Modification of the existing maximum residue level for cycloxydim in honey

Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue level (MRL) for the active substance cycloxydim in honey. The data submitted in support of the request was found to be sufficient to derive an MRL proposal for honey and other apiculture products. An analytical method based on liquid chromatography–tandem mass spectrometry (LC–MS/MS) is available for enforcement of residues in honey with a validated limit of quantification (LOQ) of 0.12 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 cycloxydim according to the reported agricultural practice is unlikely to present a risk to consumer health.

SUMMARY

In accordance with Article 6 of Regulation (EC) No 396/2005, BASF SE submitted an application to the competent national authority in the Netherlands (evaluating Member State, EMS) to modify the existing maximum residue level (MRL) for the active substance cycloxydim in honey.

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 1 October 2024. The appointed EMS (the Netherlands) assessed the dossier and declared its admissibility on 6 August 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 8 September 2025 to 29 September 2025. No additional data nor comments were submitted in the framework of the consultation.

At the end of the commenting period, the EMS proceeded drafting the evaluation report, in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and to the European Food Safety Authority (EFSA) on 15 January 2026. To accommodate for the authorised uses of cycloxydim, the EMS proposed to raise the existing MRL from the limit of quantification (LOQ) of 0.05 to 0.6 mg/kg.

On 20 January 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 identified points which needed further clarification and requested the EMS to address them. The applicant provided the requested information in an updated IUCLID dossier. The additional information was duly considered by the EMS who submitted a revised evaluation report to EFSA on 18 March 2026, which replaced the previously submitted evaluation report.

Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC, the data evaluated under previous MRL assessment and the additional data provided by the EMS in the framework of this application, the following conclusions are derived.

The metabolism of cycloxydim by foliar application was investigated in crops belonging to the groups of root crops, cereals/grass and pulses/oilseeds. Cycloxydim is rapidly and extensively metabolised to a large variety of metabolites, with the parent only detected in trace amounts following application.

Rotational crop metabolism studies have shown that the metabolism of cycloxydim in rotational crops is similar to the metabolic pathway observed in primary crops.

Studies investigating the effect of processing on the nature of cycloxydim (hydrolysis studies) demonstrated that the active substance is readily and fully degraded under hydrolytic conditions to its oxazole metabolite BH 517‐T2S (M517H017; 75%–94% total radioactive residue (TRR)) and, to a lesser extent, to the corresponding sulfoxide (BH 517‐T2SO (M517H005)), both of which are covered by the common moiety analytical methods.

Based on the metabolic pattern identified in the available studies and the toxicological relevance of metabolites and/or degradation products, the residue definitions for plant products were established as ‘cycloxydim including degradation and reaction products which can be determined as 3‐(3‐thianyl) glutaric acid S‐dioxide (BH 517‐TGSO2) and/or 3‐hydroxy‐3‐(3‐thianyl) glutaric acid S‐dioxide (BH 517‐5‐OH‐TGSO2) or derivatives thereof, calculated in total as cycloxydim’, for monitoring, and as ‘cycloxydim including degradation and reaction products which can be determined as the same moieties or methyl esters thereof, calculated in total as cycloxydim’, for risk assessment.

EFSA concluded that metabolism of cycloxydim in primary and in rotational crops, and the possible degradation in processed products has been sufficiently addressed and that the previously derived residue definitions are applicable to honey.

Studies investigating the magnitude of residues in honey were submitted in the current application. A sufficiently validated analytical method based on LC–MS/MS is available to quantify residues in honey according to the enforcement residue definition. The method enables quantification of residues at or above 0.05 mg/kg in honey (LOQ). The available semi‐field trials are sufficient to derive an MRL proposal of 0.6 mg/kg for honey.

The toxicological profile of cycloxydim was assessed in the framework of the EU pesticides peer review under Directive 91/414/EEC and an acceptable daily intake (ADI) of 0.07 mg/kg bw per day and an acute reference dose (ARfD) of 2 mg/kg bw were derived. The metabolites included in the residue definition are not of higher toxicity than the parent active substance.

The consumer risk assessment was performed with revision 3.1 of the EFSA Pesticide Residues Intake Model (PRIMo). The short‐term (acute) exposure assessment did not exceed the ARfD for honey. For the calculation of the chronic exposure, EFSA updated the most recent consumer exposure calculation performed in a recent MRL assessment with the median residue value (STMR) derived for honey from the residue trials submitted. The highest estimated long‐term dietary intake accounted for 80% of the ADI (GEMS/Food G11 diet). These results should be regarded as indicative, as uncertainties remain due to data gaps identified in the review for certain commodities. The contribution of residues expected in honey to the overall long‐term exposure accounted for 0.02% of the ADI (DE child diet). No long‐term consumer intake concerns were identified for any of the European diets incorporated in EFSA PRIMo. EFSA concluded that the proposed use of cycloxydim in honey is unlikely to pose a risk to consumers' health.

EFSA proposes to amend 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: Cycloxydim including degradation and reaction products which can be determined as 3‐(3‐thianyl)glutaric acid S‐dioxide (BH 517‐TGSO2) and/or 3‐hydroxy‐3‐(3‐thianyl)glutaric acid S‐dioxide (BH 517‐5‐OH‐TGSO2) or derivatives thereof, calculated in total as cycloxydim b
1040000	Honey and other apiculture products c	0.05*	0.6	The submitted data are sufficient to derive a MRL proposal based on the selected critical GAP on honey. Risk for consumers unlikely.

Abbreviations: GAP, Good Agricultural Practice; MRL, maximum residue level; NEU, northern Europe; SEU, southern Europe.

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

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

^b Note: BH 517‐TGSO2 new code: M517H001; BH 517‐5‐OH‐TGSO2 new code: M517H002.

^c According to Regulation (EC) No 396/2005 (as amended by Commission Regulation (EU) 2018/62) MRLs are not applicable to other apiculture products until individual products have been identified and listed within this group.

ASSESSMENT

The European Food Safety Authority (EFSA) received an application to modify the existing maximum residue level (MRL) for cycloxydim in honey. The current MRL application is not linked to one specific good agricultural practice (GAP) but is related to the existing uses in crops that might be attractive to bees and that are a potential source of residues of cycloxydim in honey. The critical GAP identified by the applicant is reported in Appendix A.

Cycloxydim is the ISO common name for (5RS)‐2‐[(EZ)‐1‐(ethoxyimino)butyl]‐3‐hydroxy‐5‐[(3RS)‐thian‐3‐yl]cyclohex‐2‐en‐1‐one (IUPAC). The chemical structures of the active substance and its main metabolites are reported in Appendix E.

