Setting of import tolerance for folpet in bananas and modification of the existing maximum residue level in honey

Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ADAMA Agriculture BV submitted a request to the competent national authority in Austria to set an import tolerance for the active substance folpet in bananas. Within the submitted application the applicant requested as well to modify the existing maximum residue level (MRL) for folpet in honey. The data submitted in support of the requests were found to be sufficient to derive an MRL proposal for bananas according to the current residue definition for enforcement. For honey however, the submitted trials were not compliant with good agricultural practice (GAP) and therefore not appropriate to derive an MRL proposal. Adequate analytical methods for enforcement, based on liquid and gas chromatography, are available to quantify residues of folpet and phthalimide in bananas and honey with lowest validated limit of quantification (LOQ) of 0.01 mg/kg (both compounds). Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of folpet residues expected in bananas and honey is unlikely to present a risk to consumer health. However, uncertainties remain regarding the long‐term exposure assessment due to missing residue data for phthalamic acid (in root crops) and phthalic acid (in all commodities except bananas and honey).

SUMMARY

In accordance with Article 6 of Regulation (EC) No 396/2005, ADAMA Agriculture BV submitted an application to the competent national authority in Austria (Rapporteur Member State (RMS)) to set import tolerance for the active substance folpet in bananas. Within the submitted application the applicant requested as well to modify the existing maximum residue level (MRL) for folpet in honey.

The application, alongside the dossier containing the supporting data in IUCLID format was submitted through the EFSA Central Submission System on 2 October 2024. The appointed RMS Austria assessed the dossier and declared its admissibility on 12 December 2024. 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 31 January 2025 to 21 February 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 23 May 2025. The RMS proposed to establish MRL for bananas imported from Ecuador and El Salvador at the level of 0.9 mg/kg and MRL for honey at the level of 0.7 mg/kg according to the existing residue definition for enforcement (i.e. ‘Folpet (sum of folpet and phthalimide, expressed as folpet)’). In addition, the RMS derived MRLs in accordance with the new residue definition for enforcement proposed in the framework of the peer review conclusion for the renewal of approval of folpet (EFSA, 2023b). Under this residue definition (‘folpet’), MRLs of 0.7 mg/kg for bananas and 0.07 mg/kg for honey were derived. However, the RMS did not support the use of this new residue definition, as folpet rapidly degrades to phthalimide during frozen storage and therefore considered more appropriate to maintain the current residue definition for enforcement.

The European Commission sent a mandate to EFSA on 20 June 2025 to assess the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified a point which needed further clarification and requested the RMS to address it. The applicant provided the requested information in an updated IUCLID dossier. The additional information was duly considered by the RMS who submitted a revised evaluation report to EFSA on 30 March 2026, which replaced the previously submitted evaluation report.

Based on the conclusions derived by EFSA in the framework of Regulation (EC) No 1107/2009, and the additional data provided by the RMS in the framework of this application, the following conclusions are derived.

The metabolism of folpet following foliar application was investigated in crops belonging to the groups of fruit crops, root crops and cereals/grass crops.

Residues in rotational crops are not expected since according to the soil degradation studies evaluated during the peer review conclusion for the renewal of the approval of folpet, the DT₉₀ values of folpet, phthalimide and the soil metabolites phthalic acid and phthalamic acid are all below the trigger value of 100 days.

Studies investigating the effect of processing on the nature of folpet (hydrolysis studies) demonstrated that the active substance completely degrades to phthalimide, predominantly under conditions of pasteurisation and further to phthalic acid under conditions simulating boiling/brewing/baking and sterilisation.

Based on the metabolic pattern identified in metabolism studies, hydrolysis studies, the toxicological relevance of metabolites and/or degradation products and the performance of the method of analysis, the following residue definitions were proposed for plant products in the framework of the peer review conclusion for the renewal of the approval of folpet:

• residue definition for enforcement (all plant commodities): folpet

• residue definitions for risk assessment:

  • −
    RA‐RD1a (fruit and cereal/grass crops): folpet and phthalimide, expressed as folpet
  • −
    RA‐RD1b (root crops): folpet and phthalamic acid, expressed as folpet
  • −
    RA‐RD2 (all plant commodities): phthalic acid

For processed plant commodities, the same residue definition for enforcement is applicable; the following residue definitions are applied for risk assessment:

• −RA‐RD1: folpet, phthalimide and phthalamic acid, expressed as folpet
• −RA‐RD2: phthalic acid

Residues in rotational crops are not expected (EFSA, 2023b). Residue definitions for enforcement, risk assessment 1a (fruit crops) and 2 are applicable to honey. The proposed residue definition for enforcement differs from the one currently set in Regulation (EC) No 396/2005, i.e. ‘Folpet (sum of folpet and phthalimide, expressed as folpet)’.

EFSA concluded that for the crops assessed in this application, metabolism of folpet 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 high performance liquid chromatography with tandem mass spectrometry (HPLC–MS/MS), gas chromatography–mass spectrometry (GC–MS) and gas chromatography with tandem mass spectrometry (GC–MS/MS), are available to quantify residues in high‐water content commodities according to the enforcement residue definitions (current and new). The methods enable quantification of residues of folpet and phthalimide at or above the limit of quantification (LOQ) of 0.01 mg/kg (both compounds using HPLC–MS/MS and phthalimide using GC–MS/MS), 0.02 mg/kg (phthalimide, using GC–MS) and 0.05 mg/kg (folpet, using GC–MS) in bananas.

The available residue trials are sufficient to derive an MRL proposal of 0.9 mg/kg for bananas according to the existing residue definition for enforcement. No MRL proposal could be derived based on the new residue definition for enforcement proposed in the context of the peer review conclusion for the renewal of the approval of folpet due to an insufficient number of residue trials with samples stored for periods supported by demonstrated storage stability of folpet in bananas.

Specific studies investigating the magnitude of folpet residues in processed commodities are not required, as significant residues are not expected in the edible portion of the raw agricultural commodity (RAC), with levels in the pulp remaining below 0.1 mg/kg.

Residues of folpet in commodities of animal origin were not assessed since the commodities under consideration in this MRL application are normally not fed to livestock.

For honey, sufficiently validated analytical methods, based on LC–MS/MS, are available to quantify residues of folpet and phthalimide in honey at the LOQ of 0.01 mg/kg. EFSA could not derive an MRL proposal in honey, as the selected critical GAP (cGAPs) on wine grapes (northern Europe (NEU)) and ornamental plants (NEU) were not considered to be sufficiently supported by the available semi‐field (tunnel) trials, due to inconsistencies between the application patterns used in the trials compared to those defined in the selected cGAPs. In contrast, the Applicant and the RMS considered the cGAPs to be adequately supported and reiterated an MRL proposal of 0.7 mg/kg based on the existing residue definition for enforcement. Further risk management considerations are required. The available monitoring programme datasets (i.e. dataset 1, including 2705 samples analysed according to the existing residue definition for enforcement in the period from 2017 to 2025; dataset 2, including 4916 samples analysed according to the newly proposed residue definition for enforcement in the period from 2009 to 2025) indicate that honey placed in the EU market complies with the existing MRL (defined for folpet); furthermore, it would also comply with the MRL established under the new residue definition for enforcement.

Since folpet is not fat soluble, investigation of the nature and magnitude of residues in fish is in principle not required according to SANCO/11187/2013. Furthermore, the commodities under consideration in this MRL application are normally not used as fish feed item.

The toxicological profile of folpet was assessed in the framework of the EU pesticides peer review under Regulation (EC) No 1107/2009 and the data were sufficient to derive an acceptable daily intake (ADI) of 0.1 mg/kg bw per day and an acute reference dose (ARfD) of 0.6 mg/kg bw. The metabolites phthalimide and phthalamic acid, are of similar toxicity as the parent active substance. The toxicological profile of the metabolite phthalic acid was assessed in the framework of the MRL review on the active substance dithianon and the data were sufficient to derive an ADI of 0.113 mg/kg bw per day and an ARfD of 1.34 mg/kg bw.

The consumer risk assessment was performed with revision 3.1 of the EFSA Pesticide Residues Intake Model (PRIMo). The risk assessment was conducted separately for RA‐RD1 (i.e. ‘folpet and phthalimide, expressed as folpet’ (fruit crops and cereal/grass crops, foliar application); ‘folpet and phthalamic acid, expressed as folpet’ (root crops, foliar application)) and RA‐RD2 (i.e. ‘phthalic acid’ (all crops, foliar application)). The tentative risk assessment values for honey were included in the calculations despite the potential overestimation, in order to allow risk managers to take an informed decision.

The short‐term exposure assessment was performed for the commodities assessed in this application and did not exceed the ARfD for both RA‐RD1 and RA‐RD2, accounting for 0.5% of the ARfD for bananas (both RA‐RD1 and RA‐RD2), and 0.2% of the ARfD (RA‐RD1) and < 0.01% of the ARfD (RA‐RD2) for honey.

The maximum estimated long‐term dietary intake was 8% of the ADI according to RA‐RD1. The contribution of residues expected in bananas to the overall long‐term exposure accounted for up to 0.16% of the ADI and 0.02% of the ADI for honey according to RA‐RD1. it is noted that for root commodities, i.e. potatoes, radishes and salsifies, STMR values were based on the previously established RA‐RD, i.e. ‘sum of folpet and phthalimide, expressed as folpet’ and not according to the RA‐RD1 as recently defined for root crops in the context of the peer review conclusion for the renewal of the approval of folpet, i.e. ‘sum of folpet and phthalamic acid, expressed as folpet’, which introduced a degree of uncertainty in the consumer risk assessment.

Due to unavailability of residue data (and STMR values) for phthalic acid (RA‐RD2) for any of the commodities with reported GAPs, except for bananas and honey, the chronic consumer risk assessment could not be finalised according to RA‐RD2. EFSA only estimated the contribution to the ADI from bananas and honey, using STMR values derived from the trials submitted for these commodities in the current MRL application. The contribution of residues expected in bananas to the overall long‐term exposure accounted for up to 0.24% of the ADI for bananas and < 0.01% of the ADI for honey according to RA‐RD2.

For RA‐RD1, EFSA concluded that the long‐term intake of residues of folpet resulting from the existing and the authorised uses of folpet on bananas in Ecuador and El Salvador and the residues in honey resulting from the authorised uses on melliferous crops will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers' health. For RA‐RD2, due to the lack of STMR values according to RA‐RD2 for the commodities with reported GAPs, with the exception of bananas, a high degree of uncertainty remains but the contribution from the commodities under assessment is very minor.

