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Summary

Penthiopyrad was approved on 1 May 2014 by means of Commission Implementing Regulation (EU) No 1187/2013 in the framework of Regulation (EC) No 1107/2009 as implemented by Commission Implementing Regulations (EU) No 540/2011 and 541/2011.

As the active substance was approved after the entry into force of Regulation (EC) No 396/2005 on 2 September 2008, the European Food Safety Authority (EFSA) is required to provide a reasoned opinion on the review of the existing maximum residue levels (MRLs) for that active substance in compliance with Article 12(1) of the aforementioned regulation.

As the basis for the MRL review, on 18 February 2020 EFSA initiated the collection of data for this active substance. In a first step, Member States and the United Kingdom were invited to submit by 26 March 2020 their national Good Agricultural Practices (GAPs) in a standardised way, in the format of specific GAP forms, allowing the designated rapporteur Member State, Sweden, to identify the critical GAPs in the format of a specific GAP overview file. Subsequently, Member States and the UK were requested to provide residue data supporting the critical GAPs, within a period of 1 month, by 23 June 2020. On the basis of all the data submitted by Member States, the UK and by the EU Reference Laboratories for Pesticides Residues (EURLs), EFSA asked the RMS to complete the Pesticide Residues Overview File (PROFile) and to prepare a supporting evaluation report. The PROFile and evaluation report, together with an updated GAP overview file were provided by the RMS to EFSA on 06 November 2020. Subsequently, EFSA performed the completeness check of these documents with the RMS. The outcome of this exercise including the clarifications provided by the RMS was compiled in the completeness check report.

Based on the information provided by the RMS, Member States, the UK and the EURLs, and taking into account the conclusions derived by EFSA in the framework of Commission Regulation (EU) No 188/2011 and the MRLs established by the Codex Alimentarius Commission, EFSA prepared in April 2021 a draft reasoned opinion, which was circulated to Member States and EURLs for consultation via a written procedure. Comments received by 13 May 2021 were considered during the finalisation of this reasoned opinion. The following conclusions are derived.

The metabolism of penthiopyrad in plants was investigated in primary and rotational crops. There was no preferential isomeric degradation in plant commodities. According to the results of the metabolism studies, the residue definition for enforcement is proposed as penthiopyrad while for risk assessment, two residue definitions are proposed: (1) sum of penthiopyrad and metabolite 753-A-OH, expressed as penthiopyrad and (2) metabolite PAM. Pending the submission of the outstanding data on the nature of metabolite PAM upon processing, the same residue definitions as derived for primary crops are proposed, on a provisional basis, to processed commodities. Fully validated analytical methods are available for the enforcement of the proposed residue definition in all matrices at the LOQ of 0.01 mg/kg. According to the EURLs, the LOQ of 0.01 mg/kg is achievable in routine analyses.

Available residue trials data were considered sufficient to derive (tentative) MRL proposals as well as risk assessment values for all commodities under evaluation, except for rice grain and buckwheat grain.

Penthiopyrad is authorised for use on crops that might be fed to livestock. Livestock dietary burden calculations were therefore performed for different groups of livestock according to OECD guidance. The dietary burdens calculated for all groups of livestock were found to exceed the trigger value of 0.1 mg/kg dry matter (DM). Behaviour of residues was therefore assessed in all commodities of animal origin.

The metabolism of penthiopyrad residues in livestock was investigated in lactating goats and laying hens at dose rate covering the maximum dietary burdens calculated in this review. There was no preferential isomeric degradation in animal commodities. According to the results of these studies, the residue definitions for enforcement and risk assessment in livestock commodities are proposed as (1) penthiopyrad and (2) metabolite PAM. An analytical method for the enforcement of the proposed residue definition at the LOQ of 0.01 mg/kg in all matrices is available. According to the EURLs, the LOQ of 0.01 mg/kg is achievable by using the QuEChERS method in routine analyses.

Livestock feeding studies on animal were used to derive MRL and risk assessment values in milk, eggs and tissues of ruminants/poultry. Since extrapolation from ruminants to pigs is acceptable, results of the livestock feeding study on ruminants were relied upon to derive the MRL and risk assessment values in pigs.

Chronic and acute consumer exposure resulting from the authorised uses reported in the framework of this review was calculated using revision 3.1 of the EFSA PRIMo. For those commodities where data were insufficient to derive an MRL, EFSA considered the existing EU MRL for an indicative calculation. The highest chronic exposure represented 10% of the ADI (Dutch toddler) and the highest acute exposure amounted to 57% of the ARfD (lettuces).

Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs have also been established for penthiopyrad. Additional calculations of the consumer exposure, considering these CXLs, were therefore carried out, the highest chronic exposure represented 10% of the ADI (Dutch toddler) and the highest acute exposure amounted to 57% of the ARfD (lettuces).

A consumer exposure for metabolite PAM and resulting from the authorised uses reported in the framework of this review was calculated using revision 3.1 of the EFSA PRIMo. For those commodities where data were not available, EFSA considered the existing EU MRL of penthiopyrad for an indicative calculation. The highest chronic exposure represented 52% of the ADI (Dutch toddler) and the highest acute exposure amounted to 63% of the ARfD (leeks).

It is highlighted that EFSA was mandated for the assessment of the toxicological profile of metabolite PAM which is currently ongoing and that the chronic and acute dietary intake calculations to PAM residues might need to be reconsidered depending on the outcome of this assessment.

Background

Regulation (EC) No 396/20051 (hereinafter referred to as ‘the Regulation’) establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. Article 12(1) of that Regulation stipulates that the European Food Safety Authority (EFSA) shall provide, within 12 months from the date of the inclusion or non-inclusion of an active substance in Annex I to Directive 91/414/EEC2 a reasoned opinion on the review of the existing MRLs for that active substance.

As penthiopyrad was approved on 1 May 2014 by means of Commission Implementing Regulation (EU) No 1187/20133 in the framework of Regulation (EC) No 1107/20094 as implemented by Commission Implementing Regulations (EU) No 540/20115 and 541/20116, EFSA initiated the review of all existing MRLs for that active substance.

By way of background information, in the framework of Commission Regulation (EU) No 188/20117, penthiopyrad was evaluated by the United Kingdom, designated as rapporteur Member State (RMS). Subsequently, a peer review on the initial evaluation of the RMS was conducted by EFSA, leading to the conclusions as set out in the EFSA scientific output (EFSA, 2013a).

According to the legal provisions, EFSA shall base its reasoned opinion in particular on the relevant assessment report prepared under Directive 91/414/EEC repealed by Regulation (EC) No 1107/2009. It should be noted, however, that, in the framework of Regulation (EC) No 1107/2009, only a few representative uses are evaluated, whereas MRLs set out in Regulation (EC) No 396/2005 should accommodate all uses authorised within the European Union (EU), and uses authorised in third countries that have a significant impact on international trade. The information included in the assessment report prepared under Regulation (EC) No 1107/2009 is therefore insufficient for the assessment of all existing MRLs for a given active substance.

To gain an overview of the pesticide residues data that have been considered for the setting of the existing MRLs, EFSA developed the Pesticide Residues Overview File (PROFile). The PROFile is an inventory of all pesticide residues data relevant to the risk assessment and MRL setting for a given active substance. This includes data on:

the nature and magnitude of residues in primary crops;
the nature and magnitude of residues in processed commodities;
the nature and magnitude of residues in rotational crops;
the nature and magnitude of residues in livestock commodities;
the analytical methods for enforcement of the proposed MRLs.

As the basis for the MRL review, on 18 February 2020, EFSA initiated the collection of data for this active substance. In a first step, Member States and the United Kingdom8 were invited to submit by 26 March 2020 their Good Agricultural Practices (GAPs) that are authorised nationally and the GAPs in non-EU countries for which import tolerances (IT) are authorised in a standardised way, in the format of specific GAP forms. In the framework of this consultation 15 Member States and the UK provided feedback on their national authorisations of penthiopyrad. Based on the GAP data submitted, the designated RMS Sweden was asked to identify the critical GAPs to be further considered in the assessment, in the format of a specific GAP overview file. Subsequently, in a second step, Member States and the UK were requested to provide residue data supporting the critical GAPs by 23 June 2020.

On the basis of all the data submitted by Member States, the UK and the EU Reference Laboratories for Pesticides Residues (EURLs), EFSA asked Sweden to complete the PROFile and to prepare a supporting evaluation report. The PROFile and the supporting evaluation report, together with an updated GAP overview file, were submitted to EFSA on 06 November 2020. Subsequently, EFSA performed the completeness check of these documents with the RMS. The outcome of this exercise including the clarifications provided by the RMS, if any, was compiled in the completeness check report.

Considering all the available information, and taking into account the MRLs established by the Codex Alimentarius Commission (CAC) (i.e. codex maximum residue limit; CXLs), EFSA prepared in April 2021 a draft reasoned opinion, which was circulated to Member States and EURLs for commenting via a written procedure. All comments received by 13 May 2021 were considered by EFSA during the finalisation of the reasoned opinion.

The evaluation report submitted by the RMS (Sweden, 2020), taking into account also the information provided by Member States during the collection of data, and the EURLs report on analytical methods (EURLs, 2020) are considered as main supporting documents to this reasoned opinion and, thus, made publicly available.

In addition, further supporting documents to this reasoned opinion are the completeness check report (EFSA, 2021a) and the Member States consultation report (EFSA, 2021b). These reports are developed to address all issues raised in the course of the review, from the initial completeness check to the reasoned opinion. Furthermore, the exposure calculations for all crops reported in the framework of this review performed using the EFSA Pesticide Residues Intake Model (PRIMo) and the PROFile as well as the GAP overview file listing all authorised uses and import tolerances are key supporting documents and made publicly available as background documents to this reasoned opinion. A screenshot of the report sheet of the PRIMo is presented in Appendix C.

Terms of Reference

According to Article 12 of Regulation (EC) No 396/2005, EFSA shall provide a reasoned opinion on:

the inclusion of the active substance in Annex IV to the Regulation, when appropriate;
the necessity of setting new MRLs for the active substance or deleting/modifying existing MRLs set out in Annex II or III of the Regulation;
the inclusion of the recommended MRLs in Annex II or III to the Regulation;
the setting of specific processing factors as referred to in Article 20(2) of the Regulation.

The active substance and its use pattern

Penthiopyrad is the ISO common name for (RS)-N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3- (trifluoromethyl)pyrazole-4-carboxamide (IUPAC).

The chemical structure of the active substance and its main metabolites are reported in Appendix F.

The EU MRLs for penthiopyrad are established in Annexes IIIA of Regulation (EC) No 396/2005. Codex maximum residue limits (CXLs) for active substance were also established by the Codex Alimentarius Commission (CAC). An overview of the MRL changes that occurred since the entry into force of the Regulation mentioned above is provided below (Table 1).

Table 1 Overview of the MRL changes since the entry into force of Regulation (EC) No 396/2005

Procedure	Legal implementation	Remarks
MRL application	Regulation (EU) 2017/10161	Apricots, peaches, barley and oat (EFSA, 2016)
Implementation of CAC 2014	Regulation (EU) 2015/8452	Azaroles/Mediterranean medlars, kaki/Japanese persimmons, peanuts/groundnuts, maize/corn (EFSA, 2014)
Implementation of CAC 2013	Regulation (EU) No 491/20143	Coconuts, pine and nut kernels, potatoes, Spring onions/green onions and Welsh onions, Solanaceae and Malvaceae (i.e. okra/lady's fingers and others), sweet corn, baby leaf crops (including brassica species), pulses (i.e. beans, lentils, peas, lupins/lupini beans and others) (EFSA, 2013b)
MRL application	Regulation (EU) No 251/20134	Tree nuts (except coconuts and pine nuts), pome fruit, cherries, peaches, plums, strawberries, root and tuber vegetables, garlic, onions, shallots, spring onions, tomatoes, peppers, aubergines, cucurbits, sweet corn, flowering brassica, head cabbage, lettuce and other salad plants including brassicacea, spinach and similar (leaves), chervil, parsley leaves, beans (with and without pods), peas (with and without pods), cardoons, celery, fennel, rhubarb, leek, dry pulses, peanuts, sunflower seed, rape seed, soya bean, cotton seed, barley, maize, oats, rye, sorghum, wheat, sugar beet and animal commodities, considering residue levels in feed items (EFSA, 2012)
MRL application	Draft Regulation SANTE/12328/20205 Not yet legally implemented	Florence fennels, celeries (EFSA, 2020)

¹Commission Regulation (EU) 2017/1016 of 14 June 2017 amending Annexes II, III and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for benzovindiflupyr, chlorantraniliprole, deltamethrin, ethofumesate, haloxyfop, Mild Pepino Mosaic Virus isolate VC1, Mild Pepino Mosaic Virus isolate VX1, oxathiapiprolin, penthiopyrad, pyraclostrobin, spirotetramat, sunflower oil, tolclofos-methyl and trinexapac in or on certain products. OJ L 159, 21.6.2017, p. 1–47.

²Commission Regulation (EU) 2015/845 of 27 May 2015 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for azoxystrobin, chlorantraniliprole, cyantraniliprole, dicamba, difenoconazole, fenpyroximate, fludioxonil, glufosinate-ammonium, imazapic, imazapyr, indoxacarb, isoxaflutole, mandipropamid, penthiopyrad, propiconazole, pyrimethanil, spirotetramat and trinexapac in or on certain products. OJ L 138, 4.6.2015, p. 1–69.

³Commission Regulation (EU) No 491/2014 of 5 May 2014 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for ametoctradin, azoxystrobin, cycloxydim, cyfluthrin, dinotefuran, fenbuconazole, fenvalerate, fludioxonil, fluopyram, flutriafol, fluxapyroxad, glufosinate-ammonium, imidacloprid, indoxacarb, MCPA, methoxyfenozide, penthiopyrad, spinetoram and trifloxystrobin in or on certain products. OJ L 146, 16.5.2014, p. 1–91.

⁴Commission Regulation (EU) No 251/2013 of 22 March 2013 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for aminopyralid, bifenazate, captan, fluazinam, fluopicolide, folpet, kresoxim-methyl, penthiopyrad, proquinazid, pyridate and tembotrione in or on certain products. OJ L 88, 27.3.2013, p. 1–44.

⁵Draft Commission Regulation SANTE/12328/2020 amending Annexes II, III and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for aclonifen, acrinathrin, Bacillus pumilus QST 2808, chlorantraniliprole, ethirimol, penthiopyrad, picloram and Pseudomonas sp. strain DSMZ 13134 in or on certain products, voted at the Standing Committee on Plants, Animals, Food and Feed Section Phytopharmaceuticals – Residues held on 23–24 November 2020. The regulation is not yet published in the Official Journal of the European Union.

For the purpose of this MRL review, all the uses of penthiopyrad currently authorised within the EU and in third countries as submitted by the Member States and the UK during the GAP collection, have been reported by the RMS in the GAP overview file. The critical GAPs identified in the GAP overview file were then summarised in the PROFile and considered in the assessment. The details of the authorised critical GAPs for penthiopyrad are given in Appendix A.

Assessment

EFSA has based its assessment on the following documents:

the PROFile submitted by the RMS;
the evaluation report accompanying the PROFile (Sweden, 2020);
the draft assessment report (DAR) and its addenda prepared under Council Directive 91/414/EEC (United Kingdom, 2012, 2013);
the conclusion on the peer review of the pesticide risk assessment of the active substance penthiopyrad (EFSA, 2013a);
the review report on penthiopyrad (European Commission, 2013);
the Joint Meeting on Pesticide residues (JMPR) Evaluation report (FAO, 2012, 2013);
the previous reasoned opinions on penthiopyrad (EFSA, 2012, 2016, 2020).

The assessment is performed in accordance with the legal provisions of the uniform principles for evaluation and authorisation of plant protection products as set out in Commission Regulation (EU) No 546/20119 and the currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues (European Commission, 1996, 1997a–g, 2000, 2010a,b, 2017; OECD, 2011, 2013).

More detailed information on the available data and on the conclusions derived by EFSA can be retrieved from the list of end points reported in Appendix B.

Residues in plants Nature of residues and methods of analysis in plants Nature of residues in primary crops

The metabolism of penthiopyrad in primary crops was studied, following foliar treatment, in fruits (grapes and tomato), leafy vegetables (cabbage), pulses and oilseeds (canola) and cereals (wheat) and assessed during the peer review (EFSA, 2013a), at application rates covering the GAPs currently under assessment. The main cleavage products identified in all commodities were metabolites PAM and PCA. There was also evidence that the thiophene ring breaks down completely and the radioactivity is incorporated into natural products such as lipids and plant matrix constituents such as carbohydrates in e.g. wheat grain. Significant amounts of mainly conjugated 753-A-OH were present in grapes and cabbage. The metabolism showed to be more extensive in rapeseed with metabolite PAM being the predominant part of the total residues (EFSA, 2013a). The same metabolism pathway was observed in all crops studied. It is noted that no preferential isomeric degradation was observed in primary crops.

A new metabolism study in sugar beet after seed treatment was assessed in the RMS evaluation report (Sweden, 2020). The study was performed with treatments at the critical dose rate of application as supported in the authorised use on sugar beet and at exaggerated rate (application rate of 14 g a.s./ha and 70 g a.s./ha, respectively (5N)). In the root tuber, the total radioactive residues (TRR) were below 0.01 mg/kg, and samples were not analysed further for metabolites. In sugar beet leaves, the maximum level of any single metabolite found was 0.003 mg/kg; the identity of the metabolites was not further investigated. As no relevant metabolite and/or a different route of degradation is expected in sugar beet root and leaves, the proposed residue definitions set for plants following foliar application also apply to sugar beet following seed treatment.

Nature of residues in rotational crops

Penthiopyrad is authorised on crops that may be grown in rotation. Penthiopyrad DT₅₀ value is 406 days (EFSA, 2013a). For metabolites PAM, PCA and DM-PCA DT₅₀ values were calculated (maximum of 45 days for metabolite PAM, 78 days for metabolite PCA and 476 days for DM-PCA) indicating that the trigger value for the DT₉₀ value would be exceeded for all these compounds (EFSA, 2013a).

One confined rotational crop study is available where penthiopyrad was applied at 800 g a.s./ha onto bare soil and lettuce, spinach, radish and wheat were planted at nominal plant back intervals (PBI) of 30, 120 and 360 days (United Kingdom, 2012) and was assessed in the framework of the peer review (EFSA, 2013a).

In lettuce (crops were analysed only 30 DAT), the main components of the TRR were metabolites DM-PAM (0.02 mg/kg) and DM-PCA (0.012 mg/kg) with other metabolites below 0.01 mg/kg. In mature spinach (120 and 365 DAT), no individual metabolites were detected at a level above 0.01 mg/kg. In samples taken from spinach, which was planted 30 DAT, metabolite DM-PCA accounted for 0.022 mg/kg and a conjugate fraction U1 for 0.046 mg/kg; no other individual compounds were detected at a level above 0.01 mg/kg.

In mature radish root (30 DAT), a conjugated fraction U1 (consisting of up to 14 conjugated components) accounted for up to 0.018 mg/kg; no other components individually exceeded 0.01 mg/kg.

In wheat grain, the TRR was characterised only for the crop which was sown 30 days after the soil treatment with penthiopyrad and only conjugate fractions U1 and U2 exceeded 0.01 mg/kg (0.014 and 0.016 mg/kg, respectively). In wheat straw samples (from 30 DAT), a wide range of metabolites was identified containing residues above 0.01 mg/kg: parent penthiopyrad (0.032 mg/kg), conjugate fraction U1 (0.248 mg/kg), metabolite 753-A-OH (0.056 mg/kg), DM-PCA (0.086 mg/kg), DM-PAM (0.034 mg/kg) and PCA (0.032 mg/kg). In wheat straw samples (from wheat sown 120 and 365 DAT), only conjugate fractions were identified and accounted for 0.014–0.028 mg/kg and 0.13 mg/kg, respectively.

An uncertainty regarding a possible shifted ratio of isomers of penthiopyrad and 753-A-OH in rotational crops compared to primary crops was noted during the peer review (EFSA, 2013a). The experts during the peer review (EFSA, 2013a) concluded that the metabolic pattern seems to be comparable to that of primary plants and that the metabolism of penthiopyrad in rotational crops proceeds in a similar pathway as in primary crops; therefore, the same residue definitions as for primary plants are applicable (EFSA, 2013a). This conclusion is applicable to the current review.

Nature of residues in processed commodities

The effect of processing on the nature of penthiopyrad residues under standard hydrolysis conditions, such as pasteurisation, baking/brewing/boiling and sterilisation, was assessed during the peer review and it was concluded that the parent compound is hydrolytically stable (EFSA, 2013a). For metabolite 753-A-OH, no experimental data were submitted; however, based on the similarity of the structure with the parent compound, it was concluded to have the same behaviour under processing conditions (EFSA, 2013a).

The effect of processing on the nature of residues of metabolite PAM was not available in the framework of the peer review (EFSA, 2013a) and no data on the nature of metabolite PAM following processing was submitted for the current assessment. Residues of metabolite PAM are higher than 0.1 mg/kg in several crops such as spring onions, lettuces, spinach, celery, cotton seed, sorghum grain (see Appendix B.1.2.1) and the highest chronic exposure represented 52% of the ADI (see Section 3.2). Since some of these crops are (or must be) eaten cooked the effect of processing on the nature of residues of metabolite PAM should be further investigated (data gap). In the absence of such required information, the same residue definitions as for the primary crops are proposed to processed commodities on a tentative basis.

Methods of analysis in plants

Analytical methods for the determination of penthiopyrad residues in plant commodities were assessed during the peer review (United Kingdom, 2012; EFSA, 2013a). The multiresidue method DFG-S19 with LC-MS/MS determination was validated for all types of plant matrices. However, a data gap for an ILV for high oil content commodities was identified. A sufficiently validated single residue method (HPLC-MS/MS, involving hydrolysis step) with an LOQ of 0.01 mg/kg for determination of penthiopyrad in all plant matrices is also available (EFSA, 2013a).

The EURLs informed EFSA that based on successful validation data within the EURLs, penthiopyrad and metabolite PAM can be monitored in high water content, high acid content, dry (high starch) and high oil content commodities each at the default LOQ of 0.01 mg/kg (EURLs, 2020). In high water content, high acid content and dry commodities even lower levels (down to 0.002 mg/kg) were successfully validated for penthiopyrad. If needed due to toxicological constraints, the LOQ for PAM may be lowered to 0.005 mg/kg as this level was successfully validated in all the above commodity groups (EURLs, 2020).

