Setting of an import tolerance maximum residue limit for dimethomorph in hops

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 hops imported from the United States. The data submitted in support of the request was sufficient to derive an MRL proposal of 50 mg/kg which is lower than the existing maximum residue level (MRL) of 80 mg/kg for hops, recommended to be maintained in the recent targeted MRL review for dimethomorph. Therefore, no modification of the existing MRL is proposed. Adequate analytical methods for enforcement are available to control the residues of dimethomorph (sum of isomers) in hops at the validated combined LOQ of 0.01 mg/kg. Dimethomorph is no longer approved for use in plant protection products in the EU. In this context, EFSA re‐assessed the consumer risk associated with dimethomorph residues considering Codex MRLs and existing import tolerances conducted in the targeted MRL review and in a recent IT application on grapes, taking into account new data on the processing for beer. EFSA concluded that the requested import tolerance in hops is unlikely to pose a risk to consumer health.

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 hops.

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 8 April 2025. The appointed rapporteur Member State (RMS) the Netherlands assessed the dossier and declared its admissibility 10 November 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 24 November 2025 to 15 December 2025. Comments were submitted in the framework of the consultation by industry associations, mainly expressing support for establishing an import tolerance in hops for dimethomorph.

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 18 June 2026. The RMS proposed to establish maximum residue levels (MRLs) for hops imported from the United States at the level of 50 mg/kg. The existing EU MRL for dimethomorph in hops is set at 80 mg/kg.

On 30 June 2026, 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 (hazard‐based cut‐off criteria), dimethomorph approval 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 not later than the expiry of the grace period, all EU authorisations for plant protection products containing dimethomorph at Member State level should 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, in 2024, the European Commission requested EFSA to carry out a targeted MRLs review for dimethomorph, limited to MRLs based on Codex MRLs and existing import tolerances, which was finalised in 2024. This targeted MRL review was performed considering the residue definition and health‐based guidance values (HBGVs) as derived in the recent EU pesticide peer review carried out by EFSA under the framework of the renewal of approval. EFSA confirmed that the current HBGVs are sufficiently protective for consumers. Moreover, the consumer exposure calculations performed by EFSA showed that the existing EU MRLs, including the ones based on CXLs or import tolerances, do not lead to consumers intake concern. To date, the conclusions of the targeted MRL review and the recommendations concerning the MRLs have not been considered and implemented yet.

Based on the conclusions derived by EFSA in the framework of Regulation (EC) No 1107/2009, the data evaluated under the follow‐up targeted MRLs review for dimethomorph, in a subsequent import tolerance MRL application on grapes, and the 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 primary 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) demonstrated 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, the toxicological relevance of metabolites and the capabilities of enforcement analytical methods, 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 hops 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 limit of quantification (LOQ) of 0.005 mg/kg (combined LOQ of 0.01 mg/kg) in the crop under consideration. Based on the available information, extraction efficiency of the solvent system used in the analytical methods for enforcement of dimethomorph in hops is not considered sufficiently demonstrated. Consequently, this is identified as a source of uncertainty in the assessment.

The available residue trials are sufficient to derive an MRL of 50 mg/kg in hops resulting from the authorised use of dimethomorph in the United States, as reported in the present MRL application. The MRL (tolerance) set in the country of origin for the residue definition as dimethomorph is 60 mg/kg. The higher MRL of 80 mg/kg, established on the basis of a Codex MRL (CXL), is currently set in the MRL regulation. As the safety of this CXL was confirmed in the recent targeted MRL review (EFSA, 2024), no modification of the existing MRL is necessary.

New studies investigating the effect of processing on the magnitude of dimethomorph residues in processed hops were submitted with the present MRL application 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 bw per day and an acute reference dose (ARfD) of 0.6 mg/kg bw.

In 2024, in the framework of a targeted MRL review, EFSA confirmed that the above‐mentioned HBGVs 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) and the recent import tolerance assessment on grapes, taking into account the new information submitted with the present import tolerance application for hops. The new information consisted of a processing factor for beer, allowing the consumer risk assessment to be further refined. No update of the residue input data previously used for the unprocessed hops was necessary, as the reported US use resulted to be less critical for residues than the uses assessed by Joint FAO/WHO Meeting on Pesticide Residues (JMPR) and in the targeted MRL review of 2024.

The short‐term exposure did not exceed the ARfD for hops with the highest exposure being 1.3% of the ARfD (adult diet). The long‐term exposure did not exceed the ADI, with the highest exposure reaching 17% of ADI (NL toddler diet). The commodities for which the existing MRLs are based on EU uses, which expired on 20 May 2025, were excluded from the calculation, unless a valid MRL alternative (e.g. CXL) was available. Provided that the recommendations of the targeted MRL review and of the recently issued EFSA opinion on grapes are implemented, EFSA concluded that the authorised US use of dimethomorph on hops will not result in a consumer exposure exceeding the health‐based guidance values and therefore is unlikely to pose a risk to consumers' health.

EFSA proposes to confirm 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, C, D.

Code a	Commodity	Existing EU MRL (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: Dimethomorph (sum of isomers)
0700000	Hops	80	No MRL change	The submitted data are sufficient to derive an MRL of 50 mg/kg for the authorised US use (terrestrial application). The MRL (tolerance) set in the United States is 60 mg/kg. A higher MRL of 80 mg/kg, established on the basis of a Codex MRL (CXL), is currently in place in the MRL Regulation. The safety of the existing MRL (CXL) was confirmed in the targeted MRL review for dimethomorph. Therefore, no change to the current MRL is proposed. Risk for consumers unlikely.

