Modification of the existing maximum residue levels for tebufenozide in tree nuts

TL;DR

This paper discusses a request to modify maximum residue levels for tebufenozide in tree nuts, based on safety assessments and available analytical methods.

Contribution

The paper provides updated MRL proposals for tebufenozide in tree nuts supported by risk assessment and analytical data.

Findings

Adequate analytical methods are available to control tebufenozide residues at 0.01 mg/kg.

Long-term intake of tebufenozide residues is unlikely to pose a risk to consumer health.

Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nisso Chemical Europe GmbH submitted a request to the competent national authority in Italy to modify the existing maximum residue levels (MRLs) for the active substance tebufenozide in tree nuts. The data submitted in support of the request were found to be sufficient to derive MRL proposals for tree nuts. Adequate analytical methods for enforcement are available to control the residues of tebufenozide in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on indicative risk assessment results, EFSA concluded that the long‐term intake of residues resulting from the use of tebufenozide according to the reported agricultural practices is unlikely to present a risk to consumer health.

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Full text

SUMMARY

In accordance with Article 6 of Regulation (EC) No 396/2005, Nisso Chemical Europe GmbH submitted an application to the competent national authority in Italy (evaluating Member State, EMS) to set new maximum residue levels (MRLs) for the active substance tebufenozide in tree nuts (Brazil nuts, cashew nuts, chestnuts, coconuts, hazelnuts/cobnuts, macadamias, pecans, pine nut kernels, pistachios and ‘others’ tree nuts).

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 September 2024. The appointed EMS, Italy, assessed the dossier and declared its admissibility on 12 March 2025. 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 3 April 2025 to 24 April 2025. 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 the European Food Safety Authority (EFSA) on 10 July 2025. To accommodate for the intended uses of tebufenozide, the EMS proposed to raise the existing MRLs for tree nuts (except almonds and walnuts) from the limit of quantification (LOQ) to 0.04 mg/kg.

On 1 September 2025, 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 15 October 2025, which replaced the previously submitted evaluation report.

Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC, the data evaluated under previous MRL assessments (including review of the existing tebufenozide MRLs according to Article 12 of Regulation (EC) No 396/2005 (MRL review)) and the additional data provided by the EMS in the framework of this application, the following conclusions are derived.

The metabolism of tebufenozide following foliar application was investigated in crops belonging to the groups of fruit crops, root crops and cereals. Studies investigating the effect of processing on the nature of tebufenozide (hydrolysis studies) demonstrated that the active substance is stable. As the proposed use of tebufenozide is on permanent crops, investigations of residues in rotational crops are not required.

Based on the metabolic pattern identified in plant metabolism studies, hydrolysis studies and the toxicological relevance of metabolites, the residue definitions for plant products were proposed as tebufenozide for enforcement and ‘sum of tebufenozide and all metabolites including ethylphenyl and dimethylphenyl structures, expressed as tebufenozide’ for risk assessment. These residue definitions are applicable to primary crops, rotational crops and processed products.

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

Sufficiently validated analytical methods based on liquid chromatography with tandem mass spectrometry (LC–MS/MS) are available to quantify residues in the crops assessed in this application according to the enforcement residue definition. The methods enable the quantification of residues at or above 0.01 mg/kg (LOQ). No extraction efficiency has been demonstrated for these methods and lack of these data introduces additional uncertainty of the present assessment.

The available residue trials are sufficient to derive an MRL proposal of 0.04 mg/kg for crops belonging to the group of ‘tree nuts’.

Specific studies investigating the magnitude of tebufenozide residues in processed commodities were not provided and are not required. This is because significant residues are not expected in raw agricultural commodities (RAC) and the individual contribution of the assessed crops to the total theoretical maximum daily intake (TMDI) is below the trigger value of 10% of the ADI.

Since by‐product (coconut meal) of one of the crops under consideration is used as feed product, a potential carry‐over into food of animal origin was assessed. The calculated livestock dietary burden exceeded the trigger value of 0.1 mg/kg dry matter (DM) for all relevant species/animal species. However, the contribution of tebufenozide residues in the crops under consideration in this MRL application to the total livestock exposure was insignificant, and therefore, a modification of the existing MRLs for commodities of animal origin was considered unnecessary.