EFSA's conclusion on the MRLs for bananas and honey are 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) b	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: folpet (sum of folpet and phthalimide, expressed as folpet) (Reg (EU) 2023/1042)
0163020	Bananas	0.03*	0.9	The submitted data are sufficient to derive an import tolerance (Ecuador, El Salvador). Risk for consumers unlikely.
1040000	Honey	0.05*	No change	The RMS supported the setting of an MRL of 0.7 mg/kg, based on overdosed semi‐tunnel trials. The MRL proposal of 0.7 mg/kg is not supported by EFSA but risk managers are provided with further information for further considerations. According to EFSA's assessment, the submitted data are not GAP‐compliant and are not considered appropriate to derive an MRL proposal. It is noted that based on the consumer risk assessment performed using risk assessment values as derived from the available overdosed trials, risk for consumers is unlikely.
Enforcement residue definition: folpet (EFSA, 2023b)
0163020	Bananas	0.03*	No change	The submitted data are not sufficient to derive an import tolerance (Ecuador, El Salvador) due to a lack of valid residue data for folpet alone (major uncertainty related to the storage stability of folpet alone in some trial samples).
1040000	Honey	0.05*	No change	The RMS supported the setting of an MRL of 0.7 mg/kg, based on overdosed semi‐tunnel trials. The MRL proposal of 0.7 mg/kg is not supported by EFSA but risk managers are provided with further information for further considerations. According to EFSA's assessment, the submitted data are not GAP‐compliant and are not considered appropriate to derive an MRL proposal. It is noted that based on the consumer risk assessment performed using risk assessment values as derived from the available overdosed trials, risk for consumers is unlikely.

Abbreviations: GAP, good agricultural practice; MRL, maximum residue level.

^*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 MRLs according to the existing residue definition, i.e. ‘Folpet (sum of folpet and phthalimide, expressed as folpet)’ (Reg (EU) 2023/1042).

ASSESSMENT

The EFSA received an application to set an import tolerance for the active substance folpet in bananas and to modify the existing MRL for folpet in honey. The detailed description of the existing uses of folpet authorised in Ecuador and El Salvador in bananas, which is the basis for the current MRL application, is reported in Appendix A.1. Concerning the request for the modification of the MRL for folpet in honey, the current MRL application is not linked to one specific GAP but is related to the existing uses in crops and plants that might be attractive to bees and that are a potential source for residues of folpet in honey. The critical GAPs identified by the applicant is reported in Appendix A.2.

Folpet is the ISO common name for N‐(trichloromethylthio)phthalimide (IUPAC). The chemical structures of the active substance and its main metabolites are reported in Appendix E.

Folpet was evaluated in the framework of Regulation (EC) No 1107/2009 ¹ with Austria designated as RMS for the representative outdoor uses as a foliar treatment on wheat, barley, wine grapes and as both glasshouse and outdoor uses on tomatoes.

The renewal assessment report (RAR) prepared by the RMS has been peer reviewed by EFSA (EFSA, 2023a). The approval of folpet was renewed ² for the use as fungicide on 4 September 2024.

The EU MRLs for folpet 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, 2014) and the proposed modifications have been implemented in the MRL legislation. After completion of the MRL review, EFSA has issued several reasoned opinions on the modification of MRLs for folpet. The proposals from these reasoned opinions have been considered in recent MRL regulations. ⁴

In accordance Article 6 of Regulation (EC) No 396/2005 and following the provisions set by the ‘Transparency Regulation’ (EU) 2019/1381 ⁵ , the applicant ADAMA Agriculture BV submitted on 2 October 2024 an application to the competent national authority in Austria, alongside the dossier containing the supporting data using the IUCLID format. The appointed RMS Austria assessed the dossier and declared its admissibility on 12 December 2024. 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 31 January 2025 to 21 February 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 23 May 2025. The RMS proposed to establish MRL for bananas imported from Ecuador and El Salvador at the level of 0.09 mg/kg and MRL for honey at the level of 0.07 mg/kg.

The European Commission sent a mandate to EFSA on 20 June 2025 to assess the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified a point which needed further clarification and requested the RMS to address it. The applicant provided the requested information in an updated IUCLID dossier. The additional information was duly considered by the RMS who submitted a revised evaluation report to EFSA on 30 March 2026 (Austria, 2025), which replaced the previously submitted evaluation report.

EFSA based its assessment on the evaluation report submitted by the RMS (Austria, 2025), the RAR (Austria, 2018, revised in 2023) prepared under Regulation (EC) 1107/2009, the Commission review report on folpet (European Commission, 2024), the conclusion on the peer review conclusion for the renewal of the approval of the active substance folpet (EFSA, 2023b), as well as the conclusions from previous EFSA opinions on folpet (2017, 2021, 2022; EFSA, 2014), including the reasoned opinion on the MRL review according to Article 12 of Regulation No 396/2005.

For this application, the data requirements established in Regulation (EU) No 283/2013 ⁶ and the guidance documents applicable at the date of submission of the IUCLID application are applicable (European Commission, 2010, 2018, 2023a, 2023b, 2023c; OECD, 2007a, 2007b, 2007c, 2007d, 2007e, 2007f, 2007g, 2007h, 2008a, 2008b, 2009, 2014, 2016, 2021). 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 RMS (Austria, 2025) and the exposure calculations using the EFSA 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 folpet in primary crops was investigated in the framework of peer review conclusion for the renewal of approval of folpet (EFSA, 2023b). Studies were conducted on commodities belonging to the groups of fruit crops (avocados, grapes), root crops (potatoes) and cereals/grass crops (wheat) following foliar application using ¹⁴C‐phenyl labelled folpet. Under the same framework, an additional metabolism study was provided on tomato plants following soil application, which was considered as supporting information only.

In the crops tested, the parent compound is degraded to phthalimide which is further hydrolysed to phthalamic acid, phthalic acid and related conjugates. The main residues in mature grapes, wheat straw and grain were folpet and phthalimide, in potato tuber phthalamic acid and in ripe avocado phthalic acid, which was also the major metabolite in all edible crop parts and feed. It was noted that phthalic acid occurs ubiquitously and it was suggested to collect data on background levels of this compound in raw agricultural commodities for all proposed uses to estimate and consider the contribution of these background levels compared to the residue levels resulting from folpet treatment according to the representative uses (EFSA, 2023b).

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

1.1.2. Nature of residues in rotational crops

As folpet and phthalimide are not regarded as soil persistent (half‐lives below 3 days), metabolism studies in rotational crops are not required (EFSA, 2023b).

1.1.3. Nature of residues in processed commodities

The effect of processing on the nature of folpet was investigated in the framework of the peer review conclusion for the renewal of approval of the active substance (EFSA, 2023b).

Two hydrolysis experiments were submitted and assessed. Both studies indicate a rapid and complete hydrolysis of folpet. The results of the two studies are comparable for pasteurisation and baking, brewing and boiling conditions. Folpet completely degraded predominantly to phthalimide (pasteurisation: 91% and 98% applied radioactivity (AR); baking, brewing/boiling: 58% and 56% AR; results given for both studies, respectively), while levels of phthalic acid increased with temperature and pH (pasteurisation: 8% and 1%, baking, brewing/boiling: 42% and 41% AR; sterilisation 81% and 45% AR). In the second study, high amounts of phthalamic acid were observed under sterilisation conditions (33% AR). In addition, 2‐cyanobenzoic acid was found under sterilisation conditions (11% AR) which is not in line with the first study. This incomplete degradation might have been caused by a different buffer system in the sterilisation experiments of this study. Overall, the main residues are formed by metabolites already identified in the plant metabolism studies (EFSA, 2023b).

1.1.4. Analytical methods for enforcement purposes in plant commodities

Analytical methods for the determination of folpet and phthalimide residues were assessed during the MRL review, two previous MRL applications and the peer review for the renewal of approval of folpet (EFSA, 2014, 2017, 2022, 2023b). These are based on HPLC–MS/MS and were fully validated in all commodity groups with a LOQ of 0.01 mg/kg for both folpet and phthalimide (EFSA, 2023b). GC–MS methods also exist for the determination of folpet and phthalimide residues with an LOQ of 0.01 mg/kg for both folpet and phthalimide in high‐oil content commodities (EFSA, 2023b), LOQs of 0.01 mg/kg and 0.05 mg/kg for folpet and phthalimide, respectively, in high acid content and dry commodities (EFSA, 2023b), LOQs of 0.05 mg/kg and 0.02 mg/kg for folpet and phthalimide, respectively, in high‐water content commodities (EFSA, 2014; EFSA, 2017), and LOQs of 0.05 mg/kg and 0.1 mg/kg for folpet and phtalimide, respectively, in hops (EFSA, 2014, 2023b); GC–MS/MS is also available for the determination of phthalimide in high‐water content commodities at the LOQ of 0.01 mg/kg (EFSA, 2022).

In addition, a new study for the validation of an analytical method was submitted with the current MRL application (Austria, 2025). The method, based on LC–MS/MS, was validated, including confirmation using two ion transitions and independent laboratory validation (ILV), for the quantification of folpet and phthalimide at or above the LOQ of 0.01 mg/kg for each analyte in high‐water content (lettuce), high‐acid content (orange), high‐oil content (oilseed rape) and dry (wheat grain) commodities. For wheat straw (dry commodity), the validated LOQs are 0.01 mg/kg and 0.05 mg/kg for folpet and phthalimide, respectively.

The methods are sufficiently validated for residues of folpet and phthalimide in the plant commodity under consideration.

The extraction efficiency of the solvent system used in the analytical method for enforcement of folpet (according to both the current Mo‐RD, ‘sum of folpet and phthalimide, expressed as folpet’ and the new Mo‐RD, ‘folpet’) in high‐water content commodities (to which the commodity under assessment belongs). The assessment was based on a comparison of the amounts of residues extracted from wheat whole plant (high‐water content matrix, cereals) using (i) the solvent system of the method for enforcement under assessment and (ii) the solvent system used in the metabolism study on potato tubers (high‐water content matrix, root crops). Due to the different metabolic pattern observed in fruit/cereal crops and root crops (see Section 1.1.1), this cross‐validation can only be regarded as indirect. Ideally, the cross‐validation should have been conducted using the solvent system applied in the metabolism study on a crop belonging to the same matrix group and showing a comparable metabolic pattern, which is not the case for root crops. A cross‐validation comparing residues extracted using the solvent systems of (i) the method for enforcement under assessment, (ii) the metabolism study in cereals and (iii) the metabolism study in potato tubers would have allowed a thorough evaluation of the extraction efficiency of the analytical method for enforcement in high‐water content commodities. EFSA acknowledges that the Applicant provided evidence demonstrating acceptable performance of the solvent system used in the metabolism study on potato tubers (high‐water content matrix, root crops) for the quantification of spiked residues of folpet, phthalimide and phthalic acid in wheat whole plant (high‐water content matrix, cereal crop). However, this evidence alone is not sufficient to demonstrate efficient extraction of incurred residues, in accordance with SANTE/2017/10632 rev. 5 (European Commission, 2023c).

