Peer review of the pesticide risk assessment of the active substance dimoxystrobin.

The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, Hungary, and co-rapporteur Member State, Ireland, for the pesticide active substance dimoxystrobin as well as the assessment of maximum residue levels (MRLs) and confirmatory data following the review of the existing MRLs of dimoxystrobin according to Article 12 of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. In June 2023, the European Commission sent a mandate confirming the need to adopt and publish a conclusion on the peer review of the pesticide risk assessment of the active substance dimoxystrobin excluding the full assessment of endocrine-disrupting properties, containing all the results of the peer review process related to the renewal of approval as well as the assessment of the application for MRL for oilseed rapeseed, poppy seed, mustard seed and gold of pleasure seed, and the MRL application addressing the confirmatory data identified during the MRL review under Article 12 of Regulation (EC) No 396/2005. The conclusions were reached on the basis of the evaluation of the representative uses of dimoxystrobin as a fungicide on oilseed rape and sunflower. MRLs were assessed in rapeseeds, poppy seed, mustard seed and Gold of pleasure seed. The reliable end points, appropriate for use in regulatory risk assessment and the proposed MRLs, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are presented where identified.

Modification of the existing maximum residue levels for lambda-cyhalothrin in celeries, fennel and rice.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Greece to modify the existing maximum residue levels (MRLs) for lambda-cyhalothrin in celeries, fennel and rice. The data submitted in support of the request were found to be sufficient to derive tentative MRL proposals for the concerned crops. They are tentative as formally the general data gap identified in the MRL review for further investigations of the toxicological properties of the compounds formed under sterilisation conditions has not yet been addressed. Adequate analytical enforcement methods are available to control the residues of lambda-cyhalothrin in the commodities under consideration. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the uses of lambda-cyhalothrin according to the reported agricultural practices is unlikely to present a risk to consumer health. The consumer risk assessment presented might need to be reconsidered in the light of the confirmatory data requested following the renewal of the approval and the review of the existing MRLs.

Setting an import tolerance for 2,4-D in soyabeans.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences submitted a request to the competent national authority in Greece to set an import tolerance for the active substance 2,4-D in genetically modified (GM) soyabeans imported from Canada and the USA. The genetic modification confers tolerance to the herbicide 2,4-D. The data submitted in support of the request provided sufficient evidence to conclude that residues of parent 2,4-D and of the metabolite 2,4-dichlorophenol (2,4-DCP), which was found in the GM soybeans treated with 2,4-D, are unlikely to present a risk for consumers. Sufficiently validated analytical methods are available to enforce the proposed maximum residue level (MRL) in soybeans.

Modification of the existing maximum residue level for metazachlor in Chinese cabbage.

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), France, received an application from BASF SE to modify the existing maximum residue level (MRL) for the active substance metazachlor in Chinese cabbage. To accommodate for the intended use of metazachlor, France proposed to raise the existing MRL from the value of 0.2 mg/kg to 0.6 mg/kg. France drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA, the data are sufficient to derive a MRL proposal of 0.6 mg/kg for the proposed use on Chinese cabbage. Adequate analytical enforcement methods are available to control the residues of metazachlor on the commodity under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of metazachlor on Chinese cabbage will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

Modification of the existing maximum residue level for deltamethrin in kale.

In accordance with Article 6 of Regulation (EC) No 396/2005, the Agriculture and Horticulture Development Board (AHDB) submitted a request to the competent authority in the United Kingdom (evaluating Member State (EMS)) to modify the existing maximum residue level (MRL) for the active substance deltamethrin in kale. To accommodate for the intended use of deltamethrin, it was considered necessary to raise the existing MRL. Based on the evaluation report prepared by the EMS in accordance with Article 8 of Regulation (EC) No 396/2005, EFSA concludes that the applicant provided sufficient data to derive an MRL proposal of 0.15 mg/kg for the proposed uses in kale. Adequate analytical enforcement methods are available to control compliance with the proposed MRL for deltamethrin in kale. In a tentative risk assessment, no consumer concern has been identified; however, the risk assessment was affected by non-standard uncertainties. Further risk management considerations are required to decide whether the MRL proposal is acceptable.

