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Review of the existing maximum residue levels for tembotrione 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 tembotrione. To assess the occurrence of tembotrione residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011 as well as the import tolerances and 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. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.


Summary
Tembotrione was approved on 1 May 2014 by means of Commission Implementing Regulation 1192/2013 under 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. To collect the relevant pesticide residues data, EFSA asked Austria, the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile) and to prepare a supporting evaluation report. The PROFile and evaluation report provided by the RMS were made available to the Member States. A request for additional information was addressed to the Member States in the framework of a completeness check period, which was initiated by EFSA on 22 September 2017 and finalised on 24 November 2017. After having considered all the information provided, EFSA prepared a completeness check report which was made available to Member States on 23 January 2018.
Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC, and the additional information provided by the RMS and Member States, EFSA prepared in June 2018 a draft reasoned opinion, which was circulated to Member States for consultation via a written procedure. Comments received by 18 July 2018 were considered during the finalisation of this reasoned opinion. The following conclusions are derived.
The metabolism of tembotrione was studied in maize grain, stover and forage (cereal crops) during the peer review. In the framework of this review, an additional metabolism study on poppy seeds (pulses/oilseed) was submitted and assessed. The parent tembotrione was rapidly metabolised and metabolites M5 (dihydroxy-tembotrione) and subsequently M6 (benzoic acid) were mainly formed. A metabolism study in fruiting vegetables or another third crop group is not available and still required in relation to a reported authorised Good Agricultural Practice (GAP) on fruit spices.
During the peer review, it was concluded that the metabolism of tembotrione in rotational crops is similar to the pathway observed in primary crops. The occurrence of significant tembotrione residues in rotational crops was considered unlikely and available studies were considered sufficient during the peer review. These conclusions are supported during this review.
Monitoring methods are available for tembotrione and its metabolite M5 with a limit of quantification (LOQ) of 0.01 mg/kg, respectively, for high water, high acid, high oil and dry commodities. A validated high-performance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS) method, independent laboratory validation (ILV) and a confirmatory liquid chromatography with tandem mass spectrometry (LC-MS/MS) method with a LOQ of 0.01 mg/kg for tembotrione and M5, respectively, are available. For spices a method for enforcement is still required.
The same residue definitions (tembotrione and its metabolite M5, expressed as tembotrione) as proposed during the peer review are still supported in this review limited to cereals, pulses and oilseeds. It is applicable to rotational crops and processed commodities. Nevertheless, no residue definitions could be proposed for fruit spices. According to the information provided by the EURLs an analytical standard is commercially available for tembotrione and metabolite M5.
The available data are considered sufficient to derive MRL proposals as well as risk assessment values for all commodities under evaluation, except for sweet corn for which tentative MRLs are derived and for fruit spices where no MRL could be derived.
A metabolism study in dairy cattle dosed with radio-labelled M5 was performed and showed that unchanged M5 was the only significant radioactive component seen in liver and kidney. During the peer review, it was concluded that only the metabolite M5 should be defined as the residue of concern in food of animal origin based on the intake of maize silage and grain where M5 residues and exposure are expected. This conclusion is supported during this review. A HPLC-MS/MS method for enforcement of metabolite M5 with a LOQ of 0.01 mg/kg in muscle, liver, kidney, liver and eggs and with a LOQ of 0.002 mg/kg in milk for M5 is available. An ILV and a confirmatory LC-MS/MS method are available.
Based on the results of the livestock feeding study and considering the calculated dietary burden, significant residues in kidney and liver of cattle and swine are expected and MRLs for these commodities can be proposed. For milk and for all other cattle and swine tissues, MRLs can be established at the LOQ. According to the information provided by the EURLs an analytical standard is commercially available for metabolite M5.