Stability of residues in plants

The storage stability of penthiopyrad, metabolites 753-A-OH, PAM, 753-F-DO, PCA and DM-PCA was investigated in the DAR (United Kingdom, 2012) and assessed in the framework of the peer review (EFSA, 2013a). It was concluded that residues of these compounds are stable when stored at ≤ –20°C for 18 months in plant commodities with high water, high acid and high oil content as well as in dry matrices and in wheat straw.

An additional storage stability study of penthiopyrad and its metabolites 753-A-OH and PAM in sugar beet roots and tops, following seed treatment, was assessed by the RMS (Sweden, 2020). The results demonstrated that penthiopyrad, metabolites 753-A-OH and PAM are stable in sugar beet tops/leaves and root specimens for at least 18 months when stored under frozen conditions at ≤ −20°C.

Proposed residue definitions

The metabolism of penthiopyrad was similar in all crops assessed following foliar application. The metabolism in rotational crops is similar to the metabolism observed in primary crops. Data on the nature of residues of metabolite PAM representative of the standard hydrolysis conditions at processing is needed, thus the residue definitions from primary crops are proposed on a provisional basis to processed commodities (see Section 1.1.3).

As the parent compound was found to be a sufficient residue marker in all crops assessed, the residue definition for enforcement is proposed as penthiopyrad.

An analytical method for the enforcement of the proposed residue definition at the LOQ of 0.01 mg/kg in all four main plant matrices is available (EFSA, 2013a). The EURLs informed EFSA that penthiopyrad can be monitored in all plant commodities at the default LOQ of 0.01 mg/kg (EURLs, 2020). The analytical standard for penthiopyrad is commercially available (EURLs, 2020).

For risk assessment, parent, metabolite 753-A-OH and metabolite PAM are toxicologically relevant and thus should be considered in the consumer exposure. Metabolite 753-A-OH is considered covered by the toxicological profile of the parent compound (EFSA, 2013a), while metabolite PAM has different toxicological endpoints (EFSA, 2016). Therefore, two separate residue definitions for risk assessment are proposed: (1) sum of penthiopyrad and metabolite 753-A-OH, expressed as penthiopyrad and (2) metabolite PAM.

Magnitude of residues in plants Magnitude of residues in primary crops

To assess the magnitude of penthiopyrad residues resulting from the reported GAPs, EFSA considered all residue trials reported by the RMS in its evaluation report (Sweden, 2020) as well as the residue trials evaluated in the framework of the peer review (EFSA, 2013a) or in the framework of previous MRL applications (EFSA, 2012, 2016, 2020). All residue trial samples considered in this framework were stored in compliance with the conditions for which storage stability of residues was demonstrated. Decline of residues during storage of the trial samples is therefore not expected.

The number of residue trials and extrapolations were evaluated in accordance with the European guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs (European Commission, 2017).

Residue trials are not available to support the authorisations on rice grain and buckwheat grain. Therefore, MRL and risk assessment values could not be derived for these crops and the following data gaps were identified:

Rice grain: Eight trials on rice grain compliant with the import tolerance GAP are required.
Buckwheat grain: Four trials on buckwheat grain compliant with the import tolerance GAP are required.

For all other crops, available residue trials are sufficient to derive (tentative) MRL and risk assessment values, taking note of the following considerations:

Apricots: Although MRL and risk assessment values can be derived from the southern outdoor data, eight trials compliant with the import tolerance GAP are still required.
Tomatoes/aubergines: Although MRL and risk assessment values can be derived from the import tolerance data, eight trials compliant with the southern outdoor GAP would in principle be required. However, since the import tolerance GAP is clearly more critical, further residue trials are not required.
Sweet peppers: Although MRL and risk assessment values can be derived from the import tolerance data, eight trials compliant with the indoor GAP would in principle be required. However, since the import tolerance GAP is clearly more critical, further residue trials are not required.
Cucumbers, gherkins: No residue trials are available to support the northern outdoor GAP and all residue trials supporting the southern outdoor GAP were performed according to a more critical GAP. Although MRL and risk assessment values can be derived from the indoor data, further residue trials compliant with the northern/southern outdoor GAP are not required since the indoor GAP is clearly more critical.
Lamb's lettuces/corn salads, cresses and other sprouts and shoots, land cresses, Roman rocket/rucola, red mustards, baby leaf crops (including brassica species), chervil, chives: Although tentative MRL and risk assessment values can be derived from the import tolerance data, eight trials compliant with the northern outdoor GAP would in principle be required. However, since the import tolerance GAP is clearly more critical, further residue trials are not required.
Lettuces: Although tentative MRL and risk assessment values can be derived from the overdosed trials on lettuces to support the southern outdoor GAP, eight trials on lettuces compliant with the southern outdoor GAP are still required.
Barley grain: Although tentative MRL and risk assessment values can be derived from the overdosed trials on barley grain to support the southern outdoor GAP, eight trials on barley grain compliant with the southern outdoor GAP are still required.

It is underlined that all required residue trials should be performed analysing the residues according to the proposed residue definitions for enforcement and risk assessment.

Magnitude of residues in rotational crops

A field rotational crop study was available for this review (United Kingdom, 2012; EFSA, 2013a). Penthiopyrad was applied at 2 × 400 g a.s./ha to barley and cucumber (treatment of cucumbers 6 days and 1 day before harvesting; treatment of barley at 56 and 32 days before harvesting). After the removal of the primary crops, lettuce, spinach, radish, wheat and barley were sown/planted 30, 60 and 120 DALA. An additional cereal planting was conducted approximately 365 days or 402 days DALA (United Kingdom, 2012).

In mature lettuce at all plant back intervals penthiopyrad and its metabolites PAM, 753-A-OH and 753-F-DO were not observed. The only metabolites present were PCA (0.012 mg/kg (only at 30 day PBI)) and DM-PCA (< 0.05 mg/kg (30 and 122-day PBI)). In non-mature lettuce DM-PCA accounted for 0.075 mg/kg at 65-day PBI and 0.1 mg/kg at 30-day PBI. In mature spinach parent penthiopyrad accounted for < 0.01 mg/kg (32 and 62-day PBI only) and metabolite DM-PCA accounted for < 0.05 mg/kg (122 day PBI only).

In mature radish roots, only parent penthiopyrad (< 0.01 mg/kg 32-day PBI, 0.017 mg/kg 62-day PBI and < 0.01 mg/kg 122-day PBI) was observed. In radish tops, the main residue was metabolite DM-PCA, accounting for 0.049 mg/kg (65-day PBI) and 0.033 mg/kg (122-day PBI).

In wheat, neither parent penthiopyrad nor metabolites PAM, 753-A-OH or 753-F-DO were present in any plant fraction (whole plant, hay, straw and grain) at any plant back intervals. In wheat grain, minor amounts of metabolite DM-PCA were observed (< 0.05 mg/kg at 65-day PBI). In wheat straw, metabolite DM-PCA was present at all plant back intervals ranging from < 0.05 mg/kg (366-day PBI) to 0.15 mg/kg (65-day PBI); metabolite PCA in straw was only present at 65-day PBI (< 0.05 mg/kg).

In barley, the only metabolites present were PCA (< 0.05 mg/kg in barley hay 32-day PBI) and DM-PCA (< 0.05 mg/kg in barley straw 402-day PBI). No other metabolites were identified in barley fractions.

In edible fractions, the only significant levels of residues were observed in mature radish roots, where parent penthiopyrad was present at 0.017 mg/kg at 62 days PBI, then decreasing to levels below 0.01 mg/kg at 122 days PBI.

DM-PCA was the only metabolite occurring at quantifiable levels in feed items (wheat straw and barley straw). However, residue levels in wheat straw were low (around 0.05 mg/kg) when compared to the contribution from primary crops (highest residue in barley straw from primary crops is 4.7 mg/kg).

Based on the study results, residues of parent and metabolites above 0.01 mg/kg cannot be excluded in rotational crops. Moreover, the rotational crop field study was performed with a total rate of 800 g a.s./ha, which is lower than the application rate of some GAPs currently authorised (e.g. tomatoes, aubergine, cucumbers, indoor), while no information on the residue levels in the tested soil is available. Therefore, the present study may not cover the concentrations of penthiopyrad and relevant persistent metabolites in soil following annual and multiannual applications according to the most critical GAPs currently authorised. Consequently, rotational crops field trials covering the PEC soil accumulation for penthiopyrad and its persistent soil metabolites and calculated based on the most critical GAPs currently authorised are required. These trials should determine the magnitude of the residues of penthiopyrad, 753-A-OH, PAM, PCA and DM-PCA in representative rotational crops at the standard plant back intervals. In the meanwhile, Member States granting authorisations for penthiopyrad should take the appropriate risk mitigation measures (e.g. define plant back interval) in order to avoid the presence of significant residues in rotational crops.

Magnitude of residues in processed commodities

The effect of industrial processing and/or household preparation was assessed on studies conducted on sugar beet, potato, soybean, plum, maize, rape seed, peanuts, apples, tomatoes, wheat and barley (EFSA, 2012; United Kingdom, 2012). Raw commodities and their processed fractions were analysed for penthiopyrad and its metabolites 753-A-OH, DM-PCA, 753-F-DO, PCA and PAM.

An overview of all available processing studies is available in Appendix B.1.2.3. For penthiopyrad, robust processing factors (fully supported by data) could be derived for processed commodities from apples, tomatoes, melons and rapeseed, while limited processing factors (not fully supported by data) were derived for processed commodities from plums, potatoes, peanuts, soyabeans, barley, maize, wheat and sugar beet.

For metabolite PAM, a data gap was identified to investigate the potential metabolites formed under standard hydrolysis conditions. Therefore, only tentative processing factors could be derived for processed commodities from apples, tomatoes, melons, rapeseed, plums, potatoes, peanuts, soyabeans, barley, maize, wheat and sugar beet.

Further processing studies are not required as they are not expected to affect the outcome of the risk assessment. However, if more robust processing factors were to be required by risk managers for enforcement purposes, additional processing studies would be needed.

Proposed MRLs

The available data are considered sufficient to derive (tentative) MRL proposals as well as risk assessment values for all commodities under evaluation, except for rice grain and buckwheat grain.

Tentative MRLs were also derived for feed crops (e.g. cereal straw, sugar beet tops) in view of the future need to set MRLs in feed items.

Specific MRLs for rotational crops are not needed, provided that Member States will take adequate risk mitigation measures (e.g. define plant back interval) in order to avoid significant residues to occur in rotational crops.

Residues in livestock

Penthiopyrad is authorised for use on crops that might be fed to livestock. Livestock dietary burden calculations were therefore performed for different groups of livestock according to OECD guidance (OECD, 2013), which has now also been agreed upon at European level. The input values for all relevant commodities are summarised in Appendix D. The dietary burdens calculated for all groups of livestock were found to exceed the trigger value of 0.1 mg/kg DM. Behaviour of residues was therefore assessed in all commodities of animal origin.

Nature of residues and methods of analysis in livestock

The metabolism of penthiopyrad residues in livestock was investigated in two studies on lactating goats and two studies on laying hens at dose rate covering the maximum dietary burdens calculated in this review (United Kingdom, 2012). These studies were assessed in the framework of the peer review (EFSA, 2013a) and in a previous MRL assessment (EFSA, 2012).

In the first poultry study, hens were orally given capsules twice per day for 14 consecutive days at a target dose level of 12 mg/kg diet per day (equivalent to 0.82 mg/kg bw per day). The study indicated that main residues were parent penthiopyrad and metabolites PCA and PAM, however since numerous metabolites were not characterised, a second study was conducted (EFSA, 2012). In the second study, hens were dosed for 7 consecutive days at a target dose level of 10.5 mg/kg diet per day (corresponding to 0.82–0.85 mg/kg bw per day). The TRR was highest in liver (0.244–0.345 mg eq./kg), followed by the whole egg (0.035–0.042 mg eq./kg), muscle (0.014–0.022 mg eq./kg) and fat (0.014–0.02 mg eq./kg). The available metabolism studies with laying hens indicate that the main residue in edible tissues and eggs was metabolite PAM while parent penthiopyrad was present in trace amounts in egg yolk and fat. The metabolism studies in poultry give no indication that the residues are accumulating in fat.

In the first metabolism study with ruminants, goats were dosed with 21.8 and 14.6 mg/kg diet, equivalent to 0.62 mg/kg bw per day and 0.41 mg/kg bw per day, respectively, for 14 days (United Kingdom, 2012). Plateau in milk was reached after 3–4 days of dosing and no bioaccumulation was observed in muscle or fat. Metabolite PAM (30.6% TRR; 0.019 mg/kg) was the only identified component above 0.01 mg/kg in milk, while penthiopyrad was not detected in milk. The major component in fat was penthiopyrad (> 32% TRR). In muscle, the major residue was metabolite PAM, accounting for 52% TRR (0.019 mg/kg). A second study was performed in order to further elucidate the metabolic pathway and the nature of residues in liver and kidney which was not fully conclusive from the first study. In the second study, goats were dosed with 10 mg/kg diet per day (0.73–0.8 mg/kg bw per day) for 5 consecutive days. Plateau was reached in milk on day 3 and 4 of dosing. In milk, the main metabolite was PAM (30.2% TRR; 0.013 mg/kg). In edible tissues, highest amounts for both radiolabels were detected in liver (0.737 and 0.657 mg eq./kg) and kidney (0.151 and 0.168 mg eq./kg). In muscle and fat, the TRR accounted for less than 0.03 mg eq./kg. Both studies with goat indicate a similar metabolic pattern and distribution of residues. Penthiopyrad was observed in trace amounts in liver, kidney and fat. The major residue in edible tissues and milk was metabolite PAM. In the liver, a large number of cysteine conjugates of 753-T-DO and 753-F-DO were present (EFSA, 2012; United Kingdom, 2012).

During the peer review, it was noted that the metabolism of PAM in livestock was not investigated separately, however since this metabolite was formed during the metabolism of penthiopyrad in animal matrices, it was concluded that the metabolism in livestock is covered by the studies performed with the parent compound (EFSA, 2013a).

EFSA concludes that the metabolism of penthiopyrad in livestock is adequately elucidated, and that penthiopyrad and metabolite PAM are the most relevant components of the residues in commodities of animal origin.

The analytical method DFG-S19 was fully validated for the determination of penthiopyrad and metabolite PAM in milk, egg, bovine meat and liver with an LOQ of 0.01 mg/kg per each analyte (EFSA, 2013a). However, a study to address the extraction efficiency was required and validation (including ILV) for fat was required (EFSA, 2013a). In addition, a single method HPLC-MS/MS (with hydrolysis step) was validated for the determination of penthiopyrad and metabolite PAM in milk, eggs, muscle, fat and liver with an LOQ of 0.01 mg/kg for each analyte (EFSA, 2013a). The EURLs informed EFSA that based on screening data, penthiopyrad can be monitored in milk, muscle and honey at the default LOQ of 0.01 mg/kg and that the default LOQ of 0.01 mg/kg should be also achievable for other animal products (e.g. liver, kidney, fat). Based on successful validation data within the EURLs, it is concluded that metabolite PAM can be monitored in liver and milk at the default LOQ of 0.01 mg/kg, and if needed due to toxicological constraints, the LOQ for PAM may be lowered to 0.005 mg/kg (EURLs, 2020). Furthermore, the default LOQ of 0.01 (or 0.005) mg/kg would be also achievable for other animal products (e.g. eggs, kidney, fat). It is noted that the analytical standards for penthiopyrad and metabolite PAM are commercially available (EURLs, 2020).

The storage stability in poultry tissues was investigated in parallel of the feeding study (EFSA, 2012; United Kingdom, 2012). Storage stability of penthiopyrad and metabolites PAM, PCA and 753-A-OH was demonstrated at –20°C for a period of 1 month, which corresponds to the period for which study samples were stored prior to analysis (United Kingdom, 2012). Residues of penthiopyrad and metabolites PAM, PCA and 753-A-OH were found to be stable at -18°C for a period of 181 days in milk (United Kingdom, 2012, 2013). Storage stability tests were not performed for bovine muscle, kidney, liver and fat as samples were analysed within 30 days.

As penthiopyrad and metabolite PAM were found to be good markers in livestock commodities, the residue definition for enforcement is proposed as penthiopyrad and metabolite PAM (EFSA, 2013a).

For risk assessment, parent and metabolite PAM are toxicologically relevant and thus should be considered in the consumer exposure. Metabolite PAM has different toxicological reference values than parent penthiopyrad; therefore, two residue definitions for risk assessment are proposed: (1) penthiopyrad and (2) metabolite PAM.

Magnitude of residues in livestock

Feeding studies were performed with dairy cows and laying hens (United Kingdom, 2012) and assessed in the framework of the peer review (EFSA, 2013a). In these studies, penthiopyrad was administered using different dosing levels ranging from 0.15 to 1.65 mg/kg bw per day in lactating cows and 0.4 to 4 mg/kg bw per day in laying hens.

The studies were used to derive MRL and risk assessment values in tissues of ruminants and poultry, milk and eggs. Since extrapolation from ruminants to pigs is acceptable, results of the livestock feeding study on ruminants were relied upon to derive the MRL and risk assessment values in pigs. In this study, samples of tissues, eggs and milk were analysed for penthiopyrad and metabolites PAM, PCA and 753-A-OH. The storage period of the samples was covered by the conditions for which storage stability was demonstrated thus decline of residues during storage of the trial samples is not expected.

Laying hens were dosed at the levels of 0.4, 1.2 and 4 mg/kg/bw for 28 days (corresponding to 5.85, 17.54 and 58.46 mg/kg DM), representing 4N, 11N and 40N of the maximum dietary burden for poultry layer. In eggs, metabolite PAM was quantified in all doses at levels ranging from 0.011 to 0.028 mg/kg. Penthiopyrad was present at concentrations ranging from 0.01 to 0.016 mg/kg. Metabolite 753-A-OH was measurable in 0.01–0.014 mg/kg (EFSA, 2012). Metabolite PCA was not detected in any sample. In liver only at the highest feeding dose levels, residues were detected. Parent penthiopyrad accounted for a maximum of 0.021 mg/kg and PAM for a maximum of 0.019 mg/kg. In muscle, only metabolite PAM was identified and at the highest dose level only (0.01 mg/kg). In skin (with fat) and abdominal fat parent penthiopyrad was detected at the highest dose only, accounting for a maximum of 0.018 mg/kg and of 0.036 mg/kg, respectively.

Dairy cows were dosed at levels of 0.15, 0.48 and 1.65 mg/kg bw per day for 28 consecutive days (corresponding to 8.4, 24.1 and 74.6 mg/kg dry matter), representing 0.8N, 2.5N and 9.5N of the maximum dietary burden estimated for dairy cattle. No measurable residues of penthiopyrad or metabolites PAM, PCA and 753-A-OH were found in milk, skim milk, cream, muscle, liver, kidney or fat samples for the lowest dose level (EFSA, 2012). At higher dose, residues of penthiopyrad were found in liver at up to 0.03 mg/kg and fat (up to 0.02 mg/kg), while metabolite PAM was found in liver (up to 0.06 mg/kg), kidney (up to 0.03 mg/kg), milk (up to 0.02 mg/kg) and fat (up to 0.02 mg/kg). All residues of penthiopyrad and PAM were eliminated within 7 days after withdrawal from the dosed feed (EFSA, 2012).

In all animal matrices, penthiopyrad and its metabolites were below 0.01 mg/kg at the feeding level closest to the expected maximum dietary burden. Therefore, penthiopyrad-related residues above the LOQ are unlikely to occur in animal products and MRLs can be proposed at the level of the LOQ (0.01 mg/kg).

Consumer risk assessment

In the framework of this review, only the uses of penthiopyrad reported in Appendix A were considered; however, the use of penthiopyrad was previously also assessed by the JMPR (FAO, 2012). The CXLs, resulting from these assessments by JMPR and adopted by the CAC, are now international recommendations that need to be considered by European risk managers when establishing MRLs. To facilitate consideration of these CXLs by risk managers, the consumer exposure was calculated both with and without consideration of the existing CXLs. It is noted that an EU reservation was made for the CXLs for products of animal origin, flowering brassicas, stone fruits and leafy vegetables (EC Reg 491/2014 and EC Reg 2015/845). Therefore, these CXLs were not considered in the assessment.

Consumer risk assessment for penthiopyrad Consumer risk assessment without consideration of the existing CXLs

Chronic and acute exposure calculations for all crops reported in the framework of this review were performed using revision 3.1 of the EFSA PRIMo (EFSA, 2018, 2019). Input values for the exposure calculations were derived in compliance with the decision tree reported in Appendix E. Hence, for those commodities where a (tentative) MRL could be derived by EFSA in the framework of this review, input values were derived according to the internationally agreed methodologies (FAO, 2009). For those commodities where data were insufficient to derive an MRL in Section 1, EFSA considered the existing EU MRL for an indicative calculation. A peeling factor (PF = 0.014) was applied to all cucurbits with inedible peel. Conversion factors from enforcement to risk assessment were derived (see Table B.1.2.1). It should be noted that the potential uptake of penthiopyrad and of the persistent soil metabolites from previous applications in crops that can be grown in rotation was not considered in this consumer risk assessment. All input values included in the exposure calculations are summarised in Appendix D.

The exposure values calculated were compared with the toxicological reference values for penthiopyrad, derived by EFSA (2013a). The highest chronic exposure was calculated for the Dutch toddler, representing 10% of the acceptable daily intake (ADI), and the highest acute exposure was calculated for lettuces representing 57% of the ARfD. Although (major) uncertainties remain due to the data gaps identified in the previous sections, this indicative exposure calculation did not indicate a risk to consumer's health.

Consumer risk assessment with consideration of the existing CXLs

To include the CXLs in the calculations of the consumer exposure, CXLs were compared with the EU MRL proposals in compliance with Appendix E and all data relevant to the consumer exposure assessment have been collected from JMPR evaluations. The residue definition for enforcement of the CXLs is penthiopyrad only. However, the CXL residue definition for the estimation of dietary intake for plant and animal commodities is sum of penthiopyrad and 1-methyl-3-trifluoromethyl-1H-pyrazole-4-carboxamide (PAM), expressed as penthiopyrad. In the JMPR evaluation (FAO, 2012), residues are expressed as penthiopyrad only and sum of penthiopyrad and PAM. For the EU, two separate definitions for risk assessment of residues in plant commodities are proposed (1) sum of penthiopyrad and metabolite 753 A-OH, expressed as penthiopyrad and (2) metabolite PAM. For azarole and kaki, the CF from enforcement to risk assessment as derived by EFSA in the previous output for pome fruits (EFSA, 2020) was applied to the input value of penthiopyrad. For baby leaf crops, since metabolite 753 A-OH was below the LOQ of 0.01 mg/kg in the residue trials analysed for parent and metabolite, the CF of 1 was used. For the remaining CXLs, the data from a previous EFSA output (EFSA, 2012) and from the RMS evaluation report (Sweden, 2020), which were supported by the same residue data set in the JMPR assessment (FAO, 2012), was used. A peeling factor (PF = 0.014) was applied to all cucurbits with inedible peel. Conversion factors from enforcement to risk assessment were derived (see Table B.1.2.1). It should be noted that the potential uptake of penthiopyrad from previous applications in crops that can be grown in rotation was not considered in this consumer risk assessment. An overview of the input values used for this exposure calculation is also provided in Appendix D.

