Evaluation of confirmatory data following the Article 12 MRL review for isoxaben

Abstract

The applicant Corteva Agriscience International Sàrl submitted a request to the competent national authority in Sweden to evaluate the confirmatory data that were identified for isoxaben in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. To address the data gaps, a new analytical method for enforcement and its independent laboratory validation (ILV), plus additional studies on the magnitude of residues were submitted by the applicant. The outstanding data gaps were sufficiently addressed. The new information provided confirmed a no‐residue situation in cotton seed and herbal infusions from flowers. The current MRL of 0.01 mg/kg for cotton seeds can therefore be confirmed. Since a more sensitive analytical enforcement method is now available, a lowering of the existing MRLs (0.05 mg/kg) for herbal infusions (flowers and roots) and hops to an limit of quantification (LOQ) of 0.01 mg/kg can be considered. The updated exposure calculations did not indicate a risk to consumers health.

SUMMARY

In 2022, when the European Food Safety Authority (EFSA) reviewed the existing Maximum Residue Levels (MRLs) for active substance isoxaben according to Article 12 of Regulation (EC) No 396/2005, EFSA identified some information as unavailable (data gaps) and derived tentative MRLs for those uses which were not fully supported by data but for which no risk to consumers was identified. The following data gaps were noted:

1. Analytical methods for the enforcement in hops and herbal infusions.

2. Additional residue trials supporting the GAPs on sage, rosemary, thyme, basil and edible flowers, cotton seeds and herbal infusions from flowers.

Tentative MRL proposals have been implemented in the MRL legislation by Commission Regulation (EU) No 2023/466 including footnotes indicating the type of confirmatory data that should be provided fully or partially reflecting the data gaps noted in the MRL review, reported above. It is noted that data gap 2 was only implemented for cotton seeds and herbal infusions from flowers. Any party having an interest in maintaining the proposed tentative MRL was requested to address the confirmatory data by day month year.

In accordance with the agreed procedure set out in the working document SANTE/10235/2016, Corteva Agriscience International Sàrl submitted an application to the competent national authority in the Sweden (rapporteur Member State, RMS) to evaluate the confirmatory data identified during the MRL review.

The application, alongside the dossier containing the supporting data in IUCLID format, was submitted through the EFSA Central Submission System on 25 February 2025. The appointed RMS Sweden assessed the dossier and declared its admissibility on 26 January 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 ran from 11 August 2025 to 1 September 2025. No additional data nor comments were submitted in the framework of the consultation.

At the end of the commenting period, the RMS proceeded drafting the evaluation report, in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and EFSA on 30 September 2025.

On 29 October 2025 the European Commission sent a mandate to EFSA to assess the application and the evaluation report as required by Article 10 of the MRL regulation.

To address data gaps identified in the framework of the MRL review in 2022, a new analytical method for enforcement and its ILV, plus additional studies on the magnitude of residues were submitted by the applicant. Data gaps 1 and 2 were both sufficiently addressed.

The new information provided confirmed a no‐residue situation in cotton seed and herbal infusions from flowers. The current MRL of 0.01 mg/kg for cotton seeds can therefore be confirmed. Since a more sensitive analytical enforcement method is now available, a lowering of the existing MRLs (0.05 mg/kg) for herbal infusions (flowers and roots) and hops to an LOQ of 0.01 mg/kg may be considered.

The summary table below provides an overview of the assessment of confirmatory data and the recommended MRL modifications to Regulation (EU) No 396/2005.

Code a	Commodity	Existing MRL b	Proposed MRL	Conclusion/recommendation
Enforcement residue definition: Isoxaben
0401090	Cotton seeds	0.01* (ft 1)	0.01*	The data gap identified in the MRL review was addressed in this submission. A no‐residue situation is confirmed. The footnote implemented in Reg. (EU) 2025/1305 can be removed. The MRL is confirmed and the current value remains unchanged
0631010	Chamomile	0.05* (ft 2)	0.01*	The data gaps identified in the MRL review were addressed in this submission. A no‐residue situation is confirmed. The footnote implemented in Reg. (EU) 2025/1305 can be removed. The current MRL value is proposed to be lowered based on the capacity of the new enforcement method assessed in the present opinion
0631020	Hibiscus/roselle	0.05* (ft 2)	0.01*	See 0631010 – Chamomile
0631030	Rose	0.05* (ft 2)	0.01*	See 0631010 – Chamomile
0631040	Jasmine	0.05* (ft 2)	0.01*	See 0631010 – Chamomile
0631050	Lime/linden	0.05* (ft 2)	0.01*	See 0631010 – Chamomile
0633010	Valerian	0.05* (ft 3)	0.01*	The data gap identified in the MRL review was addressed in this submission. A no‐residue situation is confirmed. The footnote implemented in Reg. (EU) 2025/1305 can be removed. The current MRL value is proposed to be lowered based on the capacity of the new enforcement method assessed in the present opinion
0633020	Ginseng	0.05* (ft 3)	0.01*	See 0633010 – Valerian
0700000	Hops	0.05* (ft 3)	0.01*	The data gap identified in the MRL review was addressed in this submission. The footnote implemented in Reg. (EU) 2025/1305 can be removed. The current MRL value is proposed to be lowered based on the capacity of the new enforcement method assessed in the present opinion

