Modification of the existing maximum residue level for deltamethrin in maize/corn.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Bayer SAS submitted a request to the competent national authority in Austria to modify the existing maximum residue level (MRL) for the active substance deltamethrin in maize/corn. The data submitted in support of the request were found to be sufficient to derive a MRL proposal for maize/corn. Adequate analytical methods for enforcement are available to control the residues of deltamethrin (cis-deltamethrin) in maize/corn under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg and in animal matrices at the validated LOQ of 0.01 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of deltamethrin according to the reported agricultural practices is unlikely to present a risk to consumer health. The risk assessment shall be regarded as indicative and affected by non-standard uncertainties.

Summary

In accordance with Article 6 of Regulation (EC) No 396/2005, Bayer SAS submitted an application to the competent national authority in Austria (evaluating Member State, EMS) to modify the existing maximum residue level (MRL) for the active substance deltamethrin in maize/corn. 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 7 April 2022. To accommodate for the intended indoor post‐harvest uses of deltamethrin, the EMS proposed to lower the existing MRL from 2 to 0.7 mg/kg.

EFSA assessed the application and the evaluation report as required by Article 10 of the MRL regulation. EFSA identified points which needed further clarification, which were requested from the EMS. On 5 May 2022, the EMS submitted a revised evaluation report, which replaced the previously submitted evaluation report.

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

The metabolism of deltamethrin following foliar or local applications was investigated in crops belonging to the groups of fruits (apples and tomatoes), pulses and oilseeds (cotton seed) and cereals (maize) and in rotational crops. The metabolism studies showed that the metabolic pathway in primary crops is similar in all crop groups investigated and comparable to the metabolism observed in the rotational crops. Deltamethrin was the main component of residues. Specific metabolism studies investigating the nature of deltamethrin after post‐harvest treatments are not available. Given the results of the available metabolism studies where parent deltamethrin was the main residue (up to 77% of the total radioactive residue (TRR)) with alpha‐R‐isomer and trans‐isomer accounting for ~ 30–40% of the TRR, the MRL review concluded that a more extensive metabolism is unlikely in post‐harvest treatment.

Studies investigating the effect of processing on the nature of deltamethrin (hydrolysis studies) showed that deltamethrin was stable except under sterilisation conditions with the formation of two degradation products which were considered of no toxicological relevance during the peer review of deltamethrin.

Based on the metabolic pattern identified in metabolism studies and in hydrolysis studies, the residue definition for enforcement in plant products was set as ‘deltamethrin (cis‐deltamethrin)’. For risk assessment, the residue definition was proposed as the ‘sum of cis‐deltamethrin and its alpha‐R‐isomer and trans‐isomer’ provisionally, pending further toxicological data on these compounds. Confirmatory data for additional toxicological data on the metabolites have not been requested in the context of the MRL review; however, as the assessment on the renewal of the approval of deltamethrin in the framework of Regulation (EC) No 1107/2009 is ongoing, the relevant toxicological data should be assessed in this context in view of deriving a definitive residue definition for risk assessment. The conclusions reported in this reasoned opinion may therefore need to be reconsidered in the light of the outcome of the peer review.

Sufficiently validated analytical methods are available to quantify residues in plants, including difficult matrices, and in animal products according to the enforcement residue definition. The methods enable quantification of residues at or above 0.01 mg/kg (limit of quantification (LOQ)) in plants and products of animal origin and of 0.05 mg/kg in difficult matrices. The method allows separating the isomers of deltamethrin and is therefore able to quantify the cis‐deltamethrin according to the enforcement residue definition.

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

The available residue trials are sufficient to derive a MRL proposal of 0.7 mg/kg for maize/corn for the intended indoor post‐harvest use.

Processing factors (PFs) for the crop under assessment were derived from two maize/corn processing studies and are recommended to be included in Annex VI of Regulation (EC) No 396/2005 as follows:

For the proposed indoor post‐harvest application on maize/corn under assessment, rotational crop considerations are not relevant.

As maize/corn and its by‐products are used as feed products, a potential carry‐over into the food of animal origin was considered. The nature of deltamethrin residues in livestock has been investigated during the MRL review where the following tentative residue definitions were proposed: for enforcement deltamethrin and for risk assessment the sum of deltamethrin and its alpha‐R‐isomer and trans‐isomer. Based on the estimated dietary burdens and the results of livestock feeding studies, MRLs were proposed for product of animal origin.

