Setting of import tolerances for dimethomorph in grapes

TL;DR

This paper discusses the setting of import tolerances for dimethomorph in grapes to ensure consumer safety.

Contribution

The paper confirms that current residue levels of dimethomorph in grapes do not pose a health risk to consumers.

Findings

Analytical methods can detect dimethomorph residues at 0.005 mg/kg in grapes.

Consumer exposure from dimethomorph in grapes does not exceed toxicological reference values.

Import tolerance for dimethomorph in grapes is unlikely to pose a health risk.

Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro B.V. Arnhem (NL) Freienbach Branch submitted a request to the competent national authority in the Netherlands to set an import tolerance for the active substance dimethomorph in table and wine grapes. The data submitted in support of the request indicated no need to modify the existing EU maximum residue level (MRL) for table and wine grapes. Adequate analytical methods for enforcement are available to control the residues of dimethomorph in plant matrices at the validated limit of quantification (LOQ) of 0.005 mg/kg and allow the quantitation of both E‐ and Z‐isomer individually. Since dimethomorph is a non‐approved active substance under Regulation (EC) No 1107/2009, EFSA performed a dietary consumer risk assessment considering only Codex MRLs and import tolerances implemented in the EU MRL legislation in addition to the new data provided with this import tolerance application in grapes. Provided that EU uses are withdrawn, the related MRLs are lowered to the LOQ, and the conclusions of the targeted MRL review are implemented, EFSA concluded, based on the risk assessment, that consumer exposure from the import tolerance for dimethomorph on grapes does not exceed the toxicological reference values. Consequently, the import tolerance is unlikely to pose a risk to consumers' health.

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Full text

SUMMARY

In accordance with Article 6 of Regulation (EC) No 396/2005, BASF Agro B.V. Arnhem (NL) Freienbach Branch submitted an application to the competent national authority in the Netherlands (rapporteur Member State, RMS) to set an import tolerance for the active substance dimethomorph in table and wine grapes.

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 28 February 2024. The appointed RMS, the Netherlands, assessed the dossier and declared its admissibility on 17 September 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 ran from 30 October 2024 to 20 November 2024. No additional data nor comments were submitted in the framework of the consultation.

At the end of the commenting period, the RMS 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 15 August 2025. The RMS proposed to establish maximum residue levels (MRLs) for table and wine grapes imported from the United States at the level of 3 mg/kg.

On 29 October 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.

It is noted that, in the framework of the procedure on the renewal of the approval of dimethomorph under Regulation (EC) No 1107/2009, EFSA identified several areas of concern and data gaps for the active substance. Based on the EFSA conclusions and due to the classification of dimethomorph as toxic to reproduction cat. 1B and as meeting the criteria for endocrine disruption under the CLP Regulation, dimethomorph was not renewed by Commission Implementing Regulation (EU) 2024/1207. The corresponding grace period expired on 20 May 2025.

Following the non‐renewal of approval of dimethomorph as an active substance under Regulation (EC) No 1107/2009, and after the expiry of the grace period, EU authorisations should, in principle, be withdrawn and the MRLs based on former EU uses should be lowered to the limit of quantification. However, for food and feed commodities for which Codex MRLs or import tolerances are established, an MRL may still be maintained if it is proven to be safe for consumers. Therefore, European Commission requested EFSA (2024) to carry out a targeted MRL review for dimethomorph, limited to existing MRLs based on Codex MRLs or import tolerances, which was finalised in 2024. This targeted MRL review was performed considering the residue definition and toxicological reference values (TRVs) as derived in the context of the renewal of approval carried out by EFSA. EFSA confirmed that the current TRVs are sufficiently protective for consumers. Moreover, the consumer exposure calculations performed by EFSA showed that the existing MRLs, including the ones based on Codex maximum residue limits (CXLs) or import tolerances, do not lead to consumers’ intake concern. To date, the conclusions of the targeted MRL review have not yet been implemented.