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 Existing EU MRL and corresponding footnote on confirmatory data.

ft 1: The European Food Safety Authority identified some information on residue trials as unavailable. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 6 March 2025, or, if that information is not submitted by that date, the lack of it.

ft 2: The European Food Safety Authority identified some information on residue trials and analytical methods as unavailable. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 6 March 2025, or, if that information is not submitted by that date, the lack of it.

ft 3: The European Food Safety Authority identified some information on analytical methods as unavailable. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 6 March 2025, or, if that information is not submitted by that date, the lack of it.

ASSESSMENT

The review of existing MRLs for the active substance isoxaben according to Article 12 of Regulation (EC) No 396/2005 ¹ (MRL review) has been performed in 2022 (EFSA, 2022). European Food Safety Authority (EFSA) identified some information as unavailable (data gaps) and derived tentative MRLs for those uses not fully supported by data but for which no risk to consumers was identified. The list of GAPs assessed in the framework of the MRL review that were not fully supported by data and for which confirmatory data were requested are listed in Appendix A.

Following the review of existing MRLs, the legal limits have been modified by Commission Regulation (EU) No 2023/466, ² including footnotes for tentative MRLs that specified the type of information that was identified as missing. Any party having an interest in maintaining the proposed tentative MRL was requested to address the confirmatory data by 6 March 2025.

In accordance with the specific provisions set out in the working document of the European Commission SANTE/10235/2016 (European Commission, 2020) and following the provisions set by the ‘Transparency Regulation’ (EU) 2019/1381, ³ the applicant Corteva Agriscience International Sàrl, on 25 February 2025 submitted an application to the competent national authority in Sweden (designated rapporteur Member State, RMS) to evaluate the confirmatory data identified during the MRL review alongside the dossier containing the supporting data using the IUCLID format.

To address the data gaps identified by EFSA, the applicant provided a new analytical method for enforcement and its ILV, plus additional studies on the magnitude of residues.

The RMS assessed the new information in an evaluation report, which was submitted to the European Commission and forwarded to EFSA on 30 September 2025 (Sweden, 2025). EFSA assessed the application as requested by the European Commission in accordance with Article 10 of Regulation (EC) No 396/2005.

EFSA based its assessment on the evaluation report submitted by the RMS (Sweden, 2025) and the reasoned opinion on the MRL review according to Article 12 of Regulation (EC) No 396/2005.

For this application, the data requirements established in Regulation (EU) No 544/2011 ⁴ and the relevant guidance documents at the date of implementation of the confirmatory data requirements by Regulation (EU) No 2023/466 are applicable. 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. ⁵

An updated list of end points, including the end points of relevant studies assessed previously and the confirmatory data evaluated in this application, is presented in Appendix B.

The evaluation report submitted by the RMS (Sweden, 2025) and the exposure calculations using the EFSA Pesticide Residues Intake Model (PRIMo) are made publicly available as a background document to this reasoned opinion. ⁶

1. RESIDUES IN PLANTS

1.1. Nature of residues and methods of analysis in plants

1.1.1. Nature of residues in primary crops

Not relevant for the current assessment.

1.1.2. Nature of residues in rotational crops

Not relevant for the current assessment.

1.1.3. Nature of residues in processed commodities

Not relevant for the current assessment.

1.1.4. Analytical methods for enforcement purposes in plant commodities

In order to address data gap 1 (lack of analytical methods for the enforcement in hops and herbal infusions), the applicant provided a new validated method for the determination of isoxaben residues in difficult matrices (hops and herbal infusions from flowers and roots) and its independent laboratory validation (ILV). The RMS evaluated these studies and concluded that they are acceptable (Sweden, 2025).