Based on the considerations above, the extraction efficiency of the analytical method for enforcement in high‐water content commodities is considered to be only partially demonstrated, resulting in some uncertainty for the present assessment. To satisfy the current criteria of the guidance, further investigation on this matter would be required. EFSA would therefore recommend re‐assessing the extraction efficiency in the framework of future MRL applications or the review of existing authorised uses.

1.1.5. Storage stability of residues in plants

The storage stability of folpet and the metabolite phthalimide in plant commodities stored under frozen conditions was investigated in the framework of the peer review conclusion for the renewal of approval of folpet (EFSA, 2023b). Further information on the stability of folpet, phthalimide and, additionally, phthalic acid and phthalamic acid, in plant commodities stored under frozen conditions was submitted with the current application (Austria, 2025). Although the present assessment focuses solely on high‐water content commodities, the storage stability data submitted for other commodity groups were also assessed.

In high‐water content commodities, storage stability of folpet was demonstrated for at least 12 months (onions, tomatoes). However, it could not be demonstrated for such a period in other commodities such as cucumber (at least 1 month, limited by the shorter duration of the storage stability study), apple (at least 5 months, limited by the shorter duration of the storage stability study) and lettuce (up to 6 months, due to degradation of folpet at longer storage periods). The storage stability of phthalimide was demonstrated for at least 24 months in lettuce and for at least 12 months in onions and tomatoes, but only for up to 1 month in homogenised tomatoes, due to degradation of phtalamide at longer storage periods. The storage stability of the sum of folpet and phthalimide (expressed as folpet), phthalic acid and phthalamic acid was demonstrated for at least 24 months (lettuce), when stored at or below −18°C. For the commodity assessed in the framework of the current application, which belongs to the high‐water content commodity group, storage stability of residues according to the existing residue definition for enforcement (current Mo‐RD) and the relevant residue definitions for risk assessment (see Section 1.1.6) is sufficiently investigated. A comprehensive overview of all storage stability data, including matrices other than high‐water content, can be found in Appendix B.1.1.2.

It should be noted that, for folpet alone (new Mo‐RD; see Section 1.1.6), no consistent trend in storage stability across high‐water‐content commodities could be determined. This is due to the rapid degradation of folpet observed in certain commodities (i.e. lettuce), as well as to differences in the storage period tested across studies. FAO & WHO (2025) suggest that storage stability within this commodity group appears to be pH‐dependent, with folpet being stable under frozen storage conditions for at least 12 months in commodities with low pH levels (e.g. tomato), while quickly degrading to phthalimide in commodities with higher pH levels (e.g. lettuce). In the absence of storage stability data on bananas, a conclusion regarding storage stability of folpet alone in the commodity under assessment cannot be reached. It may only be tentatively assumed that the storage stability period of folpet in this commodity could reach 12 months (optimistic scenario); however, this assumption is associated with additional non‐standard uncertainty.

1.1.6. Proposed residue definitions

Based on the metabolic pattern identified in metabolism studies, the results of hydrolysis studies, the toxicological significance of metabolites and degradation products and the capabilities of enforcement analytical methods, the following residue definitions were proposed in the framework of the peer review conclusion for the renewal of approval of folpet (EFSA, 2023b):

• residue definition for enforcement (all plant commodities) (new Mo‐RD): folpet

• residue definitions for risk assessment:

  • −
    RA‐RD1a (fruit and cereal/grass crops): folpet and phthalimide, expressed as folpet
  • −
    RA‐RD1b (root crops): folpet and phthalamic acid, expressed as folpet
  • −
    RA‐RD2 (all plant commodities): phthalic acid

For processed plant commodities, the same residue definition for enforcement is applicable; the following residue definitions are applied for risk assessment:

• −RA‐RD1: folpet, phthalimide and phthalamic acid, expressed as folpet
• −RA‐RD2: phthalic acid

Residues in rotational crops are not expected (EFSA, 2023b). The residue definition for enforcement proposed in EFSA (2023b) differs from the one currently set in Regulation (EC) No 396/2005, i.e. ‘Folpet (sum of folpet and phthalimide, expressed as folpet)’ (current Mo‐RD).

EFSA concluded that for the intended use these residue definitions are appropriate and applicable.

1.2. Magnitude of residues in plants

1.2.1. Magnitude of residues in primary crops

In support of the MRL application, the applicant submitted 12 independent and GAP‐compliant residue trials performed in bananas.

The trials were conducted in Costa Rica (4), Ecuador (4), Colombia (2) and Mexico (2) in the 2022 growing season. The trials consisted of 12 foliar broadcast treatments at a nominal application rate of 750 g a.s./ha (687–809 g a.s./ha), performed at BBCH 71–80 at last application and with an interval between applications of 4–8 days. Four trials were conducted as decline trials with samples collected at 0 (corresponding to PHI), 1, 3, 5 and 7 days after the last treatment. Decline of residues over time was observed in all decline trials. At harvest, samples were collected from both bagged and unbagged banana commodities. Only residue data for bagged banana samples were presented in the evaluation report, reflecting the standard commercial practice in Ecuador, one of the exporting countries.

The samples were analysed for folpet (new Mo‐RD), sum of folpet and phthalimide (expressed as folpet) (current Mo‐RD and RA‐RD1_{(fruit crops)}) and phthalic acid (RA‐RD2_{(all crops)}). In addition, residues of phthalamic acid were also measured (for information purpose only). According to the assessment of the RMS, the method used, based on liquid chromatography with tandem mass spectrometry (LC–MS/MS), was sufficiently validated and fit for purpose and is able to quantify residues at the LOQs of 0.01 mg/kg (folpet, phthalimide) and 0.05 mg/kg (phthalic acid, phthalamic acid) in high‐water content commodities (Austria, 2025). The extraction efficiency of the analytical method applied for data generation in high‐water content commodities was investigated via indirect cross‐validation, by comparing the amounts of residues of folpet, phthalimide and phthalic acid extracted from wheat whole plant (high‐water content matrix, cereals) using (i) the solvent system of the analytical method under assessment (which is identical to the analytical method for enforcement) and (ii) the solvent system used in the metabolism study on potato tubers (high‐water content matrix, root crops). Based on the data provided, the extraction efficiency of the analytical method for data generation in bananas (high‐water content commodities) is considered to be only partially demonstrated, resulting in additional uncertainty for the present assessment (see also Section 1.1.4).

1.2.1.1. Existing Mo‐RD and associated RA‐RDs

The samples of the residue trials were stored under conditions for which stability of the residues in high‐water content commodities has been demonstrated, according to the current residue definition for enforcement (i.e. ‘sum of folpet and phthalimide, expressed as folpet’) and the residue definitions for risk assessment in fruit crops (i.e. RA‐RD1: sum of folpet and phthalimide, expressed as folpet; RA‐RD2: phthalic acid) (Austria, 2025).

The dataset indicates concentrations of the sum of folpet and phthalimide (expressed as folpet) ranging between < 0.03 and 0.52 mg/kg in whole banana fruit and < 0.03 mg/kg in banana pulp. Phthalic acid residues ranged between < 0.05 and 0.07 mg/kg in banana pulp.

The submitted data are sufficient to derive an MRL proposal of 0.9 mg/kg according to the existing residue definition for enforcement (i.e. sum of folpet and phthalimide, expressed as folpet).

1.2.1.2. New Mo‐RD

For folpet only (the only compound included in the residue definition for enforcement proposed in the context of the peer review conclusion for the renewal of approval of folpet (EFSA, 2023b)), no consistent trend in storage stability across high‐water‐content commodities could be determined (see Section 1.1.5). In the absence of storage stability data specifically for bananas, it cannot be confirmed whether banana samples, which were stored for 159–484 days (corresponding to 5–16 months), were maintained under conditions ensuring folpet stability. Even under the optimistic assumption of a 12‐month storage stability period in high‐water content commodities, 6 out of 12 trials had samples stored beyond this duration and cannot therefore be considered suitable for MRL calculations.

It is noted that, based on the full residue dataset, an MRL option (0.7 mg/kg) in line with the new residue definition for enforcement (i.e. folpet; EFSA, 2023b) was proposed by the RMS (Austria, 2025). However, EFSA does not support this proposal, due to an insufficient number of trials with samples stored under conditions ensuring stability of folpet in bananas (6). Consequently, an MRL for bananas according to the new residue definition for enforcement could not be derived.

1.2.2. Magnitude of residues in rotational crops

As the proposed uses of folpet is on permanent crops, investigations of residues in rotational crops are not required.

1.2.3. Magnitude of residues in processed commodities

Specific processing studies for the commodity under assessment were not submitted, as the commodity is intended for fresh consumption. However, since residue data on bananas were provided for whole fruit, peel and pulp (Austria, 2025), it was possible to calculate peeling factors. The number and quality of these data are sufficient to derive robust peeling factors. ⁹

1.2.4. Proposed MRLs

The available data are considered sufficient to derive an MRL proposal of 0.9 mg/kg in bananas (whole fruit), according to the residue definition for enforcement currently in place (i.e. sum of folpet and phtalimide, expressed as folpet), as well as risk assessment values for banana pulp for the two different residue definitions for risk assessment (see Appendix B.1.2.1). In Section 4, EFSA assessed whether residues in banana pulp resulting from the uses authorised in Ecuador and El Salvador are likely to pose a risk to consumer health.

Regarding the new residue definition for enforcement proposed in the context of the peer review conclusion for the renewal of approval of folpet (EFSA, 2023b) (RD‐Mo: folpet), no MRL could be derived due to the lack of a sufficient number of valid trials.

2. RESIDUES IN LIVESTOCK AND FISH

Not relevant as the commodities under assessment are 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 time period.

In the absence of specific metabolism studies with honey bees, studies investigating the nature of residues in primary crops and rotational crops (where available) 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 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 folpet residues in honey (Austria, 2025). The method, based on LC–MS/MS, is fully validated, including confirmation and ILV, and allows quantification of residues of folpet and phthalimide at the LOQ of 0.01 mg/kg.