Chronic and acute consumer exposures resulting from the authorised uses reported in the framework of this review were calculated using revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). For those commodities where data were insufficient to derive a MRL, EFSA considered the existing EU MRL for an indicative calculation. The highest chronic exposure was calculated for UK, toddler, representing 25% of the acceptable daily intake (ADI), and the highest acute exposure was calculated for sweet corn, representing 3.2% of the acute reference dose (ARfD). It has to be noted that metabolite M5 is less toxic than the parent (ADI = 0.013 mg/kg body weight (bw) per day). During the peer review, a toxicity equivalence factor (TEF) of 0.0308 was derived. During this review, the risk assessment was carried out with the ADI of the parent without consideration of the TEF. Since no consumer concern was identified, a refined assessment considering the TEF was not carried out and is not considered necessary.
In addition, EFSA emphasises that the above studies do not investigate the possible impact of plant metabolism on the isomer ratio of tembotrione and that further investigation on this matter would in principle be required. Since guidance on the consideration of isomer ratios in the consumer risk assessment is not yet available, EFSA recommends that this issue is reconsidered when such guidance is available.   , and uses authorised in third countries that have a significant impact on international trade. The information included in the assessment report prepared under Directive 91/414/EEC 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.
Austria, the designated rapporteur Member State (RMS) in the framework of Directive 91/414/EEC, was asked to complete the PROFile for tembotrione and to prepare a supporting evaluation report (Austria, 2014). The PROFile and the supporting evaluation report were submitted to EFSA on 25 February 2014 and made available to the Member States. A request for additional information was addressed to the Member States in the framework of a completeness check period which was initiated by EFSA on 22 September 2017 and finalised on 24 November 2017. Additional evaluation reports were submitted by Austria, the Czech Republic, France, Greece, the Netherlands, Portugal, Spain, the United Kingdom and the European Union Reference Laboratories for Pesticide Residues (Austria, 2017;Czech Republic, 2017;EURL, 2017;France, 2017;Netherlands, 2017;Portugal, 2017Portugal, , 2018Spain, 2017;United Kingdom, 2017;Greece, 2018) 153, 11.6.2011, p. 187-188. opinion, which was submitted to Member States for commenting via a written procedure. All comments received by 18 July 2018 were considered by EFSA during the finalisation of the reasoned opinion. The evaluation report submitted by the RMS (Austria, 2014(Austria, , 2017 and the evaluation reports submitted by Member States Austria, the Czech Republic, France, Greece, the Netherlands, Portugal, Spain, the United Kingdom and the EURL (Czech Republic, 2017;EURL, 2017;France, 2017;Netherlands, 2017;Portugal, 2017Portugal, , 2018Spain, 2017;United Kingdom, 2017;Greece, 2018) are considered as supporting documents to this reasoned opinion and, thus, are made publicly available.
In addition, key supporting documents to this reasoned opinion are the completeness check report (EFSA, 2018a) and the Member States consultation report (EFSA, 2018b). These reports are developed to address all issues raised in the course of the review, from the initial completeness check to the reasoned opinion. Also, the chronic and acute exposure calculations for all crops reported in the framework of this review performed using the EFSA Pesticide Residues Intake Model (PRIMo) (excel file) and the PROFile are key supporting documents and made publicly available as background documents to this reasoned opinion. Furthermore, a screenshot of the Report sheet of the PRIMo(EU) 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.
Tembotrione belongs to the group of triketone compounds which are used as a post-emergence herbicide for use in maize, for grain and silage production and sweet corn. After foliar application, tembotrione is rapidly taken up into the leaves and transported to the growing parts of the plant with associated necrosis of foliar tissues.
The chemical structure of the active substance and its main metabolites are reported in Appendix F. Tembotrione was evaluated in the framework of Commission Regulation (EU) No 188/2011 with Austria designated as RMS. The representative uses supported for the peer review process were field broadcast application on maize and sweet corn for the control of grasses and broad leaved weeds. Following the peer review, which was carried out by EFSA (2013)  For the purpose of this MRL review, the critical uses of tembotrione currently authorised within the EU, as well as uses authorised in third countries that might have a significant impact on international trade, have been collected by the RMS and reported in the PROFile. The additional good agricultural practices (GAPs) reported by Member States during the completeness check were also considered. The details of the authorised GAPs for tembotrione are given in Appendix A.

