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

Abstract

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

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, Landesanstalt für Landwirtschaft und Gartenbau (LLG) submitted an application to the competent national authority in Germany (evaluating Member State, EMS) to modify the existing maximum residue levels (MRLs) for the active substance spirotetramat in herbs and edible flowers. The EMS drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 20 July 2022. To accommodate for the intended uses of spirotetramat, the EMS proposed to raise the existing MRL from 4 mg/kg to 10 mg/kg.

EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified data gaps, which were requested from the EMS. On 29 September 2022, the EMS submitted the requested information in a revised evaluation report, which replaced the previously submitted evaluation report.

Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC and Commission Regulation (EU) No 188/2011, the data evaluated under previous MRL assessments, and the additional data provided by the EMS in the framework of this application, the following conclusions are derived.

The metabolism of spirotetramat following foliar applications was investigated in crops belonging to the groups of fruit crops, root crops, leafy crops and pulses/oilseeds. A similar metabolic pattern was observed in all crops tested following foliar applications. The major part of the residues was composed of spirotetramat, its ‐enol, ‐ketohydroxy, ‐monohydroxy and ‐enol‐glucoside metabolites. Possible changes in the stereochemistry of the metabolites spirotetramat‐ketohydroxy and spirotetramat‐monohydroxy were not investigated and a data gap was identified by EFSA peer review and confirmed by the MRL review.

In rotational crops, the major residues identified were the parent compound and the same metabolites observed in primary crops.

Studies investigating the effect of processing on the nature of spirotetramat and its ‐enol, ‐ketohydroxy, ‐monohydroxy and ‐enol‐glucoside metabolites (hydrolysis studies) demonstrated that spirotetramat‐enol and spirotetramat‐monohydroxy are stable under the standard hydrolysis conditions; spirotetramat, spirotetramat‐enol‐glucoside and spirotetramat‐ketohydroxy were found to degrade to a certain extent depending on the test conditions.

Based on the metabolic pattern identified in metabolism studies, hydrolysis studies, the magnitude of spirotetramat‐MA‐amide metabolite, the toxicological significance of spirotetramat metabolites and the stability of spirotetramat during storage, the residue definitions for plant products were proposed as ‘sum of spirotetramat and spirotetramat‐enol, expressed as spirotetramat’ for enforcement and ‘sum of spirotetramat, spirotetramat‐enol, spirotetramat‐ketohydroxy, spirotetramat‐monohydroxy and spirotetramat‐enol‐glucoside, expressed as spirotetramat’ for risk assessment. These residue definitions are applicable to primary crops, rotational crops and processed products.

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

Sufficiently validated analytical methods based on high‐performance liquid chromatography with tandem mass spectroscopy (HPLC‐MS/MS) are available to quantify residues in the crops assessed in this application according to the enforcement residue definition. The methods enable quantification of residues at or above the limit of quantification (LOQ) of 0.01 mg/kg for each analyte and at or above the LOQ of 0.02 mg/kg for the enforcement residue definition in the crops assessed.

The available residue trials are sufficient to derive MRL proposals of 7 mg/kg for the whole group of herbs and edible flowers (except sage, rosemary, thyme and laurel/bay leaves), in line with the recommendation set in the EU technical guidelines on extrapolation, and 10 mg/kg for sage, rosemary, thyme and laurel/bay leaves.

Investigation of the magnitude of spirotetramat residues in rotational crops was not required, considering that the use under assessment is intended for fresh herbs raised in pots (marketed end‐product) under greenhouse conditions. Furthermore, based on the studies on the nature and magnitude of spirotetramat residues in rotational crops assessed in the framework of the EU pesticides peer review and the MRL review, it was concluded that significant residue levels of spirotetramat and its metabolites are unlikely to occur in rotational crops, provided that the active substance is used according to the proposed good agricultural practice (GAP).

Specific studies investigating the magnitude of spirotetramat residues in processed commodities are not required, as the total theoretical maximum daily intake (TMDI) of the commodities under assessment is below the trigger value of 10% of the acceptable daily intake (ADI).

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

The toxicological profile of spirotetramat was assessed in the framework of the EU pesticides peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of 0.05 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 1 mg/kg bw. It was concluded that the metabolites included in the residue definition for risk assessment are of similar toxicity as the parent active substance.

The consumer risk assessment was performed with revision 3.1 of the EFSA Pesticide Residues Intake Model (PRIMo). The short‐term exposure assessment was performed for the commodities assessed in this application. The calculations were based on the highest residues (HR) derived from supervised field trials and the short‐term exposure did not exceed the ARfD for any of the crops assessed. The long‐term (chronic) exposure assessment was performed taking into account the existing uses at EU level and the acceptable Codex maximum residue limits (CXLs). EFSA updated the calculation with the relevant supervised trials median residue values (STMR) derived from the residue trials assessed in three recent EFSA outputs and the current MRL application. The crops on which no uses were reported in the MRL review were excluded from the exposure calculation. The highest estimated long‐term dietary intake accounted for 26% of the ADI (NL toddler diet).

EFSA concluded that the proposed use of spirotetramat on herbs and edible flowers will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers' health. EFSA emphasises that the above assessment does not consider the possible impact of plant and livestock metabolism on the isomer ratio of spirotetramat and further investigation on this matter would in principle be required. EFSA notes that in view of the large margin of safety in the exposure calculations, the potential change of isomer ratios in the final residues is not expected to be of concern for the authorised and intended uses. In case future uses of active substance would lead to a higher consumer exposure, further information regarding the impact of plant and/or livestock metabolism on the isomer ratio might be required.

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

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

Code(a)	Commodity	Existing EU MRL (mg/kg)(b)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition (plants): sum of spirotetramat and spirotetramat‐enol, expressed as spirotetramat
0256010	Chervil	4	7	The submitted data are sufficient to derive an MRL proposal for the EU use. Risk for consumers unlikely.
0256020	Chives
0256030	Celery leaves
0256040	Parsley
0256080	Basil
0256100	Tarragon
0256050	Sage	4	10	The submitted data are sufficient to derive an MRL proposal for the EU use. Risk for consumers unlikely.
0256060	Rosemary
0256070	Thyme
0256090	Laurel/bay leaves

MRL: maximum residue level; EU: indoor use.

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

^(b)EU MRL derived from residue data on lettuce, according to the former residue definition for enforcement consisting of ‘sum of spirotetramat and its 4 metabolites spirotetramat‐enol, spirotetramat‐ketohydroxy, spirotetramat‐monohydroxy and spirotetramat‐enol‐glucoside, expressed as spirotetramat’ (EFSA, 2011).

Assessment

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

Spirotetramat is the ISO common name for ethyl cis‐8‐methoxy‐2‐oxo‐3‐(2,5‐xylyl)‐1‐azaspiro[4.5]dec‐3‐en‐4‐yl carbonate (IUPAC). The chemical structures of the active substance and its main metabolites are reported in Appendix E.

Spirotetramat was evaluated in the framework of Directive 91/414/EEC ¹ to be read in conjunction with Commission Regulation (EU) No 188/2011 ² with Austria designated as rapporteur Member State (RMS) for the representative uses as a foliar treatment on citrus and lettuces. The draft assessment report (DAR), prepared by the RMS has been peer reviewed by EFSA (2013). Spirotetramat was approved ³ for the use as insecticide on 1 May 2014.