The toxicological profile of tebufenozide was assessed in the framework of the EU pesticides peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.02 mg/kg body weight (bw) per day. An acute reference dose (ARfD) was deemed unnecessary. The metabolites containing ethylphenyl and dimethylphenyl structures, included in the risk assessment residue definition for plants and animal commodities, were considered, by default, of similar toxicity as the parent active substance according to the EU pesticide peer review. Since the EU policy on setting residue definitions has changed meanwhile, EFSA recommends to further reconsider this conclusion under the upcoming renewal of approval of the active substance.

The consumer risk assessment was conducted with revision 3.1 of the EFSA Pesticide Residues Intake Model (PRIMo). A long‐term dietary exposure assessment from the MRL review has been updated to include the intended uses under evaluation. All supported existing EU uses and relevant Codex MRLs (CXLs) were therefore considered. Residue values derived under subsequent MRL assessment, which included uses on apricots and peaches, were also included. The risk assessment took into account also the input values derived for CXLs in products of animal origin, recently assessed by EFSA. The conversion factors to express residue data according to the residue definition for risk assessment, tentatively derived in the EU pesticides peer review and the MRL review, were used. The results indicated no concerns for long‐term exposure across the diets considered in EFSA's PRIMo model. The highest estimated long‐term dietary intake represented 70% of the ADI, for Duch (NL) toddler diet. The largest individual contribution of the residues arising from the crops under assessment was 0.03% of the ADI. EFSA notes a non‐standard uncertainty due to tentative conversion factors, derived from metabolism studies and used for several commodities assessed under the MRL review. To enhance the robustness of the risk assessment, revision of the unspecific residue definition established in 2010 or derivation of refined conversion factors, aligned with standard practices, is recommended. Furthermore, the consumer risk assessment is to be considered as indicative, pending the confirmatory data identified in the framework of the MRL review.

No short‐term dietary risk assessment was conducted since no ARfD was derived.

EFSA concluded that the proposed uses of tebufenozide on tree nuts will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a risk to consumers' health.

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

Full details of all end points and the consumer risk assessment can be found in Appendices B, C, D.Codea CommodityExisting EU MRL (mg/kg)Proposed EU MRL (mg/kg)Comment/justification Enforcement residue definition: TebufenozideF 0120010Almonds0.05No change The submitted data are sufficient to derive an MRL proposal of 0.04 mg/kg for the intended SEU use of tebufenozide. Since the existing MRL, based on the recommended CXL in the framework of the MRL review, is adequately supported by data and higher, no change of the existing MRL is needed. 0120020Brazil nuts0.01* 0.04 The submitted data are sufficient to derive an MRL proposal for the SEU use. Risk for consumers unlikely. 0120030Cashew nuts0.01* 0.040120040Chestnuts0.01* 0.040120050Coconuts0.01* 0.040120060Hazelnuts/cobnuts0.01* 0.040120070Macadamias0.01* 0.040120080Pecans0.01* 0.040120090Pine nut kernels0.01* 0.040120100Pistachios0.01* 0.040120110Walnuts0.05No change The submitted data are sufficient to derive an MRL proposal of 0.04 mg/kg for the intended SEU use of tebufenozide. Since the existing MRL, based on the recommended CXL in the framework of the MRL review, is adequately supported by data and higher, no change of the existing MRL is needed. 0120990Othersb 0.01* 0.04 The submitted data are sufficient to derive an MRL proposal for the SEU use. Risk for consumers unlikely. Abbreviations: CXL, Codex maximum residue limit; GAP, Good Agricultural Practice; MRL, maximum residue level; SEU, southern Europe.*Indicates that the MRL is set at the limit of analytical quantification (LOQ). ^a^ Commodity code number according to Annex I of Regulation (EC) No 396/2005. ^b^ The term ‘Others’ covers any other product not explicitly mentioned under the codes within the group of ‘Tree nuts’. ^F^ Fat soluble.

ASSESSMENT

The European Food Safety Authority (EFSA) received an application to modify the existing maximum residue levels (MRLs) for tebufenozide in tree nuts. The detailed description of the intended uses of tebufenozide, which are the basis for the current MRL application, is reported in Appendix A.

Tebufenozide is the ISO common name for N‐tert‐butyl‐N′‐(4‐ethylbenzoyl)‐3,5‐dimethylbenzohydrazide (IUPAC). The chemical structure of the active substance and its metabolites is reported in Appendix E.