Abbreviations: CXL, Codex MRL; GAP, Good Agricultural Practice; MRL, maximum residue level; US, United States.

^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 hops. The detailed description of the existing use of dimethomorph authorised in USA in hops, 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, ¹ in accordance with Commission Implementing Regulation (EU) No 844/2012, ² as amended by Commission Implementing Regulation (EU) No 2018/1659, ³ EFSA identified several areas of concern ⁴ 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. ⁵ 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. ⁶ 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. ⁷

Following the non‐renewal of approval of dimethomorph as an active substance under Regulation (EC) No 1107/2009, and no later than the expiry of the grace period, all EU authorisations for plant protection products containing dimethomorph at Member State level should be withdrawn. In addition, as a consequence of the non‐renewal, only the MRLs based on Codex MRLs or import tolerances may still be maintained if it is proven they are safe for consumers. Therefore, European Commission requested EFSA to carry out a targeted MRL review for dimethomorph, re‐assessing MRLs based on Codex MRLs and existing import tolerances to confirm that they remain safe for consumers (EFSA, 2024). This targeted MRL review was performed considering the residue definition and health‐based guidance values as derived in the recent EU pesticide peer review carried out by EFSA under the framework of the renewal of approval (EFSA, 2023). Subsequently, another reasoned opinion on an import tolerance in table grapes was assessed by EFSA in 2026. To date, the conclusions of these two EFSA outputs and the associated recommendations concerning the MRLs have not been considered by risk managers. Furthermore, the EU MRLs related exclusively to former EU uses have not yet been lowered to the LOQ.

Overall, the exposure calculations performed by EFSA in the targeted MRLs 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 80 mg/kg in hops, 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) 2019/1381, ⁸ the applicant BASF Agro B.V. Arnhem (NL) Freienbach Branch submitted on 8 April 2025 an application 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 10 November 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 24 November 2025 to 15 December 2025. Comments were submitted in the framework of the consultation by industry associations, mainly expressing support for establishing an import tolerance in hops for dimethomorph. ⁹

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 18 June 2026. The RMS proposed to establish maximum residue levels (MRLs) for hops imported from the United States at the level of 50 mg/kg. The existing EU MRL for dimethomorph in hops is set at 80 mg/kg and this value was proposed to be maintained in the targeted MRL review (EFSA, 2024).

On 30 June 2026, 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, 2026), the revised 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 from the follow‐up targeted MRL review of dimethomorph (EFSA, 2024) and a recently issued opinion on grapes (EFSA, 2026).

For this application, the data requirements established in Regulation (EU) No 283/2013 ¹⁰ 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, 2008a, 2008b, 2009, 2014a, 2014b, 2018, 2021, 2025). 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. ¹¹

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

The evaluation report submitted by the EMS (Netherlands, 2026) and the exposure calculations using the EFSA Pesticide Residues Intake Model (PRIMo) are made publicly available as background documents to this reasoned opinion. ¹²

1. RESIDUES IN PLANTS

1.1. Nature of residues and methods of analysis in plants

1.1.1. Nature of residues in primary crops

The metabolism of 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 with either morpholine‐¹⁴C‐ or chlorophenyl‐¹⁴C‐labelled dimethomorph (EFSA, 2023). In the crops tested, the metabolic pathways showed 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 compounds is the quantitatively most predominant component of the total residue.

The possible shift in the E‐ and Z‐isomer ratio of the parent compound was investigated in several metabolism studies and residue field trials. Depending on the matrix and the investigated label, a shift could be observed but it was not consistently towards one of the isomers (EFSA, 2023).

For the authorised use on hops (belonging to the leafy crop category), the metabolic behaviour in primary crops is sufficiently addressed.

1.1.2. Nature of residues in rotational crops

Investigations of residues in rotational crops are not required for imported crops. Moreover, hops 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). For completeness, information on rotational crop metabolism studies has been reported in Appendix B.1.1.1.

1.1.3. Nature of residues in processed commodities

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.

1.1.4. Analytical methods for enforcement purposes in plant commodities

Analytical methods for the determination of dimethomorph residues in plant commodities using 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 several crop matrices, including hop cones (difficult matrix), leading to a combined 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 high‐water and high‐acid content commodities in the framework of the renewal of the approval for dimethomorph by cross‐validation against the solvent systems used in the metabolism studies (Netherlands, 2022). As no radiolabelled studies are available for hops and no indirect demonstration through comparison of extraction procedures employing different solvents was provided, in line with the recommendations of the guideline SANTE 2017/10632, extraction efficiency for hops cannot be considered demonstrated (European Commission, 2023c). Consequently, this is identified as a source of uncertainty in the assessment.

1.1.5. Storage stability of residues in plants

The storage stability of dimethomorph and the metabolites M550F002, M550F007 and M550F021 (morpholine) ¹³ 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 hop cones (both green and dried), which are the crop assessed in the framework of this application, dimethomorph is stable for at least 18 months when stored at −18°C.

1.1.6. Proposed residue definitions

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 for plants in previous EFSA assessments and confirmed in the latest peer review for the 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 hops assessed in this application, EFSA concluded that these residue definitions are appropriate, and no modification or further information is required.

