotational crops, the residue definition for enforcement is ‘methoxyfenozide’. In the framework of the EU pesticides peer review for the renewal of the approval, a specific residue definition was set provisionally for risk assessment in rotational crops as: ‘methoxyfenozide plus M14 and its conjugates (M15 and M40), expressed as methoxyfenozide’.

EFSA concluded that for the commodity assessed in this application, metabolism of methoxyfenozide in primary crops and the possible degradation in processed products have been sufficiently addressed and that the previously derived residue definitions are applicable. As the proposed use of methoxyfenozide is on aubergines cultivated indoor on substrates that are removed/changed at each cycle of crop cultivation, investigations of residues in rotational crops are not required in the framework of the current application.

Sufficiently validated analytical methods based on high-performance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS) are available to quantify residues of methoxyfenozide in the commodity assessed in this application according to the enforcement residue definition. The method enables the quantification of residues at or above 0.01 mg/kg (LOQ) in the crop assessed (high water content matrix). Extraction efficiency of the methods proposed for enforcement (coded 120948 and 120633) has been proven in high water content commodities.

The available residue trials are sufficient to derive an MRL proposal of 0.3 mg/kg for aubergines/eggplants by extrapolation from residue trials on tomatoes based on the intended indoor good agricultural practice (GAP).

Specific studies investigating the magnitude of methoxyfenozide residues in processed commodities to refine the dietary exposure calculation are not necessary for the crop under assessment according to the OECD Guidance on the magnitude of pesticide residues in processed commodities.

Residues of methoxyfenozide in commodities of animal origin and fish were not assessed since the commodity under consideration in this MRL application is normally not fed to livestock or used in aquaculture.

As the proposed use of methoxyfenozide is intended on aubergines grown under greenhouse conditions, investigation of residues in honey is not required, considering that honey bees are normally not used for pollination services in greenhouses and are not expected to forage in closed structures. Furthermore, the same indoor use on aubergines with one application was previously assessed by EFSA during the EU pesticides peer review of the renewal of approval and the exposure of methoxyfenozide to honey bees was considered very limited.

The toxicological profile of methoxyfenozide was assessed in the framework of EU pesticides peer review of the renewal of approval of the active substance methoxyfenozide under Regulation (EC) No 1107/2009 and the data were sufficient to derive an acceptable daily intake (ADI) of 0.1 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 0.1 mg/kg bw. The metabolites M14 and its conjugates (M15 and M40), which are included in the provisional residue definition for risk assessment in rotational crops and the metabolites M24 and its conjugate (M26) and M16, which are included in the provisional residue definition for risk assessment in products of animal origin, were concluded to be of similar toxicity as the parent active substance.

The consumer risk assessment was performed with revision 3.1 of the EFSA Pesticide Residues Intake Model (PRIMo). The short-term exposure assessment was performed only for the commodity assessed in the present MRL application and did not exceed the ARfD. For the calculation of the chronic exposure, EFSA used the median residue value (STMR) for aubergines as derived from the submitted residue trials and the STMR values derived in the MRL review, some of which needed to be reconsidered in the refined calculations performed under the following focused assessment of certain existing MRLs of concern for methoxyfenozide. In addition, the STMR values derived in support of Codex MRLs (CXLs) assessed by EFSA after the MRL review and implemented in the EU MRL legislation were used. The estimated long-term dietary intake is based on the residue definition of sole parent compound and accounted for a maximum of 6% of the ADI (IE adult diet), with aubergines contributing for a maximum of 0.02%. Pending the assessment of further data on the metabolites included in the provisional risk assessment residue definition for rotational crops and for livestock in the framework of the EU pesticides peer review, the chronic consumer risk assessment shall be regarded as indicative and affected by non-standard uncertainties.

EFSA concluded that the proposed indoor use of methoxyfenozide on aubergines/eggplants grown in substrates that are removed/changed at each cycle of crop cultivation will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers' health.

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

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

Codea	Commodity	Existing/bEU MRL (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: MethoxyfenozideF
0231030	Aubergines/eggplants	0.6 (ft)/0.01*	0.3	The submitted data are sufficient to derive an MRL proposal for the intended indoor EU use by extrapolation form residue data on tomatoes. Risk for consumers unlikely

ASSESSMENT

The European Food Safety Authority (EFSA) received an application to modify the existing maximum residue level (MRL) for methoxyfenozide in aubergines. The detailed description of the intended indoor use of methoxyfenozide, which is the basis for the current MRL application, is reported in Appendix A.

Methoxyfenozide is the ISO common name for N′-tert-butyl-N′-(3,5-dimethylbenzoyl)-3-methoxy-2-methylbenzohydrazide (IUPAC). The chemical structures of the active substance and its main metabolites are reported in Appendix E.

Methoxyfenozide was first approved¹ for the use as insecticide on 19 January 2005. The process of renewal of the first approval has been completed (EFSA, 2017). The representative uses assessed in the renewal process were foliar treatment on table and wine grapes, maize and sweet corn, fruiting vegetables (tomatoes, peppers, aubergines) and leafy vegetables (lettuce and other salad plants, spinaches and similar, herbs). However, not all the initially proposed representative uses were approved by European Commission (European Commission, 2018). The current approval of methoxyfenozide is restricted to use in greenhouses only, in order to minimise the exposure for groundwater and non-target organisms.²

The EU MRLs for methoxyfenozide are established in Annex II of Regulation (EC) No 396/2005.³ The review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (MRL review) has been performed (EFSA, 2014) and the proposed modifications have been implemented in the MRL legislation. After completion of the MRL review, EFSA has issued the conclusion on EU pesticides peer review of the renewal of approval of the active substance methoxyfenozide (EFSA, 2017), and subsequently two reasoned opinions, including the Focused assessment of certain existing MRLs of concern for methoxyfenozide (EFSA, 2020), and a Scientific report in support to the preparation of an EU position for the Codex Committee on Pesticide Residues (CCPR) meeting (EFSA, 2022). The proposals from these reasoned opinions have been considered in recent MRL regulations,⁴ and certain Codex maximum residue limits (CXLs) have been taken over in the EU MRL legislation. It is to be noted that EFSA recently issued a statement on the lack of confirmatory data following Article 12 MRL review for methoxyfenozide (EFSA, 2023) acknowledging that the confirmatory data related to the existing tentative MRL for auberges/eggplants were not submitted by the given legal deadline. EFSA therefore proposed to lower the existing tentative MRL of 0.6 mg/kg for aubergines/eggplants to the limit of quantification (LOQ) and concluded that the existing MRLs in products of animal origin are considered fully supported by data. The conclusions of this EFSA statement where not reflected so far in the MRL regulation.

In accordance Article 6 of Regulation (EC) No 396/2005 and following the provisions set by the ‘Transparency Regulation' (EU) 2019/1381,⁵ the Federal Public Service (FPS) Health, Food chain Safety and Environment submitted an application on behalf of Belgium on 13 December 2023, alongside the dossier containing the supporting data using the IUCLID format.

The EMS Belgium assessed the dossier and declared its admissibility on 29 February 2024. Subsequently, following the implementation of the EFSA's confidentiality decision, the non-confidential version of the dossier was published by EFSA, and a public consultation launched on the dossier. The consultation aimed to consult stakeholders and the public on the scientific data, studies and other information part of, or supporting, the submitted application, in order to identify whether other relevant scientific data or studies are available. The consultation run from 21 March 2024 to 11 April 2024. No additional data nor comments were submitted in the framework of the consultation.