The exposure values calculated were compared with the toxicological reference values for penthiopyrad, derived by EFSA (2013a). The highest chronic exposure was calculated for the Dutch toddler, representing 10% of the acceptable daily intake (ADI), and the highest acute exposure was calculated for lettuces representing 57% of the ARfD. Although (major) uncertainties remain due to the data gaps identified for a certain number of these CXLs, this indicative exposure calculation did not indicate a risk to consumers’ health.

Consumer risk assessment of metabolite PAM

The consumer dietary intake calculations were performed using the toxicological reference values specifically derived for metabolite PAM (EFSA, 2016) and risk assessment values derived from the current review. It is highlighted that EFSA was mandated for the assessment of the toxicological profile of metabolite PAM which is currently on going and that the chronic and acute dietary intake calculations to PAM residues might need to be reconsidered depending on the outcome of this assessment (European Commission, 2021).

Residues of metabolite PAM assessed in this review and previous MRL application (EFSA, 2012; United Kingdom, 2012) were used in the calculations as well residues of metabolite PAM which are associated to the CXLs of penthiopyrad assessed by JMPR (FAO, 2012) were considered for these calculations. For baby leaf crops and common millet, residue data for metabolite PAM available in a previous MRL application (EFSA, 2012; United Kingdom, 2012) were used in the calculations. For azaroles/kaki the residue data available by the JMPR (FAO, 2012) were recalculated to obtain the input values for PAM (EFSA, 2020). For all the other crops, risk assessment values derived from either EU or import tolerances GAPs were used in the calculations. For commodities where data were insufficient, EFSA considered the existing EU MRL of penthiopyrad for an indicative and conservative calculation. A tentative peeling factor (PF = 0.24) was applied to all cucurbits with inedible peel. It should be noted that the potential uptake of metabolite PAM from previous applications in crops that can be grown in rotation was not considered in this consumer risk assessment. An overview of the input values used for this exposure calculation is provided in Appendix D.4.

The exposure values calculated were compared with the toxicological reference values for metabolite PAM derived by EFSA (2016). The highest chronic exposure was calculated for the Dutch toddler, representing 52% of the acceptable daily intake (ADI), and the highest acute exposure was calculated for leeks representing 63% of the ARfD. Although (major) uncertainties remain due to the data gaps identified in the previous sections for metabolite PAM, this indicative exposure calculation did not indicate a risk to consumers’ health.

Conclusions

The metabolism of penthiopyrad in plants was investigated in primary and rotational crops. There was no preferential isomeric degradation in plant commodities. According to the results of the metabolism studies, the residue definition for enforcement is proposed as penthiopyrad while for risk assessment two residue definitions are proposed: (1) sum of penthiopyrad and metabolite 753-A-OH, expressed as penthiopyrad and (2) metabolite PAM. Pending the submission of the outstanding data on the nature of metabolite PAM upon processing, the same residue definitions as derived for primary crops are proposed, on a provisional basis, to processed commodities. Fully validated analytical methods are available for the enforcement of the proposed residue definition in all matrices at the LOQ of 0.01 mg/kg. According to the EURLs the LOQ of 0.01 mg/kg is achievable in routine analyses.

Penthiopyrad is authorised for use on crops that might be fed to livestock. Livestock dietary burden calculations were therefore performed for different groups of livestock according to OECD guidance. The dietary burdens calculated for all groups of livestock were found to exceed the trigger value of 0.1 mg/kg DM. Behaviour of residues was therefore assessed in all commodities of animal origin.

The metabolism of penthiopyrad residues in livestock was investigated in lactating goats and laying hens at dose rate covering the maximum dietary burdens calculated in this review. There was no preferential isomeric degradation in animal commodities. According to the results of these studies, the residue definitions for enforcement and risk assessment in livestock commodities are proposed as (1) penthiopyrad and (2) metabolite PAM. An analytical method for the enforcement of the proposed residue definition at the LOQ of 0.01 mg/kg in all matrices is available. According to the EURLs the LOQ of 0.01 is achievable by using the QuEChERS method in routine analyses.

Recommendations

MRL recommendations were derived in compliance with the decision tree reported in Appendix E of the reasoned opinion (see Table 2). All MRL values listed as ‘Recommended’ in the table are sufficiently supported by data and are therefore proposed for inclusion in Annex II to the Regulation. The remaining MRL values listed in the table are not recommended for inclusion in Annex II because they require further consideration by risk managers (see Table 2 footnotes for details). In particular, some tentative MRLs and/or existing EU MRL need(s) to be confirmed by the following data:

8 additional residue trials supporting the SEU outdoor GAP on lettuces;
8 additional residue trials supporting the SEU outdoor GAP on barley grain;
8 residue trials supporting the import tolerance GAP on rice grain;
4 residue trials supporting the import tolerance GAP on buckwheat;
a representative study investigating the nature of residues of metabolite PAM upon hydrolysis.

It is underlined that all required residue trials should be performed analysing the residues according to the proposed residue definitions for enforcement and risk assessment.

It is highlighted, however, that some of the MRLs were derived from a GAP in one climatic zone only, whereas other GAPs reported by the RMS were not fully supported by data. EFSA therefore identified the following data gaps which are not expected to impact on the validity of the MRLs derived but which might have an impact on national authorisations:

8 additional residue trials supporting the import tolerance on apricots;
Rotational crops field trials covering the PEC soil accumulation for penthiopyrad and its persistent soil metabolites and calculated based on the most critical GAPs currently authorised. These trials should determine the magnitude of the residues of penthiopyrad, metabolites 753-A-OH, PAM, PCA and DM-PCA in representative rotational crops at the standard plant back intervals.

If the above reported data gaps are not addressed in the future, Member States are recommended to withdraw or modify the relevant authorisations at national level.

EFSA also underlines that, according to the information provided by the EURLs, the analytical standard for penthiopyrad and metabolite PAM are commercially available (EURLs, 2020).

Minor deficiencies were also identified in the assessment, but these deficiencies are not expected to impact either on the validity of the MRLs derived or on the national authorisations. The following data is therefore considered desirable but not essential:

an ILV for the method DFG-S19 for the analysis of penthiopyrad in high oil content commodities.

Table 2 Summary table

Code number	Commodity	Existing EU MRL (mg/kg)	Existing CXL (mg/kg)	Outcome of the review
				MRL (mg/kg)	Comment
Enforcement residue definition: penthiopyrad
120010	Almonds	0.05	0.05	0.05	Recommendeda
120020	Brazil nuts	0.05	0.05	0.05	Recommendeda
120030	Cashew nuts	0.05	0.05	0.05	Recommendeda
120040	Chestnuts	0.05	0.05	0.05	Recommendeda
120050	Coconuts	0.05	0.05	0.05	Recommendeda
120060	Hazelnuts	0.05	0.05	0.05	Recommendeda
120070	Macadamia	0.05	0.05	0.05	Recommendeda
120080	Pecans	0.05	0.05	0.05	Recommendeda
120090	Pine nuts	0.05	0.05	0.05	Recommendeda
120100	Pistachios	0.05	0.05	0.05	Recommendeda
120110	Walnuts	0.05	0.05	0.05	Recommendeda
130010	Apples	0.5	0.4	0.5	Recommendeda
130020	Pears	0.5	0.4	0.5	Recommendeda
130030	Quinces	0.5	0.4	0.5	Recommendeda
130040	Medlar	0.5	0.4	0.5	Recommendeda
130050	Loquat	0.5	0.4	0.5	Recommendeda
140010	Apricots	4	4	3	Recommendedb
140020	Cherries	4	4	4	Recommendedb
140030	Peaches	4	4	3	Recommendedb
140040	Plums	1.5	4	1.5	Recommendedb
152000	Strawberries	3	3	3	Recommendeda
154070	Azarole (mediterranean medlar)	0.4	0.4	0.4	Recommendedc
161060	Kaki/Japanese persimmons	0.4	0.4	0.4	Recommendedc
211000	Potatoes	0.05	0.05	0.05	Recommendedd
212020	Sweet potatoes	0.04	–	0.04	Recommendede
213010	Beetroot	0.6	–	0.6	Recommendede
213020	Carrots	0.6	0.6	0.6	Recommendeda
213040	Horseradish	0.6	–	0.6	Recommendede
213050	Jerusalem artichokes	0.6	–	0.6	Recommendede
213060	Parsnips	0.6	–	0.6	Recommendede
213070	Parsley root	0.6	–	0.6	Recommendede
213080	Radishes	3	3	3	Recommendeda
213100	Swedes	0.6	–	0.6	Recommendede
213110	Turnips	0.6	–	0.6	Recommendede
220010	Garlic	0.8	–	0.8	Recommendede
220020	Onions	0.8	0.7	0.8	Recommendeda
220030	Shallots	0.8	–	0.8	Recommendede
220040	Spring onions	4	4	4	Further consideration neededf. Data gap #5
231010	Tomatoes	2	2	2	Recommendeda
231020	Peppers	2	2	2	Recommendeda
231030	Aubergines (egg plants)	2	2	2	Recommendeda
231040	Okra, lady's fingers	2	2	2	Recommendeda
232010	Cucumbers	0.7	0.5	0.7	Recommendeda
232020	Gherkins	0.7	0.5	0.7	Recommendeda
232030	Courgettes	0.7	0.5	0.7	Recommendeda
233010	Melons	0.6	0.5	0.6	Recommendeda
233020	Pumpkins	0.6	0.5	0.6	Recommendeda
233030	Watermelons	0.6	0.5	0.6	Recommendeda
234000	Sweet corn	0.02	0.02	0.02	Recommendedd
241010	Broccoli	4	5	4	Recommendedb
241020	Cauliflower	4	5	4	Recommendedb
242020	Head cabbage	4	4	4	Recommendeda
251010	Lamb's lettuce	15	30	20	Further consideration neededg. Data gap #5
251020	Lettuce	15	30	20	Further consideration neededg. Data gaps # 1 and #5
251040	Cress	15	30	20	Further consideration neededg. Data gap #5
251050	Land cress	15	30	20	Further consideration neededg. Data gap #5
251060	Rocket, Rucola	15	30	20	Further consideration neededg. Data gap #5
251070	Red mustard	15	30	20	Further consideration neededg. Data gap #5
251080	Leaves and sprouts of Brassica spp	50	50	50	Further consideration neededf. Data gap #5
252010	Spinach	30	30	30	Further consideration neededg. Data gap #5
252020	Purslane	30	30	30	Further consideration neededg. Data gap #5
252030	Beet leaves (chard)	30	30	30	Further consideration neededg. Data gap #5
256010	Chervil	20	30	20	Further consideration neededg. Data gap #5
256020	Chives	0.01*	–	20	Further consideration neededh. Data gap #5
260010	Beans (fresh, with pods)	3	3	3	Recommendeda
260020	Beans (fresh, without pods)	0.4	0.3	0.4	Recommendeda
260030	Peas (fresh, with pods)	4	3	4	Recommendeda
260040	Peas (fresh, without pods)	0.3	0.3	0.3	Recommendeda
270020	Cardoons	15	–	20	Further consideration neededh. Data gap #5
270030	Celery	15	15	15	Further consideration neededa. Data gap #5
270040	Fennel	15	–	15	Further consideration neededh. Data gap #5
270060	Leek	3	–	3	Further consideration neededh. Data gap #5
270070	Rhubarb	15	–	15	Further consideration neededh. Data gap #5
300010	Beans (dry)	0.3	0.3	0.3	Recommendedd
300020	Lentils (dry)	0.3	0.3	0.3	Recommendedd
300030	Peas (dry)	0.3	0.3	0.3	Recommendedd
300040	Lupins (dry)	0.3	0.3	0.3	Recommendedd
401020	Peanuts	0.05	0.05	0.05	Recommendedd
401050	Sunflower seed	1.5	1.5	1.5	Recommendeda
401060	Rape seed	0.5	0.5	0.5	Recommendeda
401070	Soya bean	0.3	0.3	0.3	Recommendeda
401090	Cotton seed	0.5	0.5	0.5	Further consideration neededi. Data gap #5
500010	Barley grain	0.3	0.2	0.4	Further consideration neededi. Data gap # 2
500020	Buckwheat grain	0.01*	–	0.01*	Further consideration neededj. Data gap # 4
500030	Maize grain	0.01	0.01	0.01*	Recommendeda
500040	Millet grain	0.8	0.8	0.8	Recommendedd
500050	Oats grain	0.3	0.2	0.2	Recommendeda
500060	Rice grain	0.01*	–	0.01*	Further consideration neededj. Data gap # 3
500070	Rye grain	0.1	0.1	0.15	Recommendeda
500080	Sorghum grain	0.8	0.8	0.8	Further consideration neededi. Data gap #5
500090	Wheat grain	0.1	0.1	0.15	Recommendeda
900010	Sugar beet (root)	0.5	0.5	0.5	Recommendedd
1011010	Swine meat	0.01*	0.04	0.01*	Recommendedb
1011020	Swine fat (free of lean meat)	0.01*	0.05	0.01*	Recommendedb
1011030	Swine liver	0.01*	0.08	0.01*	Recommendedb
1011040	Swine kidney	0.01*	0.08	0.01*	Recommendedb
1012010	Bovine meat	0.01*	0.04	0.01*	Recommendedb
1012020	Bovine fat	0.01*	0.05	0.01*	Recommendedb
1012030	Bovine liver	0.01*	0.08	0.01*	Recommendedb
1012040	Bovine kidney	0.01*	0.08	0.01*	Recommendedb
1013010	Sheep meat	0.01*	0.04	0.01*	Recommendedb
1013020	Sheep fat	0.01*	0.05	0.01*	Recommendedb
1013030	Sheep liver	0.01*	0.08	0.01*	Recommendedb
1013040	Sheep kidney	0.01*	0.08	0.01*	Recommendedb
1014010	Goat meat	0.01*	0.08	0.01*	Recommendedb
1014020	Goat fat	0.01*	0.08	0.01*	Recommendedb
1014030	Goat liver	0.01*	0.08	0.01*	Recommendedb
1014040	Goat kidney	0.01*	0.08	0.01*	Recommendedb
1015010	Horse meat	0.01*	0.04	0.01*	Recommendedb
1015020	Horse fat	0.01*	0.05	0.01*	Recommendedb
1015030	Horse liver	0.01*	0.08	0.01*	Recommendedb
1015040	Horse kidney	0.01*	0.08	0.01*	Recommendedb
1016010	Poultry meat	0.01*	0.03	0.01*	Recommendedb
1016020	Poultry fat	0.01*	0.03	0.01*	Recommendedb
1016030	Poultry liver	0.01*	0.03	0.01*	Recommendedb
1020010	Cattle milk	0.01*	0.03	0.01*	Recommendedb
1020020	Sheep milk	0.01*	0.04	0.01*	Recommendedb
1020030	Goat milk	0.01*	0.04	0.01*	Recommendedb
1020040	Horse milk	0.01*	0.04	0.01*	Recommendedb
1030000	Birds’ eggs	0.01*	0.03	0.01*	Recommendedb
Enforcement residue definition 2: metabolite PAM
1011010	Swine meat	–	–	0.01*	Recommendede
1011020	Swine fat (free of lean meat)	–	–	0.01*	Recommendede
1011030	Swine liver	–	–	0.01*	Recommendede
1011040	Swine kidney	–	–	0.01*	Recommendede
1012010	Bovine meat	–	–	0.01*	Recommendede
1012020	Bovine fat	–	–	0.01*	Recommendede
1012030	Bovine liver	–	–	0.01*	Recommendede
1012040	Bovine kidney	–	–	0.01*	Recommendede
1013010	Sheep meat	–	–	0.01*	Recommendede
1013020	Sheep fat	–	–	0.01*	Recommendede
1013030	Sheep liver	–	–	0.01*	Recommendede
1013040	Sheep kidney	–	–	0.01*	Recommendede
1014010	Goat meat	–	–	0.01*	Recommendede
1014020	Goat fat	–	–	0.01*	Recommendede
1014030	Goat liver	–	–	0.01*	Recommendede
1014040	Goat kidney	–	–	0.01*	Recommendede
1015010	Horse meat	–	–	0.01*	Recommendede
1015020	Horse fat	–	–	0.01*	Recommendede
1015030	Horse liver	–	–	0.01*	Recommendede
1015040	Horse kidney	–	–	0.01*	Recommendede
1016010	Poultry meat	–	–	0.01*	Recommendede
1016020	Poultry fat	–	–	0.01*	Recommendede
1016030	Poultry liver	–	–	0.01*	Recommendede
1020010	Cattle milk	–	–	0.01*	Recommendede
1020020	Sheep milk	–	–	0.01*	Recommendede
1020030	Goat milk	–	–	0.01*	Recommendede
1020040	Horse milk	–	–	0.01*	Recommendede
1030000	Birds’ eggs	–	–	0.01*	Recommendede
-	Other commodities of plant and/or animal origin	See Reg. 2015/845	–	-	Further consideration neededk

MRL: maximum residue level; CXL: codex maximum residue limit.

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

^aMRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to consumers is identified; existing CXL is covered by the recommended MRL (combination H-III in Appendix E).

^bMRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to consumers is identified; CXL was not considered further due to reservations raised by the EU delegation (combination H-II in Appendix E).

^cMRL is derived from the existing CXL, which is supported by data and for which no risk to consumers is identified; there are no relevant authorisations or import tolerances reported at EU level (combination A-VII in Appendix E).

^dMRL is derived from the existing CXL, which is supported by data and for which no risk to consumers is identified; GAP evaluated at EU level, which is also fully supported by data, leads to a lower MRL (combination H-VII in Appendix E).

^eMRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to consumers is identified; no CXL is available (combination H-I in Appendix E).

^fMRL is derived from the existing CXL, which is not sufficiently supported by data but for which no risk to consumers is identified (assuming the existing residue definition); GAP evaluated at EU level, which is also not fully supported by data, would lead to a lower tentative MRL (combination F-V in Appendix E).

^gTentative MRL is derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk to consumers was identified (assuming the existing residue definition); CXL was not considered further due to reservations raised by the EU delegation (combination F-II in Appendix E).

^hTentative MRL is derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk to consumers was identified (assuming the existing residue definition); no CXL is available (combination F-I in Appendix E).

ⁱTentative MRL is derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk to consumers was identified (assuming the existing residue definition); existing CXL is covered by the tentative MRL (combination F-III in Appendix E).

^jGAP evaluated at EU level is not supported by data but no risk to consumers was identified for the existing EU MRL (also assuming the existing residue definition); no CXL is available (combination D-I in Appendix E).

^kThere are no relevant authorisations or import tolerances reported at EU level; no CXL is available. Either a specific LOQ or the default MRL of 0.01 mg/kg may be considered (combination A-I in Appendix E).

Notes:

¹Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC. OJ L 70, 16.3.2005, p. 1–16.

²Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. OJ L 230, 19.8.1991, p. 1–32. Repealed by Regulation (EC) No 1107/2009.

³Commission Implementing Regulation (EU) No 1187/2013 of 21 November 2013 approving the active substance penthiopyrad, in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. OJ L 313, 22.11.2013, p. 42–46.

⁴Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. OJ L 309, 24.11.2009, p. 1–50.

⁵Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances. OJ L 153, 11.6.2011, p. 1–186.

⁶Commission Implementing Regulation (EU) No 541/2011 of 1 June 2011 amending Implementing Regulation (EU) No 540/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances. OJ L 153, 11.6.2011, p. 187–188.

⁷Commission Regulation (EU) No 188/2011 of 25 February 2011 laying down detailed rules for the implementation of Council Directive 91/414/EEC as regards the procedure for the assessment of active substances which were not on the market 2 years after the date of notification of that Directive. OJ No L 53, 26.2.2011, p. 51–55.

⁸The United Kingdom withdrew from EU on 1 February 2020. In accordance with the Agreement on the Withdrawal of the United Kingdom from the EU, and with the established transition period, the EU requirements on data reporting also apply to the United Kingdom data collected until 31 December 2020.

⁹Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products. OJ L 155, 11.06.2011, p. 127–175.

Abbreviations

a.i.
active ingredient

a.s.
active substance

ADI
acceptable daily intake

AR
applied radioactivity

ARfD
acute reference dose

BBCH
growth stages of mono- and dicotyledonous plants

BVL
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, Germany

bw
body weight

CAC
Codex Alimentarius Commission

CAS
Chemical Abstract Service

CCPR
Codex Committee on Pesticide Residues

CF
conversion factor for enforcement residue definition to risk assessment residue definition

CIRCA
(EU) Communication & Information Resource Centre Administrator

CS
capsule suspension

CV
coefficient of variation (relative standard deviation)

CXL
codex maximum residue limit

DALA
days after last application

DAR
draft assessment report

DAT
days after treatment

DB
dietary burden

DM
dry matter

DP
dustable powder

DS
powder for dry seed treatment

DT₉₀
period required for 90% dissipation (define method of estimation)

EC
emulsifiable concentrate

EDI
estimated daily intake

EMS
evaluating Member State

eq
residue expressed as a.s. equivalent

EURLs
European Union Reference Laboratories for Pesticide Residues (former CRLs)

FAO
Food and Agriculture Organization of the United Nations

FID
flame ionisation detector

GAP
Good Agricultural Practice

GC
gas chromatography

GC-FID
gas chromatography with flame ionisation detector

GC-MS
gas chromatography with mass spectrometry

GC-MS/MS
gas chromatography with tandem mass spectrometry

GS
growth stage

HPLC
high-performance liquid chromatography

HPLC-MS
high-performance liquid chromatography with mass spectrometry

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

ISO
International Organisation for Standardization

IUPAC
International Union of Pure and Applied Chemistry

JMPR
Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Expert Group on Pesticide Residues (Joint Meeting on Pesticide Residues)

LC
liquid chromatography

LC–MS/MS
liquid chromatography with tandem mass spectrometry

LOQ
limit of quantification

Mo
monitoring

MRL
maximum residue level

MS
Member States

MS
mass spectrometry detector

MS/MS
tandem mass spectrometry detector

MW
molecular weight

NEDI
national estimated daily intake

NESTI
national estimated short-term intake

NTMDI
national theoretical maximum daily intake

OECD
Organisation for Economic Co-operation and Development

PBI
plant back interval

PF
processing factor

PHI
preharvest interval

P_ow
partition coefficient between n-octanol and water

PRIMo
(EFSA) Pesticide Residues Intake Model

PROFile
(EFSA) Pesticide Residues Overview File

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

RA
risk assessment

RD
residue definition

RAC
raw agricultural commodity

RD
residue definition

RMS
rapporteur Member State

SANCO
Directorate-General for Health and Consumers

SC
suspension concentrate

SEU
southern European Union

SMILES
simplified molecular-input line-entry system

SL
soluble concentrate

SP
water soluble powder

STMR
supervised trials median residue

TAR
total applied radioactivity

TMDI
theoretical maximum daily intake

TRR
total radioactive residue

UV
ultraviolet (detector)

WHO
World Health Organization

WP
wettable powder

Appendix A – Summary of authorised uses considered for the review of MRLs A.1 Authorised outdoor uses in northern EU

[Table omitted. See PDF]

MS: Member State.