Tebufenozide was evaluated in the framework of Directive 91/414/EEC,1 with Germany designated as rapporteur Member State (RMS) for the representative uses as a foliar treatment on grapes and pome fruits. The draft assessment report (DAR) prepared by the RMS has been peer reviewed by EFSA (EFSA, 2010). Tebufenozide was approved2 for use as an insecticide on 1 June 2011.

The EU MRLs for tebufenozide are established in Annexes 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 carried out (EFSA, 2018b), and the proposed modifications have been implemented in the MRL legislation. Certain Codex maximum residue limits (CXLs) have been taken over in the EU MRL legislation as well. After completion of the MRL review, EFSA has issued one reasoned opinion on the modification of MRLs for tebufenozide in peaches and apricots (EFSA, 2021). The proposals from this reasoned opinion have been considered in an MRL regulation.4 Furthermore, in a recent EFSA Scientific Report on the assessment of Codex MRLs, the implementation of higher MRLs for a few commodities of animal origin was proposed, but these EFSA recommendations have not been enforced yet at the EU level.

In accordance with Article 6 of Regulation (EC) No 396/2005 and following the provisions set by the ‘Transparency Regulation' (EU) 2019/1381,5 the applicant Nisso Chemical Europe GmbH submitted on 13 September 2024 an application to the competent national authority in Italy, alongside the dossier containing the supporting data using the IUCLID format.

The appointed EMS, Italy, assessed the dossier and declared its admissibility on 12 March 2025. 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 3 April 2025 to 24 April 2025. 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 the European Food Safety Authority (EFSA) on 10 July 2025. To accommodate for the intended SEU uses of tebufenozide, the EMS proposed to raise the existing MRLs from the limit of quantification (LOQ) to 0.04 mg/kg in the group of tee nuts, except for almonds and walnuts. In these two nuts, existing MRL of 0.05 mg/kg accommodates for residues resulting from the intended uses and the EMS did not propose to change this higher value.

On 1 September 2025, 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 15 October 2025 (Italy, 2025), which replaced the previously submitted evaluation report.

EFSA based its assessment on the evaluation report submitted by the EMS (Italy, 2025), the draft assessment report (DAR) and its addenda (Germany, 2005, 2009, 2010) prepared under Directive 91/414/EEC, the Commission review report on tebufenozide (European Commission, 2011), the conclusion on the peer review of the pesticide risk assessment of the active substance tebufenozide (EFSA, 2010), as well as the conclusions from previous EFSA outputs on tebufenozide, including the reasoned opinion on the MRL review according to Article 12 of Regulation No 396/2005 (EFSA, 2014, 2018b, 2021, 2025).

For this application, the data requirements established in Regulation (EU) No 544/20116 and the guidance documents applicable at the date of submission of the IUCLID application are applicable (, 1997b, 1997c, 1997d, 1997e, 1997f, 1997g, 2010, 2023a, 2023b, 2023c; European Commission, 1997a; OECD, 2013, 2014). The assessment is conducted 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

It is noted that almonds, cashew nuts, chestnuts, coconuts, hazelnuts, macadamia, pine nuts and walnuts are melliferous crops and the uses of tebufenozide described in the current application are expected during the flowering period. However, further data were not submitted by the applicant on investigation of residues in honey and are not required according to the data requirements applicable for the assessment of the submitted application.

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 (Italy, 2025) and the exposure calculations using the EFSA Pesticide Residues Intake Model (PRIMo) are made publicly available as background documents for this reasoned opinion.8

RESIDUES IN PLANTS

1

Nature of residues and methods of analysis in plants

1.1

Nature of residues in primary crops

1.1.1

The metabolism of tebufenozide in primary crops belonging to the group of fruit crops (apples, grapes), cereals/grass (rice) and root crops (sugar beet) has been investigated after foliar application in the framework of the EU pesticides peer review and in a previous MRL application (EFSA, 2010, 2014). These studies were also considered in the review of the existing MRLs (EFSA, 2018b). In the crops tested, parent compound was the main residue, representing 71%–92% of total radioactive residues (TRR) found in fruits; 51% TRR in cereals grain and 41% TRR in roots. Metabolites < 10% of TRR were identified in apple (RH‐111788, RH‐89886, RH‐122778, RH‐120282) and rice (RH‐120970, RH‐96595, RH‐111788 and RH‐89886). In sugar beet, several metabolites were identified, all individually counting less than 3.5% and < 0.01 mg/kg in roots. No individual metabolites were identified in grapes.