Assessment
EFSA has based its assessment on the PROFile submitted by the RMS, the evaluation report accompanying the PROFile (Austria, 2014), the draft assessment report (DAR) and its addenda prepared under Council Directive 91/414/EEC (Austria, , 2012, the conclusion on the peer review of the pesticide risk assessment of the active substance tembotrione (EFSA, 2013), the previous reasoned opinion on tembotrione (EFSA, 2012) as well as the evaluation reports submitted during the completeness check (Czech Republic, 2017;EURL, 2017;France, 2017;Netherlands, 2017;Portugal, 2017;Spain, 2017;United Kingdom, 2017). 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 546/2011 7 and the currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues (European Commission, 1997a-g, 2000, 2010a,b, 2017OECD, 2011OECD, , 2013.
More detailed information on the available data and on the conclusions derived by EFSA can be retrieved from the list of end points reported in Appendix B.

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 tembotrione following foliar application was studied in maize grain, stover and forage (cereal crops) during the peer review with the test substance labelled either on the phenyl-or cyclohexyl-moiety in each crop study . In the framework of this review, an additional metabolism study on poppy seeds (pulses/oilseed) with both labels was submitted and assessed (France, 2017).
In maize, the parent tembotrione was rapidly metabolised and metabolites M5 (dihydroxytembotrione) and subsequently M6 (benzoic acid) were mainly formed. As a minor route, cleavage of the ether bond in M6 was observed resulting in the substituted benzyl alcohol metabolite M2 .
It has to be noted that a metabolism study in fruiting vegetables or another third crop group is not available and is still required to support the northern outdoor authorised GAP on fruit spices.

Nature of residues in rotational crops
Tembotrione is authorised for use on cereals which may be grown in rotation. According to the soil degradation studies evaluated in the framework of the peer review, periods required for 90% dissipation (DT 90 values) of tembotrione and its main soil metabolite M6 were up to 262 and 242 days, respectively, which is higher than the trigger value of 100 days (EFSA, 2013). Therefore, further investigation of residues in rotational crops was performed and evaluated.
During the peer review, the metabolism of tembotrione in rotational crops was studied in three rotational crop studies covering cereals, root and tuber vegetables and leafy crops grown after soil application of U-14 C-phenyl labelled tembotrione at 212 g a.s./ha which represents approximately twice the most critical GAP rate for all crops in this review.
During the peer review, it was concluded that the metabolism of tembotrione in rotational crops is similar to the pathway observed in primary crops (EFSA, 2013). This conclusion is supported in this review.

Nature of residues in processed commodities
The effect of processing under standard hydrolyses conditions on the nature of residues of tembotrione and its metabolite M5 was investigated in studies performed at three test conditions simulating pasteurisation (20 min at 90°C, pH 4), baking/brewing/boiling (60 min at 100°C, pH 5) and sterilisation (20 min at 120°C, pH 6) in the framework of the peer review .
From these studies, it can be concluded that tembotrione is stable under conditions simulating processing by pasteurisation, baking/brewing/boiling. Minor (less than 10% applied radioactivity (AR)) degradation of phenyl-and cyclohexyl-labelled tembotrione was reported under sterilisation conditions. Metabolite M5 was stable under all three processing conditions and degradation products were not formed .
Additional information was not received during this review and it is concluded that tembotrione and its metabolite M5 are stable.