Details on the validation of the analytical method and its ILV are presented in Appendix B.1.1.1.

The new enforcement method (code: CAM‐0505/001) is a single residue method involving high performance liquid chromatography with positive‐ion electrospray ionisation tandem mass spectrometry (LC–MS/MS) for the determination of isoxaben. The extraction from the samples is performed by homogenising and shaking with a solution of acetonitrile/water (70:30, v/v). Isoxaben residues were partitioned from the aqueous sample extracts with hexane during the elution process.

The analytical method was validated according to EC guidance document SANTE/2020/12830 rev.2. The available data demonstrate that this method is valid in terms of accuracy, precision, repeatability and specificity for the enforcement of isoxaben in hops, chamomile flower and valerian root, with the limit of quantification (LOQ) of 0.01 mg/kg. Consequently, the method is considered successfully validated in hops and herbal infusions. The matrix effects were found to be significant (i.e. > ± 20%) for hops, therefore matrix‐matched standards were used for analysis of all matrices.

Regarding the ILV, a separate study was reported, which independently validate the analytical method CAM‐0505/001 for the enforcement of isoxaben in difficult matrices (hops and herbal infusions) in accordance with guidance document SANTE/2020/12830 rev.2. the ILV was carried out in a different location, by different personnel and using different instrumentation. No modification of the original method other than optimisation of instrument specific parameters were necessary. The method was successfully and independently validated for the determination of isoxaben in hops and chamomile flower with a LOQ of 0.01 mg/kg. As for the primary methods, matrix effects were reported to be significant for hops and chamomile flowers.

EFSA concluded that the data gap 2 identified in the framework of the MRL review was addressed. The tentative MRLs in hops and herbal infusions can be confirmed.

1.1.5. Stability of residues in plants

Not relevant for the current assessment.

1.1.6. Proposed residue definitions

The previously derived residue definitions are still applicable.

1.2. Magnitude of residues in plants

1.2.1. Magnitude of residues in primary crops

In order to address data gap 2 (lack of trials supporting uses on cotton and herbal infusion from flowers), the applicant provided one new study on the magnitude of residues in oilseed rape (to support the MRL on cotton seed) and one new study on the magnitude of residues in chamomile (to support the MRL on herbal infusion from flowers). The individual results of the residue trials are presented in Appendix B.1.2.1.

Cotton seeds:

Authorised GAP (same GAP as in MRL review): SEU soil treatment – 1 application at BBCH 00 at 150 g a.s./ha.

No trials on cotton seed were available for the MRL review. Quantifiable residues are not expected to occur following the authorised GAP with soil treatment. As required during the MRL review, additional residue trials were now submitted to confirm this assumption. Four residue trials, performed on rapeseed in southern Europe in growing seasons 2014 and 2025, were assessed by the RMS and concluded to be valid and independent. According to the assessment of the RMS, the methods used were sufficiently validated and fit for purpose and the samples of these residue trials were stored under conditions for which integrity of the samples has been demonstrated (Sweden, 2025).

The available residue trials were performed according to the parameters of the authorised GAP, except that the timing of application was at growth stage BBCH 16–20 instead of BBCH 00, representing potentially more critical residue situation. This minor deviation is deemed acceptable considering that all results indicate isoxaben concentration to remain below the limit of detection of 0.003 mg/kg, clearly confirming the expected no‐residue situation, even under worst case conditions. For the same reason, the reduced number of trials (four instead of eight for a major crop) is also deemed acceptable. Extrapolation of trials performed on rapeseed to cotton seed is foreseen by the current guidance on MRL setting and extrapolations (SANTE/2019/12752).

Herbal infusion from flowers:

Authorised GAP in France (same GAP as in MRL review): soil treatment – 1 application at 125 g a.s./ha; PHI: 90 days.

No trials on herbal infusions from flowers were available for the MRL review. Quantifiable residues are not expected to occur following the authorised GAP with soil treatment. As required during the MRL review, additional residue trials were now submitted to confirm this assumption. Three residue trials, performed on chamomile in northern Europe, were assessed by the RMS and concluded to be valid and independent. According to the assessment of the RMS, the methods used were sufficiently validated and fit for purpose and the samples of these residue trials were stored under conditions for which integrity of the samples has been demonstrated (Sweden, 2025).