1.2. Magnitude of residues in plants

1.2.1. Magnitude of residues in primary crops

In support of this import tolerance MRL application, the applicant submitted four independent residue trials in hops. The trials are compliant with the authorised GAP involving terrestrial applications.

The trials were performed in USA during the growing seasons of 2008 (three trials) and 2024 (one trial) and consisted of three foliar treatments at a nominal application rate of 225 g a.s./ha (223–240 g a.s./ha), with last treatment performed at BBCH 84–89. The three trials conducted in 2008 each included one untreated plot and two treated plots, whereas the trial conducted in 2024 included one untreated plot and a single treated plot. In the trials conducted in 2008, the treated plots received the same application rate but differed in spray volumes: one plot was treated using a concentrate spray volume of 693–824 L/ha, while the other plot was treated using a dilute spray volume of 1405–2065 L/ha. The same equipment, i.e. airblast sprayers, was used in the two treated plots. For residue assessment, the higher residue level observed between the two treated plots in the trials conducted in 2008 was selected.

Half of the trials (two trials) were conducted as decline trials, with samples collected 0, 3, 7 (corresponding to the pre‐harvest interval, PHI), 10 and 14 days after last treatment. Decline was observed.

The samples of these residue trials were stored under conditions for which stability of the residues has been demonstrated (Netherlands, 2026). According to the assessment of the RMS, the methods used to analyse residue trial samples, based on liquid chromatography with tandem mass spectrometry (LC–MS/MS), were sufficiently validated and fit for purpose and were able to quantify residues of dimethomorph (sum of isomers) at the limit of quantification (LOQ) of 0.01 mg/kg, expressed as the combined LOQ for both isomers (Netherlands, 2026). The extraction efficiency of the analytical methods used for risk assessment cannot be considered demonstrated according to the recommendations of the guideline SANTE 2017/10632, as no radiolabelled studies are available for hops and no indirect demonstration through comparison of extraction procedures employing different solvents was provided (European Commission, 2023a, 2023b, 2023c). Consequently, this is identified as a source of uncertainty in the assessment.

The samples were analysed for the parent compound dimethomorph (sum of isomers), in accordance with the residue definitions for enforcement and risk assessment. Residues of dimethomorph at PHI or later sampling points ranged from 10.17 to 23.40 mg/kg.

Based on the submitted data and the calculations performed using the OECD MRL calculator, an MRL of 50 mg/kg was derived for dimethomorph in hops. The MRL (tolerance) set in the USA for dimethomorph in dried cone hops is 60 mg/kg. ¹⁴

1.2.2. Magnitude of residues in rotational crops

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, 2007c, 2018).

1.2.3. Magnitude of residues in processed commodities

New studies investigating the effect of processing on the magnitude of residues in processed hop products were submitted in the present MRL application (Netherlands, 2026). The studies involved three broadcast foliar applications to hops at nominal application rates of 0.151 kg dimethomorph/ha for the first application and 0.608 kg dimethomorph/ha for the subsequent two applications. The studies can be considered overdosed since the last two applications were approximately three times the authorised single application rate. Samples were collected at 10 ± 1 DALA and processed into beer, brewer's yeast and hops draff. According to the RMS, the analytical method used was demonstrated to be fit for purpose, and the samples were stored for a period covered by the available storage stability data (Netherlands, 2026). The number and quality of the processing studies are sufficient to derive robust processing factors as reported, together with the PF on beer derived in the EU pesticide peer review (EFSA, 2023), in Appendix B.1.2.3. The data indicate that dimethomorph residues concentrate in extracted hops, while dilution is observed in beer, brewer's yeast and draff.

1.2.4. Proposed MRLs

The available data are considered sufficient to derive an MRL proposal as well as risk assessment values for hops. The MRL derived from the submitted residue dataset (50 mg/kg) is lower than the current MRL in hops (80 mg/kg), established on the basis of a Codex MRL (CXL) and set under Regulation (EU) No 668/2013 ¹⁵ ; therefore, no modification of the existing MRL is proposed.

The existing MRL of 80 mg/kg was previously assessed in the targeted MRL review of dimethomorph and was not associated with consumer intake concerns (EFSA, 2024). In Section 3, EFSA additionally assessed whether residues on beer, based on the updated processing dataset submitted in the current MRL application (Netherlands, 2026), are likely to pose a consumer health risk.

2. RESIDUES IN LIVESTOCK AND FISH

Not relevant as hops are not used for feed purposes. The use of hop‐processed products in fish farming is expected to be very limited. According to the working document SANTE/10250/2021, these by‐products are incorporated only in low proportions into diets containing other cereals and cereal by‐products (European Commission, 2021). Therefore, no further investigation is considered necessary.

3. RESIDUES IN HONEY

Not relevant as the crop under assessment is non‐melliferous (European Commission, 2018).

4. CONSUMER RISK ASSESSMENT

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 sub‐groups 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 health‐based guidance 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 latest 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 ¹⁶ as toxic to reproduction, category 1B (H360F ‘may damage fertility’) ¹⁷ ;

• 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 peer review for renewal of approval carried out by EFSA (EFSA, 2023).

The targeted MRL review confirmed that these HBGVs are expected to be sufficiently protective for consumers, including the identified hazard indicative of endocrine disruption and can be used to perform a consumer risk assessment (EFSA, 2024).

