Modification of the existing maximum residue level for cyflumetofen in sweet peppers/bell peppers

TL;DR

This paper discusses a request to modify the maximum residue level of the pesticide cyflumetofen in sweet peppers to ensure consumer safety.

Contribution

The paper provides a risk assessment supporting the modification of the maximum residue level for cyflumetofen in sweet peppers.

Findings

Adequate analytical methods exist to measure cyflumetofen residues at 0.01 mg/kg in plant matrices.

Short-term and long-term residue intake from cyflumetofen in sweet peppers is unlikely to pose a risk to consumer health.

Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Certis Belchim BV submitted a request to the competent national authority in the Netherlands to modify the existing maximum residue level (MRL) for the active substance cyflumetofen in sweet peppers/bell peppers. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for sweet peppers/bell peppers. Adequate analytical methods for enforcement are available to control the residues of cyflumetofen (sum of isomers) in plant matrices at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the uses of cyflumetofen according to the reported agricultural practices is unlikely to present a risk to consumer health.

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Full text

SUMMARY

In accordance with Article 6 of Regulation (EC) No 396/2005, Certis Belchim BV 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 cyflumetofen in sweet peppers/bell peppers.

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 26 September 2024. The appointed EMS, the Netherlands, assessed the dossier and declared its admissibility on 12 March 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 7 April 2025 to 28 April 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 19 September 2025. To accommodate for the intended indoor use of cyflumetofen, the EMS proposed to raise the existing MRL from the limit of quantification of 0.01 mg/kg (LOQ) to 2 mg/kg.

On 25 September 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.

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 11 November 2025, which replaced the previously submitted evaluation report.

Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC and the data evaluated under previous MRL assessments, including the review of the existing EU MRLs according to Article 12 of Regulation (EC) No 396/2005 (hereafter MRL review), the following conclusions are derived.

The metabolism of cyflumetofen following foliar spray application was investigated in crops belonging to the group of fruit crops. Parent compound cyflumetofen was the main residue in all crops investigated. Metabolite B‐1 (free and conjugated) was detected above 10% TRR in eggplant fruit. Studies investigating the effect of processing on the nature of cyflumetofen (hydrolysis studies) demonstrated that the active substance remained stable under pasteurisation, partially degraded under cooking/boiling/baking and almost completely degraded under sterilisation conditions into metabolites B‐1, AB‐1 and A‐2. In rotational crops, cyflumetofen was not found and the major residue identified in rotated crops was trifluoroacetic acid (TFA), which is considered as toxicologically relevant and occurs in plants after the use of other pesticides as well. According to the intended use pattern, sweet peppers/bell peppers will be grown in artificial growth substrate; therefore, cyflumetofen will not come into contact with soil, and further investigations of residues in rotational crops are not required.

Based on the metabolic pattern identified in metabolism studies, hydrolysis studies, the toxicological relevance of metabolites and degradation products, the residue definitions in fruit crops were proposed as ‘cyflumetofen (sum of isomers)’ for enforcement and as ‘sum of cyflumetofen (sum of isomers) and 2‐(trifluoromethyl)benzoic acid (metabolite B‐1), expressed as cyflumetofen’ for risk assessment. These residue definitions are limited to primary fruit crops (and hops) and applicable to the intended use on fruit crops. The same residue definitions apply to rotational crops, since the MRL review concluded that, for the authorised uses of cyflumetofen, consumers are not expected to be exposed to residues of TFA. Therefore, a separate residue definition for risk assessment for rotational crops is not deemed necessary, especially in the context of this application, considering the specific use pattern on artificial growth substrate. For processed commodities, the abovementioned residue definitions were also considered applicable for the authorised uses assessed by the MRL review, on the basis of toxicological properties of all degradation products and on the basis of occurrence data, excluding significant presence of hydrolysis degradation products A‐2 and B‐1. Residue data on AB‐1 were not available in processed commodities.

