Modification of the existing maximum residue levels for prosulfocarb in herbs and edible flowers

Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Syngenta Crop Protection AG submitted a request to the competent national authority in Portugal to modify the existing maximum residue levels (MRLs) for the active substance prosulfocarb in herbs and edible flowers. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the group of herbs and edible flowers. Adequate analytical methods for enforcement are available to control the residues of prosulfocarb in the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short‐term and long‐term intake of residues resulting from the use of prosulfocarb according to the reported agricultural practice is unlikely to present a risk to consumer health.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, Syngenta Crop Protection AG submitted an application to the competent national authority in Portugal (evaluating Member State, EMS) to modify the existing maximum residue levels (MRLs) for the active substance prosulfocarb in herbs and edible flowers. The EMS drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 20 December 2021. To accommodate for the intended use of prosulfocarb, the EMS proposed to raise the existing MRL tentatively set at the value of 0.05–20 mg/kg.

EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified points which needed further clarification, which were requested from the EMS. On 11 February 2022, the EMS submitted a revised evaluation report, which replaced the previously submitted evaluation report.

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

The metabolism of prosulfocarb following post and early pre‐emergence application was investigated in crops belonging to the groups of root crops, cereals and pulses/oilseeds in the framework of the EU pesticides peer review. Due to the very low levels present in the harvested crops, the nature of residues could not be completely elucidated in plants after pre‐emergence applications. As part of this MRL application, additional data on carrot leaf from a new metabolism study in carrots were provided to support the intended use on herbs and edible flowers, which belong to the group of leafy crops. Also, a confined rotational crop study and a standard hydrolysis study investigating the nature of residues in rotational crops and under processing conditions were submitted. Apart from prosulfocarb, no major metabolites or degradation products were identified in these studies.

In the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005, EFSA provisionally defined the residue definition for enforcement and risk assessment as prosulfocarb, pending further information on the metabolism in primary crops. The results of the new metabolism study performed on carrots (only considering results in leafy parts), the new metabolism study in rotational crops and the fact that no degradation of prosulfocarb was observed in processed products, do not impact on the current residue definitions, which are applicable to the crops under assessment.

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

The available residue trials are sufficient to derive an MRL proposal of 20 mg/kg for the intended use on herbs and edible flowers. It is noted that quantifiable prosulfocarb residues were observed in untreated samples of the residue trials submitted.

Specific studies investigating the magnitude of prosulfocarb residues in processed commodities are not required. Consumption of processed fresh herbs is a rather small part of the consumer’s diet, and these commodities are mainly processed to dried herbs, for which default dehydration factors are available.

Based on the available information, EFSA concluded that significant residue levels are unlikely to occur in rotational crops provided that the active substance is used according to the proposed good agricultural practice (GAP).

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

The toxicological profile of prosulfocarb was assessed in the framework of the EU pesticides peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.005 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 0.1 mg/kg bw.

The consumer risk assessment was performed with revision 3.1 of the EFSA Pesticide Residues Intake Model (PRIMo). The short‐term exposure assessment was performed for the commodities assessed in this application in accordance with the internationally agreed methodology. The calculations show that the short‐term exposure did not exceed the ARfD for any of the crops assessed (15% of the ARfD for chervil as maximum). In the framework of the MRL review, a comprehensive long‐term exposure assessment was performed taking into account the existing uses at EU level. EFSA updated the calculation with the relevant supervised trials median residue (STMR) value derived from the residue trials submitted in support of this MRL application. The estimated long‐term dietary intake was up to 12% of the ADI (DE child diet). The highest contribution of residues expected in the commodities assessed in this application to the overall long‐term exposure was 1.13% of the ADI (for parsley).

EFSA concluded that the proposed use of prosulfocarb on herbs and edible flowers will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers’ health. The chronic exposure calculation should be regarded as indicative since for certain commodities, only tentative MRLs could be derived during the MRL review. Nevertheless, the margin of safety for the chronic exposure is sufficiently large to cover this lack of information in the context of the current application.

EFSA proposes to amend the existing MRLs as reported in the summary table below.

Full details of all end points and the consumer risk assessment can be found in Appendices B–D.

Code (a)	Commodity	Existing EU MRL (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: Prosulfocarb
256010	Chervil	0.05 (ft 1)	20	The submitted data are sufficient to derive an MRL proposal for the intended NEU use. Risk for consumers unlikely. It is noted that a footnote requesting further residue data to confirm the tentative MRL of 0.05 mg/kg was included in the EU legislation. Availability of these data for the use assessed in the MRL review shall be considered in the framework of the MRL review confirmatory data. Nevertheless, for the uses under consideration sufficient residue trials were submitted. Therefore, risk managers may consider deleting the footnotes in Regulation (EC) No 396/2005 in relation to the setting of a proposed MRL of 20 mg/kg.
256020	Chives	0.05 (ft 1)	20
256030	Celery leaves	0.05 (ft 1)	20
256040	Parsley	0.05 (ft 1)	20
256050	Sage	0.05 (ft 1)	20
256060	Rosemary	0.05 (ft 1)	20
256070	Thyme	0.05 (ft 1)	20
256080	Basil and edible flowers	0.05 (ft 1)	20
256090	Laurel/bay leaves	0.05 (ft 1)	20
256100	Tarragon	0.05 (ft 1)	20
256990	Others, herbs and edible flowers	0.05 (ft 1)	20

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

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

(ft 1): The European Food Safety Authority identified some information on residue trials as unavailable. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 17 August 2015, or, if that information is not submitted by that date, the lack of it.

Assessment

The European Food Safety Authority (EFSA) received an application to modify the existing maximum residue levels (MRLs) for the active substance prosulfocarb in herbs and edible flowers. The detailed description of the intended use of prosulfocarb, which is the basis for the current MRL application, is reported in Appendix A.