In the framework of this targeted MRL review (EFSA, 2024), EFSA performed a consumer risk assessment for dimethomorph considering the residue definition and the HBGVs derived during the renewal of the approval of dimethomorph, together with the most recent version of the EFSA Pesticide Residues Intake Model (PRIMo) (rev.3.1). The assessment considered the median (STMR) and highest (HR) residue levels derived for the Codex MRLs and the existing import tolerances (EFSA, 2012, 2016; FAO and WHO, 2007, 2014, 2016).

Recently, EFSA updated the consumer risk assessment performed as part of the targeted MRL review of 2024 with new residue data submitted in the context of an import tolerance application for grapes (EFSA, 2026).

For the current assessment, no MRL modification in hops is proposed and the residue input values derived by FAO and WHO (2007) and confirmed by EFSA (2024) for hops remains the critical data for consumer exposure. While no substantial revision of the consumer risk assessment was required for raw commodities, the consumer risk assessment was updated to incorporate the median processing factor for hops/beer derived during the peer review and confirmed in the present assessment (EFSA, 2023; Netherlands, 2026). The consumer risk assessment presented below is therefore based on the input values derived in the previous assessments (EFSA, 2024, 2026), taking such refinement into account.

Short‐term (acute) dietary risk assessment

The short‐term exposure assessment was performed in accordance with the internationally agreed methodology and focused on hops (FAO, 2016). The calculations were based on the HR value (42 mg/kg) derived from supervised field trials on hops assessed by JMPR (EFSA, 2024; FAO and WHO, 2007) (see Appendix D). For beer, a processing factor of 0.003, as derived during the peer review and confirmed in the current assessment, was used (EFSA, 2023; Netherlands, 2026). The short‐term exposure did not exceed the ARfD for hops, with the highest exposure being 1.3% of the ARfD (adult diet).

Long‐term (chronic) dietary risk assessment

The long‐term exposure assessment was performed taking into account the STMR values derived in the framework of the targeted MRL review (EFSA, 2024) – based on the existing import tolerance uses of dimethomorph reported in previous EFSA assessments (EFSA, 2012, 2016) and the implemented Codex MRLs (FAO and WHO, 2007, 2014, 2016) – and the recent import tolerance assessment on grapes (EFSA, 2026). For cucurbits with inedible peel, a peeling factor (PeF) of 0.5 was considered in the calculations. For the commodity under assessment, an update of the last long‐term consumer risk assessment was not needed, as the residue dataset submitted in the current assessment is less critical than the one previously assessed (EFSA, 2024).

The estimated long‐term dietary intake accounted for a maximum of 17% of the ADI (NL toddler diet). The contribution of residues expected in hops, the commodity assessed in this application, to the overall long‐term exposure was 0.34% of the ADI (UK adult diet). The complete list of input values is presented in Appendix D.

Provided that the EU MRLs are implemented as recommended in the targeted MRL review for dimethomorph and in a recent import tolerance assessment, the short‐term and long‐term intake of residues of dimethomorph is unlikely to present a risk to consumer health (EFSA, 2024, 2026). The new residue dataset provided for the import tolerance request on hops, which is less critical than the one assessed by EFSA (2024), do not affect the conclusions of the previous consumer risk assessments (EFSA, 2024, 2026). For further details on the exposure calculations, a screenshot of the Report sheet of the PRIMo is presented in Appendix C.

5. CONCLUSION AND RECOMMENDATIONS

The data submitted in support of this MRL application were found to be sufficient to derive an MRL of 50 mg/kg for hops in support of the authorised use in the United States. The MRL (tolerance) set in the United States is 60 mg/kg. Both levels are lower than the existing MRL of 80 mg/kg, which was recommended to be maintained in the framework of the target MRL review for dimethomorph (EFSA, 2024). Therefore, no modification of the existing MRL is proposed.

Dimethomorph is no longer approved for use as a plant protection product in the EU and, therefore, its use in the EU is currently not permitted. In this context, EFSA re‐assessed the consumer risk associated with dimethomorph residues considering Codex MRLs and existing import tolerances as assessed in the targeted MRL review and in a recent import tolerance application on grapes and updated it with new data on the processing of beer. No revision of the input values for unprocessed hops was considered necessary, as the previous assessment performed in the framework of the targeted MRL review had used higher input values associated to the Codex MRL. The existing MRL of 80 mg/kg in hops, which was previously assessed in the targeted MRL review of dimethomorph, was not associated with consumer intake concerns (EFSA, 2024). Provided that the EU MRLs are implemented as recommended in the 2024 targeted MRL review for dimethomorph and in the recent opinion on grapes (EFSA, 2024, 2026), EFSA concludes that consumer exposure would remain below the health‐based guidance values. Therefore, the requested import tolerance for dimethomorph in hops is unlikely to pose a risk to consumer health.

The MRL recommendations are summarised in Appendix B.5.