Setting of maximum residue limits for propargite in citrus fruits and tea.

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Italy received an application from Arysta LifeScience Great Britain Ltd to set maximum residue levels (MRL) for the active substance propargite in imported citrus fruits and tea. Italy drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA, the data are sufficient to derive a MRL proposal of 4 mg/kg for oranges only, as the extrapolation to the whole group is not supported by the EU rules. Based on the residue trials, an MRL of 50 mg/kg for tea could be derived. However, a risk manager decision is required whether the setting of a MRL of 50 mg/kg for tea is acceptable since the MRL reported to be into force in India is 10 mg/kg. Adequate analytical enforcement methods are available to control the residues of propargite on the commodities under consideration. Since the enforcement method of analysis is not enantioselective, residues are determined as the sum of any possible isomer ratio of the active substance propargite. EFSA concluded that the use of propargite on oranges and tea as reported in the countries of origin will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk. However, it should be noted that the risk assessment is affected by uncertainties linked to the toxicological profile and the reliability of results for some of the metabolites included in the residue definition and it is applicable to the technical propargite with the isomer ratio 99:1 under assessment.

Modification of the existing maximum residue levels for deltamethrin in celery, Florence fennel and rhubarb.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant AHDB Horticulture submitted a request to the competent authority in the United Kingdom (evaluating Member State) to modify the existing maximum residue levels (MRLs) for the active substance deltamethrin in celery, Florence fennel and rhubarb. To accommodate for the intended uses of deltamethrin in these crops, it was considered necessary to raise existing MRLs. Based on the evaluation report prepared by the EMS in accordance with Article 8 of Regulation (EC) No 396/2005, EFSA concludes that the applicant provided sufficient data to derive MRL proposals of 0.3 mg/kg for the proposed uses in celeries, Florence fennels and rhubarbs. Adequate analytical enforcement methods are available to control compliance with the proposed MRLs for deltamethrin in the commodities under consideration. Taking into account the available information, EFSA concludes that residues of deltamethrin at the level expected following the treatment according to the envisaged agricultural practices will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a consumer health risk.

Setting of maximum residue levels for spirotetramat in pomegranates and various vegetables.

In accordance with Article 6 of Regulation (EC) No 396/2005, Bayer SAS CropScience submitted an application to the competent national authority in Austria to modify the maximum residue levels (MRLs) for the active substance spirotetramat in pomegranates and various vegetables. On the basis of the Austrian evaluation report, EFSA concluded that for chicory roots and the crops belonging to the group of other root and tuber vegetables (except sugar beets) the data submitted in support of the MRL application are compliant with the data requirements; for pomegranate, a data gap was identified as regards the storage stability of residue trials. Adequate analytical enforcement methods are available to control the residues of spirotetramat in the plant matrices under consideration. Based on the risk assessment results, EFSA concluded that the proposed uses of spirotetramat on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a consumer health risk.

Modification of the existing maximum residue levels for pyraclostrobin in various crops.

In accordance with Article 6 of Regulation (EC) No 396/2005, BASF Agro SAS submitted an application to the competent national authority in France to modify the existing maximum residue levels (MRLs) for the active substance pyraclostrobin in celeriacs, spinaches, chards/beet leaves, witloofs, beans and peas with pods, peas without pods, celeries, fennels and leeks. On the basis of the French evaluation report, EFSA concluded that the data are sufficient to derive MRL proposals for all the crops under consideration. Adequate analytical enforcement methods are available to control the residues of pyraclostrobin in the commodities under consideration. EFSA performed a risk assessment in which potential acute consumer health risks for the intended use on celeries and fennels in Northern EU were identified. The intended uses of pyraclostrobin on the crops under consideration, including the Southern EU uses in celeries and fennels, will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a public health risk. For leeks, a refined acute risk assessment was proposed by the French authority, using a processing factor. Since the available data do not provide sufficient evidence that the short-term exposure is below the acute reference dose, EFSA does not propose to raise the existing MRL.