Based on the conclusions derived by EFSA in the framework of Regulation (EC) No 1107/2009, the data evaluated under the follow‐up targeted MRL review for dimethomorph and the additional data provided by the RMS in the framework of this application, the following conclusions are derived.

The metabolism of dimethomorph following foliar applications was investigated in crops belonging to the groups of fruit crops, root crops and leafy crops.

Studies investigating the effect of processing on the nature of dimethomorph (hydrolysis studies) demonstrate that the active substance is stable.

As the authorised use of dimethomorph is on a permanent imported crop, investigations of nature and magnitude of residues in rotational crops are not required.

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 ‘dimethomorph (sum of isomers)’ for enforcement and risk assessment. These residue definitions are applicable to primary crops, rotational crops, processed products and honey.

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

Sufficiently validated analytical methods based on high‐performance liquid chromatography with tandem mass spectrometry (HPLC‐MS/MS) are available to quantify residues in grapes according to the enforcement residue definition. The methods are sufficiently validated for the quantification of both E‐ and Z‐isomers of dimethomorph individually at the validated LOQ of 0.005 mg/kg in the crop under consideration.

The available residue trials confirm that the existing EU MRL of 3 mg/kg is sufficient to cover residues in table and wine grapes resulting from the authorised use of dimethomorph in United States, as reported in the present MRL application.

No new studies investigating the effect of processing on the magnitude of dimethomorph residues in processed grape products were submitted with the present MRL application. However, processing studies in grapes were evaluated in the framework of the EU pesticides peer review, and robust processing factors were derived.

Residues of dimethomorph in commodities of animal origin were not assessed, since the crop under consideration in this MRL application is not fed to livestock.

The toxicological profile of dimethomorph was assessed in 2023 in the framework of the EU pesticides peer review under Regulation (EC) No 1107/2009 and the data were sufficient to derive an acceptable daily intake (ADI) of 0.05 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 0.6 mg/kg bw.

These health‐based guidance values (HBGVs) are set based on the critical effects identified in the mammalian toxicity studies including the reproductive toxicity endpoints that lead to the classification of dimethomorph as Repr. Cat. 1B.1 Furthermore, during the peer review, dimethomorph was also concluded to meet the criteria for endocrine disruptors for humans and wild mammals as non‐target organisms. In view of the above, and under the remit of a follow‐up targeted MRL review, in 2024, EFSA was requested by European Commission to confirm if the current TRVs are protective for consumers, including ED‐related hazards. In 2024, EFSA confirmed that the above‐mentioned TRVs derived in 2023 are sufficiently protective for consumers, including the hazard indicative of endocrine disruption.

The consumer risk assessment was performed with revision 3.1 of the EFSA Pesticide Residues Intake Model (PRIMo). EFSA updated the consumer risk assessment performed in the targeted MRL review of 2024 (considering only Codex MRLs and import tolerances) with the new residue data provided with this import tolerance MRL application in grapes. The short‐term exposure did not exceed the ARfD for grapes with the highest exposure being 22.6% of the ARfD (FI 3‐year‐old children). The long‐term exposure did not exceed the ADI, with the highest exposure reaching 17% of ADI (NL toddler).

The commodities for which the existing EU MRL is based on EU uses, expired on 20 May 2025, were excluded from the calculation.

Provided that the EU uses are withdrawn and related MRLs lowered to the LOQ and the conclusions of the targeted MRL review are implemented, EFSA concluded that the authorised use of dimethomorph on grapes 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 confirm 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: Dimethomorph (sum of isomers)0151010Table grapes33The submitted data indicate no need to modify the existing EU MRL on the basis of authorised US GAP. Risk for consumers unlikely.0151020Wine grapes33The submitted data indicate no need to modify the existing EU MRL on the basis of authorised US GAP. Risk for consumers unlikely.Abbreviations: GAP, Good Agricultural Practice; MRL, maximum residue level; NEU, northern Europe; SEU, southern Europe. ^a^ Commodity code number according to Annex I of Regulation (EC) No 396/2005.