Methods of analysis in plants
Monitoring methods are available for tembotrione and its metabolite M5 with a limit of quantification (LOQ) of 0.01 mg/kg, respectively, for high water, high acid, high oil and dry commodities. A highperformance liquid chromatography with tandem mass spectrometry (HPLC-MS/MS) method is validated in tomato, orange, oil seed rape and maize grain. An independent laboratory validation (ILV) and a confirmatory liquid chromatography (LC-MS/MS) method with a LOQ of 0.01 mg/kg for tembotrione and M5, respectively, are available .
Furthermore, the EURLs provided a LC-MS/MS method for high water, high acid and dry plant commodities with a LOQ of 0.01 mg/kg for tembotrione and M5 however not for animal commodities, respectively (EURLs, 2017). The EURLs reported validation data for high water commodities for M5 during the Member State consultation (EFSA, 2018b).
It is concluded that tembotrione and its metabolite M5 can be enforced in high water, high acid, high oil and dry commodities with a LOQ of 0.01 mg/kg, respectively.
It has to be noted that no method for spices is available and is still required to support the authorised GAP on fruit spices.

Stability of residues in plants
The storage stability of tembotrione and its metabolites M6, M5 and M2 was investigated in the framework of the peer review (Austria, , 2009(Austria, , 2011. Additional storage stability studies were also assessed in the framework of this review (France, 2017).
Storage stability of tembotrione and its metabolites M6, M5 and M2 were further investigated in sunflower seeds. While the parent, M6 and M2 were stable -18°C for 33 months, M5 was reported to be stable for 26 months (Austria, 2014;France, 2017).
In high water content and in dry commodities (corn grain, forage and fodder) stored at À18°C, tembotrione, M2 and M6 are stable for at least 28 months while M5 is stable for at least 30 months. In high oil content matrices (sunflower seeds) stored at À18°C, tembotrione, M2 and M6 are stable for at least 33 months and M5 for at least 26 months.

Proposed residue definitions
In the plant metabolism studies, the main residues were the parent and its metabolites M6 (tembotrione-benzoic acid), M5 (dihydroxy-tembotrione) and M2 (tembotrione carboxy benzyl alcohol). These metabolites were therefore included in the analysis of supervised field trials. However, the data from the supervised field trials showed that the residues of the metabolites M6 and M2 were either very low or found at very early time points not reflecting the currently authorised GAP conditions. The only substance that was found in animal feed items was metabolite M5. Therefore, this metabolite even though found only in small amounts was included in the residue definitions for monitoring and risk assessment during the peer review (EFSA, 2013).
Following the review of the available metabolism studies and supervised residue trial data, including a new metabolism study and residue trials on poppy seeds, the residue definitions (tembotrione and its metabolite M5) as proposed during the peer review are still supported in this review. The same residue definition as for raw commodities is applicable to rotational crops and processed commodities.
It is noted that the proposed residue definitions are limited to cereals, pulses and oilseeds and that an additional metabolism study is still required to support the authorised GAP on fruit spices Therefore, no residue definitions could be proposed for fruit spices.
A fully validated method is available for the enforcement of tembotrione and its metabolite M5 with a combined LOQ of 0.02 mg/kg for high water, high acid, high oil and dry commodities noting that a method for fruit spices is still required. According to the information provided by the EURLs an analytical standard is commercially available for tembotrione and metabolite M5 (EFSA, 2018b).
In addition, EFSA emphasises that the above studies do not investigate the possible impact of plant metabolism on the isomer ratio of tembotrione and further investigation on this matter would in principle be required. Since guidance on the consideration of isomer ratios in the consumer risk assessment is not yet available, EFSA recommends that this issue is reconsidered when such guidance is available.