The available residue trials were performed according to the parameters of the authorised GAP, except that the pre‐harvest interval (PHI) was of 35–42 days instead of 90 days. This minor deviation is deemed acceptable considering that all results indicate isoxaben concentration to remain below the limit of detection of 0.003 mg/kg, clearly confirming the expected no‐residue situation, even under worst case conditions. For the same reason, the reduced number of trials (three instead of four for a minor crop) is also deemed acceptable. Extrapolation of trials performed on chamomile to the whole group of herbal infusions from flowers (Code: 631000) is foreseen by the current guidance on MRL setting and extrapolations (SANTE/2019/12752). Furthermore, trials performed in northern zone are sufficient to support the GAP authorised in France as according to the same guidance, herbal infusions are marked as ‘N or S’ in Annex II (distribution of crops in France).

EFSA concluded that the data gap 2 identified in the framework of the MRL review was addressed for both cotton seed and herbal infusions from flowers.

1.2.2. Magnitude of residues in rotational crops

Not relevant for the current assessment.

1.2.3. Magnitude of residues in processed commodities

Not relevant for the current assessment.

1.2.4. Proposed MRLs

The new information provided confirmed the no‐residue situation in cotton seeds and in herbal infusions. Therefore, the current tentative MRL of 0.01 mg/kg in cotton seeds is confirmed. Regarding herbal infusions (from flowers and roots), a new enforcement method was validated with the LOQ of 0.01 mg/kg (see Section 1.1.4). Therefore, a lowering of the existing tentative MRLs from the LOQ of 0.05 mg/kg for herbal infusions (flowers and roots) to 0.01 mg/kg can be proposed. The same applies to hops for which the lower achievable LOQ of 0.01 mg/kg was also validated, and for which the residue trials evaluated by the MRL review confirmed a no‐residue situation.

2. RESIDUES IN LIVESTOCK

The confirmatory data assessed in this evaluation do not have an impact on pesticide residues expected in livestock. Thus, the previous assessment of residues in livestock (EFSA, 2022) is still valid.

3. CONSUMER RISK ASSESSMENT

Chronic exposure calculations were performed in the framework of the MRL review (EFSA, 2022) using revision 3.1 of the EFSA PRIMo (EFSA, 2018, 2019).

EFSA updated these previous calculations considering the outcome of the present assessment of confirmatory data: confirming MRL and risk assessment values for cotton seed and confirming and lowering MRLs and risk assessment values for herbal infusions (dried flowers and dried roots) and hops (dried).

In addition, after the MRL review, new MRLs and risk assessment values have been implemented in EU MRL Regulation through fast track procedures between 2023 and 2025 on gherkins, peas without pods, dry beans and dry peas. For these crops respective risk assessment values were also added in the exposure calculation. Since residues are not expected to occur in commodities of animal origin, these were not considered in the exposure calculation.

All input values included in the exposure calculations are summarised in Appendix D.

The chronic exposure values calculated were compared with the ADI of 0.05 mg/kg bw per day (European Commission, 2011).

The highest chronic exposure was calculated for the Dutch toddler, representing 0.73% of the ADI. An overview of the consumer risk assessment is reported in Appendix B.3. The exposure calculations did not indicate a risk to consumer's health.

Acute exposure calculations were not carried out because an ARfD was not deemed necessary for this active substance (European Commission, 2011).

4. CONCLUSION AND RECOMMENDATIONS

To address data gaps identified in the framework of the MRL review (EFSA, 2022), a new analytical method for enforcement and its ILV, plus additional studies on the magnitude of residues were submitted by the applicant. Therefore, data gaps 1 and 2 were both sufficiently addressed.

The new information provided confirmed a no‐residue situation in cotton seed and herbal infusions from flowers. The current MRL of 0.01 mg/kg for cotton seeds can therefore be confirmed. Since a more sensitive analytical enforcement method is now available, a lowering of the existing MRLs (0.05 mg/kg) for herbal infusions (flowers and roots) and hops to an LOQ of 0.01 mg/kg can be considered.

The overview of the assessment of confirmatory data and the recommended MRL modifications are summarised in Appendix B.4.