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

3.1.2. Storage stability of residues in honey

The storage stability of residues of folpet and its metabolites phthalimide, phthalic acid and phthalamic acid in honey samples stored under frozen conditions was investigated in the current MRL application (Austria, 2025). In addition, the storage stability of residues of phthalic anhydride was also investigated in honey samples stored under frozen conditions.

It was demonstrated that residues of folpet, phthalimide, phthalic acid and phthalamic acid were stable for at least 4 months when stored at or below −18°C in honey. Residues of phthalic anhydride were stable for at least 3.5 months when stored at or below −18°C in honey.

3.1.3. Proposed residue definitions

In the absence of specific metabolism studies on honey, the studies investigating the nature of residues in primary crops and the studies investigating the degradation of the active substance during pasteurisation are considered to derive the residue definitions for honey. Taking into account the information from the residue trials provided with this application, showing quantifiable residues of folpet and its metabolites phthalimide and phthalic acid and no quantifiable residues of phthalamic acid and phthalic anhydride (see Section 3.2), the same residue definitions applicable to fruit crops are considered appropriate for honey (i.e. current Mo‐RD (Reg (EU) 2023/1042): folpet (sum of folpet and phthalimide, expressed as folpet); new Mo‐RD (EFSA, 2023b): folpet; RA‐RD1a (fruit and cereal/grass crops only): folpet and phthalimide, expressed as folpet; RA‐RD2: phthalic acid) (Austria, 2025).

3.2. Magnitude of residues in honey

In support of the MRL application in honey, the Applicant submitted four independent semi‐field (tunnel) trials conducted with Phacelia tanacetifolia as a surrogate crop. The EU critical GAPs selected by the applicant are on wine grapes (NEU) and ornamental plants (NEU). The NEU GAP on wine grapes consists of up to 8 foliar applications at a maximum nominal application rate of 1.6 kg a.s./ha, applied up to BBCH 89, with a minimum interval between applications of 7 days; the NEU GAP on ornamental plants consists of up to 4 applications at a nominal application rate of 1.92 kg a.s./ha, applicable at any BBCH stage, with an interval between applications of 8 days.

The trials were performed in Germany (2), Spain (1) and southern France (1) in 2023. Each trial consisted of two plots, one treated and one untreated. In the treated plot, folpet was applied twice as a foliar spray during flowering of the surrogate crop. Applications were made at a nominal application rate of 3 kg a.s./ha, with a 7‐day interval between applications (first treatment at BBCH 60–61 and second treatment at BBCH 63–65). Honey was sampled between 8 and 21 days after application. The amount of honey collected from the four trials ranged from 35 to 128 grams and all samples had a water content below 20%. Although a sample weight of 100 g is recommended by the European Commission (2018), it is acknowledged that achieving this target under semi‐field conditions can be challenging. Therefore, the lower sample weights of 35 and 51 grams obtained from two treated plots are only considered a minor deviation.

Samples were analysed for folpet and its metabolites phthalimide, phthalic acid, phthalamic acid and phthalic anhydride. No residues of folpet, phthalimide, phthalamic acid and phthalic anhydride were detected at or above the limit of detection (LOD) in samples from the untreated plots. Residues of phthalic acid were measured slightly above the LOQ of 0.05 mg/kg in a single untreated plot (0.054 mg/kg), which is attributable to background levels in the environment. In treated samples, residues of folpet ranged from < 0.01 to 0.035 mg/kg; residues of phthalimide ranged from 0.017 to 0.16 mg/kg; residues of phthalic acid ranged from < 0.05 to 0.06 mg/kg; residues of phthalamic acid and phthalic anhydride were below the LOQ of 0.05 mg/kg in all samples.

According to the assessment of the RMS, the methods used, based on HPLC–MS/MS, are sufficiently validated for the quantification of residues of folpet and its metabolites with LOQs of 0.01 mg/kg for folpet and phthalimide and 0.05 mg/kg for phthalic acid, phthalamic acid and phthalic anhydride. 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, 2023b). The samples of these residue trials were stored under conditions for which integrity of the samples has been demonstrated.

The RMS considered the trials submitted in the current application suitable to support the cGAPs on wine grapes and ornamental plants and, based on the available dataset, proposed MRLs of 0.7 and 0.07 mg/kg according to the existing (Reg. (EU) 2023/1042) and the new (EFSA, 2023b) residue definitions for enforcement, respectively.

EFSA, however, does not consider the honey residue trials appropriate to support the selected cGAPs and therefore does not recommend an MRL modification for honey. In EFSA's view, the trials fail to mimic the selected cGAPs due to deviations in the application pattern used. Specifically, the individual application rate in the residue trials deviate by more than 25% (+56–88%). Overall, EFSA considers that the trials were overdosed as regards to the individual application rate compared with the authorised application pattern, which may lead to an overestimation of residue levels and, consequently, of the MRL proposal derived by the RMS, which would not be in line with the ALARA principle. This issue was raised by EFSA by means of a request for additional data (clock‐stop). The RMS and the applicant did not provide additional data but provided an argumentation based on the total application rate during the flowering period. They indicate that, for both GAPs, the total rate applied in the trials (6 kg a.s./ha, based on 2 × 3 kg a.s./ha) falls within ±25% of the total application rate during flowering of wine grapes (4.8 kg a.s./ha, based on 3 × 1.6 kg a.s./ha) and ornamental plants (7.68 kg a.s./ha, based on 4 × 1.92 kg a.s./ha), and that the trials are therefore acceptable. However, according to the Technical Guidelines on pesticide residues in honey (European Commission, 2018), ‘the test substance should be applied in a realistic worst‐case scenario with respect to residues in honey’ using an application rate ‘consistent with (the) GAP’. This is because honey residue levels depend not only on the total application rate during flowering, but also on how this rate is distributed in terms of both the number of applications and the individual application rates. Bee foraging on crops treated with 2 × 3 kg a.s./ha during flowering may result in a different honey residue profile compared with foraging on crops treated with 3 × 1.6 kg a.s./ha or 4 × 1.92 kg a.s./ha, even if the total application rate during flowering falls within the ±25% tolerance. Application patterns involving higher individual application rates and a lower number of applications may result in higher peak residues in nectar, and, consequently, higher residue levels in honey, compared to patterns in which the same total amount is applied through lower individual rates distributed over more applications. Overall, the application pattern used in the honey trials is not considered representative of the selected cGAPs and may result in overestimated residue concentrations in honey. Therefore, the trials are not considered acceptable to support an MRL modification.

Magnitude of residues from EU national monitoring programme

In the framework of Article 32 of Regulation (EC) No 396/2005 (official national and EU control programmes), ¹⁰ monitoring data were submitted to EFSA. For the present assessment, an extraction of these data was performed by EFSA to retrieve the results for folpet residues in honey, according to both the existing and the new proposed residue definition for enforcement (dataset 1 and 2, respectively).

Existing residue definition for enforcement (dataset 1)

A total of 2705 samples (2297 originating from EU member states) analysed according to the existing residue definition for enforcement (‘sum of folpet and phthalimide, expressed as folpet’) are available from the period 2017 to 2025. Residue data in processed honey (30 samples), honeydew honey (19 samples), royal jelly (11 samples), comb honey (9 samples) and pollen (1 sample) was disregarded (70 samples in total), resulting in a total of 2635 retained samples.

It should be noted that the subset of the data retrieved from the year 2025 (26 samples) have not yet been validated by EFSA. Nevertheless, this data was included in the analysis for information purposes. From the overall dataset, EFSA separately analysed the residue data for the last monitoring cycle, that corresponds to the years from 2022 to 2024 (dataset 1A). This was done to identify the short‐term trends of residue occurrence in honey from recently authorised uses of plant protection products (PPP) on melliferous crops and to see the impact of more sensitive analytical methods. The overall dataset, covering the monitoring years from 2017 to 2025 (dataset 1B) was analysed to capture the long‐term dynamics of residues in honey and to reflect any differences compared to the most recent data.

Dataset 1A

A total of 1181 samples were available for dataset 1A. The LOQ of enforcement of the laboratories where these samples were analysed ranged from < 0.01 to 0.09 mg/kg. In all honey samples analysed, ‘folpet (sum of folpet and phthalimide, expressed as folpet)’ residue levels were quantified at or below the LOQs reported by the laboratories (see Table B.3.2.2). Based on the 1145 samples analysed at LOQs of 0.05 or below (including 335 samples analysed at LOQs of 0.01 or below), no exceedances of the existing MRL of 0.05 mg/kg (LOQ) were observed. The remaining 36 samples analysed at the LOQ of 0.09 mg/kg do not allow to draw any conclusion.

Dataset 1B

A total of 2635 samples were available for dataset 1B. The LOQ of enforcement of the laboratories where these samples were analysed ranged from < 0.01 to 0.1 mg/kg. In all honey samples analysed, ‘folpet (sum of folpet and phthalimide, expressed as folpet)’ residue levels were quantified at or below the LOQs reported by the laboratories (see Table B.3.2.2). Based on the 2571 samples analysed at LOQs of 0.05 or below (including 1151 samples analysed at LOQs of 0.01 or below), no exceedances of the existing MRL of 0.05 mg/kg (LOQ) were observed. The remaining 64 samples analysed with LOQs ranging from 0.09 to 0.1 mg/kg do not allow to draw any conclusion.

Overall, the available monitoring data indicate that honey placed in the EU market complies with the existing MRL.

New residue definition for enforcement (dataset 2)

A total of 4916 samples (4224 originating from EU member states) analysed according to the new residue definition for enforcement (‘folpet’) are available from the period 2009 to 2025. Residue data in processed honey (99 samples, including 2 honeydew honey samples), honeydew honey (22 samples), royal jelly (11 samples), comb honey (9 samples), pollen (5 samples) and other edible agricultural products (2 samples) was disregarded (146 samples in total), resulting in a total of 4770 retained samples.

It should be noted that the subset of the data retrieved from the year 2025 (35 samples) have not yet been validated by EFSA. Nevertheless, this data was included in the analysis for information purposes. From the overall dataset, EFSA separately analysed the residue data for the last monitoring cycle, that corresponds to the years from 2022 to 2024 (dataset 2A). This was done to identify the short‐term trends of residue occurrence in honey from recently authorised uses of plant protection products (PPP) on melliferous crops and to see the impact of more sensitive analytical methods. The overall dataset, covering the monitoring years from 2009 to 2025 (dataset 2B) was analysed to capture the long‐term dynamics of residues in honey and to reflect any differences compared to the most recent data.