ASSESSMENT

The European Food Safety Authority (EFSA) received an application to set an import tolerance for the active substance dimethomorph in table and wine grapes. The detailed description of the existing use of dimethomorph authorised in the USA in grapes, which is the basis for the current MRL application, is reported in Appendix A.

Dimethomorph is the ISO common name for (2EZ)‐3‐(4‐chlorophenyl)‐3‐(3,4‐dimethoxyphenyl)‐1‐(morpholin‐4‐yl)propanone (IUPAC). The chemical structures of the active substance and its main metabolites are reported in Appendix E.

Dimethomorph is an active substance which belongs to the class of morpholine fungicides such as tridemorph and fenpropimorph. In the framework of the procedure on the renewal of the approval of dimethomorph under Regulation (EC) No 1107/2009,2 EFSA identified several areas of concern3 and data gaps (EFSA, 2023). Based on the EFSA conclusions and due to the classification of dimethomorph as toxic to reproduction cat. 1B and meeting criteria for endocrine disruption under the CLP Regulation, dimethomorph was not renewed by Commission Implementing Regulation (EU) 2024/1207.4 Following the decision of non‐renewal of dimethomorph, the corresponding grace period expired on 20 May 2025.

The EU MRLs for dimethomorph are established in Annex II of Regulation (EC) No 396/2005.5 The review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (MRL review) has been performed (EFSA, 2011) and the proposed modifications have been implemented in the MRL legislation. After completion of the MRL review, EFSA has issued several reasoned opinions on the modification of MRLs for dimethomorph. The proposals from these reasoned opinions have been considered in MRL regulations.6

Following the non‐renewal of approval of dimethomorph as an active substance under Regulation (EC) No 1107/2009, and after the expiry of the grace period, EU authorisations should, in principle, be withdrawn and the MRLs based on former EU uses should be lowered to the limit of quantification. However, for food and feed commodities for which Codex MRLs or import tolerances are established, an MRL may still be maintained if it is proven to be safe for consumers. Therefore, the European Commission requested EFSA in 2024 to carry out a targeted MRL review for dimethomorph, limited to existing MRLs based on Codex MRLs or import tolerances, which was finalised in 2024 (EFSA, 2024). This targeted MRL review was performed considering the residue definition and toxicological reference values as derived in the context of the renewal of approval carried out by EFSA (EFSA, 2023). To date, the conclusions of the targeted MRL review have not been implemented. Furthermore, the EU MRLs related to EU uses have not yet been lowered to the LOQ.

Overall, the exposure calculations performed by EFSA in the targeted MRL review showed that the existing MRLs based on Codex MRLs or import tolerances do not lead to consumers' intake concerns. In that framework, no consumers' intake concerns were identified also for the existing MRL of 3 mg/kg in table and wine grapes, which is based on the Codex MRL.

In accordance with Article 6 of Regulation (EC) No 396/2005 and following the provisions set by the ‘Transparency Regulation’ (EU) 2019/13817, the applicant BASF Agro B.V. Arnhem (NL) Freienbach Branch submitted an application on 28 February 2024 to the competent national authority in the Netherlands, together with a dossier containing the supporting data using the IUCLID format.

The appointed RMS, the Netherlands, assessed the dossier and declared its admissibility on 17 September 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 ran from 30 October 2024 to 20 November 2024. No additional data nor comments were submitted in the framework of the consultation.

At the end of the commenting period, the RMS 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 15 August 2025. The RMS proposed to establish maximum residue levels (MRLs) for grapes imported from the United States at the level of 3 mg/kg for table and wine grapes. The existing EU MRL for dimethomorph in grapes is already set at 3 mg/kg.