For the intended uses of tebufenozide on tree nuts (fruit crops), assessed under the present application, the metabolic behaviour in primary crops is sufficiently addressed.

Nature of residues in rotational crops

1.1.2

As the intended uses of tebufenozide are on permanent crops, investigations on the nature of residues in rotational crops are not required.

Nature of residues in processed commodities

1.1.3

The effect of processing on the nature of tebufenozide was investigated in the framework of the EU pesticides peer review (EFSA, 2010). EFSA concluded that tebufenozide is hydrolytically stable under the representative processing conditions of pasteurisation, baking/brewing/boiling and sterilisation.

Analytical methods for enforcement purposes in plant commodities

1.1.4

Analytical methods for the determination of tebufenozide residues in plant commodities were assessed during the EU pesticides peer review and the MRL review (EFSA, 2010, 2018b). For the four matrix groups (high water, high acid, high oil content and dry matrices), a multiresidue method based on liquid chromatography (LC) with tandem mass spectrometry (QuEChERS, MS/MS) was validated at the limit of quantification (LOQ) of 0.01 mg/kg (EFSA, 2018b) and on high‐performance liquid chromatography with mass spectrometry (HPLC‐MS) at the LOQ of 0.02 mg/kg (EFSA, 2010). An independent laboratory validation (ILV) was available for high water content matrices for the less sensitive method (EFSA, 2010).

EFSA concludes that the analytical methods are sufficiently validated to monitor residues of tebufenozide in the crops under consideration: high oil content commodities, except chestnuts that is classified as a dry commodity according to the guidance document SANTE/2020/12830 (European Commission, 2023a).

EFSA notes that the extraction efficiency of the analytical methods applied for enforcement is not proven in line with the requirements of the extraction efficiency Guideline SANTE 2017/10632 (European Commission, 2023c). In particular, for the commodities assessed under the present application (high oil content matrix), the assessment of extraction efficiency is not feasible due to the lack of metabolism study in a high oil content matrix. For dry content matrix, to which one of the assessed commodities belongs to chestnuts, no consideration of extraction efficiency has been provided. The lack of these data introduces additional uncertainty of the present assessment. To satisfy the current criteria of the guidance, further investigation on this matter would be required. EFSA would therefore recommend reassessing the extraction efficiency in the framework of the peer review for the renewal of approval of the active substance.

Storage stability of residues in plants

1.1.5

The storage stability of tebufenozide in plants stored under frozen conditions was investigated in the framework of the EU pesticides peer review, in a previous MRL application and within the MRL review (EFSA, 2010, 2018b, 2014). Tebufenozide was proven to be stable for 36 months in high water content commodities; 32 months in high acid content commodities; 42 months in high oil content commodities; 54 months in dry commodities, when stored at −18°C. Storage stability of tebufenozide has also been demonstrated in processed apple (juice) and grape (wine) commodities for up to 6 months and 30 months, respectively, when stored at −10°C.

It was demonstrated that, in crops assessed in the framework of this application, residues were stable for at least 42 months (high oil) and 54 months (dry commodities) when stored at −18°C.

Proposed residue definitions

1.1.6

Based on the metabolic pattern identified in the plant metabolism studies, the results of hydrolysis studies and the toxicological relevance of metabolites, the following residue definitions were derived:

• residue definition for risk assessment: Sum of tebufenozide and all metabolites including ethylphenyl and dimethylphenyl structures, expressed as tebufenozide;
• residue definition for enforcement: Tebufenozide.

These residue definitions are applicable to primary crops, rotational crops and processed products. Conversion factors from enforcement to risk assessment residue definition were proposed by the EU pesticides peer review and the MRL review for: fruits and root/tuber crops (1); tentatively for cereals/grass (2) and, tentatively for leafy crops (1.4) on the basis of metabolism studies (EFSA, 2010, 2018b). For fruit crops, relevant for the current assessment, a conversion factor of 1 is therefore applicable since the main portion of residues (71%–92% of total radioactivity) in the metabolism studies was attributed to the parent compound (see Section 1.1.1).