It is to be noted that in this application a significantly lower MRL for maize/corn is proposed considering a less critical Good Agricultural Practice (GAP) than the existing EU MRL which is based on a Codex MRL. Therefore, an increase of the livestock exposure is not expected and there is no need to update the existing EU MRLs for commodities of animal origin which are based on Codex MRLs. It is, however, to be noted that during the confirmatory data assessment following the MRL review data gaps on the nature and magnitude of residues in animal commodities were referred to be considered during the ongoing renewal assessment and need still to be considered.

The toxicological profile of deltamethrin was assessed in the framework of the EU pesticides peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.01 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 0.01 mg/kg bw.

A lack of information on the toxicological profiles of the deltamethrin isomers (trans‐deltamethrin and alpha‐R‐deltamethrin) was identified in previous EFSA assessments and while the renewal assessment of the approval of deltamethrin in the framework of Regulation (EC) No 1107/2009 is currently ongoing, EFSA performed the consumer risk assessment assuming that the toxicity of these isomers is covered by the toxicological reference values set for cis‐deltamethrin.

The consumer risk assessment was performed with revision 3.1 of the EFSA Pesticide Residues Intake Model (PRIMo). In the framework of the present assessment, EFSA updated the previous scenario 2; overall the chronic exposure accounted for 99% ADI (NL toddler diet).

The short‐term exposure, calculated with the HR value and a conversion factor for risk assessment of 1 did not exceed the ARfD for maize/corn (30% ARfD) for the intended post‐harvest use. Furthermore, for maize oil the short‐term exposure resulted in 26% of the ARfD, using a processing factor of 6 for maize oil derived in this application and a conversion factor for risk assessment of 1.05. Using the new processing factor of 6 allowed to refine the acute risk assessment calculated in the framework of the assessment of confirmatory data; for maize oil produced from maize complying with the current EU MRL of 2 mg/kg, the acute exposure was estimated to amount for 65% of the ARfD.

Regarding the long‐term exposure, the calculations were performed with the input values as derived from the authorised uses reported in the framework of the MRL review, acceptable Codex MRLs, the STMR values derived from the residue trials submitted for the Article 12 confirmatory data, the recent MRL application for tomatoes and okra and the import tolerance application on mangoes and papayas. For maize/corn, the input value was the STMR value (with a conversion factor of 1 for risk assessment as applied in the previous calculations) derived from supervised trials submitted in support of the present MRL application.

With the less critical use on maize/corn assessed in this application, the chronic exposure was calculated to be 78% ADI (NL toddler diet), which is lower than the exposure calculated previously, considering the more critical GAP for maize (99% (NL toddler diet)). A long‐term consumer intake concern was not identified for the European diets incorporated in the EFSA PRIMo rev. 3.1. Maize/corn remained the main contributor with 28% ADI (NL toddler diet).

The consumer risk assessment should be regarded as indicative and affected by non‐standard uncertainties. In addition to the lack of toxicological information on alpha‐R‐isomer and the trans‐isomer of deltamethrin, the chronic risk assessment performed in the framework of the evaluation of confirmatory data following the Article 12 MRL review was affected by additional non‐standard uncertainties related to missing residue trials analysed for the provisional risk assessment residue definition and use of a conversion factor of 1 in cases, where considering overall sound evidence (body of knowledge), the two deltamethrin metabolites are unlikely to occur.

The renewal assessment of the active substance in accordance with Regulation (EC) No 1107/2009 is currently ongoing. Considering that the conclusion on the toxicological properties of metabolites of deltamethrin, and the pending decision on the definitive residue definitions, the conclusions reported in this reasoned opinion might need to be reconsidered in the light of the outcome of the peer review.

EFSA concluded that the proposed use of deltamethrin on maize/corn will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers' health.

EFSA proposes to consider an amendment of the existing MRL on maize/corn in Regulation (EU) No 396/2005 as reported in the summary table below following further risk management consideration.

EFSA noted that the estimated short‐term exposure to deltamethrin residues in dry beans for the post‐harvest use of deltamethrin exceeded the ARfD by 155% for UK infants when the calculations are performed with the HR of 0.85 mg/kg (related to the current CXL of 1 mg/kg). In the previous risk assessment for dry beans (EFSA, 2022a), the calculations were erroneously performed with the STMR of 0.4 mg/kg instead with the HR, due to a bug in the EFSA PRIMo rev. 3.1. Further refinements of the acute risk assessment for dry beans would in principle be possible because this crop is consumed only after cooking. There are indications that processing might reduce the residues, but as only one processing study is available, a robust processing factor cannot be derived. EFSA therefore revised the previously derived MRL proposal for dry beans, proposing to lower the MRL to the LOQ of 0.01 mg/kg. A corrigendum for the previous risk assessment of EFSA is under preparation.