EFSA concluded that, for the crops assessed in this application, metabolism of cyflumetofen in primary crops and the possible degradation in processed products has been sufficiently addressed and that the previously derived residue definitions are applicable.

Sufficiently validated analytical methods based on LC‐MS/MS are available to quantify residues in the crops assessed in this application according to the enforcement residue definition. The methods enable the quantification of residues at or above 0.01 mg/kg in the crops assessed (LOQ).

The available residue trials are sufficient to derive an MRL proposal of 2 mg/kg for sweet peppers/bell peppers.

Specific studies investigating the magnitude of cyflumetofen residues in processed commodities have not been provided and are not required. Although residues above 0.1 mg/kg are expected in raw agricultural commodity (RAC), the individual contribution to consumer exposure was low, with the total theoretical maximum daily intake (TMDI) being below the trigger value of 10% of the ADI.

Sweet peppers/bell peppers are normally not fed to livestock, and therefore, the nature and magnitude of cyflumetofen in livestock was not further assessed.

The toxicological profile of cyflumetofen was assessed in the framework of the EU pesticides peer review under Directive 91/414/EEC and considered during the follow‐up peer review in light of confirmatory data, and the data were sufficient to derive an acceptable daily intake (ADI) of 0.17 mg/kg body weight (bw) per day. An acute reference dose (ARfD) was deemed unnecessary. The toxicological reference values of the parent cyflumetofen are applicable to metabolite B‐1, which is included in the residue definition for risk assessment of fruit crops.

The consumer risk assessment was performed with revision 3.1 of the EFSA Pesticide Residues Intake Model (PRIMo). The short‐term exposure was not conducted as the setting of an ARfD was considered unnecessary. In the framework of the MRL review, a comprehensive long‐term consumer exposure assessment was performed. EFSA updated this calculation with the relevant supervised trials median residue (STMR) value derived from the residue trials submitted on sweet peppers.

No long‐term consumer intake concern was identified for any of the European diets incorporated in the EFSA PRIMo. The total chronic intake accounted for a maximum of 2% of the ADI (NL toddler diet). The contribution of residues expected in sweet peppers to the overall long‐term exposure accounted for less than 0.08% of the ADI (GEMS/Food G15 diet).

EFSA concluded that the existing uses and proposed indoor use of cyflumetofen on sweet peppers will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a risk to consumers' health.

The peer review of the active substance in accordance with Regulation (EC) No 1107/2009 is ongoing, and therefore, the conclusions reported in this reasoned opinion might need to be reconsidered in the light of the outcome of the peer review.

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.Codea CommodityExisting EU MRL (mg/kg)Proposed EU MRL (mg/kg)Comment/justification Enforcement residue definition: cyflumetofen (sum of isomers)0231020Sweet peppers/bell peppers0.01* 2The submitted data on peppers are sufficient to derive an MRL proposal for the intended indoor use. Risk for consumers unlikely.Abbreviations: MRL, maximum residue level; NEU, northern Europe; SEU, southern Europe; GAP, Good Agricultural Practice.*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.

ASSESSMENT

The European Food Safety Authority (EFSA) received an application to modify the existing maximum residue level (MRL) for cyflumetofen in sweet peppers/bell peppers. The detailed description of the intended European Union (EU) indoor use of cyflumetofen, which is the basis for the current MRL application, is reported in Appendix A.

Cyflumetofen is the ISO common name for 2‐methoxyethyl 2‐(4‐tert‐butylphenyl)‐2‐cyano‐3‐oxo‐3‐[2‐(trifluoromethyl)benzamido]propanoate (IUPAC). The chemical structures of the active substance and its main metabolites are reported in Appendix E.

Cyflumetofen1 was evaluated in the framework of Directive 91/414/EEC,2 with the Netherlands designated as rapporteur Member State (RMS) for the representative uses as an acaricide foliar treatment on ornamental crops, nursery trees, perennial ornamentals and public greens. The draft assessment report (DAR) prepared by the RMS has been peer reviewed by EFSA (EFSA, 2012). Cyflumetofen was approved3 for the use as acaricide on 1 June 2013, with conditions for approval of plant protection products introduced in 20194 following the assessment of the confirmatory data (EFSA, 2016). The process of peer review for the renewal of the first approval is currently ongoing.