At the end of the commenting period, the EMS proceeded drafting the evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and to EFSA on 12 April 2024. To accommodate for the intended use of methoxyfenozide, the EMS proposed to lower the existing (tentative) MRL of 0.6 mg/kg to 0.3 mg/kg.

EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified points which needed further clarification and requested the EMS to address them. On 31 May 2024, the applicant provided the requested information in an updated IUCLID dossier. The additional information was duly considered by the EMS who submitted a revised evaluation report to EFSA, which replaced the previously submitted evaluation report.

EFSA based its assessment on the evaluation report submitted by the EMS (Belgium, 2024), the renewal assessment report (United Kingdom, 2017) prepared under Regulation (EC) No 1107/2009, the Commission review report on methoxyfenozide (European Commission, 2018), the conclusion on the renewal of approval of the pesticide risk assessment of the active substance methoxyfenozide (EFSA, 2017), as well as the conclusions from previous EFSA opinions on methoxyfenozide, including the reasoned opinion on the MRL review according to Article 12 of Regulation No 396/2005 (EFSA, 2014), the focussed assessment of certain existing MRLs of concern (EFSA, 2020), the Scientific report in support to the preparation of an EU position for the Codex Committee on Pesticide Residues (CCPR) meetings (EFSA, 2013, 2022) and the statement on the lack of confirmatory data following Article 12 MRL review for methoxyfenozide (EFSA, 2023).

For this application, the data requirements established in Regulation (EU) No 283/2013⁶ and the guidance documents applicable at the date of submission of the IUCLID application are applicable (European Commission, 2010, 2020, 2021, 2022; OECD, 2007a, 2007b, 2007c, 2007d, 2007e, 2007f, 2007g, 2007h, 2008a, 2008b, 2009, 2011, 2021). The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation of Plant Protection Products adopted by Commission Regulation (EU) No 546/2011.⁷

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

The evaluation report submitted by the EMS (Belgium, 2024) and the exposure calculations using the EFSA Pesticide Residues Intake Model (PRIMo) are considered as supporting documents to this reasoned opinion and, thus, are made publicly available as background documents to this reasoned opinion.⁸

RESIDUES IN PLANTS

Nature of residues and methods of analysis in plants

Nature of residues in primary crops

The metabolism of methoxyfenozide in primary corps belonging to the group of fruit crops (apples, grapes), cereals/grass (rice), pulses/oilseeds (cotton seeds) has been assessed in the framework of the MRL review and the EU pesticides peer review for the renewal of approval of the active substance methoxyfenozide (EFSA, 2014, 2017).

After foliar applications, methoxyfenozide was the main component of the total radioactive residues (TRR) accounting for 91% TRR in apples, 80% TRR in grapes, 46–67% TRR in cotton seeds and up to 68% and 58% TRR in rice straw and grain, respectively. The other identified metabolites occurred at a level < 10% TRR. Considering that the metabolism of methoxyfenozide was found to be similar in three different crop groups, the results of these studies can be extended to all crop categories (OECD, 2007a).

For the intended use of methoxyfenozide on aubergines, which belongs to the fruiting vegetables crop group, the metabolic behaviour in primary crops is sufficiently addressed.

Nature of residues in rotational crops

Methoxyfenozide is not proposed to be used on crops that can be grown in rotation.

For the intended indoor use on aubergines (grown in substrate) assessed in this MRL application, no information is required. As specified in the GAP table (Appendix A), the substrate can be used only once at each cycle of crop cultivation.

Nevertheless, studies on the nature of residues in rotation crops are available and are reported in Appendix B for completeness.

Nature of residues in processed commodities

The effect of processing on the nature of methoxyfenozide was assessed in the framework of the MRL review and the EU pesticides peer review of approval renewal of the active substance methoxyfenozide (EFSA, 2014, 2017). These studies showed that methoxyfenozide is hydrolytically stable under standard processing conditions such as pasteurisation, baking, brewing and boiling and sterilisation.

EFSA concluded that the nature of residues of the active substance under standard hydrolysis conditions is sufficiently addressed, and further studies are not required for the intended use.

Analytical methods for enforcement purposes in plant commodities

Analytical methods for the determination of residues of methoxyfenozide in plant commodities were assessed in the context of the MRL review and the EU pesticides peer review of the renewal of approval of the active substance methoxyfenozide (EFSA, 2014, 2017).

The high-performance liquid chromatography with tandem mass spectrometry (HPLC–MS/MS) method (coded 120948) is sufficiently validated for the determination of the residues of methoxyfenozide in high water, high acid, high oil content, dry matrices and honey. The method allows quantification residues at or above the LOQ of 0.01 mg/kg. A validated multiresidue quick, easy, cheap, effective and safe (QuEChERS) method (coded 120633) based on liquid chromatography with tandem mass spectrometry (LC–MS/MS) is also available to control residues of methoxyfenozide in all plant matrices and allows quantification of residues at or above the LOQ of 0.01 mg/kg (EFSA, 2017).

A study on the extraction efficiency of the two analytical methods proposed for enforcement has been submitted in the context of the current application (Belgium, 2024). The extraction efficiency of these HPLC solvents was demonstrated by cross-validation against the solvents used in the metabolism studies in apples (high water matrices). The comparison was conducted on tomato samples containing incurred residues of methoxyfenozide analysed with each solvent system. Total extracted radioactivity with the extraction solvent used in the metabolism studies with apples (acetonitrile/0.1 M hydrochloric acid [80/20, v/v]) was very high (97% TRR in fruit) (EFSA, 2017; United Kingdom, 2017). The solvent system used in the two HPLC procedures was methanol/ water (90/10, v/v) for method coded 120948 and acetonitrile/water for method coded 120633. The residue amounts measured by the proposed enforcement methods differed by less than 30% compared to the amounts obtained when using the solvent system of the metabolism studies. EFSA concluded that the extraction efficiency of both analytical methods proposed for enforcement is proven in high water content commodities as indicated according to the requirements of the extraction efficiency Guidance, SANTE 2017/10632 (European Commission, 2022).

Aubergines belong to the high-water content commodity group. Therefore, EFSA concluded that sufficiently validated analytical methods are available for enforcing the proposed MRL for methoxyfenozide in aubergines/eggplants.

Storage stability of residues in plants

The storage stability of methoxyfenozide residues in plants stored under frozen conditions was investigated in the framework of the previous MRL application on avocados, the MRL review and the EU pesticides peer review of approval renewal of the active substance methoxyfenozide (EFSA, 2010, 2014, 2017). The results of the storage stability studies demonstrate that the residues of methoxyfenozide are stable in each of the different commodity categories for at least 12 months at −18°C.

EFSA concludes that sufficiently validated storage stability studies are available to support the use of methoxyfenozide in aubergines (high water content commodities).

Proposed residue definitions

Based on the metabolic pattern identified in metabolism studies and the results of hydrolysis studies, the toxicological relevance of metabolites, the residue definition for enforcement as ‘Methoxyfenozide’ proposed in the MRL review was confirmed in the EU pesticides peer review of the renewal of the approval of the active substance methoxyfenozide (EFSA, 2014, 2017).

This residue definition applies to primary crops, and processed products (EFSA, 2014, 2017). The residue definition for enforcement set in Regulation (EC) No 396/2005 is identical with the above-mentioned residue definition.