^aOutdoor or field use (F), greenhouse application (G) or indoor application (I).

^bCropLife International Technical Monograph no 2, 7th Edition. Revised March 2017. Catalogue of pesticide formulation types and international coding system.

^cGrowth 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.

^dPHI – minimum preharvest interval.

A.2 Authorised outdoor uses in southern EU

[Table omitted. See PDF]

MS: Member State.

^aOutdoor or field use (F), greenhouse application (G) or indoor application (I).

^bCropLife International Technical Monograph no 2, 7th Edition. Revised March 2017. Catalogue of pesticide formulation types and international coding system.

^dPHI – minimum preharvest interval.

A.3 Authorised indoor uses in the EU

[Table omitted. See PDF]

MS: Member State.

^aOutdoor or field use (F), greenhouse application (G) or indoor application (I).

^bCropLife International Technical Monograph no 2, 7th Edition. Revised March 2017. Catalogue of pesticide formulation types and international coding system.

^dPHI – minimum preharvest interval.

A.4 Import tolerance

[Table omitted. See PDF]

MS: Member State.

^aOutdoor or field use (F), greenhouse application (G) or indoor application (I).

^bCropLife International Technical Monograph no 2, 7th Edition. Revised March 2017. Catalogue of pesticide formulation types and international coding system.

^dPHI – minimum preharvest interval.

Appendix B – List of end points B.1 Residues in plants B.1.1 Nature of residues and methods of analysis in plants B.1.1.1 Metabolism studies, methods of analysis and residue definitions in plants

[Table omitted. See PDF]

[IMAGE OMITTED. SEE PDF.]

B.1.1.2 Stability of residues in plants

[Table omitted. See PDF]

^*753-A-OH not analysed in grapes.

B.1.2 Magnitude of residues in plants B.1.2.1 Summary of residues data from the supervised residue trials – Primary crops

Commodity	Region/Indoora	Residue levels observed in the supervised residue trials (mg/kg)	Comments/Source	Calculated MRL (mg/kg)	HRb (mg/kg)	STMRc (mg/kg)	CFd
Residue definition for monitoring: penthiopyrad Residue definition for risk assessment 1: sum of penthiopyrad and metabolite 753-A-OH, expressed as penthiopyrad
Tree nuts	Import (CA, US)	Mo: < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; 0.037 RA: < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; 0.047	Combined data set of trials performed on almonds (6) and pecans (6) compliant with GAP (EFSA, 2012). Extrapolation to whole group tree nuts is applicable. MRL_OECD = 0.05	0.05	0.04	< 0.01	1e
Pome fruits	NEU	Mo: 0.037; 0.044; 0.057; 0.059; 0.074; 0.083; 0.17; 0.2 RA: 0.04; 0.05; 0.07; 0.08; 0.09; 0.1; 0.18; 0.25	Combined data set of trials on apples (4) and pears (4) from trials performed with 3 × 225 g a.s./ha, PHI 21 days (EFSA, 2012) deemed acceptable since decline studies indicate that the first application does not contribute significantly to the final residue. Extrapolation to all pome fruits is applicable. MRL_OECD = 0.33	0.4	0.20	0.07	1.2
	SEU	Mo: 0.01; 0.06; 0.022; 0.026; 0.028; 0.033; 0.064; 0.1; 0.11 RA: 0.02; 0.03; 0.04; 0.04; 0.04; 0.07; 0.07; 0.11; 0.13	Combined data set of trials on apples (5) and pears (4) from trials performed with 3 × 225 g a.s./ha, PHI 21 days (EFSA, 2012) deemed acceptable since decline studies indicate that the first application does not contribute significantly to the final residue. Extrapolation to all pome fruits is applicable. Extrapolation to all pome fruits is applicable. MRL_OECD = 0.19	0.2	0.11	0.03	1.4
	Import (CA, US)	Mo: 0.12; 0.13; 0.21; 0.076; 0.135; < 0.01; 0.115; 0.155; 0.099; 0.215; 0.23; 0.15; 0.115; 0.225; 0.097; < 0.01; 0.245; 0.185; 0.18; 0.064; 0.115; 0.165; 0.035; 0.22 RA: 0.13; 0.14; 0.22; 0.09; 0.16; < 0.02; 0.13; 0.17; 0.11; 0.23; 0.26; 0.16; 0.13; 0.24; 0.11; < 0.02; 0.26; 0.2; 0.2; 0.07; 0.13; 0.21; 0.05; 0.22	Combined data set of trials on apples (14) and pears (10) compliant with GAP (EFSA, 2012). Extrapolation to all pome fruits is applicable. MRL_OECD = 0.41	0.5	0.25	0.13	1.1
Apricots	SEU	Mo (unscaled values): 0.26; 0.59; 0.62; 0.63; 0.67; 1.23; 1.31; 1.4; 2.31; 2.59 Mo (scaled values): 0.17; 0.39; 0.41; 0.42; 0.45; 0.82; 0.87; 0.93; 1.54; 1.73 RA (unscaled values): 0.27; 0.60; 0.63; 0.65; 0.68; 1.26; 1.37, 1.50, 2.33, 2.64 RA (scaled values): 0.18; 0.40; 0.42; 0.43; 0.46; 0.85; 0.91; 1.00; 1.55; 1.76	Combined data set of trials on apricots (5), peaches (4) and nectarines (1) (EFSA, 2016) scaled down using the proportionality factor of 0.67 (Sweden, 2020). MRL_OECD = 2.84	3	1.73	0.64	1
	Import (CA)	–	No residue trials available.	–	–	–	–
Cherries (sweet)	Import (CA)	Mo: 0.44; 0.9; 1.25; 0.91; 1.095; 0.38; 1.095; 1.6; 1.7 RA: 0.45; 0.95; 1.32; 0.94; 1.14; 0.395; 1.176; 1.71; 1.76	Trials on sweet cherries (4) and tart/sour cherries (5) compliant with GAP (EFSA, 2012). MRL_OECD = 3.12	4	1.70	1.10	1
Peaches	SEU	Mo (unscaled values): 0.26; 0.59; 0.62; 0.63; 0.67; 1.23; 1.31; 1.4; 2.31; 2.59 Mo (scaled values): 0.17; 0.39; 0.41; 0.42; 0.45; 0.82; 0.87; 0.93; 1.54; 1.73 RA (unscaled values): 0.27; 0.60; 0.63; 0.65; 0.68; 1.26; 1.37, 1.50, 2.33, 2.64 RA (scaled values): 0.18; 0.40; 0.42; 0.43; 0.46; 0.85; 0.91; 1.00; 1.55; 1.76	Combined data set of trials on apricots (5), peaches (4) and nectarines (1) (EFSA, 2016) scaled down using the proportionality factor of 0.67 (Sweden, 2020). MRL_OECD = 2.84	3	1.73	0.64	1
	Import (CA)	Mo: 0.605; 0.465; 0.345; 0.555; 0.7; 0.685; 0.435; 0.58; 1.4; 0.175; 0.615; 0.275; 0.2 RA: 0.625; 0.49; 0.36; 0.58; 0.74; 0.71; 0.45; 0.60; 1.41; 0.19; 0.64; 0.29; 0.21	Trials on peaches compliant with GAP (EFSA, 2012). MRL_OECD = 1.79	2	1.40	0.56	1
Plums	Import (CA)	Mo: 0.08; 0.152; 0.285; 0.77; 0.051; 0.079; 0.089; 0.047; 0.13; 0.105 RA: 0.09; 0.16; 0.29; 0.78; 0.061; 0.089; 0.099; 0.057; 0.135; 0.115	Trials on plums compliant with GAP (EFSA, 2012). MRL_OECD = 1.05	1.5	0.77	0.10	1
Strawberries	SEU	Mo (unscaled values): 0.25; 0.12; 0.24; 0.58; 0.27, 0.044; 0.47; 0.16; 0.10; 0.13; 1.1; 0.5; 0.37 Mo (scaled values): 0.18; 0.086; 0.17; 0.42; 0.19; 0.032; 0.34; 0.12; 0.072; 0.094; 0.79; 0.36; 0.27 RA (unscaled values): 0.255; 0.12; 0.247; 0.593; 0.277; 0.044; 0.47; 0.16; 0.10; 0.135; 1.103; 0.509; 0.376 RA (scaled values): 0.184; 0.086; 0.178; 0.427; 0.199; 0.032; 0.34; 0.12; 0.072; 0.097; 0.794; 0.37; 0.271	Overdosed trials on strawberries, scaled down using a proportionality factor of 0.72 (Sweden, 2020). MRL_OECD = 1.06	1.5	0.79	0.18	1
	EU	Mo (unscaled values): 0.74; 2.4; 0.78; 0.54; 0.22; 1.1; 0.25; 0.48; 0.51 Mo (scaled values): 0.53; 1.73; 0.56; 0.39; 0.16; 0.79; 0.18; 0.35; 0.37 RA (unscaled values): 0.753; 2.434; 0.78; 0.54; 0.22; 1.123; 0.25; 0.48; 0.513 RA (scaled values): 0.54; 1.75; 0.56; 0.39; 0.16; 0.81; 0.18; 0.35; 0.37	Overdosed trials on strawberries, scaled down using a proportionality factor of 0.72 (Sweden, 2020). MRL_OECD = 2.48	3	1.73	0.39	1
	Import (CA, US)	Mo: 0.37; 2; 0.455; 0.765; 0.67; 0.87; 1.35; 1.2; 0.62 RA: 0.42; 2.05; 0.47; 0.79; 0.68; 0.91; 1.38; 1.27; 0.63	Trials on strawberries compliant with GAP (EFSA, 2012). MRL_OECD = 2.98	3	2.00	0.77	1
Potatoes, Sweet potatoes	Import (CA)	Mo: 18 × < 0.01; 0.011; 0.011; 0.017; 0.033 RA: 18 × < 0.02; 0.021; 0.021; 0.027; 0.043	Trials on potatoes compliant with GAP (EFSA, 2012). Extrapolation to sweet potatoes is applicable. MRL_OECD = 0.033	0.04	0.03	< 0.01	1e
Beetroots, Carrots, Horseradishes, Jerusalem artichokes, Parsnips, Parsley roots/Hamburg roots parsley, Swedes/rutabagas, Turnips	Import (CA, US)	Mo: 0.085; 0.12; 0.051; 0.165; 0.395; 0.071; 0.021; 0.047; 0.025 RA: 0.095; 0.13; 0.061; 0.175; 0.405; 0.081; 0.031; 0.057; 0.035	Trials on carrots compliant with GAP (EFSA, 2012). Extrapolation to other root and tuber vegetables (except radishes) is applicable. MRL_OECD = 0.58	0.6	0.40	0.07	1
Radishes	Import (CA, US)	Mo: 1.15; 0.15; 0.915; < 0.01; 0.22; 0.33 RA: 1.16; 0.16; 0.0925; < 0.02; 0.023; 0.34	Trials on radishes compliant with GAP (EFSA, 2012). MRL_OECD = 2.3	3	1.15	0.28	1e
Garlic, Onions, Shallots	Import (CA, US)	Mo: 0.445; 0.054; 0.135; 0.355; 0.065; 0.05; 0.126; 0.064; 0.01; 0.014 RA: 0.455; 0.064; 0.145; 0.365; 0.075; 0.06; 0.136; 0.074; 0.02; 0.024	Trials on bulb onions compliant with GAP (EFSA, 2012). Extrapolation to garlic and shallots is applicable. MRL_OECD = 0.73	0.8	0.45	0.06	1e
Spring onions/green onions and Welsh onions, Leeks	Import (CA, US)	Mo: 0.855; 0.225; 0.21; 0.545; 0.925; 1.75 RA: 0.865; 0.235; 0.22; 0.555; 0.935; 1.76	Trials on spring onions compliant with GAP (EFSA, 2012). Extrapolation to leeks is applicable. MRL_OECD = 3.05	3 (tentative)h	1.75	0.70	1e
Tomatoes, Aubergines	SEU	Mo: 0.24; 0.29; 0.62; 0.22; 0.32; 0.18; 0.58; 0.11; 0.35 RA: 0.25; 0.3; 0.63; 0.23; 0.33; 0.19; 0.59; 0.12; 0.36	Overdosed trials on tomatoes performed with 2 applications (1 × 200 g/ha + 1 × 600 g a.s./ha instead of 1 × 480 g a.s./ha (Sweden, 2020). No additional trials required since indoor and import tolerance GAPs are more critical. MRL_OECD = 1.02	1 (tentative)f	0.62	0.29	1e
	EU	Mo: 0.38; 0.18; 0.31; 0.17; 0.24; 0.086; 0.55; 0.76; 0.15; 0.76; 0.84 RA: 0.39; 0.19; 0.32; 0.18; 0.25; 0.096; 0.56; 0.77; 0.163; 0.77; 0.85	Trials on tomatoes compliant with GAP, some values taken at longer PHIs, compliant in terms of the total seasonal application rate (EFSA, 2012). Extrapolation to aubergines is applicable. MRL_OECD = 1.51	1.5	0.84	0.31	1e
	Import (CA, US)	Mo: 0.405; 0.24; 0.4; 0.15; 1.4; 0.42; 0.085; 0.185; 0.165; 0.27; 0.355; 0.7; 0.28; 0.36; 1.3; 0.22; 0.36; 0.165; 0.16; 0.25 RA: 0.42; 0.25; 0.41; 0.16; 1,41; 0.43; 0.09; 0.2; 0.18; 0.28; 0.37; 0.71; 0.29; 0.37; 1.31; 0.23; 0.37; 0.18; 0.17; 0.26	Trials on tomatoes compliant with GAP, except for one value taken at longer PHI (EFSA, 2012). Extrapolation to aubergines is applicable. MRL_OECD = 1.81	2	1.40	0.28	1e
Sweet peppers/bell peppers, Okra/lady's fingers	EU	Mo: 0.65; 0.16; 0.53; 0.50; 0.63; 0.18; 0.43; 0.64; 0.69 RA: 0.66; 0.17; 0.54; 0.54; 0.51; 0.64; 0.19; 0.44; 0.65	Overdosed trials on peppers performed with 2 applications (1 × 200 g/ha + 1 × 600 g a.s./ha instead of 1 × 480 g a.s./ha (EFSA, 2012). No additional trials required since import tolerance GAP is more critical. GAP authorised for sweet peppers only. MRL_OECD = 1.4	1.5 (tentative)f	0.69	0.53	1
	Import (CA, US)	Mo: 0.185; 0.215; 0.145; 0.175; 0.77; 0.185; 0.17; 0.165; 0.15; 0.68; 0.22; 0.57; 0.36; 0.71; 0.33; 0.17; 1.55; 0.41; 0.885; 0.195 RA: 0.198; 0.22; 0.149; 0.18; 0.77; 0.190; 0.177; 0.173; 0.157; 0.720; 0.23; 0.57; 0.39; 0.731; 0.336; 0.175; 1.56; 0.44; 0.93; 0.21	Trials on peppers compliant with GAP (EFSA, 2012). Extrapolation to okra is applicable. MRL_OECD = 1.85	2	1.55	0.22	1
Cucumbers, Gherkins, Courgettes	NEU	–	No residue trials available. GAP authorised for cucumbers and gherkins only.	–	–	–	–
	SEU	Mo: 0,12; 0.082; 0.083; 0.16; 0.13; 0.3; 0.12; 0.053; 0.18; 0.37; 0.17; 0.28; 0.48 RA: 0.15; 0.096; 0.101; 0.18; 0.166; 0.39; 0.14; 0.068; 0.20; 0.38; 0.18; 0.29; 0.49	Overdosed trials on cucumbers and courgettes performed with 2 applications (1 × 200 g/ha + 1 × 600 g a.s./ha instead of 1 × 480 g a.s./ha (EFSA, 2012). No additional trials required since indoor GAP is more critical. Extrapolation to all cucurbits with edible peel is applicable. MRL_OECD = 0.7	0.7 (tentative)f	0.48	0.16	1
	EU	Mo: 0.13; 0.076; 0.098; 0.089; 0.29; 0.16; 0.093; 0.15; 0.3; 0.29; 0.13; 0.38; 0.46 RA: 0.154; 0.089; 0.136; 0.105; 0.355; 0.189; 0.112; 0.19; 0.333; 0.30; 0.14; 0.39; 0.474	Combined data set of trials on cucumbers (9) and courgettes (4) compliant with GAP in terms of the total seasonal application rate (EFSA, 2012). Extrapolation to all cucurbits with edible peel is applicable. MRL_OECD = 0.7	0.7	0.46	0.15	1.2
	Import (CA)	Mo: 0.015; 0.034; 0.125; 0.047; 0.043; 0.029; 0.065; 0.069; 0.086; 0.12; 0.126; 0.067; 0.18; 0.01; 0.12; 0.18; 0.19; 0.21; 0.104 RA: 0.025; 0.044; 0.136; 0.057; 0.053; 0.046; 0.075; 0.079; 0.096; 0.13; 0.139; 0.077; 0.19; 0.019; 0.13; 0.19; 0.21; 0.216; 0.114	Combined data set of trials on cucumbers (10) and courgettes (9) compliant with GAP (EFSA, 2012). Extrapolation to all cucurbits with edible peel is applicable. MRL_OECD = 0.34	0.4	0.21	0.09	1.1
Melons, Pumpkins, Watermelons	Import (CA)	Mo: 0.22; 0.165; 0.265; 0.18; 0.098; 0.26; 0.165; 0.26 RA: 0.234; 0.181; 0.275; 0.185; 0.108; 0.265; 0.175; 0.27	Trials on melons compliant with GAP (EFSA, 2012). Extrapolation to all cucurbits (inedible peel) is applicable. MRL_OECD = 0.6	0.6	0.27	0.20	1