Dataset 2A

A total of 909 samples were available for dataset 2A. The LOQ of enforcement of the laboratories where these samples were analysed ranged from < 0.01 to 0.05 mg/kg. In all honey samples analysed, except one, ‘folpet’ residue levels were quantified at or below the LOQ reported by the laboratories; in one sample, residues were measured above the LOQ of 0.01 mg/kg, specifically at the level of 0.029 mg/kg (see Table B.3.2.3). No exceedances of the existing MRL of 0.05 mg/kg (LOQ) were observed.

Dataset 2B

A total of 4770 samples were available for dataset 2B. The LOQ of enforcement of the laboratories where these samples were analysed ranged from < 0.01 to 0.5 mg/kg. In all honey samples analysed, except one, ‘folpet’ residue levels were measured at or below the LOQ reported by the laboratories; in one sample, residues were measured above the LOQ of 0.01 mg/kg, specifically at the level of 0.029 mg/kg (see Table B.3.2.3). Based on the 4624 samples analysed at LOQs of 0.05 or below (including 2820 samples analysed at LOQs of 0.01 or below), no exceedances of the existing MRL of 0.05 mg/kg (LOQ) were observed. The remaining 146 samples analysed with LOQs ranging from 0.06 to 0.5 mg/kg do not allow to draw any conclusion.

Overall, the available monitoring data indicate that honey placed in the EU market complies with the existing MRL.

3.2.1. Proposed MRLs

Based on the available trials, the RMS proposed two MRL options for folpet in honey: 0.7 mg/kg, based on the residue definition for enforcement currently in place in the regulation (i.e. sum of folpet and phtalimide, expressed as folpet; Reg. (EU) 2023/1042) and 0.07 mg/kg based on the revised residue definition for enforcement proposed in EFSA (2023b) (i.e. folpet) (see Appendix B.3.2.1).

EFSA does not consider the available data appropriate to support the selected cGAPs and to derive MRL proposals and risk assessment values for honey, as the application pattern used in the honey trials is not representative of the cGAPs and reflects a more critical scenario. Nevertheless, to provide risk managers with all necessary information, EFSA assessed whether residues in honey, as measured in the overdosed trials, are likely to pose a consumer health risk (see Section 4). It should be noted that, as the application pattern used in the trials is not representative of the selected cGAPs, this assessment is affected by uncertainties; however, it is considered conservative for honey.

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, 2018, 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 risk assessment was conducted separately for RA‐RD1 (i.e. ‘folpet and phthalimide, expressed as folpet’ (fruit crops and cereal/grass crops, foliar application); ‘folpet and phthalamic acid, expressed as folpet’ (root crops, foliar application)) and RA‐RD2 (i.e. ‘phthalic acid’ (all crops, foliar application)).

RA‐RD1

The toxicological reference values for folpet used in the risk assessment (i.e. ADI and ARfD values) were derived in the framework of the EU pesticides peer review (EFSA, 2023b; European Commission, 2024). The metabolites phthalimide and phthalamic acid, included in the first residue definition for risk assessment (RA‐RD1) were considered to be of similar toxicity than the parent compound (EFSA, 2023b).

Short‐term (acute) dietary risk assessment

The short‐term exposure assessment was performed in accordance with the internationally agreed methodology and focused on the commodities assessed in this application (FAO, 2016). For bananas, the calculations were based on the HR_pulp derived from supervised field trials assessed in the present opinion. For honey, indicative calculations were based on the HR derived from semi‐field (tunnel) residue trials not compliant with the cGAP, as the individual application rates in the trials exceeded those of the authorised GAPs. Therefore, the dietary risk assessment for this commodity is likely overestimated (risk management decisions required; see Section 3.2.1). The input values used in the exposure calculations are reported in Appendix D.1.

The short‐term exposure did not exceed the ARfD for the commodities assessed in this application, accounting for 0.5% of the ARfD for bananas and 0.2% of the ARfD for honey.

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 (EFSA, 2014). EFSA updated the calculation with the relevant supervised trials median residue (STMR) values derived in EFSA opinions published after the MRL review (EFSA, 2017, 2021, 2022) and from the residue trials for bananas and honey submitted in the current MRL application (Austria, 2025). For bananas the STMR_pulp was considered. For honey, the STMR values used were derived from semi‐field (tunnel) residue trials not compliant with the cGAP, as the individual application rates in the trials exceeded those of the authorised GAPs. Therefore, the dietary risk assessment for this commodity is likely overestimated (risk management decisions required; see Section 3.2.1). Furthermore, for root crops with reported GAPs (i.e. potatoes, radishes and salsifies), STMR values were derived according to the previously established RA‐RD, i.e. ‘sum of folpet and phthalimide, expressed as folpet’ (EFSA, 2014) and not according to the RA‐RD1 as recently defined for root crops in the context of the peer review conclusion for the renewal of approval of folpet, i.e. ‘sum of folpet and phthalamic acid, expressed as folpet’ (EFSA, 2023b). As indicated in the metabolism study on potato tubers, phthalamic acid represents the major residue component in root crops (24.6% total radioactive residue (TRR), corresponding to 0.27 mg parent equivalent/kg), while folpet and phthalimide occur only at low levels (0.1% TRR for folpet, corresponding to 0.001 mg parent equivalent/kg; 0.5% TRR for phthalimide, corresponding to 0.01 mg parent equivalent/kg) (Austria, 2018, 2023; EFSA, 2023b). As a consequence, the use of STMR values based on the previous RA‐RD is expected to underestimate the consumer exposure and to introduce an additional degree of uncertainty in the chronic consumer risk assessment which cannot be accurately quantified with the available data.

The complete list of input values is presented in Appendix D.1.

The maximum estimated long‐term dietary intake was 8% of the ADI according to RA‐RD1. The contribution of residues to the overall long‐term exposure accounted for 0.16% of the ADI for bananas (NL toddler diet) and 0.02% of the ADI for honey (DE child diet) (see Appendix B.4).

As mentioned above, for RA‐RD1, the consumer risk assessment is affected by uncertainties related to the STMR values used for honey (commodity under assessment) and root crops (commodities assessed previously). For root crops, EFSA recommends that residue data generated in accordance with the revised residue definition for risk assessment are provided in the framework of future assessment to allow an accurate estimation of consumer exposure. Nevertheless, considering the overall margin of safety calculated for the chronic dietary risk assessment, EFSA concludes that the long‐term intake of residues of folpet resulting from the intended and the authorised uses is unlikely to present a risk to consumer health and that the uncertainties identified above are not considered to affect the conclusions of the current assessment.

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

RA‐RD2

The toxicological reference values for phthalic acid, which is included in the second residue definition for risk assessment (RA‐RD2), used in the risk assessment (i.e. ADI and ARfD values) were derived in the framework of the MRL review on the active substance dithianon (EFSA, 2023a; European Commission, 2024). For phthalic acid, EFSA derived higher TRVs than for the parent compound folpet which indicates a lower toxicological concern compared with the parent. The compound is unlikely to be genotoxic (EFSA, 2023b).

Short‐term (acute) dietary risk assessment

The short‐term exposure assessment was performed in accordance with the internationally agreed methodology and focused on the commodities assessed in this application (FAO, 2016). For bananas, the calculations were based on the HR_pulp derived from supervised field trials. For honey, the calculations were based on the HR derived from semi‐field (tunnel) residue trials not compliant with the cGAP, as the individual application rates in the trials exceeded those of the authorised GAPs. Therefore, the dietary risk assessment for this commodity is likely overestimated (risk management decisions required; see Section 3.2.1). The input values used in the exposure calculations can be found in Appendix D.1.

The short‐term exposure did not exceed the ARfD for the commodities assessed in this application, accounting for 0.5% of the ARfD for bananas and < 0.01% of the ARfD for honey.

Long‐term (chronic) dietary risk assessment

Due to the recent introduction of the RA‐RD2 in the context of the renewal of approval of folpet (EFSA, 2023b), risk assessment values according to the RA‐RD2 are currently only available for the commodities assessed in the present MRL application. As a consequence, a comprehensive chronic dietary exposure assessment for phthalic acid could not be performed. EFSA only estimated the contribution to the ADI from bananas and honey, using STMR values derived from the residue trials submitted for these commodities in the current MRL application (Austria, 2025). For bananas the STMR_pulp was considered. For honey, the STMR values used were derived from semi‐field (tunnel) residue trials not compliant with the proposed cGAPs, as the individual application rates in the trials exceeded those of the authorised GAPs. Therefore, the dietary risk assessment for this commodity is likely overestimated (risk management decisions required; see Section 3.2.1). The list of input values is presented in Appendix D.1.

Despite the lower toxicity of phthalic acid compared to folpet, phthalic acid may occur at higher levels than the parent compound in plant commodities. It represents a major metabolite (EFSA, 2023b), accounting for a high proportion of the TRR in certain plant commodities (e.g. 81.9% TRR in avocados, 55.1% TRR in potato tubers; Austria, 2018, 2023). Therefore, the availability of residue data for all relevant commodities is essential to perform a consumer risk assessment. Confirmatory information should be provided and assessed in the framework of future MRL applications to determine phthalic acid residue levels resulting from the use of folpet, taking also into account its background levels in raw agricultural commodities during residue field trials (European Commission, 2024).

The contribution of residues to the overall long‐term exposure from the commodities under assessment is very low, accounting for 0.24% of the ADI for bananas (NL toddler diet) and < 0.01% of the ADI for honey (DE child diet) (see Appendix B.4).

For further details on the exposure calculations, a screenshot of the Report sheet of PRIMo is presented in Appendix C for RA‐RD1. A screenshot of PRIMo for RA‐RD2 is not provided due to the lack of residue data for commodities other than banana and honey. Nevertheless, the results of the chronic exposure assessment for these two commodities are reported in Section B.4. and the full PRIMo file is provided for information, as background document to this reasoned opinion.

5. CONCLUSION AND RECOMMENDATIONS

The dataset on bagged bananas submitted in support of this MRL application was found to be sufficient to derive an MRL proposal of 0.9 mg/kg for bananas, according to the currently applicable residue definition for enforcement. This MRL proposal is supported by EFSA.

