Modification of the existing maximum residue levels for pendimethalin in peas (with pods), beans (with pods) and leeks

Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF Agro B.V. submitted a request to the competent national authority in France to modify the existing maximum residue levels (MRLs) for the active substance pendimethalin in peas (with pods), beans (with pods) and leeks. The data submitted in support of the request were found to be sufficient to derive MRL proposals for the commodities under assessment. Adequate analytical methods for enforcement are available to control the residues of pendimethalin on the commodities under consideration at the validated 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 pendimethalin according to the reported agricultural practices is unlikely to present a risk to consumer health.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, BASF Agro B.V. submitted an application to the competent national authority in France (evaluating Member State, EMS) to modify the existing maximum residue levels (MRLs) for the active substance pendimethalin in peas (with pods), beans (with pods) and leeks. 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 3 November 2021. To accommodate for the intended uses of pendimethalin, the EMS originally proposed to raise the existing MRLs from the limit of quantification (LOQ) of 0.05 mg/kg to 0.15 mg/kg for peas (with pods) and beans (with pods) from the LOQ 0.05 mg/kg to 0.30 mg/kg for leeks.

EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified data gaps, which were requested to the EMS. On 30 September 2022, the EMS submitted the requested information in a revised evaluation report, which replaced the previously submitted evaluation report. Following the revision of the Evaluation Report, an amendment of the MRL proposal in beans (with pods) and peas (with pods) was submitted. The EMS proposed to raise the existing MRLs from the LOQ of 0.05 mg/kg to 0.09 mg/kg for peas (with pods) and to 0.06 mg/kg for beans (with pods).

Based on the conclusions derived by EFSA in the framework of Regulation (EC) No 1107/2009, 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 pendimethalin was investigated following foliar post-emergence applications in crops belonging to the groups of root crops (carrots) and cereals/grass (wheat), and following soil pre-emergence applications in crops belonging to the group of leafy crops (lettuce). In the crops tested, the parent compound was extensively degraded and most of the radioactive residues were found incorporated into natural plant constituents (carbohydrates and other polar components).

In rotational crops, a similar metabolism was observed: The parent compound was identified at low proportions, whilst the radioactive residues were mainly characterised as polar fractions further incorporated into the natural compounds of the plant tissues. The soil metabolite of pendimethalin M455H030 was recovered at low levels in radish root only and was not further considered by the EU pesticides peer review on the renewal of the approval.

Studies investigating the effect of processing on the nature of pendimethalin (hydrolysis studies) demonstrated that the active substance is stable.

Based on the metabolic pattern identified in metabolism studies, hydrolysis studies, the toxicological significance of metabolite M455H030 and the capabilities of enforcement analytical methods, the residue definitions for plant products were proposed as ‘pendimethalin’ both for enforcement and risk assessment. These residue definitions are applicable to primary crops, rotational crops, processed products and honey.

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

Sufficiently validated analytical methods based on liquid chromatography with tandem mass spectrometry (LC–MS/MS) are available to quantify residues in the crops assessed in this application according to the enforcement residue definition. The methods enable quantification of residues at or above 0.01 mg/kg in the crops assessed (LOQ). The LOQ currently in place according to the MRL legislation is 0.05 mg/kg. Extraction efficiency in the commodities under assessment was sufficiently demonstrated.

The available residue trials are sufficient to derive MRL proposals of 0.09 mg/kg for peas (with pods), 0.06 mg/kg for beans (with pods) and 0.3 mg/kg for leeks.

The occurrence of pendimethalin residues in rotational crops was investigated in the framework of the EU pesticides peer review on the renewal of the approval. Based on the available information on the nature of residues, it was 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).

Since legume crops under consideration are melliferous crops, the impact of the intended use on the residues in honey was further investigated. It is concluded that the residues in honey are not expected considering the non-systemic properties of pendimethalin, the intended period of application of the active substance on the crops under consideration (before flowering) and the general extensive metabolism of pendimethalin in crops.

Specific studies investigating the magnitude of pendimethalin residues in processed commodities are not required, as significant residues are not expected in raw agricultural commodities (RAC) and both the total theoretical maximum daily intake (TMDI) and the estimated daily intake are below the trigger value of 10% of the acceptable daily intake (ADI) and the acute reference dose (ARfD), respectively.

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

The toxicological profile of pendimethalin was assessed in the framework of the EU pesticides peer review under Regulation (EC) No 1107/2009 and the data were sufficient to derive the ADI of 0.125 mg/kg bw per day and the ARfD of 0.3 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 did not exceed the ARfD for any of the crops assessed in this application. The highest estimated long-term dietary intake accounted for 3% of the ADI (NL toddler diet).

EFSA concluded that the proposed use of pendimethalin on peas (with pods), beans (with pods) and leeks will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers' health.

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: pendimethalin (F)
0260010	Beans with pods	0.05*	0.06	The submitted data are sufficient to derive an MRL proposal for the intended NEU use. Risk for consumers unlikely.
0260030	Peas with pods	0.05*	0.09	The submitted data are sufficient to derive an MRL proposal for the intended NEU use. Risk for consumers unlikely.
0270060	Leeks	0.05*	0.3	The submitted data are sufficient to derive an MRL proposal for the intended NEU and SEU uses. Risk for consumers unlikely.

Assessment

The European Food Safety Authority (EFSA) received an application to modify the existing maximum residue levels (MRLs) for pendimethalin in peas (with pods), beans (with pods) and leeks. The detailed description of the intended uses of pendimethalin in peas (with pods), beans (with pods) and leeks, which are the basis for the current MRL application, is reported in Appendix A.

Pendimethalin is the ISO common name for N-(1-ethylpropyl)-2,6-dinitro-3,4-xylidine (IUPAC). The chemical structures of the active substance and its main metabolites are reported in Appendix E.

Pendimethalin was evaluated in the framework of Directive 91/414/EEC1 with Spain being the designated rapporteur Member State (RMS). The renewal of approval of the active substance was performed in the framework of Regulation (EC) No 1107/20092 with the Netherlands designated RMS for the representative uses as a foliar treatment on cereals, legumes and carrots. The renewal assessment report (RAR) prepared by the RMS has been peer reviewed by EFSA (2016). The approval of pendimethalin was renewed3 for the use as herbicide on 1 September 2017.

The EU MRLs for pendimethalin are established in Annex II of Regulation (EC) No 396/20054. The review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (MRL review) has been performed (EFSA, 2012) and the proposed modifications have been implemented in the MRL legislation. After completion of the MRL review, EFSA has issued several reasoned opinions on the modification of MRLs for pendimethalin (EFSA, 2013, 2014). The proposals from these reasoned opinions have been considered in recent MRL regulations.5 Certain Codex maximum residue limits (CXLs) have been taken over in the EU MRL legislation6 (FAO, 2016b). Pendimethalin in leeks has been subject to evaluation by the JMPR in 2021 (FAO, 2022). During the 53rd Session of the Codex Committee on Pesticide Residues (CCPR), the delegation of the EU noted a reservation on the advancement of the proposed Codex MRL of 0.3 mg/kg for pendimethalin in leeks due to an ongoing assessment in EU of the residue trials supporting this MRL.