The EU MRLs for spirotetramat are established in Annex II of Regulation (EC) No 396/2005 ⁴ . The review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (MRL review) has been performed (EFSA, 2020), and the proposed modifications have been implemented in the MRL legislation. After completion of the MRL review, EFSA has issued a reasoned opinion on the modification of MRLs for spirotetramat in leeks, spring onions and honey and a scientific support document on the modification of MRLs for spirotetramat in sugar beet roots. The proposals from the reasoned opinion have been considered in a recent MRL regulation. ⁵ The Codex maximum residue limit (CXL) for sugar beet roots has also been taken over in the EU MRL legislation. ⁶

In accordance with Article 6 of Regulation (EC) No 396/2005, Landesanstalt für Landwirtschaft und Gartenbau (LLG) submitted an application to the competent national authority in Germany (evaluating Member State, EMS) to modify the existing maximum residue levels (MRLs) for the active substance spirotetramat in herbs and edible flowers. The EMS drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the EFSA on 20 July 2022. To accommodate for the intended uses of spirotetramat, the EMS proposed to raise the existing MRL from 4 to 10 mg/kg.

EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified data gaps, which were requested from the EMS. On 29 September 2022, the EMS submitted the requested information in a revised evaluation report (Germany, 2022), which replaced the previously submitted evaluation report.

EFSA based its assessment on the evaluation report submitted by the EMS (Germany, 2022), the DAR and its addendum (Austria, 2008, 2013) prepared under Council Directive 91/414/EEC, the Commission review report on spirotetramat (European Commission, 2013), the conclusion on the peer review of the pesticide risk assessment of the active substance spirotetramat (EFSA, 2013), as well as the conclusions from previous EFSA opinions on spirotetramat (EFSA, 2019c, 2021a,b), including the reasoned opinion on the MRL review according to Article 12 of Regulation No 396/2005 (EFSA, 2020).

For this application, the data requirements established in Regulation (EU) No 544/2011 ⁷ and the guidance documents applicable at the date of submission of the application to the EMS are applicable (European Commission, 1997a, 1997b, 1997c, 1997d, 1997e, 1997f, 1997g, 2000, 2010a, b, 2017; OECD, 2011). The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation of Plant Protection Products adopted by Commission Regulation (EU) No 546/2011 ⁸ .

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

The evaluation report submitted by the EMS (Germany, 2022) and the exposure calculations using the EFSA Pesticide Residues Intake Model (PRIMo) are considered as supporting documents to this reasoned opinion and, thus, are made publicly available as background documents to this reasoned opinion.

1. Residues in plants

1.1. Nature of residues and methods of analysis in plants

1.1.1. Nature of residues in primary crops

The metabolism of spirotetramat in primary crops belonging to the group of fruit crops (apples), root crops (potatoes), leafy crops (lettuce) and pulses/oilseeds (cotton) following foliar applications has been investigated in the framework of the EU pesticides peer review and MRL review (EFSA, 2013, 2020).

A similar metabolic pattern was observed in all crops tested following foliar applications. The major part of the residues was composed of spirotetramat, its ‐enol, ‐ketohydroxy, ‐monohydroxy and ‐enol‐glucoside metabolites. It was noted that in the metabolism studies, the possible changes in the stereochemistry of the metabolites spirotetramat‐ketohydroxy and spirotetramat‐monohydroxy were not investigated and a data gap was identified by EFSA peer review (EFSA, 2013) and confirmed by the MRL review (EFSA, 2020). Further investigation on this matter would in principle be required.

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

1.1.2. Nature of residues in rotational crops

Crops belonging to the group of herbs and edible flowers can be grown in rotation with other crops.

According to the soil degradation studies evaluated in the framework of the peer review, the DT₉₀ value of spirotetramat accounts for 3.5 days (EFSA, 2013). The DT₉₀ of the sum of two of the major metabolites (spirotetramat‐enol and spirotetramat‐ketohydroxy) was estimated to be 105 days (EFSA, 2013), thus, slightly exceeding the trigger value of 100 days. The occurrence of spirotetramat residues in rotational crops was therefore further investigated.

One confined rotational crop study with [azaspirodecenyl‐3‐¹⁴C]‐spirotetramat was assessed in the context of the peer review (EFSA, 2013). Spirotetramat was applied at a rate of 406 g a.s./ha onto bare soil. Spring wheat, swiss chard and turnips were planted at nominal plant back intervals (PBI) of 30, 135 and 260 days after treatment (DAT). Based on this study, the peer review concluded that the metabolism and distribution of spirotetramat in rotational crops are similar to the metabolic pathway observed in primary crops (EFSA, 2013). This conclusion was supported in the framework of the MRL review (EFSA, 2020).

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

1.1.3. Nature of residues in processed commodities

The effect of processing on the nature of spirotetramat was investigated in the framework of the EU pesticides peer review and MRL review (EFSA, 2013, 2020).

Studies were conducted with spirotetramat, spirotetramat‐enol, spirotetramat‐enol‐glucoside, spirotetramat‐monohydroxy and spirotetramat‐ketohydroxy radiolabelled on the azaspirodecenyl‐ring simulating representative hydrolytic conditions for 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).

Spirotetramat and spirotetramat‐enol‐glucoside were stable under pasteurisation conditions and progressively degraded to spirotetramat‐enol during conditions representative for baking/brewing/boiling and sterilisation. Spirotetramat‐ketohydroxy was stable under pasteurisation and progressively converted to the metabolite spirotetramat‐MA‐amide under baking/brewing/boiling and sterilisation conditions. Spirotetramat‐enol and spirotetramat‐monohydroxy were seen to remain stable under all three hydrolysis conditions (EFSA, 2013, 2020).

The magnitude of spirotetramat‐MA‐amide was further investigated in the EU pesticides peer review in processed beans after sterilisation, where metabolite spirotetramat‐MA‐amide was present in low levels (< 0.01–0.02 mg/kg) and its precursor was not found in the vast majority of the samples from the supervised residue trials (Austria, 2013).

1.1.4. Analytical methods for enforcement purposes in plant commodities

Analytical methods for the determination of spirotetramat residues and residues of spirotetramat‐enol, spirotetramat‐enol‐glucoside, spirotetramat‐monohydroxy and spirotetramat‐ketohydroxy in plant commodities and honey were assessed in the context of the EU pesticides peer review, the MRL review and a recent MRL assessment (EFSA, 2013, 2020, 2021b). The methods, based on high‐performance liquid chromatography with tandem mass spectrometry (HPLC–MS/MS), are sufficiently validated and allow quantification of residues at or above the limit of quantification (LOQ) of 0.01 mg/kg for each analyte in high water, high acid, high oil content, dry matrices, hops and honey. Therefore, the combined LOQ of 0.02 mg/kg is achievable for the sum of spirotetramat and spirotetramat‐enol (according to the existing residue definition for enforcement).

According to the EU Reference Laboratories for Pesticides Residues (EURL), similar validated analytical methods are available to enforce spirotetramat and spirotetramat‐enol at combined LOQ of 0.02 mg/kg by using the QuEChERS method (EURL, 2018).

EFSA concludes that the extraction efficiency of the analytical method for enforcement in commodities belonging to the high‐water content group (method 01084) is demonstrated, considering that the extraction conditions are comparable to those used in the analytical method for risk assessment (00857), for which extraction efficiency in lettuce (high‐water content commodity) was proven in the framework of the peer review (Austria, 2008; Germany, 2022) by cross validation with the method used in the metabolism studies. This is in accordance with the EU Technical Guideline SANTE 2017/10632 on the extraction efficiency (European Commission, 2017).

Herbs and edible flowers belong to the high water content commodity group; therefore, sufficiently validated analytical methods are available for the determination of residues of spirotetramat and its ‐enol metabolite in the plant commodities under assessment.

1.1.5. Storage stability of residues in plants

The storage stability of spirotetramat and its metabolites (spirotetramat‐enol, ‐enol‐glucoside, ketohydroxy and ‐monohydroxy) in plants and honey stored under frozen conditions was investigated in the framework of the EU pesticides peer review, the MRL review and a previous MRL application (EFSA, 2013, 2020, 2021b).

