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

Abstract

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance aminopyralid. To assess the occurrence of aminopyralid residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the European authorisations reported by Member States (including the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. All information required by the regulatory framework was present and a risk to consumers was not identified.

Summary

Aminopyralid was approved on 1 January 2015 by means of Commission Implementing Regulation (EU) No 891/2014 in the framework of Regulation (EC) No 1107/2009 as amended by Commission Implementing Regulations (EU) No 540/2011 and 541/2011.

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

As the basis for the MRL review, on 14 June 2019 EFSA initiated the collection of data for this active substance. In a first step, Member States were invited to submit by 22 July 2019 their national Good Agricultural Practices (GAPs) in a standardised way, in the format of specific GAP forms, allowing the designated rapporteur Member State (RMS) Finland to identify the critical GAPs in the format of a specific GAP overview file. Subsequently, Member States were requested to provide residue data supporting the critical GAPs, within a period of 1 month, by 23 October 2019. On the basis of all the data submitted by Member States and by the EU Reference Laboratories for Pesticides Residues (EURLs), EFSA asked the RMS to complete the Pesticide Residues Overview File (PROFile) and to prepare a supporting evaluation report. The PROFile and evaluation report, together with Pesticide Residues Intake Model (PRIMo) calculations were provided by the RMS to EFSA on 31 January 2020. Subsequently, EFSA performed the completeness check of these documents with the RMS. The outcome of this exercise including the clarifications provided by the RMS, if any, was compiled in the completeness check report.

Based on the information provided by the RMS, Member States and the EURLs, and taking into account the conclusions derived by EFSA in the framework of Commission Regulation (EU) No 188/2011 and the MRLs established by the Codex Alimentarius Commission, EFSA prepared in April 2020 a draft reasoned opinion, which was circulated to Member States and EURLs for consultation via a written procedure. Comments received by 15 May 2020 were considered during the finalisation of this reasoned opinion. The following conclusions are derived.

The metabolism of aminopyralid in plants was investigated in primary and rotational crops. According to the results of the metabolism studies, the residue definition for enforcement and risk assessment can be proposed as the sum of aminopyralid and its conjugates, expressed as aminopyralid. This residue definition is also applicable to processed commodities. Fully validated analytical methods are available for the enforcement of the proposed residue definition in all four crop matrices at the limit of quantification (LOQ) of 0.01 mg/kg. According to the EURLs the LOQ of 0.05 mg/kg is achievable by using the QuEChERS method (QuOil for high oil content commodities) for the routine analysis of free aminopyralid in all matrices. A modified QuEChERS method including an alkaline hydrolysis step to release the conjugated residues of aminopyralid would be suitable to cover the proposed enforcement residue definition for food of plant origin.

Available residue trials data were sufficient to derive MRL proposals as well as risk assessment values for all commodities under evaluation. To avoid the occurrence of significant residues in succeeding crops, Member States should consider taking adequate risk mitigation measures. Alternatively, setting specific MRLs for rotational crops might be considered; in that case rotational crop residue trials would be required.

Aminopyralid is authorised for use on crops that might be fed to livestock. Livestock dietary burden calculations were, therefore, performed for different groups of livestock according to OECD guidance. The dietary burdens calculated for cattle, sheep and swine were found to exceed the trigger value of 0.1 mg/kg dry matter. Behaviour of residues was therefore assessed in these groups of livestock.

The metabolism of aminopyralid residues in livestock was investigated in lactating goats and laying hens at dose rates covering or approximating the maximum dietary burdens calculated in this review. According to the results of these studies, the residue definition for enforcement and risk assessment in livestock commodities was proposed as aminopyralid only. An analytical method for the enforcement of the proposed residue definition at the LOQ of 0.01 mg/kg in all animal matrices is available. According to the EURLs, aminopyralid can be monitored in milk and liver with an LOQ of 0.05 mg/kg, and the same LOQ of 0.05 mg/kg should be also achievable in eggs, fat, kidney and muscle.

A livestock feeding study on dairy cows was used to derive MRL and risk assessment values in milk and tissues of ruminants. Since extrapolation from ruminants to pigs is acceptable, results of this livestock feeding study were relied upon to derive the MRL and risk assessment values in pigs. Poultry are not expected to be significantly exposed to aminopyralid residues, thus no MRLs are required for this group.

Chronic and acute consumer exposure resulting from the authorised uses reported in the framework of this review was calculated using revision 3.1 of the EFSA PRIMo. The highest chronic exposure represented 0.3% of the acceptable daily intake (ADI) (NL toddler) and the highest acute exposure amounted to 0.5% of the acute reference dose (ARfD) (cattle milk).

Apart from the MRLs evaluated in the framework of this review, internationally recommended Codex residue limits (CXLs) have also been established for aminopyralid. Additional calculations of the consumer exposure, considering these CXLs, were therefore carried out. The highest chronic exposure represented 0.3% of the ADI (NL toddler) and the highest acute exposure amounted to 1% of the ARfD (bovine kidney).

These calculations indicate that the uses assessed under this review and the CXLs currently established are not expected to be of concern for European consumers.

Background

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

As aminopyralid was approved on 1 January 2015 by means of Commission Implementing Regulation (EU) No 891/20143 in the framework of Regulation (EC) No 1107/20094 as amended by Commission Implementing Regulations (EU) No 540/20115 and 541/20116, EFSA initiated the review of all existing MRLs for that active substance.

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

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

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

• the nature and magnitude of residues in primary crops;

• the nature and magnitude of residues in processed commodities;

• the nature and magnitude of residues in rotational crops;

• the nature and magnitude of residues in livestock commodities;

• the analytical methods for enforcement of the proposed MRLs.

As the basis for the MRL review, on 14 June 2019 EFSA initiated the collection of data for this active substance. In a first step, Member States were invited to submit by 22 July 2019 their Good Agricultural Practices (GAPs) that are authorised nationally, in a standardised way, in the format of specific GAP forms. In the framework of this consultation, 20 Member States provided feedback on their national authorisations of aminopyralid. Based on the GAP data submitted, the re‐assigned RMS Finland was asked to identify the critical GAPs to be further considered in the assessment, in the format of a specific GAP overview file. Subsequently, in a second step, Member States were requested to provide residue data supporting the critical GAPs by 23 October 2019.

On the basis of all the data submitted by Member States and the EU Reference Laboratories for Pesticides Residues (EURLs), EFSA asked Finland to complete the PROFile and to prepare a supporting evaluation report. The PROFile and the supporting evaluation report, together with the Pesticide Residues Intake Model (PRIMo) calculations, were submitted to EFSA on 31 January 2020. Subsequently, EFSA performed the completeness check of these documents with the RMS. The outcome of this exercise including the clarifications provided by the RMS, if any, was compiled in the completeness check report.

Considering all the available information, and taking into account the MRLs established by the Codex Alimentarius Commission (CAC) (i.e. codex maximum residue limits; CXLs), EFSA prepared in April 2020 a draft reasoned opinion, which was circulated to Member States and EURLs for commenting via a written procedure. All comments received by 15 May 2020 were considered by EFSA during the finalisation of the reasoned opinion.

The evaluation report submitted by the RMS (Finland, 2020), taking into account also the information provided by Member States during the collection of data, and the EURLs report on analytical methods (EURLs, 2019) are considered as main supporting documents to this reasoned opinion and, thus, made publicly available.

In addition, further supporting documents to this reasoned opinion are the completeness check report (EFSA, 2020a) and the Member States consultation report (EFSA, 2020b). These reports are developed to address all issues raised in the course of the review, from the initial completeness check to the reasoned opinion. Furthermore, the exposure calculations for all crops reported in the framework of this review performed using the EFSA PRIMo and the PROFile as well as the GAP overview file listing all authorised uses are key supporting documents and made publicly available as background documents to this reasoned opinion. A screenshot of the report sheet of the PRIMo is presented in Appendix C.

Terms of reference

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

• the inclusion of the active substance in Annex IV to the Regulation, when appropriate;

• the necessity of setting new MRLs for the active substance or deleting/modifying existing MRLs set out in Annex II or III of the Regulation;

• the inclusion of the recommended MRLs in Annex II or III to the Regulation;

• the setting of specific processing factors as referred to in Article 20(2) of the Regulation.

The active substance and its use pattern

Aminopyralid is the ISO common name for 4‐amino‐3,6‐dichloropyridine‐2‐carboxylic acid (IUPAC). The chemical structure of the active substance is reported in Appendix F.

The EU MRLs for aminopyralid are established in Annex III of Regulation (EC) No 396/2005. CXLs for aminopyralid were also established by the CAC. An overview of the MRL changes that occurred since the entry into force of the Regulation mentioned above is provided below (Table 1).

Table 1.

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

Procedure	Legal implementation	Remarks
MRL application	Commission Regulation (EU) 2019/1015a	Certain cereals (barley, millet, oat, rye, sorghum) (EFSA, 2019b)
MRL application	Commission Regulation (EU) 2017/171b	Maize (EFSA, 2016)
MRL application	Commission Regulation (EU) No 36/2014c	Animal commodities (EFSA, 2013a)
MRL application	Commission Regulation (EU) No 251/2013d	Rapeseed (EFSA, 2012)
MRL application	Commission Regulation (EU) No 459/2010e	Grass and bovine kidney (EFSA, 2009)
Implementation of CAC	Commission Regulation (EU) No 36/2014	Animal products The CXLs for food of animal origin were implemented as an alternative to the modifications of the MRLs requested by the applicant (see EFSA, 2013a) since the CXLs are based on the same scientific considerations. Risk managers agreed to take over the CXLs in the EU legislation although the residue definition derived at Codex level did not fully comply with the EU residue definition for enforcement

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

^aCommission Regulation (EU) 2019/1015 of 20 June 2019 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for aminopyralid, captan, cyazofamid, flutianil, kresoxim‐methyl, lambda‐cyhalothrin, mandipropamid, pyraclostrobin, spiromesifen, spirotetramat, teflubenzuron and tetraconazole in or on certain products. OJ L 165, 21.6.2019, p. 23–64.