The EU MRLs for cyflumetofen are established in Annex II of Regulation (EC) No 396/2005.5 The review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (MRL review) has been performed (EFSA, 2021b) and the proposed modifications have been implemented in the MRL legislation. For several commodities, tentative MRLs were implemented with a footnote for Article 12 confirmatory data to be addressed by 27 January 2025. So far, information to address these data gaps has not been assessed yet. Also, certain Codex maximum residue limits (CXLs) have been taken over in the EU MRL legislation.6 After completion of the MRL review, EFSA has issued no further reasoned opinions on the modification of MRLs for cyflumetofen.

In accordance with Article 6 of Regulation (EC) No 396/2005 and following the provisions set by the ‘Transparency Regulation’ (EU) 2019/13817, the applicant Certis Belchim BV submitted on 26 September 2024 an application to the competent national authority in the Netherlands, alongside the dossier containing the supporting data using the IUCLID format to modify the existing MRLs for the active substance cyflumetofen in sweet peppers.

The appointed EMS, the Netherlands, assessed the dossier and declared its admissibility on 12 March 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 7 April 2025 to 28 April 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 19 September 2025. To accommodate for the intended indoor use of cyflumetofen, the EMS proposed to raise the existing MRL from the limit of quantification of 0.01 (LOQ) to 2 mg/kg.

On 25 September 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.

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 11 November 2025 (Netherlands, 2025), which replaced the previously submitted evaluation report.

EFSA based its assessment on the evaluation report submitted by the EMS (Netherlands, 2025), the draft assessment report (DAR) and its addendum (Netherlands, 2010, 2011) prepared under Council Directive 91/414/EEC, the revised Commission review report on cyflumetofen (European Commission, 2019), the conclusions on the peer review of the pesticide risk assessment of the active substance cyflumetofen (EFSA, 2012, 2016), as well as the conclusions from previous EFSA opinions on cyflumetofen (EFSA, 2021a), including the reasoned opinion on the MRL review according to Article 12 of Regulation No 396/2005 (EFSA, 2021b) and the scientific reports prepared in support to the assessment of the Codex residue limits (CXLs) (EFSA, 2015, 2024).

For this application, the data requirements established in Regulation (EU) No 544/20118 and the guidance documents applicable at the date of submission of the IUCLID application are applicable (, 1997b, 1997c, 1997d, 1997e, 1997f, 1997g, 2010, 2023a, 2023b, 2023c, 2025; European Commission, 1997a). 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 546/2011.9

As the EU pesticides peer review on renewal of approval of cyflumetofen in accordance with Regulation (EC) No 1107/2009 is not yet finalised, the conclusions reported in this reasoned opinion may need to be reconsidered in light of the outcome of the peer review.

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 (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.10

RESIDUES IN PLANTS

1

Nature of residues and methods of analysis in plants

1.1

Nature of residues in primary crops

1.1.1

The metabolism of cyflumetofen in primary crops belonging to the group of fruit crops (mandarin, apple and aubergine/eggplant) has been investigated in the framework of the MRL review and EU pesticides peer review (EFSA, 2012, 2021b). No additional studies were submitted in support of the current MRL application.

The studies were conducted with a single foliar application of ^14^C‐cyflumetofen, either labelled on the tert ‐butyl phenyl ring or the trifluoromethyl phenyl ring at a dose of 600 g a.s./ha.