During the EU pesticides peer review, it was concluded that spirotetramat and spirotetramat‐enol residues were individually not stable when stored under frozen conditions in high water, high oil and high starch content commodities. It was observed that spirotetramat significantly degrades to spirotetramat‐enol during storage. However, when analysed for the sum of spirotetramat and spirotetramat‐enol, the total residues were demonstrated to be stable for at least 18 months when stored at or below −18°C. Spirotetramat‐enol‐glucoside, spirotetramat‐ketohydroxy and spirotetramat‐monohydroxy were all found to be stable (individually) for at least 18 months when stored at or below −18°C in the same matrices (EFSA, 2013, 2020). It is noted that the results observed at 18 months were taken from an interim report, while the final report of the study was investigating storage stability until 24 months.

In the context of the current application, the follow‐up report (24 months) on the above storage stability of spirotetramat residues in matrices with high water content (beans with pods, lettuce, tomato), high oil content (almond), high starch content (potato) and processed commodities (tomato paste) was provided (Germany, 2022). This study supersedes the interim report (18 months) submitted and assessed during the EU pesticide peer review. Based on this study, it is concluded that residues of spirotetramat and spirotetramat‐enol (analysed together), spirotetramat‐enol‐glucoside, spirotetramat‐ketohydroxy and spirotetramat‐monohydroxy (individually) are stable for 24 months in commodities belonging to the high water, high oil, high starch content matrices and tomato paste (processed commodity) when stored at or below −18°C.

In conclusion, it is demonstrated that in the commodities assessed in the framework of this application, belonging to the high water content matrix group, the residues of spirotetramat and spirotetramat‐enol residues (analysed together) and spirotetramat‐enol‐glucoside, spirotetramat‐ketohydroxy, spirotetramat‐monohydroxy are stable for a period of 24 months at −18°C.

1.1.6. Proposed residue definitions

Based on the metabolic pattern identified in metabolism studies, hydrolysis studies, the magnitude of spirotetramat‐MA‐amide metabolite (generated in low concentrations from spirotetramat‐ketohydroxy under baking/brewing/boiling and sterilisation conditions), the toxicological significance of metabolites and considering that spirotetramat was not stable under frozen storage conditions in several matrices and degraded to spirotetramat‐enol, the following residue definitions were proposed in the EU pesticides peer review and confirmed in the MRL review (EFSA, 2013, 2020):

• residue definition for enforcement: sum of spirotetramat and spirotetramat‐enol, expressed as spirotetramat.

• residue definition for risk assessment: sum of spirotetramat, spirotetramat‐enol, spirotetramat‐ketohydroxy, spirotetramat‐monohydroxy and spirotetramat‐enol‐glucoside, expressed as spirotetramat;

The same residue definitions are applicable to rotational crops and processed products.

It is noted that the above residue definition for enforcement (proposed by the MRL review) has entered into force with Reg. (EU) 2021/644.

Taking into account the proposed use assessed in this application, EFSA concluded that these residue definitions are appropriate and no further information is required.

1.2. Magnitude of residues in plants

1.2.1. Magnitude of residues in primary crops

In support of the MRL application, the applicant submitted seven independent and GAP‐compliant indoor residue trials performed in herbs and edible flowers raised in pots: basil (2), celery leaves (1), parsley (2) and sage (2). The trials were performed in Germany in 2016, 2017 and 2018. Five trials (basil (1), celery leaves (1), parsley (1) and sage (2)) were designed as decline trials (samples taken 3, 7 (corresponding to the intended preharvest interval, PHI) and 14 days after the treatment).

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

The samples were analysed for the parent compound and the metabolites included in the residue definitions for enforcement and risk assessment. The methods used in the analysis of samples in the context of the residue trials (00857 and QuEChERS methods) are based on LC–MS/MS and allowed a quantification of residues of spirotetramat and its metabolites at the LOQ of 0.01 mg/kg per analyte. According to the assessment of the EMS, the methods used were sufficiently validated and fit for purpose (Germany, 2022).

It is acknowledged that a study on extraction efficiency of the analytical method 00857 in high‐water content commodities was submitted in the framework of the peer review (Austria, 2008). This study demonstrates extraction efficiency of the method 00857 via cross‐validation against the analytical method used in the lettuce metabolism study, in accordance with the EU Technical Guideline SANTE 2017/10632 on extraction efficiency (European Commission, 2017). EFSA also acknowledges that extraction efficiency of the QuEChERS method is also demonstrated, considering that the extraction conditions are comparable to those used in the 00857 method, where extraction efficiency was proven for commodities belonging to the group of high water content matrices.

The EMS proposed to extrapolate residue data from the trials performed on basil, celery leaves, parsley and sage to the whole group of herbs and edible flowers and derived an MRL of 10 mg/kg. However, according to the EU technical guidelines (TG) on extrapolation (European Commission, 2020), trials on sage should not be included in the data set for extrapolation to the whole group of herbs and edible flowers. In line with the TG recommendation and considering the rationale behind this (i.e. sage, as well as rosemary, thyme and laurel/bay leaves, are herbs with high essential oil content, this being a characteristics which may result in different accumulations of residues in these commodities compared to other herbs), EFSA disregarded trials on sage and derived an MRL proposal of 7 mg/kg for the group of herbs and edible flowers, based on the residue trials on basil, parsley and celery leaves. This MRL is only proposed for chervil, chives, celery leaves, parsley, basil and tarragon.

Considering that the GAP under assessment is intended for all herbs and edible flowers, including sage itself, residue data on this commodity were included in the data set to derive an MRL proposal of 10 mg/kg for sage, rosemary, thyme and laurel/bay leaves.

The residue data from the supervised residue trials in primary crops are summarised in Appendix B.1.2.1.

1.2.2. Magnitude of residues in rotational crops

Not relevant as the use under assessment is on fresh herbs raised in pots (marketed end‐product) under greenhouse conditions (Germany, 2022).

Furthermore, on the basis of the confined rotational crop study performed with bare soil application at 406 g a.s./ha (9N rate of the intended GAP on herbs and edible flowers) and assessed in the framework of the EU pesticides peer review and the MRL review (EFSA, 2013, 2020), EFSA concludes that relevant residue levels of spirotetramat and its major metabolites are unlikely to occur in rotational crops provided that spirotetramat is applied in compliance with the intended GAP on herbs and edible flowers.

The same conclusion is confirmed by a field rotational crop study performed on mustard green, turnip and wheat treated with a total rate of 172–180 g a.s./ha (corresponding to 4N the rate of the intended GAP on herbs and edible flowers). In all rotated crops, sampled between 34 and 257 DAT (34–46 DAT for mustard greens, 48–59 DAT for turnip tops and roots, 94–185 DAT for wheat forage, 154–222 DAT for hay, 191–257 DAT for wheat grain and straw), residues of spirotetramat and its metabolites were all below LOQ (0.01 mg/kg for each compound).

1.2.3. Magnitude of residues in processed commodities

New studies investigating the magnitude of spirotetramat residues in processed commodities were not submitted in the context of the present assessment. Such studies are not required for the crops under assessment considering that the contribution of residues in the crops under consideration to the overall dietary exposure is expected to be below 10% of the ADI (European Commission, 1997d).

1.2.4. Proposed MRLs

The available data are considered sufficient to derive MRL proposals as well as risk assessment values for the commodities under evaluation (see Appendix B.1.2.1).

An MRL of 7 mg/kg is proposed for chervil, chives, celery leaves, parsley, basil and tarragon.

An MRL of 10 mg/kg is proposed for sage, rosemary, thyme and laurel/bay leaves.