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

Assessment

The European Food Safety Authority (EFSA) received an application to modify the existing maximum residue level (MRL) for deltamethrin in maize/corn. The detailed description of the intended uses of, which are the basis for the current MRL application, is reported in Appendix A.

Deltamethrin is the ISO common name for (S)‐α‐cyano‐3‐phenoxybenzyl (1R, 3R)‐3‐(2,2‐dibromovinyl)‐2,2‐dimethylcyclopropanecarboxylate (IUPAC). The chemical structures of the active substance and its main metabolites are reported in Appendix E.

Deltamethrin was evaluated in the framework of Directive 91/414/EEC1 with Sweden designated as rapporteur Member State (RMS) for the representative uses as a foliar treatment on a large number of crops (including root and tuber vegetables, fruits and fruiting vegetables, leafy vegetables and oilseeds), and as a post‐harvest treatment on pulses, potatoes and cereals. The draft assessment report (DAR) prepared by the RMS was not peer reviewed by EFSA. Therefore, no EFSA conclusion is available. Deltamethrin was approved2 for the use as insecticide on 1 November 2003.

The process of renewal of the first approval is currently ongoing.

EU MRLs for deltamethrin are established in Annex II of Regulation (EC) No 396/20053. The review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (MRL review) has been performed (EFSA, 2015) and the proposed modifications have been implemented in the MRL legislation. After completion of the MRL review, EFSA has issued several reasoned opinions on the modification of MRLs for deltamethrin. The proposals from certain reasoned opinions have been considered in recent MRL regulations.4 Certain Codex maximum residue limits (CXLs) have been taken over in the EU MRL legislation.5 Furthermore, EFSA has recently performed an evaluation of the confirmatory data following the Article 12 MRL review in a combined assessment with the Article 10 MRL application on tomatoes and okra/lady's finger and an Article 10 import tolerance assessment on mangoes and papayas (EFSA, 2022a,b); this EFSA reasoned opinion was also taken in consideration in the present assessment.

In accordance with Article 6 of Regulation (EC) No 396/2005, Bayer SAS submitted an application to the competent national authority in Austria (evaluating Member State, EMS) to modify the existing MRL for the active substance deltamethrin in maize/corn. 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 7 April 2022. To accommodate for the intended uses of deltamethrin, the EMS proposed to lower the existing MRL from 2 to 0.7 mg/kg.

EFSA identified points which needed further clarification, which were requested from the EMS. On 5 May 2022, the EMS submitted a revised evaluation report (Austria, 2021), which replaced the previously submitted evaluation report.

EFSA based its assessment on the evaluation report submitted by the EMS (Austria, 2021), the DAR and its addendum (Sweden, 1998, 2002) prepared under Directive 91/414/EEC, the Commission review report on deltamethrin (European Commission, 2002), the reasoned opinion on the MRL review according to Article 12 of Regulation No 396/2005 (EFSA, 2015) and its confirmatory data assessment (EFSA, 2022a), as well as the conclusions from previous EFSA opinions on deltamethrin (EFSA, 2017a, 2018b, 2020, 2022a,b) and the EFSA scientific report (EFSA, 2017b).

For this application, the data requirements established in Regulation (EU) No 544/20116 and the guidance documents applicable at the date of submission of the application to the EMS are applicable (European Commission, 1997a–b, c d e, f, g, 2017, 2020, 2021; OECD, 2011). The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation of Plant Protection Products adopted by Commission Regulation (EU) No 546/20117.

The EU pesticides peer review for the renewal of approval of deltamethrin in accordance with Regulation (EC) No 1107/2009 is ongoing and therefore the conclusions reported in this reasoned opinion may need to be reconsidered in the light of the outcome of the peer review.

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 (Austria, 2021) and the exposure calculations using the EFSA Pesticide Residues Intake Model (PRIMo) are considered as supporting documents to this reasoned opinion and, thus, are made publicly available as background documents to this reasoned opinion.

Residues in plants

Nature of residues and methods of analysis in plants

Nature of residues in primary crops

The metabolism of deltamethrin in primary crops belonging to the groups of fruits (apples and tomatoes), pulses and oilseeds (cotton seed) and cereals (maize) was investigated in the framework of the MRL review (EFSA, 2015). The metabolism studies after foliar and local treatment showed that the metabolic pathway is similar in all crop groups investigated. Deltamethrin was the main component of residues (up to 77% of the total radioactive residue (TRR)) with alpha‐R‐isomer and trans‐isomer accounting for ~ 30–40% of the TRR.

Studies investigating the metabolism of deltamethrin following post‐harvest treatment are not available and are not required. The MRL review concluded that, when applied post‐harvest, deltamethrin is not expected to undergo a more extensive metabolism (EFSA, 2015). This reasoning was supported in a previous post‐harvest MRL application on carob (EFSA, 2020).