^bCommission Regulation (EU) 2017/171 of 30 January 2017 amending Annexes II, III and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for aminopyralid, azoxystrobin, cyantraniliprole, cyflufenamid, cyproconazole, diethofencarb, dithiocarbamates, fluazifop‐P, fluopyram, haloxyfop, isofetamid, metalaxyl, prohexadione, propaquizafop, pyrimethanil, Trichoderma atroviride strain SC1 and zoxamide in or on certain products. OJ L 30, 3.2.2017, p. 45–111.

^cCommission Regulation (EU) No 36/2014 of 16 January 2014 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for aminopyralid, chlorantraniliprole, cyflufenamid, mepiquat, metalaxyl‐M, propamocarb, pyriofenone and quinoxyfen in or on certain products. OJ L 17, 21.1.2014, p. 1–41.

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

^eCommission Regulation (EU) No 459/2010 of 27 May 2010 amending Annexes II, III and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for certain pesticides in or on certain products. OJ L 129, 28.5.2010, p. 3–49.

For the purpose of this MRL review, all the uses of aminopyralid currently authorised within the EU as submitted by the Member States during the GAP collection, have been reported by the RMS in the GAP overview file. The critical GAPs identified in the GAP overview file were then summarised in the PROFile and considered in the assessment. The details of the authorised critical GAPs for aminopyralid are given in Appendix A. The RMS did not report any use authorised in third countries that might have a significant impact on international trade.

Assessment

EFSA has based its assessment on the following documents:

• the PROFile submitted by the RMS;

• the evaluation report accompanying the PROFile (Finland, 2020);

• the draft assessment report (DAR) and its addenda prepared under Council Directive 91/414/EEC (United Kingdom, 2006, 2013);

• the conclusion on the peer review of the pesticide risk assessment of the active substance aminopyralid (EFSA, 2013b);

• the Joint Meeting on Pesticide residues (JMPR) Evaluation reports (FAO, 2006, 2007);

• the previous reasoned opinions on aminopyralid (EFSA, 2009, 2012, 2013a, 2016, 2019b).

The assessment is performed in accordance with the legal provisions of the uniform principles for evaluation and authorisation of plant protection products as set out in Commission Regulation (EU) No 546/20118 and the currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues (OECD, 2013, 2008, 2011;European Commission, 1997a, b, c, d, e, f, g, 2000, a, b, 2017).

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

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 aminopyralid was investigated in three varieties of grass and in cereals (United Kingdom, 2006, 2013) and assessed in the framework of the peer review (EFSA, 2013b). In both studies, aminopyralid radiolabelled in the positions 2 and 6 of the pyridine ring of the molecule, was applied as a single foliar treatment.

In the first study, after one foliar application of 360 g a.s./ha on common pasture grasses, most of the radioactive residues were extracted (90–99% of the total radioactive residues; TRR). In fresh grass, residue levels ranged from 19 to 37 mg eq/kg 7 days after treatment (DAT), decreasing to 5–7 mg eq/kg 42 DAT. In hay 42 DAT, residues were higher ranging from 13 to 23 mg eq/kg. In all three varieties, the major component identified in fresh grass was parent aminopyralid, accounting for 48–68% TRR 7 days after treatment and decreasing to 22–31% TRR (up to 35% TRR in hay) after 42 days. The decrease of the parent, unconjugated aminopyralid, was balanced with a constant increase of the conjugated fraction mostly composed of glucose conjugates, from 19–39% TRR to 50–60% TRR (EFSA, 2013b).

In a second study, wheat was treated with one foliar application of 40 g a.s./ha (4N the application rate of the GAP on cereals) and 80 g a.s./ha (8N rate). Total residue levels of aminopyralid in grain were 0.039 to 0.084 mg eq/kg (at 4N rate and 8N rate, respectively), while total radioactive residues were higher in forage (up to 0.87 mg eq/kg), hay (up to 0.69 mg eq/kg) and straw (up to 0.62 mg eq/kg). A similar profile as in grass was observed in wheat, with a steady decrease of unconjugated aminopyralid, from 87–90% TRR in forage (0 DAT) to 8–11% TRR in straw (86 DAT), compensated by an increase of the conjugated fractions, similarly composed of glucose conjugates of aminopyralid, from 7–9% TRR to 63–70% TRR (EFSA, 2013b).

The metabolism of aminopyralid was also investigated in oilseeds and assessed in the framework of a previous MRL application but not peer reviewed (France, 2011; EFSA, 2012). After one foliar treatment on rapeseed with 14 g a.s./ha of aminopyralid radiolabelled in the positions 2 and 6 of the pyridine ring, total residue levels from successive sampling decreased from 0.08 mg eq/kg to 0.04 mg eq/kg in immature seeds and were 0.003 mg eq/kg in mature seeds. The major components identified were also unconjugated aminopyralid (up to 78% TRR just after application) and its conjugates (up to 60% TRR at harvest) which were released as aminopyralid upon hydrolytic extraction conditions (France, 2011; EFSA, 2012). As it was observed in the wheat and grass studies, residue levels of the unconjugated aminopyralid declined while at longer harvest intervals the levels of conjugates increased.

The metabolic pathway of aminopyralid was similar in cereals, grass and oilseeds.

1.1.2. Nature of residues in rotational crops

Aminopyralid is authorised on crops that may be grown in rotation. The field DT₉₀ reported in the soil degradation studies evaluated in the framework of the peer review was 116 days (EFSA, 2013b). Therefore, the possible occurrence of residues in rotational crops needs to be assessed.

One confined rotational crop study with aminopyralid radiolabelled in the positions 2 and 6 of the pyridine ring of the molecule was available for this review (EFSA, 2013b; United Kingdom, 2013). In this study, aminopyralid was applied at a low rate of 10 g a.s./ha onto bare soil. Crops were planted at nominal plant‐back intervals (PBI) of 90 and 120 DAT. Crops planted at each interval consisted of leafy vegetables (lettuce), roots (turnip) and cereals (sorghum). Residues in all crops were generally low, ranging from < 0.001 to 0.006 mg eq/kg in edible parts of the crops and reaching up to 0.03 mg eq/kg in feed items (sorghum forage and stover). The major compounds further characterised were aminopyralid (free or conjugated) and it was concluded that the metabolic pathway was similar as in primary crops. However, this study performed at a dose rate equivalent to 0.2N the application of the most critical GAP for grass and considering two PBI only, was not considered sufficient to conclude on the residues in rotational crops.

Thus, an additional confined rotational crop study was recently submitted and assessed in the framework of a previous MRL application, however not peer reviewed (United Kingdom, 2017; EFSA, 2019b). In this study, aminopyralid radiolabelled in the positions 2 and 6 of the pyridine ring was applied at 63.9 g a.s./ha to bare soil (just above 1N rate for grass, a 6N rate for cereals). Leafy vegetables (lettuce), roots (turnip) and cereals (wheat) were planted at PBIs of 30, 120 and 365 days. Leafy vegetables were also planted 180 and 300 DAT. However, due to phytotoxic effects, lettuce did not grow and was replaced with mustard planted at PBIs of 300 and 365 days. The major compound characterised in all samples was aminopyralid (free or conjugated), accounting for 35–95% TRR, with residue levels ranging from 0.01 mg eq/kg (wheat grain, 30 DAT) to 0.66 mg eq/kg (wheat hay, 120 DAT), and highest levels observed in wheat hay and straw. In turnips and wheat, residues generally increased between PBIs of 30 and 120 DAT, before decreasing significantly 365 DAT, while in mustard greens residues increased between 300 and 365 DAT In turnip roots and wheat grain at a PBI of 365 days, residues were too low to be characterised (United Kingdom, 2017; EFSA, 2019b).

Based on the available data, it can be concluded that the metabolism and distribution of aminopyralid in rotational crops is similar to the metabolic pathway observed in primary crops.

1.1.3. Nature of residues in processed commodities

Studies investigating the nature of aminopyralid residues in processed commodities were assessed in the framework of a previous application to modify MRLs in cereals (United Kingdom, 2017; EFSA, 2019b), however, not peer reviewed. These studies were conducted with radiolabelled aminopyralid in the positions 2 and 6 of the pyridine ring simulating representative hydrolytic conditions for pasteurisation (20 min at 90°C, pH 4), boiling/brewing/baking (60 min at 100°C, pH 5) and sterilisation (20 min at 120°C, pH 6). Aminopyralid was stable to hydrolysis under standard conditions of pasteurisation, baking/brewing/boiling and sterilisation.

1.1.4. Methods of analysis in plants

During the peer review, a hyphenated analytical method based on high‐performance liquid chromatography (HPLC) coupled to tandem mass spectrometry (MS/MS) detection was validated for the determination of aminopyralid free and conjugated (measured as aminopyralid) in all four crop matrices (high water, high acid, high oil content and dry commodities), with a limit of quantification (LOQ) of 0.01 mg/kg. The method includes hydrolytic conditions that release free aminopyralid from its conjugates. It is supported by an independent laboratory validation (ILV).