The residue definition for risk assessment is set as ‘Methoxyfenozide’ for primary crops. In the conclusion on the EU pesticides peer review of the renewal of approval of the active substance methoxyfenozide, EFSA proposed a specific residue definition for risk assessment for rotational crops as ‘Methoxyfenozide plus M14 and its conjugates (M15 and M40), expressed as methoxyfenozide’ on a provisional basis (EFSA, 2017).

Taking into account the proposed indoor use on aubergines not grown in rotation assessed in this application, EFSA concluded that these residue definitions for enforcement and risk assessment as ‘Methoxyfenozide’ are appropriate and no further information is required.

Magnitude of residues in plants

Magnitude of residues in primary crops

In support of the intended indoor EU GAP for aubergines, the applicant submitted three independent GAP-compliant residue trials on tomatoes conducted in Germany, France and Italy during the growing season of 2017. In the three residue trials, the single application was made at the rate of ± 25% of the intended nominal rate of 0.144 kg a.s./ha (within acceptable deviation; European Commission, 2020). Subsequently, the samples from treated aubergines were collected at the intended preharvest interval (PHI) of 1 day. In two decline trials conducted in France and Italy, the sampling was performed immediately after the application and at 1 day (corresponding to the intended PHI), 3, 7 and 14 days after the application (Belgium, 2024).

To complete the data set, the EMS considered the results from the eight indoor trials on tomatoes assessed previously by EFSA in the framework of the EU pesticides peer review of the renewal of approval of the active substance methoxyfenozide (EFSA, 2017; United Kingdom, 2017). Among the previously assessed trials, five trials are fully compliant with the intended GAP on aubergines and are considered valid for extrapolation. EFSA disregarded the remaining three trials performed in 2013⁹ because conducted at an application rate (188–200 g/ha) deviating by more than the acceptable ± 25%.

These five valid trials were performed in Italy, Greece, France and Spain in 2015. In all residue trials, one application was made at a single rate equivalent to 0.142–149 kg a.s./ha (within acceptable deviation in application rate). Three trials were of decline design (samples were taken 0, 1, corresponding to the intended PHI, 3, 6 or 7 days, and 13 or 14 days after the treatment).

Considering all eight GAP-compliant trials, the residue levels in tomatoes ranged between 0.023 and 0.168 mg/kg. No residues of methoxyfenozide at or above the LOQ of the analytical method of methoxyfenozide was found in any of the untreated specimens.

The number of trials performed on tomatoes is sufficient to derive by extrapolation an MRL proposal of 0.3 mg/kg for the intended indoor use of methoxyfenozide on aubergines. The proposed extrapolation is acceptable according to the EU technical guidelines (European Commission, 2020).

The residue data from the supervised residue trials in primary crops are summarised in Appendix B.1.2.1. Before analyses, the samples from the new residue trials on tomatoes were stored under conditions for which the integrity had been demonstrated (Belgium, 2024). Samples assessed in the EFSA Conclusion were previously concluded as valid (EFSA, 2017).

The method used for the analysis of residues of methoxyfenozide in aubergines in the three newly submitted trials is based on HPLC–MS/MS and enables quantification of residues at or above the LOQ of 0.01 mg/kg in the commodity assessed. According to the EMS, the method (coded 120948) used to analyse samples for methoxyfenozide residues was sufficiently validated and fit for purpose (Belgium, 2024). Since the method is the same as the monitoring analytical method, its extraction efficiency can be considered proven (see Section 1.1.4).

Magnitude of residues in rotational crops

Not relevant as the intended use under assessment is on aubergines grown under greenhouse on substrates that are removed/changed at each cycle of crop cultivation as specified in the GAP table (see Appendix A).

Magnitude of residues in processed commodities

In principle, specific processing studies should be provided since the level of residues in the raw agricultural commodity (RAC) to be processed showed to be above the value of 0.1 mg/kg reported in Regulation (EU) No 283/2013. However, EFSA notes that aubergine is not reported in the compilation of possible processed commodities important for the calculation of the dietary exposure of humans (OECD, 2008a). Therefore, EFSA concluded that specific processing studies with aubergines to refine the dietary exposure calculation are not necessary for the crop under assessment.

This is in line with the EFSA conclusion in the framework of the renewal of the approval where processing studies were not provided and the data gap for such studies was not identified for aubergines, which was one of the representative uses (EFSA, 2017).

Proposed MRLs

The data submitted in support of this MRL application were found to be sufficient to derive an MRL proposal of 0.3 mg/kg for aubergines/eggplants (see Appendix B.5).

In Section 4, EFSA assessed whether residues resulting from the intended use are likely to pose a consumer health risk.

RESIDUES IN LIVESTOCK AND FISH

Not relevant as aubergines are not used for feed purposes.

RESIDUES IN HONEY

The EMS provided the argument that the intended use is an indoor use to waive the requirement of investigation of residues in honey. EFSA shared this position considering that honey bees are normally not used for pollination services in greenhouses and are not expected to forage in closed structures. In any case, during the EU pesticides peer review of the renewal of approval of the active substance methoxyfenozide, the exposure of methoxyfenozide to honey bees was considered very limited for the same indoor use on aubergines with one application (European Commission, 2018). EFSA concluded that for the GAP under assessment, further data are not required.

CONSUMER RISK ASSESSMENT

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

The toxicological reference values for methoxyfenozide used in the risk assessment (i.e. ADI of 0.1 mg/kg body weight per day and ARfD of 0.1 mg/kg bw) were derived in the framework of the EU pesticides peer review of approval of the active substance methoxyfenozide (European Commission, 2018). It is noted that, in the framework of the EU pesticides peer review, the residue definition for risk assessment for rotational crops and the residue definition for risk assessment for animal matrices have been changed compared to those derived in the MRL review (EFSA, 2014). The metabolites M14 and its conjugates (M15 and M40), which are included in the provisional residue definition for risk assessment in rotational crops and the metabolites M24 and its conjugate (M26) and M16, which are included in the provisional residue definition for risk assessment in products of animal origin, were concluded to be at least as toxic as the parent active substance. Data gaps were identified for the metabolites included in the provisional risk assessment residue definition for rotational crops and for livestock (EFSA, 2017).

Short-term (acute) dietary risk assessment

The short-term exposure assessment was performed in accordance with the internationally agreed methodology and focused on the commodity assessed in this application (FAO, 2016). The calculations were based on the HR (expressed according to the residue definition for risk assessment) derived from supervised field trials and the complete list of input values can be found in Appendix D.1. The short-term exposure did not exceed the ARfD.

Long-term (chronic) dietary risk assessment

For the calculation of the chronic exposure, EFSA used the median residue value (STMR) for aubergines as derived from the submitted residue trials and the STMR values derived in the MRL review (EFSA, 2014), some of which needed to be reconsidered in the refined calculations performed under the focused assessment of certain existing MRLs of concern for methoxyfenozide (EFSA, 2020). Additionally, the STMR values derived in support of CXLs assessed by EFSA after the MRL review and implemented in the EU MRL legislation (EFSA, 2022; FAO, 2021) were used. The calculation was refined for citrus fruits with the peeling factor of 0.3 to take into account the edible portion of these commodities. The STMR values¹⁰ for the crops which can be grown in rotation and for products of animal origin are based on the residue definition of sole parent compound. The input values used in the exposure calculations are summarised in Appendix D.1.