ABBREVIATIONS

a.s.

active substance

ADI

acceptable daily intake

AR

applied radioactivity

ARfD

acute reference dose

BBCH

growth stages of mono‐ and dicotyledonous plants

Bw

body weight

CAC

Codex Alimentarius Commission

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

DT₉₀

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

Dw

dry weight

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/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

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

NOAEL

no observed adverse effect level

OECD

Organisation for Economic Co‐operation and Development

PBI

plant‐back interval

PF

processing factor

PHI

pre‐harvest interval

PRIMo

(EFSA) Pesticide Residues Intake Model

QuEChERS

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

RA

risk assessment

RAC

raw agricultural commodity

RD

residue definition

RMS

rapporteur Member State

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

UV

ultraviolet (detector)

WHO

World Health Organization

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2025‐00195

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APPENDIX A. Summary of GAPs assessed in the evaluation of confirmatory data

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.	Method kind	Range of growth stages & season c	Number min–max	Interval between application (min)	g a.s./hL min–max	Water L/ha min–max	Rate	Unit
MRL review GAPs (confirmatory data, authorised uses) (EFSA, 2022 )
Cotton seeds	SEU	F	Dicotyledonous weeds	SC	500 g/L	spraying (3SPRYM) on soil (subsurface)	BBCH 00	1	–	37.5–75	200–400	150	g/ha	n.a.	Crop destination: grown for harvesting fresh (3HFRED). Not relevant User: professional
Herbal infusion from flowers and roots	EU (FR)	F	Weeds	SC	125 g/L	Soil treatment on soil (surface)	Not specified	1	–	–	–	125	g/ha	90	Crop destination: grown for harvesting fresh (3HFRED) User: professional
Hops	NEU (BE, IR)	F	Annual dicots	SC	500 g/L	spraying (3SPRYM) on foliage/plant	BBCH 00–08 (application during dormancy)	1	–	–	–	250	g/ha	n.a.	Crop destination: grown for harvesting fresh (3HFRED) User: professional

Abbreviations: 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, 6th Edition. Revised May 2008. 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

	Crop groups	Crop(s)	Application(s)	Sampling (DAT)	Comment/source
Primary crops (available studies)	Fruit crops	Grapes	Soil treatment, 1 × 2008–2204 g a.s./ha g a.s./ha	At maturity	Radiolabelled isoxaben: U‐phenyl‐14C radiolabel and isoxazole‐5‐14C radiolabel (EFSA, 2022)
	Leafy crops	Leeks	Soil/Foliar treatment, 1 × 250 g a.s./ha	119 (BBCH 49)	Radiolabelled isoxaben: U‐phenyl‐14C radiolabel and isoxazole‐5‐14C radiolabel (EFSA, 2022). Treatment was done as foliar spray to the immature leek plants (growth stage BBCH 14) and the surrounding soil
	Cereals/grass	Barley	Soil/Foliar treatment, 1 × 200 g a.s./ha	7, 14, 28 and 87 days	Radiolabelled isoxaben: U‐phenyl‐14C radiolabel and isoxazole‐5‐14C radiolabel (EFSA, 2010). Treatments were done at pre‐emergence to early post‐emergence stage
		Barley, wheat	Soil/Foliar treatment, 1 × 250 g a.s./ha or 1 × 200 or 500 g a.s./ha	8–9 months

	Crop groups	Crop(s)	Application(s)	PBI (DAT)	Comment/source
Rotational crops (available studies)	Root/tuber crops	Radish	Bare soil, 250 g a.s./ha	30, 120, 189, 365	Radiolabelled isoxaben: U‐phenyl‐14C radiolabel and isoxazole‐5‐14C radiolabel (EFSA, 2022). Phytotoxicity observed at 120 DAT
	Leafy crops	Lettuce	Bare soil, 250 g a.s./ha	30, 120, 189, 365	Radiolabelled isoxaben: U‐phenyl‐14C radiolabel and isoxazole‐5‐14C radiolabel (EFSA, 2022). Phytotoxicity observed at 30 DAT and 120 DAT
	Cereal (small grain)	Wheat	Bare soil, 250 g a.s./ha	30, 120, 365	Radiolabelled isoxaben: U‐phenyl‐14C radiolabel and isoxazole‐5‐14C radiolabel (EFSA, 2022)
	Other	–	–	–	–

	Conditions	Stable?	Comment/source
Processed commodities (hydrolysis study)	Pasteurisation (20 min, 90°C, pH 4)	Not triggered	–
	Baking, brewing and boiling (60 min, 100°C, pH 5)	Not triggered	–
	Sterilisation (20 min, 120°C, pH 6)	Not triggered	–
	Other processing conditions	–	–