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

2. Residues in livestock

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

3. Consumer risk assessment

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

The toxicological reference values for spirotetramat used in the risk assessment (i.e. ADI and ARfD values) were derived in the framework of the EU pesticides peer review (European Commission, 2013). The toxicological reference values derived for spirotetramat also apply to the metabolites included in the residue definition for risk assessment (EFSA, 2013).

Short‐term (acute) dietary risk assessment

The short‐term exposure assessment was performed for the commodities assessed in this application in accordance with the internationally agreed methodology (FAO, 2016). The calculations were based on the HR (expressed according to the residue definition for risk assessment) derived from supervised field trials and the complete list of input values can be found in Appendix D.1.

The short‐term exposure did not exceed the ARfD for any the crops assessed in this application. The highest acute consumer exposure for the group of herbs and edible flowers was calculated for chervil and parsley (0.5% of ARfD) and was lower for other crops of this group. No acute exposure calculation could be performed for other herbs as specific consumption data are not available (see Appendix B.3).

Long‐term (chronic) dietary risk assessment

The long‐term exposure assessment was performed taking into account the STMR values derived for the commodities assessed in this application; for the remaining commodities covered by the MRL regulation, the existing EU MRLs and STMR values derived in the MRL review and in previous MRL applications were selected as input values (EFSA, 2019c, 2020, 2021b). The input values used in the exposure calculations are summarised in Appendix D.1.

The highest estimated long‐term dietary intake accounted for 26% of the ADI (NL toddler diet). The contribution of residues expected in the commodities assessed in this application to the overall long‐term exposure is presented in more detail in Appendix B.3.

EFSA concluded that the long‐term intake of residues of spirotetramat resulting from the existing and the intended uses is unlikely to present a risk to consumer health. In the framework of the MRL review, it was highlighted that the possible impact of plant and animal metabolism on the isomer ratio of the active was not investigated. Further investigation on this matter would in principle be required. It is noted that the EFSA guidance on the risk assessment of compounds that may have stereoisomers has been issued (EFSA, 2019b). EFSA would therefore recommend to reconsider this point in the framework of the peer review for the renewal of approval of the active substance. However, EFSA notes that in view of the large margin of safety in the exposure calculations, the potential change of isomer ratios in the final residues is not expected to be of concern for the authorised and intended uses. In case future uses of active substance would lead to a higher consumer exposure, further information regarding the impact of plant and/or livestock metabolism on the isomer ratio might be required.

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

4. Conclusion and recommendations

The data submitted in support of this MRL application were found to be sufficient to derive an MRL proposal for herbs and edible flowers. It is noted that the proposal of EFSA to derive an MRL of 7 mg/kg for chervil, chives, celery leaves, parsley, basil and tarragon and an MRL of 10 mg/kg for sage, rosemary, thyme and laurel/bay leaves is based on the interpretation of the EU technical guidelines on extrapolation (European Commission, 2020), which specify that trials on sage should not be included in the data set for extrapolation to the whole group of herbs and edible flowers.

EFSA concluded that the proposed use of spirotetramat on herbs and edible flowers will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers' health. Should risk managers decide to implement the MRL of 10 mg/kg to the whole group of herbs and edible flowers (in line with the proposal of the EMS), it is noted that the same conclusion would still be valid.

EFSA emphasises that the above assessment does not consider the possible impact of plant and livestock metabolism on the isomer ratio of spirotetramat and further investigation on this matter would in principle be required. In addition, possible changes in the stereochemistry of the metabolites spirotetramat‐ketohydroxy and spirotetramat‐monohydroxy were not investigated and a data gap was identified by EFSA peer review and confirmed by the MRL review. EFSA further notes that in view of the large margin of safety in the exposure calculations, the potential change of isomer ratios in the final residues is not expected to be of concern for the authorised uses. In case future uses of active substance would lead to a higher consumer exposure, further information regarding the impact of plant and/or livestock metabolism on the isomer ratio might be required.

The MRL recommendations are summarised in Appendix B.4.

Abbreviations

a.s.

active substance

ADI

acceptable daily intake

AR

applied radioactivity

ARfD

acute reference dose

BBCH

growth stages of mono‐ and dicotyledonous plants

bw

body weight

CCPR

Codex Committee on Pesticide Residues

CF

conversion factor for enforcement to risk assessment residue definition

CXL

Codex maximum residue limit

DALA

days after last application

DAR

draft assessment report

DAT

days after treatment

DS

powder for dry seed treatment

DT₉₀

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

ECD

electron capture detector

EMS

evaluating Member State

eq

residue expressed as a.s. equivalent

EURL

EU Reference Laboratory (former Community Reference Laboratory (CRL))

FAO

Food and Agriculture Organisation of the United Nations

GAP

Good Agricultural Practice

GR

granule

GS

growth stage

HPLC

high‐performance liquid chromatography

HPLC‐MS/MS

high‐performance liquid chromatography with tandem mass spectrometry

HR

highest residue

IEDI

international estimated daily intake

IESTI

international estimated short‐term intake

ILV

independent laboratory validation

ISO

International Organisation for Standardisation

IUPAC

International Union of Pure and Applied Chemistry

JMPR

Joint FAO/WHO Meeting on Pesticide Residues

LOQ

limit of quantification

MRL

maximum residue level

MS

Member States

MS

mass spectrometry detector

MS/MS

tandem mass spectrometry detector

NEU

northern Europe

OECD

Organisation for Economic Co‐operation and Development

PBI

plant back interval

PHI

preharvest interval

P_ow

partition coefficient between n‐octanol and water

PRIMo

(EFSA) Pesticide Residues Intake Model

QuEChERS

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

RA

risk assessment

RAC

raw agricultural commodity

RD

residue definition

RMS

rapporteur Member State

SANCO

Directorate‐General for Health and Consumers

SC

suspension concentrate

SEU

southern Europe

STMR

supervised trials median residue

TMDI

theoretical maximum daily intake

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

Crop and/or situation	NEU, SEU, MS or country	F G or I(a)	Pests or Group of pests controlled	Preparation		Application				Application rate per treatment				PHI (days)(d)	Remarks
				Type(b)	Conc. a.s.	Method kind	Range of growth stages & season(c)	Number min–max	Interval between application (days) min–max	g a.s./hL min–max	Water (L/ha) min–max	Rate min–max	Unit
Herbs and edible flowers	Germany	G	aphids	SC	100 g/L	Foliar treatment ‐ broadcast spraying	BBCH 14–48	1	n.a.	7.5–11.25	400–600	45	g a.s./ha	7	Pot culture

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

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

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

^(c)Growth stage range from first to last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 3–8,263–3,152‐4), including, where relevant, information on season at time of application.

^(d)PHI – minimum preharvest interval.