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

EFSA concludes that these residue definitions are appropriate for the intended uses assessed in this application. Nevertheless, since the metabolites included in the risk assessment residue definition were considered, by default, of similar toxicity as the parent active substance according to the EU pesticide peer review and given that the EU policy on setting residue definitions has changed meanwhile, EFSA recommends to further reconsider this conclusion under the upcoming renewal of approval of the active substance.

Magnitude of residues in plants

1.2

Magnitude of residues in primary crops

1.2.1

In support of the MRL application, the applicant submitted in total four independent and GAP compliant residue trials, two of them conducted with almonds and two with hazelnuts. Trials were carried out over one growing season of 2023 in Italy, Spain and Greece, representing a wide geographical area, thus partially compensating the deviation from the requirement that trials shall be carried out over at least two growing seasons. Since, in addition, two different crops were used (almond, hazelnut), the variability in residue levels is deemed sufficiently covered and no further data is considered as needed.

Crops were treated with three applications, each accounting for 142–158 g active substance (a.s.)/ha, with an interval between applications of 12–14 days. Last application was carried out at the BBCH 75–81 and sampling occurred at the PHI of 29–30 days. Under the applicable data requirements of Regulation (EC) No 544/2011, half of the field trials should follow a decline design to demonstrate the effect of time on residue levels. No decline trials were submitted, however, given the long intended PHI of 30 days, residue levels are expected to reach the peak by harvest, with no subsequent increase anticipated. Therefore, additional decline data were not further requested.

Samples of the provided field trials were analysed only for the parent compound, and no data were provided according to the residue definition for risk assessment (RA‐RD). Additional data were not requested, as metabolism studies in fruit crops indicated that residues consist almost entirely of the parent compound (71%–92% of the TRR found in fruits). Consequently, no conversion factor (i.e. a default value of 1 applied) was proposed under the EU pesticides peer review (EFSA, 2010). The previously applied conversion factor of 1 for fruit crops is therefore considered applicable to the current risk assessment (EFSA, 2018a, 2021). EFSA anyway notes that field trials on representative fruit crops confirming the metabolic pattern observed in metabolism studies – where only the parent compound is expected to be quantifiable – would be desirable in the future.

According to the assessment of the EMS, the methods used for the analysis of samples were sufficiently validated and fit for purpose. EFSA notes that the extraction efficiency of the analytical method applied for residue trials is not proven as indicated according to the requirements of the extraction efficiency Guideline, SANTE 2017/10632 (European Commission, 2023c) for majority of the commodities, due to the lack of a radiolabelled study in high oil matrix. The lack of these data introduces additional uncertainty of the present assessment. The samples of the provided residue trials were stored under conditions for which storage stability of tebufenozide residues has been demonstrated (Italy, 2025).

The submitted data are sufficient to propose an MRL of 0.04 mg/kg for the entire tree nut group. Almonds and hazelnuts are representative crops of this crop group, and EU Guidance on extrapolation allows extrapolation from two or more representative crops to the whole group of tree nuts. Furthermore, all components of the group are minor crops, and a minimum of four trials is sufficient to support the MRL proposal (European Commission, 2023b).

Magnitude of residues in rotational crops

1.2.2

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

Magnitude of residues in processed commodities

1.2.3

Processing studies for the crops under assessment are neither available nor required since residues of tebufenozide in raw agricultural commodities are below the threshold value of 0.1 mg/kg and the individual contribution of the assessed crops to the total theoretical maximum daily intake (TMDI) is below the trigger value of 10% of the ADI (See Section 1.2.1).

Proposed MRLs

1.2.4

The available data are considered sufficient to derive MRL proposals as well as risk assessment values for the commodities under evaluation (tree nuts). It should be noted that the currently existing MRLs for almonds and walnuts, based on Codex MRLs (CXLs) that were recommended for inclusion in the MRL legislation under the MRL review, are higher than the MRL derived according to the intended SEU GAP under this assessment. Therefore, no MRL change is proposed for these two commodities.

In Section 3, EFSA assessed whether residues on these crops resulting from the intended uses are likely to pose a consumer health risk.

RESIDUES IN LIVESTOCK

2

By‐product of one of the assessed tree nut crops (coconuts) may be used for feed purposes (coconut meal). Hence, it was necessary to update the previous dietary burden calculation for livestock to estimate whether the intended use of tebufenozide would have an impact on the residues expected in food of animal origin (EFSA, 2018b).