Sweet corn	Import (CA, US)	Mo: 11 × < 0.01 RA: 11 × < 0.02	Trials on sweet corn compliant with GAP (EFSA, 2012): MRL_OECD = 0.01	0.01*	< 0.01	< 0.01	1e
Broccoli, Cauliflowers	Import (CA, US)	Mo: 0.65; 1.9; 2.35; 1.39; 0.87; 1.35; 1.85; 0.505; 0.11; 0.495 RA: 0.66; 1.91; 2.36; 1.395; 0.88; 1.36; 1.86; 0.515; 0.12; 0.505	Combined data set of 7 trials with broccoli and 3 trials with cauliflower, performed with 1 × 150 g a.s./ha + 2 × 450 g a.s./ha (EFSA, 2012) deemed acceptable since decline studies show first application did not contribute to residues in crop. MRL_OECD = 4.08	4	2.35	1.11	1
Head cabbages	Import (CA, US)	Mo: 2.25; 0.024; 1.45; 1.25; 0.09; 0.995; 0.22; 0.475; 0.19; 0.29 RA: 2.27; 0.03; 1.46; 1.26; 0.099; 1.005; 0.23; 0.49; 0.2; 0.3	Trials on head cabbages compliant with GAP (EFSA, 2012). MRL_OECD = 3.67	4	2.25	0.38	1
Lamb's lettuces/corn salads, Cresses and other sprouts and shoots, Land cresses, Roman rocket/rucola, Red mustards, Chervil, Chives	SEU	Mo: 2.1; 1.1; 0.86; 0.66; 11; 1.9; 0.23 RA: 2.128; 1.118; 0.888; 0.712; 11.054; 1.924; 0.235	Overdosed trials on open leaf varieties lettuces performed with 2 × 400 g a.s./ha (Sweden, 2020). GAP authorised for lamb's lettuces, cresses, land cresses, Roman rocket, red mustards No additional trials required since import tolerance GAP is more critical. MRL_OECD = 17.69	20 (tentative)f	11	1.1	1
	Import (CA, US)	Mo: 1.15; 1.8; 4.1; 1.1; 5.3; 11; 4.35; 7.4; 3.5; 1.95; 1.75; 1.15 RA: 1.18; 1.87; 4.18; 1.12; 5.36; 11.08; 4.405; 7.45; 3.52; 1.98; 1.83; 1.17	Trials performed in leafy (open head) lettuce compliant with GAP (EFSA, 2012). Extrapolation to lamb`s lettuce, cress, land cress, rocket/rucola, red mustard, baby leaf crops, chervil and chives is applicable. MRL_OECD = 15.8	20 (tentative)h	11	2.73	1
Lettuces	SEU	Mo: 2.1; 1.1; 0.86; 0.66; 11; 1.9; 0.23; < 0.01; 9.1; 0.058; 1.1 RA: 2.128; 1.118; 0.888; 0.712; 11.054; 1.924; 0.235; < 0.02; 9.14; 0.064; 1.112	Overdosed trials on open head (7) and closed head (4) lettuces, performed with 2 × 400 g a.s./ha (Sweden, 2020). MRL_OECD = 17.71	20 (tentative)^(f),(h)	11	1.1	1
	Import (CA, US)	Mo: 0.365; 2.25; 0.49; 0.41; 0.365; 2.8; 1.6; 0.59; 0.37; 3.4; 2; < 0.01; 1.15; 1.8; 4.1; 1.1; 5.3; 11; 4.35; 7.4; 3.5; 1.95; 1.75; 1.15 RA: 0.39; 2.29; 0.52; 0.42; 0.38; 2.85; 1.63; 0.61; 0.39; 3.42; 2.03; < 0.02; 1.18; 1.87; 4.18; 1.12; 5.36; 11.08; 4.405; 7.45; 3.52; 1.98; 1.83; 1.17	Residue trials performed in both closed head (12) and leafy (open head) lettuce (10) compliant with GAP (EFSA, 2012). MRL_OECD = 12.75	15	11	1.78	1
Spinaches, Purslanes, Chards/beet leaves	SEU	Mo: 2.1; 1.1; 0.86; 0.66; 11; 1.9; 0.23 RA: 2.128; 1.118; 0.888; 0.712; 11.054; 1.924; 0.235	Overdosed trials on open leaf varieties lettuces performed with 2 × 400 g a.s./ha (Sweden, 2020). No additional trials required since import tolerance GAP is more critical. MRL_OECD = 17.71	20 (tentative)f	11	1.1	1
	Import (CA, US)	Mo: 2.7; 2.8; 1.45; 0.805; 8.05; 11.2; 15; 2.75; 2.0; 1.15 RA: 2.75; 2.86; 1.49; 0.83; 8.09; 11.26; 15.04; 2.83; 2.04; 1.17	Trials on spinaches compliant with GAP (EFSA, 2012). Extrapolation to purslane and chards is applicable. MRL_OECD = 24.41	30 (tentative)h	15	2.73	1
Beans (with pods)	Import (CA, US)	Mo: 0.77; 0.985; 0.155; 1.5; 0.9; 0.465; 0.125; 0.36 RA: 0.78; 0.995; 0.165; 1.51; 0.91; 0.475; 0.135; 0.37	Trials on beans with pods, performed with 3 applications (1 × 150 g a.s./ha + 2 × 450 g a.s./ha) since the first application is expected to have a minor influence on the final residue, are deemed acceptable (EFSA, 2012). MRL_OECD = 2.54	3	1.50	0.62	1e
Beans (without pods)	Import (CA, US)	Mo: 0.055; 0.035; 0.245; 0.049; 0.024; 0.125; 0.011 RA: 0.066; 0.045; 0.255; 0.059; 0.034; 0.135; 0.021	Trials on beans without pods, performed with 3 applications (1 × 150 g a.s./ha + 2 × 450 g a.s./ha) acceptable since the first application is expected to have a minor influence on the final residue (EFSA, 2012) MRL_OECD = 0.41	0.4	0.25	0.05	1e
Peas (with pods)	Import (CA, US)	Mo: 1.5; 0.88; 1.025; 1.25 RA: 1.51; 0.89; 1.035; 1.26	Trials on peas with pods, performed with 3 applications (1 × 150 g a.s./ha + 2 × 450 g a.s./ha) since the first application is expected to have a minor influence on the final residue, are deemed acceptable (EFSA, 2012) MRL_OECD = 3.49	4	1.50	1.14	1
Peas (without pods)	Import (CA, US)	Mo: 0.09; 0.067; 0.14; 0.07; 0.04; 0.077; 0.04 RA: 0.1; 0.077; 0.15; 0.08; 0.05; 0.087; 0.05	Trials on peas without pods, performed with 3 applications (1 × 150 g a.s./ha + 2 × 450 g a.s./ha) acceptable since the first application is expected to have a minor influence on the final residue (EFSA, 2012) MRL_OECD = 0.22	0.3	0.14	0.07	1e
Cardoons, Florence fennels, celeries, rhubarbs	SEU	Mo: 0.61; 0.66; 6.5; 7.4 RA: 0.62; 0.67; 6.5; 7.4	Trials on celeries compliant with GAP (EFSA, 2020). GAP authorised for cardoons only. MRL_OECD = 18.45	20 (tentative)h	7.40	3.58	1
	Import (CA, US)	Mo: 5.75; 2.8; 2; 8.65; 2.45; 1.65; 3; 3.1; 2.1; 5.3; 5.25 RA: 5.78; 2.81; 2.02; 8.67; 2.46; 1.66; 3.02; 3.11; 2.11; 5.33; 5.27	Trials on celeries compliant with GAP (EFSA, 2012). Extrapolation to cardoons, Florence fennels, celeries and rhubarbs is applicable. MRL_OECD = 12.44	15	8.65	3.01	1
Beans (dry), Lentils dry), Peas (dry), Lupins/lupini beans (dry)	Import (CA)	Mo: 0.0125; < 0.01; 0.011; 0.088; < 0.01; < 0.01; 0.014; < 0.01; < 0.01; 0.032; < 0.01; 0.01; 0.025; < 0.01; < 0.01; < 0.01; < 0.01; 0.01; 0.033; < 0.01; 0.026; < 0.01; < 0.01; 0.195; 0.01; < 0.01; < 0.01; < 0.01 RA: 0.023; < 0.02; 0.021; 0.098; < 0.02; < 0.02; 0.024; < 0.02; < 0.02; 0.042; < 0.02; 0.021; 0.035; < 0.02; < 0.02; < 0.02; < 0.02; 0.021; 0.043; < 0.02; 0.036; < 0.02; < 0.02; 0.208; < 0.02; < 0.02; < 0.02; < 0.02	Combined residue data set of trials on dry beans (14) and dry peas (14), performed with 2 × 300 g a.s./ha and PHI 21 days (EFSA, 2012). Maximum seasonal rate is for 600 g a.s./ha. MRL_OECD = 0.20	0.2	0.2	0.01	2
Peanuts/groundnuts	Import (CA, US)	Mo: < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; 0.01; < 0.01; < 0.01; < 0.01; 0.034; < 0.01 RA: < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; 0.02; < 0.02; < 0.02; < 0.02; 0.044; < 0.02	Trials on peanuts compliant with GAP (EFSA, 2012). MRL_OECD = 0.04	0.04	0.03	< 0.01	1e
Sunflower seeds	Import (US)	Mo: 0.0795; < 0.01; 0.10; 0.44; 0.34; 0.079; 0.078; 0.81; 0.275 RA: 0.089; < 0.02; 0.11; 0.467; 0.35; 0.089; 0.088; 0.857; 0.289	Trials on sunflower seed compliant with GAP (EFSA, 2012). MRL_OECD = 1.27	1.5	0.81	0.10	1.1
Rapeseeds/canola seeds	Import (CA, US)	Mo: < 0.01; < 0.01; < 0.01;0.095; 0.125; < 0.01; 0.024; 0.08; 0.065; 0.028; 0.025; 0.054; 0.039; 0.017; 0.033; 0.079; 0.052; 0.415; 0.011; < 0.01; < 0.01 RA: < 0.02; < 0.02; < 0.02; 0.11; 0.135; < 0.02; 0.034; 0.091; 0.075; 0.038; 0.035; 0.064; 0.049; 0.027; 0.043; 0.09; 0.062; 0.429; 0.021; < 0.02; < 0.02	Trials on rapeseed compliant with GAP (EFSA, 2012). MRL_OECD = 0.42	0.5	0.42	0.03	1.4
Soyabeans	Import (CA, US)	Mo: < 0.01; 0.049; 0.022; < 0.01; 0.013; 0.022; < 0.01; < 0.01; 0.025; 0.011; 0.068; 0.014; < 0.01; 0.056; 0.21; < 0.01; < 0.01; < 0.01; 0.012; < 0.01 RA: < 0.02; 0.059; 0.032; < 0.02; 0.023; 0.032; < 0.02; < 0.02; 0.035; 0.021; 0.078; 0.024; < 0.02; 0.066; 0.225; 0.02; 0.02; < 0.02; 0.022; 0.02	Trials on soyabeans compliant with GAP (EFSA, 2012). MRL_OECD = 0.21	0.3	0.21	0.01	1.9
Cotton seeds	Import (US)	Mo: .036; 0.125; 0.23; 0.11; 0.25; 0.13; 0.093; 0.039; 0.01 RA: < 0.02; 0.15; 0.10; < 0.02; 0.046; 0.16; 0.24; 0.12; 0.263; 0.14; 0.12; 0.05; 0.022	Trials on cotton seed performed with 3 applications, in-furrow early application is not expected to have a significant impact on the final residue levels in the crop and therefore these residue trials considered acceptable (EFSA, 2012). MRL_OECD = 0.41	0.5 (tentative)h	0.25	0.09	1.3
Barley grains, Oat grains	NEU	Mo: 0.071; 0.069; 0.034; 0.074; 0.086; 0.072; 0.01; 0.022; < 0.01 RA: 0.081; 0.08; 0.047; 0.087; 0.097; 0.082; 0.02; 0.032; < 0.02	Trials on barley within the 25% deviation rule (EFSA, 2016). Extrapolation to oats is applicable. MRL_OECD = 0.17	0.2	0.09	0.07	1.2
	SEU	Mo: 5 × < 0.01; 0.058; 0.044; 0.12; 0.20 RA: 5 × < 0.02; 0.07; 0.066; 0.154; 0.23	Overdosed trials on barley grain performed with 2 × 250 g a.s./ha (EFSA, 2016). GAP authorised for barley only. MRL_OECD = 0.32	0.4 (tentative)f	0.20	< 0.01	2
	Import (CA)	Mo: < 0.01; 0.11; < 0.01; 0.011; 0.03; 0.02; 0.024; 6 × < 0.01 RA: < 0.02; 0.12; < 0.02; 0.021; 0.04; 0.03; 0.034; 6 × < 0.02	Trials on barley compliant with GAP (EFSA, 2012). Extrapolation to oats is applicable. MRL_OECD = 0.13	0.15	0.11	0.01	1e
Buckwheat and other pseudo-cereal grains	Import (CA)	Mo: – RA: –	No residue trials available.	–	–	–	–
Maize/corn grains, Common millet/proso millet grains	Import (CA)	Mo: 15 × < 0.01 RA: 15 × < 0.02	Trials compliant with GAP (EFSA, 2012). Extrapolation to less critical GAP on common millet is applicable. MRL_OECD = 0.01	0.01*	< 0.01	< 0.01	1e
Rice grains	Import (CA)	Mo: – RA: –	No residue trials available.	–	–	–	–
Sorghum grains	Import (CA)	Mo: 0.275; 0.12; 0.39; 0.18; 0.155; 0.43; 0.06; 0.3; 0.093 RA: 0.3; 0.134; 0.419; 0.19; 0.17; 0.55; 0.07; 0.337; 0.10	Trials on sorghum compliant with GAP (EFSA, 2012). MRL_OECD = 0.75	0.8 (tentative)h	0.43	0.18	1.1
Wheat grains Rye grains	NEU	Mo: 5 × < 0.01; 0.012; 2 × 0.015; 0.081 RA: 5 × < 0.02; 0.022; 2 × 0.025; 0.091	Trials performed on wheat grain compliant with GAP (EFSA, 2012). Extrapolation to rye is applicable. MRL_OECD = 0.11	0.15	0.08	< 0.01	1e
	SEU	Mo: 6 × < 0.01 RA: 6 × < 0.02	Trials performed on wheat (EFSA, 2012) with 2 × 300 g a.s./ha are deemed acceptable to support less critical GAP since all residues below LOQ (0.01 mg/kg). Extrapolation to rye is applicable. MRL_OECD = 0.01	0.01*	< 0.01	< 0.01	1e
		Import (CA)	Mo: < 0.01; 0.012; < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; < 0.01; 0.0185; < 0.01; 0.034; < 0.01; 0.017; < 0.01; < 0.01; 0.011; < 0.01 RA: < 0.02; 0.022; < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; < 0.02; 0.029; < 0.02; 0.044; < 0.02; 0.027; < 0.02; < 0.02; 0.021; < 0.02	Trials performed on wheat, with last application at a growth stage of BBCH 51–69 (end of flowering) (EFSA, 2012). Extrapolation to rye is applicable. MRL_OECD = 0.034	0.04	0.03	< 0.01	1e
Sugar beet roots	NEU	Mo: 4 × < 0.01 RA: 4 × < 0.02	Residue trials on sugar beet roots compliant with GAP (Sweden, 2020) MRL_OECD = 0.01	0.01*	< 0.01	< 0.01	1
	SEU	Mo: 4 × < 0.01 RA: 4 × < 0.02	Residue trials on sugar beet roots compliant with GAP (Sweden, 2020) MRL_OECD = 0.01	0.01*	< 0.01	< 0.01	1
	Import (CA)	Mo: 0.0165; 0.195; 0.085; 0.015; 0.185; 0.18; 0.019; 0.133; 0.09; 0.033; 0.042; 0.27 RA: 0.027; 0.21; 0.095; 0.025; 0.195; 0.19; 0.03; 0.28; 0.14; 0.1; 0.043; 0.052	Trials performed on sugar beet with to 2 × 450 g a.s./ha with 7 ±1 days interval between applications and PHI 7 days (EFSA, 2012). Maximum seasonal rate is for 900 g a.s./ha. MRL_OECD = 0.45	0.5	0.27	0.09	1.1
Barley straw Oat straw	NEU	Mo: 0.68; 0.28; 0.6; 0.3; 0.2; 0.18; 0.15; 0.259; 0.051 RA: 0.73; 0.33; 0.71; 0.39; 0.25; 0.23; 0.2; 0.31; 0.10	Trials on barley straw within the 25% deviation rate (EFSA, 2016). Extrapolation to oat straw is applicable. MRL_OECD = 1.13	1.50	0.68	0.26	1.3
	SEU	Mo: 0.085; < 0.05; 0.075; 0.076; 0.17; 0.32; 0.38; 0.26; 4.7 RA: 0.14; 0.10; 0.13; 0.22; 0.54; 0.6; 0.155; 0.37; 5.12	Trials on barley straw performed with 2 × 250 g a.s./ha (EFSA, 2016). GAP authorised for barley straw only. MRL_OECD = 6.73	7 (tentative)^(f),(g)	4.7	0.17	1.7
Wheat straw Rye straw	NEU	Mo: < 0.05; 0.059; 0.13; 1.1; < 0.05; < 0.05; 0.54; 0.17, 2.3 RA: 0.15; 0.113; 0.21; 2.46; 1.49; < 0.1; 0.174; 0.67; 0.41	Trials performed on wheat straw compliant with GAP (EFSA, 2012). Extrapolation to rye straw is applicable. MRL_OECD = 3.54	4 (tentative)g	2.30	0.13	1.9
	SEU	Mo: 0.055; < 0.05; 0.084; 0.14; 0.79; 0.05RA: 0.114; 0.117; 0.16; 0.263; 1.15; 0.2	Trials performed on wheat straw with 2 × 300 g a.s./ha (EFSA, 2012). Extrapolation to rye straw is applicable. MRL_OECD = 1.37	1.50	0.79	0.07	2
Sugar beet tops	NEU	Mo: 4 × < 0.01 RA: 4 × < 0.02	Trials on sugar beet tops compliant with GAP (Sweden, 2020). MRL_OECD = 0.01	0.01* (tentative)g	< 0.01	< 0.01	1e
	SEU	Mo: 4 × < 0.01 RA: 4 × < 0.02	Trials on sugar beet tops compliant with GAP (Sweden, 2020). MRL_OECD = 0.01	0.01* (tentative)g	< 0.01	< 0.01	1e