ABBREVIATIONS

ADI

acceptable daily intake

ARfD

acute reference dose

a.s.

active substance

BBCH

growth stages of mono‐ and dicotyledonous plants

bw

body weight

CAS

Chemical Abstract Service

CF

conversion factor for enforcement to risk assessment residue definition

CIPAC

Collaborative International Pesticide Analytical Council

CXL

Codex maximum residue limit

DALA

days after last application

DAR

draft assessment report

DAT

days after treatment

DM

dry matter

EMS

evaluating Member State

eq

residue expressed as a.s. equivalent

EURL

EU Reference Laboratory (former Community Reference Laboratory (CRL))

FAO

Food and Agriculture Organization of the United Nations

GAP

Good Agricultural Practice

HPLC–MS/MS

high‐performance liquid chromatography with tandem mass spectrometry

HR

highest residue

IEDI

international estimated daily intake

IESTI

international estimated short‐term intake

ILV

independent laboratory validation

InChiKey

International Chemical Identifier Key

ISO

International Organisation for Standardisation

IUPAC

International Union of Pure and Applied Chemistry

JMPR

Joint FAO/WHO Meeting on Pesticide Residues

K_oc

organic carbon adsorption coefficient

LC

liquid chromatography

LOQ

limit of quantification

MRL

maximum residue level

MS/MS

tandem mass spectrometry detector

MW

molecular weight

NEU

northern Europe

OECD

Organisation for Economic Co‐operation and Development

PBI

plant‐back interval

PeF

peeling factor

PF

processing factor

PHI

pre‐harvest interval

PRIMo

(EFSA) Pesticide Residues Intake Model

RA

risk assessment

RAC

raw agricultural commodity

RD

residue definition

RMS

rapporteur Member State

SC

suspension concentrate

SEU

southern Europe

SMILES

simplified molecular‐input line‐entry system

STMR

supervised trials median residue

WHO

World Health Organization

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2025‐00249

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 A. Summary of existing GAP triggering the amendment of existing EU MRLs

Crop and/or situation	NEU, SEU, MS or country	F G or I a	Pests or group of pests controlled	Preparation		Application				Application rate per treatment				PHI (days) d	Remarks
				Type b	Conc. a.s. (g/L)	Method kind	Range of growth stages & season c	Number min–max	Interval between application (days) min–max	g a.s./hL min–max	Water (L/ha) min–max	Rate min–max	Unit
Hops	US	F	Pseudoperonospora humuli	SC	225	Foliar spray (terrestrial spraying)	Before disease development	1–3	10	0.098–0.125	187	0.183–0.233	kg a.s/ha	7	Maximum application rate/year: 0.657 kg a.s./ha. No more than two sequential applications before alternating to a labelled fungicide with a different mode of action.
Hops	US	F	Pseudoperonospora humuli	SC	225	Foliar spray (aerial spraying) e	Before disease development	1–3	10	0.389–0.498	47	0.183–0.233	kg a.s/ha	7

Abbreviations: a.s., active substance; GAP, Good Agricultural Practice; MRL, maximum residue level; MS, Member State; NEU, northern European Union; SEU, southern European Union.

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

^b CropLife International Technical Monograph no 2, 7th Edition. Revised March 2017. Catalogue of pesticide formulation types and international coding system.

^c Growth stage range from first to last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 3–8263–3152‐4), including, where relevant, information on season at time of application.

^d PHI – minimum pre‐harvest interval.

^e The residue trials submitted with the current IT application are compliant with the authorised terrestrial GAP; however, it remains unclear whether they are fully representative of the aerial use.

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	Grape	4 × 0.9 kg/ha (chlorophenyl label)	35 DALA	EFSA (2023)
		Grape	1 × 0.3 + 2 × 0.6 kg/ha (chlorophenyl label)	14, 28 DAT	EFSA (2023)
		Grape	1 × 0.3 + 2 × 0.6 kg/ha (morpholine label)	28 DAT	EFSA (2023)
		Tomato	8 mg/L, hydroponic system (chlorophenyl label)	7, 14, 28 DAT	EFSA (2023)
	Root crops	Potato	4 × 0.6 kg/ha (chlorophenyl label)	7 DALA	EFSA (2023)
		Potato	4 × 0.6 kg/ha (morpholine label)	7 DALA	EFSA (2023)
		Potato	3 × 0.3 kg/ha (chlorophenyl label)	28 DALA	EFSA (2023)
	Leafy crops	Lettuce	4 × 1.14 kg/ha (chlorophenyl label)	4 DALA	EFSA (2023)
		Lettuce	3 × 0.225 kg/ha (morpholine label)	7 DALA (also 7 days after first application)	EFSA (2023)
	Cereals/grass	–
	Pulses/oilseeds	–
	Miscellaneous	–

Rotational crops (available studies)	Crop groups	Crops	Application	PBI (DAT)	Comment/Source
	Root/tuber crops	Carrot	4 kg a.s./ha (bare soil, indoor application, chlorophenyl label)	29, 120, 361	EFSA (2023)
		Radish	1.7 kg a.s./ha (bare soil, outdoor application. chlorophenyl label)	30, 60, 274, 394	EFSA (2023)
		Radish	1.5 kg a.s./ha (bare soil, outdoor application morpholine label)	29	EFSA (2023)
	Leafy crops	Lettuce	4 kg a.s./ha (bare soil, indoor application, chlorophenyl label)	29, 120, 361	EFSA (2023)
		Lettuce	1.7 kg a.s./ha (bare soil, outdoor application. chlorophenyl label)	30, 60, 274, 394	EFSA (2023)
		Lettuce	1.5 kg a.s./ha (bare soil, outdoor application. morpholine label)	29	EFSA (2023)
	Cereal (small grain)	Wheat	4 kg a.s./ha (bare soil, indoor application, chlorophenyl label)	29, 120, 361	EFSA (2023)
		Wheat	1.7 kg a.s./ha (bare soil, outdoor application. chlorophenyl label)	30, 60, 274, 394	EFSA (2023)
		Wheat	1.5 kg a.s./ha (bare soil, outdoor application. morpholine label)	29	EFSA (2023)
	Other	Soybean	1.7 kg a.s./ha (bare soil, outdoor application. chlorophenyl label)	274	EFSA (2023)