The input values for the exposure calculations for livestock are presented in Appendix D.1. The results of the dietary burden calculation are presented in Appendix B.2.

Although exposure for all livestock species exceeded the trigger value of 0.1 mg/kg dry matter (DM), set under Regulation (EU) No 544/2011, the median and maximum animal burden remained similar to the previous calculations (EFSA, 2018b). Therefore, the carry‐over of residues of tebufenozide and its relevant metabolites from coconut meal into food of animal commodities was not further investigated in the framework of the current application, and the conclusions drawn in the MRL review are applicable. Since the updated livestock dietary burden has not been changed, EFSA is not proposing a modification of the existing EU MRLs in products of animal origin.

CONSUMER RISK ASSESSMENT

3

EFSA conducted 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 value for tebufenozide used in the risk assessment (i.e. ADI value) was derived in the framework of the EU pesticides peer review (European Commission, 2011; as revised in 2021). An acute reference dose (ARfD) was not allocated as not considered necessary. The metabolites containing ethylphenyl and dimethylphenyl structures, included in the risk assessment residue definition for plants and animal commodities, were considered, by default, of similar toxicity as the parent active substance according to the EU pesticide peer review (EFSA, 2010). EFSA recommends to further consider this conclusion under the upcoming renewal of approval of the active substance.

Short‐term (acute) dietary risk assessment

Considering the toxicological profile of the active substance, a short‐term dietary risk assessment was not required.

Long‐term (chronic) dietary risk assessment

In the framework of the MRL review, a comprehensive long‐term exposure assessment was conducted, taking into account the existing uses at EU level and the acceptable CXLs (EFSA, 2018b). EFSA updated the calculation with the relevant supervised trial median residue value according to the residue definition for enforcement (STMR_Mo_) derived from the residue trials submitted in support of this MRL application for all tree nuts except almonds and walnuts. For these two crops, the existing MRL remains higher from the one derived under this assessment. In addition, STMR_Mo_ derived in EFSA opinion published after the MRL review was included (EFSA, 2021). Although not yet implemented into the EU legislation, CXLs recently assessed by EFSA were also considered in the exposure calculations for a more comprehensive overview (EFSA, 2025; FAO and WHO, 2025). The input values used in the exposure calculations are summarised in Appendix D.2.

The estimated long‐term dietary intake accounted for a maximum of 70% of the ADI (NL toddler diet). The contribution of residues expected in the commodities assessed in this application to the overall long‐term exposure accounted for a maximum of 0.03% of ADI (coconuts). Further details on individual contribution of assessed crops are presented in Appendix B.3.

For plums, strawberries and courgettes, existing EU MRLs were lowered to the LOQ of 0.01 mg/kg in the Regulation (EU) 2019/9739 as no supporting data were submitted during the MRL review. The corresponding input values were therefore excluded from this exposure calculation, assuming no national authorisation is in place any longer. For the rest of commodities, where both CXLs and EU uses are available, regardless of whether the implemented MRL is based on a CXL or EU use, a higher STMR‐Mo value was always selected for the calculation between the two. The same approach was followed for non‐implemented CXLs, recently recommended by EFSA. The peeling factor of 0.18 derived in the MRL review was included for citrus to take into account that residues shall refer to the edible portion of these fruits. Tentative MRLs were set for cherries (sweet), rice, swine (liver, kidney, edible offal), bovine (liver, kidney, edible offal), sheep (fat, liver, kidney, edible offal), goat (fat, liver, kidney, edible offal), equine (liver, kidney, edible offal), poultry (muscle, fat, liver, kidney, edible offal), milk (cattle, sheep, goat, horse) and birds' eggs in Regulation (EU) 2019/973 as some information was not available.

To comply with the residue definition for risk assessment, the tentative conversion factors (CF) from enforcement to risk assessment that were derived in the framework of the EU peer review and MRL review based on the results of the metabolism studies in plants and animals were used in the dietary exposure calculation. For leafy and brassica vegetables, tentatively derived conversion factor for leafy crops was applied; for sugar cane, rape seed and rice, tentative conversion factor derived for cereals was applied. Tentative conversion factors were also applied to the input values for animal commodities. For fruit crops, CF adjustment was not necessary (i.e. CF equal to 1 applied) (EFSA, 2018b).