Exceedances of the ADI are not indicated for any of the consumer diet groups. The highest estimated long-term dietary exposure is reported for the IE adult diet representing up to 6% of the ADI of methoxyfenozide. The contribution of residues expected in aubergines to the overall long-term exposure accounted for a maximum of 0.02% of the ADI (see Appendix B.4).

The contribution of residues expected in the commodities assessed in this application to the overall exposure is presented in more detail in Appendix B.4. EFSA concluded that the short-term and long-term intake of residues of methoxyfenozide resulting from the existing and the intended use is unlikely to present a risk to consumer health. Pending the assessment of further data on the metabolites included in the provisional risk assessment residue definition for rotational crops and for livestock (EFSA, 2017), the chronic consumer risk assessment shall be regarded as indicative and affected by non-standard uncertainties.

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

CONCLUSION AND RECOMMENDATIONS

The data submitted in support of this MRL application were found to be sufficient to derive an MRL proposal for aubergines/eggplants.

EFSA concluded that the proposed indoor use of methoxyfenozide on aubergines will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers' health. The chronic consumer risk assessment shall be regarded as indicative and affected by non-standard uncertainties related to the missing information identified during the EU pesticides peer review.

The MRL recommendation is summarised in Appendix B.5.

ABBREVIATIONS

• a.s.
• active substance
• ADI
• acceptable daily intake
• AR
• applied radioactivity
• ARfD
• acute reference dose
• BBCH
• growth stages of mono- and dicotyledonous plants
• bw
• body weight
• CCPR
• Codex Committee on Pesticide Residues
• CF
• conversion factor for enforcement to risk assessment residue definition
• CXL
• Codex maximum residue limit
• DALA
• days after last application
• DAT
• days after treatment
• EC
• emulsifiable concentrate
• ECD
• electron capture detector
• EMS
• evaluating Member State
• eq
• residue expressed as a.s. equivalent
• FAO
• Food and Agriculture Organization of the United Nations
• GAP
• Good Agricultural Practice
• HPLC
• high performance liquid chromatography
• HPLC-MS
• high performance liquid chromatography with mass spectrometry
• HPLC-MS/MS
• high performance liquid chromatography with tandem mass spectrometry
• IEDI
• international estimated daily intake
• IESTI
• international estimated short-term intake
• ILV
• independent laboratory validation
• ISO
• International Organisation for Standardisation
• IUPAC
• International Union of Pure and Applied Chemistry
• JMPR
• Joint FAO/WHO Meeting on Pesticide Residues
• LC
• liquid chromatography
• LOQ
• limit of quantification
• MRL
• maximum residue level
• MS
• Member States
• MS
• mass spectrometry detector
• MS/MS
• tandem mass spectrometry detector
• MW
• molecular weight
• NEU
• northern Europe
• OECD
• Organisation for Economic Co-operation and Development
• PBI
• plant back intervalPF
• processing factor
• PHI
• preharvest interval
• P_ow
• partition coefficient between n-octanol and water
• PRIMo
• (EFSA) Pesticide Residues Intake Model
• QuEChERS
• Quick, Easy, Cheap, Effective, Rugged, and Safe (analytical method)
• RA
• risk assessment
• RAC
• raw agricultural commodity
• SANCO
• Directorate-General for Health and Consumers
• SCPAFF
• Standing Committee on Plants, Animals, Food and Feed (formerly: Standing Committee on the Food Chain and Animal Health; SCFCAH)
• SEU
• southern Europe
• STMR
• supervised trials median residue
• TRR
• total radioactive residue
• WHO
• World Health Organization

ACKNOWLEDGEMENTS

EFSA wishes to thank Stathis Anagnos, Mavriou Galini, Matteo Lazzari and Elena Taglianini for the support provided to this scientific output.

CONFLICT OF INTEREST

If you wish to access the declaration of interests of any expert contributing to an EFSA scientific assessment, please contact [email protected].

REQUESTOR

European Commission

QUESTION NUMBER

EFSA-Q-2023-00884

COPYRIGHT FOR NON-EFSA CONTENT

EFSA may include images or other content for which it does not hold copyright. In such cases, EFSA indicates the copyright holder and users should seek permission to reproduce the content from the original source.

Appendix

APPENDIX A - Summary of intended GAP triggering the amendment of existing EU MRLs

Crop and/or situation	NEU, SEU, MS or country	F G or Ia	Pests or group of pests controlled	Preparation	Application	Application rate per treatment	PHI (days)d	Remarks
Typeb	Conc. a.s. (g/L)	Method kind	Range of growth stages and seasonc	Number Min–max	Interval between application (days) Min–max	g a.s./hL Min–max	Water (L/ha) Min–max	Rate Min–max	Unit
Aubergines/eggplants	EU	G	Mamestra (BARABR) Spodoptera (SPODSP) Autographa (PYTOGA) Tuta absoluta (GNORAB) eggs and larvae	SC	240	Foliar spray	61–71	1	–	9.6–28.8	500–1500	0.144	kg a.i./ha	1	Cultivation on substrates that are removed or changed at each cycle of crop cultivation

Appendix

APPENDIX B - List of end points

B.1

Residues in plants

B.1.1

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

B.1.1.1

Metabolism studies, analytical methods and residue definitions in plants

Primary crops (available studies)	Crop groups	Crops	Applications	Sampling	Comment/source
	Fruit crops	Apples	Foliar, 2 × 1.10 kg a.s./ha, interval: 33 days	0, 7, 14, 36 DALA	Radiolabelled methoxyfenozide: Mixture of non-labelled, 13C-carbonyl- and A-ring (14C-methoxyphenyl)-labelled methoxyfenozide (EFSA, 2014, 2017)
Grapes	Foliar, 2 × 1.12 kg a.s./ha, interval: 28 days	27 DALA	Radiolabelled methoxyfenozide: t-butyl-labelled [14C]/ [13C]methoxyfenozide (EFSA, 2014, 2017)
Cereals/grass	Rice	Foliar, 2 × 0.6 kg a.s./ha, interval: 37 days	14, 31, 62 DALA	Radiolabelled methoxyfenozide: Separately labelled in the B-ring and t-butyl site (EFSA, 2014, 2017)
Foliar, 0.6 kg a.s./ha + 0.31 kg as/ha, interval: 37 days	Radiolabelled methoxyfenozide: 14C-methoxyfenozide labelled in the A-ring (EFSA, 2014, 2017)
Pulses/oilseeds	Cotton seeds	Foliar, 2 × 1.1 kg a.s./ha, interval: 31 days	7, 14, 21 DALA	Radiolabelled methoxyfenozide: 14C-methoxyfenozide, separately labelled in the A-ring, B-ring and t-butyl site (EFSA, 2014, 2017)
Rotational crops (available studies)	Crop groups	Crops	Application	PBI (DAT)	Comment/Source
	Root/tuber crops	White radish	Bare soil application, 3 × 0.75 kg a.s./ha	31, 91, 364	Studies with radiolabelled methoxyfenozide: 14C-methoxyphenyl, 14C-dimethylphenyl or 14C-t-butyl-methoxyfenozide (EFSA, 2014, 2017)
Leafy crops	Mustard
Cereals (small grain)	Wheat
Processed commodities (hydrolysis study)	Conditions	Stable?	Comment/Source
	Pasteurisation (20 min, 90°C, pH 4)	Yes	EFSA (2014, 2017)
Baking, brewing and boiling (60 min, 100°C, pH 5)	Yes	EFSA (2014, 2017)
Sterilisation (20 min, 120°C, pH 6)	Yes	EFSA (2014, 2017)