Cycloxydim was evaluated in the framework of Directive 91/414/EEC ¹ with Austria designated as rapporteur Member State (RMS) for the representative uses as outdoor foliar applications against perennial grasses in rapeseeds/canola seeds, sugar beet roots, potatoes, beans and tolerant maize/corn (derived by natural plant breeding). The draft assessment report (DAR) prepared by the RMS has been peer reviewed by EFSA (EFSA, 2010). Cycloxydim was approved ² for the use as herbicide only, on 1 June 2011. The approval of cycloxydim expires on 31 August 2026. The process of renewal of the first approval has not yet been initiated.

The EU MRLs for cycloxydim are established in Annex II of Regulation (EC) No 396/2005. ³ The review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (MRL review) has been performed (EFSA, 2020) and the proposed modifications have been implemented in the MRL legislation. After completion of the MRL review, EFSA has issued a reasoned opinion on the modification of MRLs for cycloxydim. The proposals from this reasoned opinion have been considered in recent MRL regulations. ⁴ Furthermore, certain Codex maximum residue limits (CXLs) have also been taken over in the EU MRL legislation.

In accordance with Article 6 of Regulation (EC) No 396/2005 and following the provisions set by the ‘Transparency Regulation’ (EU) 2019/1381, ⁵ the applicant BASF SE submitted on 1 October 2024 an application to the competent national authority in the Netherlands, alongside the dossier containing the supporting data using the IUCLID format.

The appointed EMS (the Netherlands) assessed the dossier and declared its admissibility on 6 August 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 8 September 2025 to 29 September 2025. No additional data nor comments were submitted in the framework of the consultation.

At the end of the commenting period, the EMS proceeded drafting the evaluation report, in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and to the European Food Safety Authority (EFSA) on 15 January 2026. To accommodate for the authorised uses of cycloxydim, the EMS proposed to raise the existing MRL from the LOQ of 0.05 mg/kg to 0.6 mg/kg.

On 20 January 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 identified points which needed further clarification and requested the EMS to address them. The applicant provided the requested information in an updated IUCLID dossier. The additional information was duly considered by the EMS who submitted a revised evaluation report to EFSA on 18 March 2026, which replaced the previously submitted evaluation report.

EFSA based its assessment on the evaluation report submitted by the EMS (the Netherlands, 2025), the DAR and its addenda (Austria, 2006, 2009, 2010) prepared under Council Directive 91/414/EEC, the confirmatory data submitted under the peer review (Austria, 2013), the Commission review report on cycloxydim (European Commission, 2014), the conclusion on the peer review of the pesticide risk assessment of the active substance cycloxydim (EFSA, 2010), as well as the conclusions from a previous EFSA opinions on cycloxydim (EFSA, 2015, 2018b, 2024), including the reasoned opinion on the MRL review according to Article 12 of Regulation No 396/2005 (EFSA, 2020).

For this application, the data requirements established in Regulation (EU) No 544/2011 ⁶ and the guidance documents applicable at the date of submission of the IUCLID application are applicable (European Commission, 1997a, 1997b, 1997c, 1997d, 1997e, 1997f, 1997g, 2010, 2023a, 2023b, 2023c; OECD, 2011, 2013). 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. ⁷

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 (the 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. ⁸

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 cycloxydim was investigated in primary crops belonging to the group of root crops (sugar beet roots), cereals/grass (cycloxydim tolerant maize/corn) and pulses/oilseeds (soybean) in the framework of the EU pesticides peer review (EFSA, 2010). No additional studies were submitted in support of the current MRL application.

In the crops tested, the metabolism of cycloxydim was investigated by foliar application with ¹⁴C‐labelling on the cyclohexanone ring. During the peer review of the pesticide risk assessment of the active substance cycloxydim, the experts concluded that cycloxydim is rapidly and intensively metabolised, the parent being never detected in plants except in trace amounts when samples are collected just after application. The metabolism proceeds first by oxidation to the sulphoxide and sulphone metabolites M517H003 and M517H022. Further loss of the alkyl side chain at the oxime group gives the imine metabolites M517H015 and M517H014, and the oxazole metabolites M517H005 and M517H006 are formed by Beckman rearrangement. All these metabolites are also found in their hydroxylated forms at the cyclohexanone moiety (e.g. M517H010, M517H030). In addition, cleavage of the cyclohexenone ring results in substituted glutaric acid derivative metabolites (M517H021, M517H001) (EFSA, 2010).

The metabolic pathway of cycloxydim follows a similar pattern in all crop groups investigated. For the current assessment on honey, the metabolic behaviour in primary crops is considered sufficiently addressed.

1.1.2. Nature of residues in rotational crops

Cycloxydim is authorised on several crops that can be grown in rotation with other crops. According to the soil degradation studies evaluated in the framework of the peer review, the DT₉₀ values reported were 8.6 days for cycloxydim and up to 46 days for the major soil metabolite BH 517‐TSO (EFSA, 2010). As the soil persistence of cycloxydim and its major soil metabolite is low, the investigation of the nature of residues in rotational crops was not required.

Nonetheless, a rotational crop metabolism study has been performed in the framework of the peer review. In this confined rotational crop study, cycloxydim ¹⁴C‐labelled on the cyclohexanone ring was applied at 650 g/ha onto bare soil and residues in succeeding crops were investigated in radish (root crop), lettuce (leafy crop) and wheat (cereals). Crops were planted at plant‐back intervals (PBI) of 30, 120 and 365 days after treatment (DAT). It was concluded that the metabolism of cycloxydim in rotational crops is similar to the metabolic pathway observed in primary crops (EFSA, 2010).

For the current assessment on honey, no further information is required.

1.1.3. Nature of residues in processed commodities

The effect of processing on the nature of cycloxydim was investigated in the framework of the EU pesticides peer review (EFSA, 2010). These studies were conducted with cycloxydim ¹⁴C‐labelled on the cyclohexanone ring by simulating representative hydrolytic conditions for pasteurisation (20 min at 90°C, pH 4), boiling/brewing/baking (60 min at 100°C, pH 5) and sterilisation (20 min at 120°C, pH 6).

The studies demonstrated that cycloxydim is readily and fully degraded under all hydrolytic conditions to its oxazole metabolite M517H017, 75%–94% AR and to a lesser extent to the oxazole sulfoxide M517H005). Both metabolites are covered by the enforcement residue definition and analysed by the common moiety methods, hence no additional data on the nature of residue in processed commodities is required (EFSA, 2020).

1.1.4. Analytical methods for enforcement purposes in plant commodities

Not relevant as the current assessment is in honey (see Section 3).

1.1.5. Storage stability of residues in plants

Not relevant as the current assessment is in honey (see Section 3).