In the crops tested, parent compound cyflumetofen was the main residue, representing the major component of the total radioactive residues (TRR) ranging from 67% to 84% and 77%–87% 7 days after application, and 44%–65% and 44%–81% after 30 days on fruits and leaves, respectively. Although several metabolites were identified, only 2‐(trifluoromethyl)benzoic acid (metabolite B‐1, free and conjugated) was detected above 10% TRR (up to 15% and 16% TRR, free and conjugated, respectively, in eggplant fruits) and AB‐6 at 10% TRR in eggplant leaves. It was noted that, in the metabolism studies, the possible changes in the stereochemistry of the active substance were not investigated and a data gap was identified by EFSA (EFSA, 2012). The EU pesticides peer review concluded that, in fruit crops, the relevant compounds for the risk assessment are parent cyflumetofen and its metabolite B‐1, considering that B‐1 (free and conjugated) was detected in eggplant fruit at similar levels and proportions as cyflumetofen (EFSA, 2012).

For the intended use, the metabolic behaviour in primary crops is sufficiently addressed.

Nature of residues in rotational crops

1.1.2

According to the soil degradation studies assessed by the EU pesticides peer review, the DT_90_ value for cyflumetofen and its main soil metabolites B‐1, AB‐1 and B‐3 in laboratory studies was below the trigger value of 100 days in different types of soils (EFSA, 2012). From the rotational crop metabolism studies assessed in the framework of the peer review, it was concluded that accumulation in soil of cyflumetofen is not expected. However, in rotational crops, the only major radioactive residue, identified in all crop matrices, was trifluoroacetic acid (TFA) (EFSA, 2012), which can be formed from the parent compound cyflumetofen by degradation in the soil and uptake by the plants or from metabolite B‐1. Furthermore, TFA is very persistent in soil (DT 50 > 1000 days) and occurs ubiquitously in the environment from a variety of other sources (EFSA, 2021b).

However, since the proposed use of cyflumetofen is indoor on an artificial substrate, cyflumetofen will not come into contact with soil under the conditions of use assessed and investigations of residues in rotational crops are not required for the current application.

Nature of residues in processed commodities

1.1.3

The effect of processing on the nature of cyflumetofen was investigated in the framework of the MRL review (EFSA, 2021b) and in a previous MRL application (EFSA, 2021a). Studies were conducted with cyflumetofen radiolabelled on the butylphenyl ring or the trifluoromethyl phenyl ring. These studies showed that the cyflumetofen remained stable under pasteurisation, degraded partially under cooking/boiling/baking and almost completely under sterilisation conditions into metabolites B‐1, AB‐1 and A‐2.

Under standard boiling/baking/brewing conditions (60 min, 100°C, pH 5) and under sterilisation conditions (20 min, 120°C, pH 6), a cyflumetofen conversion of 40% and 49% to form metabolite AB‐1 and of 53% and 44% to form metabolite A‐2 was observed, respectively (butylphenyl‐label study). Metabolite B‐1 was the major degradation product (up to 73% AR, sterilisation conditions) in the benzoyl‐labelled study (see Appendix B.1.1.1).

The toxicological relevance of metabolite B‐1 was assessed in the framework of the EU pesticides peer review (EFSA, 2012) and of metabolites AB‐1 and A‐2 in the context of a previous MRL application (EFSA, 2021a). It was concluded that metabolite B‐1 is covered by the toxicological profile of the parent compound (EFSA, 2012). For what concerns the other two metabolites, the data indicated that the toxicity of AB‐1 is covered by the parent compound, whereas A‐2 was considered as unlikely to be genotoxic in vitro but with a chronic toxicity qualitatively different than the parent compound. Therefore, a different acceptable daily intake (ADI) of 0.0036 mg/kg body weight (bw) per day was set for A‐2. An acute reference dose (ARfD) was not set and not considered necessary (see details in paragraph 1.1.6).

Analytical methods for enforcement purposes in plant commodities

1.1.4

Analytical methods to quantify residues of cyflumetofen by liquid chromatography with tandem mass spectrometry (LC–MS/MS) monitoring two ion transitions were proposed for enforcement purposes (Netherlands, 2025). The methods were sufficiently validated in terms of specificity, linearity, precision, accuracy and allowed quantifying residues at or above the limit of quantification (LOQ) of 0.01 mg/kg in high water (sweet pepper) matrix.