1.2.
Magnitude of residues in plants 1.

Magnitude of residues in primary crops
To assess the magnitude of tembotrione residues resulting from the reported GAPs, EFSA considered all residue trials reported by the RMS in its evaluation report (Austria, 2014), including residue trials evaluated in the framework of the peer review (EFSA, 2013;Austria, 2014) or in the framework of a previous MRL application (EFSA, 2012) and additional data submitted during the completeness check (Austria, 2017;Czech Republic, 2017;France, 2017;Netherlands, 2017;Portugal, 2017Portugal, , 2018Spain, 2017;United Kingdom, 2017;Greece, 2018). All residue trial samples considered in this framework were stored in compliance with the demonstrated storage conditions.
The number of residue trials and extrapolations were evaluated in accordance with the European guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs (European Commission, 2017).
Residue trials are not available to support the northern outdoor GAP on fruit spices and the Czech Republic proposed to waive a need for residue trials because the crop is harvested 1 year after treatment and a no residue situation was to be anticipated (Czech Republic, 2017). However, considering that this crop group is not covered by a metabolism study, this proposed waiver is not considered acceptable. Therefore, MRLs and risk assessment values could not be derived for this crop and a full data set supporting the northern outdoor GAP on fruit spices is still required.
For sweet corn, only tentative MRL and risk assessment values could be derived by EFSA and the following data gap was identified: • All available residue trials supporting the import tolerance were performed with two instead of one application and residues were analysed using a method with a higher LOQ of 0.02 mg/kg for each compound. Although residues were found above the LOQ in one trial only (M5: 0.024 mg/kg), the derived MRL and risk assessment values are expected to be overestimated. Therefore, eight additional trials on sweet corn compliant with the US import tolerance and analysed with an analytical method validated at a lower combined LOQ of 0.02 mg/kg are still required.
For all other crops, available residue trials were sufficient to derive MRL and risk assessment values taking note of the following considerations: • Poppy seeds: only two residue trials are available to support the southern outdoor GAP and five to support the northern outdoor GAP. Additional trials would be in principle still required. However, the reduced number of trials is considered acceptable for a minor crop. In addition, the southern European Union (SEU) and the northern European Union (NEU) GAPs are the same and all available trials were below the LOQ. Further residue trials are therefore not required. Magnitude of residues in rotational crops.
Confined rotational crop studies were investigated during the peer review (EFSA, 2013). Tembotrione was applied on bare sandy loam soil with approximately twice the critical GAP rate (212 g a.s./ha). Swiss chard, turnips and spring wheat were planted 90 DAT. The TRR for swiss chard, turnip tops and roots was 0.134, 0.050 and 0.013 mg eq/kg. The TRR for wheat forage, wheat hay and wheat straw and wheat grain was 0.031, 0.246, 0.188 and 0.178 mg eq/kg, respectively. The principal residues were identified as metabolites M6 and M2 .
For a realistic prediction of possible soil degradation in succeeding crops, field tests have been performed. Tembotrione residues including its metabolites M2, M5 and M6 after two applications (2 9 92 g a.s./ha) to corn were investigated to determine a plant-back interval (PBI) for leafy vegetables, root crops and cucurbits. It was reported during the peer review that tembotrione and its metabolites in the raw agricultural commodity (RAC) of mustard green, turnips and summer squash grown at a PBI of 90-120 days were below the LOQ.
In addition the magnitude of tembotrione and metabolites M2, M5 and M6 in or on winter wheat raw agricultural commodities when used as a rotational crop after two applications of tembotrione (actual application rates ranged from 0.091 to 0.099 g a.s./ha) was determined. Winter wheat was planted at PBIs of 83 and 158 days after the last application to corn. Residues for M2, M5 and M6 were reported in mg tembotrione eq/kg however total residue levels were below LOQ in forage, hay, grain and straw for both PBIs (Austria, 2009).
The occurrence of significant tembotrione residues at shorter PBIs was considered unlikely and available studies were considered sufficient during the peer review (EFSA, 2013). This conclusion is supported during this review.
Therefore, these studies are considered sufficient by EFSA to demonstrate the absence of residues in rotational crops, provided that tembotrione is applied in compliance with the GAPs reported in Appendix A.

