Modification of the existing maximum residue levels for sulfoxaflor in various crops

Abstract

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 Greece to modify the existing maximum residue levels (MRLs) for the active substance sulfoxaflor in lettuce and salad plants (except lettuce), beans with pods and peas without pods. The data submitted in support of the request 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 sulfoxaflor in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of sulfoxaflor according to the reported agricultural practices is unlikely to present a risk to consumer health.

Modification of the existing maximum residue level for flonicamid in honey

“…Regarding commodities not included in the present MRL applications, it should be noted that the short‐term exposure was found to exceed the ARfD for pears and peaches (105% and 114% of ARfD, respectively) as already identified in previous assessments (EFSA, 2019b, 2020a, 2020b, 2023, 2024). This exceedance is due to differences in the revised PRIMo versions compared to the version used in the MRL review 14 (EFSA, 2014).…”

“…EFSA based its assessment on the evaluation report submitted by the EMS (Finland, 2024), the DAR and its addendum (France, 2005, 2009) prepared under Directive 91/414/EEC, the Commission review report on flonicamid (European Commission, 2010a), the conclusion on the peer review of the pesticide risk assessment of the active substance flonicamid (EFSA, 2010), as well as the conclusions from previous EFSA opinions on flonicamid (EFSA, 2010, 2015, 2016a, 2017a, 2017b, 2018b, 2018c, 2018d, 2019b, 2020b, 2023, 2024), including the MRL review (EFSA, 2014) and the subsequent evaluation of the confirmatory data on the MRL review according to Article 12 of Regulation No 396/2005 (EFSA, 2020a). It is further noted that the import tolerance proposals derived by EFSA in 2020 (EFSA, 2020b) are not yet implemented in EU Regulations, and the MRL proposal assessed by EFSA in the most recent output (EFSA, 2024) are included in in the draft regulation PLAN/2024/791 which is not yet published in the EU Official Journal. However, conclusions reached in these EFSA outputs (EFSA, 2020b, 2024) although not yet taken over in the MRL regulation, will be considered for the present assessment.…”

“…It is further noted that the import tolerance proposals derived by EFSA in 2020 (EFSA, 2020b) are not yet implemented in EU Regulations, and the MRL proposal assessed by EFSA in the most recent output (EFSA, 2024) are included in in the draft regulation PLAN/2024/791 which is not yet published in the EU Official Journal. However, conclusions reached in these EFSA outputs (EFSA, 2020b, 2024) although not yet taken over in the MRL regulation, will be considered for the present assessment.…”

“…Therefore, options for further refinement of the risk assessment shall be explored, e.g. in the process of the renewal of the approval or under a specific mandate or to consider lowering the existing MRLs for pears (0.3 mg/kg) and peaches (0.4 mg/kg) to the LOQ (EFSA, 2024).…”

Modification of the existing maximum residue level for flonicamid in honey

“…Regarding commodities not included in the present MRL applications, it should be noted that the short‐term exposure was found to exceed the ARfD for pears and peaches (105% and 114% of ARfD, respectively) as already identified in previous assessments (EFSA, 2019b, 2020a, 2020b, 2023, 2024). This exceedance is due to differences in the revised PRIMo versions compared to the version used in the MRL review 14 (EFSA, 2014).…”

“…EFSA based its assessment on the evaluation report submitted by the EMS (Finland, 2024), the DAR and its addendum (France, 2005, 2009) prepared under Directive 91/414/EEC, the Commission review report on flonicamid (European Commission, 2010a), the conclusion on the peer review of the pesticide risk assessment of the active substance flonicamid (EFSA, 2010), as well as the conclusions from previous EFSA opinions on flonicamid (EFSA, 2010, 2015, 2016a, 2017a, 2017b, 2018b, 2018c, 2018d, 2019b, 2020b, 2023, 2024), including the MRL review (EFSA, 2014) and the subsequent evaluation of the confirmatory data on the MRL review according to Article 12 of Regulation No 396/2005 (EFSA, 2020a). It is further noted that the import tolerance proposals derived by EFSA in 2020 (EFSA, 2020b) are not yet implemented in EU Regulations, and the MRL proposal assessed by EFSA in the most recent output (EFSA, 2024) are included in in the draft regulation PLAN/2024/791 which is not yet published in the EU Official Journal. However, conclusions reached in these EFSA outputs (EFSA, 2020b, 2024) although not yet taken over in the MRL regulation, will be considered for the present assessment.…”