In accordance with Article 6 of Regulation (EC) No 396/2005, BASF Agro B.V. submitted an application to the competent national authority in France (evaluating Member State, EMS) to modify the existing MRLs for the active substance pendimethalin in peas (with pods), beans (with pods) and leeks. 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 EFSA on 3 November 2021. To accommodate for the intended uses of pendimethalin, the EMS proposed to raise the existing MRLs from the limit of quantification (LOQ) of 0.05 mg/kg to 0.15 mg/kg for peas (with pods) and beans (with pods) and from the LOQ of 0.05 mg/kg to 0.30 mg/kg for leeks.

EFSA assessed the application and the evaluation report as required by Article 10 of the MRL Regulation. During the assessment, EFSA identified data gaps, which were requested to the EMS. On 30 September 2022, the EMS submitted the requested information in a revised evaluation report (France, 2021), which replaced the previously submitted evaluation report. Following the revision of the Evaluation Report, an amendment of the MRL proposal in beans (with pods) and peas (with pods) was submitted. The EMS proposed to raise the existing MRLs from the LOQ of 0.05 mg/kg to 0.09 mg/kg for peas (with pods) and to 0.06 mg/kg for beans (with pods).

EFSA based its assessment on the evaluation report submitted by the EMS (France, 2021), the renewal assessment report (RAR) and its addendum (Netherlands, 2015a, 2015b) prepared under Regulation (EC) 1107/2009, the Commission review report on pendimethalin (European Commission, 2017a), the conclusion on the peer review of the renewal of approval of the active substance pendimethalin (EFSA, 2016), hereafter referred to as EU pesticides peer review, as well as the conclusions from previous EFSA opinions on pendimethalin, including the reasoned opinion on the MRL review according to Article 12 of Regulation No 396/2005, and JMPR evaluations (EFSA, 2012, 2013, 2014, 2018b; FAO, 2016b).

For this application, the data requirements established in Regulation (EU) No 283/20137 and the guidance documents applicable at the date of submission of the application to the EMS are applicable (OECD, 2007a,b,c,d,e,f,g,h, 2008a,b, 2009a,b, 2011, 2013, 2016, 2018; European Commission, 2010, 2017b, 2018, 2020, 2021). The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation of Plant Protection Products adopted by Commission Regulation (EU) No 546/20118.

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 (France, 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.

Residues in plants

Nature of residues and methods of analysis in plants and honey

Nature of residues in primary crops

The metabolism of pendimethalin in primary crops belonging to the group of root crops (carrot), leafy crops (lettuce) and cereals/grass (wheat) has been investigated for soil pre-emergence and foliar post-emergence applications in the framework of the EU pesticides peer review (EFSA, 2016).

In the crops tested, most of the radioactive residues were incorporated into natural plant constituents (up to 60% of the total radioactive residue (TRR) in wheat grain, up to 63% TRR in wheat straw, 63% TRR in carrot and 34% TRR in lettuce). The parent compound was extensively degraded in all wheat plant parts and accounted for only 1% TRR in grain, 1.8% TRR in straw and 2.8% TRR in forage. A similar metabolic pathway was observed in carrot root and mature lettuce where pendimethalin occurred at a level of 16% TRR and 14% TRR, respectively, whilst a major part of the radioactivity was characterised as carbohydrates (63% TRR and 34% TRR in carrot and lettuce, respectively).

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

Nature of residues in rotational crops

The environmental fate and behaviour of pendimethalin in soil has been investigated in the framework of the EU pesticides peer review of pendimethalin and the submitted studies indicate that pendimethalin in soil exhibits medium to high persistence and forms metabolites M455H001 (max. 6.9% of applied radioactivity (AR); moderate to medium persistence) and M455H033 (max. 25.9% AR; very low to low persistence) under aerobic and anaerobic conditions, respectively (EFSA, 2016). Thus, the nature and magnitude of residues in rotational crops need to be further investigated.

A confined rotational crop metabolism study on leafy crops, root and tuber crops, and cereals after a bare soil application of pendimethalin of 2 kg a.s./ha (1.7N rate of the Good Agricultural Practices - GAPs under consideration) was assessed in the framework of the EU pesticides peer review (EFSA, 2016). The radioactive residues were characterised as polar fractions further incorporated into the natural compounds of the plant tissues (16% of TRR in wheat straw, up to 81% of TRR in wheat grain).

The parent compound was identified at low proportions (< 1% TRR in wheat grain (plant back interval (PBI) of 120 days)) and up to 19% TRR in immature lettuce (PBI of 365 days; with TRR of 0.02 mg eq./kg). The soil metabolite M455H030 was identified in radish root only (13% TRR, 0.011 mg/kg) at 30 days PBI. This compound was concluded to be unlikely genotoxic and, in view of its low concentration in radish root, a specific residue definition for rotational crops was not deemed necessary by the EU pesticides peer review (EFSA, 2016).

The metabolism of pendimethalin was found to be similar in all investigated crops with the formation of numerous minor metabolites and unidentified polar compounds. On the basis of the outcome of this metabolism study, the EU pesticides peer review concluded that for the representative uses assessed on primary crops in the peer review, the rotational crop field studies are not required.

For the proposed use assessed in this application, no further information is required.

Nature of residues in processed commodities

The effect of processing on the nature of pendimethalin was investigated in the framework of the EU pesticides peer review of pendimethalin (EFSA, 2016). It was shown that pendimethalin is hydrolytically stable under standard processing conditions.

Nature of residues in honey

Since the uses of pendimethalin are intended on legumes which according to EU Technical Guidelines on pesticide residues in honey (European Commission, 2018) are considered melliferous crops, the nature of pendimethalin in honey and the potential carry-over of residues into honey was further assessed.

Honey is a product produced by bees from sugary secretions of plants (floral nectar mainly) through regurgitation, enzymatic conversion and water evaporation and followed by storage in the beehives for a certain time period. In the absence of specific metabolism studies with honeybees, studies investigating the nature of residues in primary crops and rotational crops and studies investigating the degradation during pasteurisation should be considered to determine the nature of residues in honey (European Commission, 2018). It is likely that the nature of residues in pollen and nectar collected from primary and rotational crops, as well as in honey (resulting from the residues in floral nectar), is the same as in primary and rotational crops.

Considering that sufficient data investigating the metabolic profile in primary and rotational crops and the degradation of pendimethalin under standard hydrolysis conditions are available, no further information is required for the current application according to the guidelines. However, it would be desirable to further investigate whether enzymatic processes involved in the production of honey occurring in the bee gut or during the storage in the beehive have an impact on the nature of residues in honey.

Analytical methods for enforcement purposes in plant commodities

Analytical methods for the determination of pendimethalin residues in plant matrices were assessed during the EU pesticides peer review (EFSA, 2016). It was concluded that a published QuEChERS method based on liquid chromatography with tandem mass spectrometry (LC–MS/MS) is available to control residues of pendimethalin in plant matrices and allows quantification of residues at or above the LOQ of 0.01 mg/kg.

EFSA concludes that the extraction efficiency of the analytical method for enforcement (QuEChERS) is sufficiently demonstrated via radio-cross-validation with the method used in the lettuce metabolism study (Netherlands, 2015a; France, 2021) and in line to the requirements of the extraction efficiency Guidance (European Commission, 2017b).