EFSA concludes that, for the crops under assessment (matrix with high‐water content), sufficiently validated analytical methods are available to quantify residues of cyflumetofen according to the established residue definition for enforcement.

Storage stability of residues in plants

1.1.5

The storage stability of cyflumetofen and its metabolite B‐1 was investigated in the framework of a previous MRL application and the MRL review (EFSA, 2021a, 2021b). The storage stability of cyflumetofen was demonstrated for at least 25 months in wheat grains (high starch content), almond nutmeal (high oil content), in apple fruits (high water content) and apple juice (processed products), in orange fruits (high acid content) and orange juice and oil (processed products), 3 months in lettuces (high water content) and radish roots (high starch content) when stored frozen (−20°C to −10°C). Regarding the storage stability of metabolite B‐1, several deficiencies were observed in the studies. However, despite the variability, the graphical presentation of the recoveries according to current guidance (European Commission, 1997f) showed no large fluctuation attributable to the residue decline. Based on the available data and the interpolation method, residues of metabolite B‐1 were considered stable for 22 months in wheat grains (high starch content), for 25 months in apple fruit and juice (high water content), about 30 months in orange fruit and juice (high acid content), 21 months in radish root (high starch content) and 30 months in almond nutmeal (high oil content matrix). For lettuces and orange oils, the data were inconclusive (EFSA, 2021a).

A new storage stability study was submitted in the framework of this application (Netherlands, 2025). The storage stability assessment was carried out over a 13‐month period with analysis scheduled at the following time points: 0, 1, 3, 6, 12 and 13 months. At each time point, duplicate frozen stability samples were analysed along with duplicate procedural fresh fortification samples, a reagent blank and at least one procedural control sample. Procedural fresh fortification samples were also fortified at 0.1 mg/kg of cyflumetofen (0.05 mg/kg per enantiomer) and 0.1 mg/kg of metabolite B1 to allow for comparison to stored frozen samples (Netherlands, 2025). Based on the available data and in agreement with the EMS, EFSA concluded that cyflumetofen (enantiomer 1 and 2) and metabolite B1 are shown to be stable at −20°C for at least 13 months in sweet pepper.

See Appendix B.1.1.2 for details on storage stability.

Proposed residue definitions

1.1.6

Based on the metabolic pattern identified in metabolism studies, the results of hydrolysis studies, the toxicological relevance of metabolites and degradation products and the capabilities of enforcement analytical methods, the following residue definitions were proposed:

• residue definition for risk assessment: sum of cyflumetofen (sum of isomers) and 2‐(trifluoromethyl)benzoic acid (metabolite B‐1), expressed as cyflumetofen;
• residue definition for enforcement: cyflumetofen (sum of isomers).

The parent compound was found to be a sufficient marker for enforcement, and this residue definition is limited to fruit crops and to the use on hops (EFSA, 2021b). This residue definition for enforcement set in Regulation (EC) No 396/2005 is identical with the above‐mentioned residue definition.

Regarding risk assessment, metabolite B‐1 is considered to be the main metabolite in fruit crops according to metabolism studies as well as the main degradation product in processed commodities. Metabolite B‐1 is a major metabolite formed in rats following oral ingestion and was considered covered by the toxicological profile of the parent compound (EFSA, 2021b).

According to standard hydrolysis studies, additional two degradation products – AB‐1 and A‐2 – are formed at significant levels. The toxicological relevance of AB‐1 and A‐2 has been assessed in the framework of a previous MRL application (EFSA, 2021a). The data indicated that the toxicity of AB‐1 is covered by the parent compound, whereas A‐2 was considered as unlikely to be genotoxic in vitro but with a chronic toxicity qualitatively different than the parent compound. A specific acceptable daily intake (ADI) of 0.0036 mg/kg body weight (bw) per day was set for A‐2. An acute reference dose (ARfD) was not set and not considered necessary.