B.1.1.2. Stability of residues in plants

	Category	Commodity	T (°C)	Stability period		Compounds covered	Comment/source
				Value	Unit
Plant products (available studies)	High‐water content	Endives	−20	12	Months	Isoxaben	EFSA (2010)
	High‐oil content	Rapeseed	−18	12	Months	Isoxaben	EFSA (2022)
	High‐protein content	Dry bean	−18	12	Months	Isoxaben	EFSA (2022)
	High‐starch content	Cereal grain	−20	24	Months	Isoxaben	EFSA (2010)
	High‐acid content	Grapes	−20	24	Months	Isoxaben	EFSA (2010)
	Others	Straw	−20	24	Months	Isoxaben	EFSA (2010)

B.1.2. Magnitude of residues in plants

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

Commodity	Region/indoor 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
Cotton seeds	SEU	4 × < 0.01	Residue trials on oilseed rape performed at a more critical GAP compared to cotton seed (1 application at BBCH 16–20 instead of BBCH 00). This deviation and the reduced number of trials (4 instead of 8) are deemed acceptable considering the no‐residue situation. It is noted that residues of isoxaben were even below the limit of detection in all samples (i.e. < 0.003 mg/kg) Extrapolation from oilseed rape to cotton seed is possible	0.01 *	0.01	0.01	n.r.
Herbal infusion from flowers	NEU	3 × < 0.01	Residue trials on chamomile performed at a more critical GAP (PHI 35–42 days instead of 90 days). This deviation and the reduced number of trials (3 instead of 4) are deemed acceptable considering the no‐residue situation. It is noted that residues of isoxaben were even below the limit of detection in all samples (i.e. < 0.003 mg/kg) Extrapolation to whole group of herbal infusion from flowers and roots is possible	0.01 *	0.01	0.01	n.r.

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

^*Indicates that the MRL is proposed at the limit of quantification.

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

^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.

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.

B.2. RESIDUES IN LIVESTOCK

Not relevant in the framework of the present MRL application.

B.3. CONSUMER RISK ASSESSMENT

The acute risk assessment is not relevant since no ARfD has been considered necessary.

B.4. RECOMMENDED MRLS

Code a	Commodity	Existing MRL b	Proposed MRL	Conclusion/recommendation
Enforcement residue definition: Isoxaben
0401090	Cotton seeds	0.01* (ft 1)	0.01*	The data gap identified in the MRL review was addressed in this submission. A no‐residue situation is confirmed. The footnote implemented in Reg. (EU) 2025/1305 can be removed. The MRL is confirmed and the current value remains unchanged
0631010	Chamomile	0.05* (ft 2)	0.01*	The data gaps identified in the MRL review were addressed in this submission. A no‐residue situation is confirmed. The footnote implemented in Reg. (EU) 2025/1305 can be removed. The current MRL value is proposed to be lowered based on the capacity of the new enforcement method assessed in the present opinion
0631020	Hibiscus/roselle	0.05* (ft 2)	0.01*	See 0631010 – Chamomile
0631030	Rose	0.05* (ft 2)	0.01*	See 0631010 – Chamomile
0631040	Jasmine	0.05* (ft 2)	0.01*	See 0631010 – Chamomile
0631050	Lime/linden	0.05* (ft 2)	0.01*	See 0631010 – Chamomile
0633010	Valerian	0.05* (ft 3)	0.01*	The data gap identified in the MRL review was addressed in this submission. A no‐residue situation is confirmed. The footnote implemented in Reg. (EU) 2025/1305 can be removed. The current MRL value is proposed to be lowered based on the capacity of the new enforcement method assessed in the present opinion
0633020	Ginseng	0.05* (ft 3)	0.01*	See 0633010 – Valerian
0700000	Hops	0.05* (ft 3)	0.01*	The data gap identified in the MRL review was addressed in this submission. The footnote implemented in Reg. (EU) 2025/1305 can be removed. The current MRL value is proposed to be lowered based on the capacity of the new enforcement method assessed in the present opinion

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 Existing EU MRL and corresponding footnote on confirmatory data.

ft 1: The European Food Safety Authority identified some information on residue trials as unavailable. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 6 March 2025, or, if that information is not submitted by that date, the lack of it.

ft 2: The European Food Safety Authority identified some information on residue trials and analytical methods as unavailable. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 6 March 2025, or, if that information is not submitted by that date, the lack of it.

ft 3: The European Food Safety Authority identified some information on analytical methods as unavailable. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 6 March 2025, or, if that information is not submitted by that date, the lack of it.