The crops under consideration in the present MRL application belong to the high-water content commodity group (OECD, 2007f). Therefore, sufficiently validated methods for the enforcement of pendimethalin residues in peas with pods, beans with pods and leeks are available.

Storage stability of residues in plants

The storage stability of pendimethalin in plants stored under frozen conditions was investigated in the framework of the EU pesticides peer review (EFSA, 2016). A data gap on storage stability in a second matrix of a high-water content commodity group was identified by the EU pesticides peer review (studies with alfalfa were available, demonstrating storage stability of pendimethalin for 43 months when stored at ≤ −10°C).

A new study on storage stability of residues in frozen samples of plant parts classified as matrices with high-water content (wheat forage), high-protein content (peas, dried) and high-starch content matrices (carrots, potatoes) was submitted with the current application (France, 2021).

It was demonstrated that in the commodities assessed in the framework of this application, belonging to the category of high-water content matrices, residues were stable for at least 24 months when stored at −18°C. No further data are required for the present assessment.

Proposed residue definitions

Based on the metabolic pattern identified in metabolism studies (although no clear residue marker could be determined), the results of hydrolysis studies, the toxicological significance of metabolite M455H030 (which is unlikely to be genotoxic) and the capabilities of enforcement analytical methods, the residue definitions for enforcement and risk assessment were set as ‘pendimethalin’ by the peer review (EFSA, 2016).

The same residue definitions are applicable to rotational crops and processed products. In the absence of specific metabolism studies on honey, the same residue definitions are also proposed for honey.

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

EFSA concluded that these residue definitions are appropriate for the crops under consideration and no further information is required.

Magnitude of residues in plants and honey

Magnitude of residues in primary crops

In support of the current MRL application, residue trials performed in peas with pods, beans with pods and leeks were provided.

The design of the trials did not allow investigation of decline of residues over time. However, this is considered a minor deficiency, taking into account that residues were measured at long intervals after the application (at least 46 days after treatment) and that the treatments are intended to take place at pre- to early post-emergence, before the harvestable and edible part of the crop is formed.

The samples of residue trials were stored under conditions for which integrity of the samples has been demonstrated.

The methods used in the analysis of samples of beans with pods, peas with pods and leek in the context of the residue trials selected for MRL and risk assessment value calculations are based on high-performance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS). The samples were analysed for the parent compound in line with the residue definitions for enforcement and risk assessment. According to the assessment of the EMS, the method used (L0163/01) was sufficiently validated and fit for purpose (France, 2021). Extraction efficiency was also sufficiently demonstrated via radio-cross-validation with the method used in the lettuce metabolism study (Netherlands, 2015a; France, 2021) and in line to the requirements of the extraction efficiency Guidance (European Commission, 2017b).

Beans with pods

NEU zone

Pre-emergence GAP: 1 × 1.183 kg a.s./ha, BBCH 00–08, PHI: defined by time of application

Four independent and GAP-compliant NEU residue trials were conducted on peas with pods during the growing season of 2015 in Germany, northern France, the Netherlands and the United Kingdom. The trial plots received a foliar treatment at application rates of 1.01–1.16 kg a.s./ha, at BBCH of 00–07. In one trial, the treatment was performed at BBCH 09; this is considered only a minor deviation. Samples were collected 71–77 days after application. Residues in all trial samples were below the LOQ of 0.01 mg/kg.

In addition, eight NEU trials on peas with pods assessed in the context of the MRL review were considered (EFSA, 2012). These trials were performed according to a more critical application pattern (1 × 2 kg a.s./ha, BBCH: 08, PHI n.a.). Despite a higher application rate, residues were measured below the LOQ of 0.05 mg/kg in all trials.

The applicant proposes to extrapolate the available residue data on peas with pods to beans with pods. Such an extrapolation is possible according to EU Technical Guidelines on extrapolation (European Commission, 2020).

Overall, considering that a more critical pre-emergence NEU GAP on beans with pods was already assessed in the context of the MRL review (EFSA, 2012), and that the intended NEU use is not expected to lead to residue above the enforcement LOQ (0.05 mg/kg as currently set in the MRL legislation), it is concluded that a new MRL recommendation is not needed for the intended pre-emergence NEU use on beans with pods. Should risk managers decide to lower the existing enforcement LOQ to 0.01 mg/kg, the derived MRL proposal in support of the pre-emergence use would be at the LOQ of 0.05 mg/kg.

Early post-emergence GAP: 1 × 0.728 kg a.s./ha, BBCH 00–13, PHI: defined by time of application

Eight independent NEU residue trials were conducted on peas with pods (4) and beans with pods (4) during the growing seasons of 2013, 2016 and 2017 in Austria, Germany, northern France, the Netherlands and the United Kingdom. The treatment was performed at BBCH 13–14. Five trials (4 on peas with pods and 1 on beans with pods) were overdosed for more than 25% of the intended application rate. Therefore, the proportionality approach was applied and all residue trial data were scaled to match the intended GAP. Samples were collected 49–109 days after application.

The residue data on beans with pods and peas with pods were combined to derive an MRL proposal. Extrapolation to beans with pods from the combined residue data set is possible according to EU Technical Guidelines on extrapolation (European Commission, 2020).

The NEU GAP on beans with pods (early post-emergence) is sufficiently supported by data. On the basis of the early post-emergence NEU trials, an MRL of 0.06 mg/kg was derived for beans with pods.

SEU zone

Although no SEU GAP on beans with pods was submitted in the context of the current MRL application, four pre-emergence and two early post-emergence SEU residue trials on peas with pods were submitted. These trials were not assessed, considering that no pre- and early post-emergence SEU GAP on beans with pods was submitted in the context of the current MRL application.

Peas with pods

NEU zone

Post-emergence GAP: 1 × 1.2 kg a.s./ha, BBCH 11–16, PHI: defined by time of application

Eight independent NEU residue trials were conducted on peas with pods (4) and beans with pods (4) during the growing seasons of 2013, 2016 and 2017 in Austria, Germany, Northern France, the Netherlands and the United Kingdom. Seven trials (4 on peas with pods and 3 on beans with pods) were performed according to the intended GAP, at application rates of 0.89–1.07 kg a.s./ha and at BBCH 13–14; one trial on beans with pods was underdosed for more than 25% of the intended application rate and was therefore disregarded. Samples were collected 49–109 days after application.

Extrapolation among peas with pods and beans with pods is possible according to EU Technical Guidelines on extrapolation (European Commission, 2020). The data sets on beans and peas with pods were combined to derive an MRL of 0.09 mg/kg for peas with pods.

SEU zone

A post-emergence SEU GAP on peas with pods (i.e. 1 × 1.2 kg a.s./ha, BBCH 11–16, PHI: defined by time of application) was originally submitted in the context of the current MRL application. This GAP was insufficiently supported by SEU residue trials on peas with pods (2) and thereafter withdrawn in the revised evaluation report. This scenario is therefore considered not relevant.

Leek

French pre- and post-plantation GAPs on leek were submitted in the context of the current MRL application. Considering that France belongs both to NEU and SEU zones, both NEU and SEU trials were submitted by the Applicant and assessed by the EMS.