After the assessment of available processing studies providing occurrence data on B‐1 and A‐2, the MRL review concluded that an additional risk assessment residue definition for processed products is not deemed necessary, as based on the available studies, the formation of metabolites other than B‐1 is expected to be low. B‐1, if present, was significantly lower than parent cyflumetofen. Considering the toxicity profile of AB‐1 and A‐2, as well as low calculated chronic exposure to cyflumetofen, the MRL concluded that the risk assessment residue definition is applicable also for processed products (EFSA, 2021b). However, the MRL review also noted that in case further uses are authorised in the future, the need to consider metabolites AB‐1 and/or A‐2 in the residue definition may need to be reviewed (EFSA, 2021b). For the intended use on sweet peppers/bell peppers, EFSA concludes that the existing residue definitions are applicable.

In addition, the available plant metabolism studies do not investigate the possible impact of plant metabolism on the isomer ratio of cyflumetofen and further investigation on this matter would in principle be required. However, the MRL review concluded that, in view of the large margin of safety in the exposure calculation, the potential change in isomer ratios in the final residue is not expected to be of concern for the authorised uses assessed (EFSA, 2021b). The same can be concluded for the intended use on peppers. However, in case future uses of the active substance would lead to higher consumer exposure, further information regarding the impact of plant metabolism on the isomer ratio might be required.

Regarding rotational crops, the TFA is the only major metabolite relevant. It is formed by the extensive metabolism of cyflumetofen in soil and was not identified in the metabolism of primary crops. It is a common metabolite found ubiquitously in the environment from various sources. The MRL review (EFSA, 2021b) concluded that, for the authorised uses of cyflumetofen, consumers are not expected to be exposed to significant residues of this metabolite, and therefore, a separate residue definition for risk assessment for rotational crops is not deemed necessary. The relevance of TFA for the use intended in the present MRL application was not further investigated given that sweet peppers/bell peppers will be grown in artificial substrate.

Taking into account the additional information provided, and the proposed use assessed in this application, EFSA concluded that these residue definitions are appropriate, and no further information is required.

Magnitude of residues in plants

1.2

Magnitude of residues in primary crops

1.2.1

In support of the MRL application, the applicant submitted indoor residue trials performed in sweet peppers. The samples were analysed for the parent compound and for the metabolite B‐1, currently included in the risk assessment residue definition. Residues were analysed according to the same analytical method with an LOQ of 0.01 mg/kg for metabolite B‐1 and cyflumetofen (0.005 mg/kg per enantiomer). In order to express residue data according to the risk assessment residue definition, molecular weight conversion factors were applied. According to the assessment of the EMS, the methods used were sufficiently validated and fit for purpose (Netherlands, 2025).

Intended EU indoor GAP of cyflumetofen on sweet peppers/bell peppers: two foliar applications (interval between applications: 7 days) × 300 g a.s./ha; PHI = 1 day (Netherlands, 2025)

Eight GAP‐compliant residue trials on sweet peppers conducted indoor in the EU over one growing season (2022) were submitted in support of the intended indoor use. The indoor trial locations were both NEU and SEU (Italy, Spain, France). Samples were stored for up to 7 months and are covered by all available storage stability data of 13 months for parent cyflumetofen and its metabolite B‐1 (Netherlands, 2025). EFSA agreed with the selection of residues by the EMS, which added the values of the two cyflumetofen enantiomers to the value of metabolite B‐1, expressed as cyflumetofen. Residues of cyflumetofen and B‐1 included in the calculated sum were selected at the same PHI level.

For the EU indoor use, an MRL proposal of 2 mg/kg can be derived for cyflumetofen in sweet peppers. The residues of B‐1 metabolite were mostly below the individual LOQ of 0.01 mg/kg, apart from two samples where residues measured 0.01 mg/kg.

It is to be noted that the availability of a chiral mass spectrometry column used in the analytical method for both enforcement and risk assessment allowed for the determination of the two cyflumetofen enantiomers (Netherlands, 2025).

The residue levels in the supervised residue trials submitted are reported in Appendix B.1.2.1.