Magnitude of residues in processed commodities
Studies investigating the magnitude of residues in whole grain milling grits (large), meal, flour, refined oil (following wet and dry milling), starch and silage production were evaluated during the peer review (EFSA, 2013). An overview of these studies is given in Appendix B.1.2.3.
Robust processing factors could not be derived since for each processed commodity only one study was available. Considering that corn silage was the main contributor to the dietary burden of cattle and swine (see Section B.1.2.3), additional processing studies are still desirable to refine the dietary burden. 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 required.

Proposed MRLs
Consequently, the available data are considered sufficient to derive MRL proposals as well as risk assessment values for all commodities under evaluation, except for sweet corn for which tentative MRLs are derived and for fruit spices where no MRL could be derived. Tentative MRLs were also derived for feed crops (cereal straw and forage) in view of the future need to set MRLs in feed items.

Residues in livestock
Tembotrione is authorised for use on common millet, maize, sorghum forage which might be fed to livestock. Livestock dietary burdens were therefore calculated 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 (all), dairy cattle 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.

Nature of residues and methods of analysis in livestock
Studies on laying hen and lactating cows were performed with phenyl-U-14 C-and cyclohexyl-U-14 Clabelled tembotrione at dosing levels of 0.08 and 0.85 mg/kg body weight (bw) per day and of 0.03 and 0.3 mg/kg bw per day and metabolite M5 at a dosing level of 0.26 mg/kg bw per day.
Tembotrione was not extensively metabolised and remained the major compound in all tissues. In the hen study, the parent ranged in tissues between 25% and 97.1% TRR (7-2,037 mg eq/kg) and in the lactating cow study 21-96% TRR (3-2,046 mg eq/kg) with highest concentrations in the liver and kidney. Hydroxylation was observed in the hen study (4% TRR (61 mg eq/kg)) in the liver only and in the lactating cow unidentified metabolites in liver and kidney were reported below 3.5% TRR (106 mg eq/kg). A metabolism study in dairy cattle dosed with radiolabelled M5 was performed and showed that unchanged M5 was the only significant radioactive component seen in liver and kidney (69.9% TRR (427 mg eq/kg); 85.5% TRR (133 mg eq/kg)) .
During the peer review, it was concluded that only the metabolite M5 should be defined as the residue of concern in food of animal origin since on the intake of maize silage and grain where residues of M5; however, no significant residues of tembotrione were reported. Therefore, only exposure to M5 is to be expected. Hence, in view of the livestock dietary burden, the residue definition for monitoring and risk assessment in ruminants was set as metabolite M5 only EFSA, 2013). This conclusion is still supported during this review. Since the general metabolic pathways in rodents and ruminants were found to be comparable; the findings in ruminants can therefore be extrapolated to swine.
A HPLC-MS/MS method for enforcement of metabolite M5 with a LOQ of 0.01 mg/kg in muscle, liver, kidney, liver and eggs and with a LOQ of 0.002 mg/kg in milk for M5 is available. An ILV and a confirmatory LC-MS/MS method were provided . According to the information provided by the EURLs, an analytical standard is commercially available for metabolite M5 (EFSA, 2018b).
Storage stability studies in all animal tissues are not available for tembotrione or any of the metabolites and are not required because the samples of the animal feeding studies were stored frozen and were analysed within 30 days .

2.2.
Magnitude of residues in livestock MRL and risk assessment values for animal products were derived according to the OECD guidance which was agreed upon at the European level (OECD, 2013). The overview of the study results used to derive risk assessment values and MRL proposals are summarised in Appendix B.2.2.
During the peer review, one livestock feeding study performed on dairy cattle was evaluated by the RMS in the DAR EFSA, 2013). Four dose levels were tested (0.002, 0.018, 0.055 and 0.182 mg/kg bw per day) for 28-30 days, whereby the second lowest dietary burden is closest to the calculated dietary burden for cattle (all) and dairy cattle (1.1N) and the lowest to swine (0.6N). Samples of milk, fat, kidney, liver and muscle were analysed for metabolite M5 with the validated LOQ of 0.002 mg/kg for milk and 0.01 mg/kg for tissues.
Residues of M5 were below the LOQ in milk, muscle and fat at all dose levels and in liver and kidney at the lowest dose level. However at the three higher dose levels in kidney mean residue levels of 0.015 mg/kg, 0.042 mg/kg and of 0.142 mg/kg and in kidney and 0.032 mg/kg, 0.132 mg/kg and 0.341 mg/kg in liver were reported.
Based on the results of the livestock feeding study and considering the calculated dietary burden, significant residues in kidney and liver of cattle and swine are expected and MRLs for these commodities are proposed. For milk and for all other cattle and swine tissues MRLs can be established at the LOQ.
MRLs for poultry and sheep products are not required because they are not expected to be exposed to significant levels of M5 residues.