NEU zone

Pre-plantation GAP: 1 × 1.183 kg a.s./ha, BBCH 11–15, PHI: defined by time of application

Two independent NEU residue trials submitted in the context of the Article 12 Confirmatory data application were reconsidered by the EMS (EFSA, 2018b). The trials were conducted on leeks during the growing seasons of 1976 and 1997 in northern France and Germany. The trial plots received a preplanting treatment at a GAP-compliant application rate of 1.32 kg a.s./ha and at an overdosed application rate of 1.56 kg a.s./ha. Samples were collected 91 and 184 days after application. Residues were measured below the LOQs of 0.05 mg/kg and 0.02 mg/kg.

The number of trials is not sufficient to derive robust MRL and risk assessment values in support of the preplantation NEU GAP on leeks.

Post-plantation GAP: 1 × 1.183 kg a.s./ha, BBCH 11–15, PHI: defined by time of application

Eight independent NEU residue trials were conducted on leeks during the growing seasons of 2018 and 2019 in Denmark, Germany, northern France, Poland and the Netherlands. The trial plots received a foliar treatment at application rates of 1.22–1.41 kg a.s./ha, at BBCH of 13–15, in compliance with the intended FR GAP on leeks. Samples were collected 46–111 days after application. According to the assessment of the EMS, the method used (L0163/01) was sufficiently validated and fit for purpose. Extraction efficiency was also sufficiently demonstrated (Netherlands, 2015a; France, 2021). The residue trials data indicate that an MRL of 0.03 mg/kg would be sufficient to support the intended use. This MRL proposal, however, is lower than the current enforcement LOQ of 0.05 mg/kg.

In addition, 10 NEU trials on leek submitted in the context of the Article 12 Confirmatory data application were considered (EFSA, 2018b). These were performed according to a more critical application pattern (1 × 1.64 kg a.s./ha, BBCH 00–13, PHI: n.a.). Since residues in all trials were below LOQ of 0.02 mg/kg, the application of proportionality principle to derive residue values for the intended GAP is not applicable. The residue data confirm that at the intended GAP, no residues above the enforcement LOQ of 0.05 mg/kg will occur.

To derive an MRL proposal and risk assessment values in support of the NEU post-plantation use on leek, the available data sets were combined and an MRL proposal of 0.04 mg/kg was derived. It is noted that the proposed MRL is below the existing enforcement LOQ of 0.05 mg/kg. Should risk managers decide to lower the existing enforcement LOQ, a lower MRL of 0.04 mg/kg would be sufficient in support of the intended NEU post-plantation use.

SEU zone

Pre-plantation GAP: 1 × 1.183 kg a.s./ha, BBCH 11–14, PHI: defined by time of application

Three independent and GAP-compliant SEU residue trials on leek were performed during the growing seasons of 1976 and 2002 in southern France. The trial plots received a preplanting treatment at an application rate of 1.32 kg a.s./ha. Samples were collected 107–134 days after application. Residues were measured below the LOQ of 0.05 mg/kg. An additional independent and GAP compliant residue trial on leek would in principle be required; however, considering that residues below the LOQ of 0.05 mg/kg were measured, the number of trials is considered acceptable.

Detailed validation data of the analytical methods RLA 12673.01V and RLA 10471V used for the quantification of residues in samples collected from these trials (including information on extraction efficiency) were not provided. However, for the method RLA 12673.01 V, the EMS reported satisfactory overall recovery (84%), sufficient number of fortification levels investigated and overall concluded that the residue trial study is valid (France, 2021). For the method RLA 10471 V, the only information submitted on the validity of analytical method was that the overall validated sensitivity of the method support the LOQ of 0.05 mg/kg. This is not sufficient to conclude on the validity of results provided for the residue trials performed in 1976.

In conclusion, MRL proposal and risk assessment values could not be derived based on the SEU trials performed at preplantation.

Post-plantation GAP: 1 × 1.183 kg a.s./ha, BBCH 11–14, PHI: defined by time of application

Four independent SEU residue trials were conducted on leeks during the growing seasons of 2012, 2013 and 2017 in Greece, Italy and Southern France. Two trial plots received a foliar treatment at GAP-compliant application rates of 1.25 and 1.27 kg a.s./ha, at BBCH of 13–15. Samples were collected 105 and 146 days after application. Residues of pendimethalin were at the levels of 0.082 mg/kg and 0.23 mg/kg. Two trial plots received an overdosed foliar treatment at application rates of 1.79 and 1.99 kg a.s./ha. Samples were collected 44 and 57 days after application. Since residues were below the LOQ of 0.01 mg/kg in the overdosed trials, the application of the proportionality principle to derive residue values for the intended GAP is not applicable (EFSA, 2018c).

The post-plantation GAP on leeks is sufficiently supported by SEU data. On the basis of the post-plantation SEU trials, an MRL of 0.5 mg/kg was derived for leeks.

In conclusion, it is noted that the EMS proposed to derive an overall MRL of 0.3 mg/kg for leeks, based on the combined SEU and NEU post-plantation data sets. It must be noted that residue trials from NEU and SEU should in principle not be combined, unless the criteria for combining NEU and SEU trial data sets described in the Technical Guidelines on MRL setting (European Commission, 2020) are all met. Considering that in this case one of the criteria is not met (i.e. the MRL proposals derived for the individual data sets do not fall into the same or neighbouring MRL classes), EFSA would in principle not be in favour of combining the two data sets. However, considering that

• the GAP under assessment is intended for France and a sufficient number of NEU trials were submitted (these being already sufficient in support of the intended French GAP);
• the use is intended for early post-emergence crop stages (BBCH 11–15);
• NEU and SEU data sets belong to the same statistical population according to the Mann–Whitney U-test;
• the distribution of the residue data from both NEU and SEU trials shows that pendimethalin residues are frequently measured at levels below the LOQs of 0.01 and 0.02 mg/kg (i.e. in a total of 19 of 22 trials, with unexpectedly higher residue levels of 0.082 and 0.23 mg/kg measured in the SEU data set);
• leek is a minor crop in the SEU zone.

EFSA considered it appropriate in this case to derive an MRL of 0.3 mg/kg based on the combined NEU and SEU data sets. This is in line with the CXL derived based on the JMPR assessment (EFSA, 2022) and with the EMS approach.

Magnitude of residues in rotational crops

Based on the results of the confined rotational crop metabolism study assessed in the EU pesticides peer review, indicating a low concentration of pendimethalin and its metabolite M455H030 in rotational crops following a bare soil treatment with pendimethalin at 2 kg a.s./ha, the EU peer review on the renewal of the approval concluded that a field rotational crop study to assess the magnitude of residues in rotational crops is not required (EFSA, 2016). The conclusion was derived for the representative uses assessed for the renewal of the approval.

Since the maximum annual application rate for the crops under consideration (i.e. 1.2 kg a.s./ha) is lower than the application rate tested in the confined rotational crop metabolism study and is within the same range as in the representative uses assed for the renewal of the approval, the same conclusion as above is set out, provided that the active substance is applied according to the proposed GAP.