Magnitude of residues in rotational crops

1.2.2

According to the intended use pattern, the peppers will be grown in artificial growth substrate, and therefore, the investigation of magnitude of residues in rotational crops is not relevant for the present MRL application.

Magnitude of residues in processed commodities

1.2.3

The studies investigating the effect of industrial processing and/or household preparation on the magnitude of residues in processed peppers were not submitted with the present MRL application and are not required. Although residues in raw peppers were detected above the trigger value of 0.1 mg/kg, the individual contribution of residues in pepper to the theoretical maximum daily intake (TMDI) is less than 10% of the acceptable daily intake (ADI) (European Commission, 1997d) and therefore, according to the applicable legal framework of the present assessment, the processing studies are not deemed necessary. Furthermore, there are no consumption data available for processed peppers in the EFSA PRIMo, and therefore, processing studies in this case would be of limited value for refinement of the consumer exposure.

Proposed MRLs

1.2.4

The available data are considered sufficient to derive MRL proposals as well as risk assessment values for the commodity under evaluation (see Appendix B.4). In Section 3, EFSA assessed whether residues on these crops, resulting from the intended use, are likely to pose a consumer health risk.

RESIDUES IN LIVESTOCK

2

Not relevant as peppers are not used for feed purposes.

CONSUMER RISK ASSESSMENT

3

EFSA performed a dietary risk assessment using revision 3.1 of the EFSA PRIMo (EFSA, 2018, 2019a). This exposure assessment model contains food consumption data for different subgroups 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 value (i.e. ADI of 0.17 mg/kg bw day) for cyflumetofen used in the risk assessment was derived in the framework of the EU pesticides peer review. The setting of an ARfD was deemed unnecessary (European Commission, 2019). The toxicological reference values of the parent cyflumetofen are applicable to the metabolite B‐1 included in the risk assessment residue definition, as it was considered to be of similar toxicity as the parent compound (EFSA, 2012).

Short‐term (acute) dietary risk assessment

Considering the toxicological profile of the active substance, a short‐term dietary risk assessment was not required.

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 (EFSA, 2021b). EFSA updated the calculation with the relevant STMR value derived from the residue trials submitted in support of this MRL application for sweet peppers. A peeling factor of 0.17 derived in the context of a previous MRL application was used for citrus fruits (EFSA, 2021a) and the default MRL value of 0.05 mg/kg for honey. According to Regulation (EU) 2025/116411 for cucumbers and cherries, a Codex MRL has been taken over in the EU legislation in 2025, and therefore, for these commodities, the risk assessment values were derived by the JMPR in 2024 (FAO and WHO, 2024). The crops for which no GAP was reported in the framework of the MRL review or in subsequent EFSA outputs were not included in the calculation.

The complete list of input values used in the exposure calculations is summarised in Appendix D.1.

No long‐term consumer intake concern was identified for any of the European diets incorporated in the EFSA PRIMo. The total chronic intake accounted for a maximum of 2% of the ADI (NL toddler diet); the contribution of the residues in the evaluated crop accounted for 0.08% of ADI (sweet peppers/bell peppers). The details on the overall long‐term exposure are presented in Appendix B.3.

EFSA concluded that the long‐term intake of residues of cyflumetofen resulting from the existing and the intended uses is unlikely to present a risk to consumer health.

In the framework of the peer review, it was highlighted that metabolism studies did not investigate the possible impact of plant and animal metabolism on the isomer ratio of cyflumetofen. However, in view of the large margin of safety in the exposure calculation, the potential change in isomer ratios in the final residue is not expected to be of concern for the intended use in the framework of this application. It is noted that the EFSA guidance on the risk assessment of compounds that may have stereoisomers has been issued (EFSA, 2019b). EFSA would recommend reconsidering this point in the broader framework of the peer review for the renewal of approval of the active substance.

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

CONCLUSION AND RECOMMENDATIONS

4

The data submitted in support of this MRL application were found to be sufficient to derive an MRL proposal and risk assessment values for sweet peppers/bell peppers.