Consumer risk assessment
In the framework of this review, only the uses of active substance reported by the RMS in Appendix A were considered.
Chronic and acute exposure calculations for all crops reported in the framework of this review were performed using revision 2 of the EFSA PRIMo (EFSA, 2007). Input values for the exposure calculations were derived in compliance with the decision tree reported in Appendix E. Hence, for those commodities where a (tentative) MRL could be derived by EFSA in the framework of this review, input values were derived according to the internationally agreed methodologies (FAO, 2009). For fruit spices where residue data were waved because no residues are expected, EFSA considered the existing EU MRL at the LOQ for an indicative calculation. All input values included in the exposure calculations are summarised in Appendix D.
The exposures calculated were compared with the toxicological reference values for tembotrione, derived by EFSA (2013) under Directive 91/414/EEC. The highest chronic exposure was calculated for UK, toddler, representing 25% of the acceptable daily intake (ADI), and the highest acute exposure was calculated for sweet corn, representing 3.2% of the acute reference dose (ARfD).
It has to be noted that metabolite M5 is less toxic than the parent (ADI = 0.013 mg/kg bw per day). During the peer review, a toxicity equivalence factor (TEF) of 0.0308 was derived (EFSA, 2013). In a previous MRL application, this factor was considered for dietary risk assessment of bovine and swine liver and kidney where the metabolite M5 is the relevant residue (EFSA, 2012). During this review, the risk assessment was carried out with the ADI of the parent without consideration of the TEF. Since no consumer concern was identified, a refined assessment considering the TEF was not carried out and is not considered necessary.
It can be concluded that although uncertainties remain due to the data gaps identified in the previous sections, this indicative exposure calculation did not indicate a risk to consumers.