Magnitude of residues in honey

Specific studies investigating the magnitude of pendimethalin residues in honey were not submitted. In line with the EMS conclusions, these are not needed considering the intended period of application (before flowering of the crops, at pre- and early post-emergence), the non-systemicity of a.s. and its general extensive metabolism, which suggest that pendimethalin residues in honey are expected to be negligible. In addition, data from the 2-year US monitoring programme of honey for consumer's exposure showed that no residues of pendimethalin above the LOQ of 0.05 mg/kg were measured in honey, indicating that the existing EU MRL of 0.05 mg/kg established in honey is fit for purpose for use with consumer safety protection goals.

Magnitude of residues in processed commodities

Specific studies investigating the magnitude of pendimethalin residues in processed commodities were not submitted. These are not required, considering that the level of residues measured in the residue trials on peas with pods, beans with pods and leeks was less than 0.1 mg/kg (except in one trial where a residue level of 0.23 mg pendimethalin/kg was measured in leek; considered acceptable based on expert judgement) and that the contribution of the commodities under consideration to the theoretical maximum daily intake (TMDI) is < 10% of the acceptable daily intake (ADI) and the estimated daily intake is < 10% of the acute reference dose (ARfD) for any European consumer group diet.

Proposed MRLs

The available data are considered sufficient to derive MRL proposals as well as risk assessment values for the commodities under evaluation (see Appendix B.1.2.1). In Section 3, EFSA assessed whether residues on these crops resulting from the intended uses are likely to pose a consumer health risk.

Residues in livestock

Not relevant as peas (with pods), beans (with pods) and leeks are not used for feed purposes.

A study on a new method of analysis for enforcement in animal commodities (method D1601/01) and two feeding studies on laying hens and lactating cows were submitted by the Applicant under the present assessment. These studies were not assessed as considered not relevant in the context of the current MRL application.

Consumer risk assessment

EFSA performed a dietary risk assessment using revision 3.1 of the EFSA PRIMo (EFSA, 2018a, 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, 2016a).

The toxicological reference values for pendimethalin used in the risk assessment (i.e. ADI and ARfD values) were derived in the framework of the EU pesticides peer review (European Commission, 2017).

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, 2016a). The calculations were based on the highest residue values (HR) derived from supervised field trials and the complete list of input values can be found in Appendix D.1.

The short-term exposure did not exceed the ARfD for any the crops assessed in this application. The acute consumer exposure calculated for the commodities under assessment accounted to 4.5% of ARfD for leeks and 0.2% of ARfD for both beans and peas with pods (see Appendix B.3).

Long-term (chronic) dietary risk assessment

The long-term exposure assessment was performed, taking into account the supervised trials median residue (STMR) values derived for the commodities assessed in this application from the submitted residue trials; for the remaining commodities covered by the MRL regulation, the existing EU MRLs and, where available, the STMR values derived in previous EFSA reasoned opinions and a JMPR assessment were selected as input values (EFSA, 2012, 2013, 2014; FAO, 2016b). The complete list of input values is presented in Appendix D.1.

The highest estimated long-term dietary intake accounted for 3% of the ADI (NL toddler diet). The contribution of residues expected in the commodities assessed in this application to the overall long-term exposure is presented in more detail in Appendix B.3.

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

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

Conclusion and Recommendations

The data submitted in support of this MRL application were found to be sufficient to derive an MRL proposal for peas (with pods), beans (with pods) and leeks.

EFSA concluded that the proposed use of pendimethalin on peas (with pods), beans (with pods) and leeks will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers' health.

The MRL recommendations are summarised in Appendix B.4.

Abbreviations

• ADI
• acceptable daily intake
• AR
• applied radioactivity
• ARfD
• acute reference dose
• BBCH
• growth stages of mono- and dicotyledonous plants
• bw
• body weight
• CCPR
• Codex Committee on Pesticide Residues
• CS
• capsule suspension
• CXL
• Codex maximum residue limit
• DAT
• days after treatment
• EC
• emulsifiable concentrate
• EMS
• evaluating Member State
• FAO
• Food and Agriculture Organisation of the United Nations
• GAP
• Good Agricultural Practice
• HPLC-MS/MS
• high performance liquid chromatography with tandem mass spectrometry
• HR
• highest residue
• ISO
• International Organisation for Standardisation
• IUPAC
• International Union of Pure and Applied Chemistry
• JMPR
• Joint FAO/WHO Meeting on Pesticide Residues
• LC
• liquid chromatography
• LOQ
• limit of quantification
• MRL
• maximum residue level
• MS
• mass spectrometry detector
• MS/MS
• tandem mass spectrometry detector
• NEU
• northern Europe
• OECD
• Organisation for Economic Co-operation and Development
• PBI
• plant back interval
• PHI
• preharvest interval
• PRIMo
• (EFSA) Pesticide Residues Intake Model
• QuEChERS
• Quick, Easy, Cheap, Effective, Rugged, and Safe (analytical method)
• RAC
• raw agricultural commodity
• RAR
• Renewal Assessment Report
• RMS
• rapporteur Member State
• SANCO
• Directorate-General for Health and Consumers
• SC
• suspension concentrate
• SEU
• southern Europe
• STMR
• supervised trials median residue
• TMDI
• theoretical maximum daily intake
• TRR
• total radioactive residue
• WHO
• World Health Organisation

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 (min)	g a.s./hL min–max	Water L/ha min–max	Rate	Unit
Beans (with pods)	NEU	F	Dicotyledonous weeds (TTTDS)	CS	455	Soil treatment – spraying	Pre-emergence (BBCH 00–08)	1	–		100–400	0.728	kg a.s./ha	F	Garden beans (PHSSP)
NEU	F	Dicotyledonous weeds (TTTDS)	CS	455	Foliar treatment – broadcast spraying	Early post-emergence (BBCH 09–13)	1	–		100–400	0.728	kg a.s./ha	F	Garden beans (PHSSP) Identified as critical early post-emergence GAP on beans (with pods)
NEU	F	Dicotyledonous weeds (TTTDS)	CS	455	Foliar treatment – broadcast spraying	Early post-emergence (BBCH 10–13)	1	–		100–400	0.66	kg a.s./ha	F	Garden beans (PHSSS)
NEU	F	Annual dicotyledonous weeds (TTTDS/3A NDIT)	CS	455	Soil treatment – spraying	Pre-emergence (BBCH 00–08)	1	–		200–400	1.183	kg a.s./ha	F	Runner beans (PHSC); Climbing French beans (PHSVX) Identified as critical pre-emergence GAP on beans (with pods)
Peas (with pods)	NEU	F	Broadleaved weeds and grasses	SC	400	Foliar treatment – broadcast spraying	post-emergence (BBCH 11–16)	1	–		100–400	1.2	kg a.s./ha	F	Identified as critical post-emergence GAP on peas (with pods)
Leeks	SEU/NEU (France)	F	Broadleaved weeds and grasses	SC	400	Broadcast spraying 1) bare soil 2) foliar treatment	BBCH 11–15 1) Pre-plantation 2) post-plantation	1	–		100–400	1.2	kg a.s./ha	F	Including leek with short cycle (2–3 months). The treatments are performed separately: either at pre-planting or post planting of leek.