Processed commodities (hydrolysis study)	Conditions	Stable?	Comment/Source
Dimethomorph	Pasteurisation (20 min, 90°C, pH 4)	Yes	EFSA (2023)
	Baking, brewing and boiling (60 min, 100°C, pH 5)	Yes	EFSA (2023)
	Sterilisation (20 min, 120°C, pH 6)	Yes	EFSA (2023)
	Other processing conditions	–	EFSA (2023)
M550F002 18	Pasteurisation (20 min, 90°C, pH 4)	Yes	EFSA (2023)
	Baking, brewing and boiling (60 min, 100°C, pH 5)	Yes	EFSA (2023)
	Sterilisation (20 min, 120°C, pH 6)	Yes	EFSA (2023)
	Other processing conditions	–

B.1.1.2. Stability of residues in plants

Plant products (available studies)	Category	Commodity	T (°C)	Stability period		Compounds covered a	Comment/source
				Value	Unit
	High‐water content	Broccoli	−10°C	24	Month	Dimethomorph	EFSA (2023)
		Spinach	‐10°C	24	Month	Dimethomorph	EFSA (2023)
		Lettuce	−18°C	< 1	Month	M550F002	EFSA (2023)
			−18°C	< 1	Month	M550F007	EFSA (2023)
			−18°C	24	Month	Morpholine	EFSA (2023)
		Tomato	−10°C	21	Month	Dimethomorph	EFSA (2023)
	High‐oil content	Hops green cones, hops dried cones	−18°C	18	Month	Dimethomorph	EFSA (2023)
		Canola seed	−10°C	Max. 8	Month	Dimethomorph	EFSA (2023)
		Rape seed	−18°C	12 (incurred)	Month	Dimethomorph	EFSA (2023)
			−18°C	24	Month	M550F002	EFSA (2023)
			−18°C	24	Month	M550F007	EFSA (2023)
			−18°C	3	Month	Morpholine	EFSA (2023)
	High‐protein content	Navy bean dried seed	−20°C	24 (separate dimethomorph isomers analysed)	Month	Dimethomorph	EFSA (2023)
		Dried bean seeds	−18°C	24	Month	M550F002	EFSA (2023)
			−18°C	24	Month	M550F007	EFSA (2023)
		Dried peas	−18°C	24	Month	Morpholine	EFSA (2023)
	High‐starch content	Potatoes	−18°C	24	Month	Dimethomorph	EFSA (2023)
			−18°C	24	Month	M550F002	EFSA (2023)
			−18°C	24	Month	M550F007	EFSA (2023)
			−18°C	24	Month	Morpholine	EFSA (2023)
	High acid content	Grapes	−18°C	24	Month	Dimethomorph	EFSA (2023)
		Strawberry	−20°C	24 (separate dimethomorph isomers were analysed)	Month	Dimethomorph	EFSA (2023)
			−18°C	24	Month	M550F002	EFSA (2023)
			−18°C	24	Month	M550F007	EFSA (2023)
			−20°C	24	Month	Morpholine	EFSA (2023)
	Processed products	Raisins	−18°C	14	Month	Dimethomorph	EFSA (2023)
		Must/juice, grape waste material	−18°C	16	Month	Dimethomorph	EFSA (2023)
		Spent hops, beer, brewer's yeast	−18°C	18	Month	Dimethomorph	EFSA (2023)
		Tomato puree, juice, paste, dry pomace	−10°C	21	Month	Dimethomorph	EFSA (2023)

^a M550F002 and M550F007 are minor metabolites found in primary and rotational crops, covered by the parent toxicity and not included in the plant residue definition for enforcement and risk assessment. M550F007 is also found as minor metabolite in livestock but not included in the livestock residue definition for enforcement and risk assessment. Morpholine (M550F021) is a metabolite found in ruminant's kidney, liver and milk cream in relevant amounts. It is provisionally included in the residue definition risk assessment for ruminants, pending the requested data on genotoxicity (EFSA, 2023).

Since storage stability data for dimethomorph are available on at least one crop from all five commodity groupings (OECD 506), storage stability for 8 months (based on the shortest period (high oil)) can be assumed for all crop categories (EFSA, 2023).

General remark: It should be noted that the OECD Guideline 506 on the stability of pesticides has since been updated (OECD, 2025). In this revision, the previously used matrix groups ‘high starch’ and ‘high protein’ (OECD, 2007e) are no longer applicable. Instead, root and tuber vegetables are now classified under the ‘high‐water’ matrix group, while pulses, cereal grains, straw and dried fruits fall under the ‘dry’ matrix group. Furthermore, hops are no longer among high oil content and are reclassified between high water (green hops) and dry (dried hops).

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)	HR b (mg/kg)	STMR c (mg/kg)	CF d
Hops	US	Mo/RA: 10.17; 12.58; 19.87 e ; 23.40 f	Residue trials on hops compliant with GAP (terrestrial application).	50	23.40	16.23	1

Abbreviations: GAP, Good Agricultural Practice; Mo, monitoring; MRL, maximum residue level; RA, risk assessment.

^a NEU: Outdoor trials conducted in northern Europe, SEU: Outdoor trials conducted in southern Europe, EU: indoor EU trials or Country code: if non‐EU trials. US: United States.