Modification of the existing maximum residue level for pencycuron in potatoes.

In accordance with Article 6 of Regulation (EC) No 396/2005, Bayer CropScience submitted an application to raise the existing maximum residue limit (MRL) for the active substance pencycuron in potatoes from 0.1 to 0.2 mg/kg. The competent authority in the Netherlands drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA, the submitted data on the residue behaviour of pencycuron provide evidence that for the intended use of the active substance a MRL of 0.2 mg/kg would be required. An indicative risk assessment for residues of parent pencycuron did not identify a consumer health risk. However, the available data did not sufficiently elucidate the degradation products formed in processed products. Since a reliable dietary risk assessment for processed potatoes could not be performed, EFSA does not propose a modification of the existing MRL for potatoes.

Modification of the existing maximum residue level for tolclofos-methyl in potatoes.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Sumitomo Chemical Agro Europe S.A.S submitted a request to the competent national authority of Finland to modify the existing maximum residue level (MRL) for the active substance tolclofos-methyl in potatoes. The data submitted in support of the request were found to be sufficient to derive an MRL proposal of 0.2 mg/kg. An amendment of the existing MRLs for food of animal origin was not found necessary. Adequate analytical enforcement methods are available to control the residues of tolclofos-methyl in potatoes. Based on the risk assessment results, EFSA concluded that the proposed use of tolclofos-methyl on potatoes will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk.

Modification of the existing maximum residue levels for etridiazole in various crops.

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), the Netherlands, received an application from Arysta LifeScience Great Britain Limited to modify the existing maximum residue levels (MRLs) for the active substance etridiazole in various crops. To accommodate for the intended uses of etridiazole, the Netherlands proposed to raise the existing MRLs from the limit of quantification (LOQ) of 0.05* mg/kg to 0.4 mg/kg in gherkin, courgette and other cucurbits with edible peel, and to raise the existing MRL value of 0.1 mg/kg to 0.4 mg/kg in cucumber. The Netherlands drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. Although the intended uses on gherkin, courgette and other cucurbits with edible peel are supported by residue trials, EFSA did not derive MRL proposals because appropriate information on the toxicological profile and on the relevance of the major plant metabolites 5-hydroxyethoxyetridiazole acid and 3-hydroxymethyletridiazole has not been provided. Thus, the tentative risk assessment is affected by a high degree of uncertainty.

Modification of the existing maximum residue level for metaldehyde in leek.

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), Austria, received an application from De Sangosse SAS to modify the existing maximum residue level (MRL) for the active substance metaldehyde in leek. To accommodate for the intended use of metaldehyde, Austria proposed to raise the existing MRL from the value of 0.5 mg/kg to 1.5 mg/kg. Austria drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA. According to EFSA, the data are sufficient to derive a MRL proposal of 1.5 mg/kg for the proposed use on leek. Adequate analytical enforcement methods are available to control the residues of metaldehyde on the commodity under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of metaldehyde on leek will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

Modification of existing maximum residue levels for flonicamid in various commodities.

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), the Netherlands, received two applications from ISK Biosciences Europe N.V. to modify the existing maximum residue levels (MRLs) for the active substance flonicamid in various commodities. EFSA concludes that the data submitted were sufficient to derive MRL proposals of 0.3 mg/kg for apricots, 0.5 mg/kg for head cabbage, and 1.5 mg/kg for beans and peas with pods. No change of the existing MRL set at the limit of quantification (LOQ) of 0.03 mg/kg was required for sugar beet. Furthermore, EFSA derived new MRL proposals for some commodities of animal origin. Adequate analytical enforcement methods are available to control the residues of flonicamid on the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed use of flonicamid on the commodities under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk.