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/or degradation products and the capabilities of enforcement analytical methods, the following residue definitions were proposed by the EU pesticides peer review and confirmed by the MRL review (EFSA, 2010, 2020):

• residue definition for risk assessment: Cycloxydim including degradation and reaction products which can be determined as 3‐(3‐thianyl)glutaric acid S‐dioxide (BH 517‐TGSO2) and/or 3‐hydroxy‐3‐(3‐thianyl) glutaric acid S‐dioxide(BH 517‐5‐OH‐TGSO2) or methyl esters thereof, calculated in total as cycloxydim. ⁹

• residue definition for enforcement: Cycloxydim including degradation and reaction products which can be determined as 3‐(3‐thianyl) glutaric acid S‐dioxide (BH 517‐TGSO2) and/or 3‐hydroxy‐3‐(3‐thianyl) glutaric acid S‐dioxide (BH 517‐5‐OH‐TGSO2) or methyl esters thereof, calculated in total as cycloxydim.

It should be noted that during the course of the evaluation of the present MRL application, the previous residue definition for monitoring ‘Cycloxydim including degradation and reaction products which can be determined as 3‐(3‐thianyl) glutaric acid S‐dioxide (BH 517‐TGSO2) and/or 3‐hydroxy‐3‐(3‐thianyl) glutaric acid S‐dioxide (BH 517‐5‐OH‐TGSO2) or methyl esters thereof, calculated in total as cycloxydim’ was superseded in the EU pesticides database by ‘Cycloxydim including degradation and reaction products which can be determined as 3‐(3‐thianyl) glutaric acid S‐dioxide (BH 517‐TGSO2) and/or 3‐hydroxy‐3‐(3‐thianyl) glutaric acid S‐dioxide (BH 517‐5‐OH‐TGSO2) or derivatives thereof, calculated in total as cycloxydim’ on August 16th 2023 according to Commission Regulation (No) 2023/173. ¹⁰ The residue definition for risk assessment was not changed. Consequently, the residue definitions for risk assessment and monitoring that used to be the same, now differ from one another. Considering that the modification only involves a terminological change without altering the practical implementation, the EMS and EFSA are of the opinion that the residue definitions for risk assessment and monitoring are equivalent. The toxicity of the metabolites included in the residue definitions are considered to be covered by that of the parent (EFSA, 2010, 2020).

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 with the above‐mentioned residue definition.

As highlighted in the MRL review (EFSA, 2020), the EURLs emphasised that the monitoring of the current and complex residue definition is very difficult, entailing a complex analytical procedure not routinely used in enforcement labs and appealed for a simplified residue definition. Moreover, the residue definition is not specific to cycloxydim and may conceal a non‐authorised use of the more toxic non‐approved active substance profoxydim. In addition, EFSA notes that the possible impact of plant metabolism on the isomer ratio of cycloxydim was not assessed and further investigation on this matter would in principle be required. However, as cycloxydim (1:1 racemic mixture) is instantaneously metabolised following treatment, the isomeric ratio is unlikely to have a significant impact on its metabolism (EFSA, 2020).

Nevertheless, EFSA is of the opinion that further investigation of the enforcement residue definition and the isomerisation of cycloxydim in the upcoming renewal of the approval of cycloxydim would allow the refinement of such information.

1.2. Magnitude of residues in plants

Not relevant as the current assessment is in honey (see Section 3).

2. RESIDUES IN LIVESTOCK AND FISH

Not relevant as honey is not used for feed purposes.

3. RESIDUES IN HONEY

3.1. Nature of residues in honey

Honey is produced by bees from sugary secretions of plants (floral nectar mainly) through regurgitation, enzymatic conversion and water evaporation and followed by storage in the bee hives for a certain period.

In the absence of specific metabolism studies with honey bees, studies investigating the nature of residues in primary crops and rotational crops and studies investigating the degradation during pasteurisation should be considered to determine the nature of residues in honey (European Commission, 2018). It is likely that the nature of residues in pollen and nectar collected from primary and rotational crops, as well as in honey (resulting from the residues in floral nectar), is the same as in primary and rotational crops.

Considering that sufficient data investigating the metabolic profile in primary and rotational crops and the degradation of the active substance under standard hydrolysis conditions are available, no further information is required for the current application according to the guidelines.

3.1.1. Analytical methods for enforcement in honey

In the framework of the present assessment the applicant submitted a new method for enforcement of cycloxydim residues in honey (the Netherlands, 2025). The method, based on LC–MS/MS after extraction with 2‐propanol/water and oxidation of cycloxydim and its metabolites to the common moieties M517H001 and M517H002, is sufficiently validated and allows the determination of cycloxydim and its metabolites in honey at or above the LOQ of 0.12 mg/kg (combined; LOQ: 0.062 mg/kg for M517H001 and 0.058 mg/kg for M517H002). Confirmation was performed by use of a second mass transition, but no validation data (linearity, accuracy, repeatability and specificity) were provided for the confirmatory transition. Independent laboratory validation (ILV) was performed. As the ILV study showed acceptable performance for the second mass transition using the same extraction procedure as the primary method, the EMS considered this aspect to be covered for the primary method as well and EFSA considered this justification sufficient. It is noted that this method will be reassessed in the framework of the peer review and therefore the conclusions reported in this reasoned opinion might need to be reconsidered.

Information on extraction efficiency of the analytical methods for enforcement of residues in honey is not required according to the guidance document on extraction efficiency (European Commission, 2023).

3.1.2. Storage stability of residues in honey

The storage stability of residues of cycloxydim in honey samples stored under frozen conditions was not investigated in the current MRL application. This was not required as samples from the trials were stored for less than 30 days before analysis (the Netherlands, 2025).

3.1.3. Proposed residue definitions

In the absence of specific metabolism studies on honey, the studies investigating the nature of residues in primary and rotational crops and studies investigating the degradation of the active substance during pasteurisation are considered to derive the residue definitions for honey; the same residue definitions as mentioned for plant commodities are therefore proposed (see Section 1.1.6).

3.2. Magnitude of residues in honey

Studies investigating the magnitude of residues in honey were submitted in the current application. The EU critical GAP selected by the applicant for grapevine (SEU; table and wine grapes) consists of a single spray application at a nominal application rate of 500 g a.s./ha, applied up to BBCH 79. In support of this cGAP, four independent and GAP‐compliant semi‐field (tunnel) residue trials were conducted in 2023 in Germany (two trials) and Spain (two trials) using oilseed rape as a surrogate melliferous crop. Cycloxydim was applied once by foliar spray at a nominal rate of 500 g a.s./ha at BBCH 55, which corresponds to the stage when individual flower buds (main inflorescence) are visible but still closed. This application timing is acceptable, given that cycloxydim is a systemic compound and residues may occur in nectar and honey even when applications are performed before flowering (BBCH < 60).