GAP: Good Agricultural Practice; OECD: Organisation for Economic Co-operation and Development; MRL: maximum residue level.

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

Mo: residue levels expressed according to the monitoring residue definition; RA: residue levels expressed according to risk assessment residue definition.

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

^bHighest residue. The highest residue for risk assessment (RA) refers to the whole commodity and not to the edible portion.

^cSupervised trials median residue. The median residue for risk assessment (RA) refers to the whole commodity and not to the edible portion.

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

^eSince the residues of metabolite 753-A-OH are below the LOQ of 0.01 mg/kg, the conversion factor from enforcement to the risk assessment residue definition proposed as 1.

^fMRL is tentative since trials are overdosed or performed with a different GAP.

^gMRL is tentative in the view of future setting of MRLs for feed items.

^hMRL is tentative because metabolite PAM is present at above 0.1 mg/kg and information on the nature of metabolite PAM upon hydrolysis is missing.

B.1.2.2 Summary of residues data from the supervised residue trials – Primary crops (metabolite PAM)

Commodity	Region/Indoora	Residue levels observed in the supervised residue trials (mg/kg)	Comments/Source	HRb (mg/kg)	STMRc (mg/kg)
Residue definition for risk assessment 2: metabolite PAM
Tree nuts	Import (CA, US)	RA: 12 × < 0.01	Combined data set of trials performed on almonds (6) and pecans (6) compliant with GAP (EFSA, 2012). Extrapolation to whole group tree nuts is applicable.	< 0.01	< 0.01
Pome fruits	NEU	RA: 7 × < 0.01; 0.01	Combined data set of trials on apples (4) and pears (4) from trials performed with 3 × 225 g a.s./ha, PHI 21 days (EFSA, 2012). Extrapolation to all pome fruits is applicable.	< 0.01	< 0.01
	SEU	RA: 9 × < 0.01	Combined data set of trials on apples (5) and pears (4) from trials performed with 3 × 225 g a.s./ha, PHI 21 days (EFSA, 2012). Extrapolation to all pome fruits is applicable. Extrapolation to all pome fruits is applicable.	< 0.01	< 0.01
	Import (CA, US)	RA: 15 × < 0.01; 2 × 0.01; 0.012; 2 × 0.013; 0.014; 2 × 0.016; 0.02	Combined data set of trials on apples (14) and pears (10) compliant with GAP (EFSA, 2012). Extrapolation to all pome fruits is applicable.	0.02	< 0.01
Apricots	SEU	RA (unscaled values): 8 × 0.01; 0.011, 0.013 RA (scaled values): 10×< 0.01	Combined data set of trials on apricots (5), peaches (4) and nectarines (1) (EFSA, 2016) scaled down using the proportionality factor of 0.67 (Sweden, 2020).	< 0.01	< 0.01
	Import (CA)	RA: –	No residue trials available.	–	–
Cherries (sweet)	Import (CA)	RA: 9 × < 0.01	Trials on sweet cherries (4) and tart cherries (5) compliant with GAP (EFSA, 2012).	< 0.01	< 0.01
Peaches	SEU	RA (unscaled values): 8 × 0.01; 0.011, 0.013 RA (scaled values): 10 × 0.01	Combined data set of trials on apricots (5), peaches (4) and nectarines (1) (EFSA, 2016) scaled down using the proportionality factor of 0.67 (Sweden, 2020).	< 0.01	< 0.01
	Import (CA)	RA: 13 × < 0.01	Trials on peaches compliant with GAP (EFSA, 2012).	< 0.01	< 0.01
Plums	Import (CA)	RA: 10 × < 0.01	Trials on plums compliant with GAP (EFSA, 2012).	< 0.01	< 0.01
Strawberries	SEU	RA (unscaled values): 9 × < 0.0033; 2 × 0.006; 2 × 0.004 RA (scaled values): 13 × < 0.01	Overdosed trials on strawberries, scaled down using a proportionality factor of 0.72 (Sweden, 2020).	< 0.01	< 0.01
	EU	RA (unscaled values): 0.0013; 2 × 0.004; 5 × < 0.0033; 0.008 RA (scaled values): 9 × < 0.01	Overdosed trials on strawberries, scaled down using a proportionality factor of 0.72 (Sweden, 2020).	< 0.01	< 0.01
	Import (CA, US)	RA: 3 × < 0.01; 0.01; 0.019; 0.02; 0.026; 0.034; 0.059	Trials on strawberries compliant with GAP (EFSA, 2012).	0.059	0.019
Potatoes, Sweet potatoes	Import (CA)	RA: 22 × < 0.01	Trials on potatoes compliant with GAP (EFSA, 2012). Extrapolation to sweet potatoes is applicable.	< 0.01	< 0.01
Beetroots, Carrots, Horseradishes, Jerusalem artichokes, Parsnips, Parsley roots/Hamburg roots parsley, Swedes/rutabagas, Turnips	Import (CA, US)	RA: 9 × < 0.01	Trials on carrots compliant with GAP (EFSA, 2012). Extrapolation to other root and tuber vegetables (except radishes) is applicable.	< 0.01	< 0.01
Radishes	Import (CA, US)	RA: 6 × < 0.01	Trials on radishes compliant with GAP (EFSA, 2012).	< 0.01	< 0.01
Garlic, Onions, Shallots	Import (CA, US)	RA: 8 × < 0.01; 0.015	Trials on bulb onions compliant with GAP (EFSA, 2012). Extrapolation to shallots and garlic is applicable.	0.02	< 0.01
Spring onions/green onions and Welsh onions, Leeks	Import (CA, US)	RA: 0.0285; 0.0645; 0.0695; 0.1; 0.145; 0.255	Trials on spring onions compliant with GAP (EFSA, 2012). Extrapolation to leeks is applicable.	0.26	0.085
Tomatoes, Aubergines	SEU	RA: 9 × < 0.01	Overdosed trials on tomatoes performed with 2 applications (1 × 200 g/ha + 1 × 600 g a.s./ha instead of 1 × 480 g a.s./ha (Sweden, 2020) acceptable since residues were below the LOQ.	< 0.01	< 0.01
	EU	RA: 11 × < 0.01	Trials on tomatoes compliant with GAP, some values taken at longer PHIs, compliant in terms of the total seasonal application rate (EFSA, 2012). Extrapolation to aubergines is applicable.	< 0.01	< 0.01
	Import (CA, US)	RA: 17 × < 0.01; 0.01; 0.014; 0.019	Trials on tomatoes compliant with GAP, except for one value taken at longer PHI (EFSA, 2012). Extrapolation to aubergines is applicable.	0.019	< 0.01
Sweet peppers/bell peppers, Okra/lady's fingers	EU	RA: 9 × < 0.01	Trials on peppers performed with 1 × 200 g a.s./ha + 1 × 600 g a.s./ha (EFSA, 2012). GAP authorised for sweet peppers/bell peppers, only.	< 0.01	< 0.01
	Import (CA, US)	RA: 13 × < 0.01; 0.011; 0.011; 0.0125; 0.016; 0.019; 0.02; 0.026	Trials on peppers compliant with GAP (EFSA, 2012). Extrapolation to okra is applicable.	0.03	< 0.01
Cucumbers, Gherkins, Courgettes	NEU	RA: –	No residue trials available.	–	–
	SEU	RA: 13 × < 0.01	Trials performed with 1 × 200 g a.s./ha + 1 × 600 g a.s./ha, 9 trials on cucumbers and 4 on courgettes (EFSA, 2012).	< 0.01	< 0.01
	EU	RA: 13 × < 0.01	Combined data set of trials on cucumbers (9) and courgettes (4) compliant with compliant with GAP in terms of the total seasonal application rate (EFSA, 2012). Extrapolation to all cucurbits with edible peel is applicable.	< 0.01	< 0.01
	Import (CA)	RA: 16 × < 0.01; 0.01; 0.014; 0.018	Combined data set of trials on cucumbers (10) and courgettes (9) compliant with GAP (EFSA, 2012). Extrapolation to all cucurbits (edible peel) is applicable.	0.02	< 0.01
Melons, Pumpkins, Watermelons	Import (CA)	RA: 3 × < 0.01; 0.013; 0.013; 0.014; 0.017, 0.0265	Trials on melons compliant with GAP (EFSA, 2012). Extrapolation to all cucurbits (inedible peel) is applicable.	0.03	< 0.01
Sweet corn	Import (CA, US)	RA: 11 × < 0.01	Trials on sweet corn compliant with GAP (EFSA, 2012).	< 0.01	< 0.01
Broccoli, Cauliflowers	Import (CA, US)	RA: 7 × < 0.01; 0.016; 0.015; 0.024	Combined data set, 7 trials with broccoli and 3 trials with cauliflower, with 3 applications (1 × 150 g a.s./ha + 2 × 450 g a.s./ha) deemed acceptable since decline studies showed number applications did not contribute to residues in crop (EFSA, 2012).	0.02	< 0.01
Head cabbages	Import (CA, US)	RA: 5 × < 0.01; 0.0175; 0.0135; 0.021; 0.011; 0.065	Trials on head cabbages compliant with GAP (EFSA, 2012).	0.07	< 0.01
Lamb's lettuces/corn salads, Cresses and other sprouts and shoots, Land cresses, Roman rocket/rucola, Red mustards, Baby leaf crops (including brassica species), Chards/beet leaves, Chervil, Chives	SEU	RA: 0.027; 0.020; 0.0445; 0.021; 0.022; 0.024; < 0.01;	Overdosed trials on open head lettuces performed with 2 × 400 g a.s./ha (Sweden, 2020).	0.05	0.02
	Import (CA, US)	RA: 0.023; 0.026; 0.027; 0.033; 0.04; 0.0595; 0.067; 0.12; 0.12; 0.145;0.185; 0.255	Trials performed in leafy (open head) lettuce compliant with GAP (EFSA, 2012). Extrapolation to lamb`s lettuce, cress, land cress, rocket/rucola, red mustard, baby leaf crops, chervil and chives is applicable.	0.26	0.06
Lettuces	SEU	RA: 0.027; 0.020; 0.0445; 0.021; 0.022; 0.024; < 0.01; < 0.01; 0.068; 0.009; < 0.01	Trials performed with both open (7) and closed head (4) lettuces performed with 2 × 400 g a.s./ha instead of 1 × 300 g a.s./ha (Sweden, 2020).	0.07	0.02
	Import (CA, US)	RA: 3 × < 0.01; 0.017; 0.018; 0.0205; 0.023; 0.026; 0.027; 0.033; 0.0365; 0.04; 0.0405; 0.047; 0.0595; 0.0595; 0.067; 0.11; 0.12; 0.12; 0.145; 0.185; 0.255	Residue trials performed in both head (12) and leafy (open) lettuce (12) (EFSA, 2012).	0.26	0.04
Spinaches, Purslanes, Chards/beet leaves	SEU	RA: 0.027; 0.020; 0.0445; 0.021; 0.022; 0.024; < 0.01;	Overdosed trials on open head lettuces performed with 2 × 400 g a.s./ha (Sweden, 2020).	0.05	0.02
	Import (CA, US)	RA: 0.076; 0.11; 0.115; 0.18; 0.205; 0.23; 0.285; 0.415; 0.505; 0.58	Trials on spinach compliant with GAP (EFSA, 2012). Extrapolation to purslane and chards is applicable.	0.58	0.22
Beans (with pods)	Import (CA, US)	RA: < 0.01; 0.033; 0.01; < 0.01; < 0.01; 0.0135; < 0.01; < 0.01	Trials on beans with pods, performed with 3 applications (1 × 150 g a.s./ha + 2 × 450 g a.s./ha) since the first application is expected to have a minor influence on the final residue, are deemed acceptable (EFSA, 2012).	0.03	< 0.01
Beans (without pods)	Import (CA, US)	RA: 0.01; < 0.01; < 0.01; < 0.01; < 0.01; 0.021; < 0.01	Trials on beans without pods, performed with 3 applications (1 × 150 g a.s./ha + 2 × 450 g a.s./ha) since the first application is expected to have a minor influence on the final residue, are deemed acceptable (EFSA, 2012).	0.02	< 0.01
Peas (with pods)	Import (CA, US)	RA: 0.029; < 0.01; 0.014; 0.018	Trials on peas with pods, performed with 3 applications (1 × 150 g a.s./ha + 2 × 450 g a.s./ha) since the first application is expected to have a minor influence on the final residue, are deemed acceptable (EFSA, 2012)	0.03	0.02
Peas (without pods)	Import (CA, US)	RA: 7 × < 0.01	Trials on peas without pods, performed with 3 applications (1 × 150 g a.s./ha + 2 × 450 g a.s./ha) since the first application is expected to have a minor influence on the final residue, are deemed acceptable (EFSA, 2012).	< 0.01	< 0.01
Cardoons, Celeries, Florence fennels, Rhubarbs	SEU	RA: 0.011; 0.015; 0.026; 0.038	Trials on celeries compliant with GAP (EFSA, 2020). Extrapolation to Florence fennels is applicable. GAP authorised for cardoons and rhubarbs only.	0.04	0.02
	Import (CA, US)	RA: 0.014; 0.0195; 0.04; 0.042; 0.043; 0.06; 0.066; 0.068; 0.12; 0.17; 0.18	Trials on celeries compliant with GAP (EFSA, 2012). Extrapolation to cardoons, Florence fennels and rhubarbs is applicable.	0.18	0.06
Beans (dry), Lentils dry), Peas (dry), Lupins/lupini beans (dry)	Import (CA)	RA: 26 × 0.01; 0.017; 0.0525	Combined residue data set of trials on dry beans (14) and dry peas (14), performed with 2 × 300 g a.s./ha and PHI 21 days (EFSA, 2012). Maximum seasonal rate is for 600 g a.s./ha.	0.05	< 0.01
Peanuts/groundnuts	Import (CA, US)	RA: 12 × < 0.01; 0.012	Trials on peanuts compliant with GAP (EFSA, 2012).	0.01	< 0.01
Sunflower seeds	Import (US)	RA: 5 × < 0.01; 0.023; 0.069; 0.071; 0.089	Trials on sunflower seed compliant with GAP (EFSA, 2012).	0.09	< 0.01
Rapeseeds/canola seeds	Import (CA, US)	RA: 8 × < 0.01; 0.014; 0.012; 0.013; 0.026; 0.01; 0.032; 0.018; 0.034; 0.042; 0.022; 0.011; 0.015; 0.057	Trials on rapeseed compliant with GAP (EFSA, 2012).	0.06	0.01
Soyabeans	Import (CA, US)	RA: 16 × < 0.01; 0.01; 0.011; 0.012; 0.012	Trials on soyabean compliant with GAP (EFSA, 2012).	0.01	< 0.01
Cotton seeds	Import (US)	RA: 0.011; 0.013; 0.014; 0.015; 0.016; 0.018; 0.023; 0.033; 0.051; 0.071; 0.073; 0.089; 0.13	Trials on cotton seed performed with 3 applications, in-furrow early application is not expected to have a significant impact on the final residue levels in the crop and therefore these residue trials are considered acceptable (EFSA, 2012).	0.13	0.02
Barley grains, Oat grains	NEU	RA: 7 × < 0.01; 0.018; 0.018;	Trials on barley within the 25% deviation rule (EFSA, 2016). Extrapolation to oats is applicable.	0.02	< 0.01
	SEU	RA: 6 × < 0.01; 0.017; 0.018; 0.048;	Trials performed with 2 × 250 g a.s./ha on barley grain (EFSA, 2016). GAP authorised for barley only.	0.05	< 0.01
	Import (CA)	RA: 11 × < 0.01; 0.011; 0.015	Trials on barley compliant with GAP (EFSA, 2012). Extrapolation to oats is applicable.	0.02	< 0.01
Buckwheat and other pseudo-cereal grains	Import (CA)	RA:	No residue trials available.	–	–
Maize/corn grains, Common millet/proso millet grains	Import (CA)	RA: 15 × < 0.01	Trials compliant with GAP (EFSA, 2012). Extrapolation to less critical GAP on common millet is applicable.	< 0.01	< 0.01
Rice grains	Import (CA)	RA:	No residue trials available.	–	–
Sorghum grains	Import (CA)	RA: 0.011; 0.013; 0.019; 0.022; 0.023; 0.032; 0.033; 0.052; 0.145	Trials on sorghum compliant with GAP (EFSA, 2012).	0.15	0.02
Wheat grains Rye grains	NEU	RA: 9 × < 0.01	Trials performed on wheat within the 25% deviation rule (EFSA, 2012). Extrapolation to rye is applicable.	< 0.01	< 0.01
	SEU	RA: 6 × < 0.01	Trials performed on wheat (EFSA, 2012) with 2 × 300 g a.s./ha are deemed acceptable to support less critical GAP since all residues below LOQ (0.01 mg/kg). Extrapolation to rye is applicable.	< 0.01	< 0.01
	Import (CA)	RA: 23 × < 0.01; 0.01; 0.012, 0.012	Trials performed on wheat, with last application at a growth stage of BBCH 51–69 (end of flowering) (EFSA, 2012). Extrapolation to rye is applicable.	0.01	< 0.01
Sugar beet roots	NEU	RA: 4 × < 0.01	Residue trials on sugar beet roots compliant with GAP (Sweden, 2020).	< 0.01	< 0.01
	SEU	RA: 4 × < 0.01	Residue trials on sugar beet roots compliant with GAP (Sweden, 2020).	< 0.01	< 0.01
	Import (CA)	RA: 11 × < 0.01; 0.011	Trials performed on sugar beet with to 2 × 450 g a.s./ha with 7 ±1 days interval between applications and PHI 7 days (EFSA, 2012). Maximum seasonal rate is for 900 g a.s./ha.	< 0.01	0.01
Barley straw Oat straw	NEU	RA: 7 × < 0.05; 0.08	Trials on barley straw within the 25% deviation rate (EFSA, 2016). Extrapolation to oat straw is applicable.	0.08	< 0.05
	SEU	RA: 6 × 0.05; 0.12; 0.14; 0.94	Trials performed with 2 × 250 g a.s./ha on barley grain (EFSA, 2016). GAP authorised for barley straw only.	0.94	0.05
Wheat straw Rye straw	NEU	RA: 8 × < 0.05; 0.17	Trials performed on wheat straw within the 25% deviation rule (EFSA, 2012). Extrapolation to rye straw is applicable.	0.17	< 0.05
	SEU	RA: < 0.05; < 0.05; < 0.05; < 0.05; 0.072; 0.28	Trials performed on wheat straw (EFSA, 2012) with 2 × 300 g a.s./ha are deemed acceptable to support less critical GAP. Extrapolation to rye straw is applicable.	0.28	< 0.05
Sugar beet tops	NEU	RA: 4 × < 0.01	Trials on sugar beet tops compliant with GAP (Sweden, 2020).	< 0.01	< 0.01

GAP: Good Agricultural Practice; OECD: Organisation for Economic Co-operation and Development; MRL: maximum residue level; Mo: residue levels expressed according to the monitoring residue definition; RA: residue levels expressed according to risk assessment residue definition.

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

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

^bHighest residue. The highest residue for risk assessment (RA) refers to the whole commodity and not to the edible portion.

^cSupervised trials median residue. The median residue for risk assessment (RA) refers to the whole commodity and not to the edible portion.

B.1.2.3 Residues in rotational crops

a) Overall summary

[IMAGE OMITTED. SEE PDF.]

B.1.2.4 Processing factors

[Table omitted. See PDF]

PF: Processing factor (=Residue level in processed commodity expressed according to RD-Mo/Residue level in raw commodity expressed according to RD-Mo); CF_p: Conversion factor for risk assessment in processed commodity (=Residue level in processed commodity expressed according to RD-RA/Residue level in processed commodity expressed according to RD-Mo); n.r.: not reported.

^aStudies with residues in the RAC at or close to the LOQ were disregarded (unless concentration may occur).

^bMedian of the individual conversion factors for each processing residues trial. When residues of metabolite 753-A-OH were below the LOQ of 0.01 mg/kg, the conversion factor from enforcement to the risk assessment residue definition was proposed as 1.

^cA tentative PF is derived based on a limited data set.

^dAn average PF from two trials with different PHI intervals (7 days and 14 days).

^eA tentative PF is derived based on a limited data set and because information on the nature of metabolite PAM upon hydrolysis is missing.

B.2 Residues in livestock

[Table omitted. See PDF]

^aWhen one group of livestock includes several subgroups (e.g. poultry ‘all’ including broiler, layer and turkey), the result of the most critical subgroup is identified from the maximum dietary burdens expressed as ‘mg/kg bw per day’.

^bThe most critical commodity is the major contributor identified from the maximum dietary burden expressed as ‘mg/kg bw per day’.

^cThe dietary burden (DB) calculation for metabolite PAM was made considering the residues from penthiopyrad, so the values calculated in the PROFile were replaced with the DB values from penthiopyrad, as the DB resulting from the uptake of penthiopyrad is much higher.

B.2.1 Nature of residues and methods of analysis in livestock B.2.1.1 Metabolism studies, methods of analysis and residue definitions in livestock

Livestock (available studies)	Animal	Dose (mg/kg bw/d)	Duration (days)	Comment/Source
	Laying hen	0.82 (study 1) and 0.82–0.85 (study 2)	14 (study 1) and 7 (study 2)	Radiolabelled active substance: [¹⁴C]-pyrazole and thienyl penthiopyrad ring (United Kingdom, 2012; EFSA, 2013a)
	Lactating goat	0.41–0.62 (study 1) and z0.73–0.80 (study 2)	7 (study 1) and 5 (study 2)	Radiolabelled active substance: [¹⁴C]-pyrazole and thienyl penthiopyrad ring. Studies on goat (United Kingdom, 2012; EFSA, 2013a)
	Pig	–	–	–
	Fish	–	–	–

[IMAGE OMITTED. SEE PDF.]

B.2.1.2 Stability of residues in livestock

[Table omitted. See PDF]

B.2.2 Magnitude of residues in livestock B.2.2.1 Summary of the residue data from livestock feeding studies – penthiopyrad

[Table omitted. See PDF]

n.a.: not applicable; n.r. : not reported.

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

^aMedian residues expressed according to the residue definition for monitoring, recalculated at the 1N rate for the median dietary burden.

^bHighest residues expressed according to the residue definition for monitoring, recalculated at the 1N rate for the maximum dietary burden.

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

^dClosest feeding level and N dose rate related to the maximum dietary burden.

^eFor milk, mean was derived from samplings performed from day 1 to day 28 (daily mean of 11 cows).

^fSince extrapolation from cattle to other ruminants and swine is acceptable, results of the livestock feeding study on ruminants were relied upon to derive the MRL and risk assessment values in sheep and swine.

^gFor eggs, mean and highest residues were derived from samplings performed from day 1 to day 28 (daily mean or daily highest of 60 laying hens).

B.2.2.2 Summary of the residue data from livestock feeding studies – metabolite PAM (from the intake of penthiopyrad)

[Table omitted. See PDF]

n.a.: not applicable; n.r. : not reported.

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

^aMedian residues expressed according to the residue definition for monitoring, recalculated at the 1N rate for the median dietary burden.

^bHighest residues expressed according to the residue definition for monitoring, recalculated at the 1N rate for the maximum dietary burden.

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

^dClosest feeding level and N dose rate related to the maximum dietary burden.

^eFor milk, mean was derived from samplings performed from day 1 to day 28 (daily mean of 11 cows).

^gFor eggs, mean and highest residues were derived from samplings performed from day 1 to day 28 (daily mean or daily highest of 60 laying hens).

B.3 Consumer risk assessment B.3.1 Consumer risk assessment of penthiopyrad without consideration of the existing CXLs

[IMAGE OMITTED. SEE PDF.]

Consumer exposure assessment through drinking water resulting from groundwater metabolite(s) according to SANCO/221/2000 rev.10 Final (25/02/2003).

[IMAGE OMITTED. SEE PDF.]

B.3.2 Consumer risk assessment of penthiopyrad with consideration of the existing CXLs

[IMAGE OMITTED. SEE PDF.]

B.3.3 Consumer risk assessment of metabolite PAM

[IMAGE OMITTED. SEE PDF.]

B.4 Proposed MRLs

Code number	Commodity	Existing EU MRL (mg/kg)	Existing CXL (mg/kg)	Outcome of the review
				MRL (mg/kg)	Comment
Enforcement residue definition: penthiopyrad
120010	Almonds	0.05	0.05	0.05	Recommendeda
120020	Brazil nuts	0.05	0.05	0.05	Recommendeda
120030	Cashew nuts	0.05	0.05	0.05	Recommendeda
120040	Chestnuts	0.05	0.05	0.05	Recommendeda
120050	Coconuts	0.05	0.05	0.05	Recommendeda
120060	Hazelnuts	0.05	0.05	0.05	Recommendeda
120070	Macadamia	0.05	0.05	0.05	Recommendeda
120080	Pecans	0.05	0.05	0.05	Recommendeda
120090	Pine nuts	0.05	0.05	0.05	Recommendeda
120100	Pistachios	0.05	0.05	0.05	Recommendeda
120110	Walnuts	0.05	0.05	0.05	Recommendeda
130010	Apples	0.5	0.4	0.5	Recommendeda
130020	Pears	0.5	0.4	0.5	Recommendeda
130030	Quinces	0.5	0.4	0.5	Recommendeda
130040	Medlar	0.5	0.4	0.5	Recommendeda
130050	Loquat	0.5	0.4	0.5	Recommendeda
140010	Apricots	4	4	3	Recommendedb
140020	Cherries	4	4	4	Recommendedb
140030	Peaches	4	4	3	Recommendedb
140040	Plums	1.5	4	1.5	Recommendedb
152000	Strawberries	3	3	3	Recommendeda
154070	Azarole (mediterranean medlar)	0.4	0.4	0.4	Recommendedc
161060	Kaki/Japanese persimmons	0.4	0.4	0.4	Recommendedc
211000	Potatoes	0.05	0.05	0.05	Recommendedd
212020	Sweet potatoes	0.04	–	0.04	Recommendede
213010	Beetroot	0.6	–	0.6	Recommendede
213020	Carrots	0.6	0.6	0.6	Recommendeda
213040	Horseradish	0.6	–	0.6	Recommendede
213050	Jerusalem artichokes	0.6	–	0.6	Recommendede
213060	Parsnips	0.6	–	0.6	Recommendede
213070	Parsley root	0.6	–	0.6	Recommendede
213080	Radishes	3	3	3	Recommendeda
213100	Swedes	0.6	–	0.6	Recommendede
213110	Turnips	0.6	–	0.6	Recommendede
220010	Garlic	0.8	–	0.8	Recommendede
220020	Onions	0.8	0.7	0.8	Recommendeda
220030	Shallots	0.8	–	0.8	Recommendede
220040	Spring onions	4	4	4	Further consideration neededf. Data gap #5
231010	Tomatoes	2	2	2	Recommendeda
231020	Peppers	2	2	2	Recommendeda
231030	Aubergines (egg plants)	2	2	2	Recommendeda
231040	Okra, lady's fingers	2	2	2	Recommendeda
232010	Cucumbers	0.7	0.5	0.7	Recommendeda
232020	Gherkins	0.7	0.5	0.7	Recommendeda
232030	Courgettes	0.7	0.5	0.7	Recommendeda
233010	Melons	0.6	0.5	0.6	Recommendeda
233020	Pumpkins	0.6	0.5	0.6	Recommendeda
233030	Watermelons	0.6	0.5	0.6	Recommendeda
234000	Sweet corn	0.02	0.02	0.02	Recommendedd
241010	Broccoli	4	5	4	Recommendedb
241020	Cauliflower	4	5	4	Recommendedb
242020	Head cabbage	4	4	4	Recommendeda
251010	Lamb's lettuce	15	30	20	Further consideration neededg. Data gap #5
251020	Lettuce	15	30	20	Further consideration neededg. Data gaps # 1 and #5
251040	Cress	15	30	20	Further consideration neededg. Data gap #5
251050	Land cress	15	30	20	Further consideration neededg. Data gap #5
251060	Rocket, Rucola	15	30	20	Further consideration neededg. Data gap #5
251070	Red mustard	15	30	20	Further consideration neededg. Data gap #5
251080	Leaves and sprouts of Brassica spp	50	50	50	Further consideration neededf. Data gap #5
252010	Spinach	30	30	30	Further consideration neededg. Data gap #5
252020	Purslane	30	30	30	Further consideration neededg. Data gap #5
252030	Beet leaves (chard)	30	30	30	Further consideration neededg. Data gap #5
256010	Chervil	20	30	20	Further consideration neededg. Data gap #5
256020	Chives	0.01*	–	20	Further consideration neededh. Data gap #5
260010	Beans (fresh, with pods)	3	3	3	Recommendeda
260020	Beans (fresh, without pods)	0.4	0.3	0.4	Recommendeda
260030	Peas (fresh, with pods)	4	3	4	Recommendeda
260040	Peas (fresh, without pods)	0.3	0.3	0.3	Recommendeda
270020	Cardoons	15	–	20	Further consideration neededh. Data gap #5
270030	Celery	15	15	15	Further consideration neededa. Data gap #5
270040	Fennel	15	–	15	Further consideration neededh. Data gap #5
270060	Leek	3	–	3	Further consideration neededh. Data gap #5
270070	Rhubarb	15	–	15	Further consideration neededh. Data gap #5
300010	Beans (dry)	0.3	0.3	0.3	Recommendedd
300020	Lentils (dry)	0.3	0.3	0.3	Recommendedd
300030	Peas (dry)	0.3	0.3	0.3	Recommendedd
300040	Lupins (dry)	0.3	0.3	0.3	Recommendedd
401020	Peanuts	0.05	0.05	0.05	Recommendedd
401050	Sunflower seed	1.5	1.5	1.5	Recommendeda
401060	Rape seed	0.5	0.5	0.5	Recommendeda
401070	Soya bean	0.3	0.3	0.3	Recommendeda
401090	Cotton seed	0.5	0.5	0.5	Further consideration neededi. Data gap #5
500010	Barley grain	0.3	0.2	0.4	Further consideration neededi. Data gap # 2
500020	Buckwheat grain	0.01*	–	0.01*	Further consideration neededj. Data gap # 4
500030	Maize grain	0.01	0.01	0.01*	Recommendeda
500040	Millet grain	0.8	0.8	0.8	Recommendedd
500050	Oats grain	0.3	0.2	0.2	Recommendeda
500060	Rice grain	0.01*	–	0.01*	Further consideration neededj. Data gap # 3
500070	Rye grain	0.1	0.1	0.15	Recommendeda
500080	Sorghum grain	0.8	0.8	0.8	Further consideration neededi. Data gap #5
500090	Wheat grain	0.1	0.1	0.15	Recommendeda
900010	Sugar beet (root)	0.5	0.5	0.5	Recommendedd
1011010	Swine meat	0.01*	0.04	0.01*	Recommendedb
1011020	Swine fat (free of lean meat)	0.01*	0.05	0.01*	Recommendedb
1011030	Swine liver	0.01*	0.08	0.01*	Recommendedb
1011040	Swine kidney	0.01*	0.08	0.01*	Recommendedb
1012010	Bovine meat	0.01*	0.04	0.01*	Recommendedb
1012020	Bovine fat	0.01*	0.05	0.01*	Recommendedb
1012030	Bovine liver	0.01*	0.08	0.01*	Recommended b
1012040	Bovine kidney	0.01*	0.08	0.01*	Recommendedb
1013010	Sheep meat	0.01*	0.04	0.01*	Recommendedb
1013020	Sheep fat	0.01*	0.05	0.01*	Recommendedb
1013030	Sheep liver	0.01*	0.08	0.01*	Recommendedb
1013040	Sheep kidney	0.01*	0.08	0.01*	Recommendedb
1014010	Goat meat	0.01*	0.08	0.01*	Recommendedb
1014020	Goat fat	0.01*	0.08	0.01*	Recommendedb
1014030	Goat liver	0.01*	0.08	0.01*	Recommendedb
1014040	Goat kidney	0.01*	0.08	0.01*	Recommendedb
1015010	Horse meat	0.01*	0.04	0.01*	Recommendedb
1015020	Horse fat	0.01*	0.05	0.01*	Recommendedb
1015030	Horse liver	0.01*	0.08	0.01*	Recommendedb
1015040	Horse kidney	0.01*	0.08	0.01*	Recommendedb
1016010	Poultry meat	0.01*	0.03	0.01*	Recommendedb
1016020	Poultry fat	0.01*	0.03	0.01*	Recommendedb
1016030	Poultry liver	0.01*	0.03	0.01*	Recommendedb
1020010	Cattle milk	0.01*	0.03	0.01*	Recommendedb
1020020	Sheep milk	0.01*	0.04	0.01*	Recommendedb
1020030	Goat milk	0.01*	0.04	0.01*	Recommendedb
1020040	Horse milk	0.01*	0.04	0.01*	Recommendedb
1030000	Birds’ eggs	0.01*	0.03	0.01*	Recommendedb
Enforcement residue definition 2: metabolite PAM
1011010	Swine meat	–	–	0.01*	Recommendede
1011020	Swine fat (free of lean meat)	–	–	0.01*	Recommendede
1011030	Swine liver	–	–	0.01*	Recommendede
1011040	Swine kidney	–	–	0.01*	Recommendede
1012010	Bovine meat	–	–	0.01*	Recommendede
1012020	Bovine fat	–	–	0.01*	Recommendede
1012030	Bovine liver	–	–	0.01*	Recommendede
1012040	Bovine kidney	–	–	0.01*	Recommendede
1013010	Sheep meat	–	–	0.01*	Recommendede
1013020	Sheep fat	–	–	0.01*	Recommendede
1013030	Sheep liver	–	–	0.01*	Recommendede
1013040	Sheep kidney	–	–	0.01*	Recommendede
1014010	Goat meat	–	–	0.01*	Recommendede
1014020	Goat fat	–	–	0.01*	Recommendede
1014030	Goat liver	–	–	0.01*	Recommendede
1014040	Goat kidney	–	–	0.01*	Recommendede
1015010	Horse meat	–	–	0.01*	Recommendede
1015020	Horse fat	–	–	0.01*	Recommendede
1015030	Horse liver	–	–	0.01*	Recommendede
1015040	Horse kidney	–	–	0.01*	Recommendede
1016010	Poultry meat	–	–	0.01*	Recommendede
1016020	Poultry fat	–	–	0.01*	Recommendede
1016030	Poultry liver	–	–	0.01*	Recommendede
1020010	Cattle milk	–	–	0.01*	Recommendede
1020020	Sheep milk	–	–	0.01*	Recommendede
1020030	Goat milk	–	–	0.01*	Recommendede
1020040	Horse milk	–	–	0.01*	Recommendede
1030000	Birds’ eggs	–	–	0.01*	Recommendede
–	Other commodities of plant and/or animal origin	See Reg. 2015/845	–	–	Further consideration needed(k)