Appendix B – List of end points

B.1 Residues in plants

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

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

Primary crops (available studies)	Crop groups	Crop(s)	Application(s)	Sampling (DAT)	Comment/Source
Fruit crops	–
Root crops	Carrot	1 × 2.0 kg a.s./ha	57	Foliar post-emergence applications. Radiolabelled active substance: 14C-phenyl and 13C-4-methyl group labelled pendimethalin (EFSA, 2016)
Leafy crops	Lettuce	1 × 1.6 kg a.s./ha	27, 48	Soil pre-emergence treatment. Radiolabelled active substance: 14C-phenyl and 13C-4-methyl group labelled pendimethalin (EFSA, 2016)
Cereals/grass	Wheat	1 × 2.0 kg a.s./ha	27, 73	Foliar post-emergence applications. Radiolabelled active substance: 14C-phenyl and 13C-4-methyl group labelled pendimethalin (EFSA, 2016)
Pulses/oilseeds	–
Miscellaneous	–
Rotational crops (available studies)	Crop groups	Crop(s)	Application(s)	PBI (DAT)	Comment/Source
Root/tuber crops	White radish	Bare soil, 2.0 kg a.s./ha	30, 120, 365	Bare soil application, ploughing at 20 cm before sowing (EFSA, 2016)
Leafy crops	Lettuce	Bare soil, 2.0 kg a.s./ha	30, 120, 365
Cereal (small grain)	Spring wheat	Bare soil, 2.0 kg a.s./ha	30, 120, 365
Other	–
Processed commodities (hydrolysis study)	Conditions	Stable?	Comment/Source
Pasteurisation (20 min, 90°C, pH 4)	Yes	EFSA (2016)
Baking, brewing and boiling (60 min, 100°C, pH 5)	Yes	EFSA (2016)
Sterilisation (20 min, 120°C, pH 6)	Yes	EFSA (2016)
Other processing conditions	–

B.1.1.2 Stability of residues in plants

Plant products (available studies)	Category	Commodity	T (°C)	Stability period	Compounds covered	Comment/Source
Value	Unit
High-water content	Alfalfa, forage	≤ −10	43	Months	Pendimethalin	EFSA (2016)
Wheat, forage	−18	24	Months	Pendimethalin	France (2021)
High-oil content	Soybean, seed	≤ −14	24	Months	Pendimethalin	EFSA (2016)
High protein content	Alfalfa, hay	≤ −10	43	Months	Pendimethalin	EFSA (2016)
Pea, dried	−18	24	Months	Pendimethalin	France (2021)
Dry/High starch	Corn, grain	≤ −14	18	Months	Pendimethalin	EFSA (2016)
Alfalfa, seed	≤ −14	43	Months	Pendimethalin	EFSA (2016)
Carrot, potato	−18	24	Months	Pendimethalin	France (2021)
High acid content	Orange	≤ −10	24	Months	Pendimethalin	EFSA (2016)
Others	Tobacco	≤ −18	12	Months	Pendimethalin	EFSA (2016)

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)
Beans with pods	NEU (pre-emergence GAP: 1 × 1.183 kg/ha, BBCH 00–08)	4 × < 0.01	Residue trials on peas with pods compliant with the intended GAP. Four additional trials would in principle be required to allow extrapolation to beans with pods; however, considering that residues below the LOQ of 0.01 mg/kg were measured, the number of trials is considered acceptable to extrapolate to beans with pods. The enforcement LOQ in MRL legislation is currently set to 0.05 mg/kg.	0.01*	0.01	0.01	1
EFSA, 2012: 8 × < 0.05	Overdosed (1 × 2 kg a.s./ha, BBCH 00–08) residue trials on peas with pods assessed during the MRL review. Residue trials confirm residues < LOQ. Extrapolation to beans with pods possible. Based on the submitted data on peas with pods, it is concluded that no residues above the enforcement LOQ of 0.05 mg/kg will occur following the intended use on beans with pods in NEU.	0.05*	0.05	0.05	1
NEU (early post-emergence GAP: 1 × 0.728 kg/ha, BBCH 00–13)	Unscaled residues: Peas with pods: < 0.01(e); 0.017(e); 0.018(e); 0.057(e) Beans with pods: 2 × < 0.01; 0.014; 0.017 Scaled residues: Peas with pods: < 0.01(e); 0.012(e) (SF: 0.73); 0.013(e) (SF: 0.70); 0.039(e) (SF:0.68) Beans with pods: 2 × < 0.01; 0.011 (SF: 0.82); 0.013 (SF: 0.79)	Four overdosed residue trials on peas with pods (1 × 1.001–1.07 kg a.s./ha) and four GAP-compliant trials on beans with pods available. All residue trials were scaled to match the intended GAP. The scaling factors (SF) applied are reported in brackets after the scaled residue value. Extrapolation to beans with pods possible from a combined residue data set on beans and peas with pods.	0.06	0.04	0.01	1
P eas with pods	NEU (post-emergence GAP: 1 × 1.2 kg/ha, BBCH 11–16)	Peas with pods: < 0.01; 0.017; 0.018; 0.057 Beans with pods: < 0.01; 0.014; 0.017	GAP-compliant residue trials on peas and beans with pods. Extrapolation to peas with pods possible from a combined residue data set on beans and peas with pods.	0.09	0.06	0.02	1
Leeks	NEU (pre-plantation GAP: 1 × 1.2 kg/ha, BBCH 11–15)	< 0.02; < 0.05	Residue trials on leek. One compliant with GAP; the other one overdosed (1.3 N). The number of trials is not sufficient to derive robust MRL and risk assessment values.	–	–	–	–
NEU (post-plantation GAP: 1 × 1.2 kg/ha, BBCH 11–15)	7 × < 0.01; 0.02	Residue trials on leek compliant with post-plantation GAP. The derived MRL proposal from this data set is covered by the MRL of 0.05* mg/kg currently set by Reg. (EU) 2019/1791.	0.03	0.02	0.01	1
EFSA, 2018b: 10 × < 0.02	Residue trials on leek submitted in the context of the Art.12 Conf. data assessment (EFSA, 2018b). Trials compliant with the more critical NEU GAP on leeks assessed by EFSA (EFSA, 2018b) (1 × 1.64 kg a.s./ha, BBCH 00–13, PHI: defined by time of application). Since residues in all trials were below LOQ, the application of proportionality principle to derive residue values for the intended GAP is not applicable. The data confirm that at the intended GAP, no residues above the LOQ of 0.02 mg/kg will occur. This is covered by the existing MRL of 0.05* mg/kg currently set by Reg. (EU) 2019/1791.	0.02*	0.02	0.02	1
Combined (France, 2021 + EFSA, 2018b): 7 × < 0.01; 10 × < 0.02; 0.02	See comments above for each data set. The derived MRL proposal from the combined data set is covered by the MRL of 0.05* mg/kg currently set by Reg. (EU) 2019/1791. Should risk managers decide to lower the existing enforcement LOQ, a lower MRL of 0.04 mg/kg would be sufficient in support of the intended NEU use.	0.04	0.02	0.02	1
SEU (pre-plantation GAP: 1 × 1.2 kg/ha, BBCH 11–15)	3 × < 0.05	Residue trials on leek compliant with GAP. An additional trial would in principle be required; however, considering that residues below the LOQ of 0.05 mg/kg were measured, the number of trials is considered acceptable. Nevertheless, MRL proposal was not derived considering that information on the validation of the analytical methods used for the quantification of residues in samples collected from these trials is either not available or is insufficient.	–	–	–	–
SEU (post-plantation GAP: 1 × 1.2 kg/ha, BBCH 11–15)	2 × < 0.01; 0.082; 0.23	Two residue trials on leek compliant with GAP (measured residues: 0.082, 0.23 mg/kg); two residue trials on leek overdosed beyond 25% deviation (1 × 1.79–1.99 kg a.s./ha). Since residues below the LOQ of 0.01 mg/kg were measured in the overdosed trials, the application of the proportionality principle to derive residue values for the intended GAP is not applicable. The data are acceptable to derive MRL and risk assessment values for leeks.	0.5	0.23	0.05	1
	NEU + SEU (post-plantation GAP: 1 × 1.2 kg/ha, BBCH 11–15)	9 × < 0.01; 10 × < 0.02; 0.02; 0.082; 0.23	EFSA would in principle not be in favour of combining the two data sets, as the criteria for combining NEU and SEU trial data sets, as described in the Technical Guidelines on MRL setting SANTE/2019/12752 (European Commission, 2020), are not all met (i.e. the MRL proposals derived for the individual data sets do not fall into the same or neighbouring MRL classes). However, considering that (a) the GAP under assessment is intended for France and a sufficient number of NEU trials were submitted (these being already sufficient in support of the intended French GAP); (b) the use is intended for early post-emergence crop stages (BBCH 11–15); (c) NEU and SEU data sets belong to the same statistical population according to the Mann–Whitney U-test; (d) the distribution of the residue data from both NEU and SEU trials shows that pendimethalin residues are frequently measured at levels below the LOQs of 0.01 and 0.02 mg/kg (i.e. in a total of 19 out of 22 trials, with unexpectedly higher residue levels of 0.082 and 0.23 mg/kg measured in the SEU data set); (e) leek is a minor crop in the SEU zone; EFSA considered it appropriate in this case to derive an MRL based on the combined NEU and SEU data sets.	0.3	0.23	0.02	1