One beehive per plot was placed in the tunnels at BBCH 61–63 and honey samples were collected 20–54 days after application. The samples of these residue trials were stored for no more than 30 days before analysis. Residues of cycloxydim in honey, determined according to the common moiety residue definition and expressed as parent equivalents, ranged from < 0.12 to 0.33 mg/kg. No residues at or above the LOQ were detected in honey samples from untreated plots.

According to the assessment of the EMS, the analytical methods used are sufficiently validated for the quantification of residues of cycloxydim and are fit for purpose. Information on extraction efficiency of the analytical methods for data generation in honey samples is not available and is not required according to the guidance document on extraction efficiency (European Commission, 2023).

3.2.1. Proposed MRLs

The available data are considered sufficient to derive an MRL proposal of 0.6 mg/kg as well as risk assessment values for honey (see Appendix B.3.2.1). In Section 4, EFSA assessed whether residues on these crops resulting from the intended uses are likely to pose a consumer health risk.

It should be noted that currently, MRLs set for honey are not applicable to other apicultural products according to Annex I of Regulation (EC) No 396/2005 as amended by Commission Regulation (EU) 2018/62. ¹¹

4. CONSUMER RISK ASSESSMENT

EFSA performed a dietary risk assessment using revision 3.1 of the EFSA PRIMo (EFSA, 2018a, 2019). This exposure assessment model contains food consumption data for different 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 toxicological reference values for cycloxydim used in the risk assessment (i.e. ADI of 0.07 mg/kg bw per day and 2 mg/kg bw ARfD values) were derived in the framework of the EU pesticides peer review (European Commission, 2010). The metabolites included in the risk assessment residue definition were considered to be of similar toxicity/not more toxic than the parent compound (EFSA, 2010, 2020).

Short‐term (acute) dietary risk assessment

The short‐term exposure assessment was performed in accordance with the internationally agreed methodology and focused on honey, which is the only commodity assessed in this application. The calculations were based on the HR derived from semi‐field trials assessed in this application and the complete list of input values can be found in Appendix C.

The short‐term exposure did not exceed the ARfD for honey (the commodity assessed in this application).

Long‐term (chronic) dietary risk assessment

In the framework of the MRL review a comprehensive long‐term exposure assessment was performed, taking into account the existing uses at EU level and the acceptable CXLs (FAO, 2013). EFSA updated the calculation with the relevant STMR values derived in a recent EFSA opinion (EFSA, 2024) and from the residue trials submitted in support of the present MRL application for honey (The Netherlands, 2025). Crops on which no uses have been reported in the present and previous assessments were excluded from the exposure calculation.

The input values used in the exposure calculations are summarised in Appendix D.1.

The estimated long‐term dietary intake was up to 80% of the ADI (GEMS/Food G11 diet). The contribution of residues expected in honey and other apiculture products (the commodity assessed in this application) to the overall long‐term exposure was low, accounting for 0.02% of the ADI (DE child diet).

EFSA concluded that the long‐term intake of residues of cycloxydim resulting from the existing uses and the proposed MRL for honey is unlikely to present a risk to consumer health. It is noted, however, that some MRLs are affected by uncertainties due to data gaps identified in the context of the MRL review (on herbal infusions from roots, spring onions, Lamb's lettuces, escaroles/broad‐leaved endives, cresses and other sprouts and shoots, and land cresses). Data on these commodities will be evaluated in the context of the ongoing confirmatory data assessment. Consequently, the chronic exposure assessment will be subject to revisions depending on the outcome of the evaluation.

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

5. CONCLUSION AND RECOMMENDATIONS

The data submitted in support of this MRL application were found to be sufficient to derive an MRL proposal for honey.

Although uncertainties remain due to data gaps identified in the review of existing MRLs (EFSA, 2020), based on the indicative exposure calculations, EFSA concluded that the proposed use of cycloxydim on honey 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 recommendation is summarised in Appendix B.5.

ABBREVIATIONS

ADI

acceptable daily intake

AR

applied radioactivity

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

CXL

Codex maximum residue limit

DAR

draft assessment report

DAT

days after treatment

DM

dry matter

DT₉₀

period required for 90% dissipation (define method of estimation)

dw

dry weight

EC

emulsifiable concentrate

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

GC–MS

gas chromatography with mass spectrometry

GC–MS/MS

gas chromatography with tandem mass spectrometry

GLP

Good Laboratory 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

IPCS

International Programme of Chemical Safety

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

LOAEL

lowest observed adverse effect level

LOD

limit of detection

LOQ

limit of quantification

MRL

maximum residue level

MS

Member States

MS/MS

tandem mass spectrometry detector

MW

molecular weight

NEU

northern Europe

OECD

Organisation for Economic Co‐operation and Development

PBI

plant‐back interval

PHI

pre‐harvest interval

P_ow

partition coefficient between n‐octanol and water

PRIMo

(EFSA) Pesticide Residues Intake Model

PROFile

(EFSA) Pesticide Residues Overview File

QuEChERS

Quick, Easy, Cheap, Effective, Rugged and Safe (analytical method)

RA

risk assessment

RAC

raw agricultural commodity

RD

residue definition

RMS

rapporteur Member State

RPF

relative potency factor

SANCO

Directorate‐General for Health and Consumers

SC

suspension concentrate

SEU

southern Europe

STMR

supervised trials median residue

TAR

total applied radioactivity

TMDI

theoretical maximum daily intake

TRR

total radioactive residue

WHO

World Health Organization

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2024‐00597

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APPENDIX A. Critical GAP triggering the assessment of an MRL in honey

The GAP outlined below has been identified by the applicant as the worst‐case authorised EU GAP of cycloxydim on primary crops for the residue carry‐over to honey. On the basis of this GAP the worst‐case treatment pattern (application rate and timing) was selected to design tunnel trials with oilseed rape (melliferous surrogate crop) to investigate magnitude of residues in honey.

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
Grapevine (table and wine grapes)	SEU (EL, IT)	F	Weeds	EC	100	Spray	Until BBCH 79	1	N/A	333	150–400	500	g a.s./ha	42	Existing authorised EU use (assessed in EFSA, 2020).

Abbreviations: a.s., active substance; EC, emulsifiable concentrate; 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.