For honey, an MRL of 0.7 mg/kg was proposed by the RMS based on the submitted residue trials. However, as these trials were not compliant with either of the selected cGAPs on wine grapes and ornamental plants, this proposal could not be supported by EFSA. The RMS's proposal is however reported for transparency and for consideration by risk managers. Available EU monitoring data on honey were assessed as supplementary information and indicate that honey placed in the EU market generally complies with the existing MRL, which is currently set at the LOQ of 0.05* mg/kg.

Based on the datasets on bagged bananas and honey, the RMS also derived alternative MRL options of 0.7 mg/kg for bananas and 0.07 mg/kg for honey, according to the new residue definition for enforcement (i.e. ‘folpet’) proposed in the framework of the renewal of approval of folpet (EFSA, 2023b), which is not currently implemented. EFSA does not support these alternative MRL options considering that the dataset for bananas lacks a sufficient number of residue trials with samples stored for durations for which stability of folpet has been demonstrated (in bananas or high‐water content commodities) and that the second MRL option for honey is based on residue trials that are not compliant with the relevant cGAPs and therefore cannot be used for MRL calculation.

EFSA concluded that the authorised South American use of folpet on bananas does not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers' health. For honey, no consumer risk is indicated based on the conservative (likely overestimated) exposure estimates derived from the available non‐GAP‐compliant trials. For all other uses assessed in the context of the MRL review and previous applications (EFSA, 2014, 2017, 2021, 2022), uncertainties remain regarding the exposure to phthalamic acid from root crops, due to the lack of residue data measured in accordance with the recently established RA‐RD1b, and regarding exposure to phthalic acid for all commodities with authorised uses of folpet, with the exception of bananas and honey. In particular, due to the uncertainties related to phthalic acid, the long‐term consumer risk assessment according to the residue definition for risk assessment RA‐RD2 could not be finalised.

The MRL recommendations are summarised in Appendix B.4.

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

cGAP

critical GAP

DAT

days after treatment

DT₉₀

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

EEA

European Economic Area

EFTA

European Free Trade Association

EURL

EU Reference Laboratory (former Community Reference Laboratory (CRL))

FAO

Food and Agriculture Organization of the United Nations

GAP

good agricultural practice

GC

gas chromatography

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

InChiKey

International Chemical Identifier Key

ISO

International Organization for Standardization

IUPAC

International Union of Pure and Applied Chemistry

LC

liquid chromatography

LOD

limit of detection

LOQ

limit of quantification

Mo

monitoring

MRL

maximum residue level

MS

mass spectrometrty

MS

Member State

MS/MS

tandem mass spectrometry detector

NEU

northern Europe

OECD

Organisation for Economic Co‐operation and Development

PBI

plant‐back interval

PeF

peeling factor

PF

processing factor

PHI

pre‐harvest interval

PPP

plant protection products

PRIMo

(EFSA) Pesticide Residues Intake Model

QuEChERS

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

RA

risk assessment

RAC

raw agricultural commodity

RAR

renewal assessment report

RD

residue definition

RMS

rapporteur Member State

SANCO

Directorate‐General for Health and Consumers

SC

suspension concentrate

SEU

southern Europe

SMILES

simplified molecular‐input line‐entry system

STMR

supervised trials median residue

TRR

total radioactive residue

WG

water‐dispersible granule

WHO

World Health Organization

REQUESTOR

European Commission

QUESTION NUMBER

EFSA‐Q‐2024‐00601

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APPENDIX A. Summary of the GAPs triggering the amendment of existing EU MRLs

A.1. SUMMARY OF THE AUTHORISED GAPS TRIGGERING THE AMENDMENT OF EXISTING EU MRL

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
				Type b	Conc. a.s. (g/L)	Method kind	Range of growth stages & season c	Number min–max	Interval between application (days) min–max	kg a.s./hL min–max	Water (L/ha) min–max	Rate min–max	Unit	PHI (days) d	Remarks
Banana	Ecuador	F	Mycosphaerella fijiensis Var.difformis	SC	500	Foliar application	71‐89 e	12 f	4–7	2.5–4.2	18–30	0.75	kg a.s./ha	0	The standard commercial practice involves application to bagged bananas. See footnotes e and f
Banana	El Salvador	F	Mycosphaerella fijiensis Var.difformis	SC	500	Foliar application	71‐89 e	12 f	4–7	2.5–4.2	18–30	0.50–0.75	kg a.s./ha	0	The standard commercial practice involves application to bagged bananas. See footnotes e and f

Abbreviations: a.s., folpet; GAP, good agricultural practice; MRL, maximum residue level; MS, Member State; n.a., not applicable; SC, suspension concentrate.

^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 – pre‐harvest interval.

^e According to the RMS, growth stage at application was defined based on commercial practice, in close consultation with growers (Austria, 2025).

^f According to the RMS, the number of applications is usually not reported in the labels in Latin American (LATAM) countries. The values reported in this table were identified in close consultation with growers and are based on commercial practice (Austria, 2025).

A.2. CRITICAL GAP TRIGGERING THE ASSESSMENT OF AN MRL IN HONEY

The GAPs outlined below have been identified by the applicant as worst‐case authorised EU GAPs of folpet on primary crops for residue carry‐over to 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
				Type b	Conc. a.s. (g/kg)	Method kind	Range of growth stages and season c	Number min–max	Interval between application (days) min–max	kg a.s./hL min–max	Water (L/ha) min–max	Rate min–max	Unit	PHI (days) d	Remarks
Wine grapes	NEU	F	Downy mildew	WG	800	Foliar application	≤ 89	8	7–10	0.08–0.4	400–1000	0.8–1.6	kg a.s./ha	35	Representative critical GAP for honey. 1 kg product/ha up to BBCH 61; 2 kg product/ha from BBCH 61 (Austria, 2025)
Ornamental plants (including chrysanthemum)	NEU	F	Downy mildew, leaf spot, grey mould	WG	800	Foliar application	No restriction	4	8	0.32–0.48	400–600	1.92	kg a.s./ha	–	Unrestricted application. Individual blooms flower for 15–20 days, whole plants flower for 4–8 weeks (Austria, 2025)

Abbreviations: a.s., folpet; GAP, good agricultural practice; MRL, maximum residue level; MS, Member State; n.a., not applicable; WG, water‐dispersible granules.

^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 – 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
	Fruit crops	Grapes	Foliar, 3 × 1.5 kg/ha	23	Active radiolabelled substance: phenyl‐14C folpet (EFSA, 2023b).
		Avocados	Foliar, 3 × 3.36 kg/ha	21, 97	Active radiolabelled substance: phenyl‐14C folpet (EFSA, 2023b).
		Tomatoes	Soil, 1 × 0.1 mg/plant	1, 4, 7, 11	Active radiolabelled substance: carbonyl‐14C folpet applied via nutrient solution to roots. This study is considered as supportive only, due to shortcoming (no GLP, application mode and no info on storages stability) (EFSA, 2023b).
	Root crops	Potatoes	Foliar, 5 × 2 kg/ha	1 (after 1st, 2nd and 3rd application), 3 and 5 (after last application)	Active radiolabelled substance: phenyl‐14C folpet (EFSA, 2023b).
	Leafy crops	–	–	–	–
	Cereals/grass	Wheat	Foliar, 2 × 1.6 kg/ha	1 (after 1st application), 1 (after 2nd application), 28 and 39 after last application	Active radiolabelled substance: phenyl‐14C folpet (EFSA, 2023b).
	Pulses/oilseeds	–	–	–	–
	Miscellaneous	–	–	–	–

Rotational crops (available studies)	Crop groups	Crop(s)	Application(s)	PBI (DAT)	Comment/Source
	Root/tuber crops	–	–	–	Folpet and phthalimide half‐lives are < 3 days. Metabolism studies in rotational crops are not required (EFSA, 2023b).
	Leafy crops	–	–	–
	Cereal (small grain)	–	–	–
	Other	–	–	–

Processed commodities (hydrolysis study)	Conditions	Stable?	Comment/Source
	Pasteurisation (20 min, 90°C, pH 4)	No	Active radiolabelled substance: phenyl‐U‐14C‐folpet. Folpet completely degrades to phthalimide, predominantly under conditions of pasteurisation and further to phthalic acid under conditions simulating boiling/brewing/baking and sterilisation (EFSA, 2023b).
	Baking, brewing and boiling (60 min, 100°C, pH 5)	No
	Sterilisation (20 min, 120°C, pH 6)	No
	Other processing conditions	–