B.1.1.2

Stability of residues in plants

Plant products (available studies)	Category	Commodity	T (°C)	Stability period	Compounds covered	Comment/source
Value	Unit
	High water content	Apples	−20	12	Months	Methoxyfenozide	EFSA (2014, 2017)
Tomatoes	−20	12	Months	Methoxyfenozide	EFSA (2017)
High oil content	Cotton seed	−20	23.5	Months	Methoxyfenozide	EFSA (2017)
Corn (maize) oil	−10	6	Months	Methoxyfenozide	EFSA (2017)
Avocados	−20	22	Months	Methoxyfenozide	EFSA (2010)
High protein content	Beans, dry	≤ 20	11	Months	Methoxyfenozide	EFSA (2017)
Peas, dry	≤ 20	14	Months	Methoxyfenozide	EFSA (2014, 2017)
Dry/high starch	Maize grain	−20	13	Months	Methoxyfenozide	EFSA (2017)
High acid content	Oranges	−18	15	Months	Methoxyfenozide	EFSA (2017)
Grapes	−18	15	Months	Methoxyfenozide	EFSA (2017)

B.1.2

Magnitude of residues in plants

B.1.2.1

Summary of residues data from the supervised residue trials

Commodity	Region/a	Residue levels observed in the supervised residue trials (mg/kg)	Comments/source	Calculated MRL (mg/kg)	HRb (mg/kg)	STMRc (mg/kg)	CFd
Aubergines	EU	0.019e, 0.023, 0.032, 0.050; 0.071, 0.079, 0.128e, 0.168	Indoor residue trials on tomatoes compliant with the GAP on aubergines Three new trials (underlined) (Belgium, 2024) and five trials previously assessed by EFSA (EFSA, 2017) Extrapolation to aubergines possible (European Commission, 2020)	0.3	0.168	0.061	n.a.

B.1.2.2

Residues in rotational crops

B.1.2.3

Processing factors

No processing studies were submitted in the framework of the present MRL application.

B.2

Residues in livestock and fish

Not relevant.

B.3

Residues in honey

Not relevant.

B.4

Consumer risk assessment

B.5

Recommended MRLs

Codea	Commodity	Existing/b EU MRL (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: MethoxyfenozideF
0231030	Aubergines/eggplants	0.6 (ft)/0.01*	0.3	The submitted data are sufficient to derive an MRL proposal for the intended indoor EU use by extrapolation form residue data on tomatoes. Risk for consumers unlikely

Appendix

APPENDIX C - Pesticide Residue Intake Model (PRIMo)