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	Crop(s)	Application(s)	Sampling (DAT)	Comment/Source
	Root crops	Sugar beet	Nutrient solution: 200 g/ha	7, 22, 46, 77, 119	Root uptake. Radiolabelled active substance: 14C‐cyclohexanone (Austria, 2006)
			Foliar: 650 g/ha	1, 94	Radiolabelled active substance: 14C‐cyclohexanone (Austria, 2006; EFSA, 2010)
	Cereals/grass	Maize	Foliar: 400 g/ha (BBCH 22–23)	72, 96	Cycloxydim tolerant maize selected by plant breeding. Radiolabelled active substance: 14C‐ cyclohexanone (Austria, 2006; EFSA, 2010)
			Foliar: 800 g/ha (BBCH 61–67)	54
	Pulses/oilseeds	Soybean	Foliar: 200 g/ha at fruit setting or at 3 leaf or 2 leaf stage	45 or 71 or 82	Radiolabelled active substance: 14C‐ cyclohexanone (Austria, 2006; EFSA, 2010)
			Foliar treatment: 1000 g/ha (at flowering)	69

Rotational crops (available studies)	Crop groups	Crop(s)	Application(s)	PBI (DAT)	Comment/Source
	Root/tuber crops	Radish	Bare soil 1 × 650 g/ha	30, 120, 365	Radiolabelled active substance:14C‐cyclohexanone (Austria, 2006; EFSA, 2010)
	Leafy crops	Lettuce	Bare soil 1 × 650 g/ha	30, 120, 365
	Cereal (small grain)	Wheat	Bare soil 1 × 650 g/ha	30, 120, 365

Processed commodities (hydrolysis study)	Conditions	Stable?	Comment/Source
	Pasteurisation (20 min, 90°C, pH 4)	No	Cycloxydim is almost totally degraded to BH517‐T2S (new code: M517H017) and BH517‐T2SO (new code: M517H005) under standard hydrolysis conditions (EFSA, 2010)
	Baking, brewing and boiling (60 min, 100°C, pH 5)	No
	Sterilisation (20 min, 120°C, pH 6)	No

B.1.1.2. Stability of residues in plants

Not relevant for the present MRL application on honey.

B.1.2. Magnitude of residues in plants

B.1.2.1. Summary of residues data from the supervised residue trials

Not relevant for the present MRL application on honey.

B.1.2.2. Residues in rotational crops

B.1.2.3. Processing factors

No processing studies were submitted in the framework of the present MRL application. Not relevant for the present application on honey.

B.2. RESIDUES IN LIVESTOCK

Not relevant.

B.3. RESIDUES IN HONEY

B.3.1. Nature of residues and analytical methods for enforcement purposes in honey

B.3.1.1. Metabolism studies, analytical methods and residue definitions in honey

B.3.1.2. Storage stability of residues in honey

No data submitted and not required since all honey samples were analysed within 30 days after collection.

B.3.2. Magnitude of residues in honey

B.3.2.1. 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
Honey	NEU, SEU	2× < 0.12, 0.14, 0.33	Residue trials on oilseed rape supporting MRL for honey (the Netherlands, 2025).	0.6	0.33	0.13	n.r.

Abbreviations: GAP, Good Agricultural Practice; Mo, monitoring; MRL, maximum residue level; n.r., not relevant; 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.

^b Highest residue.

^c Supervised trials median residue.

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

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: Cycloxydim including degradation and reaction products which can be determined as 3‐(3‐thianyl)glutaric acid S‐dioxide (BH 517‐TGSO2) and/or 3‐hydroxy‐3‐(3‐thianyl)glutaric acid S‐dioxide (BH 517‐5‐OH‐TGSO2) or derivatives thereof, calculated in total as cycloxydim b
1040000	Honey and other apiculture products c	0.05*	0.6	The submitted data are sufficient to derive a MRL proposal based on the selected critical GAP on honey. Risk for consumers unlikely.

Abbreviations: GAP, Good Agricultural Practice; MRL, maximum residue level, NEU, northern Europe; SEU, southern Europe.

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

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

^b BH 517‐TGSO2 new code: M517H001; BH 517‐5‐OH‐TGSO2 new code: M517H002.

^c According to Regulation (EC) No 396/2005 (as amended by Commission Regulation (EU) 2018/62) MRLs are not applicable to other apiculture products until individual products have been identified and listed within this group.

APPENDIX C. Pesticide Residue Intake Model (PRIMo)