B.1.2.2 Residues in rotational crops

B.1.2.3 Residues in honey

No studies investigating the magnitude of pendimethalin residues in honey were submitted. These are not needed considering the intended period of application (before flowering of the crops, at pre- and early post-emergence), the non-systemicity of pendimethalin and its general extensive metabolism, which suggest that pendimethalin residues in honey are expected to be negligible.

B.1.2.4 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: pendimethalin(F)
0260010	Beans with pods	0.05*	0.06	The submitted data are sufficient to derive an MRL proposal for the intended NEU use. Risk for consumers unlikely.
0260030	Peas with pods	0.05*	0.09	The submitted data are sufficient to derive an MRL proposal for the intended NEU use. Risk for consumers unlikely.
0270060	Leeks	0.05*	0.3	The submitted data are sufficient to derive an MRL proposal for the intended SEU and NEU uses. Risk for consumers unlikely.

Appendix C – Pesticide Residue Intake Model (PRIMo)

Appendix D – Input values for the exposure calculations

D.1 Consumer risk assessment

Commodity	Existing/Proposed MRL (mg/kg)	Source	Chronic risk assessment	Acute risk assessment
Input value (mg/kg)	Comment	Input value (mg/kg)	Comment (a)
Risk assessment residue definition (plant and animal commodities): pendimethalin
Beans (with pods)	0.06	MRL proposal	0.01	STMR-RAC	0.04	HR-RAC
Peas (with pods)	0.09	MRL proposal	0.02	STMR-RAC	0.06	HR-RAC
Leeks	0.3	MRL proposal	0.02	STMR-RAC	0.23	HR-RAC
Citrus fruits	0.05	EFSA (2012)	0.05	STMR-RAC	0.05	HR-RAC
Tree nuts	0.05	EFSA (2012)	0.05	STMR-RAC	0.05	HR-RAC
Pome fruits	0.05	EFSA (2012)	0.05	STMR-RAC	0.05	HR-RAC
Stone fruits	0.05	EFSA (2012)	0.05	STMR-RAC	0.05	HR-RAC
Berries and small fruits (table and wine grapes, strawberries, cane fruits, other small and fruit berries)	0.05	EFSA (2012)	0.05	STMR-RAC	0.05	HR-RAC
Miscellaneous fruits (edible peel, inedible peel small, inedible peel large)	0.05	Reg. (EU) 2019/1791	0.05	LOQ	0.05	LOQ
Potatoes	0.05	EFSA (2012)	0.05	STMR-RAC	0.05	HR-RAC
Tropical root and tuber vegetables	0.05	Reg. (EU) 2019/1791	0.05	LOQ	0.05	LOQ
Beetroots, Jerusalem artichokes, Radishes	0.05	Reg. (EU) 2019/1791	0.05	LOQ	0.05	LOQ
Carrots, Horseradishes, Parsnips, Parsley roots/Hamburg roots parsley, Salsifies	0.7	EFSA (2014)	0.05	STMR-RAC	0.41	HR-RAC
Celeriacs/turnip-rooted celeries	0.2	EFSA (2014)	0.02	STMR-RAC	0.12	HR-RAC
Swedes/rutabagas, Turnips	0.4	EFSA (2014)	0.05	STMR-RAC	0.23	HR-RAC
Other root and tuber vegetables	0.05	Reg. (EU) 2019/1791	0.05	LOQ	–	–
Garlic, Onions, Shallots	0.05	EFSA (2012)	0.05	STMR-RAC	0.05	HR-RAC
Spring onions/green onions and Welsh onions	0.05	EFSA (2012)	0.02	STMR-RAC	0.03	HR-RAC
Other bulb vegetables	0.05	EFSA (2012)	0.05	LOQ	–	–
Fruiting vegetables (Solanacea, Cucurbits with edible peel, Cucurbits with inedible peel, Sweet corn, Other fruiting vegetables)	0.05	EFSA (2012)	0.05	STMR-RAC	0.05	HR-RAC
Flowering brassica, Head brassica	0.05	EFSA (2012)	0.05	STMR-RAC	0.05	HR-RAC
Leafy brassica	0.5	EFSA (2012)	0.05	STMR-RAC	0.25	HR-RAC
Kohlrabies	0.3	EFSA (2012)	0.06	STMR-RAC	0.13	HR-RAC
Lamb's lettuce/corn salads, Cress and other sprouts and shoots, Roman rocket/rucola, Baby leaf crops (including brassica species)	0.6	EFSA (2012)	0.05	STMR-RAC	0.39	HR-RAC
Lettuces	4	FAO (2016b)	0.06	STMR-RAC	2.20	HR-RAC
Escaroles/broad-leaved endives	0.05	EFSA (2012)	0.05	STMR-RAC	0.05	HR-RAC
Land cress, Red mustards, Other lettuce and other salad plants	0.05	Reg. (EU) 2019/1791	0.05	LOQ	0.05	LOQ
Spinach & similar (leaves), Grape leaves and similar species, Watercress, Witloofs/Belgian endives	0.05	Reg. (EU) 2019/1791	0.05	LOQ	0.05	LOQ
Herbs and edible flowers (except parsley and sage)	0.6	EFSA (2012)	0.05	STMR-RAC	0.39	HR-RAC
Parsley, Sage	2	EFSA (2012)	0.20	STMR-RAC	0.76	HR-RAC
Legume vegetables (except beans and peas with pods)	0.05	EFSA (2012)	0.05	STMR-RAC	0.05	HR-RAC
Asparagus	0.1	FAO (2016b)	0.05	STMR-RAC	0.06	HR-RAC
Cardoons, Bamboo shoots, Palm hearts, Other stem vegetables	0.05	Reg. (EU) 2019/1791	0.05	LOQ	0.05	LOQ
Celeries, Florence fennels	0.1	EFSA (2012)	0.04	STMR-RAC	0.07	HR-RAC
Globe artichokes, Rhubarbs	0.05	EFSA (2012)	0.05	STMR-RAC	0.05	HR-RAC
Fungi, Algae and prokaryotes organisms	0.05	Reg. (EU) 2019/1791	0.05	LOQ	0.05	LOQ