Modification of the existing maximum residue level for penconazole in grapes.

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State, Italy, received an application from Syngenta to modify the existing maximum residue level (MRL) for the active substance penconazole in grapes. The data submitted in support of the request are sufficient to derive a MRL proposal of 0.4 mg/kg for the intended use on grapes. Adequate analytical enforcement methods are available to control the residues of penconazole in grapes. Based on the risk assessment results, EFSA concludes that the intended use of penconazole on grapes will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk. However, these results should be considered provisional due to the fact that the risk assessment for triazole derivate metabolites is still pending.

Setting of an import tolerance for 2,4-D in maize.

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Greece received an application from Dow AgroSciences to set an import tolerance for the active substance 2,4-D in genetically modified (GM) maize imported from Canada and the USA. The modification confers tolerance to the herbicide 2,4-D. Greece drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005 which was submitted to the European Commission and forwarded to EFSA. According to EFSA, the data submitted are sufficient to conclude that a change of the existing maximum residue level (MRL) set at the limit of quantification (LOQ) of 0.05 mg/kg in maize is not required. Analytical enforcement methods are available to control the residues of 2,4-D in cereals and no risk for consumers was identified for the notified use on GM maize expressing the aryloxyalkanoate dioxygenase 1 (AAD-1) protein imported from Canada and the USA.

Modification of the existing maximum residue levels for spinetoram in various crops.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dow AgroSciences Ltd submitted a request to the competent national authority in France and the Netherlands to modify the existing maximum residue levels (MRL) for the active substance spinetoram in several crops. The data submitted in support of the requests were found to be sufficient for making several MRL proposals for the crops under consideration. Adequate analytical methods for enforcement are available to control the residues of spinetoram on the commodities under consideration. Based on the risk assessment results, EFSA concluded that a risk from short-term intake cannot be excluded for escaroles. Therefore, no MRL has been proposed for this use. Furthermore, in a screening step, risk to consumers has been identified for the current use of spinetoram in lettuce. EFSA therefore proposes to lower the current MRL for lettuce to a safe limit. For the remaining crops, the expected short-term exposure is unlikely to present a risk to consumer health. The long-term intake of residues resulting from the uses of spinetoram according to the reported agricultural practices is unlikely to present a risk to public health.

Modification of the existing maximum residue levels for difenoconazole in various crops.

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member States (EMS), Greece and Austria, received applications from Syngenta and Adama, respectively, to modify the existing maximum residue levels (MRLs) for the active substance difenoconazole in various crops and barley, respectively. The data submitted in support of the requests were found to be sufficient to derive MRL proposals for all crops under consideration. Adequate analytical methods for enforcement are available to control the residues of difenoconazole on the commodities under consideration. Based on the risk assessment results, EFSA concludes that the proposed uses of difenoconazole on the commodities under consideration will not result in a consumer exposure exceeding the toxicological reference values for the active substance and therefore are unlikely to pose a consumer health risk, except for the indoor use on scaroles. An acute consumer risk cannot be excluded for this use and a lower MRL is proposed based on the outdoor uses only.

Modification of the existing maximum residue levels for fluxapyroxad in various crops.

In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member States (EMS), the Netherlands and the United Kingdom, received an application from BASF SE to modify the existing maximum residue levels (MRLs) for the active substance fluxapyroxad in several crops in order to accommodate for proposed new uses in Europe and for the import of crops. According to EFSA, the data are sufficient to derive MRL proposals for all the crops assessed, except for citrus fruits other than oranges and grapefruits. Adequate analytical enforcement methods are available to control the residues of fluxapyroxad on the commodities under consideration, but additional validation data on herbal infusion and spices would be desirable. Based on the risk assessment results, EFSA concluded that the proposed uses on various crops of fluxapyroxad and the use authorised in Brazil on oranges and grapefruits for which import of crops has been requested, will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a consumer health risk.