Appendix

APPENDIX D - Input values for the exposure calculations

D.1

Consumer risk assessment

Commodity	Existing/Proposed MRL (mg/kg)	Source	Chronic risk assessment	Acute risk assessment
Input valuea (mg/kg)	Comment	Input valuea (mg/kg)	Commentb
Risk assessment residue definition: MethoxyfenozideF
Grapefruits	2	FAO (2012)	0.084	STMR-RAC*PeF	0.51	HR-RAC*PeF
Oranges	2	FAO (2012)	0.084	STMR-RAC*PeF	0.51	HR-RAC*PeF
Lemons	2	FAO (2012)	0.084	STMR-RAC*PeF	0.51	HR-RAC*PeF
Limes	2	FAO (2012)	0.084	STMR-RAC*PeF	0.51	HR-RAC*PeF
Mandarins	2	FAO (2012)	0.084	STMR-RAC*PeF	0.51	HR-RAC*PeF
Other citrus fruit	2	FAO (2012)	0.084	STMR-RAC*PeF
Almonds	0.1	FAO (2003)	0.021	STMR-RAC	0.074	HR-RAC
Brazil nuts	0.1	FAO (2003)	0.021	STMR-RAC	0.074	HR-RAC
Cashew nuts	0.1	FAO (2003)	0.021	STMR-RAC	0.074	HR-RAC
Chestnuts	0.1	FAO (2003)	0.021	STMR-RAC	0.074	HR-RAC
Coconuts	0.1	FAO (2003)	0.021	STMR-RAC	0.074	HR-RAC
Hazelnuts/cobnuts	0.1	FAO (2003)	0.021	STMR-RAC	0.074	HR-RAC
Macadamia	0.1	FAO (2003)	0.021	STMR-RAC	0.074	HR-RAC
Pecans	0.1	FAO (2003)	0.021	STMR-RAC	0.074	HR-RAC
Pine nut kernels	0.1	FAO (2003)	0.021	STMR-RAC	0.074	HR-RAC
Pistachios	0.1	FAO (2003)	0.021	STMR-RAC	0.074	HR-RAC
Walnuts	0.1	FAO (2003)	0.021	STMR-RAC	0.074	HR-RAC
Other tree nuts	0.1	FAO (2003)	0.021	STMR-RAC
Quinces	2	FAO (2003)	0.43	STMR-RAC	1.0	HR-RAC
Medlar	2	FAO (2003)	0.43	STMR-RAC	1.0	HR-RAC
Loquats/J. medlars	2	FAO (2003)	0.43	STMR-RAC	1.0	HR-RAC
Apricots	2	FAO (2003)	0.34	STMR-RAC	1.4	HR-RAC
Cherries (sweet)	2	FAO (2003)	0.34	STMR-RAC	1.4	HR-RAC
Plums	2	FAO (2003)	0.34	STMR-RAC	1.4	HR-RAC
Table grapes	1	FAO (2003)	0.33	STMR-RAC	0.84	HR-RAC
Wine grapes	1	FAO (2003)	0.33	STMR-RAC	0.84	HR-RAC
Strawberries	2	FAO (2009)	0.24	STMR-RAC	1.2	HR-RAC
Blueberries	4	FAO (2009)	0.13	STMR-RAC	2.0	HR-RAC
Cranberries	0.7	FAO (2006)	0.085	STMR-RAC	0.39	HR-RAC
Avocados	0.7	FAO (2009)	0.13	STMR-RAC	0.41	HR-RAC
Papayas	1	FAO (2009)	0.31	STMR-RAC	0.33	HR-RAC
Granate apples/pomegranates	0.6	EFSA (2010, 2014)	0.125	STMR-RAC	0.36	HR-RAC
Sweet potatoes	0.02	FAO (2009)	0.01	STMR-RAC	0.012	HR-RAC
Carrots	0.5	FAO (2009)	0.13	STMR-RAC	0.31	HR-RAC
Radishes	0.4	FAO (2009)	0.08	STMR-RAC	0.12	HR-RAC
Tomatoes	0.6	EFSA (2020)	0.14	STMR-RAC	0.46	HR-RAC
Sweet peppers/bell peppers	2	FAO (2003)	0.16	STMR-RAC	0.94	HR-RAC
Aubergines/egg plants	0.3	Proposed MRL	0.061	STMR-RAC	0.168	HR-RAC
Cucumbers	0.3	FAO (2012)	0.091	STMR-RAC	0.15	HR-RAC
Gherkins	0.3	FAO (2012)	0.091	STMR-RAC	0.15	HR-RAC
Courgettes	0.3	FAO (2012)	0.091	STMR-RAC	0.15	HR-RAC
Other cucurbits - edible peel	0.3	FAO (2012)	0.091	STMR-RAC
Melons	0.3	FAO (2012)	0.091	STMR-RAC	0.15	HR-RAC
Pumpkins	0.3	FAO (2012)	0.091	STMR-RAC	0.15	HR-RAC
Sweet corn	0.02	FAO (2003)	0.02	STMR-RAC	0.02	HR-RAC
Lamb's lettuce/corn saladsd	4	EFSA (2014)	1.128	STMR-RAC	2.385	HR-RAC
Lettucesd	4	EFSA (2014)	1.128	STMR-RAC	2.385	HR-RAC
Cress and other sprouts and shootsd	4	EFSA (2014)	1.128	STMR-RAC	2.385	HR-RAC
Land cressd	4	EFSA (2014)	1.128	STMR-RAC	2.385	HR-RAC
Roman rocket/rucolad	4	EFSA (2014)	1.128	STMR-RAC	2.385	HR-RAC
Red mustardsd	4	EFSA (2014)	1.128	STMR-RAC	2.385	HR-RAC
Baby leaf crops (including brassica species)d	4	EFSA (2014)	1.128	STMR-RAC	2.385	HR-RAC
Spinachesd	4	EFSA (2014)	1.128	STMR-RAC	2.385	HR-RAC
Purslanesd	4	EFSA (2014)	1.128	STMR-RAC	2.385	HR-RAC
Chards/beet leavesd	4	EFSA (2014)	1.128	STMR-RAC	2.385	HR-RAC
Other spinach and similard	4	EFSA (2014)	1.128	STMR-RAC
Chervild	4	EFSA (2014)	1.128	STMR-RAC	2.385	HR-RAC
Chivesd	4	EFSA (2014)	1.128	STMR-RAC	2.385	HR-RAC
Celery leavesd	4	EFSA (2014)	1.128	STMR-RAC	2.385	HR-RAC
Parsleyd	4	EFSA (2014)	1.128	STMR-RAC	2.385	HR-RAC
Saged	4	EFSA (2014)	1.128	STMR-RAC	2.385	HR-RAC
Rosemaryd	4	EFSA (2014)	1.128	STMR-RAC	2.385	HR-RAC
Thymed	4	EFSA (2014)	1.128	STMR-RAC	2.385	HR-RAC
Basil and edible flowers	80	FAO (2021)	19	STMR-RAC	47	HR-RAC
Laurel/bay leavesd	4	EFSA (2014)	1.128	STMR-RAC	2.385	HR-RAC
Tarragond	4	EFSA (2014)	1.128	STMR-RAC	2.385	HR-RAC
Other herbsd	4	EFSA (2014)	1.128	STMR-RAC
Beans (with pods)	2	FAO (2009)	0.07	STMR-RAC	0.99	HR-RAC
Beans (without pods)	0.3	FAO (2009)	0.05	STMR-RAC	0.18	HR-RAC
Peas (with pods)	2	FAO (2012)	0.1	STMR-RAC	0.81	HR-RAC
Peas (without pods)	0.3	FAO (2009)	0.05	STMR-RAC	0.18	HR-RAC
Beans	0.5	FAO (2009)	0.05	STMR-RAC	0.05	STMR-RAC
Peas	5	FAO (2012)	0.17	STMR-RAC	0.17	STMR-RAC
Peanuts/groundnuts	0.03	FAO (2009)	0.01	STMR-RAC	0.01	STMR-RAC
Cotton seeds	7	FAO (2003)	0.46	STMR-RAC	0.46	STMR-RAC
Maize/corn	0.02*	FAO (2003)	0.02	STMR-RAC	0.02	STMR-RAC
Tea (dried leaves of Camellia sinensis)	80	FAO (2021)	28.5	STMR-RAC	28.5	STMR-RAC
Coffee beans	0.15	FAO (2021)	0.028	STMR-RAC	0.028	STMR-RAC
Sugar beet roots	0.3	FAO (2009)	0.11	STMR-RAC	0.18	HR-RAC
Sugar canes	0.015	FAO (2021)	0.01	STMR-RAC	0.01	HR-RAC
Swine: Muscle/meatc	0.01	EFSA (2014)	0.01	STMR-RAC	0.053	HR-RAC
Swine: Fat tissue	0.3	FAO (2012)	0.036	STMR-RAC	0.24	HR-RAC
Swine: Liver	0.2	FAO (2012)	0.025	STMR-RAC	0.096	HR-RAC
Swine: Kidney	0.2	FAO (2012)	0.025	STMR-RAC	0.096	HR-RAC
Swine: Edible offal (other than liver and kidney)	0.2	FAO (2012)	0.025	STMR-RAC	0.096	HR-RAC
Swine: Other products	0.01	EU MRL	0.01	LOQ	0.01	LOQ
Bovine: Muscle/meatc	0.01	EFSA (2014)	0.01	STMR-RAC	0.053	HR-RAC
Bovine: Fat tissue	0.3	FAO (2012)	0.036	STMR-RAC	0.24	HR-RAC
Bovine: Liver	0.2	FAO (2012)	0.025	STMR-RAC	0.096	HR-RAC
Bovine: Kidney	0.2	FAO (2012)	0.025	STMR-RAC	0.096	HR-RAC
Bovine: Edible offal (other than liver and kidney)	0.2	FAO (2012)	0.025	STMR-RAC	0.096	HR-RAC
Bovine: Other products	0.01	EU MRL	0.01	LOQ	0.01	LOQ
Sheep: Muscle/meatc	0.01	EFSA (2014)	0.01	STMR-RAC	0.053	HR-RAC
Sheep: Fat tissue	0.3	FAO (2012)	0.036	STMR-RAC	0.24	HR-RAC
Sheep: Liver	0.2	FAO (2012)	0.025	STMR-RAC	0.096	HR-RAC
Sheep: Kidney	0.2	FAO (2012)	0.025	STMR-RAC	0.096	HR-RAC
Sheep: Edible offal (other than liver and kidney)	0.2	FAO (2012)	0.025	STMR-RAC	0.096	HR-RAC
Sheep: other products	0.01	EU MRL	0.01	LOQ
Goat: Muscle/meatc	0.01	EFSA (2014)	0.01	STMR-RAC	0.053	HR-RAC
Goat: Fat tissue	0.3	FAO (2012)	0.036	STMR-RAC	0.24	HR-RAC
Goat: Liver	0.2	FAO (2012)	0.025	STMR-RAC	0.096	HR-RAC
Goat: Kidney	0.2	FAO (2012)	0.025	STMR-RAC	0.096	HR-RAC
Goat: Edible offal (other than liver and kidney)	0.2	FAO (2012)	0.025	STMR-RAC	0.096	HR-RAC
Goat: other products	0.01	EU MRL	0.01	LOQ
Equine: Muscle/meatc	0.01	EFSA (2014)	0.01	STMR-RAC	0.053	HR-RAC
Equine: Fat tissue	0.3	FAO (2012)	0.036	STMR-RAC	0.24	HR-RAC
Equine: Liver	0.2	FAO (2012)	0.025	STMR-RAC	0.096	HR-RAC
Equine: Kidney	0.2	FAO (2012)	0.025	STMR-RAC	0.096	HR-RAC
Equine: Edible offal (other than liver and kidney)	0.2	FAO (2012)	0.025	STMR-RAC	0.096	HR-RAC
Equine: Other products	0.01	EU MRL	0.01	LOQ
Other farmed animals: Muscle/meatc	0.01	EFSA (2014)	0.01	STMR-RAC	0.053	HR-RAC
Other farmed animals: Fat tissue	0.3	FAO (2012)	0.036	STMR-RAC	0.24	HR-RAC
Other farmed animals: Liver	0.2	FAO (2012)	0.025	STMR-RAC	0.096	HR-RAC
Other farmed animals: Kidney	0.2	FAO (2012)	0.025	STMR-RAC	0.096	HR-RAC
Other farmed animals: Edible offal (other than liver and kidney)	0.2	FAO (2012)	0.025	STMR-RAC	0.096	HR-RAC
Other farmed animals: Other products	0.01	EU MRL	0.01	LOQ
Milk: Cattle	0.05	FAO (2003)	0.004	STMR-RAC	0.004	STMR-RAC
Milk: Sheep	0.05	FAO (2003)	0.004	STMR-RAC	0.004	STMR-RAC
Milk: Goat	0.05	FAO (2003)	0.004	STMR-RAC	0.004	STMR-RAC
Milk: Horse	0.05	FAO (2003)	0.004	STMR-RAC	0.004	STMR-RAC
Milk: Others	0.05	FAO (2003)	0.004	STMR-RAC	0.004	STMR-RAC