During the completeness check, the EURLs provided a QuEChERS multi‐residue analytical method using HPLC–MS/MS with an LOQ of 0.05 mg/kg for the routine analysis of free aminopyralid in high water content, high acid content and dry commodities. During the Member State consultation, the EURLs provided an updated evaluation report and additional validation data for high oil content commodities with the same LOQ of 0.05 mg/kg. However, this method does not cover the default LOQ of 0.01 mg/kg, neither the proposed residue definition for enforcement since aminopyralid conjugates are not analysed. According to the EURLs, aminopyralid is stable under alkaline hydrolysis and as the conjugates residues of aminopyralid are mostly glucosides (easy to breakup), it is confirmed that a modified QuEChERS method including an alkaline hydrolysis step would be suitable for the determination of aminopyralid (free and conjugated) (EURLs, 2019). However, validation data for this method were not provided by the EURLs.

1.1.5. Stability of residues in plants

The storage stability of aminopyralid residues was investigated in wheat (grain, forage, hay and straw) and grass (forage) in the framework of the peer review (EFSA, 2013b; United Kingdom, 2013) and in rapeseed (forage, seeds, rape oil) in a new study submitted under this review, however not peer reviewed (Finland, 2020).

In high water content and dry commodities, the available studies demonstrated storage stability for aminopyralid for a period of 16 months when stored at –20°C, while in high oil content matrices, the new study reported by Finland demonstrates the storage stability for up to 25 months.

1.1.6. Proposed residue definitions

The metabolism of aminopyralid was similar in all crops assessed. The metabolism in rotational crops is similar to the metabolism observed in primary crops and the processing of aminopyralid is not expected to modify the nature of residues.

Based on the metabolism studies, unconjugated aminopyralid is not a sufficient marker as its conjugates were found to represent a major part of the radioactive residues. Both parent and its conjugated are toxicologically relevant and thus should be considered in the consumer exposure. Therefore, the residue definition for enforcement and risk assessment in cereals/grass and oilseeds is proposed as the sum of aminopyralid and its conjugates, expressed as aminopyralid. This residue definition was already proposed during the peer review (in cereals only) and supported in all assessments performed in the framework of previous MRL applications. It is noted that the residue definition for enforcement currently established in the Regulation (EC) 396/2005 is limited to the parent only.

Considering that an analytical method involving an alkaline hydrolysis step for the enforcement of the proposed residue definition at the LOQ of 0.01 mg/kg in all matrices is available (EFSA, 2013b), and that conjugates were analysed for in all the supervised residue trials, this residue definition derived during the peer review is still considered appropriate and relevant under the current review.

According to the EURLs, the LOQ of 0.05 mg/kg is achievable in high water content, high oil content, high acid content and dry commodities by using the QuEChERS method for the routine analysis of free aminopyralid. A modified QuEChERS method releasing conjugates would be suitable to cover the proposed enforcement residue definition (see Section 1.1.4). Considering the reasons mentioned above and that such conjugates are not easy to address through conversion factors, the EURLs also support the proposal that the residue definition should include the conjugates (EURLs, 2019).

1.2. Magnitude of residues in plants

1.2.1. Magnitude of residues in primary crops

To assess the magnitude of aminopyralid residues resulting from the reported GAPs, EFSA considered all residue trials reported by the RMS in its evaluation report (Finland, 2020) as well as the residue trials evaluated in the framework of the peer review (EFSA, 2013b) or in the framework of previous MRL applications (EFSA, 2012, 2016, 2019b). All residue trial samples considered in this framework were stored in compliance with the conditions for which storage stability of residues was demonstrated. Decline of residues during storage of the trial samples is therefore not expected.

The number of residue trials and extrapolations were evaluated in accordance with the European guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs (European Commission, 2017). It should be noted that according to these European guidelines, residue trials both in barley and in wheat could have been used by extrapolation to derive MRL and risk assessment values for oat and rye. Under the last MRL application, both options were proposed, and risk managers supported the extrapolation from barley to set MRLs for oat and rye. Nevertheless, considering that residues in wheat straw represented a more critical situation compared to barley, residue levels in wheat straw were extrapolated to oat and rye straw (EFSA, 2019b). The same approach was followed for this Article 12 review (see Appendix B.1.2.1).

The available residue trials are sufficient to derive MRL and risk assessment values for all crops under assessment.

1.2.2. Magnitude of residues in rotational crops

There were no studies investigating the magnitude of residues in rotational crops available for this review.

Based on the available confined rotational crop studies (see Section 1.1.2), the occurrence of residues in rotational crops above 0.01 mg/kg, could not be fully excluded when aminopyralid is applied following the GAPs reported in Appendix A.

Consequently, to avoid the presence of aminopyralid residues in rotational crops, Member States should consider the need of defining plant‐back restrictions when granting authorisations for plant protection products containing aminopyralid. Alternatively, setting MRLs for rotational crops might be considered, but would require rotational crop residue trials covering the most critical GAP currently authorised (data gap).

Several Member States already reported in their GAPs that mitigation measures (90‐day PBI and label restrictions) were implemented, while granting authorisations. Nevertheless, considering the results of the confined study performed at 60 g a.s./ha, this 90‐day PBI may not be sufficient.

1.2.3. Magnitude of residues in processed commodities

The effect of industrial processing and/or household preparation was first assessed on studies conducted in wheat in the framework of the peer review (United Kingdom, 2006; EFSA, 2013b). An additional study performed in wheat and barley was assessed in the framework of a recent MRL application (United Kingdom, 2017; EFSA, 2019b), however not peer reviewed. An overview of all available processing studies is available in Appendix B.1.2.3.

A robust processing factor (based on a sufficient number of studies) could be derived for wheat bran, while tentative processing factors (not fully supported by data) were derived for all other processed products of wheat (fine and coarse bran, flour, wholemeal flour and wholemeal bread) and of barley (brewing malt, spent grains, brewer's yeast and beer) (EFSA, 2019b).

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

1.2.4. Proposed MRLs

The available data are considered sufficient to derive MRL proposals as well as risk assessment values for all commodities under evaluation.

MRLs were also derived for feed crops in view of the future need to set MRLs in feed items.

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

2. Residues in livestock

Aminopyralid is authorised for use on cereals, grass and rapeseed that might be fed to livestock. Livestock dietary burden calculations were therefore performed for different groups of livestock according to OECD guidance (OECD, 2013), which has now also been agreed upon at European level. The input values for all relevant commodities are summarised in Appendix D. The dietary burdens calculated for cattle, sheep and swine were found to exceed the trigger value of 0.1 mg/kg dry matter (DM).

2.1. Nature of residues and methods of analysis in livestock

The metabolism of aminopyralid residues in livestock was investigated in lactating goats and laying hens at dose rates covering or approximating the maximum dietary burdens calculated in this review (Finland, 2020). These studies, assessed in the framework of the peer review (United Kingdom, 2006, 2013; EFSA, 2013b), sufficiently address the metabolism in livestock.

In all studies, aminopyralid was radiolabelled in the positions 2 and 6 of the pyridine ring of the molecule. The study performed on lactating goats (at ca. 1N the dietary burden calculated for ruminants) indicates that transfer of residues is insignificant, as aminopyralid is intensively excreted and no more than 0.07% of the administered dose was recovered in milk and edible matrices. TRRs were below 0.01 mg eq/kg in all matrices (from 0.001 to 0.008 mg eq/kg), except in kidney (0.07 mg eq/kg) where residues were characterised and 80% TRR was identified as aminopyralid (EFSA, 2013b).

Although not required under the current review, a study on laying hens (131N the dietary burden calculated for poultry) was available in which, as for ruminants, aminopyralid was almost totally excreted and TRRs in all matrices were significantly lower than 0.01 mg eq/kg (representing less than 0.05% of the administered dose). Residues were thus, not characterised.

The storage stability of aminopyralid was not demonstrated, however all samples analysed were stored for less than 30 days.

EFSA concludes that the metabolism of aminopyralid in livestock is adequately elucidated. As aminopyralid is not significantly metabolised or conjugated and is the most relevant compound in livestock commodities, the residue definition for enforcement and risk assessment in livestock commodities is proposed as aminopyralid only.

An analytical method for the enforcement of the proposed residue definition using HPLC–MS/MS was fully validated in all animal matrices with an LOQ of 0.01 mg/kg, and supported by an ILV (EFSA, 2013b). During the Member State consultation, EURLs provided additional validation data for food of animal origin, concluding that aminopyralid can be monitored in milk and liver with an LOQ of 0.05 mg/kg. According to the EURLs, judging from the analytical behaviour of aminopyralid, an LOQ of 0.05 mg/kg should be also achievable in eggs, fat, kidney and muscle (EURLs, 2019).

2.2. Magnitude of residues in livestock

In the framework of the peer review, a feeding study was performed with dairy cows (United Kingdom, 2006). In these studies, aminopyralid was administered using different dosing levels ranging from 32.8 mg/kg DM (equivalent to 1.26 mg/kg body weight (bw) per day) to 644.7 mg/kg DM (equivalent to 24.8 mg/kg bw per day), corresponding to 3.2N to 62.9N the maximum dietary burden calculated for dairy cattle. In this study, samples of tissues and milk were analysed for aminopyralid and the results confirmed the intensive excretion of aminopyralid observed in the metabolism study.