Therefore, for the intended post‐harvest use on maize/corn, the metabolic behaviour in primary crops is sufficiently addressed.

Nature of residues in rotational crops

Deltamethrin is proposed to be used as a post‐harvest indoor treatment on maize/corn. Therefore, rotational crop considerations for the application under assessment are in principle not required. Notably, a rotational crop metabolism study is available and was assessed in the framework of the MRL review. EFSA concluded that the metabolism in rotational crops was comparable to that in primary crops (EFSA, 2015).

Nature of residues in processed commodities

The effect of processing on the nature of deltamethrin has been investigated in the framework of Directive 91/414/EEC (Sweden, 2002) and in the framework of the MRL review (EFSA, 2015).

It was concluded that deltamethrin is hydrolytically stable under conditions simulating pasteurisation and brewing, baking and boiling. Under sterilisation conditions significant degradation of deltamethrin in two main metabolites was observed, which were considered during the peer review as well‐known plant metabolites with no toxicological relevance and therefore this evidence base was accepted during the MRL review (EFSA, 2015).

Analytical methods for enforcement purposes in plant commodities

Analytical methods for the determination of deltamethrin residues in plants were assessed during the MRL review and in previous MRL applications (EFSA, 2015, 2017a, 2018b).

During the MRL review, an analytical method quantifying deltamethrin in plant matrices with high water content, high fat content, acidic and dry commodities using gas chromatography with electron capture detector (GC‐ECD) was evaluated and validated at the limit of quantification (LOQ) of 0.02 mg/kg. However, as this method was not considered highly specific, a confirmatory method was required as Article 12 confirmatory data (EFSA, 2015).

This data gap was addressed in the framework of the assessment of the confirmatory data of the MRL review (EFSA, 2022a). EFSA concluded that a full validation of a multi‐residue DFG S19 method for the analysis of cis‐deltamethrin residues by gas chromatography with mass selective detection (GS‐MSD) was provided for high water content, high acid content, high fat content and dry matrices at the LOQ of 0.01 mg/kg. The method allows separating the isomers of deltamethrin.

The same analytical method (DFG S19) was also reported in the evaluation report submitted in the present application (Austria, 2021) and is therefore considered valid.

EFSA concludes that analytical methods are available for monitoring deltamethrin residues in dry commodities to which maize/corn grains belong.

Storage stability of residues in plants

The applicant provided the same storage stability study with cis‐deltamethrin, trans‐deltamethrin and alpha‐R‐deltamethrin in maize/corn grain (dry commodity) and in maize forage, maize starch and maize flour which was assessed during the confirmatory data assessment (EFSA, 2022a).

It can be concluded that, cis‐deltamethrin and trans‐deltamethrin were stable in maize grain for 16 months, whereby the stability of alpha‐R‐deltamethrin was determined for up to 23 months when stored below between −23°C and −27°C. Under similar storage conditions, in the other maize plant parts (maize forage and stover) and processed products (maize flour and starch), stability of the deltamethrin isomers varied between 13 (maize forage) to 16 (maize starch) months except for the alpha‐R‐isomer where storage stability in maize forage and maize stover could not be concluded from the available studies. Details on the storage stability studies are presented in Appendix B.1.1.2.

Proposed residue definitions

Based on the metabolic pattern identified in metabolism studies, the results of hydrolysis studies, the toxicological significance of isomers and metabolites, the capabilities of enforcement analytical methods, the following residue definitions were proposed:

Residue definition for enforcement: Deltamethrin (cis‐deltamethrin).

Residue definition for risk assessment: Sum of cis‐deltamethrin and its alpha‐R‐isomer and trans‐isomer (provisional).

The same residue definitions are applicable to rotational crops and, provisionally, in processed products (EFSA, 2015). The residue definition for enforcement set in Regulation (EC) No 396/2005 is identical with the residue definition mentioned above.

The risk assessment residue definition was established on a provisional basis, pending the assessment of further toxicological data investigating the toxicological properties of the alpha‐R‐isomer and trans‐isomer of deltamethrin (EFSA, 2015) (see also Section 3). For the proposed use assessed in this application (post‐harvest treatment on maize), EFSA considered these residue definitions in line with the previous assessments.