APPENDIX D. Input values for the exposure calculations

D.1. 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: Cycloxydim including degradation and reaction products which can be determined as 3‐(3‐thianyl)glutaric acid S‐dioxide (BH 517‐TGSO2) and/or 3‐hydroxy‐3‐(3‐thianyl)glutaric acid S‐dioxide (BH 517‐5‐OH‐TGSO2) or methyl esters thereof, calculated in total as cycloxydim c
Honey and other apiculture products d	0.6	Proposed MRL	0.13	STMR‐RAC	0.33	HR‐RAC
Apples	0.4	EFSA (2024)	0.11	STMR‐RAC	0.28	HR‐RAC
Pears	0.4	EFSA (2024)	0.11	STMR‐RAC	0.28	HR‐RAC
Quinces	0.4	EFSA (2024)	0.11	STMR‐RAC	0.28	HR‐RAC
Medlar	0.4	EFSA (2024)	0.11	STMR‐RAC	0.28	HR‐RAC
Loquats/Japanese medlars	0.4	EFSA (2024)	0.11	STMR‐RAC	0.28	HR‐RAC
Other pome fruit	0.4	EFSA (2024)	0.11	STMR‐RAC
Apricots	0.09*	EFSA (2024)	0.09	STMR‐RAC	0.09	HR‐RAC
Cherries (sweet)	0.09*	FAO (2013)	0.09	STMR‐RAC	0.09	HR‐RAC
Peaches	0.09*	EFSA (2024)	0.09	STMR‐RAC	0.09	HR‐RAC
Plums	0.09*	FAO (2013)	0.09	STMR‐RAC	0.09	HR‐RAC
Other stone fruit	0.09*	EFSA (2024)	0.09	STMR‐RAC
Table grapes	0.3	EFSA (2020)	0.11	STMR‐RAC	0.18	HR‐RAC
Wine grapes	0.3	EFSA (2020)	0.11	STMR‐RAC	0.18	HR‐RAC
Strawberries	4	EFSA (2020)	0.94	STMR‐RAC	2.20	HR‐RAC
Potatoes	4	EFSA (2020)	0.69	STMR‐RAC	2.70	HR‐RAC
Sweet potatoes	0.6	EFSA (2020)	0.10	STMR‐RAC	0.46	HR‐RAC
Beetroots	3	EFSA (2020)	0.28	STMR‐RAC	1.30	HR‐RAC
Carrots	5	FAO (2013)	0.44	STMR‐RAC	3	HR‐RAC
Celeriacs/turnip rooted celeries	3	EFSA (2020)	0.28	STMR‐RAC	1.30	HR‐RAC
Horseradishes	3	EFSA (2020)	0.28	STMR‐RAC	1.30	HR‐RAC
Jerusalem artichokes	0.9	EFSA (2020)	0.24	STMR‐RAC	0.53	HR‐RAC
Parsnips	3	EFSA (2020)	0.28	STMR‐RAC	1.30	HR‐RAC
Parsley roots/Hamburg roots parsley	1	EFSA (2020)	0.32	STMR‐RAC	0.46	HR‐RAC
Radishes	3	EFSA (2020)	0.28	STMR‐RAC	1.30	HR‐RAC
Salsifies	3	EFSA (2020)	0.43	STMR‐RAC	1.30	HR‐RAC
Swedes/rutabagas	1	EFSA (2020)	0.32	STMR‐RAC	0.46	HR‐RAC
Turnips	3	EFSA (2020)	0.32	STMR‐RAC	1.30	HR‐RAC
Other root and tuber vegetables	0.9	EFSA (2020)	0.24	STMR‐RAC
Garlic	1.5	EFSA (2020)	0.28	STMR‐RAC	0.98	HR‐RAC
Onions	3	FAO (2013)	0.32	STMR‐RAC	1.30	HR‐RAC
\Shallots	1.5	EFSA (2020)	0.28	STMR‐RAC	0.98	HR‐RAC
Spring onions/green onions and Welsh onions	0.3 e	EFSA (2020)	0.11	STMR‐RAC	0.13	HR‐RAC
Other bulb vegetables	0.3	EFSA (2020)	0.11	STMR‐RAC
Tomatoes	1.5	EFSA (2020)	0.49	STMR‐RAC	0.84	HR‐RAC
Sweet peppers/bell peppers	9	EFSA (2020)	1.58	STMR‐RAC	5.34	HR‐RAC
Aubergines/egg plants	1.5	EFSA (2020)	0.49	STMR‐RAC	0.84	HR‐RAC
Broccoli	9	FAO (2013)	1.95	STMR‐RAC	6	HR‐RAC
Cauliflowers	9	FAO (2013)	1.95	STMR‐RAC	6	HR‐RAC
Other flowering brassica	9	FAO (2013)	1.95	STMR‐RAC
Brussels sprouts	9	FAO (2013)	1.95	STMR‐RAC	6	HR‐RAC
Head cabbages	9	FAO (2013)	1.95	STMR‐RAC	6	HR‐RAC
Other head brassica	9	FAO (2013)	1.95	STMR‐RAC
Chinese cabbages/pe‐tsai	3	EFSA (2020)	0.79	STMR‐RAC	1.80	HR‐RAC
Kales	3	EFSA (2020)	0.79	STMR‐RAC	1.80	HR‐RAC
Other leafy brassica	3	EFSA (2020)	0.79	STMR‐RAC
Kohlrabies	9	FAO (2013)	1.95	STMR‐RAC	6	HR‐RAC
Lamb's lettuce/corn salads	2 e	EFSA (2020)	0.15	STMR‐RAC	1.1	HR‐RAC
Lettuces	1.5	EFSA (2020)	0.41	STMR‐RAC	0.71	HR‐RAC
Escaroles/broad‐leaved endives	1 e	EFSA (2020)	0.26	STMR‐RAC	0.73	HR‐RAC
Cress and other sprouts and shoots	1 e	EFSA (2020)	0.26	STMR‐RAC	0.73	HR‐RAC
Land cress	1 e	EFSA (2020)	0.26	STMR‐RAC	0.73	HR‐RAC
Roman rocket/rucola	3	EFSA (2020)	0.29	STMR‐RAC	1.10	HR‐RAC
Red mustards	3	EFSA (2020)	0.29	STMR‐RAC	1.10	HR‐RAC
Baby leaf crops (including brassica species)	3	EFSA (2020)	0.29	STMR‐RAC	1.10	HR‐RAC
Other lettuce and other salad plants	1	EFSA (2020)	0.26	STMR‐RAC
Spinaches	2	EFSA (2020)	0.21	STMR‐RAC	0.84	HR‐RAC
Purslanes	2	EFSA (2020)	0.21	STMR‐RAC	0.84	HR‐RAC
Chards/beet leaves	2	EFSA (2020)	0.21	STMR‐RAC	0.84	HR‐RAC
Other spinach and similar	2	EFSA (2020)	0.21	STMR‐RAC
Chervil	2	EFSA (2020)	0.21	STMR‐RAC	0.84	HR‐RAC
Chives	0.8	EFSA (2020)	0.19	STMR‐RAC	0.43	HR‐RAC
Celery leaves	2	EFSA (2020)	0.21	STMR‐RAC	0.84	HR‐RAC
Parsley	2	EFSA (2020)	0.21	STMR‐RAC	0.84	HR‐RAC