Prosulfocarb is the ISO common name for S‐benzyl dipropyl (thiocarbamate) (IUPAC). The chemical structure of the active substance and its main metabolites are reported in Appendix E.

Prosulfocarb was evaluated in the framework of Directive 91/414/EEC ¹ with Portugal designated as rapporteur Member State (RMS). The representative uses were early outdoor applications on wheat and potatoes both in northern and southern Europe. The draft assessment report (DAR) prepared by the RMS has been peer reviewed by EFSA (EFSA, 2007). Prosulfocarb was approved ² for the use as herbicide only on 1 November 2009.

The EU MRLs for prosulfocarb are established in Annexes II of Regulation (EC) No 396/2005 ³ . The review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (MRL review) has been performed (EFSA, 2011) and the proposed modifications have been implemented in the MRL legislation. After completion of the MRL review, EFSA has issued one reasoned opinion on the modification of MRLs for prosulfocarb.

In accordance with Article 6 of Regulation (EC) No 396/2005, Syngenta Crop Protection AG submitted an application to the competent national authority in Portugal (evaluating Member State, EMS) to modify the existing maximum residue levels (MRLs) for the active substance prosulfocarb in herbs and edible flowers. The EMS drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 20 December 2021. To accommodate for the intended uses of prosulfocarb, the EMS proposed to raise the existing MRL tentatively set at 0.05–20 mg/kg.

EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified points which needed further clarification, which were requested from the EMS. On 11 February 2022, the EMS submitted a revised evaluation report, which replaced the previously submitted evaluation report. It is noted that in the evaluation reported, the EMS also assessed validation data for the methods of analysis in spices, animal commodities and body fluids and tissues and a new metabolism study on barley. Since not relevant for the present MRL application, EFSA did not consider this information.

EFSA based its assessment on the evaluation report submitted by the EMS (Portugal, 2021), the draft assessment report (DAR) and its revision and addendum (Sweden, 2005, 2006, 2007) prepared under Directive 91/414/EEC, the Commission review report on prosulfocarb (European Commission, 2007), the conclusion on the peer review of the pesticide risk assessment of the active substance prosulfocarb (EFSA, 2007), as well as the conclusions from previous EFSA opinion on prosulfocarb, including the reasoned opinion on the MRL review according to Article 12 of Regulation No 396/2005 (EFSA, 2011,2013).

For this application, the data requirements established in Regulation (EU) No 544/2011 ⁴ and the guidance documents applicable at the date of submission of the application to the EMS are applicable (European Commission, 1997a–g, 2000, 2010, 2017, 2020, 2021; OECD, 2011). The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation of Plant Protection Products adopted by Commission Regulation (EU) No 546/2011 ⁵ .

A selected list of end points of the studies assessed by EFSA in the framework of this MRL application including the end points of relevant studies assessed previously is presented in Appendix B.

The evaluation report submitted by the EMS (Portugal, 2021) and the exposure calculations using the EFSA Pesticide Residues Intake Model (PRIMo) are considered as supporting documents to this reasoned opinion and, thus, are made publicly available as background documents to this reasoned opinion.

1. Residues in plants

1.1. Nature of residues and methods of analysis in plants

1.1.1. Nature of residues in primary crops

The metabolism of prosulfocarb in primary corps belonging to the group of root crops (potatoes) and pulses/oilseeds (peas) after pre‐emergence soil application and to the group of cereals/grass (wheat, barley) after early post‐emergence foliar application has been assessed in the framework EU pesticides peer review (EFSA, 2007). The metabolic pathway of prosulfocarb could be elucidated in cereals only. Results indicated that parent prosulfocarb was the major component of the total radioactive residue (TRR) in immature foliage 7 PHI along with several metabolites in aqueous phase. In the studies conducted pre‐mergence, samples were taken at the time of harvest when residues were too low for further investigations. Hence, the MRL review requested to provide additional information on the metabolism of prosulfocarb in primary crops with short vegetation period, mainly those belonging to the group of Apiaceae (EFSA, 2011). This data gap was translated into a footnote in Regulation (EU) No 777/2013 ⁶ to support authorised uses in root (carrots, celeriac, horseradish, parsnips, parsley roots, salsify) and stem (celeries) crops.

For the herbs assessed in the present MRL application, which belong to the leafy crop group, a representative metabolism study is not available and was not submitted. Instead, the applicant proposed to consider the results of a new metabolism study in carrots (root crop). In addition to the root, the nature of residues was investigated also in the leaf of carrots (Portugal, 2021). EFSA agreed with the EMS to consider the results of the new metabolism study in carrots for the aerial parts as a surrogate of a metabolism study performed on leafy crops in order to support the intended use on the minor leafy crops under assessment. The lack of a metabolism study conducted with a crop belonging to the category of leafy crops is considered a minor deviation of the present application. Nonetheless, for applications to set MRLs on other leafy crops in future, the metabolism of prosulfocarb in the leafy crop group shall be addressed (either demonstrating the route of degradation of the a.s. is similar in three categories or providing a metabolism study on a representative crop of the leafy group).

In this study, field grown carrots received a single foliar application at 4.2 kg/ha (ca 2.6 times the intended use in herbs) early pre‐emergence. Samples of roots and leaves were collected at 21 (immature stage) and 58 days (mature stage) after the treatment (DAT). At 21 DAT, the total radiative residue (TRR) in carrot leaves was corresponding to 74.13 mg/kg eq and decreased at the following time point, whereas the levels in the roots were significantly lower. Total extractability was 98.7 and 97.6% TRR at 21 and 58 DAT, respectively, when extracted with acetonitrile/water (80/20, v/v).