Magnitude of residues in plants

Magnitude of residues in primary crops

In support of the MRL application, the applicant submitted six GAP‐compliant residue trials performed in maize/corn according to the intended GAP: post‐harvest indoor GAP on maize/corn of 1 × 0.5 g a.i./ton, PHI = not applicable. Four trials were performed in 2018 in Germany, Belgium, South of France and Italy and two trials (also used for processing studies) were performed in 2019 in the United States. The trial performed in Germany in 2018 was excluded because of unreliably reported information regarding the number of treatments which might have been two instead of one application (Austria, 2021). Therefore, a total of five supporting trials is available for which sampling was performed at time zero (before and after treatment), after 1 and 3 weeks and after 3 months. The highest residue value of each decline trial was considered to derive the MRL proposal.

The samples of these residue trials were analysed for the parent compound deltamethrin (cis‐deltamethrin) and for the two isomers (trans‐isomer and alpha‐R‐isomer) which are included in the residue definition risk assessment. The results support a previous conclusion that residues of both isomers above the LOQ of 0.01 mg/kg are not expected under the proposed post‐harvest use (EFSA, 2020, 2022a). Trial samples were stored under conditions for which integrity has been demonstrated. According to the assessment of the EMS, the methods used to analyse deltamethrin (cis‐deltamethrin) and for the two isomers (trans‐isomer and alpha‐R‐isomer) were sufficiently validated and fit for purpose (Austria, 2021).

Under the data requirements established under Regulation (EC) No 544/2011 a minimum of four trials are required for post‐harvest treatment (European Commission, 2020). EFSA concludes that the available trials suffice to derive an MRL proposal of 0.7 mg/kg on maize/corn in support of the intended post‐harvest indoor GAP.

For informational purposes, it is outlined that during the MRL review, the same GAP as the one under assessment was assessed. In support of this GAP however, only four trials on wheat and four trials on barley were available (EFSA, 2015; Austria, 2021). The two isomer metabolites included in the residue definitions for risk assessment were not analysed in these trials. Therefore, a tentative MRL was derived by the MRL review (EFSA, 2015). In its evaluation report, the EMS proposed originally to consider a combined data set of the wheat and barley trials assessed in the MRL review and the trials on maize/corn newly submitted in the present application. Based on this approach, a MRL proposal of 0.8 mg/kg would be calculated however, this is reported for informational purposes only because the EMS supported the EFSA consideration (Austria, 2021).

See Appendix B.1.2.1 for an overview of the available data.

Magnitude of residues in rotational crops

For the post‐harvest indoor use under consideration, a rotational crop assessment is not considered as relevant.

Nevertheless, for information, the possible transfer of deltamethrin residues to crops that are grown in crop rotation has however been assessed in the MRL review where it was concluded that provided that deltamethrin is applied according to the proposed GAPs, no significant residues in rotational crops are expected (EFSA, 2015).

Magnitude of residues in processed commodities

Two newly provided processing studies in maize/corn were assessed by the EMS: one for a dry milled and one for a wet milled process. Trial and processing samples were stored under conditions for which integrity has been demonstrated. According to the assessment of the EMS, the methods used to analyse deltamethrin (cis‐deltamethrin, alpha‐R‐deltamethrin and trans‐deltamethrin) in maize/corn and all processed fractions were sufficiently validated and fit for purpose. It is acknowledged that formally three processing studies would be required under Regulation (EC) No 544/20118. However, the deviation in the number of studies is considered as acceptable the submitted studies are fully valid and compliant with the data requirements of Regulation (EU) No 283/20139, therefore the lack of additional trial is considered a minor data gap.

These studies demonstrated that dry milled germ, grits and middlings, wet milled gluten, germ and starch processing lead to a reduction of residues (mean processing factor (PFs) between < 0.04 and 0.7) whereby dry milled aspirated grain fraction, bran, flour, meal, refined oil (mean processing factor (PFs) between 1.5 and 155) and wet milled refined oil (mean processing factor (PF) of 1.2 to 1.4) lead to a concentration of residues. For wet milled gluten free meal, a tentative PF of 1.4 was derived because the two studies diverted by 58% which is above 50% (Austria, 2021; OECD, 508). In this case, a third study would be required to consolidate the PF.

The number and quality of the processing studies are sufficient to derive robust processing factors based on the residue definition for monitoring which are recommended to be included in Annex VI of Regulation (EC) No 396/200510. In addition, conversion factors for the consumer risk assessment are derived. For an overview of the studies and derived processing factors see Appendix B.1.2.3.

Proposed MRLs

The available data are considered sufficient to derive a MRL proposal of 0.7 mg/kg as well as risk assessment values for the commodity under evaluation (see Appendix B.1.2.1). In Section 3, EFSA assessed whether residues on this crop resulting from the intended post‐harvest use on maize/corn are unlikely to pose a consumer health risk.