APPENDIX C.  

APPENDIX D. Input values for the exposure calculations

D.1. CONSUMER RISK ASSESSMENT

Commodity	Existing/proposed MRL (mg/kg)	Source	Chronic risk assessment
			Input value a (mg/kg)	Comment
Grapefruits	0.01*	EFSA (2022)	0.01	STMR‐RAC
Oranges	0.01*	EFSA (2022)	0.01	STMR‐RAC
Lemons	0.01*	EFSA (2022)	0.01	STMR‐RAC
Limes	0.01*	EFSA (2022)	0.01	STMR‐RAC
Mandarins	0.01*	EFSA (2022)	0.01	STMR‐RAC
Almonds	0.01*	EFSA (2022)	0.01	STMR‐RAC
Chestnuts	0.01*	EFSA (2022)	0.01	STMR‐RAC
Hazelnuts/cobnuts	0.01*	EFSA (2022)	0.01	STMR‐RAC
Walnuts	0.01*	EFSA (2022)	0.01	STMR‐RAC
Apples	0.01*	EFSA (2022)	0.01	STMR‐RAC
Pears	0.01*	EFSA (2022)	0.01	STMR‐RAC
Quinces	0.01*	EFSA (2022)	0.01	STMR‐RAC
Medlar	0.01*	EFSA (2022)	0.01	STMR‐RAC
Loquats/Japanese medlars	0.01*	EFSA (2022)	0.01	STMR‐RAC
Apricots	0.01*	EFSA (2022)	0.01	STMR‐RAC
Cherries (sweet)	0.01*	EFSA (2022)	0.01	STMR‐RAC
Peaches	0.01*	EFSA (2022)	0.01	STMR‐RAC
Plums	0.01*	EFSA (2022)	0.01	STMR‐RAC
Table grapes	0.01*	EFSA (2022)	0.01	STMR‐RAC
Wine grapes	0.01*	EFSA (2022)	0.01	STMR‐RAC
Strawberries	0.01*	EFSA (2022)	0.01	STMR‐RAC
Blackberries	0.01*	EFSA (2022)	0.01	STMR‐RAC
Dewberries	0.01*	EFSA (2022)	0.01	STMR‐RAC
Raspberries (red and yellow)	0.01*	EFSA (2022)	0.01	STMR‐RAC
Blueberries	0.01*	EFSA (2022)	0.01	STMR‐RAC
Cranberries	0.01*	EFSA (2022)	0.01	STMR‐RAC
Currants (red, black and white)	0.01*	EFSA (2022)	0.01	STMR‐RAC
Gooseberries (green, red and yellow)	0.01*	EFSA (2022)	0.01	STMR‐RAC
Rose hips	0.01*	EFSA (2022)	0.01	STMR‐RAC
Mulberries (black and white)	0.01*	EFSA (2022)	0.01	STMR‐RAC
Azarole/Mediteranean medlar	0.01*	EFSA (2022)	0.01	STMR‐RAC
Elderberries	0.01*	EFSA (2022)	0.01	STMR‐RAC
Kiwi fruits (green, red, yellow)	0.01*	EFSA (2022)	0.01	STMR‐RAC
Bananas	0.01*	EFSA (2022)	0.01	STMR‐RAC
Carrots	0.01*	EFSA (2022)	0.01	STMR‐RAC
Horseradishes	0.01*	EFSA (2022)	0.01	STMR‐RAC
Parsnips	0.01*	EFSA (2022)	0.01	STMR‐RAC
Garlic	0.01*	EFSA (2022)	0.01	STMR‐RAC
Onions	0.01*	EFSA (2022)	0.01	STMR‐RAC
Shallots	0.01*	EFSA (2022)	0.01	STMR‐RAC
Spring onions/green onions and Welsh onions	0.01*	EFSA (2022)	0.01	STMR‐RAC
Gherkins	0.05	Fast track procedure (see EU Reg 2023/1719) b	0.05	STMR‐RAC
Courgettes	0.05	EFSA (2022)	0.05	STMR‐RAC
Melons	0.01*	EFSA (2022)	0.01	STMR‐RAC
Pumpkins	0.01*	EFSA (2022)	0.01	STMR‐RAC
Witloofs/Belgian endives	0.01*	EFSA (2022)	0.01	STMR‐RAC
Chives	0.01*	EFSA (2022)	0.01	STMR‐RAC
Celery leaves	0.01*	EFSA (2022)	0.01	STMR‐RAC
Sage	0.01*	EFSA (2022)	0.01	STMR‐RAC
Rosemary	0.01*	EFSA (2022)	0.01	STMR‐RAC
Thyme	0.01*	EFSA (2022)	0.01	STMR‐RAC
Basil and edible flowers	0.01*	EFSA (2022)	0.01	STMR‐RAC
Beans (without pods)	0.02	EFSA (2022)	0.02	STMR‐RAC
Peas (without pods)	0.02	Fast track procedure (see EU Reg 2023/466) c	0.02	STMR‐RAC
Asparagus	0.01*	EFSA (2022)	0.01	STMR‐RAC
Leeks	0.01*	EFSA (2022)	0.01	STMR‐RAC
Rhubarbs	0.01*	EFSA (2022)	0.01	STMR‐RAC
Beans	0.02	Fast track procedure (see EU Reg 2025/1305) d	0.02	STMR‐RAC
Peas	0.02	Fast track procedure (see EU Reg 2025/1305) d	0.02	STMR‐RAC
Rapeseeds/canola seeds	0.01*	EFSA (2022)	0.01	STMR‐RAC
Cotton seeds	0.01 *	Proposed MRL	0.01	STMR‐RAC
Barley	0.01*	EFSA (2022)	0.01	STMR‐RAC
Oat	0.01*	EFSA (2022)	0.01	STMR‐RAC
Rye	0.01*	EFSA (2022)	0.01	STMR‐RAC
Wheat	0.01*	EFSA (2022)	0.01	STMR‐RAC
Herbal infusions (dried flowers) Chamomille Hybiscus/roselle Rose Jasmine Lime/linden	0.01 *	Proposed MRL	0.01	STMR‐RAC
Herbal infusions (dried roots) Valerian root Ginseng root	0.01 *	Proposed MRL	0.01	STMR‐RAC
Hops (dried)	0.01 *	Proposed MRL	0.01	STMR‐RAC
Chicory roots	0.01*	EFSA (2022)	0.01	STMR‐RAC