The study performed on dairy cows was used to derive MRL and risk assessment values for all commodities of ruminants, in compliance with the latest recommendations on this matter (FAO, 2009). Since extrapolation from ruminants to pigs is acceptable, results of the livestock feeding study on ruminants were relied upon to derive the MRL and risk assessment values in pigs. Significant levels of aminopyralid are only expected in kidney, where the mean levels were 0.07 and 0.15 mg/kg for the two lowest dose rates. For milk and all other tissues of ruminants, no residues were found above the LOQ at any dosing levels and MRLs can be proposed at the LOQ (0.01 mg/kg). All the samples analysed were stored for less than 30 days, thus decline of residues during storage of the trial samples is not expected.

No study was available for poultry; however MRLs are not required since poultry are not expected to be exposed to significant levels of aminopyralid residues.

3. Consumer risk assessment

In the framework of this review, only the uses of aminopyralid reported by the RMS in Appendix A were considered; however, the use of aminopyralid was previously also assessed by the JMPR (FAO, 2006, 2007). The CXLs, resulting from this assessment by JMPR and adopted by the CAC, are now international recommendations that need to be considered by European risk managers when establishing MRLs. To facilitate consideration of these CXLs by risk managers, the consumer exposure was calculated both with and without consideration of the existing CXLs.

3.1. Consumer risk assessment without consideration of the existing CXLs

Chronic and acute exposure calculations for all crops reported in the framework of this review were performed using revision 3.1 of the EFSA PRIMo (EFSA, 2018, 2019a). Input values for the exposure calculations were derived in compliance with the decision tree reported in Appendix E. Hence, for those commodities where an MRL could be derived by EFSA in the framework of this review, input values were derived according to the internationally agreed methodologies (FAO, 2009). All input values included in the exposure calculations are summarised in Appendix D.

The exposure values calculated were compared with the toxicological reference values for aminopyralid, derived by EFSA (2013b). The highest chronic exposure was calculated for NL toddler, representing 0.3% of the acceptable daily intake (ADI), and the highest acute exposure was calculated for milk from cattle, representing 0.5% of the acute reference dose (ARfD). These calculations indicate that the uses assessed under this review result in a consumer exposure lower than the toxicological reference values. Therefore, these uses are unlikely to pose a risk to consumer's health.

3.2. Consumer risk assessment with consideration of the existing CXLs

To include the CXLs in the calculations of the consumer exposure, CXLs were compared with the EU MRL proposals in compliance with Appendix E and all data relevant to the consumer exposure assessment have been collected from JMPR evaluations. An overview of the input values used for this exposure calculation is also provided in Appendix D.

The CXLs established by JMPR were derived following a different enforcement residue definition (aminopyralid and its conjugates that can be hydrolysed, expressed as aminopyralid) both for plants and animal commodities, that does not fully comply with the ones proposed under this review. Although JMPR included aminopyralid conjugates in its residue definition for enforcement of animal commodities, this difference is of no relevance in practice as under the EU evaluation the conjugates are not found in significant amount in livestock (EFSA, 2013a). Thus, it can be concluded that CXLs and MRL proposals are comparable. It is to note that risk managers already agreed to take over the CXLs derived for commodities of ruminants in the European regulation (see Table 1).

Although a CXL is not set for fat, considering that the CXLs derived for all livestock commodities are higher than the ones derived from the European uses, EFSA calculated the CXLs for fat, based on the data available in the JMPR report (FAO, 2006).

Chronic and acute exposure calculations were also performed using revision 3.1 of the EFSA PRIMo and the exposure values calculated were compared with the toxicological reference values derived for aminopyralid. The highest chronic exposure was calculated for NL toddler, representing 0.3% of the ADI, and the highest acute exposure was calculated for bovine kidney, representing 1% of the ARfD. Based on these calculations, EFSA concludes that the CXLs are not expected to be of concern for European consumers.

Conclusions

The metabolism of aminopyralid in plants was investigated in primary and rotational crops. According to the results of the metabolism studies, the residue definition for enforcement and risk assessment can be proposed as the sum of aminopyralid and its conjugates, expressed as aminopyralid. This residue definition is also applicable to processed commodities. Fully validated analytical methods are available for the enforcement of the proposed residue definition in all four crop matrices at the LOQ of 0.01 mg/kg. According to the EURLs the LOQ of 0.05 mg/kg is achievable by using the QuEChERS method (QuOil for high oil content commodities) for the routine analysis of free aminopyralid in all matrices. A modified QuEChERS method including an alkaline hydrolysis step to release the conjugated residues of aminopyralid would be suitable to cover the proposed enforcement residue definition for food of plant origin.

Available residue trials data were sufficient to derive MRL proposals as well as risk assessment values for all commodities under evaluation. To avoid the occurrence of significant residues in succeeding crops, Member States should consider taking adequate risk mitigation measures. Alternatively, setting specific MRLs for rotational crops might be considered; in that case rotational crop residue trials would be required.

Aminopyralid is authorised for use on crops that might be fed to livestock. Livestock dietary burden calculations were therefore performed for different groups of livestock according to OECD guidance. The dietary burdens calculated for cattle, sheep and swine were found to exceed the trigger value of 0.1 mg/kg DM. Behaviour of residues was therefore assessed in these groups of livestock.

The metabolism of aminopyralid residues in livestock was investigated in lactating goats and laying hens at dose rates covering or approximating the maximum dietary burdens calculated in this review. According to the results of these studies, the residue definition for enforcement and risk assessment in livestock commodities was proposed as aminopyralid only. An analytical method for the enforcement of the proposed residue definition at the LOQ of 0.01 mg/kg in all animal matrices is available. According to the EURLs, aminopyralid can be monitored in milk and liver with an LOQ of 0.05 mg/kg, and the same LOQ of 0.05 mg/kg should be also achievable in eggs, fat, kidney and muscle.

A livestock feeding study on dairy cows was used to derive MRL and risk assessment values in milk and tissues of ruminants. Since extrapolation from ruminants to pigs is acceptable, results of this livestock feeding study were relied upon to derive the MRL and risk assessment values in pigs. Poultry are not expected to be significantly exposed to aminopyralid residues, thus no MRLs are required for this group.

Chronic and acute consumer exposure resulting from the authorised uses reported in the framework of this review was calculated using revision 3.1 of the EFSA PRIMo. The highest chronic exposure represented 0.3% of the ADI (NL toddler) and the highest acute exposure amounted to 0.5% of the ARfD (cattle milk).

Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs have also been established for aminopyralid. Additional calculations of the consumer exposure, considering these CXLs, were therefore carried out. The highest chronic exposure represented 0.3% of the ADI (NL toddler) and the highest acute exposure amounted to 1% of the ARfD (bovine kidney).

These calculations indicate that the uses assessed under this review and the CXLs currently established are not expected to be of concern for European consumers.

Recommendations

MRL recommendations were derived in compliance with the decision tree reported in Appendix E of the reasoned opinion (see Table 2). All MRL values listed as ‘Recommended’ in the table are sufficiently supported by data and are therefore proposed for inclusion in Annex II to the Regulation. The remaining MRL values listed in the table are not recommended for inclusion in Annex II because they require further consideration by risk managers (see Table 2 footnotes for details).

Table 2.

Summary table

Code number	Commodity	Existing EU MRL (mg/kg)	Existing CXL (mg/kg)	Outcome of the review
				MRL (mg/kg)	Comment
Enforcement residue definition (existing): aminopyralid Enforcement residue definition (proposed): sum of aminopyralid and its conjugates, expressed as aminopyralid
401060	Rapeseed	0.03	–	0.03	Recommendeda
500010	Barley grain	0.15	0.1	0.15	Recommendedb
500030	Maize grain	0.05	–	0.05	Recommendeda
500040	Millet grain	0.05	–	0.05	Recommendeda
500050	Oats grain	0.15	0.1	0.15	Recommendedb
500070	Rye grain	0.15	–	0.15	Recommendeda
500080	Sorghum grain	0.05	–	0.05	Recommendeda
500090	Wheat grain	0.1	0.1	0.1	Recommendedc
Enforcement residue definition 2: aminopyralid
1011010	Swine meat	0.01*	0.1	0.1	Recommendedc
1011020	Swine fat (free of lean meat)	0.02	0.1	0.1	Recommendedc
1011030	Swine liver	0.02	0.05	0.05	Recommendedc
1011040	Swine kidney	0.3	1	1	Recommendedc
1012010	Bovine meat	0.1	0.1	0.1	Recommendedc
1012020	Bovine fat	0.1	0.1	0.1	Recommendedc
1012030	Bovine liver	0.05	0.05	0.05	Recommendedc
1012040	Bovine kidney	1	1	1	Recommendedc
1013010	Sheep meat	0.1	0.1	0.1	Recommendedc
1013020	Sheep fat	0.1	0.1	0.1	Recommendedc
1013030	Sheep liver	0.05	0.05	0.05	Recommendedc
1013040	Sheep kidney	1	1	1	Recommendedc
1014010	Goat meat	0.1	0.1	0.1	Recommendedc
1014020	Goat fat	0.1	0.1	0.1	Recommendedc
1014030	Goat liver	0.05	0.05	0.05	Recommendedc
1014040	Goat kidney	1	1	1	Recommendedc
1015010	Horse meat	0.1	0.1	0.1	Recommendedc
1015020	Horse fat	0.1	0.1	0.1	Recommendedc
1015030	Horse liver	0.05	0.05	0.05	Recommendedc
1015040	Horse kidney	1	1	1	Recommendedc
1016010	Poultry meat	0.01*	0.01*	0.01*	Recommendedd
1016020	Poultry fat	0.02	0.01*	0.01*	Recommendedd
1016030	Poultry liver	0.02	0.01*	0.01*	Recommendedd
1020010	Cattle milk	0.02	0.02	0.02	Recommendedc
1020020	Sheep milk	0.02	0.02	0.02	Recommendedc
1020030	Goat milk	0.02	0.02	0.02	Recommendedc
1020040	Horse milk	0.02	0.02	0.02	Recommendedc
1030000	Birds’ eggs	0.01*	0.01*	0.01*	Recommendedd
–	Other commodities of plant and/or animal origin	See Reg. 2019/1015	–	–	Further consideration needede

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

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

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

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

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

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

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

EFSA identified the following data gap which is not expected to impact on the validity of the MRLs derived but which might have an impact on national authorisations:

• a representative field rotational crop study covering the most critical GAP currently authorised.