On 29 October 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 based its assessment on the evaluation report submitted by the RMS (Netherlands, 2025), the renewal assessment report (RAR) (Netherlands, 2022) prepared under Regulation (EC) 1107/2009, the Commission review report on dimethomorph (European Commission, 2024), the conclusion on the peer review of the pesticide risk assessment of the active substance dimethomorph (EFSA, 2023) as well as the conclusions form the follow‐up targeted MRL review of dimethomorph (EFSA, 2024).

For this application, the data requirements established in Regulation (EU) No 283/20138 and the guidance documents applicable at the date of submission of the IUCLID application are applicable (European Commission, 2010, 2023a, 2023b, 2023c; OECD, 2007a, 2007b, 2007c, 2007d, 2007e, 2007f, 2007g, 2007h, 2008a, 2008b, 2009, 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 546/2011.9

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 (Netherlands, 2025) and the exposure calculations using the EFSA Pesticide Residues Intake Model (PRIMo) are made publicly available as background documents to this reasoned opinion.10

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 dimethomorph in primary crops belonging to the group of fruit crops, root crops and leafy crops has been investigated in the framework of the EU pesticides peer review (EFSA, 2023).

In the crops tested by applying morpholine‐^14^C‐ and chlorophenyl‐^14^C‐labelled dimethomorph, the metabolic pathways show a common pattern regarding the nature of residues. The metabolism of dimethomorph in plants is not extensive after foliar spray applications, and the unchanged parent compound is the quantitatively most predominant component of the total residue.

For the authorised use on grapes, the metabolic behaviour in primary crops is sufficiently addressed.

Nature of residues in rotational crops

1.1.2

Investigations of residues in rotational crops are not required for imported crops. Moreover, grapes are permanent crops and are not expected to be grown in rotation with other plants. Therefore, no studies on the nature of residues of dimethomorph in rotational crops are required in the framework of this application (OECD, 2007b).

Nature of residues in processed commodities

1.1.3

The effect of processing on the nature of dimethomorph was investigated in the framework of the EU pesticide peer review (EFSA, 2023). These studies showed that dimethomorph is hydrolytically stable under standard processing conditions representative of pasteurisation, baking, boiling, brewing and sterilisation.

Analytical methods for enforcement purposes in plant commodities

1.1.4

Analytical methods for the determination of dimethomorph residues in plant commodities using high‐performance liquid chromatography with tandem mass spectrometry (HPLC‐MS/MS) were assessed during the EU pesticide peer review (EFSA, 2023). The methods are sufficiently validated for the quantification of both E‐ and Z‐isomers of dimethomorph individually at the validated LOQ of 0.005 mg/kg in grapes, leading to an LOQ of 0.01 mg/kg based on the enforcement residue definition, expressed as dimethomorph (sum of isomers).

The extraction efficiency of the analytical methods for enforcement was demonstrated in the framework of the renewal of the approval for dimethomorph since these analytical methods used the identical extraction solvent mixture used in the metabolism studies; thus, the extraction efficiency data generated within the metabolism studies are also valid for these methods (Netherlands, 2022).

Storage stability of residues in plants

1.1.5

The storage stability of dimethomorph and the metabolites M550F002, M550F007 and M550F021 (morpholine)11 in plant matrices stored under frozen conditions was investigated in the framework of the EU pesticide peer review (EFSA, 2023).

It was demonstrated that in grapes, which are the crop assessed in the framework of this application, dimethomorph is stable for at least 24 months when stored at −18°C.

Proposed residue definitions

1.1.6

Based on the metabolic pattern identified in metabolism studies, the results of hydrolysis studies, the toxicological relevance of metabolites and the capabilities of enforcement analytical methods, the following residue definitions were proposed in previous EFSA assessments and confirmed in the latest renewal of approval of dimethomorph (EFSA, 2023):

• residue definition for risk assessment: dimethomorph (sum of isomers)
• residue definition for enforcement: dimethomorph (sum of isomers)

The same residue definitions are applicable to rotational crops and processed products.