Sage	2	EFSA (2020)	0.21	STMR‐RAC	0.84	HR‐RAC
Rosemary	2	EFSA (2020)	0.21	STMR‐RAC	0.84	HR‐RAC
Thyme	2	EFSA (2020)	0.21	STMR‐RAC	0.84	HR‐RAC
Basil and edible flowers	2	EFSA (2020)	0.21	STMR‐RAC	0.84	HR‐RAC
Laurel/bay leaves	2	EFSA (2020)	0.21	STMR‐RAC	0.84	HR‐RAC
Tarragon	2	EFSA (2020)	0.21	STMR‐RAC	0.84	HR‐RAC
Other herbs	0.8	EFSA (2020)	0.19	STMR‐RAC
Beans (with pods)	15	FAO (2013)	0.35	STMR‐RAC	11	HR‐RAC
Beans (without pods)	15	EFSA (2020)	3.86	STMR‐RAC	9.14	HR‐RAC
Peas (with pods)	9	EFSA (2024)	1.20	STMR‐RAC	4.50	HR‐RAC
Peas (without pods)	15	EFSA (2020)	3.86	STMR‐RAC	9.14	HR‐RAC
Lentils (fresh)	15	EFSA (2020)	1.28	STMR‐RAC	7.50	HR‐RAC
Other legume vegetables (fresh)	2	EFSA (2020)	0.30	STMR‐RAC
Asparagus	0.09*	EFSA (2020)	0.09	STMR‐RAC	0.09	HR‐RAC
Florence fennels	0.09*	EFSA (2020)	0.09	STMR‐RAC	0.09	HR‐RAC
Globe artichokes	0.09*	EFSA (2020)	0.09	STMR‐RAC	0.09	HR‐RAC
Leeks	4	EFSA (2020)	0.25	STMR‐RAC	2.16	HR‐RAC
Beans	30	FAO (2013)	4.40	STMR‐RAC	4.40	STMR‐RAC
Lentils	20	EFSA (2020)	3.49	STMR‐RAC	3.49	STMR‐RAC
Peas	30	FAO (2013)	4.65	STMR‐RAC	4.65	STMR‐RAC
Lupins/lupini beans	20	EFSA (2020)	3.49	STMR‐RAC	3.49	STMR‐RAC
Other pulses	20	EFSA (2020)	3.49	STMR‐RAC
Linseeds	7	EFSA (2020)	1.39	STMR‐RAC	1.39	STMR‐RAC
Poppy seeds	7	EFSA (2020)	0.54	STMR‐RAC	0.54	STMR‐RAC
Sunflower seeds	7	EFSA (2020)	1.39	STMR‐RAC	1.39	STMR‐RAC
Rapeseeds/canola seeds	7	EFSA (2020)	1.39	STMR‐RAC	1.39	STMR‐RAC
Soyabeans	80	FAO (2013)	13	STMR‐RAC	13	STMR‐RAC
Mustard seeds	6	EFSA (2020)	1.39	STMR‐RAC	1.39	STMR‐RAC
Cotton seeds	7	EFSA (2020)	0.54	STMR‐RAC	0.54	STMR‐RAC
Borage seeds	7	EFSA (2020)	0.54	STMR‐RAC	0.54	STMR‐RAC
Maize/corn	0.3	EFSA (2024)	0.12	STMR‐RAC	0.12	STMR‐RAC
Rice	0.09*	EFSA (2020)	0.09	STMR‐RAC	0.09	STMR‐RAC
Valerian root	9 e	EFSA (2020)	2.35	STMR‐RAC	5.30	HR‐RAC
Ginseng root	9 e	EFSA (2020)	2.35	STMR‐RAC	5.30	HR‐RAC
Other herbal infusions (dried roots)	9	EFSA (2020)	2.35	STMR‐RAC
Sugar beet roots	0.3	EFSA (2024)	0.12	STMR‐RAC	0.25	HR‐RAC
Swine: Muscle/meat	0.06	FAO (2013)	0.02	STMR‐RAC	0.05	HR‐RAC
Swine: Fat tissue	0.1	FAO (2013)	0.02	STMR‐RAC	0.07	HR‐RAC
Swine: Liver	0.5	FAO (2013)	0.10	STMR‐RAC	0.40	HR‐RAC
Swine: Kidney	0.5	FAO (2013)	0.10	STMR‐RAC	0.40	HR‐RAC
Swine: Edible offals (other than liver and kidney)	0.5	FAO (2013)	0.10	STMR‐RAC	0.40	HR‐RAC
Bovine and Equine: Muscle/meat	0.1	EFSA (2020)	0.07	STMR‐RAC	0.09	HR‐RAC
Bovine and Equine: Fat tissue	0.15	EFSA (2020)	0.11	STMR‐RAC	0.15	HR‐RAC
Bovine and Equine: Liver	0.5	EFSA (2020)	0.32	STMR‐RAC	0.41	HR‐RAC
Bovine and Equine: Kidney	0.8	EFSA (2020)	0.55	STMR‐RAC	0.77	HR‐RAC
Bovine and Equine: Edible offals (other than liver and kidney)	0.8	EFSA (2020)	0.55	STMR‐RAC	0.77	HR‐RAC
Sheep and Goat: Muscle/meat	0.1	EFSA (2020)	0.08	STMR‐RAC	0.10	HR‐RAC
Sheep and Goat: Fat tissue	0.2	EFSA (2020)	0.12	STMR‐RAC	0.16	HR‐RAC
Sheep and Goat: Liver	0.5	EFSA (2020)	0.35	STMR‐RAC	0.43	HR‐RAC
Sheep and Goat: Kidney	0.9	EFSA (2020)	0.62	STMR‐RAC	0.83	HR‐RAC
Sheep and Goat: Edible offals (other than liver and kidney)	0.9	EFSA (2020)	0.62	STMR‐RAC	0.83	HR‐RAC
Poultry: Muscle/meat	0.03*	FAO (2013)			0.030	HR‐RAC
Poultry: Fat tissue	0.03*	FAO (2013)			0.030	HR‐RAC
Poultry: Liver	0.03	EFSA (2020)	0.02	STMR‐RAC	0.02	HR‐RAC
Poultry: Kidney	0.03	EFSA (2020)	0.02	STMR‐RAC	0.02	HR‐RAC
Poultry: Edible offals (other than liver and kidney)	0.03	EFSA (2020)	0.02	STMR‐RAC	0.02	HR‐RAC
Other farmed animals: Muscle/meat	0.1	EFSA (2020)	0.11	STMR‐RAC	0.09	HR‐RAC
Other farmed animals: Fat tissue	0.15	EFSA (2020)	0.11	STMR‐RAC	0.15	HR‐RAC
Other farmed animals: Liver	0.5	EFSA (2020)	0.32	STMR‐RAC	0.41	HR‐RAC
Other farmed animals: Kidney	0.8	EFSA (2020)	0.55	STMR‐RAC	0.77	HR‐RAC
Other farmed animals: Edible offals (other than liver and kidney)	0.8	EFSA (2020)	0.55	STMR‐RAC	0.77	HR‐RAC
Milk: Cattle and Horse	0.06	EFSA (2020)	0.05	STMR‐RAC	0.05	STMR‐RAC
Milk: Sheep, Goat and Others	0.06	EFSA (2020)	0.05	STMR‐RAC	0.05	STMR‐RAC
Eggs	0.15	FAO (2013)	0.02	STMR‐RAC	0.09	HR‐RAC