Residues in livestock

Maize/corn and its by‐products may be fed to livestock. Therefore, a consideration of deltamethrin residues in livestock is required in the framework of this MRL application. It is noted that maize forage and maize stover are feed items however are not relevant for the post‐harvest indoor use under consideration.

The most recent livestock dietary burden evaluation was performed in the confirmatory data assessment (EFSA, 2022a) considering the calculation in the EFSA opinion on the modification of deltamethrin residues in kales (EFSA, 2018b). Notably, the dietary burden for livestock was calculated considering the use in several products or by‐products for which data gaps identified have not been fully addressed and a risk management decision on whether to maintain the current MRLs (CXLs) set by Codex in 2004 is still required (i.e. citrus, potatoes, etc.) (EFSA, 2022a).

During the recent confirmatory data assessment, it was noted that the existing EU MRLs for livestock commodities which reflect CXLs were derived from significantly higher livestock dietary burdens calculated by the JMPR (FAO, 2002). Therefore, EFSA concluded that a change of the existing MRLs for products of animal origin is not required (EFSA, 2022a).

Based on the conclusion of the confirmatory data assessment, the current application to lower the existing MRL for maize/corn from 2 mg/kg with an STMR of 0.7 mg/kg to an MRL of 0.7 mg/kg with an STMR of 0.40 mg/kg will result in a decrease of the livestock dietary burden. Therefore, an update of the dietary burden calculation is not required in the frame of this application and the conclusions derived in the framework of the confirmatory data assessment are still applicable.

The results of the previous calculations were reported for information:

Codex Maximum dietary burden 7.0 mg/kg DM, 6.3 mg/kg DM and 2.7 mg/kg DM for beef ruminants, dairy ruminants and poultry, respectively (FAO, 2002).

EU Median dietary burden: 1.89 mg/kg DM, 2.47 mg/kg DM and 1.71 mg/kg DM for beef ruminants, dairy ruminants and poultry, respectively (EFSA, 2018b).

In the confirmatory data assessment following the MRL review, EFSA concluded that the data gaps relating to products of animal origin included as footnotes in the legislation with exception of the point on the analytical method, are still pending until a valid residue definition for risk assessment is derived (EFSA, 2022a). The data gap for the method of analyses (data gap number (4)11 in the confirmatory data assessment) for animal commodities was considered as addressed because a sufficiently validated multi residue DFG S19 method for enforcement using GC‐MSD for milk, egg, muscle, liver and kidney and fat with an LOQ of 0.01 mg/kg for cis‐deltamethrin was provided.

The method allowed separation of the three isomers of deltamethrin (alpha‐R‐deltamethrin, cis‐deltamethrin and trans‐deltamethrin). The EMS noted that the extraction efficacy of the confirmatory method is not addressed (Austria, 2020; EFSA, 2022a). Therefore, it is recommended to consider this point during the ongoing renewal assessment.

Consumer risk assessment

EFSA performed a dietary risk assessment using revision 3.1. of the EFSA PRIMo (EFSA, 2018a, 2019). This exposure assessment model contains food consumption data for different sub‐groups 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 deltamethrin used in the risk assessment (i.e. ADI and ARfD values) were derived in the framework of the EU pesticides peer review (European Commission, 2002). A lack of information on the toxicological profiles of the deltamethrin isomers (trans‐deltamethrin and alpha‐R‐deltamethrin) was identified in previous EFSA assessments (EFSA, 2015, 2017a, 2018b, 2020, 2022a). EFSA therefore, reiterated in this assessment the need to assess these toxicological data in the framework of the renewal of the approval of the active substance deltamethrin. Meanwhile, the consumer risk assessment was performed using the ADI/ARfD derived in 2002, assuming that the toxicity of these isomers is covered by the toxicological reference values set for cis‐deltamethrin and noting that for the crop under assessment, the deltamethrin isomers were not present in quantifiable concentrations.

In the framework of the evaluation of confirmatory data following the Article 12 MRL review for deltamethrin, a comprehensive long‐term exposure assessment was performed and recently updated in the frame of an import tolerance applications on mangoes and papaya (EFSA, 2022a,b). In the framework of the assessment of confirmatory data, EFSA prepared two scenarios: In scenario 1, EFSA considered uses those uses that were fully supported by a complete data set according to the residue definition for risk assessment. In this scenario, the long‐term exposure resulted in 95% ADI (NL toddler diet). In scenario 2, uses not fully supported by complete data sets according to the residue definition for risk assessment were also included, when sufficient evidence was available that the metabolites comprised in the risk assessment residue definition were unlikely to occur. Scenario 2 included uses which were not exceeding the ARfD. Scenario 2 was meant to provide additional information for risk managers to decide whether, despite the data gaps not fully addressed, certain MRLs could be maintained, considering that the residue definition for risk assessment might need to be reviewed in the light of new information on residue trials. Overall, the chronic exposure represented 99% of the ADI (NL toddler diet) in scenario 2 (EFSA, 2022a,b).