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

For the authorised use on grapes assessed in this application, EFSA concluded that these residue definitions are appropriate, and no modification or further information is required.

Magnitude of residues in plants

1.2

Magnitude of residues in primary crops

1.2.1

In support of this import tolerance MRL application, the applicant submitted residue trials performed in grapes. The samples were analysed for the parent compound. According to the assessment of the EMS, the methods used were sufficiently validated and fit for purpose (Netherlands, 2025).

The extraction efficiency of the analytical methods used for risk assessment was demonstrated since these analytical methods used the identical extraction solvent mixture used in the metabolism studies; thus, the extraction efficiency data generated in the metabolism studies are also valid for the analytical methods used for risk assessment (Netherlands, 2025).

The samples of these residue trials were stored under conditions (less than 12 months) for which stability of the residue samples has been demonstrated.

GAP grapes (USA): 4 × 183–233 g a.s. /ha, 7–10 days interval, PHI: 14 days

The applicant provided 16 independent residue trials on grapes performed in various locations in the USA and in Brazil during the period 2008–2010. At each location, four foliar applications at 0.225 kg a.s./ha at a 7‐day interval and with a PHI of 14 days were made, in line with the authorised critical USA GAP as reported in Appendix A. This data set meets the minimum requirements of eight GAP compliant trials on grapes as it is a major crop worldwide (table and wine grape) according to SANTE/2019/12752 (European Commission, 2023b).

The residue trials performed in the USA (12 harvest trials) have been previously evaluated by the JMPR in 2014 (FAO and WHO, 2014) and used to establish the Codex MRL for dimethomorph in grapes at 3 mg/kg. In 2015, EFSA provided support for the preparation of the EU position for the 47th session of the Codex Committee on Pesticide Residues (CCPR) where it concluded that the Codex MRL of dimethomorph in grapes, as proposed by the JMPR in 2014, was sufficiently supported by data and safe for consumers (EFSA, 2015). Furthermore, no reservations were expressed by the EU delegation for the MRL in grapes at the 38th Session of Codex Alimentarius Commission (CAC, 2015).

Additionally, within this import tolerance MRL application, the applicant submitted four independent decline field trials on grapes, carried out in Brazil. Moreover, one decline field trial from the USA (previously assessed) was also available. This USA decline field trial was not independent of one of the USA harvest trials (the harvest trial reported higher residue levels of dimethomorph at a PHI of 14 days and was therefore selected for the MRL calculation), but the data were still valid to determine residue decline. Based on the data of these five decline field trials, a decline of dimethomorph at later PHIs was observed.

Based on all available data, an MRL of 3 mg/kg, as currently in force according to Regulation (EU) 2020/1633, is confirmed for dimethomorph in table and wine grapes accommodating the authorised use in the United States.

Magnitude of residues in rotational crops

1.2.2

Investigations of residues in rotational crops are not required for imported crops or for permanent crops. Therefore, no studies on the magnitude of residues of dimethomorph in rotational crops are required in the framework of this application (OECD, 2007d).

Magnitude of residues in processed commodities

1.2.3

New studies investigating the effect of processing on the magnitude of residues in processed grape products were not submitted with the present MRL application.

Processing studies in grapes were investigated in the framework of the EU pesticide peer review (EFSA, 2023). The number and quality of the processing studies were sufficient to derive robust processing factors as reported in Appendix B.1.2.3. (Processing Factors). The data indicate that dimethomorph residues concentrate in pomace and raisins, while a dilution is observed in wine.

Proposed MRLs

1.2.4

The available data are considered sufficient to derive an MRL proposal as well as risk assessment values for table and wine grapes. In Section 3, EFSA assessed whether residues on grapes resulting from the uses authorised in the USA are likely to pose a consumer health risk.

RESIDUES IN LIVESTOCK

2

Not relevant as grapes are not used for feed purposes.