Pending the submission of this study, Member States granting authorisations for aminopyralid should take the appropriate risk mitigation measures or modify the relevant authorisations in order to avoid the presence of significant residues in rotational crops.

Abbreviations

a.s.

active substance

ADI

acceptable daily intake

ARfD

acute reference dose

BBCH

growth stages of mono‐ and dicotyledonous plants

bw

body weight

CF

conversion factor for enforcement residue definition to risk assessment residue definition

cGAP

critical GAP

CXL

codex maximum residue limit

DAR

draft assessment report

DAT

days after treatment

DB

dietary burden

DM

dry matter

DT₉₀

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

EMS

evaluating Member State

eq

residue expressed as a.s. equivalent

EURLs

European Union Reference Laboratories for Pesticide Residues (former CRLs)

FAO

Food and Agriculture Organization of the United Nations

GAP

Good Agricultural Practice

HPLC‐MS/MS

high performance liquid chromatography with tandem mass spectrometry

HR

highest residue

IEDI

international estimated daily intake

IESTI

international estimated short‐term intake

ILV

independent laboratory validation

ISO

International Organisation for Standardization

IUPAC

International Union of Pure and Applied Chemistry

JMPR

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

LOQ

limit of quantification

Mo

monitoring

MRL

maximum residue level

MS

Member States

NEDI

national estimated daily intake

NESTI

national estimated short‐term intake

NEU

northern European Union

NTMDI

national theoretical maximum daily intake

OECD

Organisation for Economic Co‐operation and Development

PBI

plant‐back interval

PF

processing factor

PHI

preharvest interval

P_ow

partition coefficient between n‐octanol and water

PRIMo

(EFSA) Pesticide Residues Intake Model

PROFile

(EFSA) Pesticide Residues Overview File

QuEChERS

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

RA

risk assessment

RAC

raw agricultural commodity

RD

residue definition

RMS

rapporteur Member State

SANCO

Directorate‐General for Health and Consumers

SC

suspension concentrate

SEU

southern European Union

SMILES

simplified molecular‐input line‐entry system

SL

soluble concentrate

STMR

supervised trials median residue

TMDI

theoretical maximum daily intake

TRR

total radioactive residue

WG

water‐dispersible granule

Appendix A – Summary of authorised uses considered for the review of MRLs

A.1. Authorised outdoor uses in northern EU

Crop and/or situation	MS or country	F G or Ia	Pests or group of pests controlled	Preparation		Application				Application rate per treatment			PHI (days)d	Remarks
				Typeb	Conc. a.s.	Method kind	Range of growth stages & seasonc	Number min–max	Minimum interval (days)	a.s./hL min–max	Water L/ha min–max	Rate and unit
Rapeseeds	HU	F	Broadleaved weeds	SL	40 g/L	Foliar treatment – spraying	12–31	1	n.a.	–	–	12 g a.s./ha	n.a.	–
Barley	CZ, DK, EE, FI, HU, LT, NO, SE	F	Broadleaved weeds			Foliar treatment – spraying	32	1	n.a.	–	–	10 g a.s./ha	n.a.	Registered as an SE (10 g/L) or a WG (300 g/kg) formulation. Application from BBCH 13–30 to BBCH 32
Maize	HU, RO	F	Broadleaved weeds	SE	300 g/L	Foliar treatment – spraying	12–16	1	n.a.	–	–	10 g a.s./ha	n.a.	Also reported as an SE formulation (11.8 g/L), with tractor mounted broadcast spray
Common millet	HU, RO	F	Broadleaved weeds	SE	300 g/L	Foliar treatment – spraying	12–16	1	n.a.	–	–	10 g a.s./ha	n.a.	Also reported as an SE formulation (11.8 g/L), with tractor mounted broadcast spray
Oat	DK, EE, FI, LT, SE	F	Broadleaved weeds			Foliar treatment – spraying	32	1	n.a.	–	–	10 g a.s./ha	n.a.	Registered as an SE (10 g/L) or a WG (300 g/kg) formulation. Application from BBCH 13–30 to BBCH 32
Rye	CZ, DK, EE, HU, LT, NO, PL, SE	F	Broadleaved weeds			Foliar treatment – spraying	32	1	n.a.	–	–	10 g a.s./ha	n.a.	Registered as an SE (10 g/L) or a WG (50 or 300 g/kg) formulation. Application from BBCH 13–30 to BBCH 32
Sorghum	HU, RO	F	Broadleaved weeds	SE	300 g/L	Foliar treatment – spraying	12–16	1	n.a.	–	–	10 g a.s./ha	n.a.	Also reported as an SE formulation (11.8 g/L), with tractor mounted broadcast spray
Wheat	CZ, DK, EE, FI, HU, LT, NO, PL, SE	F	Broadleaved weeds			Foliar treatment – spraying	32	1	n.a.	–	–	10 g a.s./ha	n.a.	Authorised also for triticale and spelt
Grass (for forage)	AT, BE, IE, FR, DE, UK	F	Broadleaved weeds	EW	30 g/L	Foliar treatment – spraying	29–32	1	n.a.	–	–	60 g a.s./ha	7	Registered as an ME formulation (30 g/L) in AT and DE, and as an SL formulation (30 g/L) in FR

MS: Member State; a.s.: active substance; n.a: not applicable; MRL: maximum residue level; SL: soluble concentrate; SE: Suspo‐emulsion; EW: Emulsion, oil in water; WG: water‐dispersible granule; ME: Micro‐emulsion.

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

CropLife International Technical Monograph no 2, 6th Edition. Revised May 2008. Catalogue of pesticide.

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.

PHI: minimum preharvest interval.

A.2. Authorised outdoor uses in southern EU

Crop and/or situation	MS or country	F G or Ia	Pests or group of pests controlled	Preparation		Application				Application rate per treatment			PHI (days)d	Remarks
				Typeb	Conc. a.s.	Method kind	Range of growth stages & seasonc	Number min‐max	Minimum interval (days)	a.s./hL min–max	Water L/ha min–max	Rate and unit
Rapeseeds	BG, FR	F	Broadleaved weeds	SL	40 g/L	Foliar treatment – spraying	12–39	1	n.a.	–	–	8 g a.s./ha	n.a.	Registered in FR as an SC formulation (5,3 g/L): 1 × 7.95 g as/ha, BBCH 14‐18, PHI n.a.
Barley	ES	F	Broadleaved weeds	WG	30% (w/w)	Foliar treatment – spraying	21–32	1	n.a.	–	–	11.8 g a.s./ha	n.a.	–
Maize	EL	F	Broadleaved weeds	WG	300 g/kg	Foliar treatment – spraying	12–16	1	n.a.	–	–	9.9 g a.s./ha	n.a.	–
Common millet	BG, EL	F	Broadleaved weeds	SE	300 g/L	Foliar treatment – spraying	12–16	1	n.a.	–	–	10 g a.s./ha	n.a.	–
Oat	BG, EL	F	Broadleaved weeds	SE	300 g/L	Foliar treatment – spraying	21–32	1	n.a.	–	–	10 g a.s./ha	n.a.	–
Rye	BG, EL	F	Broadleaved weeds	SE	300 g/L	Foliar treatment – spraying	21–32	1	n.a.	–	–	10 g a.s./ha	n.a.	Registered also as a WG formulation (50 g/kg) in FR (1 × 7.5 g a.s./ha, BBCH 21‐32)
Sorghum	BG, EL	F	Broadleaved weeds	SE	300 g/L	Foliar treatment – spraying	12–16	1	n.a.	–	–	10 g a.s./ha	n.a.	–
Wheat	ES	F	Broadleaved weeds	WG	30% (w/w)	Foliar treatment – spraying	21–32	1	n.a.	–	–	11.8 g a.s./ha	n.a.	Authorised also for triticale and spelt
Grass (for forage)	FR	F	Broadleaved weeds	SL	30 g/L	Foliar treatment – spraying	29–32	1	n.a.	–	–	60 g a.s./ha	7	–

MS: Member State; a.s.: active substance; n.a.: not applicable; SL: soluble concentrate; SC: suspension concentrate; SE: Suspo‐emulsion; WG: water‐dispersible granule.

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

^bCropLife International Technical Monograph no 2, 6th Edition. Revised May 2008. Catalogue of pesticide.

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

^dPHI: minimum preharvest interval.