Conclusions
The metabolism of tembotrione was studied in maize grain, stover and forage (cereal crops) during the peer review. In the framework of this review, an additional metabolism study on poppy seeds (pulses/oilseed) was submitted and assessed. The parent tembotrione was rapidly metabolised and metabolites M5 (dihydroxy-tembotrione) and subsequently M6 (benzoic acid) were mainly formed. A metabolism study in fruiting vegetables or another third crop group is not available and still required in relation to a reported authorised GAP on fruit spices.
During the peer review, it was concluded that the metabolism of tembotrione in rotational crops is similar to the pathway observed in primary crops. The occurrence of significant tembotrione residues in rotational crops was considered unlikely and available studies were considered sufficient during the peer review. These conclusions are supported during this review.
Monitoring methods are available for tembotrione and its metabolite M5 with an LOQ of 0.01 mg/kg, respectively, for high water, high acid, high oil and dry commodities. A validated HPLC-MS/MS method, an ILV and a confirmatory LC-MS/MS method with an LOQ of 0.01 mg/kg for tembotrione and M5, respectively, are available. For spices, a method for enforcement is still required.
The same residue definitions (tembotrione and its metabolite M5, expressed as tembotrione) as proposed during the peer review are still supported in this review limited to cereals, pulses and oilseeds. It is applicable to rotational crops and processed commodities. Nevertheless, no residue definitions could be proposed for fruit spices. According to the information provided by the EURLs, an analytical standard is commercially available for tembotrione and metabolite M5.
The available data are considered sufficient to derive MRL proposals as well as risk assessment values for all commodities under evaluation, except for sweet corn for which tentative MRLs are derived and for fruit spices where no MRL could be derived. A metabolism study in dairy cattle dosed with radiolabelled M5 was performed and showed that unchanged M5 was the only significant radioactive component seen in liver and kidney. During the peer review, it was concluded that only the metabolite M5 should be defined as the residue of concern in food of animal origin based on the intake of maize silage and grain where M5 residues and exposure are expected. This conclusion is supported during this review. A HPLC-MS/MS method for enforcement of metabolite M5 with an LOQ of 0.01 mg/kg in muscle, liver, kidney, liver and eggs and with an LOQ of 0.002 mg/kg in milk for M5 is available. An ILV and a confirmatory LC-MS/MS method are available.
Based on the results of the livestock feeding study and considering the calculated dietary burden, significant residues in kidney and liver of cattle and swine are expected and MRLs for these commodities can be proposed. For milk and for all other cattle and swine tissues, MRLs can be established at the LOQ. According to the information provided by the EURLs, an analytical standard is commercially available for metabolite M5.
Chronic and acute consumer exposures resulting from the authorised uses reported in the framework of this review were calculated using revision 2 of the EFSA PRIMo. For those commodities where data were insufficient to derive an MRL, EFSA considered the existing EU MRL for an indicative calculation. The highest chronic exposure was calculated for UK, toddler, representing 25% of the ADI, and the highest acute exposure was calculated for sweet corn, representing 3.2% of the ARfD. It has to be noted that metabolite M5 is less toxic than the parent (ADI = 0.013 mg/kg bw per day). During the peer review, a TEF of 0.0308 was derived. During this review, the risk assessment was carried out with the ADI of the parent without consideration of the TEF. Since no consumer concern was identified, a refined assessment considering the TEF was not carried out and is not considered necessary.
In addition, EFSA emphasises that the above studies do not investigate the possible impact of plant metabolism on the isomer ratio of tembotrione and that further investigation on this matter would in principle be required. Since guidance on the consideration of isomer ratios in the consumer risk assessment is not yet available, EFSA recommends that this issue is reconsidered when such guidance is available.

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 further details). In particular, some tentative MRLs need to be confirmed by the following data: • additional residue trials for sweet corn; • a representative study investigating metabolism in fruit crops; • an analytical method for enforcement for fruit spices; • additional residue trials on fruit spices.

Sheep (all diets)
MRLs are not required since dietary burden was below the trigger value.

Sheep (dairy only)
MRLs are not required since dietary burden was below the trigger value.
Swine (e) Closest feeding level (0.018 mg/kg bw; 5 9 N rate) (c)  Maize grains 0.02* 0.02* Recommended (c) 500040 Common millet 0.02* 0.02* Recommended (c) 500080 Sorghum grains 0.02* 0.02* Recommended (c) 820000 Fruit spices 0.05* 0.05* Further consideration needed (d) Enforcement residue definition 2 (animal commodities): M5 (4,6-dihydroxy tembotrione), only group of commodities Indicates that the input value is proposed at the limit of quantification. (a): For corn field milled by-products, hominy meal, dry distillers grain, gluten feed, gluten meal, millet and sorghum grain no default processing factor was applied because tembotrione is applied early in the growing season and residues are expected to be below the LOQ. Concentration of residues in these commodities is therefore not expected. (b): For sorghum silage, in the absence of processing factors supported by data, default processing factors of 0.6 was included in the calculation to consider the potential concentration of residues in these commodities.  (c) 0.05* EU MRL (c) Risk assessment residue definition 2 (animal commodities): M5 (4,6-dihydroxy tembotrione), only Swine meat 0.01* 0.8 9 STMR muscle + 0.2 9 STMR fat (d) 0.01* 0.8 9 HR muscle + 0.2 9 HR fat (d) Swine