^b Highest residue. The highest residue for risk assessment refers to the whole commodity and not to the edible portion.

^c Supervised trials median residue. The median residue for risk assessment refers to the whole commodity and not to the edible portion.

^d Conversion factor to recalculate residues according to the residue definition for monitoring to the residue definition for risk assessment.

^e Residue level measured at a later sampling point than the PHI of the US GAP.

^f Residue level representing the mean of two samples.

B.1.2.2. Residues in rotational crops

B.1.2.3. Processing Factors

Processed commodity	Number of valid studies a	Processing factor (PF)		CFP b	Comment/source
		Individual values	Median PF
Hops, beer	2 (4 trials)	< 0.001; 0.001; 0.003; 0.004	0.003	n.a.	EFSA (2023)
	1 (3 trials)	2 × 0.003, 0.004		n.a.	Netherlands (2026)
Hops, brewer's yeast	1 (3 trials)	0.013, 0.019, 0.024	0.019	n.a	Netherlands (2026)
Hops, extracted hops	1 (3 trials)	2.389, 2.867, 3.043	2.867	n.a.	Netherlands (2026)
Hops, draff	1 (3 trials)	0.087; 0.096, 0.106	0.096	n.a.	Netherlands (2026)

Note: European database of processing factors for pesticides residues in food: https://zenodo.org/records/6827098.

Abbreviation: PF, processing factor.

^a Studies with residues in the RAC at or close to the LOQ are disregarded (unless concentration may occur).

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

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

Code a	Commodity	Existing EU MRL (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: Dimethomorph (sum of isomers)
0700000	Hops	80	No MRL change	The submitted data are sufficient to derive an MRL of 50 mg/kg for the authorised US use (terrestrial application). The MRL (tolerance) set in the United States is 60 mg/kg. A higher MRL of 80 mg/kg, established on the basis of a Codex MRL (CXL), is currently in place in the MRL Regulation. The safety of the existing MRL (CXL) was confirmed in the targeted MRL review for dimethomorph (EFSA, 2024). Therefore, no change to the current MRL is proposed. Risk for consumers unlikely.

Abbreviations: GAP, Good Agricultural Practice; MRL, maximum residue level.

^a Commodity code number according to Annex I of Regulation (EC) No 396/2005.

APPENDIX C. Pesticide Residue Intake Model (PRIMo)

APPENDIX D. Consumer risk assessment

Commodity	Existing/proposed MRL (mg/kg)	Source	Chronic risk assessment		Acute risk assessment
			Input value a (mg/kg)	Comment	Input value a (mg/kg)	Comment b
Risk assessment residue definition: dimethomorph (sum of isomers)
HOPS (dried)	80	CXL (EFSA, 2024; FAO and WHO, 2007)	26	STMR‐RAC	42	HR‐RAC
Table and wine grapes	3	IT US (EFSA, 2026)	0.56	STMR‐RAC	1.86	HR‐RAC
Strawberries	0.5	CXL (EFSA, 2024; FAO and WHO, 2014)	0.05	STMR‐RAC	0.24	HR‐RAC
Papayas	0.7	IT Brazil (EFSA, 2016, 2024)	0.35	STMR‐RAC	0.67	HR‐RAC
Pineapples	0.01*	CXL (EFSA, 2024; FAO and WHO, 2007)	0.01*	STMR‐RAC	0.01*	HR‐RAC
Potatoes	0.05	CXL (EFSA, 2024; FAO and WHO, 2007)	0.02	STMR‐RAC	0.05	HR‐RAC
Garlic, onions, shallots	0.6	IT US/CAN (EFSA, 2012, 2024)	0.2	STMR‐RAC	0.4	HR‐RAC
Spring onions/green onions and Welsh onions	9	CXL (EFSA, 2024, FAO and WHO, 2014)	2.1	STMR‐RAC	6.6	HR‐RAC
Cucumbers, gherkins, courgettes	0.5	CXL (EFSA, 2024; FAO and WHO, 2007)	0.15	STMR‐RAC	0.24	HR‐RAC
Other cucurbits ‐ edible peel	0.5	CXL (EFSA, 2024; FAO and WHO, 2007)	0.15	STMR‐RAC	–	–
Melons, pumpkins, watermelons	0.5	CXL (EFSA, 2024; FAO and WHO, 2007)	0.02	STMR‐RAC (0.04) × PeF (0.5)	0.12	HR‐RAC (0.24) × PeF (0.5)
Other cucurbits ‐ inedible peel	0.5	CXL (EFSA, 2024; FAO and WHO, 2007)	0.02	STMR‐RAC (0.04) × PeF (0.5)	–	–
Broccoli	5	IT US/CAN (EFSA, 2012, 2024)	1.3	STMR‐RAC	2.62	HR‐RAC
Head cabbages	6	CXL (EFSA, 2024; FAO and WHO, 2014)	1.2	STMR‐RAC	4.61	HR‐RAC
Kohlrabies	0.02	CXL (EFSA, 2024; FAO and WHO, 2007)	0.02	STMR‐RAC	0.02	HR‐RAC
Lamb's lettuce/corn salads	10	CXL (EFSA, 2024; FAO and WHO, 2007)	3.35	STMR‐RAC	7.1	HR‐RAC
Lettuces	15	IT US/CAN (EFSA, 2012, 2024)	3.48	STMR‐RAC	10.7	HR‐RAC
Spinaches	30	CXL (EFSA, 2024, FAO and WHO, 2014)	8.3	STMR‐RAC	11.5	HR‐RAC
Peas (without pods)	0.15	CXL (EFSA, 2024, FAO and WHO, 2014)	0.01	STMR‐RAC	0.063	HR‐RAC
Celeries	15	IT US/CAN (EFSA, 2012, 2024)	2.48	STMR‐RAC	8.82	HR‐RAC
Globe artichokes	2	CXL (EFSA, 2024; FAO and WHO, 2014)	0.25	STMR‐RAC	1.14	HR‐RAC
Leeks	0.8	CXL (EFSA, 2024; FAO and WHO, 2014)	0.08	STMR‐RAC	0.69	HR‐RAC
Products of animal origin, tissues	0.01*	CXL (EFSA, 2024; FAO and WHO, 2007)	0.01*	LOQ	0.01*	LOQ
Milk	0.01*	CXL (EFSA, 2024; FAO and WHO, 2007)	0.01*	LOQ	0.01*	LOQ
Bird eggs	0.01*	CXL (EFSA, 2024; FAO and WHO, 2007)	0.01*	LOQ	0.01*	LOQ