EFSA concluded that the long‐term intake of residues resulting from the existing uses and the proposed use of cyflumetofen on sweet peppers/bell peppers will not result in a consumer exposure exceeding the toxicological reference value and is therefore unlikely to pose a risk to consumers' health.

It is to be noted that the available plant metabolism studies presented in this output do not investigate the possible impact of plant metabolism on the isomer ratio of cyflumetofen and further investigation on this matter would in principle be required. EFSA concluded that the long‐term intake of residues resulting from the existing uses and the proposed use of cyflumetofen on sweet peppers/bell peppers will not result in a consumer exposure exceeding the toxicological reference value and is therefore unlikely to pose a risk to consumers' health. However, in case future uses of the active substance would lead to higher consumer exposure, further information regarding the impact of plant metabolism on the isomer ratio might be required.

The MRL recommendations are summarised in Appendix B.4.

ABBREVIATIONSADIacceptable daily intakeARapplied radioactivityARfDacute reference dosea.s.active substanceBBCHgrowth stages of mono‐ and dicotyledonous plantsbwbody weightCACCodex Alimentarius CommissionCASChemical Abstract ServiceCCPRCodex Committee on Pesticide ResiduesCENEuropean Committee for Standardisation (Comité Européen de Normalisation)CFconversion factor for enforcement to risk assessment residue definitionCIRCA(EU) Communication & Information Resource Centre AdministratorCScapsule suspensionCVcoefficient of variation (relative standard deviation)CXLCodex maximum residue limitDARdraft assessment reportDATdays after treatmentDMdry matterDPdustable powderDSpowder for dry seed treatmentDT_90_ period required for 90% dissipation (define method of estimation)ECemulsifiable concentrateEDIestimated daily intakeEMSevaluating Member Stateeqresidue expressed as a.s. equivalentESIelectrospray ionisationEURLEU Reference Laboratory (former Community Reference Laboratory (CRL))FAOFood and Agriculture Organization of the United NationsFIDflame ionisation detectorFLDfluorescence detectorFPDflame photometric detectorGAPGood Agricultural PracticeGCgas chromatographyGC‐FIDgas chromatography with flame ionisation detectorGC‐MSgas chromatography with mass spectrometryGC‐MS/MSgas chromatography with tandem mass spectrometryGC‐NPDgas chromatography with nitrogen/phosphorous detectorGCPFGlobal Crop Protection Federation (formerly International Group of National Associations of Manufacturers of Agrochemical Products (GIFAP))GRgranuleHRhighest residueIEDIinternational estimated daily intakeIESTIinternational estimated short‐term intakeILVindependent laboratory validationISOInternational Organisation for StandardisationIUPACInternational Union of Pure and Applied ChemistryJMPRJoint FAO/WHO Meeting on Pesticide ResiduesLCliquid chromatographyLOQlimit of quantificationMRLmaximum residue levelMSmass spectrometry detectorMSMember StatesMS/MStandem mass spectrometry detectorMWmolecular weightNEUnorthern EuropeNPDnitrogen/phosphorous detectorOECDOrganisation for Economic Co‐operation and DevelopmentPBIplant back intervalPFprocessing factorPHIpreharvest intervalP_ow_ partition coefficient between n‐octanol and waterPRIMo(EFSA) Pesticide Residues Intake ModelRArisk assessmentRACraw agricultural commodityRDresidue definitionRMSrapporteur Member StateSANCODirectorate‐General for Health and ConsumersSCsuspension concentrateSEUsouthern EuropeSGwater‐soluble granuleSLsoluble concentrateSPwater‐soluble powderSTMRsupervised trials median residueTARtotal applied radioactivityTMDItheoretical maximum daily intakeTRRtotal radioactive residueUVultraviolet (detector)WGwater‐dispersible granuleWHOWorld Health OrganizationWPwettable powderYFyield factorZCmixed CS and SC formulation

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2024‐00590

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