B.1.1.2. Stability of residues in plants

Plant products (available studies)	Category	Commodity	T (°C)	Stability period		Compounds covered	Comment/ Source
				Value	Unit
	High‐water content	Apples	< −18	5	Months	Folpet	EFSA (2023b)
Onions, tomatoes (whole)		< −18	12	Months	Folpet	EFSA (2023b)
< −18		12	Months	Phthalimide	EFSA (2023b)
Tomatoes (homogenised)	< −18	12	Months	Folpet	EFSA (2023b)
< −18	1	Month	Phthalimide	Significant decrease was observed after 1 month (EFSA, 2023b)
		Cucumbers	< −18	1	Month	Folpet	EFSA (2023b)
Lettuce		< −18	2.5	Months	Folpet	EFSA (2023b)
		< −20	6	Months	Folpet	Significant decrease was observed after 6 months (Austria, 2025)
		< −20	24	Months	Sum of folpet and phthalimide, expressed as folpet	Austria (2025)
< −20	24	Months	Phthalimide	Austria (2025)
< −20	24	Months	Phthalic acid	Austria (2025)
< −20	24	Months	Phthalamic acid	Austria (2025)
Wheat plants	< −18	18	Months	Phthalimide	EFSA (2023b)
High‐oil content	Olives	< −18	12	Months	Folpet	EFSA (2023b)
	< −18	12	Months	Phthalimide	EFSA (2023b)
	Oilseed rape seed	< −20	24	Months	Folpet	Austria (2025)
< −20		24	Months	Phthalimide	Austria (2025)
< −20	24	Months	Phthalic acid	Austria (2025)
< −20	24	Months	Phthalamic acid	Austria (2025)
High‐starch content	Cereals	< −18	18	Months	Folpet	EFSA (2023b)
	< −18	18	Months	Phthalimide	EFSA (2023b)
	Wheat grain	< −20	18	Months	Folpet	Significant decrease was observed after 18 months (Austria, 2025)
< −20		24	Months	Phthalimide	Austria (2025)
< −20	24	Months	Phthalic acid	Austria (2025)
< −20	24	Months	Phthalamic acid	Austria (2025)
High‐protein content	Dry beans	< −20	Not stable	Months	Folpet	Austria (2025)
		< −20	24	Months	Sum of folpet and phthalimide, expressed as folpet	Austria (2025)
		< −20	24	Months	Phthalimide	Austria (2025)
< −20	24	Months	Phthalic acid	Austria (2025)
< −20	24	Months	Phthalamic acid	Austria (2025)
High‐acid content	Grapes (whole fruit)	< −18	12	Months	Folpet	EFSA (2023b)
	< −18	13	Month	Phthalimide	EFSA (2023b)
	Grapes (homogenised)	< −18	6	Months	Folpet	EFSA (2023b)
	< −18	6	Months	Phthalimide	EFSA (2023b)
	Cranberries	< −18	6	Months	Folpet	EFSA (2023b)
Orange (whole fruit)	< −20	24	Months	Folpet	Austria (2025)
	< −20	24	Months	Phthalimide	Austria (2025)
< −20	24	Months	Phthalic acid	Austria (2025)
< −20	24	Months	Phthalamic acid	Austria (2025)
Processed products	Must, wine, grape wet pomace, tomato juice	< −18	6	Months	Folpet, phthalimide	EFSA (2023b)
	Grape juice	< −18	1	Month	Folpet	EFSA (2023b)
Canned fruit	< −18	3	Months	Folpet	EFSA (2023b)
< −18	1	Month	Phthalimide	Significant decrease was observed after 1 month (EFSA, 2023b)
	Ketchup	< −18	6	Months	Folpet	EFSA (2023b)
	< −18	1	Month	Phthalimide	Significant decrease was observed after 1 month (EFSA, 2023b)
	Olive oil (raw and refined)	< −18	12	Months	Folpet	EFSA (2023b)
< −18	12	Months	Phthalimide	EFSA (2023b)
Apple wet pomace	< −18	1	Month	Folpet	EFSA (2023b)
Others	Straw	< −18	18	Months	Folpet	EFSA (2023b)
	< −18	18	Months	Phthalimide	EFSA (2023b)
	Wheat straw	< −20	24	Months	Folpet	Austria (2025)
< −20		24	Months	Phthalimide	Austria (2025)
< −20	24	Months	Phthalic acid	Austria (2025)
< −20	24	Months	Phthalamic acid	Austria (2025)

B.1.2. Magnitude of residues in plants

B.1.2.1. 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
Current Mo‐RD e : folpet (sum of folpet and phthalimide, expressed as folpet) (Reg (EU) 2023/1042)
Bananas	South America	Whole fruit: 3 × < 0.03; 0.03; 3 × 0.06: 0.11; 0.13; 0.15; 0.51 f ; 0.52 f Pulp: RA‐RD1 h : 12 × < 0.03 RA‐RD2 i : 8 × < 0.05; 2 × 0.05; 0.06; 0.07	Residue trials on bananas (bagged) compliant with GAP (Austria, 2025).	0.9	Mo‐RD e : 0.52 Pulp: RA‐RD1 h : 0.03 RA‐RD2 i : 0.068	Mo‐RD e : 0.06 Pulp: RA‐RD1 h : 0.03 RA‐RD2 i : 0.050	1
New Mo‐RD g : folpet (EFSA, 2023b)
Bananas	South America (Costa Rica, Ecuador, Colombia, Mexico)	Whole fruit: 3 × < 0.01 j ; 0.01 k ; 0.04 j ; 2 × 0.04 k ; 0.07 j ; 0.08 j ; 0.08 k ; 0.37 f , k ; 0.43 f , k	Residue trials on bananas (bagged) compliant with GAP. Sample storage periods are not supported by specific storage stability data for folpet in bananas (footnote k) (see Section 1.1.5). Even when considering only samples stored up to the highest storage stability of 12 months demonstrated for folpet in some high‐water content commodities (i.e. tomatoes and onions) (footnote j), the number of trials is insufficient to derive an MRL.	–	–	–	–

Abbreviations: GAP, good agricultural practice; Mo, monitoring; MRL, maximum residue level; 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, EU: indoor EU trials or Country code: if non‐EU trials.

^b Highest residue. The highest residue for risk assessment refers to the edible portion (fruit pulp).

^c Supervised trials median residue. The median residue for risk assessment refers to the edible portion (fruit pulp).

^d Conversion factor to recalculate residues according to the current residue definition for monitoring to the residue definition for risk assessment 1.

^e Residue definition for enforcement in plant commodities currently in place (Reg. (EU) 2023/1042), i.e. ‘folpet (sum of folpet and phthalimide, expressed as folpet)’.

^f Residue measured at longer PHI.

^g New residue definition for enforcement in plant commodities, i.e. ‘folpet’, as proposed in the framework of the renewal of the approval of folpet (EFSA, 2023b).

^h Residue definition for risk assessment 1 (applicable to fruit and cereal/grass crops), i.e. sum of folpet and phthalimide, expressed as folpet (EFSA, 2023b).

ⁱ Residue definition for risk assessment 2 (applicable to all plant commodities), i.e. phthalic acid (EFSA, 2023b).

^j Residue level measured from samples stored between 159 and 351 days (corresponding to 5–12 months).

^k Residue level measured from samples stored between 404–484 days (corresponding to 13–16 months), beyond the maximum period for which storage stability of folpet in high‐water content commodities is demonstrated (12 months).

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, however, since residue data on bananas were provided for whole fruit, peel and pulp, peeling factors were calculated by EFSA.

Processed commodity	Number of valid studies a	Peeling factor (PeF)		CFPe b	Comment/source
		Individual values	Median PF
Banana, peeled	9	0.10; 0.20; 2 × 0.22; 0.27; 0.47; 0.48; 0.50; 0.94	0.27	1	Calculated based on trials included in Austria (2025)

Note: European database of processing factors for pesticides residues in food: https://zenodo.org/records/6827098.

Abbreviation: PeF, peeling factor.

^a Studies with residues in the RAC (whole fruit) at or close to the LOQ were disregarded (unless concentration occurs).

^b Conversion factor for risk assessment in the peeled commodity; median of the individual conversion factors for each residues trial.

B.2. RESIDUES IN LIVESTOCK AND FISH

Not relevant as the commodities under assessment are not used for feed purposes.

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

Products of animal origin (available studies)	Category	Commodity	T (°C)	Stability period		Compounds covered	Comment/source
				Value	Unit
	Bee products	Honey	< −18	4	Months	Folpet	Austria (2025)
			< −18	4	Months	Phthalimide	Austria (2025)
			< −18	4	Months	Phthalic acid	Austria (2025)
			< −18	4	Months	Phthalamic acid	Austria (2025)
			< −18	3.5	Months	Phthalic anhydride	Austria (2025)

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
Current Mo‐RD e : folpet (sum of folpet and phthalimide, expressed as folpet) (Reg (EU) 2023/1042)
Honey	NEU	Mo‐RD e , RA‐RD1 g : 0.044; 0.120; 0.210; 0.330 RA‐RD2 h : < 0.05; 0.054; 0.058; 0.060	Residue trials on honey non‐compliant with GAP (overdosed in terms of individual application rate). Nevertheless, the RMS considered the dataset suitable to derive an MRL proposal for honey (Austria, 2025). EFSA does not consider the dataset appropriate to support the RMS MRL proposal.	0.7	Mo‐RD e , RA‐RD1 g : 0.330 RA‐RD2 h : 0.060	Mo‐RD e , RA‐RD1 g : 0.165 RA‐RD2 h : 0.056	1
New Mo‐RD f : folpet (EFSA, 2023b)
Honey	NEU	Mo‐RD f : 2 × < 0.01; 0.013; 0.035 RA‐RD1 g : 0.044; 0.120; 0.210; 0.330 RA‐RD2 h : < 0.05; 0.054; 0.058; 0.060	Residue trials on honey non‐compliant with GAP (overdosed in terms of individual application rate). Nevertheless, the RMS considered the dataset suitable to derive an MRL proposal for honey (Austria, 2025). EFSA does not consider the dataset appropriate to support the RMS MRL proposal.	0.07	Mo‐RD f : 0.035 RA‐RD1 g : 0.330 RA‐RD2 h : 0.060	Mo‐RD f : 0.012 RA‐RD1 g : 0.165 RA‐RD2 h : 0.056	1

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, 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 1.

^e Residue definition for enforcement in plant commodities currently in place (Reg. (EU) 2023/1042), i.e. ‘folpet (sum of folpet and phthalimide, expressed as folpet)’. Applicable to honey as well (Austria, 2025).

^f New residue definition for enforcement in plant commodities, i.e. ‘folpet’, as proposed in the framework of the renewal of the approval of folpet (EFSA, 2023b). Applicable to honey as well (Austria, 2025).

^g Residue definition for risk assessment 1 (applicable to fruit and cereal/grass crops), i.e. sum of folpet and phthalimide, expressed as folpet (EFSA, 2023b). Applicable to honey as well (Austria, 2025).

^h Residue definition for risk assessment 2 (applicable to all plant commodities), i.e. phthalic acid (EFSA, 2023b). Applicable to honey as well (Austria, 2025).