The identification of the radioactive residues revealed unchanged prosulfocarb as the predominant residue in carrot leaves at both time points (78.8–72.3% TRR). No major metabolites were identified. Aside the parent compound, the metabolite R393096 was observed (maximum 1.7% TRR, 1.27 mg/kg eq, 21 DAT) together with the metabolite R331405, but at very low level (0.02% TRR, 0.011 mg/kg eq, 21 DAT). The metabolite SYN545179 was also identified in carrot leaves, but levels were not measured. Based on two‐dimensional thin‐layer chromatography (2D‐TLC) measurements, SYN545179 was reported to be included in a radio‐chromatogram region representing no more than the 0.6% TRR (1.91 mg eq/kg, 21 DAT) and the 3.8% TRR (0.82 mg eq/kg, 58 DAT); therefore, it can be concluded that SYN545179 is a minor metabolite in carrot leaves not expected to significantly contribute to the dietary burden in the crops under assessment. Three unknown metabolites were present at levels individually not exceeding 0.6% TRR. The remainder of the radioactivity, composed of polar material, was postulated as associated with natural components as demonstrated in the roots and in the previous studies on primary crop metabolism, but no attempts were undertaken to further characterise or identify it.

The results of this study suggest a comparable metabolic pathway of prosulfocarb between carrot leaves and barley (study assessed in the EU pesticide peer review), although less extensive, with prosulfocarb as major component of the TRR, a number of identified and unidentified minor metabolites and a portion of radioactive residue incorporated into natural products.

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

1.1.2. Nature of residues in rotational crops

Prosulfocarb is proposed to be used on crops that can be grown in rotation with other crops. A confined rotational crop study with radiolabelled prosulfocarb was provided (Portugal, 2021). Rotational crops (lettuces, turnips, wheat) were planted at three different plant back intervals (PBI) (30, 169 and 275 days) in a sandy loam soil that had been previously treated at 3.52–3.87 kg/ha with [¹⁴C]‐prosulfocarb.

At all plant back intervals and in all investigated crops, the TRR was above the LOQ and reached a maximum of 1.12 mg eq/kg (wheat hay, PBI 30 days, determined by direct quantification of the samples). A progressive decline was observed after the PBI of 30 days.

The extractability was relatively high for lettuce and turnip (leaves and roots) and represented 55.6–93.0% TRR throughout all three PBI. In wheat forage and hay, the level of extractability declined from 74–76.9% TRR at PBI 30 days to 44.4–51.5% TRR at PBI 275 days, whereas in straw, it ranged from 44.3% TRR to 61.9% TRR. The level of extractability in wheat grain was low (24.4% TRR to 36.7% TRR). TRR was extracted by acetonitrile, acetonitrile/water and water (80:20, 50:50, 20:80, v/v). A range of hydrolytic techniques (acid, base and enzyme) was used and the extracts. Chromatographic analysis of these fractions showed that residue was highly polar in nature and no prosulfocarb or any of its metabolites were released.

Parent prosulfocarb (0.7% TRR; 0.005 mg eq/kg) and the metabolite R331282 (1.4% TRR; 0.01 mg eq/kg) were identified in wheat forage at PBI 30 days, but they were not detectable in any other plant extracts analysed from the different PBIs. The majority of the residues was associated with polar components suggesting incorporation in natural compounds, as observed in primary crops.

The results of the confined rotational crop study show that the metabolism of prosulfocarb in rotated crops is similar for all investigated crop groups and indicated that the potential for uptake of prosulfocarb and its degradation products from the soil by the succeeding crops is low. The findings are in agreement with the results of the field dissipation studies assessed in the EU pesticides peer review (EFSA, 2007), which demonstrated that the degradation rate of prosulfocarb in soil is rapid (maximum DT₉₀ of 48 days).

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

1.1.3. Nature of residues in processed commodities

Study investigating the effect of processing on the nature of residues of prosulfocarb was submitted with the current MRL application (Portugal, 2021). The hydrolysis study used radiolabelled prosulfocarb and simulated the typical standard processing conditions of pasteurisation, baking/brewing/boiling and sterilisation. After incubation at 90°C (pH 4) for 20 min, 100°C (pH 5) for 60 min or 120°C (pH 6) for 20 min, 98.3–99.9% of the applied radioactivity was unchanged prosulfocarb.

EFSA concluded that prosulfocarb is hydrolytically stable under standard processing conditions.

1.1.4. Analytical methods for enforcement purposes in plant commodities

Analytical methods for the determination of prosulfocarb residues were assessed during the MRL review (EFSA, 2011). Multi‐residue methods, such as the DFG S19 using gas chromatography with mass spectrometry (GC‐MS) and the QuEChERS method using high‐performance liquid chromatography with tandem mass spectrometry (HPLC‐MS/MS), are sufficiently validated for the determination of prosulfocarb in high water content, high fat content, acidic and dry commodities (EFSA, 2007, 2011). Further validation data of the QuEChERS HPLC‐MS/MS method in high water content matrices (parsley, carrots) using two mass transitions (for quantification and for confirmation) and its independent laboratory validation (ILV) were provided in the present application (Portugal, 2021). All these methods allow quantifying residues at or above the LOQ of 0.01 mg/kg.

The extraction efficiency of the QuEChERS method LC‐MS/MS in parsley (intended use) is sufficiently demonstrated by cross‐validation with the method used in metabolism study on carrot leaves (see Section 1.1.1). Both methods used acetonitrile for extraction prior to the HPLC‐MS/MS determination.