Appendix

APPENDIX E - Used compound codes

Code/trivial namea	IUPAC name/SMILES notation/InChiKeyb	Structural formulac
Methoxyfenozide	N′-tert-butyl-N′-(3,5-dimethylbenzoyl)-3-methoxy-2-methylbenzohydrazide Cc1c(cccc1OC)C(=O)NN(C(=O)c1cc(C)cc(C)c1)C(C)(C)C QCAWEPFNJXQPAN-UHFFFAOYSA-N
RH-151055 (M15)	N′-tert-butyl-N′-[(3,5-dimethylphenyl)carbonyl]-3-(β-D-glucopyranosyloxy)-2-methylbenzohydrazide Cc1cc(cc(C)c1)C(=O)N(NC(=O)c1cccc(O[C@@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)c1C)C(C)(C)C VHKCDHSPIZEGQX-MYIDKPJBSA-N
RH-141518 (M16)	3-({2-tert-butyl-2-[(3,5-dimethylphenyl)carbonyl]hydrazinyl}carbonyl)-2-methylphenyl β-D-glucopyranosiduronic acid Cc1cc(cc(C)c1)C(=O)N(NC(=O)c1cccc(O[C@@H]2O[C@@H]([C@@H](O)[C@H](O)[C@H]2O)C(=O)O)c1C)C(C)(C)C FUJHMNHUDPEZMS-OWCDONTQSA-N
H-141511 (M24)	N′-tert-butyl-3-hydroxy-N′-{[3-(hydroxymethyl)-5-methylphenyl]carbonyl}-2-methylbenzohydrazide Cc1c(cccc1O)C(=O)NN(C(=O)c2cc(C)cc(CO)c2)C(C)(C)C MHGWYSDXXRVOHH-UHFFFAOYSA-N
RH-141519 (M26)	3-[(2-tert-butyl-2-{[3-(hydroxymethyl)-5-methylphenyl]carbonyl}hydrazinyl)carbonyl]-2-methylphenyl β-D-glucopyranosiduronic acid Cc1cc(cc(CO)c1)C(=O)N(NC(=O)c3cccc(O[C@@H]2O[C@@H]([C@@H](O)[C@H](O)[C@H]2O)C(=O)O)c3C)C(C)(C)C GGZPIWMHIRUFCY-OWCDONTQSA-N
RH-152072 (M40)	3-[2-tert-butyl-2-(3,5-dimethylbenzoyl)hydrazinecarbonyl]-2-methylphenyl 4-O-(carboxyacetyl)- β-D-glucopyranoside Cc1cc(cc(C)c1)C(=O)N(NC(=O)c1cccc(O[C@@H]2O[C@H](CO)[C@@H](OC(=O)CC(=O)O)[C@H](O)[C@H]2O)c1C)C(C)(C)C RYBFHXAIXNLVPB-GCVKPHKGSA-N
RH-117236 (M14)	N-tert-butyl-N′-(3,5-dimethylbenzoyl)-3-hydroxy-2-methylbenzohydrazide Cc1c(cccc1O)C(=O)NN(C(=O)c2cc(C)cc(C)c2)C(C)(C)C BFKZZXWIAWMKQB-UHFFFAOYSA-N

References

Belgium. (2024). Evaluation report on the modification of MRLs for methoxyfenozide in aubergines. February 2024, revised in May 2024, 44 pp. www.efsa.europa.eu

EFSA (European Food Safety Authority). (2010). Reasoned opinion on the modification of the existing MRLs for methoxyfenozide in various fruits. EFSA Journal, 8(11), 1902. https://doi.org/10.2903/j.efsa.2010.1902, www.efsa.europa.eu/efsajournal.htm

EFSA (European Food Safety Authority). (2013). Scientific support for preparing an EU position for the 45th session of the codex committee on pesticide residues (CCPR). EFSA Journal, 11(7), 3312. https://doi.org/10.2903/j.efsa.2013.3312

EFSA (European Food Safety Authority). (2014). Reasoned opinion on the review of the existing maximum residue levels (MRLs) for methoxyfenozide according to article 12 of regulation (EC) No 396/2005. EFSA Journal, 12(1), 3509. https://doi.org/10.2903/j.efsa.2014.3509

EFSA (European Food Safety Authority), Arena, M., Auteri, D., Barmaz, S., Bellisai, G., Brancato, A., Brocca, D., Bura, L., Byers, H., Chiusolo, A., Court Marques, D., Crivellente, F., De Lentdecker, C., De Maglie, M., Egsmose, M., Erdos, Z., Fait, G., Ferreira, L., Goumenou, M., … Villamar‐Bouza, L. (2017). Conclusion on the peer review of the pesticide risk assessment of the active substance methoxyfenozide. EFSA Journal, 15(9), 4978. https://doi.org/10.2903/j.efsa.2017.4978

EFSA (European Food Safety Authority), Brancato, A., Brocca, D., Ferreira, L., Greco, L., Jarrah, S., Leuschner, R., Medina, P., Miron, I., Nougadere, A., Pedersen, R., Reich, H., Santos, M., Stanek, A., Tarazona, J., Theobald, A., & Villamar‐Bouza, L. (2018a). Guidance on use of EFSA pesticide residue intake model (EFSA PRIMo revision 3). EFSA Journal, 16(1), 5147. https://doi.org/10.2903/j.efsa.2018.5147

EFSA (European Food Safety Authority). (2018b). Recommendations on the use of the proportionality approach in the framework of risk assessment for pesticide residues. EFSA supporting publication, EN‐1503. https://doi.org/10.2903/sp.efsa.2017.EN‐1503

EFSA (European Food Safety Authority), Anastassiadou, M., Brancato, A., Carrasco Cabrera, L., Ferreira, L., Greco, L., Jarrah, S., Kazocina, A., Leuschner, R., Magrans, J. O., Miron, I., Pedersen, R., Raczyk, M., Reich, H., Ruocco, S., Sacchi, A., Santos, M., Stanek, A., Tarazona, J., … Verani, A. (2019). Pesticide Residue Intake Model‐ EFSA PRIMo revision 3.1 (update of EFSA PRIMo revision 3). EFSA supporting publication, EN‐1605. https://doi.org/10.2903/sp.efsa.2019.EN‐1605