MRL: maximum residue level; CXL: codex maximum residue limit.

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

^eMRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to consumers is identified; no CXL is available (combination H-I in Appendix E).

Appendix C – Pesticide Residue Intake Model (PRIMo)

PRIMo(EU)

PRIMo(CXL)

PRIMo(for metabolite PAM)

Appendix D – Input values for the exposure calculations D.1 Livestock dietary burden calculations

Feed commodity	Median dietary burden		Maximum dietary burden
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Risk assessment residue definition 1: sum of penthiopyrad and 753-A-OH, expressed as penthiopyrad
Barley straw	0.45	STMRMo × CF (1.7)	8.15	HRMo × CF (1.7)
Beet, sugar tops	0.01	STMR	0.01	HR
Cabbage, heads leaves	0.4	STMRMo × CF (1)	2.32	HRMo × CF (1)
Oat straw	0.32	STMRMo × CF (1.3)	0.85	HRMo × CF (1.3)
Rye straw	0.26	STMRMo × CF (2)	4.57	HRMo × CF (2)
Triticale straw	0.26	STMRMo × CF (2)	4.57	HRMo × CF (2)
Wheat straw	0.26	STMRMo × CF (2)	4.57	HRMo × CF (2)
Carrot culls	0.08	STMRMo × CF (1.1)	0.45	HRMo × CF (1.1)
Potato culls	0.01	STMR	0.03	HR
Swede roots	0.08	STMRMo × CF (1.1)	0.45	HRMo × CF (1.1)
Turnip roots	0.08	STMRMo × CF (1.1)	0.45	HRMo × CF (1.1)
Barley grain	0.14	STMRMo × CF (2)	0.14	STMRMo × CF (2)
Bean seed (dry)	0.02	STMRMo × CF (2)	0.02	STMRMo × CF (2)
Corn, field (Maize) grain	0.01	STMR	0.01	STMR
Corn, pop grain	0.01	STMR	0.01	STMR
Cotton undelinted seed	0.12	STMRMo × CF (1.3)	0.12	STMRMo × CF (1.3)
Cowpea seed	0.02	STMRMo × CF (2)	0.02	STMRMo × CF (2)
Lupin seed	0.02	STMRMo × CF (2)	0.02	STMRMo × CF (2)
Millet grain	0.01	STMR	0.01	STMR
Oat grain	0.14	STMRMo × CF (2)	0.14	STMRMo × CF (2)
Pea (Field pea) seed (dry)	0.02	STMRMo × CF (2)	0.02	STMRMo × CF (2)
Rye grain	0.01	STMR	0.01	STMR
Sorghum grain	0.2	STMRMo × CF (1.1)	0.2	STMRMo × CF (1.1)
Soybean seed	0.02	STMRMo × CF (1.9)	0.02	STMRMo × CF (1.9)
Triticale grain	0.01	STMR	0.01	STMR
Wheat grain	0.01	STMR	0.01	STMR
Apple pomace, wet	0.67	STMR × PF (5.1)	0.67	STMR × PF (5.1)
Beet, sugar dried pulp	0.49	STMR × PF (5.7)	0.49	STMR × PF (5.7)
Beet, sugar ensiled pulp	0.1	STMRMo × CF (1.1)	0.1	STMRMo × CF (1.1)
Beet, sugar molasses	0.01	STMR × PF (0.2)	0.01	STMR × PF (0.2)
Brewer's grain dried	0.14	STMRMo × CF (2)a	0.14	STMRMo × CF (2)a
Canola (Rape seed) meal	0.04	STMR × PF (1.3)	0.04	STMR × PF (1.3)
Coconut meal	0.02	STMR × default PF (1.5)b	0.02	STMR × default PF (1.5)b
Corn, field milled by-pdts	0.01	STMR × PF (1.3)	0.01	STMR × PF (1.3)
Corn, field hominy meal	0.01	STMR × PF (1)	0.01	STMR × PF (1)
Corn, field gluten feed	0.01	STMRa	0.01	STMRa
Corn, field gluten, meal	0.01	STMRa	0.01	STMRa
Cotton meal	0.15	STMRMo × CF (1.3) × default PF (1.3)b	0.15	STMRMo × CF (1.3) × default PF (1.3)b
Distiller's grain dried	0.03	STMR × default PF (3.3)b	0.03	STMR × default PF (3.3)b
Lupin seed meal	0.02	STMRMo × CF (2) × default PF (1.1)b	0.02	STMRMo × CF (2) × default PF (1.1)b
Peanut meal	0.004	STMR × PF (0.4)	0.004	STMR × PF (0.4)
Potato process waste	0.2	STMR × default PF (20)b	0.2	STMR × default PF (20)b
Potato dried pulp	0.38	STMR × default PF (38)b	0.38	STMR × default PF (38)b
Rape meal	0.04	STMR × PF (1.3)	0.04	STMR × PF (1.3)
Soybean meal	0.01	STMR × PF (0.5)	0.01	STMR × PF (0.5)
Soybean hulls	0.02	STMRMo × CF (1.9)a	0.02	STMRMo × CF (1.9)a
Sunflower meal	0.22	STMRMo × CF (1.1) × default PF (2)b	0.22	STMRMo × CF (1.1) × default PF (2)b
Wheat gluten meal	0.02	STMR × default PF (1.8)b	0.02	STMR × default PF (1.8)b
Wheat milled by-pdts	0.02	STMR × PF (1.8)	0.02	STMR × PF (1.8)
Risk assessment residue definition 2: metabolite PAM
Barley straw	0.05	STMR	0.94	HR
Beet, sugar tops	0.01	STMR	0.01	HR
Cabbage, heads leaves	0.01	STMR	0.07	HR
Oat straw	0.05	STMR	0.08	HR
Rye straw	0.05	STMR	0.28	HR
Triticale straw	0.05	STMR	0.28	HR
Wheat straw	0.05	STMR	0.28	HR
Carrot culls	0.01	STMR	0.01	HR
Potato culls	0.01	STMR	0.01	HR
Swede roots	0.01	STMR	0.01	HR
Turnip roots	0.01	STMR	0.01	HR
Barley grain	0.01	STMR	0.01	STMR
Bean seed (dry)	0.01	STMR	0.01	STMR
Corn, field (Maize) grain	0.01	STMR	0.01	STMR
Corn, pop grain	0.01	STMR	0.01	STMR
Cotton undelinted seed	0.02	STMR	0.02	STMR
Cowpea seed	0.01	STMR	0.01	STMR
Lupin seed	0.01	STMR	0.01	STMR
Millet grain	0.01	STMR	0.01	STMR
Oat grain	0.01	STMR	0.01	STMR
Pea (Field pea) seed (dry)	0.01	STMR	0.01	STMR
Rye grain	0.01	STMR	0.01	STMR
Sorghum grain	0.02	STMR	0.02	STMR
Soybean seed	0.01	STMR	0.01	STMR
Triticale grain	0.01	STMR	0.01	STMR
Wheat grain	0.01	STMR	0.01	STMR
Apple pomace, wet	0.01	STMRa	0.01	STMRa
Beet, sugar dried pulp	0.01	STMRa	0.01	STMRa
Beet, sugar ensiled pulp	0.01	STMRa	0.01	STMRa
Beet, sugar molasses	0.04	STMR × PF (3.6)	0.04	STMR × PF (3.6)
Brewer's grain dried	0.01	STMRa	0.01	STMRa
Canola (Rape seed) meal	0.01	STMR × PF (0.5)	0.01	STMR × PF (0.5)
Coconut meal	0.02	STMR × default PF (1.5)b	0.02	STMR × default PF (1.5)b
Corn, field milled by-pdts	0.01	STMRa	0.01	STMRa
Corn, field hominy meal	0.01	STMRa	0.01	STMRa
Corn, field gluten feed	0.01	STMRa	0.01	STMRa
Corn, field gluten, meal	0.01	STMRa	0.01	STMRa
Cotton meal	0.03	STMR × default PF (1.3)b	0.03	STMR × default PF (1.3)b
Distiller's grain dried	0.01	STMRa	0.01	STMRa
Lupin seed meal	0.01	STMR × default PF (1.1)b	0.01	STMR × default PF (1.1)b
Peanut meal	0.02	STMR × PF (1.6)	0.02	STMR × PF (1.6)
Potato process waste	0.01	STMRa	0.01	STMRa
Potato dried pulp	0.01	STMRa	0.01	STMRa
Rape meal	0.01	STMR × PF (0.5)	0.01	STMR × PF (0.5)
Soybean meal	0.01	STMR × PF (1)	0.01	STMR × PF (1)
Soybean hulls	0.01	STMRa	0.01	STMRa
Sunflower meal	0.02	STMR × default PF (2)b	0.02	STMR × default PF (2)b
Wheat gluten meal	0.01	STMRa	0.01	STMRa
Wheat milled by-pdts	0.02	STMR × PF (1.8)	0.02	STMR × PF (1.8)

STMR: supervised trials median residue; HR: highest residue; PF: processing factor.

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

^aFor these feed items no default processing factor was applied because residues are expected to be below the LOQ. Concentration of residues in these commodities is therefore not expected.

^bIn the absence of processing factors supported by data, default the processing factor of was included in the calculation to consider the potential concentration of residues in these commodities.

D.2 Consumer risk assessment without consideration of the existing CXLs – penthiopyrad

Commodity	Chronic risk assessment		Acute risk assessment
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Risk assessment residue definition 1: sum of penthiopyrad and 753-A-OH, expressed as penthiopyrad
Almonds	0.01*	STMR	0.04	HR
Brazil nuts	0.01*	STMR	0.04	HR
Cashew nuts	0.01*	STMR	0.04	HR
Chestnuts	0.01*	STMR	0.04	HR
Coconuts	0.01*	STMR	0.04	HR
Hazelnuts/cobnuts	0.01*	STMR	0.04	HR
Macadamias	0.01*	STMR	0.04	HR
Pecans	0.01*	STMR	0.04	HR
Pine nut kernels	0.01*	STMR	0.04	HR
Pistachios	0.01*	STMR	0.04	HR
Walnuts	0.01*	STMR	0.04	HR
Apples	0.19	STMR_Mo × CF (1.4)	0.35	HR_Mo × CF (1.4)
Pears	0.19	STMR_Mo × CF (1.4)	0.35	HR_Mo × CF (1.4)
Quinces	0.16	STMR_Mo × CF (1.2)	0.30	HR_Mo × CF (1.2)
Medlars	0.15	STMR_Mo × CF (1.1)	0.27	HR_Mo × CF (1.1)
Loquats/Japanese medlars	0.15	STMR_Mo × CF (1.1)	0.27	HR_Mo × CF (1.1)
Apricots	0.65	STMR_Mo × CF (1)	1.77	HR_Mo × CF (1)
Cherries (sweet)	1.14	STMR_Mo × CF (1)	1.77	HR_Mo × CF (1)
Peaches	0.66	STMR_Mo × × CF (1)	1.81	HR_Mo × CF (1)
Plums	0.11	STMR_Mo × CF (1.1)	0.85	HR_Mo × CF (1)
Strawberries	0.79	STMR_Mo × CF (1)	2.07	HR_Mo × CF (1)
Potatoes	0.01*	STMR	0.03	HR
Sweet potatoes	0.01*	STMR	0.03	HR
Beetroots	0.08	STMR_Mo × CF (1.1)	0.45	HR_Mo × CF (1.1)
Carrots	0.08	STMR_Mo × CF (1.1)	0.45	HR_Mo × CF (1.1)
Horseradishes	0.08	STMR_Mo × CF (1.1)	0.45	HR_Mo × CF (1.1)
Jerusalem artichokes	0.08	STMR_Mo × CF (1.1)	0.45	HR_Mo × CF (1.1)
Parsnips	0.08	STMR_Mo × CF (1.1)	0.45	HR_Mo × CF (1.1)
Parsley roots/Hamburg roots parsley	0.08	STMR_Mo × CF (1.1)	0.45	HR_Mo × CF (1.1)
Radishes	0.28	STMR	1.15	HR
Swedes/rutabagas	0.08	STMR_Mo × CF (1.1)	0.45	HR_Mo × CF (1.1)
Turnips	0.08	STMR_Mo × CF (1.1)	0.45	HR_Mo × CF (1.1)
Garlic	0.06	STMR	0.45	HR
Onions	0.06	STMR	0.45	HR
Shallots	0.06	STMR	0.45	HR
Spring onions/green onions and Welsh onions	0.70	STMR (tentative)	1.75	HR (tentative)
Tomatoes	0.31	STMR	1.40	HR
Sweet peppers/bell peppers	0.55	STMR_Mo × CF (1)	1.60	HR_Mo × CF (1)
Aubergines/eggplants	0.31	STMR	1.40	HR
Okra/lady's fingers	0.23	STMR_Mo × CF (1)	1.60	HR_Mo × CF (1)
Cucumbers	0.19	STMR_Mo × CF (1.2)	0.57	HR_Mo × CF (1.2)
Gherkins	0.19	STMR_Mo × CF (1.2)	0.57	HR_Mo × CF (1.2)
Courgettes	0.19	STMR_Mo × CF (1.18)	0.57	HR_Mo × CF (1.2)
Melons	0.003	STMR × CF (1.1) × PF (0.014)	0.004	HR × CF (1.15) × PF (0.014)
Pumpkins	0.003	STMR × CF (1.1) × PF (0.014)	0.004	HR × CF (1.1) × PF (0.014)
Watermelons	0.003	STMR × CF (1.1) × PF (0.014)	0.004	HR × CF (1.1) × PF (0.014)
Sweet corn	0.01*	STMR	0.01*	HR
Broccoli	1.12	STMR_Mo × CF (1)	2.37	HR_Mo × CF (1)
Cauliflowers	1.12	STMR_Mo × CF (1)	2.37	HR_Mo × CF (1)
Head cabbages	0.40	STMR_Mo × CF (1)	2.32	HR_Mo × CF (1)
Lamb's lettuces/corn salads	2.77	STMR_Mo × CF (1) (tentative)	11.2	HR_Mo × CF (1) (tentative)
Lettuces	1.81	STMR_Mo × CF (1) (tentative)	11.2	HR_Mo × CF (1) (tentative)
Cresses and other sprouts and shoots	2.77	STMR_Mo × CF (1) (tentative)	11.2	HR_Mo × CF (1) (tentative)
Land cresses	2.77	STMR_Mo × CF (1) (tentative)	11.2	HR_Mo × CF (1) (tentative)
Roman rocket/rucola	2.77	STMR_Mo × CF (1) (tentative)	11.2	HR_Mo × CF (1) (tentative)
Red mustards	2.77	STMR_Mo × CF (1) (tentative)	11.2	HR_Mo × CF (1) (tentative)
Baby leaf crops (including brassica species)	2.77	STMR_Mo × CF (1) (tentative)	11.2	HR_Mo × CF (1) (tentative)
Spinaches	2.77	STMR_Mo × CF (1) (tentative)	15.29	HR_Mo × CF (1) (tentative)
Purslanes	2.77	STMR_Mo × CF (1)	15.29	HR_Mo × CF (1)
Chards/beet leaves	2.77	STMR_Mo × CF (1)	15.29	HR_Mo × CF (1)
Chervil	2.77	STMR_Mo × CF (1)	11.2	HR_Mo × CF (1)
Chives	2.77	STMR_Mo × CF (1)	11.2	HR_Mo × CF (1)
Beans (with pods)	0.62	STMR	1.50	HR
Beans (without pods)	0.05	STMR	0.25	HR
Peas (with pods)	1.15	STMR_Mo × CF (1)	1.51	HR_Mo × CF (1)
Peas (without pods)	0.07	STMR	0.14	HR
Cardoons	3.61	STMR_Mo × CF (1) (tentative)	8.72	HR_Mo × CF (1) (tentative)
Celeries	3.01	STMR (tentative)	8.69	HR (tentative)
Florence fennels	3.01	STMR (tentative)	8.69	HR (tentative)
Leeks	0.70	STMR (tentative)	1.75	HR (tentative)
Rhubarbs	3.01	STMR (tentative)	8.69	HR (tentative)
Beans (dry)	0.02	STMR_Mo × CF (2)	0.02	STMR_Mo × CF (2)
Lentils (dry)	0.02	STMR_Mo × CF (2)	0.02	STMR_Mo × CF (2)
Peas (dry)	0.02	STMR_Mo × CF (2)	0.02	STMR_Mo × CF (2)
Lupins/lupini beans (dry)	0.02	STMR_Mo × CF (2)	0.02	STMR_Mo × CF (2)
Peanuts/groundnuts	0.01*	STMR	0.01*	STMR
Sunflower seeds	0.11	STMR_Mo × CF (1.1)	0.11	STMR_Mo × CF (1.1)
Rapeseeds/canola seeds	0.04	STMR_Mo × CF (1.4)	0.04	STMR_Mo × CF (1.4)
Soyabeans	0.02	STMR_Mo × CF (1.9)	0.02	STMR_Mo × CF (1.9)
Cotton seeds	0.12	STMR_Mo × CF (1.3) (tentative)	0.12	STMR_Mo × CF (1.3) (tentative)
Barley grains	0.14	STMR_Mo × CF (2) (tentative)	0.14	STMR_Mo × CF (2) (tentative)
Buckwheat and other pseudo-cereal grains	0.01*	EU MRL	0.01*	EU MRL
Maize/corn grains	0.01*	STMR	0.01*	STMR
Common millet/proso millet grains	0.01*	STMR	0.01*	STMR
Oat grains	0.14	STMR_Mo × CF (2)	0.14	STMR_Mo × CF (2)
Rice grains	0.01*	EU MRL	0.01*	EU MRL
Rye grains	0.01	STMR	0.01	STMR
Sorghum grains	0.20	STMR_Mo × CF (1.1) (tentative)	0.20	STMR_Mo × CF (1.1) (tentative)
Wheat grains	0.01	STMR	0.01	STMR
Sugar beet roots	0.10	STMR_Mo × CF (1.1) (tentative)	0.30	HR_Mo × CF (1.1)
Risk assessment residue definition 2: penthiopyrad
Swine meat	0.01*	SMTR	0.01*	HR
Swine fat	0.01*	SMTR	0.01*	HR
Swine liver	0.01*	SMTR	0.01*	HR
Swine kidney	0.01*	SMTR	0.01*	HR
Bovine and equine meat	0.01*	SMTR	0.01*	HR
Bovine and equine fat	0.01*	SMTR	0.01*	HR
Bovine and equine liver	0.01*	SMTR	0.01*	HR
Bovine and equine kidney	0.01*	SMTR	0.01*	HR
Sheep and goat meat	0.01*	SMTR	0.01*	HR
Sheep and goat fat	0.01*	SMTR	0.01*	HR
Sheep and goat liver	0.01*	SMTR	0.01*	HR
Sheep and goat kidney	0.01*	SMTR	0.01*	HR
Poultry meat	0.01*	STMR	0.01*	HR
Poultry fat	0.01*	SMTR	0.01*	HR
Poultry liver	0.01*	SMTR	0.01*	HR
Cattle and horse milk	0.01*	SMTR	0.01*	HR
Sheep and goat milk	0.01*	SMTR	0.01*	HR
Birds eggs	0.01*	SMTR	0.01*	HR