1.1.5. Storage stability of residues in plants

The storage stability of prosulfocarb in plants stored under frozen conditions was investigated in the framework of the EU pesticides peer review and the MRL review (EFSA, 2007, 2011). It was demonstrated that in crops assessed in the framework of this application, residues were stable for at least 18 months when stored at −18°C.

1.1.6. Proposed residue definitions

Based on the metabolic pattern identified in metabolism studies and the capabilities of enforcement analytical methods, in the framework of the MRL review, EFSA provisionally defined the residue definition for enforcement and risk assessment as ‘prosulfocarb’, since the metabolic pattern in plants could not be fully elucidated from the available metabolism studies (EFSA, 2011).

The residue definition for enforcement set in Regulation (EC) No 396/2005 is identical with the above‐mentioned residue definition.

Taking into account the additional information provided with this MRL application on the metabolism in the leafy part of carrots, in rotational crops and the results of the standard hydrolysis study, EFSA concluded that the current provisional residue definitions are applicable to fresh herbs and edible flowers. EFSA would recommend further considering and concluding on a definitive residue definition for enforcement and risk assessment for prosulfocarb in plants in the framework of the renewal of the approval of the active substance, where the new metabolism study in barley (cereals) and results in carrot roots will be assessed.

1.2. Magnitude of residues in plants

1.2.1. Magnitude of residues in primary crops

In support of the NEU outdoor use, the applicant submitted in total seven residue trials on parsley (five), lemon balm ⁷ (one) and dill leaves⁷ (one) and proposed to extrapolate the results to the whole group of herbs and edible flowers (Portugal, 2021). All trials were performed in Germany in 2014. Although the BBCH (40–47) of the intended GAP was not always 100% matched, all trials were fully compliant with the intended PHI of 21 days. One value (11.8 mg/kg) was identified as statistical outlier using the Dixon’s Q‐test, but no information and no obvious defects in the trial justified the exclusion of this value from the calculation.

Prosulfocarb residues were quantified (0.027–0.047 mg/kg) in untreated control samples from three residue trials. These levels are corresponding to a maximum of 4.1% compared to the concentration observed in the treated samples, percentage that is dropping down to 1.6% for the residue levels selected for the MRL setting. A possible explanation of the findings was not provided. The relatively high vapour pressure of prosulfocarb (0.00079 Pa at 20°C) and the dissipation studies assessed in the EU pesticides peer review (EFSA, 2007), support the assumption that small amounts of prosulfocarb might be transferred from treated areas. Notwithstanding the shortcoming related to the presence of prosulfocarb in untreated control samples, EFSA agrees with the EMS and the applicant that these levels of quantification are not having a significant impact on the MRL calculation.

A total of six independent GAP‐compliant residue trials are available and results can be extrapolated to the whole group of herbs and edible flowers (European Commission, 2020).

According to the assessment of the EMS, the method used was sufficiently validated and fit for purpose. The EMS noted that the extraction efficiency for the analytical methods used for the residue trials was not provided as indicated according to the requirements of the extraction efficiency Guidance SANTE 2017/10632 (European Commission, 2017). Further investigation on this matter would in principle be required. EFSA would therefore recommend reconsidering this point in the framework of the renewal of approval of the active substance process. The samples of these residue trials were stored under conditions for which integrity of the samples has been demonstrated.

1.2.2. Magnitude of residues in rotational crops

Rotational crop field studies investigating the magnitude of residues in rotational crop were not provided and are not required. Since the maximum annual application rate for the crops under consideration is ~ 2.3 times lower than the application rate tested in the confined rotational crop study (see Section 1.1.2), EFSA concluded that significant residues of prosulfocarb are not expected in rotational crops, provided that the active substance is applied according to the proposed GAP.

1.2.3. Magnitude of residues in processed commodities

Specific processing studies for the crops under assessment were not provided and are not required since their individual total theoretical maximum daily intake (TMDI) is expected to be below the trigger value of 10% of the ADI (European Commission, 1997d), except for parsley and basil. Fresh herbs may be processed into dried herbs (OECD, 2008). In the absence of specific processing studies on parsley and basil, the generic dehydration factor of 6 and 7, respectively, derived based on a simple calculation on water loss is considered as sufficient (Scholz et al., 2018).

1.2.4. Proposed MRLs

The available data are considered sufficient to derive an MRL proposal of 20 mg/kg as well as risk assessment values for herbs and edible flowers (see Appendix B.4 and B.1.2.1).

EFSA noted that the existing MRL of 0.05 mg/kg was tentatively derived in the MRL review based on an authorised use (NEU/SEU, pre‐emergence soil spraying treatment) which is quite different than the intended use under assessment. A footnote requesting further residue data to confirm the tentative MRL of 0.05 mg/kg was included in the EU legislation. Availability of these data for the use assessed in the MRL review shall be considered in the framework of the MRL review confirmatory data.

In Section 3, EFSA assessed whether residues on these crops resulting from the intended use are likely to pose a consumer health risk.

2. Residues in livestock

Not relevant as herbs and edible flowers are not used for feed purpose.

3. Consumer risk assessment

EFSA performed a dietary risk assessment using revision 3.1 of the EFSA PRIMo (EFSA, 2018, 2019). This exposure assessment model contains food consumption data for different subgroups of the EU population and allows the acute and chronic exposure assessment to be performed in accordance with the internationally agreed methodology for pesticide residues (FAO, 2016).

The toxicological reference values for prosulfocarb used in the risk assessment (i.e. ADI and ARfD values) were derived in the framework of the EU pesticides peer review (European Commission, 2007).

Short‐term (acute) dietary risk assessment

The short‐term exposure assessment was performed for the commodities assessed in this application in accordance with the internationally agreed methodology (FAO, 2016). The calculations were based on the HR derived from supervised field trials submitted in support of this MRL application for herbs and edible flowers. The list of input values can be found in Appendix D.1.