Abbreviations: HR‐RAC, highest residue in raw agricultural commodity; PeF, Peeling factor; STMR‐RAC, supervised trials median residue in raw agricultural commodity.

^*Indicates that the MRL is set at the limit of analytical quantification (LOQ).

^a Figures in the table are rounded to two digits, but the calculations are normally performed with the actually calculated values (which may contain more digits). To reproduce dietary burden calculations, the unrounded values need to be used.

^b Input values for the commodities which are not under consideration for the acute risk assessment are reported in grey.

APPENDIX E. Used compound codes

Code/trivial name a	IUPAC name/SMILES notation/InChiKey b	Structural formula c
Dimethomorph	(2EZ)‐3‐(4‐chlorophenyl)‐3‐(3,4‐dimethoxyphenyl)‐1‐(morpholin‐4‐yl)propanone Z‐isomer: O=C(\C=C(/c1ccc(OC)c(OC)c1)\c1ccc(Cl)cc1)N1CCOCC1 QNBTYORWCCMPQP‐JXAWBTAJSA‐N E‐isomer: O=C(\C=C(\c1ccc(OC)c(OC)c1)/c1ccc(Cl)cc1)N1CCOCC1 QNBTYORWCCMPQP‐NBVRZTHBSA‐N	Z‐isomer:
		E‐isomer:
M550F002	4‐[(1E)‐1‐(4‐chlorophenyl)‐3‐(morpholin‐4‐yl)‐3‐oxoprop‐1‐en‐1‐yl]‐2‐methoxyphenyl hexopyranoside O[C@H]1C(O[C@H](CO)[C@@H](O)[C@@H]1O)Oc1ccc(cc1OC)/C(=C/C(=O)N1CCOCC1)/c1ccc(Cl)cc1 UBNREEHHXZTZBU‐SUHHPTDKSA‐N
	4‐[(1Z)‐1‐(4‐chlorophenyl)‐3‐(morpholin‐4‐yl)‐3‐oxoprop‐1‐en‐1‐yl]‐2‐methoxyphenyl D‐glucopyranoside O[C@H]1C(O[C@H](CO)[C@@H](O)[C@@H]1O)Oc1ccc(cc1OC)\C(=C/C(=O)N1CCOCC1)\c1ccc(Cl)cc1 UBNREEHHXZTZBU‐PRPWQQQDSA‐N
M550F007	(2Z)‐3‐(4‐chlorophenyl)‐3‐(4‐hydroxy‐3‐methoxyphenyl)‐1‐(morpholin‐4‐yl)prop‐2‐en‐1‐one O=C(\C=C(/c1ccc(O)c(OC)c1)\c1ccc(Cl)cc1)N1CCOCC1 DZHMQVGPRFIRMK‐LGMDPLHJSA‐N
	(2E)‐3‐(4‐chlorophenyl)‐3‐(4‐hydroxy‐3‐methoxyphenyl)‐1‐(morpholin‐4‐yl)prop‐2‐en‐1‐one O=C(\C=C(\c1ccc(O)c(OC)c1)/c1ccc(Cl)cc1)N1CCOCC1 DZHMQVGPRFIRMK‐GHRIWEEISA‐N
M550F021, morpholine	Morpholine O1CCNCC1 YNAVUWVOSKDBBP‐UHFFFAOYSA‐N

Abbreviations: InChiKey, International Chemical Identifier Key; IUPAC, International Union of Pure and Applied Chemistry; SMILES: simplified molecular‐input line‐entry system.

^a The metabolite name in bold is the name used in the conclusion.

^b ACD/Name 2025.2.4 ACD/Labs 2025.2.4 (File Version N25E41, Build 147950, 03 February 2026).

^c ACD/ChemSketch 2025.2.5 (File Version C65H41, Build 147869, 26 January 2026).

EFSA (European Food Safety Authority) , Bellisai, G. , Bernasconi, G. , Castellan, I. , del Aguila, M. , Ferreira, L. , Leuschner, R. , Mioč, A. , Szot, M. , Tiramani, M. , & Verani, A. (2026). Setting of an import tolerance maximum residue limit for dimethomorph in hops. EFSA Journal, 24(10), e10360. 10.2903/j.efsa.2026.10360