Appendix B – List of end points

B.1. Residues in plants

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

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

Primary crops (available studies)	Crop groups	Crop(s)	Application(s)	Sampling (DAT)	Comment/source
	Fruit crops	Apple	Foliar: 2 × 576 g/ha, BBCH 69, 71	63 DALA	[azaspirodecenyl‐3‐14C]‐spirotetramat (EFSA, 2013)
	Root crops	Potato	Foliar: 3 × 96 g/ha, BBCH 75, 85, 93	14 DALA	[azaspirodecenyl‐3‐14C]‐spirotetramat (EFSA, 2013)
	Leafy crops	Lettuce	Foliar: 2 × 72 g/ha, BBCH 41, 45	7 DALA	[azaspirodecenyl‐3‐14C]‐spirotetramat (EFSA, 2013)
	Pulses/oilseeds	Cotton	Foliar: 2 × (92 + 172) g/ha, BBCH 15, 85	19 DAT, 39 DALA	[azaspirodecenyl‐3‐14C]‐spirotetramat (EFSA, 2013)

Rotational crops (available studies)	Crop groups	Crop(s)	Application(s)	PBI (DAT)	Comment/source
	Root/tuber crops	Turnip	Bare soil, 1 × 406 g/ha	30, 135, 260	[azaspirodecenyl‐3‐14C]‐spirotetramat (EFSA, 2013)
	Leafy crops	Swiss chard	Bare soil, 1 × 406 g/ha	30, 135, 260	[azaspirodecenyl‐3‐14C]‐spirotetramat (EFSA, 2013)
	Cereal (small grain)	Spring wheat	Bare soil, 1 × 406 g/ha	30, 135, 260	[azaspirodecenyl‐3‐14C]‐spirotetramat (EFSA, 2013)

Processed commodities (hydrolysis study)	Conditions	Stable?	Comment/source
	Spirotetramat, spirotetramat‐enol‐glucoside
	Pasteurisation (20 min, 90°C, pH 4)	Yes	[azaspirodecenyl‐3‐14C]‐spirotetramat; [azaspirodecenyl‐3‐14C]‐spirotetramat‐enol‐glucoside. Both compounds degraded to spirotetramat‐enol under baking/brewing/boiling (15% and 10% degradation, respectively) and sterilisation (85% and 40% degradation, respectively) conditions (EFSA, 2013, 2020).
	Baking, brewing and boiling (60 min, 100°C, pH 5)	No
	Sterilisation (20 min, 120°C, pH 6)	No
	Spirotetramat‐enol, spirotetramat‐monohydroxy
	Pasteurisation (20 min, 90°C, pH 4)	Yes	[azaspirodecenyl‐3‐14C]‐ spirotetramat‐enol; [azaspirodecenyl‐3‐14C]‐spirotetramat‐monohydroxy (EFSA, 2013, 2020).
	Baking, brewing and boiling (60 min, 100°C, pH 5)	Yes
	Sterilisation (20 min, 120°C, pH 6)	Yes
	Spirotetramat‐ketohydroxy
	Pasteurisation (20 min, 90°C, pH 4)	Yes	[azaspirodecenyl‐3‐14C]‐spirotetramat‐ketohydroxy. Spirotetramat‐ketohydroxy converted to the metabolite spirotetramat‐MA‐amide under baking/brewing/boiling (5% degradation) and sterilisation (99% degradation) conditions (EFSA, 2013, 2020).
	Baking, brewing and boiling (60 min, 100°C, pH 5)	Yes
	Sterilisation (20 min, 120°C, pH 6)	No

B.1.1.2. Storage stability of residues in plants

Plant products (available studies)	Category	Commodity	T (°C)	Stability period		Compounds covered	Comment/source
				Value	Unit
	High water content	Lettuce	−18	6	Months	Spi	EFSA (2013)
		Beans with pods	−18	1	Months	Spi	EFSA (2016), Germany (2022)
		Tomato	−18	24	Months	Spi	Germany (2022)
		Lettuce	−18	2	Months	Spi‐enol	EFSA (2016)
		Beans with pods	−18	1	Months	Spi‐enol	EFSA (2016), Germany (2022)
		Tomato	−18	24	Months	Spi‐enol	Germany (2022)
		Lettuce, beans with pods, tomato	−18	24	Months	Spi + enol (analysed together)	Germany (2022)
		Lettuce, beans with pods	−18	24	Months	Spi‐ketohydroxy	Germany (2022)
		Lettuce, beans with pods	−18	24	Months	Spi‐enol‐Glc	Germany (2022)
		Lettuce, beans with pods	−18	24	Months	Spi‐monohydroxy	Germany (2022)
	High oil content	Almond (nutmeat)	−18	1	Month	Spi	EFSA (2013)
		Almond (nutmeat)	−18	18	Months	Spi‐enol	EFSA (2013), Germany (2022)
		Almond (nutmeat)	−18	24	Months	Spi + enol (analysed together)	Germany (2022)
		Almond (nutmeat)	−18	24	Months	Spi‐ketohydroxy	Germany (2022)
		Almond (nutmeat)	−18	24	Months	Spi‐enol‐Glc	Germany (2022)
		Almond (nutmeat)	−18	24	Months	Spi‐monohydroxy	Germany (2022)
	High protein content	Beans (dry)	−18	24	Months	Spi	EFSA (2020)
		Beans (dry)	−18	24	Months	Spi‐enol	EFSA (2020)
		Beans (dry)	−18	24	Months	Spi‐ketohydroxy	EFSA (2020)
		Beans (dry)	−18	24	Months	Spi‐enol‐Glc	EFSA (2020)
		Beans (dry)	−18	24	Months	Spi‐monohydroxy	EFSA (2020)
	High starch content	Potato	−18	2	Months	Spi	EFSA (2016)
		Potato	−18	12	Months	Spi‐enol	EFSA (2013), Germany (2022)(a)
		Potato	−18	24	Months	Spi + enol (analysed together)	Germany (2022)(b)
		Potato	−18	24	Months	Spi‐ketohydroxy	Germany (2022)
		Potato	−18	24	Months	Spi‐enol‐Glc	Germany (2022)
		Potato	−18	24	Months	Spi‐monohydroxy	Germany (2022)
	High acid content	Kiwi fruit	−18	24	Months	Spi	EFSA (2020)
		Kiwi fruit	−18	24	Months	Spi‐enol	EFSA (2020)
		Kiwi fruit	−18	24	Months	Spi‐ketohydroxy	EFSA (2020)
		Kiwi fruit	−18	24	Months	Spi‐enol‐Glc	EFSA (2020)
		Kiwi fruit	−18	24	Months	Spi‐monohydroxy	EFSA (2020)
	Processed products	Orange juice, prune	−18	5	Months	Spi	EFSA (2013)
		Orange juice, prune	−18	5	Months	Spi‐enol	EFSA (2013)
		Orange juice, prune	−18	5	Months	Spi + enol (analysed together)	EFSA (2013)
		Orange juice, prune	−18	5	Months	Spi‐ketohydroxy	EFSA (2013)
		Orange juice, prune	−18	5	Months	Spi‐enol‐Glc	EFSA (2013)
		Orange juice, prune	−18	5	Months	Spi‐monohydroxy	EFSA (2013)
		Tomato paste	−18	24	Months	Spi	Germany (2022)
		Tomato paste	−18	3	Months	Spi‐enol	EFSA (2013), Germany (2022)
		Tomato paste	−18	24	Months	Spi + enol (analysed together)	Germany (2022)
		Tomato paste	−18	24	Months	Spi‐ketohydroxy	Germany (2022)
		Tomato paste	−18	24	Months	Spi‐enol‐Glc	Germany (2022)
		Tomato paste	−18	24	Months	Spi‐monohydroxy	Germany (2022)
		Honey	−18	6	Months	Spi	EFSA (2021b)
		Honey	−18	6	Months	Spi‐enol	EFSA (2021b)
		Honey	−18	6	Months	Spi‐ketohydroxy	EFSA (2021b)
		Honey	−18	6	Months	Spi‐enol‐Glc	EFSA (2021b)
		Honey	−18	6	Months	Spi‐monohydroxy	EFSA (2021b)

Spi: spirotetramat; spi‐enol, spirotetramat‐enol; spi + enol: spirotetramat plus spirotetramat‐enol; spi‐ketohydroxy: spirotetramat‐ketohydroxy; spi‐monohydroxy: spirotetramat‐monohydroxy; spi‐enol‐Glc: spirotetramat‐enol glucoside.

^(a)Although the level of residue seems to have declined by more than 30% after 3‐ and 6‐month storage (average recoveries of 60% and 69%, respectively), it is considered that the samples are sufficiently stable over 12 months frozen storage in potato, as the recoveries at the later time point of 12 months were again above 70% (average recovery: 73%; recovery range: 71%–75%).