The short‐term exposure did not exceed the ARfD for any of the crops assessed in this application (see Appendix B.3).

Long‐term (chronic) dietary risk assessment

In the framework of the MRL review, a comprehensive long‐term exposure assessment was performed, taking into account the existing uses at EU level (EFSA, 2011). EFSA updated the calculation with the relevant STMR value derived from the residue trials submitted in support of this MRL application for herbs and edible flowers. The complete list of input values is presented in Appendix D.1.

The estimated long‐term dietary intake was up to 12% of the ADI (DE child diet). The contribution of residues expected in the commodities assessed in this application to the overall long‐term exposure is very low (max 1.13% ADI for parsley) and it is presented in more detail in Appendix B.3.

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

The chronic exposure calculation should be regarded as indicative. An updated long‐term consumer risk assessment shall be performed in the framework of the assessment of the MRL review confirmatory data for prosulfocarb, when the missing information identified regarding certain authorised uses and additional residue data will be available to EFSA. Nevertheless, the margin of safety for the chronic exposure is sufficiently large to cover this lack of information in the context of the present application.

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

4. Conclusion and Recommendations

The data submitted in support of this MRL application were found to be sufficient to derive an MRL proposal for herbs and edible flowers.

EFSA noted that the existing MRL of 0.05 mg/kg was tentatively derived in the MRL review based on an authorised use (NEU/SEU, pre‐emergence soil spraying treatment) which is quite different than the intended use under assessment. A footnote requesting further residue data to confirm the tentative MRL of 0.05 mg/kg was included in the EU legislation. Availability of these data for the use assessed in the MRL review shall be considered in the framework of the MRL review confirmatory data. Nevertheless, for the uses under consideration, sufficient residue trials were submitted. Therefore, risk managers may consider deleting the footnotes in Regulation (EC) No 396/2005 in relation to the setting of a proposed MRL of 20 mg/kg.

EFSA concluded that the proposed use of prosulfocarb on herbs and edible flowers will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers’ health. The chronic exposure calculation should be regarded as indicative since for certain commodities only, tentative MRLs could be derived during the MRL review. Nevertheless, the margin for the chronic exposure is sufficiently large to cover this lack of information in the context of the present application.

The MRL recommendations are summarised in Appendix B.4.

Abbreviations

a.s.

active substance

ADI

acceptable daily intake

AR

applied radioactivity

ARfD

acute reference dose

BBCH

growth stages of mono‐ and dicotyledonous plants

bw

body weight

CF

conversion factor for enforcement to risk assessment residue definition

CXL

Codex maximum residue limit

DAR

draft assessment report

DAT

days after treatment

DT₉₀

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

EC

emulsifiable concentrate

EMS

evaluating Member State

eq

residue expressed as a.s. equivalent

FAO

Food and Agriculture Organization of the United Nations

GAP

Good Agricultural Practice

GC‐MS

gas chromatography with mass spectrometry

GC‐MS/MS

gas chromatography with tandem mass spectrometry

GC‐NPD

gas chromatography with nitrogen/phosphorous detector

GLP

Good Laboratory Practice

GR

Granule

GS

growth stage

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 Standardisation

IUPAC

International Union of Pure and Applied Chemistry

LOQ

limit of quantification

MRL

maximum residue level

MS

Member States

NEU

northern Europe

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

QuEChERS

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

RA

risk assessment

RAC

raw agricultural commodity

RD

residue definition

RMS

rapporteur Member State

RPF

relative potency factor

SANCO

Directorate‐General for Health and Consumers

SC

suspension concentrate

SEU

southern Europe

STMR

supervised trials median residue

TRR

total radioactive residue

UV

ultraviolet (detector)

WHO

World Health Organization

Appendix A – Summary of intended GAP triggering the amendment of existing EU MRLs

Crop and/or situation	NEU, SEU, MS or country	F G or I (a)	Pests or Group of pests controlled	Preparation		Application				Application rate per treatment				PHI (days) (d)	Remarks
				Type (b)	Conc. a.s. (g/L)	Method kind	Range of growth stages & season (c)	Number min‐max	Interval between application (days) min–max	g a.s./hL min–max	Water (L/ha) min–max	Rate min–max	Unit
Chervil	NEU	F	Weeds	EC	800	Foliar treatment – broadcast spraying	BBCH 40–47	1	n.a.	–	300–400	1.6	kg a.i./ha	21
Chives	NEU	F	Weeds	EC	800	Foliar treatment – broadcast spraying	BBCH 40–47	1	n.a.	–	300–400	1.6	kg a.i./ha	21
Celery leaves	NEU	F	Weeds	EC	800	Foliar treatment – broadcast spraying	BBCH 40–47	1	n.a.	–	300–400	1.6	kg a.i./ha	21
Parsley	NEU	F	Weeds	EC	800	Foliar treatment – broadcast spraying	BBCH 40–47	1	n.a.	–	300–400	1.6	kg a.i./ha	21
Sage	NEU	F	Weeds	EC	800	Foliar treatment – broadcast spraying	BBCH 40–47	1	n.a.	–	300–400	1.6	kg a.i./ha	21
Rosemary	NEU	F	Weeds	EC	800	Foliar treatment – broadcast spraying	BBCH 40–47	1	n.a.	–	300–400	1.6	kg a.i./ha	21
Thyme	NEU	F	Weeds	EC	800	Foliar treatment – broadcast spraying	BBCH 40–47	1	n.a.	–	300–400	1.6	kg a.i./ha	21
Basil and edible flowers	NEU	F	Weeds	EC	800	Foliar treatment – broadcast spraying	BBCH 40–47	1	n.a.	–	300–400	1.6	kg a.i./ha	21
Laurel/ bay leaves	NEU	F	Weeds	EC	800	Foliar treatment – broadcast spraying	BBCH 40–47	1	n.a.	–	300–400	1.6	kg a.i./ha	21
Tarragon	NEU	F	Weeds	EC	800	Foliar treatment – broadcast spraying	BBCH 40–47	1	n.a.	–	300–400	1.6	kg a.i./ha	21
Others, herbs and edible flowers	NEU	F	Weeds	EC	800	Foliar treatment – broadcast spraying	BBCH 40–47	1	n.a.	–	300–400	1.6	kg a.i./ha	21