Abbreviations: HR‐RAC, highest residue in raw agricultural commodity; PeF, Peeling factor; STMR‐RAC, supervised trials median residue in raw agricultural commodity. Crops under consideration in the present assessment are highlighted in bold.

^*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.

^c BH 517‐TGSO2 new code: M517H001; BH 517‐5‐OH‐TGSO2 new code: M517H002.

^d According to Regulation (EC) No 396/2005 (as amended by Commission Regulation (EU) 2018/62) MRLs are not applicable to other apiculture products until individual products have been identified and listed within this group.

^e Tentative MRL derived from a GAP evaluated at EU level which is not fully supported by data, but for which no risk to consumers was identified (assuming the existing residue definition) (EFSA, 2020).

APPENDIX E. Used compound codes

Code/trivial name a	IUPAC name/SMILES notation/InChiKey b	Structural formula c
Cycloxydim BH 517 H E/Z isomer	(5RS)‐2‐[(EZ)‐1‐(ethoxyimino)butyl]‐3‐hydroxy‐5‐[(3RS)‐thian‐3‐yl]cyclohex‐2‐en‐1‐one O=C1CC(CC(O)=C1/C(CCC)=N/OCC)C1CCCSC1 GGWHBJGBERXSLL‐UHFFFAOYSA‐N
M517H003 (old code: BH 517‐TSO) E/Z isomer MW = 341.5	3‐[4‐(N‐ethoxybutanimidoyl)‐3‐hydroxy‐5‐oxocyclohex‐3‐en‐1‐yl]‐1λ4‐thian‐1‐one O=S1CCCC(C1)C1CC(O)=C(C(=O)C1)/C(CCC)=N/OCC SVKHAVSUBSUFBQ‐UHFFFAOYSA‐N
M517H022 (old code: BH 517‐TSO2) E/Z isomer	3‐[4‐(N‐ethoxybutanimidoyl)‐3‐hydroxy‐5‐oxocyclohex‐3‐en‐1‐yl]‐1λ6‐thiane‐1,1‐dione O=S1(=O)CCCC(C1)C1CC(O)=C(C(=O)C1)/C(CCC)=N/OCC LOLAMFUBYOYBMU‐UHFFFAOYSA‐N
M517H015 (old code: BH 517‐T1SO)	3‐(4‐butanimidoyl‐3‐hydroxy‐5‐oxocyclohex‐3‐en‐1‐yl)‐1λ4‐thian‐1‐one O=S1CC(CCC1)C1CC(=O)C(=C(O)C1)C(=N)CCC KLBKPSHYURKCMK‐UHFFFAOYSA‐N
M517H014 (old code: BH 517‐T1SO2)	3‐(4‐butanimidoyl‐3‐hydroxy‐5‐oxocyclohex‐3‐en‐1‐yl)‐1λ6‐thiane‐1,1‐dione O=S1(=O)CC(CCC1)C1CC(=O)C(=C(O)C1)C(=N)CCC ISTHBMFBYWKVPJ‐UHFFFAOYSA‐N
M517H005 (old code: BH‐517‐T2SO)	6‐(1‐oxo‐1λ4‐thian‐3‐yl)‐2‐propyl‐6,7‐dihydro‐1,3‐benzoxazol‐4(5H)‐one O=S1CC(CCC1)C1Cc2oc(CCC)nc2C(=O)C1 JITWEXSKOFSQCI‐UHFFFAOYSA‐N
M517H006 (old code: BH 517‐T2SO2)	3‐(4‐oxo‐2‐propyl‐4,5,6,7‐tetrahydro‐1,3‐benzoxazol‐6‐yl)‐1λ6‐thiane‐1,1‐dione O=S1(=O)CC(CCC1)C1Cc2oc(CCC)nc2C(=O)C1 SSLMIMBQRXNQPD‐UHFFFAOYSA‐N
M517H021 (old code: BH 517‐TGSO)	3‐(1‐oxo‐1λ4‐thian‐3‐yl)pentanedioic acid O=S1CC(CCC1)C(CC(O)=O)CC(O)=O DVZHDNBXUJHHIV‐UHFFFAOYSA‐N
M517H001 (old code: BH 517‐TGSO2) (also oxidation product of cycloxydim) MW = 264.3	3‐(1,1‐dioxo‐1λ6‐thian‐3‐yl)pentanedioic acid O=S1(=O)CC(CCC1)C(CC(O)=O)CC(O)=O ZQTHHTAJXROHTN‐UHFFFAOYSA‐N
M517H002 (old codes: BH 517‐5‐OH‐TGSO2 or BH 517‐OH‐TGSO2) (also oxidation product of BH 517‐5‐OH‐TSO2) MW = 280.3	3‐(1,1‐dioxo‐1λ6‐thian‐3‐yl)‐3‐hydroxypentanedioic acid O=S1(=O)CC(CCC1)C(O)(CC(O)=O)CC(O)=O PVMXEMADFFDQHF‐UHFFFAOYSA‐N
M517H010 (old code: BH 517‐5‐OH‐TSO)	3‐{4‐[(1E)‐N‐ethoxybutanimidoyl]‐1,3‐dihydroxy‐5‐oxocyclohex‐3‐en‐1‐yl}‐1λ4‐thian‐1‐one O=S1CCCC(C1)C1(O)CC(O)=C(C(=O)C1)/C(CCC)=N/OCC FBBQDUMANSBOGQ‐QGOAFFKASA‐N
M517H011 (old code: BH 517‐5‐OH‐TSO2)	3‐{4‐[(1E)‐N‐ethoxybutanimidoyl]‐1,3‐dihydroxy‐5‐oxocyclohex‐3‐en‐1‐yl}‐1λ6‐thiane‐1,1‐dione O=S1(=O)CCCC(C1)C1(O)CC(O)=C(C(=O)C1)/C(CCC)=N/OCC XJZOLYXZPUWXGQ‐QGOAFFKASA‐N
M517H017 (old code: BH 517‐T2S)	4(5H)‐benzoxazolone, 6,7‐dihydro‐2‐propyl‐6‐(tetrahydro‐2H‐thiopyran‐3‐yl)‐ O=C1CC(Cc2oc(CCC)nc21)C1CSCCC1 KNQGJXMVSRCBKV‐UHFFFAOYSA‐N
M517H009 (old code: BH 517‐5‐OH TS)	2‐[1‐N‐ethoxybutanimidoyl]‐3,5‐dihydroxy‐5‐(thian‐3‐yl)cyclohex‐2‐en‐1‐one OC1(CC(O)=C(C(=O)C1)/C(CCC)=N/OCC)C1CCCSC1 FCKZLDDDXXPDOX‐ UHFFFAOYSA‐N
M517H030 (old code: BH 517‐6‐OH‐T2SO)	6‐hydroxy‐6‐(1‐oxo‐1λ4‐thian‐3‐yl)‐2‐propyl‐6,7‐dihydro‐1,3‐benzoxazol‐4(5H)‐one O=S1CC(CCC1)C1(O)CC2OC(CCC)NC2C(=O)C1 GGCBYWMUJXYVBK‐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 2024.2.3 ACD/Labs 2024.2.3 (File Version N25E41, Build 142837, 21 January 2025).

^c ACD/ChemSketch 2024.2.3 ACD/Labs 2024.2.3 (File Version C45H41, Build 142855, 23 January 2025).

EFSA (European Food Safety Authority) , Bellisai, G. , Bernasconi, G. , Cabrera, L. C. , Castellan, I. , del Aguila, M. , Ferreira, L. , Greco, L. , Lawal, A. I. , Leuschner, R. , Mioč, A. , Nave, S. , Reich, H. , Ruocco, S. , Scarlato, A. P. , Szot, M. , Theobald, A. , Tiramani, M. , Verani, A. , & Zioga, E. (2026). Modification of the existing maximum residue level for cycloxydim in honey. EFSA Journal, 24(5), e10093. 10.2903/j.efsa.2026.10093