“…It is further noted that the import tolerance proposals derived by EFSA in 2020 (EFSA, 2020b) are not yet implemented in EU Regulations, and the MRL proposal assessed by EFSA in the most recent output (EFSA, 2024) are included in in the draft regulation PLAN/2024/791 which is not yet published in the EU Official Journal. However, conclusions reached in these EFSA outputs (EFSA, 2020b, 2024) although not yet taken over in the MRL regulation, will be considered for the present assessment.…”

“…Therefore, options for further refinement of the risk assessment shall be explored, e.g. in the process of the renewal of the approval or under a specific mandate or to consider lowering the existing MRLs for pears (0.3 mg/kg) and peaches (0.4 mg/kg) to the LOQ (EFSA, 2024).…”

Sulfoxaflor biodegradation: environmental fate, degrading microorganisms, and mechanisms of nitrile hydratase-mediated catalysis

“…This unified pathway explains why all strains produce the same dominant metabolite. X11719474, the amide metabolite of SXF, persists in crops (notably rotational and leafy ones) with residues occasionally exceeding the limit of quantification (LOQ), requiring risk mitigation for specific uses ( EFSA et al, 2022 ). A critical note is that the metabolite X11719474 exhibits higher aquatic toxicity to aquatic invertebrates (e.g., Daphnia magna ) than the parent compound SXF ( Łukaszewicz et al, 2023 ).…”

Modification of the existing maximum residue level for flonicamid in honey

“…Regarding commodities not included in the present MRL applications, it should be noted that the short‐term exposure was found to exceed the ARfD for pears and peaches (105% and 114% of ARfD, respectively) as already identified in previous assessments (EFSA, 2019b, 2020a, 2020b, 2023, 2024). This exceedance is due to differences in the revised PRIMo versions compared to the version used in the MRL review 14 (EFSA, 2014).…”

“…EFSA based its assessment on the evaluation report submitted by the EMS (Finland, 2024), the DAR and its addendum (France, 2005, 2009) prepared under Directive 91/414/EEC, the Commission review report on flonicamid (European Commission, 2010a), the conclusion on the peer review of the pesticide risk assessment of the active substance flonicamid (EFSA, 2010), as well as the conclusions from previous EFSA opinions on flonicamid (EFSA, 2010, 2015, 2016a, 2017a, 2017b, 2018b, 2018c, 2018d, 2019b, 2020b, 2023, 2024), including the MRL review (EFSA, 2014) and the subsequent evaluation of the confirmatory data on the MRL review according to Article 12 of Regulation No 396/2005 (EFSA, 2020a). It is further noted that the import tolerance proposals derived by EFSA in 2020 (EFSA, 2020b) are not yet implemented in EU Regulations, and the MRL proposal assessed by EFSA in the most recent output (EFSA, 2024) are included in in the draft regulation PLAN/2024/791 which is not yet published in the EU Official Journal. However, conclusions reached in these EFSA outputs (EFSA, 2020b, 2024) although not yet taken over in the MRL regulation, will be considered for the present assessment.…”

“…It is further noted that the import tolerance proposals derived by EFSA in 2020 (EFSA, 2020b) are not yet implemented in EU Regulations, and the MRL proposal assessed by EFSA in the most recent output (EFSA, 2024) are included in in the draft regulation PLAN/2024/791 which is not yet published in the EU Official Journal. However, conclusions reached in these EFSA outputs (EFSA, 2020b, 2024) although not yet taken over in the MRL regulation, will be considered for the present assessment.…”