Appendix B – List of end points

B.1. Residues in plants

B.1.1. Nature of residues and methods of analysis in plants

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

Primary crops (available studies)	Crop groups	Crop(s)	Application(s)	Sampling (DAT)	Comment/Source
	Cereals/grass	Grass	Foliar, 1 × 360 g a.s./ha	0, 7, 14, 21 (fresh) 42 (fresh and hay)	Study on three varieties of grass, with 14C‐aminopyralid labelled in the positions 2 and 6 of the pyridine ring. Portions of the 42 DAT fresh samples were allowed to air dry for 2 days to provide hay samples (United Kingdom 2006; EFSA, 2013b)
		Wheat	Foliar, 1 × 40 g a.s./ha at BBCH 26‐28 Foliar, 1 × 80 g a.s./ha at BBCH 26‐28	0, 14 (forage) 35 (hay) 86 (straw and grain)	14C‐aminopyralid labelled in the positions 2 and 6 of the pyridine ring (United Kingdom 2006; EFSA, 2013b)
	Pulses/oilseeds	Rapeseed	Foliar, 1 × 14 g a.s./ha at BBCH 51	0, 7, 14, 28 (immature) 62 (mature seeds and rest of the plant)	14C‐aminopyralid labelled in the positions 2 and 6 of the pyridine ring (France, 2011; EFSA, 2012)

Rotational crops (available studies)	Crop groups	Crop(s)	Application(s)	PBI (DAT)	Comment/Source
	Root/tuber crops	Turnip	Bare soil, 1 × 10 g a.s./ha	90, 120	14C‐aminopyralid labelled in the positions 2 and 6 of the pyridine ring (United Kingdom 2006; EFSA, 2013b)
		Turnip	Bare soil, 1 × 63.9 g a.s./ha	30, 120, 365	14C‐aminopyralid labelled in the positions 2 and 6 of the pyridine ring (United Kingdom, 2017; EFSA, 2019b)
	Leafy crops	Lettuce	Bare soil, 1 × 10 g a.s./ha	90, 120	14C‐aminopyralid labelled in the positions 2 and 6 of the pyridine ring (United Kingdom 2006; EFSA, 2013b)
		Lettuce	Bare soil, 1 × 63.9 g a.s./ha	30, 120, 180, 300, 365	14C‐aminopyralid labelled in the positions 2 and 6 of the pyridine ring. Lettuces did not grow due to phytotoxic effects and was then replaced with mustard at PBIs 300 and 365 days (United Kingdom, 2017; EFSA, 2019b)
		Green mustard	Bare soil, 1 × 63.9 g a.s./ha	300, 365	14C‐aminopyralid labelled in the positions 2 and 6 of the pyridine ring (United Kingdom, 2017; EFSA, 2019b)
	Cereal (small grain)	Sorghum	Bare soil, 1 × 10 g a.s./ha	90, 120	14C‐aminopyralid labelled in the positions 2 and 6 of the pyridine ring (United Kingdom 2006; EFSA, 2013b)
		Wheat	Bare soil, 1 × 63.9 g a.s./ha	30, 120, 365	14C‐aminopyralid labelled in the positions 2 and 6 of the pyridine ring (United Kingdom, 2017; EFSA, 2019b)

Processed commodities (hydrolysis study)	Conditions	Stable?	Comment/Source
	Pasteurisation (20 min, 90°C, pH 4)	Yes	14C‐aminopyralid labelled in the positions 2 and 6 of the pyridine ring (United Kingdom, 2017; EFSA, 2019b)
	Baking, brewing and boiling (60 min, 100°C, pH 5)	Yes	14C‐aminopyralid labelled in the positions 2 and 6 of the pyridine ring (United Kingdom, 2017; EFSA, 2019b)
	Sterilisation (20 min, 120°C, pH 6)	Yes	14C‐aminopyralid labelled in the positions 2 and 6 of the pyridine ring (United Kingdom, 2017; EFSA, 2019b)

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	Wheat forage, grass forage	–20°C	16	Months	Aminopyralid and its conjugates	United Kingdom (2013), EFSA (2013b)
	High oil content	Rapeseed	–20°C	25	Months	Aminopyralid and its conjugates	Finland (2020) (study from the Registration Report assessed by Poland in 2016)
	Dry/High starch content	Wheat grain, wheat hay	–20°C	16	Months	Aminopyralid and its conjugates	United Kingdom (2013), EFSA (2013b)
	Others	Wheat straw	–20°C	16	Months	Aminopyralid and its conjugates	United Kingdom (2013), EFSA (2013b)

B.1.2. Magnitude of residues in plants

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

Commodity	Region/Indoora	Residue levels observed in the supervised residue trials (mg/kg)	Comments/Source	Calculated MRL (mg/kg)	HRb (mg/kg)	STMRc (mg/kg)	CFd
Rapeseeds/canola seeds	NEU	11 × < 0.01; 0.02	8 GAP‐compliant trials and 4 overdosed trials deemed acceptable since residues from these trials < LOQ (EFSA, 2012) MRLOECD = 0.02 Demonstrated stability: Yes	0.03	0.02	0.01	1.00
	SEU	6 × < 0.01; 4 × 0.01; 0.02	Overdosed trials (performed at 1.4 to 1.6 N) deemed acceptable since calculated MRLs and risk assessment values are covered by the ones from the northern dataset (EFSA, 2012) MRLOECD = 0.02 Demonstrated stability: Yes	0.03	0.02	0.01	1.00
Barley grains Oat grains Rye grains	NEU	< 0.01; 0.02; 4 × 0.03; 2 × 0.04; 4 × 0.05; 0.06; 2 × 0.08	Trials on barley compliant with the GAP. Northern and southern data were combined to derive MRLs and risk assessment values (United Kingdom, 2017; EFSA, 2019b) Extrapolation to oat and rye is acceptable MRLOECD = 0.14 Demonstrated stability: Yes	0.15	0.09	0.04	1.00
	SEU	< 0.01; 2 × 0.02; 0.03; 2 × 0.04; 2 × 0.06; 2 × 0.09
Maize/corn grains Common millet/proso millet grains Sorghum grains	NEU	10 × < 0.01; 0.01; 0.04	Trials on maize compliant with GAP. Northern and southern data were combined to derive MRLs and risk assessment values (EFSA, 2016; Hungary, 2016) Extrapolation to millet and sorghum is acceptable MRLOECD = 0.04 Demonstrated stability: Yes	0.05e	0.04	0.01	1.00
	SEU	8 × < 0.01
Wheat grains	NEU	12 × < 0.01; 5 × 0.01; 4 × 0.02; 0.03; 0.04	Trials on wheat compliant with GAP. Northern and southern data were combined to derive MRLs and risk assessment values (United Kingdom, 2017; EFSA, 2019b) MRLOECD = 0.04 Demonstrated stability: Yes	0.04	0.04	0.01	1.00
	SEU	7 × < 0.01; 5 × 0.01; 0.02
Grass forage	NEU	0.78; 0.82; 0.98; 1.00; 2 × 1.03; 2 × 1.05; 1.09; 1.18; 1.19; 1.26; 1.35; 1.37; 1.76; 1.84; 1.87; 1.93; 2.79; 2.97	Trials on grass (forage) compliant with GAP. Northern and southern data were combined to derive MRLs and risk assessment values (EFSA, 2013b; United Kingdom, 2013) MRLOECD = 5.14 Demonstrated stability: Yes	6.00	4.26	1.19	1.00
	SEU	0.16; 0.66; 0.84; 0.99; 1.00; 1.16; 1.32; 2.01; 2.11; 2.18; 2.19; 3.93; 4.26
Barley straw	NEU	3 × 0.01; 4 × 0.02; 2 × 0.03; 2 × 0.04; 3 × 0.05; 0.06	Trials on barley compliant with the GAP. Northern and southern data were combined to derive MRLs and risk assessment values (United Kingdom, 2017; EFSA, 2019b) MRLOECD = 0.14 Demonstrated stability: Yes	0.15	0.13	0.04	1.00
	SEU	3 × 0.03; 3 × 0.04; 0.05; 0.06; 0.08; 0.13
Maize/corn stover Common millet straw Sorghum stover	NEU	7 × < 0.01; 2 × 0.01; 2 × 0.02; 0.12	Trials on maize compliant with GAP. Northern and southern data were combined to derive MRL and risk assessment values (EFSA, 2016; Hungary, 2016) Extrapolation to millet and sorghum is acceptable MRLOECD = 0.12 Demonstrated stability: Yes	0.15	0.12	0.01	1.00
	SEU	7 × < 0.01; 0.02
Wheat straw Oat straw Rye straw	NEU	< 0.01; 4 × 0.02; 3 × 0.03; 5 × 0.04; 4 × 0.05; 2 × 0.07; 2 × 0.08; 0.09; 0.27	Trials on wheat compliant with GAP. Northern and southern data were combined to derive MRLs and risk assessment values. Extrapolation to oat straw and rye straw is acceptable (considering that the wheat straw represents a more critical situation than barley) (United Kingdom, 2017; EFSA, 2019b) MRLOECD = 0.27 Demonstrated stability: Yes	0.30	0.27	0.05	1.00
	SEU	2 × < 0.01; 2 × 0.03; 0.04; 0.05; 2 × 0.06; 2 × 0.08; 0.12; 2 × 0.13

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

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

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

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

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

^eThe calculated MRL would be 0.04 mg/kg, however, considering the highest residue of 0.04 mg/kg, an MRL of 0.05 mg/kg was proposed (EFSA, 2016).