CONSUMER RISK ASSESSMENT

3

EFSA performed a dietary risk assessment using revision 3.1 of the EFSA PRIMo (EFSA, 2018, 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/WHO, 2016).

The toxicological reference values for dimethomorph used in the risk assessment (i.e. ADI: 0.05 mg/kg bw per day and ARfD: 0.6 mg/kg bw) were derived in the framework of the EU pesticides peer review (European Commission, 2024).

During the procedure on the renewal of the approval of dimethomorph under Regulation (EC) No 1107/2009, EFSA identified several areas of concern and data gaps for the active substance:

• –dimethomorph is classified according to Regulation (EC) No 1272/2008 as toxic to reproduction, category 1B (H360F ‘may damage fertility’);12
• –dimethomorph meets the criteria for endocrine disruptors for humans and wild mammals as non‐target organisms.

Based on these EFSA conclusions, dimethomorph was non‐renewed by Commission Implementing Regulation (EU) 2024/1207. Following the non‐renewal of approval of dimethomorph as an active substance under Regulation (EC) No 1107/2009, and after the expiry date of the grace period on 20 May 2025, EU authorisations should in principle be withdrawn and the MRLs based on former EU uses lowered to the limit of quantification. However, for food and feed commodities for which Codex MRLs or import tolerances are established, an MRL may still be maintained if it is proven to be safe for consumers. Therefore, the European Commission requested EFSA in 2024 to carry out a targeted MRL review for dimethomorph, limited to existing MRLs based on Codex MRLs or import tolerances (EFSA, 2024). This targeted MRL review was performed considering the residue definition and toxicological reference values as derived in the context of the renewal of approval carried out by EFSA (EFSA, 2023).

In the framework of this targeted MRL review (EFSA, 2024), EFSA considered all the Codex MRLs and import tolerances that are covered by the existing EU MRLs. Therefore, the import tolerance uses of dimethomorph reported in previous EFSA assessments (EFSA, 2012, 2016) and the uses of dimethomorph previously assessed by the JMPR (FAO and WHO, 2007, 2014, 2016) were considered.

The targeted MRL review confirmed that the toxicological reference values derived in 2023 are expected to be protective for endocrine disruption and concluded that the Codex MRLs and import tolerances do not lead to a consumer intake concern (EFSA, 2024). EFSA has now updated the consumer risk assessment performed in the targeted MRL review of 2024 with the new residue data on grapes provided with this import tolerance MRL application for grapes.

Short‐term (acute) dietary risk assessment

The short‐term exposure assessment was performed in accordance with the internationally agreed methodology and focused on grapes. The calculations were based on the HR value (1.86 mg/kg) derived from supervised field trials on grapes and the complete list of input values can be found in Appendix D. The short‐term exposure did not exceed the ARfD for grapes with the highest exposure being 22.6% of the ARfD (FI 3‐year‐old children).

Long‐term (chronic) dietary risk assessment

In the framework of the targeted MRL review (EFSA, 2024), a comprehensive long‐term exposure assessment was performed, considering the import tolerance uses of dimethomorph reported in previous EFSA assessments (EFSA, 2012, 2016) and the uses of dimethomorph previously assessed by the JMPR (FAO and WHO, 2007, 2014, 2016). EFSA updated the calculation with the relevant STMR value derived from the residue trials submitted in support of this import tolerance MRL application for grapes. EFSA notes that, with the enlarged residue data set, the MRL proposal for grapes does not change while a lower STMR (0.56 vs. 0.6 mg/kg) than that derived for the existing Codex MRL is calculated. For the exposure assessment, EFSA used the value as derived under the present assessment considering that it is derived from a broader residue data set.

The input values used in the exposure calculations are summarised in Appendix D.