Pulses	0.15	EFSA (2012)	0.06	STMR-RAC	0.06	STMR-RAC
Linseeds, Poppy seeds, Sesame seeds, Rapeseeds/canola seeds, Mustard seeds, Pumpkin seeds, Safflower seeds, Borage seeds, Gold of pleasure seeds, Hemp seeds, Castor beans, Other oilseeds	0.05	Reg. (EU) 2019/1791	0.05	LOQ	0.05	LOQ
Peanuts/groundnuts, Sunflower seeds, Soya beans, Cotton seeds	0.05	EFSA (2012)	0.05	STMR-RAC	0.05	STMR-RAC
Oil fruits	0.05	Reg. (EU) 2019/1791	0.05	LOQ	0.05	LOQ
Cereals (except buckwheat and other pseudo-cereals)	0.05	EFSA (2012)	0.05	STMR-RAC	0.05	STMR-RAC
Buckwheat and other pseudo-cereals	0.05	Reg. (EU) 2019/1791	0.05	LOQ	0.05	LOQ
Tea (dried leaves of Camellia sinensis), Coffee beans, Herbal infusions (dried flowers), Herbal infusions (dried leaves), Herbal infusions (any other part of the plant)	0.05	Reg. (EU) 2019/1791	0.05	LOQ	0.05	LOQ
Herbal infusions (dried roots)	0.5	EFSA (2013)	0.13	STMR-RAC	0.3	HR-RAC
Cocoa beans, Carobs/Saint John's bread	0.05	Reg. (EU) 2019/1791	0.05	LOQ	0.05	LOQ
Hops	0.05	Reg. (EU) 2019/1791	0.05	LOQ	0.05	LOQ
Spices	0.05	Reg. (EU) 2019/1791	0.05	LOQ	0.05	LOQ
Sugar plants (except sugar canes and chicory roots)	0.05	Reg. (EU) 2019/1791	0.05	LOQ	0.05	LOQ
Sugar canes	0.05	EFSA (2012)	0.05	STMR-RAC	0.05	HR-RAC
Chicory roots	0.2	EFSA (2014)	0.05	STMR-RAC	0.14	HR-RAC
Mammals: Muscle/meat	0.01	Reg. (EU) 2019/1791	0.05	LOQ	0.05	LOQ
Mammals: Fat tissue	0.2	FAO (2016b)	0.051	STMR-RAC	0.19	HR-RAC
Mammals: Liver, Kidney, Edible offals (other than liver and kidney)	0.05	FAO (2016b)	0.026	STMR-RAC	0.05	HR-RAC
Mammals: Other products	0.01	FAO (2016b)	0.01	LOQ	0.01	LOQ
Poultry: Muscle/meat	0.01	FAO (2016b)	0.01	LOQ	0.01	LOQ
Poultry: Fat tissue	0.01	FAO (2016b)	0.01	LOQ	0.01	LOQ
Poultry: Liver, Kidney, Edible offals (other than liver and kidney)	0.01	FAO (2016b)	0.01	LOQ	0.01	LOQ
Poultry: Other products	0.01	FAO (2016b)	0.01	LOQ	–	–
Milk (all mammals)	0.02	FAO (2016b)	0.01	STMR-RAC	0.01	STMR-RAC
Eggs (chicken)	0.01	FAO (2016b)	0.01	STMR-RAC	0.01	LOQ
Eggs (all other birds)	0.01	Reg. (EU) 2019/1791	0.01	LOQ	0.01	LOQ
Honey and other apiculture products	0.05	Reg. (EU) 2019/1791	0.05	LOQ	0.05	LOQ
Amphibians and reptiles	0.01	Reg. (EU) 2019/1791	0.01	LOQ	0.01	LOQ
Terrestrial invertebrate animals	0.01	Reg. (EU) 2019/1791	0.01	LOQ	0.01	LOQ
Wild terrestrial vertebrate animals	0.01	Reg. (EU) 2019/1791	0.01	LOQ	0.01	LOQ

Appendix E – Used compound codes

Code/trivial name (a)	IUPAC name/SMILES notation/InChiKey (b)	Structural formula (c)
Pendimethalin	N-(1-ethylpropyl)-2,6-dinitro-3.4-xylidene [O-][N+](=O)c1c(C)c(C)cc([N+]([O-])=O)c1NC(CC)CC CHIFOSRWCNZCFN-UHFFFAOYSA-N
M455H030	3-hydroxy-6-methyl-2,4-dinitrobenzyl hexopyranoside [O-][N+](=O)c2cc(C)c(COC1OC(CO)C(O)C(O)C1O)c([N+]([O-])=O)c2O 4-hydroxy-2-methyl-3,5-dinitrobenzyl hexopyranoside [O-][N+](=O)c2cc(COC1OC(CO)C(O)C(O)C1O)c(C)c([N+]([O-])=O)c2O
M455H001	2-methyl-3,5-dinitro-4-(pentan-3-ylamino)benzoic acid CCC(CC)Nc1c(cc(C(=O)O)c(C)c1[N+](=O)[O-])[N+](=O)[O-]
M455H033	4,5-dimethyl-3-nitro-N2-(pentan-3-yl)benzene-1,2-diamine [O-][N+](=O)c1c(C)c(C)cc(N)c1NC(CC)CC

References

EFSA (European Food Safety Authority), 2012. Reasoned opinion on the review of the existing maximum residue levels (MRLs) for pendimethalin according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2012;10(4): [eLocator: 2683], 57 pp. [DOI: https://dx.doi.org/10.2903/j.efsa.2012.2683]

OECD (Organisation for Economic Co‐operation and Development) 2011. OECD MRL calculator: spreadsheet for single data set and spreadsheet for multiple data set, 2 March 2011. In: Pesticide Publications/Publications on Pesticide Residues.

OECD (Organisation for Economic Co‐operation and Development), 2013. Guidance document on residues in livestock. In: Series on Pesticides No 73. ENV/JM/MONO(2013)8, 04 September 2013.

OECD (Organisation for Economic Co‐operation and Development), 2016. Guidance Document on Crop Field Trials. In: Series on Pesticides No 66/Series on Testing and Assessment No 164. 2nd Edition. ENV/JM/MONO(2011)50/REV1, ENV/JM/MONO(2011)50/REV1/ANN, 7 September 2016.

OECD (Organisation for Economic Co‐operation and Development), 2018. Guidance Document on Residues in Rotational Crops. In: Series on Pesticides No 97. ENV/JM/MONO(2018)9, 22 May 2018.