^(b)Although the level of residue seems to have declined by slightly more than 30% at 18 months (average recovery of 68%), it is considered that the samples are sufficiently stable over 24 months frozen storage in potato, as the recoveries at the latest time point were again above 70% (average recovery: 85%; recovery range: 82%–87%).

B.1.2. Magnitude of residues in plants

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

Commodity	Region(a)	Residue levels observed in the supervised residue trials (mg/kg)	Comments/source	Calculated MRL (mg/kg)	HR(b) (mg/kg)	STMR(c) (mg/kg)	CF(d)
Chervil, Chives, Celery leaves, Parsley, Basil, Tarragon	Indoor (EU)	Mo: Basil: 0.15; 1.6 Parsley: 1.3; 1.5 Celery leaves: 3.8 RA: Basil: 0.21; 1.8; Parsley: 1.5; 1.9 Celery leaves: 4	Residue trials on basil (2), parsley (2) and celery leaves (1) compliant with GAP. Extrapolation to the whole group of herbs and edible flowers (0256000) is possible. Two additional residue trials on sage were also submitted. These cannot be included in the data set for extrapolation to the whole group of herbs and edible flowers, according to European Commission, 2020. However, considering that the GAP is intended for all herbs and edible flowers, residue data on sage are considered to derive an MRL proposal and risk assessment values for sage and other herbs with high essential oil content such as rosemary, thyme and laurel/bay leaves (see below).	7	Mo: 3.80 RA: 4.00	Mo: 1.50 RA: 1.80	1.2
Sage, Rosemary, Thyme, Laurel/bay leaves	Indoor (EU)	Mo: Basil: 0.15; 1.6 Parsley: 1.3; 1.5 Celery leaves: 3.8 Sage: 3.2; 5.5 RA: Basil: 0.21; 1.8; Parsley: 1.5; 1.9 Celery leaves: 4 Sage: 3.3; 5.5	Residue trials on basil (2), parsley (2), celery leaves (1) and sage (2) compliant with GAP. Considering that the GAP is intended for all herbs and edible flowers, including sage, rosemary, thyme, laurel/bay leaves, residue data on sage are considered to derive an MRL proposal and risk assessment values for these commodities.	10	Mo: 5.50 RA: 5.50	Mo: 1.60 RA: 1.90	1.1

MRL: maximum residue level; GAP: Good Agricultural Practice; Mo: monitoring; RA: risk assessment.

^(a)EU: indoor EU trials.

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

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

^(d)Conversion factor to recalculate residues according to the residue definition for monitoring to the residue definition for risk assessment.

B.1.2.2. Residues in rotational crops

B.1.2.3. Processing factors

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

B.2. Residues in livestock

Not relevant.

B.3. Consumer risk assessment

B.4. Recommended MRLs

Code(a)	Commodity	Existing EU MRL (mg/kg)(b)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition (plants): sum of spirotetramat and spirotetramat‐enol, expressed as spirotetramat
0256010	Chervil	4	7	The submitted data are sufficient to derive an MRL proposal for the EU use. Risk for consumers unlikely.
0256020	Chives
0256030	Celery leaves
0256040	Parsley
0256080	Basil
0256100	Tarragon
0256050	Sage	4	10	The submitted data are sufficient to derive an MRL proposal for the EU use. Risk for consumers unlikely.
0256060	Rosemary
0256070	Thyme
0256090	Laurel/bay leaves

MRL: maximum residue level; EU: indoor use.

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

^(b)EU MRL derived from residue data on lettuce, according to the former residue definition for enforcement consisting of ‘sum of spirotetramat and its 4 metabolites spirotetramat‐enol, spirotetramat‐ketohydroxy, spirotetramat‐monohydroxy and spirotetramat‐enol‐glucoside, expressed as spirotetramat’ (EFSA, 2011).

Appendix C – Pesticide Residue Intake Model (PRIMo)