B.1.2.2. Residues in rotational crops

Overall summary

B.1.2.3. Processing factors

Processed commodity	Number of valid studiesa	Processing factor (PF)		Comment/Source
		Individual values	Median PF
Wheat, bran	1	n.r.	2.4b	EFSA (2013b, 2019b)
Wheat, coarse bran	1	4; 4.6	4.3c	United Kingdom (2017), EFSA, 2019b)
Wheat, fine bran	1	1.1; 1.3	1.2c	United Kingdom (2017), EFSA, 2019b)
Wheat, flour	1	n.r.	0.2c	EFSA (2013b, 2019b)
Wheat, wholemeal flour	1	1; 1.2	1.1c	United Kingdom, 2017; EFSA, 2019b
Wheat, wholemeal bread	1	0.8; 0.8	0.8c	United Kingdom, 2017; EFSA, 2019b
Barley, brewing malt	1	1.47	1.47c	United Kingdom, 2017; EFSA, 2019b
Barley, spent grain	1	0.75	0.75c	United Kingdom, 2017; EFSA, 2019b
Barley, brewer's yeast	1	0.31	0.31c	United Kingdom, 2017; EFSA, 2019b
Barley, beer	1	0.31	0.31c	United Kingdom, 2017; EFSA, 2019b

PF: Processing factor (=Residue level in processed commodity expressed according to RD‐Mo/Residue level in raw commodity expressed according to RD‐Mo); n.r.: not reported.

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

^bFor wheat bran, EFSA calculated the median PF of 2.4 considering the 3 available individual processing values.

^cA tentative PF is derived based on a limited dataset.

B.2. Residues in livestock

Relevant groups (subgroups)	Dietary burden expressed in				Most critical subgroupa	Most critical commodityb	Trigger exceeded (Yes/No)	Comments
	mg/kg bw per day		mg/kg DM
	Median	Maximum	Median	Maximum
Cattle (all)	0.11	0.39	2.89	10.3	Dairy cattle	Grass, forage (fresh)	Yes	–
Cattle (dairy only)	0.11	0.39	2.89	10.3	Dairy cattle	Grass, forage (fresh)	Yes	–
Sheep (all)	0.15	0.54	4.53	16.2	Ram/Ewe	Grass, forage (fresh)	Yes	–
Sheep (ewe only)	0.15	0.54	4.53	16.2	Ram/Ewe	Grass, forage (fresh)	Yes	–
Swine (all)	0.02	0.08	1.00	3.45	Swine (breeding)	Grass, silage	Yes	–
Poultry (all)	0.004	0.006	0.06	0.08	Poultry layer	Wheat straw	No	–
Poultry (layer only)	0.004	0.006	0.06	0.08	Poultry layer	Wheat straw	No	–

bw: body weight; DM: dry matter.

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

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

B.2.1. Nature of residues and methods of analysis in livestock

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

Livestock (available studies)	Animal	Dose (mg/kg bw/day)	Duration (days)	Comment/Source
	Laying hen	0.79	7	Study performed with 14C‐aminopyralid labelled in the positions 2 and 6 of the pyridine ring. Dose rate recalculated assuming body weight of 1.9 kg and feed intake of 0.13 kg per day (United Kingdom, 2006; EFSA, 2013b)
	Lactating ruminants	0.50	6	Study performed on goats with 14C‐aminopyralid labelled in the positions 2 and 6 of the pyridine ring. Dose rate recalculated assuming body weight of 70 kg and feed intake of 2 kg per day (United Kingdom, 2006; EFSA, 2013b)

B.2.1.2. Stability of residues in livestock

No studies are available, however not needed, as all livestock samples were stored for less than 30 days.

B.2.2. Magnitude of residues in livestock

B.2.2.1. Summary of the residue data from livestock feeding studies

Animal commodity	Residues at the closest feeding level (mg/kg)		Estimated value at 1N		MRL proposal (mg/kg)
	Mean	Highest	STMRMo b (mg/kg)	HRMo c (mg/kg)
Cattle (all) – Closest feeding level (1.26 mg/kg bw; 3.2 N rate)d
Muscle	< 0.01	< 0.01	0.01	0.01	0.01*
Fat	< 0.01	< 0.01	0.01	0.01	0.01*
Liver	< 0.01	< 0.01	0.01	0.01	0.01*
Kidney	0.07	0.10	0.01	0.03	0.04
Cattle (dairy only) – Closest feeding level (1.26 mg/kg bw; 3.2 N rate)d
Milke	< 0.01	< 0.01	0.01	0.01	0.01*
Sheep (all) f − Closest feeding level (1.26 mg/kg bw; 2.3 N rate)d
Muscle	< 0.01	< 0.01	0.01	0.01	0.01*
Fat	< 0.01	< 0.01	0.01	0.01	0.01*
Liver	< 0.01	< 0.01	0.01	0.01	0.01*
Kidney	0.07	0.10	0.01	0.04	0.05
Sheep (ewe only) f – Closest feeding level (1.26 mg/kg bw; 2.3 N rate)d
Milke	< 0.01	< 0.01	0.01	0.01	0.01*
Swine (all) f – Closest feeding level (1.26 mg/kg bw; 15.8 N rate)d
Muscle	< 0.01	< 0.01	0.01	0.01	0.01*
Fat	< 0.01	< 0.01	0.01	0.01	0.01*
Liver	< 0.01	< 0.01	0.01	0.01	0.01*
Kidney	0.07	0.10	0.01	0.01	0.01*
Poultry (all) – no feeding study available and not required
Muscle	–	–	–	–	–
Fat	–	–	–	–	–
Liver	–	–	–	–	–
Poultry (layer only) – no feeding study available and not required
Eggs	–	–	–	–	–

^aIndicates that the MRL is proposed at the limit of quantification.

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

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

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

^eFor milk, mean was derived from samplings performed from day 2 to day 28 (daily mean of 3 cows).

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

B.3. Consumer risk assessment

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

Consumer exposure assessment through drinking water resulting from groundwater metabolite(s) according to SANCO/221/2000 rev.10 Final (25/2/2003)

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

B.4. Proposed MRLs

Code number	Commodity	Existing EU MRL (mg/kg)	Existing CXL (mg/kg)	Outcome of the review
				MRL (mg/kg)	Comment
Enforcement residue definition (existing): aminopyralidEnforcement residue definition (proposed): sum of aminopyralid and its conjugates, expressed as aminopyralid
401060	Rapeseed	0.03	–	0.03	Recommendedb
500010	Barley grain	0.15	0.1	0.15	Recommendedc
500030	Maize grain	0.05	–	0.05	Recommendedb
500040	Millet grain	0.05	–	0.05	Recommendedb
500050	Oats grain	0.15	0.1	0.15	Recommendedc
500070	Rye grain	0.15	–	0.15	Recommendedb
500080	Sorghum grain	0.05	–	0.05	Recommendedb
500090	Wheat grain	0.1	0.1	0.1	Recommendedd
Enforcement residue definition 2: aminopyralid
1011010	Swine meat	0.01*	0.1	0.1	Recommendedd
1011020	Swine fat (free of lean meat)	0.02	0.1	0.1	Recommendedd
1011030	Swine liver	0.02	0.05	0.05	Recommendedd
1011040	Swine kidney	0.3	1	1	Recommendedd
1012010	Bovine meat	0.1	0.1	0.1	Recommendedd
1012020	Bovine fat	0.1	0.1	0.1	Recommendedd
1012030	Bovine liver	0.05	0.05	0.05	Recommendedd
1012040	Bovine kidney	1	1	1	Recommendedd
1013010	Sheep meat	0.1	0.1	0.1	Recommendedd
1013020	Sheep fat	0.1	0.1	0.1	Recommendedd
1013030	Sheep liver	0.05	0.05	0.05	Recommendedd
1013040	Sheep kidney	1	1	1	Recommendedd
1014010	Goat meat	0.1	0.1	0.1	Recommendedd
1014020	Goat fat	0.1	0.1	0.1	Recommendedd
1014030	Goat liver	0.05	0.05	0.05	Recommendedd
1014040	Goat kidney	1	1	1	Recommendedd
1015010	Horse meat	0.1	0.1	0.1	Recommendedd
1015020	Horse fat	0.1	0.1	0.1	Recommendedd
1015030	Horse liver	0.05	0.05	0.05	Recommendedd
1015040	Horse kidney	1	1	1	Recommendedd
1016010	Poultry meat	0.01*	0.01*	0.01*	Recommendede
1016020	Poultry fat	0.02	0.01*	0.01*	Recommendede
1016030	Poultry liver	0.02	0.01*	0.01*	Recommendede
1020010	Cattle milk	0.02	0.02	0.02	Recommendedd
1020020	Sheep milk	0.02	0.02	0.02	Recommendedd
1020030	Goat milk	0.02	0.02	0.02	Recommendedd
1020040	Horse milk	0.02	0.02	0.02	Recommendedd
1030000	Birds’ eggs	0.01*	0.01*	0.01*	Recommendede
–	Other commodities of plant and/or animal origin	See Reg. 2019/1015	–	–	Further consideration neededf

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

^aIndicates that the MRL is set at the limit of quantification.

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

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

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

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

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

Appendix C – Pesticide Residue Intake Model (PRIMo)

1.