EFSA notes that non‐standard uncertainties in the risk assessment stem from the use of tentative conversion factors10 for several commodities assessed under the MRL review. To enhance the robustness of the assessment, revision of the unspecific residue definition for risk assessment, established in 2010, or derivation of refined conversion factors aligned with standard practices is recommended.

Based on the presented calculations above, EFSA concludes that the proposed uses of tebufenozide are acceptable with regard to consumer exposure. The long‐term intake of residues of tebufenozide resulting from the existing and the intended uses is unlikely to present a risk to consumer health. The conducted risk assessment remains indicative, pending the confirmatory data identified in the framework of the MRL review.

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

CONCLUSION AND RECOMMENDATIONS

4

The data submitted in support of this MRL application were sufficient to propose an MRL for all crops within the tree nuts group (including almonds, Brazil nuts, cashew nuts, chestnuts, coconuts, hazelnuts/cobnuts, macadamias, pecans, pine nut kernels, pistachios, walnuts and others). For almonds and walnuts, the existing MRLs that are based on CXLs recommended during the MRL review and that were implemented in the legislation, are higher than the MRL calculated from the data assessed in this application. Therefore, no changes to the MRLs for these two commodities are proposed.

EFSA concludes that the proposed use of tebufenozide on tree nuts will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a risk to consumers' health. It is recognised that the estimated exposure is affected by non‐standard uncertainties due to the use of tentative conversion factors derived from metabolism studies to account for residues included in the risk assessment residue definition which unspecifically includes all metabolites with the ethylphenyl and dimethylphenyl structures. To enhance the robustness of the risk assessment, revision of the unspecific residue definition or derivation of refined conversion factors aligned with standard practices is recommended. The conducted risk assessment is anyway indicative, pending the confirmatory data identified in the framework of the MRL review.

The MRL recommendations are summarised in Appendix B.4.

ABBREVIATIONSa.s.active substanceADIacceptable daily intakeARapplied radioactivityARfDacute reference doseBBCHgrowth stages of mono‐ and dicotyledonous plantsbwbody weightCACCodex Alimentarius CommissionCASChemical Abstract ServiceCCPRCodex Committee on Pesticide ResiduesCENEuropean Committee for Standardisation (Comité Européen de Normalisation)CFconversion factor for enforcement to risk assessment residue definitionCScapsule suspensionCVcoefficient of variation (relative standard deviation)CXLCodex maximum residue limitDARdraft assessment reportDATdays after treatmentDMdry matterDPdustable powderDSpowder for dry seed treatmentECemulsifiable concentrateECDelectron capture detectorEDIestimated daily intakeEMSevaluating Member Stateeqresidue expressed as a.s. equivalentFAOFood and Agriculture Organization of the United NationsGAPGood Agricultural PracticeGCgas chromatographyGC‐FIDgas chromatography with flame ionisation detectorGC‐MSgas chromatography with mass spectrometryGC‐MS/MSgas chromatography with tandem mass spectrometryGC‐NPDgas chromatography with nitrogen/phosphorous detectorGRgranuleHPLC‐MS/MShigh‐performance liquid chromatography with tandem mass spectrometryHRhighest residueIEDIinternational estimated daily intakeILVindependent laboratory validationISOInternational Organisation for StandardisationIUPACInternational Union of Pure and Applied ChemistryLCliquid chromatographyLOQlimit of quantificationMRLmaximum residue levelMSMember StatesMSmass spectrometry detectorMS/MStandem mass spectrometry detectorMWmolecular weightNEUnorthern EuropeNPDnitrogen/phosphorous detectorOECDOrganisation for Economic Co‐operation and DevelopmentPFprocessing factorPHIpreharvest intervalP_ow_ partition coefficient between n‐octanol and waterPRIMo(EFSA) Pesticide Residues Intake ModelRArisk assessmentRACraw agricultural commodityRDresidue definitionRMSrapporteur Member StateSCsuspension concentrateSEUsouthern EuropeSGwater‐soluble granuleSLsoluble concentrateSTMRsupervised trials median residueTARtotal applied radioactivityTMDItheoretical maximum daily intakeTRRtotal radioactive residueUVultraviolet (detector)

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2024‐00574

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