Appendix D – Input values for the exposure calculations

D.1. Consumer risk assessment

Commodity	Existing/proposed MRL (mg/kg)	Source	Chronic risk assessment		Acute risk assessment
			Input value (mg/kg)	Comment(a)	Input value (mg/kg)	Comment(b)
Risk assessment residue definition (plant commodities): sum of spirotetramat, spirotetramat‐enol, spirotetramat‐ketohydroxy, spirotetramat‐monohydroxy and spirotetramat‐enol‐glucoside, expressed as spirotetramat
Chervil, Chives, Celery leaves, Parsley, Basil, Tarragon	7	Proposed MRL	1.80	STMR‐RAC (c)	4.00	HR‐RAC
Sage, Rosemary, Thyme, Laurel/bay leaves	10	Proposed MRL	1.90	STMR‐RAC (c)	5.50	HR‐RAC
Citrus fruits	0.5	Codex MRL; EFSA (2020)	0.20	STMR‐RAC (0.17) × CF (2) × PeF (0.6)	0.37	HR‐RAC (0.31) × CF (2) × PeF (0.6)
Tree nuts	0.5	Codex MRL; EFSA (2020)	0.13	STMR‐RAC (0.08) × CF (1.6)	0.40	HR‐RAC (0.25) × CF (1.6)
Pome fruits	0.7	Codex MRL; EFSA (2020)	0.14	STMR‐RAC (0.11) × CF (1.3)	0.64	HR‐RAC (0.49) × CF (1.3)
Stone fruits	3	Codex MRL; EFSA (2020)	1.56	STMR‐RAC (1.30) × CF (1.2)	1.92	HR‐RAC (1.60) × CF (1.2)
Table and wine grapes	2	Codex MRL; EFSA (2020)	0.43	STMR‐RAC (0.31) × CF (1.4)	1.40	HR‐RAC (1.00) × CF (1.4)
Strawberries	0.3	EFSA (2020)	0.13	STMR‐RAC (0.05) × CF (2.5)	0.40	HR‐RAC (0.16) × CF (2.5)
Other small fruits and berries	1.5	EFSA (2019c)	0.56	STMR‐RAC(c)	0.95	HR‐RAC
Table olives	1.5	EFSA (2020)	0.30	STMR‐RAC (0.28) × CF (1.1)	1.00	HR‐RAC (0.91) × CF (1.1)
Kumquats	0.02*	existing EU MRL	0.02*	LOQ × CF (1)	0.02*	LOQ × CF (1)
Kaki/Japanese persimmons	0.4	EFSA (2020)	0.13	STMR‐RAC (0.09) × CF (1.5)	0.23	HR‐RAC (0.15) × CF (1.5)
Kiwi fruits (green, red, yellow)	3	EFSA (2020)	0.36	STMR‐RAC (0.30) × CF (1.2)	1.97	HR‐RAC (1.64) × CF (1.2)
Litchis/lychees	15	Codex MRL; EFSA (2020)	1.62	STMR‐RAC (0.85) × CF (1.9)	9.88	HR‐RAC (5.20) × CF (1.9)
Avocados	0.4	EFSA (2020)	0.12	STMR‐RAC (0.10) × CF (1.2)	0.21	HR‐RAC (0.18) × CF (1.2)
Bananas	0.4	EFSA (2020)	0.09	STMR‐RAC (0.12) × CF (1.7) × PeF (0.46)	0.13	HR‐RAC (0.17) × CF (1.7) × PeF (0.46)
Mangoes	0.3	Codex MRL; EFSA (2020)(d)	0.16	STMR‐RAC (0.08) × CF (2.0)	0.36	HR‐RAC (0.18) × CF (2.0)
Papayas	0.4	Codex MRL; EFSA (2020)	0.17	STMR‐RAC (0.13) × CF (1.3)	0.23	HR‐RAC (0.18) × CF (1.3)
Granate apples/pomegranates	0.4	EFSA (2020)	0.20	STMR‐RAC (0.15) × CF (1.4)	0.22	HR‐RAC (0.16) × CF (1.4)
Guavas	2	EFSA (2020)	0.55	STMR‐RAC (0.50) × CF (1.1)	0.96	HR‐RAC (0.87) × CF (1.1)
Pineapples	0.15	EFSA (2020)	0.07	STMR‐RAC (0.04) × CF (1.8)	0.14	HR‐RAC (0.08) × CF (1.8)
Potatoes	0.8	Codex MRL; EFSA (2020)	0.11	STMR‐RAC (0.09) × CF (1.3)	0.48	HR‐RAC (0.37) × CF (1.3)
Other root and tuber vegetables except sugar beet (213000)	0.07	EFSA (2020)	0.05	STMR‐RAC (0.02) × CF (2.5)	0.12	HR‐RAC (0.05) × CF (2.5)
Garlic	0.3	EFSA (2020)	0.10	STMR‐RAC (0.07) × CF (1.5)	0.26	HR‐RAC (0.17) × CF (1.5)
Onions	0.4	Codex MRL; EFSA (2020)	0.11	STMR‐RAC (0.04) × CF (2.8)	0.58	HR‐RAC (0.21) × CF (2.75)
Shallots	0.3	EFSA (2020)	0.10	STMR‐RAC (0.07) × CF (1.5)	0.26	HR‐RAC (0.07) × CF (1.5)
Spring onions/green onions and Welsh onions	0.9	EFSA (2021b)	0.10	STMR‐RAC (0.06) × CF (1.6)	0.75	HR‐RAC (0.47) × CF (1.6)
Solanaceae, except sweet peppers/bell peppers	1	Codex MRL; EFSA (2020)	0.52	STMR‐RAC (0.37) × CF (1.4)	1.06	HR‐RAC (0.76) × CF (1.4)
Sweet peppers/bell peppers	1	EFSA (2020)	0.3	STMR‐RAC (0.25) × CF (1.2)	0.82	HR‐RAC (0.68) × CF (1.2)
Cucurbits with edible peel	0.2	Codex MRL; EFSA (2020)	0.06	STMR‐RAC (0.02) × CF (2.9)	0.38	HR‐RAC (0.13) × CF (2.9)
Cucurbits with inedible peel	0.2	Codex MRL; EFSA (2020)	0.06	STMR‐RAC (0.02) × CF (2.9)	0.38	HR‐RAC (0.13) × CF (2.9)
Sweet corn	1.5	Codex MRL; EFSA (2020)	0.31	STMR‐RAC (0.24) × CF (1.3)	0.72	HR‐RAC (0.55) × CF (1.3)
Flowering brassica	1	Codex MRL; EFSA (2020)	0.43	STMR‐RAC (0.16) × CF (2.7)	1.05	HR‐RAC (0.39) × CF (2.7)
Brussels sprouts	0.3	EFSA (2020)(e)	0.12	STMR‐RAC (0.07) × CF (1.7)	0.24	HR‐RAC (0.14) × CF (1.7)
Head cabbages	2	Codex MRL; EFSA (2020)	0.36	STMR‐RAC (0.15) × CF (2.4)	2.14	HR‐RAC (0.89) × CF (2.4)
Leafy brassica	7	Codex MRL; EFSA (2020)	3.64	STMR‐RAC (2.80) × CF (1.3)	6.50	HR‐RAC (5.00) × CF (1.3)
Kohlrabies	1.5	EFSA (2020)(e)	0.42	STMR‐RAC (0.35) × CF (1.2)	0.64	HR‐RAC (0.53) × CF (1.2)
Lettuce and other salad plants including Brassicaceae	7	Codex MRL; EFSA (2020)	3.64	STMR‐RAC (2.80) × CF (1.3)	6.50	HR‐RAC (5.00) × CF (1.3)
Spinach and similar (leaves)	7	Codex MRL; EFSA (2020)	3.64	STMR‐RAC (2.80) × CF (1.3)	6.50	HR‐RAC (5.00) × CF (1.3)
Watercress	7	Codex MRL; EFSA (2020)	3.64	STMR‐RAC (2.80) × CF (1.3)	6.50	HR‐RAC (5.00) × CF (1.3)
Witloofs/Belgian endives	0.03	EFSA (2020)	0.02	STMR‐RAC (0.02) × CF (1.0)	0.02	HR‐RAC (0.02) × CF (1.0)
Beans and peas (with pods)	2	EFSA (2020)	1.17	STMR‐RAC (0.51) × CF (2.3)	2.75	HR‐RAC (1.19) × CF (2.3)
Beans and peas (without pods)	1.5	Codex MRL; EFSA (2020)	0.52	STMR‐RAC (0.40) × CF (1.3)	0.87	HR‐RAC (0.67) × CF (1.3)
Lentils (fresh)	1.5	Codex MRL; EFSA (2020)	0.52	STMR‐RAC (0.40) × CF (1.3)	0.87	HR‐RAC (0.67) × CF (1.3)
Celeries	4	EFSA (2020)	0.75	STMR‐RAC (0.50) × CF (1.5)	2.04	HR‐RAC (1.36) × CF (1.5)
Florence fennels	4	EFSA (2020)	0.75	STMR‐RAC (0.50) × CF (1.5)	2.04	HR‐RAC (1.36) × CF (1.5)
Globe artichokes	1	Codex MRL; EFSA (2020)	0.41	STMR‐RAC (0.27) × CF (1.5)	0.74	HR‐RAC (0.49) × CF (1.5)
Leeks	0.9	EFSA (2021b)	0.10	STMR‐RAC (0.06) × CF (1.6)	0.75	HR‐RAC (0.47) × CF (1.6)
Rhubarbs	4	EFSA (2020)	0.75	STMR‐RAC (0.50) × CF (1.5)	2.04	HR‐RAC (1.36) × CF (1.5)
Beans, peas, other pulses	2	Codex MRL; EFSA (2020)	0.25	STMR‐RAC (0.10) × CF (2.5)	0.25	STMR‐RAC (0.10) × CF (2.5)
Lentils, lupins/lupini beans	2	Codex MRL; EFSA (2020)	0.21	STMR‐RAC (0.16) × CF (1.3)	0.21	STMR‐RAC (0.16) × CF (1.3)
Soya beans	4	EFSA (2020)	0.39	STMR‐RAC (0.32) × CF (1.2)	0.39	STMR‐RAC (0.32) × CF (1.2)
Cotton seeds	0.4	Codex MRL; EFSA (2020)	0.09	STMR‐RAC (0.04) × CF (2.3)	0.09	STMR‐RAC (0.04) × CF (2.3)
Olives for oil production	1.5	EFSA (2020)	0.30	STMR‐RAC (0.28) × CF (1.1)	0.30	STMR‐RAC (0.28) × CF (1.1)
Herbal infusions (dried flowers)	0.1*	existing EU MRL	0.10*	LOQ × CF (1.0)	0.10*	LOQ × CF (1.0)
Herbal infusions (dried leaves)	50	EFSA (2020)	24.00	STMR‐RAC (15.00) × CF (1.6)	43.20	HR‐RAC (27.00) × CF (1.6)
HOPS (dried)	15	Codex MRL; EFSA (2020)	5.16	STMR‐RAC (4.30) × CF (1.2)	5.88	HR‐RAC (4.90) × CF (1.2)
Sugar beet roots	0.06	Codex MRL; EFSA (2021a)	0.05	STMR‐RAC	0.07	HR‐RAC
Chicory roots	0.07	EFSA (2020)	0.05	STMR‐RAC (0.02) × CF (2.5)	0.12	HR‐RAC (0.05) × CF (2.5)
Risk assessment residue definition (animal commodities): Sum of spirotetramat‐enol and spirotetramat‐enol‐GA, expressed as spirotetramat
Meat (mammals)	0.05	Codex MRL; EFSA (2020)	0.02	STMR‐RAC (0.01) × CF (1.5)	0.03	HR‐RAC (0.02) × CF (1.5)
Fat tissue (mammals)	0.02*	existing EU MRL	0.01*	STMR‐RAC (0.01) × CF (1.0)	0.01*	HR‐RAC (0.01) × CF (1.0)
Liver (mammals)	0.7	Codex MRL; EFSA (2020)	0.24	STMR‐RAC (0.16) × CF (1.5)	0.83	HR‐RAC (0.55) × CF (1.5)
Kidney (mammals)	0.7	Codex MRL; EFSA (2020)	0.24	STMR‐RAC (0.16) × CF (1.5)	0.83	HR‐RAC (0.55) × CF (1.5)
Edible offals (other than liver and kidney) (mammals)	0.7	Codex MRL; EFSA (2020)	0.24	STMR‐RAC (0.16) × CF (1.5)	0.83	HR‐RAC (0.55) × CF (1.5)
Other products (mammals)	0.02*	existing EU MRL	0.02*	LOQ	0.02*	LOQ
Meat (poultry)	0.02*	existing EU MRL	0.01*	STMR‐RAC (0.01) × CF (1.0)	0.01*	HR‐RAC (0.01) × CF (1.0)
Fat tissue (poultry)	0.02*	existing EU MRL	0.01*	STMR‐RAC (0.01) × CF (1.0)	0.01*	HR‐RAC (0.01) × CF (1.0)
Liver (poultry)	0.02*	existing EU MRL	0.01*	STMR‐RAC (0.01) × CF (1.0)	0.01*	HR‐RAC (0.01) × CF (1.0)
Kidney (poultry)	0.02*	existing EU MRL	0.02*	LOQ	0.02*	LOQ
Edible offals (other than liver and kidney) (poultry)	0.02*	existing EU MRL	0.02*	LOQ	0.02*	LOQ
Other products (poultry)	0.02*	existing EU MRL	0.02*	LOQ
Milk	0.01*	Codex MRL; EFSA (2020)	0.01*	STMR‐RAC (0.01*) × CF (1.0)	0.01*	STMR‐RAC (0.01*) × CF (1.0)
Eggs	0.01*	Codex MRL; EFSA (2020)	0.01*	STMR‐RAC (0.01*) × CF (1.0)	0.01*	STMR‐RAC (0.01*) × CF (1.0)
Honey and other apiculture products	0.5	EFSA (2021b)	0.13	STMR‐RAC (0.09) × CF (1.4)	0.35	HR‐RAC (0.25) × CF (1.4)