The long‐term exposure did not exceed the ADI, with the highest exposure reaching 17% of ADI (NL toddler). The contribution of residues expected in grapes, the commodity assessed in this application, to the overall long‐term exposure is presented in more detail in Appendix D.

Provided that the EU uses are withdrawn and related MRLs lowered to the LOQ and the conclusions of the targeted MRL review implemented, EFSA concluded that the short‐term and long‐term intake of residues of dimethomorph is unlikely to present a risk to consumer health. 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 found to be sufficient to derive an MRL proposal for table and wine grapes in support of the authorised use in the United States.

Following the non‐renewal of approval of dimethomorph as an active substance under Regulation (EC) No 1107/2009, and after the expiry date of the grace period, EU authorisations should in principle be withdrawn and the MRLs based on former EU uses lowered to the limit of quantification. However, for food and feed commodities for which Codex MRLs or import tolerances are established, an MRL may still be maintained if it is proven to be safe for consumers. Therefore, the European Commission requested EFSA in 2024 to carry out a targeted MRL review for dimethomorph, limited to existing MRLs based on Codex MRLs or import tolerances, which was finalised in 2024 (EFSA, 2024). This targeted MRL review was performed considering the residue definition and toxicological reference values as derived in the context of the renewal of approval carried out by EFSA (EFSA, 2023). The targeted MRL review concluded that (1) the toxicological reference values derived in 2023 are expected to be protective for endocrine disruption (EFSA, 2024) and (2) Codex MRLs or import tolerances implemented in the EU legislation do not lead to consumer intake concerns.

EFSA updated the consumer risk assessment performed in the targeted MRL review of 2024 with the new data provided with this import tolerance MRL application in grapes. Provided that the EU uses are withdrawn and the conclusions of the targeted MRL review are implemented, EFSA concluded that the authorised use of dimethomorph on grapes will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers' health.

The MRL recommendations are summarised in Appendix B.4.

ABBREVIATIONSADIacceptable daily intakeARfDacute reference dosea.s.active substanceBBCHgrowth stages of mono‐ and dicotyledonous plantsbwbody weightCACCodex Alimentarius CommissionCCPRCodex Committee on Pesticide Residues.CFconversion factor for enforcement to risk assessment residue definitionCIRCA(EU) Communication & Information Resource Centre AdministratorCScapsule suspensionCVcoefficient of variation (relative standard deviation)CXLCodex maximum residue limitDARdraft assessment reportDATdays after treatmentDPdustable powderDSpowder for dry seed treatmentECemulsifiable concentrateECDelectron capture detectorEDIestimated daily intakeEMSevaluating Member StateFAOFood and Agriculture Organization of the United NationsFIDflame ionisation detectorGAPGood Agricultural PracticeGCgas chromatographyGRgranuleHPLC‐MS/MS:high performance liquid chromatography with tandem mass spectrometryHRhighest residueIEDIinternational estimated daily intakeIESTIinternational estimated short‐term intakeILVindependent laboratory validationISOInternational Organisation for StandardisationIUPACInternational Union of Pure and Applied ChemistryJMPRJoint FAO/WHO Meeting on Pesticide Residues.LCliquid chromatographyLOQlimit of quantificationMRLmaximum residue levelMSMember StatesMWmolecular weight.NEUnorthern EuropeNPDnitrogen/phosphorous detectorOECDOrganisation for Economic Co‐operation and DevelopmentPBIplant back intervalPFprocessing factor.PHIpreharvest interval.P_ow_ partition coefficient between n‐octanol and waterPRIMo(EFSA) Pesticide Residues Intake Model.RArisk assessmentRACraw agricultural commodityRDresidue definitionRMSrapporteur Member State.SCsuspension concentrate.SEUsouthern EuropeSGwater‐soluble granuleSLsoluble concentrateSTMRsupervised trials median residueTARtotal applied radioactivityTRRtotal radioactive residueUVultraviolet (detector)WHOWorld Health OrganizationWPwettable powder

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2024‐00120

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