“…Therefore, options for further refinement of the risk assessment shall be explored, e.g. in the process of the renewal of the approval or under a specific mandate or to consider lowering the existing MRLs for pears (0.3 mg/kg) and peaches (0.4 mg/kg) to the LOQ (EFSA, 2024).…”

Sulfoxaflor biodegradation: environmental fate, degrading microorganisms, and mechanisms of nitrile hydratase-mediated catalysis

“…This unified pathway explains why all strains produce the same dominant metabolite. X11719474, the amide metabolite of SXF, persists in crops (notably rotational and leafy ones) with residues occasionally exceeding the limit of quantification (LOQ), requiring risk mitigation for specific uses ( EFSA et al, 2022 ). A critical note is that the metabolite X11719474 exhibits higher aquatic toxicity to aquatic invertebrates (e.g., Daphnia magna ) than the parent compound SXF ( Łukaszewicz et al, 2023 ).…”

Modification of the existing maximum residue level for flonicamid in honey

“…Regarding commodities not included in the present MRL applications, it should be noted that the short‐term exposure was found to exceed the ARfD for pears and peaches (105% and 114% of ARfD, respectively) as already identified in previous assessments (EFSA, 2019b, 2020a, 2020b, 2023, 2024). This exceedance is due to differences in the revised PRIMo versions compared to the version used in the MRL review 14 (EFSA, 2014).…”

“…EFSA based its assessment on the evaluation report submitted by the EMS (Finland, 2024), the DAR and its addendum (France, 2005, 2009) prepared under Directive 91/414/EEC, the Commission review report on flonicamid (European Commission, 2010a), the conclusion on the peer review of the pesticide risk assessment of the active substance flonicamid (EFSA, 2010), as well as the conclusions from previous EFSA opinions on flonicamid (EFSA, 2010, 2015, 2016a, 2017a, 2017b, 2018b, 2018c, 2018d, 2019b, 2020b, 2023, 2024), including the MRL review (EFSA, 2014) and the subsequent evaluation of the confirmatory data on the MRL review according to Article 12 of Regulation No 396/2005 (EFSA, 2020a). It is further noted that the import tolerance proposals derived by EFSA in 2020 (EFSA, 2020b) are not yet implemented in EU Regulations, and the MRL proposal assessed by EFSA in the most recent output (EFSA, 2024) are included in in the draft regulation PLAN/2024/791 which is not yet published in the EU Official Journal. However, conclusions reached in these EFSA outputs (EFSA, 2020b, 2024) although not yet taken over in the MRL regulation, will be considered for the present assessment.…”

“…It is further noted that the import tolerance proposals derived by EFSA in 2020 (EFSA, 2020b) are not yet implemented in EU Regulations, and the MRL proposal assessed by EFSA in the most recent output (EFSA, 2024) are included in in the draft regulation PLAN/2024/791 which is not yet published in the EU Official Journal. However, conclusions reached in these EFSA outputs (EFSA, 2020b, 2024) although not yet taken over in the MRL regulation, will be considered for the present assessment.…”

“…Therefore, options for further refinement of the risk assessment shall be explored, e.g. in the process of the renewal of the approval or under a specific mandate or to consider lowering the existing MRLs for pears (0.3 mg/kg) and peaches (0.4 mg/kg) to the LOQ (EFSA, 2024).…”

Sulfoxaflor biodegradation: environmental fate, degrading microorganisms, and mechanisms of nitrile hydratase-mediated catalysis

“…This unified pathway explains why all strains produce the same dominant metabolite. X11719474, the amide metabolite of SXF, persists in crops (notably rotational and leafy ones) with residues occasionally exceeding the limit of quantification (LOQ), requiring risk mitigation for specific uses ( EFSA et al, 2022 ). A critical note is that the metabolite X11719474 exhibits higher aquatic toxicity to aquatic invertebrates (e.g., Daphnia magna ) than the parent compound SXF ( Łukaszewicz et al, 2023 ).…”