MRL: maximum residue level; GAP: Good Agricultural Practice; NEU: northern European Union; SEU: southern European Union; MS: Member State; a.s.: active substance; EC: Emulsifiable concentrate.

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

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

^(c)Growth stage range from first to last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 3‐8263‐3152‐4), including, where relevant, information on season at time of application.

^(d)PHI – minimum preharvest interval.

Appendix B – List of end points

B.1. Residues in plants

B.1.1. Nature of residues and analytical methods for enforcement purposes in plant commodities

B.1.1.1. Metabolism studies, analytical methods and residue definitions in plants

Primary crops (available studies)	Crop groups	Crops	Application	Sampling (DAT)	Comment/Source
	Fruit crops	–	–	–	–
	Root crops	Potatoes	Soil, 1 × 3.42 kg/ha 23 days pre‐emergence	105	Radiolabelled active substance: [14C‐phenyl] prosulfocarb (EFSA, 2007)
		Carrots	Foliar, 1 × 4.18 kg/ha at BBCH 14	21, 58 (roots, leaves)	Radiolabelled active substance: [U‐14C‐pheny] prosulfocarb (Portugal, 2021)
	Leafy crops	–	–	–	–
	Cereals/grass	Wheat	Foliar, 1 × 3.64 kg/ha at BBCH 10–11	283 (grain, straw)	Radiolabelled active substance: [14C‐phenyl] prosulfocarb (EFSA, 2007)
		Barley	Foliar, 1 × 4 kg/ha at BBCH 10–11	7, 14, 161 (immature), maturity (grain, straw)	Radiolabelled active substance: [14C‐phenyl] prosulfocarb (EFSA, 2007)
	Pulses/ oilseeds	Peas	Soil: 1 × 4.05 kg/ha 1 day pre‐sowing	At maturity	Radiolabelled active substance: [14C‐phenyl] prosulfocarb (EFSA, 2007)

Rotational crops (available studies)	Crop groups	Crops	Application	PBI (DAT)	Comment/Source
	Root/tuber crops	Turnips	Bare soil, 1 × 3.52–3.87 kg/ha	30, 169, 275	Radiolabelled active substance: [U‐14C‐pheny] prosulfocarb (Portugal, 2021)
	Leafy crops	Lettuces	Bare soil, 1 × 3.52–3.87 kg/ha	30, 169, 275
	Cereal (small grain)	Wheat	Bare soil, 1 × 3.52–3.87 kg/ha	30, 169, 275
	Other	–	–	–

Processed commodities (hydrolysis study)	Conditions			Stable	Comment/Source
	Pasteurisation (20 min, 90°C, pH 4)			Yes	Prosulfocarb: 99.3–99.8% AR (Portugal, )
	Baking, brewing and boiling (60 min, 100°C, pH 5)			Yes	Prosulfocarb: 98.7–99.7% AR (Portugal, )
	Sterilisation (20 min, 120°C, pH 6)			Yes	Prosulfocarb: 98.3–98.9% AR (Portugal, )
	Other processing conditions			–	–

B.1.1.2. Stability of residues in plants

Plant product (available studies)	Category	Commodity	T (°C)	Stability period		Compounds covered	Comment/ Source
				Value	Unit
	High water content	Potato	–18	18	Months	prosulfocarb	EFSA (2007)
		Wheat forage	–18	25	Months	prosulfocarb	EFSA (2007)
	High oil content	–	–	–	–	–	–
	High protein content	Dried bean	–18	18	Months	prosulfocarb	EFSA (2007)
		Dried pea
	Dry/High starch	Wheat grain	–18	25	Months	prosulfocarb	EFSA (2007)
	High acid content	–	–	–	–	–	–
	Processed products	–	–	–	–	–	–
	Others	Wheat straw	–18	25	Months	prosulfocarb	EFSA (2007)

B.1.2. Magnitude of residues in plants

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

Commodity	Region/ (a)	Residue levels observed in the supervised residue trials (mg/kg)	Comments/Source	Calculated MRL (mg/kg)	HR (b) (mg/kg)	STMR (c) (mg/kg)	CF (d)
Herbs and edible flowers	NEU	0.39; 0.43; 0.78; 1.90; 3.93; 11.80	Residue trials on parsley (four) lemon balm (one) and dill leaves (one) compliant with intended GAP. Extrapolation to the group of herbs and edible flowers possible. Positive findings (0.027–0.047 mg/kg) in untreated control samples from three trials (underlined values are from the compared treated sample).	20	11.80	1.34	n/a

MRL: maximum residue level; GAP: Good Agricultural Practice.

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

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

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

^(d)Conversion factor to recalculate residues according to the residue definition for monitoring to the residue definition for risk assessment. n/a: not applicable.

B.1.2.2. Residues in rotational crops

B.1.2.3. Processing factors

No processing studies were submitted in the framework of the present MRL application.