EFSA (European Food Safety Authority), Anastassiadou, M., Bernasconi, G., Brancato, A., Carrasco Cabrera, L., Ferreira, L., Greco, L., Jarrah, S., Kazocina, A., Leuschner, R., Magrans, J. O., Miron, I., Nave, S., Pedersen, R., Reich, H., Rojas, A., Sacchi, A., Santos, M., Scarlato, A. P., … Verani, A. (2020). Reasoned opinion on the focussed assessment of certain existing MRLs of concern for methoxyfenozide. EFSA Journal, 18(12), 6330. https://doi.org/10.2903/j.efsa.2020.6330

EFSA (European Food Safety Authority). (2022). Scientific support for preparing an EU position in the 53rd session of the codex committee on pesticide residues (CCPR). EFSA Journal, 20(9), 7521. https://doi.org/10.2903/j.efsa.2022.7521

EFSA (European Food Safety Authority). (2023). Statement on the lack of confirmatory data following article 12 MRL reviews for 2,4‐DB, iodosulfuron‐methyl, mesotrione, methoxyfenozide and pyraflufen‐ethyl. EFSA Journal, 21(5), 8013. https://doi.org/10.2903/j.efsa.2023.8013

European Commission. (2010). Classes to be used for the setting of EU pesticide Maximum Residue Levels (MRLs). SANCO 10634/2010‐rev. 0, Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting of 23–24 March 2010.

European Commission. (2018). Final renewal report for the active substance methoxyfenozide. Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 13 December 2018 in view of the renewal of the approval of active substance methoxyfenozide in accordance with Regulation (EC) No 1107/2009. SANTE/10295/2018 Rev 3, 13 December 2018.

European Commission. (2020). Technical guidelines on data requirements for setting maximum residue levels, comparability of residue trials and extrapolation on residue data on products from plant and animal origin. SANTE/2019/12752, 10 May 2023.

European Commission. (2021). Guidance Document on Pesticide Analytical Methods for Risk Assessment and Post‐approval Control and Monitoring Purposes. SANTE/2020/12830, Rev.1 24. February 2021.

European Commission. (2022). Technical Guideline on the Evaluation of Extraction Efficiency of Residue Analytical Methods. SANTE 2017/10632, Rev. 5, 11 May 2023.

FAO (Food and Agriculture Organisation of the United Nations). (2003). Methoxyfenozide. In: Pesticide residues in food – 2003. Report of the joint meeting of the FAO panel of experts on pesticide residues in food and the environment and the WHO Core assessment group on pesticide residues. FAO Plant Production and Protection Paper 176.

FAO (Food and Agriculture Organisation of the United Nations). (2006). Methoxyfenozide. In: Pesticide residues in food – 2006. Report of the joint meeting of the FAO panel of experts on pesticide residues in food and the environment and the WHO Core assessment group on pesticide residues. FAO Plant Production and Protection Paper 187.

FAO (Food and Agriculture Organisation of the United Nations). (2009). Submission and evaluation of pesticide residues data for the estimation of maximum residue levels in food and feed. Pesticide residues. 2nd Ed. FAO Plant Production and Protection Paper 197, 264 pp.

FAO (Food and Agriculture Organisation of the United Nations). (2012). Methoxyfenozide. In: Pesticide residues in food – 2012. Report of the joint meeting of the FAO panel of experts on pesticide residues in food and the environment and the WHO Core assessment group on pesticide residues. FAO Plant Production and Protection Paper 215.

FAO (Food and Agriculture Organization of the United Nations). (2016). Submission and evaluation of pesticide residues data for the estimation of maximum residue levels in food and feed. Pesticide residues. 3rd Ed. FAO Plant Production and Protection Paper 225, 298 pp.

FAO (Food and Agriculture Organization of the United Nations). (2021). Report of the joint meeting of the FAO panel of experts on pesticide residues in food and the environment and the WHO Core assessment group on pesticide residues. Rome, Italy, 17–21 May and 7–11 June 2021. Pesticide residue in food 2021. 493 pp.

OECD (Organisation for Economic Co‐operation and Development). (2007a). Test No. 501: Metabolism in crops, OECD guidelines for the testing of chemicals, section 5. OECD Publishing. https://doi.org/10.1787/9789264061835

OECD (Organisation for Economic Co‐operation and Development). (2007b). Test No. 502: Metabolism in rotational crops, OECD guidelines for the testing of chemicals, section 5, OECD Publishing, Paris, 25 January 2007. https://doi.org/10.1787/9789264061859

OECD (Organisation for Economic Co‐operation and Development). (2007c). Test No. 503: Metabolism in livestock, OECD guidelines for the testing of chemicals, section 5. OECD Publishing. https://doi.org/10.1787/9789264061873

OECD (Organisation for Economic Co‐operation and Development). (2007d). Test No. 504: Residues in rotational crops (limited field studies), OECD guidelines for the testing of chemicals, section 5. OECD Publishing. https://doi.org/10.1787/9789264013384

OECD (Organisation for Economic Co‐operation and Development). (2007e). Test No. 505: Residues in livestock, OECD guidelines for the testing of chemicals, section 5. OECD Publishing. https://doi.org/10.1787/9789264061903

OECD (Organisation for Economic Co‐operation and Development). (2007f). Guidance document on pesticide residue analytical methods. In: Series on pesticides No 39/series on testing and assessment No 72. ENV/JM/MONO(2007)17, 13 August 2007.

OECD (Organisation for Economic Co‐operation and Development). (2007g). Test No 506: Stability of pesticide residues in stored commodities, OECD guidelines for the testing of chemicals, section 5. OECD Publishing. https://doi.org/10.1787/9789264061927

OECD (Organisation for Economic Co‐operation and Development). (2007h). Test No. 507: Nature of the pesticide residues in processed commodities ‐ high temperature hydrolysis, OECD guidelines for the testing of chemicals, section 5. OECD Publishing. https://doi.org/10.1787/9789264067431

OECD (Organisation for Economic Co‐operation and Development). (2008a). Guidance document on the magnitude of pesticide residues in processed commodities. In: Series of testing and assessment No 96. ENV/JM/MONO(2008)23, 29 July 2008.

OECD (Organisation for Economic Co‐operation and Development). (2008b). Test No. 508: Magnitude of the pesticide residues in processed commodities, OECD guidelines for the testing of chemicals, section 5. OECD Publishing. https://doi.org/10.1787/9789264067622

OECD (Organisation for Economic Co‐operation and Development). (2009). Definition of residue. In: Series on pesticides, No 31; series on testing and assessment, No. 63. ENV/JM/MONO(2009)30, revision, published 28 July 2009.

OECD (Organisation for Economic Co‐operation and Development). (2011). OECD MRL calculator: Spreadsheet for single data set and spreadsheet for multiple data set, 2 march 2011. In: Pesticide Publications/Publications on Pesticide Residues. https://www.oecd.org

OECD (Organisation for Economic Co‐operation and Development). (2021). Test No. 509: Crop field trial, OECD guidelines for the testing of chemicals, section 5. OECD Publishing. https://doi.org/10.1787/9789264076457‐en

United Kingdom. (2017). Revised Renewal Assessment Report (RAR) on methoxyfenozide prepared by the rapporteur Member State the United Kingdom in the framework of Commission Implementing Regulation (EU) No 844/2012, July 2017. www.efsa.europa.eu