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

D.3 Consumer risk assessment with consideration of the existing CXLs – penthiopyrad

Commodity	Chronic risk assessment		Acute risk assessment
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Risk assessment residue definition 1: sum of penthiopyrad and 753-A-OH, expressed as penthiopyrad
Almonds	0.01*	STMR	0.04	HR
Brazil nuts	0.01*	STMR	0.04	HR
Cashew nuts	0.01*	STMR	0.04	HR
Chestnuts	0.01*	STMR	0.04	HR
Coconuts	0.01*	STMR	0.04	HR
Hazelnuts/cobnuts	0.01*	STMR	0.04	HR
Macadamias	0.01*	STMR	0.04	HR
Pecans	0.01*	STMR	0.04	HR
Pine nut kernels	0.01*	STMR	0.04	HR
Pistachios	0.01*	STMR	0.04	HR
Walnuts	0.01*	STMR	0.04	HR
Apples	0.19	STMR_Mo × CF (1.4)	0.35	HR_Mo × CF (1.4)
Pears	0.19	STMR_Mo × CF (1.4)	0.35	HR_Mo × CF (1.4)
Quinces	0.16	STMR_Mo × CF (1.2)	0.30	HR_Mo × CF (1.2)
Medlars	0.15	STMR_Mo × CF (1.1)	0.27	HR_Mo × CF (1.1)
Loquats/Japanese medlars	0.15	STMR_Mo × CF (1.1)	0.27	HR_Mo × CF (1.1)
Apricots	0.65	STMR_Mo × CF (1)	1.77	HR_Mo × CF (1)
Cherries (sweet)	1.14	STMR_Mo × CF (1)	1.77	HR_Mo × CF (1)
Peaches	0.66	STMR_Mo × CF (1)	1.81	HR_Mo × CF (1)
Plums	0.11	STMR_Mo × CF (1)	0.85	HR_Mo × CF (1)
Strawberries	0.79	STMR_Mo × CF (1)	2.07	HR_Mo × CF (1)
Azarole/Mediterranean medlar	0.18	STMR(CXL) × CF (1.3)	0.33	HR(CXL) × CF (1.3)
Kaki/Japanese persimmons	0.18	STMR(CXL) × CF (1.3)	0.33	HR(CXL) × CF (1.3)
Potatoes	0.01*	STMR	0.03	HR
Sweet potatoes	0.01*	STMR	0.03	HR
Beetroots	0.08	STMR_Mo × CF (1.1)	0.45	HR_Mo × CF (1.1)
Carrots	0.08	STMR_Mo × CF (1.1)	0.45	HR_Mo × CF (1.1)
Horseradishes	0.08	STMR_Mo × CF (1.1)	0.45	HR_Mo × CF (1.1)
Jerusalem artichokes	0.08	STMR_Mo × CF (1.1)	0.45	HR_Mo × CF (1.1)
Parsnips	0.08	STMR_Mo × CF (1.1)	0.45	HR_Mo × CF (1.1)
Parsley roots/Hamburg roots parsley	0.08	STMR_Mo × CF (1.1)	0.45	HR_Mo × CF (1.1)
Radishes	0.28	STMR	1.15	HR
Swedes/rutabagas	0.08	STMR_Mo × CF (1.1)	0.45	HR_Mo × CF (1.1)
Turnips	0.08	STMR_Mo × CF (1.1)	0.45	HR_Mo × CF (1.1)
Garlic	0.06	STMR	0.45	HR
Onions	0.06	STMR	0.45	HR
Shallots	0.06	STMR	0.45	HR
Spring onions/green onions and Welsh onions	0.70	STMR (tentative)	1.75	HR (tentative)
Tomatoes	0.31	STMR	1.40	HR
Sweet peppers/bell peppers	0.55	STMR_Mo × CF (1)	1.60	HR_Mo × CF (1)
Aubergines/eggplants	0.31	STMR	1.40	HR
Okra/lady's fingers	0.23	STMR_Mo × CF (1)	1.60	HR_Mo × CF (1)
Cucumbers	0.19	STMR_Mo × CF (1.2)	0.57	HR_Mo × CF (1.2)
Gherkins	0.19	STMR_Mo × CF (1.2)	0.57	HR_Mo × CF (1.2)
Courgettes	0.19	STMR_Mo × CF (1.2)	0.57	HR_Mo × CF (1.2)
Melons	0.003	STMR × PF (0.014)	0.004	HR × PF (0.014)
Pumpkins	0.003	STMR × PF (0.014)	0.004	HR × PF (0.014)
Watermelons	0.003	STMR × PF (0.014)	0.004	HR × PF (0.014)
Sweet corn	0.01*	STMR	0.01*	HR
Broccoli	1.12	STMR_Mo × CF (1)	2.37	HR_Mo × CF (1)
Cauliflowers	1.12	STMR_Mo × CF (1)	2.37	HR_Mo × CF (1)
Head cabbages	0.40	STMR_Mo × CF (1)	2.32	HR_Mo × CF (1)
Lamb's lettuces/corn salads	2.77	STMR_Mo × CF (1) (tentative)	11.2	HR_Mo × CF (1) (tentative)
Lettuces	1.81	STMR_Mo × CF (1) (tentative)	11.2	HR_Mo × CF (1) (tentative)
Cresses and other sprouts and shoots	2.77	STMR_Mo × CF (1) (tentative)	11.2	HR_Mo × CF (1) (tentative)
Land cresses	2.77	STMR_Mo × CF (1) (tentative)	11.2	HR_Mo × CF (1) (tentative)
Roman rocket/rucola	2.77	STMR_Mo × CF (1) (tentative)	11.2	HR_Mo × CF (1) (tentative)
Red mustards	2.77	STMR_Mo × CF (1) (tentative)	11.2	HR_Mo × CF (1) (tentative)
Baby leaf crops (including brassica species)	9.55	STMR_Mo × CF (1) (tentative)	23	HR_Mo × CF (1) (tentative)
Spinaches	2.77	STMR_Mo × CF (1) (tentative)	15.29	HR_Mo × CF (1) (tentative)
Purslanes	2.77	STMR_Mo × CF (1) (tentative)	15.29	HR_Mo × CF (1) (tentative)
Chards/beet leaves	2.77	STMR_Mo × CF (1) (tentative)	15.29	HR_Mo × CF (1) (tentative)
Chervil	2.77	STMR_Mo × CF (1) (tentative)	11.18	HR_Mo × CF (1) (tentative)
Chives	2.77	STMR_Mo × CF (1) (tentative)	11.18	HR_Mo × CF (1) (tentative)
Beans (with pods)	0.62	STMR	1.50	HR
Beans (without pods)	0.05	STMR	0.25	HR
Peas (with pods)	1.15	STMR_Mo × CF (1)	1.51	HR_Mo × CF (1)
Peas (without pods)	0.07	STMR	0.14	HR
Cardoons	3.61	STMR_Mo × CF (1) (tentative)	8.72	HR_Mo × CF (1) (tentative)
Celeries	3.01	STMR (tentative)	8.69	HR (tentative)
Florence fennels	3.01	STMR (tentative)	8.69	HR (tentative)
Leeks	0.70	STMR (tentative)	1.75	HR (tentative)
Rhubarbs	3.01	STMR (tentative)	8.69	HR (tentative)
Beans (dry)	0.02	STMR(CXL)_Mo × CF (2)	0.02	STMR_Mo × CF (2)
Lentils (dry)	0.02	STMR(CXL)_Mo × CF (2)	0.02	STMR(CXL)_Mo × CF (2)
Peas (dry)	0.02	STMR(CXL)_Mo × CF (2)	0.02	STMR(CXL)_Mo × CF (2)
Lupins/lupini beans (dry)	0.02	STMR(CXL)_Mo × CF (2)	0.02	STMR(CXL)_Mo × CF (2)
Peanuts/groundnuts	0.01*	STMR	0.01*	STMR
Sunflower seeds	0.11	STMR_Mo × CF (1.1)	0.11	STMR_Mo × CF (1.1)
Rapeseeds/canola seeds	0.04	STMR_Mo × CF (1.4)	0.04	STMR_Mo × CF (1.4)
Soyabeans	0.02	STMR_Mo × CF (1.9)	0.02	STMR_Mo × CF (1.9)
Cotton seeds	0.12	STMR_Mo × CF (1.3) (tentative)	0.12	STMR_Mo × CF (1.3) (tentative)
Barley grains	0.14	STMR_Mo × CF (2) (tentative)	0.14	STMR_Mo × CF (2) (tentative)
Buckwheat and other pseudo-cereal grains	0.01*	EU MRL	0.01*	EU MRL
Maize/corn grains	0.01*	STMR	0.01*	STMR
Common millet/proso millet grains	0.2	STMR(CXL)_Mo × CF (1.1)	0.2	STMR(CXL)_Mo × CF (1.1)
Oat grains	0.14	STMR_Mo × CF (2)	0.14	STMR_Mo × CF (2)
Rice grains	0.01*	EU MRL	0.01*	EU MRL
Rye grains	0.01	STMR	0.01	STMR
Sorghum grains	0.20	STMR_Mo × CF (1.1) (tentative)	0.20	STMR_Mo × CF (1.1) (tentative)
Wheat grains	0.01	STMR	0.01	STMR
Sugar beet roots	0.10	STMR × CF (1.1)	0.30	HR × CF (1.1)
Risk assessment residue definition 2: penthiopyrad
Swine meat	0.01*	SMTR	0.01*	HR
Swine fat	0.01*	SMTR	0.01*	HR
Swine liver	0.01*	SMTR	0.01*	HR
Swine kidney	0.01*	SMTR	0.01*	HR
Bovine and equine meat	0.01*	SMTR	0.01*	HR
Bovine and equine fat	0.01*	SMTR	0.01*	HR
Bovine and equine liver	0.01*	SMTR	0.01*	HR
Bovine and equine kidney	0.01*	SMTR	0.01*	HR
Sheep and goat meat	0.01*	SMTR	0.01*	HR
Sheep and goat fat	0.01*	SMTR	0.01*	HR
Sheep and goat liver	0.01*	SMTR	0.01*	HR
Sheep and goat kidney	0.01*	SMTR	0.01*	HR
Poultry meat	0.01*	STMR	0.01*	HR
Poultry fat	0.01*	SMTR	0.01*	HR
Poultry liver	0.01*	SMTR	0.01*	HR
Cattle and horse milk	0.01*	SMTR	0.01*	HR
Sheep and goat milk	0.01*	SMTR	0.01*	HR
Birds eggs	0.01*	SMTR	0.01*	HR

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

D.4 Consumer risk assessment for metabolite PAM

Commodity	Chronic risk assessment		Acute risk assessment
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Risk assessment residue definition: metabolite PAM
Almonds	0.01*	STMR	0.01*	HR
Brazil nuts	0.01*	STMR	0.01*	HR
Cashew nuts	0.01*	STMR	0.01*	HR
Chestnuts	0.01*	STMR	0.01*	HR
Coconuts	0.01*	STMR	0.01*	HR
Hazelnuts/cobnuts	0.01*	STMR	0.01*	HR
Macadamias	0.01*	STMR	0.01*	HR
Pecans	0.01*	STMR	0.01*	HR
Pine nut kernels	0.01*	STMR	0.01*	HR
Pistachios	0.01*	STMR	0.01*	HR
Walnuts	0.01*	STMR	0.01*	HR
Apples	0.01*	STMR	0.02	HR
Pears	0.01*	STMR	0.02	HR
Quinces	0.01*	STMR	0.02	HR
Medlars	0.01*	STMR	0.02	HR
Loquats/Japanese medlars	0.01*	STMR	0.02	HR
Apricots	0.01*	STMR	0.01*	HR
Cherries (sweet)	0.01*	STMR	0.01*	HR
Peaches	0.01*	STMR	0.01*	HR
Plums	0.01*	STMR	0.01*	HR
Strawberries	0.02	STMR	0.06	HR
Azarole/Mediterranean medlar	0.011	STMR(CXL)	0.016	HR(CXL)
Kaki/Japanese persimmons	0.011	STMR(CXL)	0.016	HR(CXL)
Potatoes	0.01*	STMR	0.01*	HR
Sweet potatoes	0.01*	STMR	0.01*	HR
Beetroots	0.01*	STMR	0.01*	HR
Carrots	0.01*	STMR	0.01*	HR
Horseradishes	0.01*	STMR	0.01*	HR
Jerusalem artichokes	0.01*	STMR	0.01*	HR
Parsnips	0.01*	STMR	0.01*	HR
Parsley roots/Hamburg roots parsley	0.01*	STMR	0.01*	HR
Radishes	0.01*	STMR	0.01*	HR
Swedes/rutabagas	0.01*	STMR	0.01*	HR
Turnips	0.01*	STMR	0.01*	HR
Garlic	0.01*	STMR	0.02	HR
Onions	0.01*	STMR	0.02	HR
Shallots	0.01*	STMR	0.02	HR
Spring onions/green onions and Welsh onions	0.08	STMR	0.26	HR
Tomatoes	0.01*	STMR	0.02	HR
Sweet peppers/bell peppers	0.01*	STMR	0.03	HR
Aubergines/eggplants	0.01*	STMR	0.02	HR
Okra/lady's fingers	0.01*	STMR	0.03	HR
Cucumbers	0.01*	STMR	0.02	HR
Gherkins	0.01*	STMR	0.02	HR
Courgettes	0.01*	STMR	0.02	HR
Melons	0.003	STMR × PF (0.24)	0.006	HR × PF (0.24)
Pumpkins	0.003	STMR × PF (0.24)	0.006	HR × PF (0.24)
Watermelons	0.003	STMR × PF (0.24)	0.006	HR × PF (0.24)
Sweet corn	0.01*	STMR	0.01*	HR
Broccoli	0.01*	STMR	0.02	HR
Cauliflowers	0.01*	STMR	0.02	HR
Head cabbages	0.01*	STMR	0.07	HR
Lamb's lettuces/corn salads	0.06	STMR	0.26	HR
Lettuces	0.04	STMR	0.26	HR
Cresses and other sprouts and shoots	0.06	STMR	0.26	HR
Land cresses	0.06	STMR	0.26	HR
Roman rocket/rucola	0.06	STMR	0.26	HR
Red mustards	0.06	STMR	0.26	HR
Baby leaf crops (including brassica species)	0.06	STMR	0.26	HR
Spinaches	0.22	STMR	0.58	HR
Purslanes	0.22	STMR	0.58	HR
Chards/beet leaves	0.22	STMR	0.58	HR
Chervil	0.06	STMR	0.26	HR
Chives	0.06	STMR	0.26	HR
Beans (with pods)	0.01*	STMR	0.03	HR
Beans (without pods)	0.01*	STMR	0.02	HR
Peas (with pods)	0.02	STMR	0.03	HR
Peas (without pods)	0.01*	STMR	0.01*	HR
Cardoons	0.01*	STMR	0.18	HR
Celeries	0.06	STMR	0.18	HR
Florence fennels	0.06	STMR	0.18	HR
Leeks	0.08	STMR	0.26	HR
Rhubarbs	0.06	STMR	0.18	HR
Beans (dry)	0.01*	STMR	0.01*	STMR
Lentils (dry)	0.01*	STMR	0.01*	STMR
Peas (dry)	0.01*	STMR	0.01*	STMR
Lupins/lupini beans (dry)	0.01*	STMR	0.01*	STMR
Peanuts/groundnuts	0.01*	STMR	0.01*	STMR
Sunflower seeds	0.01*	STMR	0.01*	STMR
Rapeseeds/canola seeds	0.01	STMR	0.01	STMR
Soyabeans	0.01*	STMR	0.01*	STMR
Cotton seeds	0.02	STMR	0.02	STMR
Barley grains	0.01*	STMR	0.01*	STMR
Buckwheat and other pseudo-cereal grains	0.01*	EU MRLa	0.01*	EU MRLa
Maize/corn grains	0.01*	STMR	0.01*	STMR
Common millet/proso millet grains	0.02	STMR	0.02	STMR
Oat grains	0.01*	STMR	0.01*	STMR
Rice grains	0.01*	EU MRLa	0.01*	EU MRLa
Rye grains	0.01*	STMR	0.01*	STMR
Sorghum grains	0.02	STMR	0.02	STMR
Wheat grains	0.01*	STMR	0.01*	STMR
Sugar beet roots	0.01*	STMR	0.01*	HR
Swine meat	0.01*	SMTR	0.01*	HR
Swine fat	0.01*	SMTR	0.01*	HR
Swine liver	0.01*	SMTR	0.01*	HR
Swine kidney	0.01*	SMTR	0.01*	HR
Bovine and equine meat	0.01*	SMTR	0.01*	HR
Bovine and equine fat	0.01*	SMTR	0.01*	HR
Bovine and equine liver	0.01*	SMTR	0.01*	HR
Bovine and equine kidney	0.01*	SMTR	0.01*	HR
Sheep and goat meat	0.01*	SMTR	0.01*	HR
Sheep and goat fat	0.01*	SMTR	0.01*	HR
Sheep and goat liver	0.01*	SMTR	0.01*	HR
Sheep and goat kidney	0.01*	SMTR	0.01*	HR
Poultry meat	0.01*	STMR	0.01*	HR
Poultry fat	0.01*	SMTR	0.01*	HR
Poultry liver	0.01*	SMTR	0.01*	HR
Cattle and horse milk	0.01*	SMTR	0.01*	HR
Sheep and goat milk	0.01*	SMTR	0.01*	HR
Birds eggs	0.01*	SMTR	0.01*	HR

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

^aInput value is the EU MRL of penthiopyrad.

Appendix E – Decision tree for deriving MRL recommendations

Appendix F – Used compound codes

Code/Trivial name	Chemical namea	Structural formulab
Penthiopyrad MW=359.42	(RS)-N-[2-(1,3-dimethylbutyl)-3-thienyl]-1-methyl-3-(trifluoromethyl)pyrazole-4-carboxamide (IUPAC)  O=C(Nc1ccsc1C(C)CC(C)C)c1cn(C)nc1C(F)(F)F PFFIDZXUXFLSSR-UHFFFAOYSA-N	[IMAGE OMITTED. SEE PDF.]
753-A-OH MW=375.42	N-[2-(4-hydroxy-4-methylpentan-2-yl)thiophen-3-yl]-1-methyl-3-(trifluoromethyl)-1H-pyrazole-4-carboxamide O=C(Nc1ccsc1C(C)CC(C)(C)O)c1cn(C)nc1C(F)(F)F PTOONGKKGPZDRB-UHFFFAOYSA-N	[IMAGE OMITTED. SEE PDF.]
PAM MW=193.13	1-methyl-3-(trifluoromethyl)-1H-pyrazole-4-carboxamide FC(F)(F)c1nn(C)cc1C(N)=O UTBJLKDVQNCKAS-UHFFFAOYSA-N	[IMAGE OMITTED. SEE PDF.]
DM-PAM	3-(trifluoromethyl)-1H-pyrazole-4-carboxamide O=C(N)c1c[NH]nc1C(F)(F)F KWZDGXNAUOZDOT-UHFFFAOYSA-N	[IMAGE OMITTED. SEE PDF.]
DM-PCA	3-(trifluoromethyl)-1H-pyrazole-4-carboxylic acid OC(=O)c1c[NH]nc1C(F)(F)F VHKMTORCXXPIFI-UHFFFAOYSA-N	[IMAGE OMITTED. SEE PDF.]
753-T-DO	N-[2-hydroxy-2-(4-methylpentan-2-yl)-5-oxo-2,5-dihydrothiophen-3-yl]-1-methyl-3-(trifluoromethyl)-1H-pyrazole-4-carboxamide OC1(SC(=O)C=C1NC(=O)c1cn(C)nc1C(F)(F)F)C(C)CC(C)C XHRDZJHMDZCQRN-UHFFFAOYSA-N	[IMAGE OMITTED. SEE PDF.]
753-F-DO	N-[5-hydroxy-5-(1,3-dimethylbutyl)-2-oxo-2,5-dihydrothiophen-4-yl]-1-methyl-3-trifluoromethyl-1H-pyrazole-4-carboxamide OC1(SC(=O)C=C1NC(=O)c1cn(C)nc1C(F)(F)F)C(C)CC(C)C XHRDZJHMDZCQRN-UHFFFAOYSA-N	[IMAGE OMITTED. SEE PDF.]
PCA	1-methyl-3-(trifluoromethyl)-1H-pyrazole-4-carboxylic acid FC(F)(F)c1nn(C)cc1C(=O)O FZNKJQNEJGXCJH-UHFFFAOYSA-N	[IMAGE OMITTED. SEE PDF.]

^aACD/Name 2020.2.1 ACD/Labs 2020 Release (File version N15E41, Build 116563, 15 June 2020).

^bACD/ChemSketch 2020.2.1 ACD/Labs 2020 Release (File version C25H41, Build 121153, 22 March 2021).

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Abstract

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According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance penthiopyrad. To assess the occurrence of penthiopyrad residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the import tolerances and European authorisations reported by Member States and the UK (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.

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Title

Review of the existing maximum residue levels for penthiopyrad according to Article 12 of Regulation (EC) No 396/2005

Author

Bellisai, Giulia; Bernasconi, Giovanni; Brancato, Alba; Luis Carrasco Cabrera; Ferreira, Lucien; Giner, German; Greco, Luna; Jarrah, Samira; Kazocina, Aija; Leuschner, Renata; Jose Oriol Magrans; Miron, Ileana; Nave, Stefanie; Pedersen, Ragnor; Reich, Hermine; Ruocco, Silvia; Santos, Miguel; Scarlato, Alessia Pia; Theobald, Anne; Vagenende, Benedicte; Verani, Alessia

Section

Reasoned Opinion

Publication year

2021

Publication date

Sep 2021

Publisher

John Wiley & Sons, Inc.

ISSN

18314732

Source type

Scholarly Journal

Language of publication

English

DOI

https://doi.org/10.2903/j.efsa.2021.6810

ProQuest document ID

2577753970

Review of the existing maximum residue levels for penthiopyrad according to Article 12 of Regulation (EC) No 396/2005

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