STMR‐RAC: supervised trials median residue in raw agricultural commodity; HR‐RAC: highest residue in raw agricultural commodity; PeF: Peeling factor.

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

^(a)For those commodities which final chronic risk assessment values were calculated by applying a CF, STMR‐RAC were derived based on residue measured according to the residue definition for monitoring under Reg. (EU) 396/2005.

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

^(c)Risk assessment values derived according to the residue definition for risk assessment (EFSA, 2019c; Germany, 2022).

^(d)MRL and risk assessment values derived based on residue measured in the fruit without stone (pulp and skin) (EFSA, 2020).

^(e)Tentative MRL derived from a GAP evaluated at EU level not fully supported by data but for which no risk to consumers was identified (EFSA, 2020).

Appendix E – Used compound codes

Code/trivial name (a)	IUPAC name/SMILES notation/InChiKey (b)	Structural formula (c)
Spirotetramat (BYI 08330)	ethyl cis‐8‐methoxy‐2‐oxo‐3‐(2,5‐xylyl)‐1‐azaspiro[4.5]dec‐3‐en‐4‐yl carbonate O=C(OCC)OC1 = C(C(=O)N[C@@]21CC[C@H](CC2)OC)c1cc(C)ccc1C CLSVJBIHYWPGQY‐GGYDESQDSA‐N
Spirotetramat‐enol	(5 s,8 s)‐3‐(2,5‐dimethylphenyl)‐4‐hydroxy‐8‐methoxy‐1‐azaspiro[4.5]dec‐3‐en‐2‐one Cc1cc(C = 2C(=O)N[C@]3(CC[C@H](CC3)OC)C = 2O)c(C)cc1 IDJJHEIUIYGFDX‐QGGXVJLZSA‐N
Spirotetramat‐ketohydroxy	(5 s,8 s)‐3‐(2,5‐dimethylphenyl)‐3‐hydroxy‐8‐methoxy‐1‐azaspiro[4.5]decane‐2,4‐dione Unstated stereochemistry Cc1cc(c(C)cc1)C1(O)C(=O)N[C@]2(CC[C@H](CC2)OC)C1 = O XOVCVOLJZHNHLA‐GESSKKQQSA‐N
Spirotetramat‐monohydroxy	(5 s,8 s)‐3‐(2,5‐dimethylphenyl)‐4‐hydroxy‐8‐methoxy‐1‐azaspiro[4.5]decan‐2‐one Unstated stereochemistry Cc1cc(C2C(=O)N[C@@]3(CC[C@@H](CC3)OC)C2O)c(C)cc1 HPQGJNTUXNUIDL‐RMVSHPHESA‐N
Spirotetramat‐enol‐glucoside (spirotetramat‐enol‐Glc)	(5 s,8R)‐3‐(2,5‐dimethylphenyl)‐8‐methoxy‐2‐oxo‐1‐azaspiro[4.5]dec‐3‐en‐4‐yl β‐D‐glucopyranoside Cc1cc(c(C)cc1)C1 = C(O[C@@H]2O[C@H](CO)[C@H](O)[C@H](O)[C@H]2O)[C@]2(CC[C@H](OC)CC2)NC1 = O UZUGTDHNHPYPHX‐UHFFFAOYSA‐N
Spirotetramat‐MA‐amide	cis‐1‐[2‐(2,5‐dimethylphenyl)(hydroxy)acetamido]‐4‐methoxycyclohexanecarboxylic acid unstated stereochemistry CO[C@@H]1CC[C@](NC(=O)C(O)c2cc(C)ccc2C)(CC1)C(=O)O BQMSZJLYWPKQFG‐ZSGNYYCVSA‐N
Spirotetramat‐enol‐GA	(5 s,8 S)‐3‐(2,5‐dimethylphenyl)‐8‐methoxy‐2‐oxo‐1‐azaspiro[4.5]dec‐3‐en‐4‐yl D‐glucopyranosiduronic acid Cc1cc(c(C)cc1)C1 = C(OC2O[C@@H]([C@@H](O)[C@H](O)[C@H]2O)C(=O)O)[C@]2(CC[C@H](OC)CC2)NC1 = O BKIJPFZWNISEGV‐QEKYSDTLSA‐N

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

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

(b): ACD/Name 2019.1.3 ACD/Labs 2019 Release (File version N05E41, Build 111,418, 3 September 2019).

(c): ACD/ChemSketch 2019.1.3 ACD/Labs 2019 Release (File version C05H41, Build 111,302, 27 August 2019).

Suggested citation: EFSA (European Food Safety Authority) , Bellisai G, Bernasconi G, Brancato A, Carrasco Cabrera L, Castellan I, Del Aguila M, Ferreira L, Giner Santonja G, Greco L, Jarrah S, Leuschner R, Magrans JO, Miron I, Nave S, Pedersen R, Reich H, Robinson T, Ruocco S, Santos M, Scarlato AP, Theobald A, Verani A, 2022. Reasoned Opinion on the modification of the existing maximum residue levels for spirotetramat in herbs and edible flowers. EFSA Journal 2022;20(12):7668, 35 pp. 10.2903/j.efsa.2022.7668