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 calculated values (which may contain more digits). To reproduce dietary burden calculations, the unrounded values need to be used.

^b Commission Regulation (EU) 2023/1719 of 8 September 2023 amending Annexes II and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for isoxaben, metaldehyde, Metarhizium brunneum strain Ma 43, paclobutrazol and Straight Chain Lepidopteran Pheromones (SCLP) in or on certain products. C/2023/6009. OJ L 223, 11.9.2023, pp. 9–25.

^c Commission Regulation (EU) 2023/466 of 3 March 2023 amending Annexes II, III and V to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for isoxaben, novaluron and tetraconazole in or on certain products. C/2023/1388. OJ L 68, 6.3.2023, pp. 55–93.

^d Commission Regulation (EU) 2025/1305 of 2 July 2025 amending Annexes II, III and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for amidosulfuron, azoxystrobin, hexythiazox, isoxaben, picloram, propamocarb, sodium silver thiosulfate and tefluthrin in or on certain products. C/2025/4303. OJ L, 2025/1305, 3.7.2025, ELI: http://data.europa.eu/eli/reg/2025/1305/oj.

APPENDIX E. Used compound codes

Code/trivial name a	IUPAC name/SMILES notation/InChiKey b	Structural formula c
Isoxaben	N‐[3‐(1‐ethyl‐1‐methylpropyl)isoxazol‐5‐yl]‐2,6‐dimethoxybenzamide PMHURSZHKKJGBM‐UHFFFAOYSA‐N COc1cccc(OC)c1C(=O)Nc1onc(c1)C(C)(CC)CC

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. , Carrasco Cabrera, L. , Castellan, I. , del Aguila, M. , Ferreira, L. , Greco, L. , Leuschner, R. , Mioč, A. , Nave, S. , Reich, H. , Ruocco, S. , Scarlato, A. P. , Szot, M. , Theobald, A. , Tiramani, M. , Verani, A. , & Zioga, E. (2026). Evaluation of confirmatory data following the Article 12 MRL review for isoxaben. EFSA Journal, 24(5), e10084. 10.2903/j.efsa.2026.10084