EFSA updated the input values of the previous scenario 2 by considering the new STMR value for maize/corn derived from five post‐harvest trials. The input values used in the exposure calculations are summarised in Appendix C.1.

Considering the above‐mentioned assumptions and uncertainties, the chronic exposure of the current assessment does not exceed the ADI. The maximum chronic exposure was observed for the Dutch toddler (78% ADI), maize/corn being the highest contributor with 28 ADI %, followed by wheat (18%) and milk (10%). Notably, the margin of safety increased considerably compared to the previously calculated exposure (99% of the ADI for the Dutch toddler diet) (EFSA, 2022a,b).

The short‐term exposure assessment was performed for maize/corn. The calculations performed with the HR of 0.44 mg/kg, expressed according to the residue definition for monitoring by considering a conversion factor of 1 for risk assessment. The short‐term exposure for maize/corn represented 30% of the ARfD and did not indicate a risk to consumer. These input values can be found in Appendix C.1.

For maize oil, a processing factor of 6 was derived from new processing studies; a conversion factor of 1.05 for risk assessment is used. The ARfD attributed to maize oil accounted for 26% of the ARfD (see Appendix B.3).

For information, it is also outlined that in the previous calculation, performed with the HR value related to the CXL and the default processing factor of 25 an exceedance of 256% of the ARfD for maize/oil was observed which would decrease when applying the derived processing factor and the conversion factor (6 × 1.05) in this assessment to 65% (EFSA, 2022a,b).

In the context of the current risk assessment, EFSA noted that the estimated short‐term exposure to deltamethrin residues in dry beans for the post‐harvest use of deltamethrin exceeded the ARfD by 155% for UK infants when the calculations are performed with the HR of 0.85 mg/kg (related to the current CXL of 1 mg/kg). An exceedance of the ARfD for the CXL of dry beans was previously reported in the MRL review (EFSA, 2015). In the previous risk assessment for dry beans (EFSA, 2022a), the calculations were erroneously performed with the STMR of 0.4 mg/kg instead with the HR, due to a bug in the EFSA PRIMo rev. 3.1.12 It is noted that further refinements of the acute risk assessment for dry beans would in principle be possible because this crop is consumed after processing (cooked). However, only one processing study was assessed during the MRL review which indicated a processing factor of 0.1 (EFSA, 2015). At present a robust processing factor based on a single study for risk assessment cannot be derived. EFSA therefore revised the previously derived MRL proposal for dry beans, which should be lowered to the LOQ of 0.01 mg/kg. A corrigendum for the previous risk assessment of EFSA is under preparation.

Overall, the consumer risk assessment should be regarded as indicative and affected by non‐standard uncertainties. During the previous assessments, the following elements were highlighted by EFSA (EFSA, 2022a,b):

Lack of information on the actual occurrence of residues of trans‐deltamethrin and alpha‐R‐deltamethrin in certain crops;

Lack of information on the toxicological profile of trans‐deltamethrin and alpha‐R‐deltamethrin;

Lack of information on the metabolism of trans‐deltamethrin and alpha‐R‐deltamethrin in livestock;

Absence of adequate livestock feeding studies in cows and hens, investigating residues in all relevant tissues and matrices according to the residue definitions for monitoring and risk assessment simultaneously.

Although a high degree of uncertainty remains due to the points identified above, EFSA concluded that neither the long‐term nor short‐term intake of residues of deltamethrin in maize/corn indicated a dietary consumer risk with any diet included in PRIMo 3.1 (see Appendix B.3).

For further details on the exposure calculations, a screenshot of the Report sheet of the PRIMo 3.1. is presented in Appendix C.

Conclusion and recommendations

The data submitted in support of this MRL application were found to be sufficient to derive a MRL proposal for maize/corn of 0.7 mg/kg.

This proposed MRL derived from the assessed GAP in this application and the current higher MRL of 2 mg/kg implemented in EU legislation13 are both not resulting in a consumer exposure exceeding the toxicological reference values and are therefore unlikely to pose a risk to consumers' health. Notably, the margin of safety is higher when considering the newly proposed MRL (78% ADI for the Dutch toddler diet) instead of the current MRL (99% of the ADI for the Dutch toddler diet).