B.2. Residues in livestock

Not relevant

B.3. Consumer risk assessment

B.4. Recommended MRLs

Code (a)	Commodity	Existing EU MRL (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: Prosulfocarb
256010	Chervil	0.05 (ft 1)	20	The submitted data are sufficient to derive an MRL proposal for the intended NEU use. Risk for consumers unlikely. It is noted that a footnote requesting further residue data to confirm the tentative MRL of 0.05 mg/kg was included in the EU legislation. Availability of these data for the use assessed in the MRL review shall be considered in the framework of the MRL review confirmatory data. Nevertheless, for the uses under consideration sufficient residue trials were submitted. Therefore, risk managers may consider deleting the footnotes in Regulation (EC) No 396/2005 in relation to the setting of a proposed MRL of 20 mg/kg.
256020	Chives	0.05 (ft 1)	20
256030	Celery leaves	0.05 (ft 1)	20
256040	Parsley	0.05 (ft 1)	20
256050	Sage	0.05 (ft 1)	20
256060	Rosemary	0.05 (ft 1)	20
256070	Thyme	0.05 (ft 1)	20
256080	Basil and edible flowers	0.05 (ft 1)	20
256090	Laurel/bay leaves	0.05 (ft 1)	20
256100	Tarragon	0.05 (ft 1)	20
256990	Others, herbs and edible flowers	0.05 (ft 1)	20

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

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

(ft 1): The European Food Safety Authority identified some information on residue trials as unavailable. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 17 August 2015, or, if that information is not submitted by that date, the lack of it.

Appendix C – Pesticide Residue Intake Model (PRIMo)

Appendix D – Input values for the exposure calculations

D.1. Consumer risk assessment

Commodity	Existing/proposed MRL	Source/type of MRL	Chronic risk assessment		Acute risk assessment
			Input value (mg/kg)	Comment	Input value (mg/kg)	Comment (a)
Risk assessment residue definition: Prosulfocarb (provisional)
Strawberries (b)	0.05	EFSA (2011)	0.05	MRL	0.05	MRL
Potatoes	0.01	EFSA (2011)	0.01	STMR‐RAC	0.01	HR‐RAC
Carrots (b)	1	EFSA (2011)	0.34	STMR‐RAC	0.75	HR‐RAC
Celeriacs/turnip rooted celeries (b)	0.08	EFSA (2011)	0.03	STMR‐RAC	0.04	HR‐RAC
Horseradishes (b)	0.08	EFSA (2011)	0.01	STMR‐RAC	0.06	HR‐RAC
Parsnips (b)	0.08	EFSA (2011)	0.01	STMR‐RAC	0.06	HR‐RAC
Parsley roots (b)	0.08	EFSA (2011)	0.01	STMR‐RAC	0.06	HR‐RAC
Salsifies (b)	0.08	EFSA (2011)	0.01	STMR‐RAC	0.06	HR‐RAC
Onions	0.03	EFSA (2011)	0.01	STMR‐RAC	0.02	HR‐RAC
Shallots	0.03	EFSA (2011)	0.01	STMR‐RAC	0.02	HR‐RAC
Spring, green, Welsh onions	0.02	EFSA (2011)	0.02	STMR‐RAC	0.02	HR‐RAC
Chervil	20	Intended	1.34	STMR‐RAC	11.80	HR‐RAC
Chives	20	Intended	1.34	STMR‐RAC	11.80	HR‐RAC
Celery leaves	20	Intended	1.34	STMR‐RAC	11.80	HR‐RAC
Parsley	20	Intended	1.34	STMR‐RAC	11.80	HR‐RAC
Sage	20	Intended	1.34	STMR‐RAC	11.80	HR‐RAC
Rosemary	20	Intended	1.34	STMR‐RAC	11.80	HR‐RAC
Thyme	20	Intended	1.34	STMR‐RAC	11.80	HR‐RAC
Basil & edible flowers	20	Intended	1.34	STMR‐RAC	11.80	HR‐RAC
Laurel/bay leaves	20	Intended	1.34	STMR‐RAC	11.80	HR‐RAC
Tarragon	20	Intended	1.34	STMR‐RAC	11.80	HR‐RAC
Other herbs	20	Intended	1.34	STMR‐RAC	11.80	HR‐RAC
Beans (with pods)	0.01	EFSA (2011)	0.01	STMR‐RAC	0.01	HR‐RAC
Beans (w/out pods)	0.01	EFSA (2011)	0.01	STMR‐RAC	0.01	HR‐RAC
Peas (with pods)	0.01	EFSA (2011)	0.01	STMR‐RAC	0.01	HR‐RAC
Peas (w/out pods)	0.01	EFSA (2011)	0.01	STMR‐RAC	0.01	HR‐RAC
Asparagus	0.01	EFSA (2011)	0.01	STMR‐RAC	0.01	HR‐RAC
Celeries (b)	1.5	EFSA (2011)	0.19	STMR‐RAC	0.77	HR‐RAC
Globe artichokes	0.01	EFSA (2011)	0.01	STMR‐RAC	0.01	HR‐RAC
Leeks	0.01	EFSA (2011)	0.01	STMR‐RAC	0.01	HR‐RAC
Beans	0.01	EFSA (2011)	0.01	STMR‐RAC	0.01	STMR‐RAC
Peas	0.01	EFSA (2011)	0.01	STMR‐RAC	0.01	STMR‐RAC
Poppy seeds	0.02	EFSA (2011)	0.01	STMR‐RAC	0.01	STMR‐RAC
Sunflower seeds	0.02	EFSA (2011)	0.01	STMR‐RAC	0.01	STMR‐RAC
Barley	0.01	EFSA (2011)	0.01	STMR‐RAC	0.01	STMR‐RAC
Oat	0.01	EFSA (2011)	0.01	STMR‐RAC	0.01	STMR‐RAC
Rye	0.01	EFSA (2011)	0.01	STMR‐RAC	0.01	STMR‐RAC
Wheat	0.01	EFSA (2011)	0.01	STMR‐RAC	0.01	STMR‐RAC
Anise/aniseed(b)	0.3	EFSA (2011)	0.05	STMR‐RAC	0.09	HR‐RAC
Black caraway/black cumin (b)	0.3	EFSA (2011)	0.05	STMR‐RAC	0.09	HR‐RAC
Celery seed (b)	0.3	EFSA (2011)	0.05	STMR‐RAC	0.09	HR‐RAC
Coriander seed (b)	0.3	EFSA (2011)	0.05	STMR‐RAC	0.09	HR‐RAC
Cumin seed (b)	0.3	EFSA (2011)	0.05	STMR‐RAC	0.09	HR‐RAC
Dill seed (b)	0.3	EFSA (2011)	0.05	STMR‐RAC	0.09	HR‐RAC
Fennel seed (b)	0.3	EFSA (2011)	0.05	STMR‐RAC	0.09	HR‐RAC
Fenugreek (b)	0.3	EFSA (2011)	0.05	STMR‐RAC	0.09	HR‐RAC
Nutmeg (b)	0.3	EFSA (2011)	0.05	STMR‐RAC	0.09	HR‐RAC
Other spices (seeds) (b)	0.3	EFSA (2011)	0.05	STMR‐RAC	0.09	HR‐RAC
Allspice/pimento (b)	0.3	EFSA (2011)	0.05	STMR‐RAC	0.09	HR‐RAC
Sichuan pepper (b)	0.3	EFSA (2011)	0.05	STMR‐RAC	0.09	HR‐RAC
Caraway (b)	0.3	EFSA (2011)	0.05	STMR‐RAC	0.09	HR‐RAC
Cardamom (b)	0.3	EFSA (2011)	0.05	STMR‐RAC	0.09	HR‐RAC
Juniper berry	0.3	EFSA (2011)	0.05	STMR‐RAC	0.09	HR‐RAC
Peppercorn (black, green, white) (b)	0.3	EFSA (2011)	0.05	STMR‐RAC	0.09	HR‐RAC
Vanilla pods	0.3	EFSA (2011)	0.05	STMR‐RAC	0.09	HR‐RAC
Tamarind (b)	0.3	EFSA (2011)	0.05	STMR‐RAC	0.09	HR‐RAC
Other spices (fruits) (b)	0.3	EFSA (2011)	0.05	STMR‐RAC	0.09	HR‐RAC