• PRIMo(EU)

• PRIMo(CX)

Appendix D – Input values for the exposure calculations

D.1. Livestock dietary burden calculations

Feed commodity	Median dietary burden		Maximum dietary burden
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Risk assessment residue definition: sum of aminopyralid and its conjugates, expressed as aminopyralid
Barley straw	0.04	STMR	0.13	HR
Corn, field stover (fodder)	0.01*	STMR	0.12	HR
Corn, pop stover (fodder)	0.01*	STMR	0.12	HR
Grass forage (fresh)	1.19	STMR	4.26	HR
Grass hay	4.17	STMR × default PF (3.5)a	14.91	HR × default PF (3.5)a
Grass silage	1.9	STMR × default PF (1.6)a	6.82	HR × default PF (1.6)a
Millet straw (fodder, dry)	0.01*	STMR	0.12	HR
Oat straw	0.05	STMR	0.27	HR
Rye straw	0.05	STMR	0.27	HR
Sorghum, grain stover	0.01*	STMR	0.12	HR
Triticale straw	0.05	STMR	0.27	HR
Wheat straw	0.05	STMR	0.27	HR
Barley grain	0.04	STMR	0.04	STMR
Corn, field (Maize) grain	0.01*	STMR	0.01*	STMR
Corn, pop grain	0.01*	STMR	0.01*	STMR
Millet grain	0.01*	STMR	0.01*	STMR
Oat grain	0.04	STMR	0.04	STMR
Rye grain	0.04	STMR	0.04	STMR
Sorghum grain	0.01*	STMR	0.01*	STMR
Triticale grain	0.01*	STMR	0.01*	STMR
Wheat grain	0.01*	STMR	0.01*	STMR
Brewer's grain dried	0.13	STMR × default PF (3.3)a	0.13	STMR × default PF (3.3)a
Canola (Rapeseed) meal	0.02	STMR × default PF (2)a	0.02	STMR × default PF (2)a
Corn, field milled by‐pdts	0.01*	STMR × default PF (1)a	0.01*	STMR × default PF (1)a
Corn, field hominy meal	0.06	STMR × default PF (6)a	0.06	STMR × default PF (6)a
Corn, field gluten feed	0.03	STMR × default PF (2.5)a	0.03	STMR × default PF (2.5)a
Corn, field gluten, meal	0.01*	STMR × default PF (1)a	0.01*	STMR × default PF (1)a
Distiller's grain dried	0.03	STMR × default PF (3.3)a	0.03	STMR × default PF (3.3)a
Rape meal	0.02	STMR × default PF (2)a	0.02	STMR × default PF (2)a
Wheat gluten meal	0.02	STMR × default PF (1.8)a	0.02	STMR × default PF (1.8)a
Wheat milled by‐pdts	0.02	STMR × PF (2.4)	0.02	STMR × PF (2.4)

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

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

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

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

Commodity	Chronic risk assessment		Acute risk assessment
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Risk assessment residue definition 1: sum of aminopyralid and its conjugates, expressed as aminopyralid
Rapeseeds/canola seeds	0.01*	STMR	0.01*	STMR
Barley	0.04	STMR	0.04	STMR
Maize/corn	0.01*	STMR	0.01*	STMR
Common millet/proso millet	0.01*	STMR	0.01*	STMR
Oat	0.04	STMR	0.04	STMR
Rye	0.04	STMR	0.04	STMR
Sorghum	0.01*	STMR	0.01*	STMR
Wheat	0.01*	STMR	0.01*	STMR
Risk assessment residue definition 2: aminopyralid
Swine: Muscle/meat	0.01*	STMR	0.01*	HR
Swine: Fat tissue	0.01*	STMR	0.01*	HR
Swine: Liver	0.01*	STMR	0.01*	HR
Swine: Kidney	0.01*	STMR	0.01*	HR
Bovine: Muscle/meat	0.01*	STMR	0.01*	HR
Bovine: Fat tissue	0.01*	STMR	0.01*	HR
Bovine: Liver	0.01*	STMR	0.01*	HR
Bovine: Kidney	0.01*	STMR	0.03	HR
Sheep: Muscle/meat	0.01*	STMR	0.01*	HR
Sheep: Fat tissue	0.01*	STMR	0.01*	HR
Sheep: Liver	0.01*	STMR	0.01*	HR
Sheep: Kidney	0.01*	STMR	0.04	HR
Goat: Muscle/meat	0.01*	STMR	0.01*	HR
Goat: Fat tissue	0.01*	STMR	0.01*	HR
Goat: Liver	0.01*	STMR	0.01*	HR
Goat: Kidney	0.01*	STMR	0.04	HR
Equine: Muscle/meat	0.01*	STMR	0.01*	HR
Equine: Fat tissue	0.01*	STMR	0.01*	HR
Equine: Liver	0.01*	STMR	0.01*	HR
Equine: Kidney	0.01*	STMR	0.03	HR
Milk: Cattle	0.01*	STMR	0.01*	STMR
Milk: Sheep	0.01*	STMR	0.01*	STMR
Milk: Goat	0.01*	STMR	0.01*	STMR
Milk: Horse	0.01*	STMR	0.01*	STMR

STMR: supervised trials median residue; HR: highest residue.

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

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

Commodity	Chronic risk assessment		Acute risk assessment
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Risk assessment residue definition 1: sum of aminopyralid and its conjugates, expressed as aminopyralid
Rapeseeds/canola seeds	0.01*	STMR	0.01*	STMR
Barley	0.04	STMR	0.04	STMR
Maize/corn	0.01*	STMR	0.01*	STMR
Common millet/proso millet	0.01*	STMR	0.01*	STMR
Oat	0.04	STMR	0.04	STMR
Rye	0.04	STMR	0.04	STMR
Sorghum	0.01*	STMR	0.01*	STMR
Wheat	0.01*	STMR (CXL)	0.01*	STMR (CXL)
Risk assessment residue definition 2: aminopyralid
Swine: Meat	0.01*	STMR (CXL)	0.03	HR (CXL)
Swine: Fat tissue	0.01*	STMR (CXL)	0.05	HR (CXL)
Swine: Liver	0.01*	STMR (CXL)	0.03	HR (CXL)
Swine: Kidney	0.1	STMR (CXL)	0.87	HR (CXL)
Bovine: Meat	0.01*	STMR (CXL)	0.03	HR (CXL)
Bovine: Fat tissue	0.01*	STMR (CXL)	0.05	HR (CXL)
Bovine: Liver	0.01*	STMR (CXL)	0.03	HR (CXL)
Bovine: Kidney	0.1	STMR (CXL)	0.87	HR (CXL)
Sheep: Meat	0.01*	STMR (CXL)	0.03	HR (CXL)
Sheep: Fat tissue	0.01*	STMR (CXL)	0.05	HR (CXL)
Sheep: Liver	0.01*	STMR (CXL)	0.03	HR (CXL)
Sheep: Kidney	0.1	STMR (CXL)	0.87	HR (CXL)
Goat: Meat	0.01*	STMR (CXL)	0.03	HR (CXL)
Goat: Fat tissue	0.01*	STMR (CXL)	0.05	HR (CXL)
Goat: Liver	0.01*	STMR (CXL)	0.03	HR (CXL)
Goat: Kidney	0.1	STMR (CXL)	0.87	HR (CXL)
Equine: Meat	0.01*	STMR (CXL)	0.03	HR (CXL)
Equine: Fat tissue	0.01*	STMR (CXL)	0.05	HR (CXL)
Equine: Liver	0.01*	STMR (CXL)	0.03	HR (CXL)
Equine: Kidney	0.1	STMR (CXL)	0.87	HR (CXL)
Poultry: Meat	0.01*	STMR (CXL)	0.01*	HR (CXL)
Poultry: Fat	0.01*	STMR (CXL)	0.01*	HR (CXL)
Poultry: Liver	0.01*	STMR (CXL)	0.01*	HR (CXL)
Milk: Cattle	0.01*	STMR (CXL)	0.01*	STMR (CXL)
Milk: Sheep	0.01*	STMR (CXL)	0.01*	STMR (CXL)
Milk: Goat	0.01*	STMR (CXL)	0.01*	STMR (CXL)
Milk: Horse	0.01*	STMR (CXL)	0.01*	STMR (CXL)
Eggs: Chicken	0.01*	STMR (CXL)	0.01*	HR (CXL)

STMR: supervised trials median residue; HR: highest residue; CXL: Codex maximum residue limits.

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

Appendix E – Decision tree for deriving MRL recommendations

1.

Appendix F – Used compound codes

1.

Code/trivial namea	IUPAC name/SMILES notation/InChiKeyb	Structural formulac
Aminopyralid	4‐amino‐3,6‐dichloropyridine‐2‐carboxylic acid or 4‐amino‐3,6‐dichloropicolinic acid NIXXQNOQHKNPEJ‐UHFFFAOYSA‐N

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

^aThe metabolite name in bold is the name used in the conclusion.

^bACD/Name 2019.1.1 ACD/Labs 2019 Release (File version N05E41, Build 110555, 18 July 2019).

^cACD/ChemSketch 2019.1.1 ACD/Labs 2019 Release (File version C05H41, Build 110712, 24 July 2019).

Suggested citation: EFSA (European Food Safety Authority) , Anastassiadou M, Bernasconi G, Brancato A, Carrasco Cabrera L, Ferreira L, Greco L, Jarrah S, Kazocina A, Leuschner R, Magrans JO, Miron I, Nave S, Pedersen R, Reich H, Rojas A, Sacchi A, Santos M, Stanek A, Theobald A, Vagenende B and Verani A, 2020. Reasoned Opinion on the review of the existing maximum residue levels for aminopyralid according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2020;18(8):6229, 45 pp. 10.2903/j.efsa.2020.6229