B.3.2.2. Summary of monitoring data on honey submitted to EFSA under Art. 32 of Reg. (EC) No 396/2005 (dataset 1)

LOQ	Dataset 1A Monitoring period: 2022–2024			Dataset 1B Monitoring period: 2017–2025
	Number of samples	Number of LOQ exceedances	Number of MRL exceedances	Number of samples	Number of LOQ exceedances	Number of MRL exceedances
0.00003	53	0	0	169	0	0
0.005	2	0	0	2	0	0
0.007	13	0	0	13	0	0
0.01	267	0	0	967	0	0
0.015	–	–	–	27	0	0
0.02	437	0	0	805	0	0
0.024	–	–	–	1	0	0
0.03	309	0	0	460	0	0
0.05	64	0	0	127	0	0
0.09	36	0	0	56	0	0
0.1	–	–	–	8	0	0

B.3.2.3. Summary of monitoring data on honey submitted to EFSA under Art. 32 of Reg. (EC) No 396/2005 (dataset 2)

LOQ	Dataset 2A Monitoring period: 2022–2024			Dataset 2B Monitoring period: 2009–2025
	Number of samples	Number of LOQ exceedances	Number of MRL exceedances	Number of samples	Number of LOQ exceedances	Number of MRL exceedances
0.00001	53	0	0	169	0	0
0.005	–	–	–	56	0	0
0.006	–	–	–	22	0	0
0.007	13	0	0	61	0	0
0.008	–	–	–	4	0	0
0.01	619	1 (0.029 mg/kg)	0	2508	1 (0.029 mg/kg)	0
0.02	–	–	–	831	0	0
0.03	–	–	–	2	0	0
0.04	64	0	0	217	0	0
0.05	160	0	0	754	0	0
0.06	–	–	–	7	0	0
0.1	–	–	–	138	0	0
0.5	–	–	–	1	0	0

B.4. CONSUMER RISK ASSESSMENT

B.5. RECOMMENDED MRLS

Code a	Commodity	Existing EU MRL (mg/kg) b	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: folpet (sum of folpet and phthalimide, expressed as folpet) (Reg (EU) 2023/1042)
0163020	Bananas	0.03*	0.9	The submitted data are sufficient to derive an import tolerance (Ecuador, El Salvador). Risk for consumers unlikely.
1040000	Honey	0.05*	No change	The RMS supported the setting of an MRL of 0.7 mg/kg, based on overdosed semi‐tunnel trials. The MRL proposal of 0.7 mg/kg is not supported by EFSA but risk managers are provided with further information for further considerations. According to EFSA's assessment, the submitted data are not GAP‐compliant and are not considered appropriate to derive an MRL proposal. It is noted that based on the consumer risk assessment performed using risk assessment values as derived from the available overdosed trials, risk for consumers is unlikely.
Enforcement residue definition: folpet (EFSA, 2023b)
0163020	Bananas	0.03*	No change	The submitted data are not sufficient to derive an import tolerance (Ecuador, El Salvador) due to a lack of valid residue data for folpet alone (major uncertainty related to the storage stability of folpet alone in some trial samples).
1040000	Honey	0.05*	No change	The RMS supported the setting of an MRL of 0.7 mg/kg, based on overdosed semi‐tunnel trials. The MRL proposal of 0.7 mg/kg is not supported by EFSA but risk managers are provided with further information for further considerations. According to EFSA's assessment, the submitted data are not GAP‐compliant and are not considered appropriate to derive an MRL proposal. It is noted that based on the consumer risk assessment performed using risk assessment values as derived from the available overdosed trials, risk for consumers is 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 Folpet (sum of folpet and phthalimide, expressed as folpet) (Reg (EU) 2023/1042).

APPENDIX C. Pesticide Residue Intake Model (PRIMo)

PRIMo – RA‐RD1

PRIMo – RA‐RD2

PRIMo for RA‐RD2 screenshot is not here provided due to lack of residue data according to RA‐RD2 for commodities other than banana and honey. Still, the results of the chronic exposure for these two commodities are reported in B.4 and the full PRIMo file provided for information, as background document to this reasoned opinion.

APPENDIX D. Input values for the exposure calculations

D.1. CONSUMER RISK ASSESSMENT

Exposure to residues according to residue definition for risk assessment 1 (RA‐RD1) in primary crops

Commodity	Existing/proposed MRL a (mg/kg)	Source	Chronic risk assessment		Acute risk assessment
			Input value b (mg/kg)	Comment	Input value b (mg/kg)	Comment c
Risk assessment residue definition 1a (fruit and cereal/grass crops): sum of folpet and phthalimide, expressed as folpet Risk assessment residue definition 1b (root crops): sum of folpet and phthalamic acid, expressed as folpet
Bananas	0.9	MRL proposal	0.03	STMR‐RACpulp	0.03	HR‐RACpulp
Honey and other apiculture products d	0.7	RMS MRL proposal e	0.17	STMR e	0.33	HR e
Apples, pears	0.3	EFSA (2017)	0.06	STMR‐RAC	0.19	HR‐RAC
Table grapes	6	EFSA (2014)	1.18	STMR‐RAC	2.85	HR‐RAC
Wine grapes	20	EFSA (2014)	1.67	STMR‐RAC	2.81	HR‐RAC
Strawberries f	5	EFSA (2014)	1.3	STMR‐RAC	2.2	HR‐RAC
Table olives f	0.15	EFSA (2014)	0.15	STMR‐RAC	0.15	HR‐RAC
Potatoes f	0.06	EFSA (2014)	0.1	STMR‐RAC g	0.1	HR‐RAC g
Radishes f , salsifies f	0.04	EFSA (2014)	0.04	STMR‐RAC g	0.04	HR‐RAC g
Tomatoes f	5	EFSA (2014)	0.7	STMR‐RAC	2.8	HR‐RAC
Melons f	0.4	EFSA (2014)	0.03	STMR‐RAC	0.17	HR‐RAC
Lettuces	1.5	EFSA (2022)	0.19	STMR‐RAC	0.86	HR‐RAC
Olives for oil production f	0.15	EFSA (2014)	0.15	STMR‐RAC	0.15	STMR‐RAC
Barley, oat	2	EFSA (2021)	0.18	STMR‐RAC	0.18	STMR‐RAC
Rye	0.3	EFSA (2021)	0.12	STMR‐RAC	0.12	STMR‐RAC
Wheat f	0.4	EFSA (2014)	0.12	STMR‐RAC	0.12	STMR‐RAC
HOPS (dried) f	400	EFSA (2014)	82	STMR‐RAC	192	HR‐RAC
Risk assessment residue definition (animal commodities): Phthalimide, expressed as folpet
Muscle/meat (all animal groups, except poultry)	0.05*	EFSA (2014)	0.05	LOQ	0.05	LOQ
Muscle/meat (poultry) f	0.05*	EFSA (2014)	0.05	LOQ	0.05	LOQ
Fat tissue (all animal groups, except poultry)	0.05*	EFSA (2014)	0.05	LOQ	0.05	LOQ
Fat tissue (poultry) f	0.05*	EFSA (2014)	0.05	LOQ	0.05	LOQ
Liver (all animal groups, except poultry)	0.05*	EFSA (2014)	0.05	LOQ	0.05	LOQ
Liver (poultry) f	0.05*	EFSA (2014)	0.05	LOQ	0.05	LOQ
Kidney (all animal groups)	0.05*	EFSA (2014)	0.05	LOQ	0.05	LOQ
Edible offal (other than liver and kidney) (all animal groups)	0.05*	EFSA (2014)	0.05	LOQ	0.05	LOQ
Other products (all animal groups)	0.05*	EFSA (2014)	0.05	LOQ	0.05	LOQ
Milk	0.05*	EFSA (2014)	0.05	LOQ	0.05	LOQ
Eggs f	0.05*	EFSA (2014)	0.05	LOQ	0.05	LOQ

Abbreviations: HR‐RAC, highest residue in raw agricultural commodity; PeF, Peeling factor; STMR‐RAC, supervised trials median residue in raw agricultural commodity.

^a MRLs were calculated on the basis of the residue definition for monitoring under Reg. (EU) 396/2005.

^b 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.

^c Input values for the commodities which are not under consideration for the acute risk assessment are reported in grey.

^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 MRL proposal and risk assessment values derived by the RMS, based on the residue dataset submitted in the present MRL application (Austria, 2025). The dataset was obtained from semi‐field (tunnel) trials not compliant with the selected cGAP and considered overdosed.

^f For this commodity, a tentative MRL was derived from a GAP evaluated at EU level which is not fully supported by data, but for which no risk to consumers was identified (EFSA, 2014).

^g Risk assessment values derived for the ‘sum of folpet and phthalimide, expressed as folpet’ (EFSA, 2014). This residue definition is superseded by the RA‐RD1 recently established in the peer review conclusion for the renewal of approval of folpet for root crops (RA‐RD1(root crops): sum of folpet and phthalamic acid, expressed as folpet) (EFSA, 2023b).

Exposure to residues according to residue definition for risk assessment 2 (RA‐RD2) in primary crops

Commodity	Existing/proposed MRL a (mg/kg)	Source	Chronic risk assessment		Acute risk assessment
			Input value b , c (mg/kg)	Comment	Input value b , c (mg/kg)	Comment
Risk assessment residue definition 2 (all crops): phthalic acid
Bananas	0.9	MRL proposal	0.05	STMR‐RACpulp	0.068	HR‐RACpulp
Honey and other apiculture products d	0.7	RMS MRL proposal e	0.06	STMR e	0.06	HR e
Other commodities	No data available for phthalic acid in other commodities.

Abbreviations: HR‐RAC, highest residue in raw agricultural commodity; PeF, Peeling factor; STMR‐RAC, supervised trials median residue in raw agricultural commodity.

^a MRLs were calculated on the basis of the residue definition for monitoring under Reg. (EU) 396/2005.

^b 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.

^c Risk assessment values according to RA‐RD2 (EFSA, 2023b) are only available for the commodities under assessment.

^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 MRL proposal and risk assessment values derived by the RMS, based on the residue dataset submitted in the present MRL application (Austria, 2025). The dataset was obtained from semi‐field (tunnel) trials not compliant with the selected cGAPs and considered overdosed.

APPENDIX E. Used compound codes

Code/trivial name a	IUPAC name/SMILES notation/InChiKey b	Structural formula c
Folpet	N‐[(trichloromethylthio)]phthalimide ClC(Cl)(Cl)SN2C(=O)c1ccccc1C2=O HKIOYBQGHSTUDB‐UHFFFAOYSA‐N
Phthalimide	1H‐isoindole‐1,3(2H)‐dione O=C1NC(=O)c2ccccc12 XKJCHHZQLQNZHY‐UHFFFAOYSA‐N
Phthalamic acid	2‐carbamoylbenzoic acid OC(=O)c1ccccc1C(N)=O CYMRPDYINXWJFU‐UHFFFAOYSA‐N
Phthalic acid	benzene‐1,2‐dicarboxylic acid OC(=O)c1ccccc1C(=O)O XNGIFLGASWRNHJ‐UHFFFAOYSA‐N
Phthalic anhydride	2‐benzofuran‐1,3‐dione O=C1OC(=O)c2ccccc12 LGRFSURHDFAFJT‐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 2025.2.4 ACD/Labs 2025.2.4 (File Version N25E41, Build 147950, 03 Feb 2026).

^c ACD/ChemSketch 2025.2.4 ACD/Labs 2025.2.4 (File Version C65H41, Build 147869, 26 Jan 2026).

EFSA (European Food Safety Authority) , Bellisai, G. , Bernasconi, G. , Castellan, I. , del Aguila, M. , Ferreira, L. , Leuschner, R. , Mioč, A. , Szot, M. , Tiramani, M. , & Verani, A. (2026). Setting of import tolerance for folpet in bananas and modification of the existing maximum residue level in honey. EFSA Journal, 24(7), e10168. 10.2903/j.efsa.2026.10168