STMR‐RAC: supervised trials median residue in raw agricultural commodity; HR‐RAC: highest residue in raw agricultural commodity;

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

^(b)The MRLs derived in the framework of the MRL review for prosulfocarb according to Article 12 of Regulation (EC) No 396/2005 are to be considered as tentative since not fully supported by data but for which no risk to consumers was identified (EFSA, 2011).

Appendix E – Used compound codes

Code/trivial name (a)	IUPAC name/SMILES notation/InChiKey (b)	Structural formula (c)
Prosulfocarb	S‐benzyl dipropylcarbamothioate CCCN(CCC)C(=O)SCc1ccccc1 NQLVQOSNDJXLKG‐UHFFFAOYSA‐N
SYN545179 CSCD097565	2‐hydroxy‐3‐(phenylmethanesulfinyl)propanoic acid O = S(Cc1ccccc1)CC(O)C(=O)O YNOJBQFYBFKIEB‐UHFFFAOYSA‐N
SYN545179 sugar conjugate Metabolite 2B	2‐(hexopyranosyloxy)‐3‐(phenylmethanesulfinyl)propanoic acid O = C(O)C(CS(=O)Cc1ccccc1)OC1OC(CO)C(O)C(O)C1O HMYMPGXAFSJXBT‐UHFFFAOYSA‐N
Prosulfocarb Sulfoxide SYN521384 R331405 CSCC152912	(dipropylamino)(phenylmethanesulfinyl)methanone O = S(Cc1ccccc1)C(=O)N(CCC)CCC SRUUWJFBIOVZLU‐UHFFFAOYSA‐N
Despropyl prosulfocarb R393096 CSAA022183	S‐benzyl N‐propylcarbamothioate CCCNC(=O)SCc1ccccc1 NEZSFVLAFFWDQG‐UHFFFAOYSA‐N S
R331282 CSAA283309	S‐benzyl carbamothioate NC(=O)SCc1ccccc1 LOFZYSZWOLKUGE‐UHFFFAOYSA‐N

IUPAC: International Union of Pure and Applied Chemistry; SMILES: simplified molecular‐input line‐entry system; InChiKey: International Chemical Identifier Key.

^(a)The metabolite name in bold is the name used in the conclusion.

^(b)ACD/Name 2021.1.3 ACD/Labs 2021.1.3 (File Version N15E41, Build 123232, 7 July 2021).

^(c)ACD/ChemSketch 2021.1.3 ACD/Labs 2021.1.3 (File Version C25H41, Build 123835, 28 August 2021).

Suggested citation: EFSA (European Food Safety Authority) , Bellisai G, Bernasconi G, Brancato A, Carrasco Cabrera L, Castellan I, Ferreira L, Giner G, Greco L, Jarrah S, Leuschner R, Magrans JO, Miron I, Nave S, Pedersen R, Reich H, Robinson T, Ruocco S, Santos M, Scarlato AP, Theobald A and Verani A, 2022. Reasoned Opinion on the modification of the existing maximum residue levels for prosulfocarb in herbs and edible flowers. EFSA Journal 2022;20(5):7334, 25 pp. 10.2903/j.efsa.2022.7334