Therefore, further risk management considerations are required as to whether the current EU MRL (based on a Codex MRL (CXL) for a post‐harvest use derived in 2004 for a wider residue definition for enforcement (sum of deltamethrin and its alpha‐R‐ and trans‐isomers) shall be maintained or whether it shall be lowered to 0.7 mg/kg is a less critical use than the use on which the current MRL is based. The possible impact of this decision on the overall chronic exposure may also be considered by risk managers.

An application, of the newly derived PF for maize oil in the acute exposure calculation instead of the default processing factor, the exposure calculations for maize oil do not exceed the ARfD (65% ARfD) for the current EU MRL of 2 mg/kg nor for the derived MRL of 0.70 mg/kg (26% ARfD) in this application.

A lack of information on the toxicological profiles of the deltamethrin isomers (trans‐deltamethrin and alpha‐R‐deltamethrin) was identified in previous EFSA assessments and has still not been addressed. Therefore, the risk assessment residue definition, which currently includes both deltamethrin isomers is still considered as provisional. EFSA reiterates its proposal to assess the toxicity of deltamethrin isomers in the framework of the renewal of the approval of deltamethrin, which is currently ongoing. Meanwhile, the consumer risk assessment was performed assuming that the toxicity of these isomers is covered by the toxicological reference values set for cis‐deltamethrin and should be regarded as indicative and affected by non‐standard uncertainties.

EFSA also noted that the estimated short‐term exposure to deltamethrin residues in dry beans for the post‐harvest use of deltamethrin exceeded the ARfD by 155% for UK infants when the calculations are performed with the HR of 0.85 mg/kg (related to the current CXL of 1 mg/kg). In the previous risk assessment for dry beans (EFSA, 2022a), the calculations were erroneously performed with the STMR of 0.4 mg/kg instead with the HR, due to a bug in the EFSA PRIMo rev. 3.1. Further refinements of the acute risk assessment for dry beans would in principle be possible because this crop is consumed only after cooking. There are indications that processing might reduce the residues, but as only one processing study is available, a robust processing factor cannot be derived. EFSA therefore revised the previously derived MRL proposal for dry beans, proposing to lower the MRL to the LOQ of 0.01 mg/kg. A corrigendum for the previous risk assessment of EFSA is under preparation.

The renewal assessment of the active substance in accordance with Regulation (EC) No 1107/2009 is currently ongoing. Considering that the conclusion on the toxicological properties of metabolites of deltamethrin, and the pending decision on the definitive residue definitions, the conclusions reported in this reasoned opinion might need to be reconsidered in the light of the outcome of the peer review.

The MRL recommendations are summarised in Appendix B.4.

active substance

acceptable daily intake

acute reference dose

growth stages of mono‐ and dicotyledonous plants

body weight

Codex Committee on Pesticide Residues

conversion factor for enforcement to risk assessment residue definition

Codex maximum residue limit

draft assessment report

days after treatment

dry matter

emulsifiable concentrate

evaluating Member State

residue expressed as a.s. equivalent

Food and Agriculture Organization of the United Nations

Good Agricultural Practice

gas chromatography with electron capture detector

gas chromatography with mass selective detection.

highest residue

international estimated daily intake

international estimated short‐term intake

independent laboratory validation

International Organisation for Standardisation

International Union of Pure and Applied Chemistry

Joint FAO/WHO Meeting on Pesticide Residues

limit of quantification

maximum residue level

Member States

northern Europe

Organisation for Economic Co‐operation and Development

plant‐back interval

processing factor

preharvest interval

(EFSA) Pesticide Residues Intake Model

(EFSA) Pesticide Residues Overview File

risk assessment

raw agricultural commodity

residue definition

rapporteur Member State

Directorate‐General for Health and Consumers

southern Europe

supervised trials median residue

total radioactive residue

ultra‐low volume (ULV) liquid

World Health Organization

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

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

B.1.1.2 Stability of residues in plants

B.1.2 Magnitude of residues in plants

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

B.1.2.2 Residues in rotational crops

B.1.2.3 Processing factors

B.2 Residues in livestock

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

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

B.3 Consumer risk assessment

B.4 Recommended MRLs

Appendix C – Pesticide Residue Intake Model (PRIMo)

C.1 Consumer risk assessment

Appendix D – Used compound codes

– Aspirated grain fractions:	155	– Bran, dry milled:	2.4
– Flour, dry milled:	3.4	– Germ, dry milled:	0.7
– Grits; dry milled:	0.2	– Meal, dry milled:	1.5
– Middlings, dry milled:	0.2	– Refined oil, dry milled:	6.0
– Gluten, wet milled:	0.5	– Refined oil, wet milled	1.2
– Germ, wet milled:	0.3
– Starch, wet milled	< 0.04

Code (a)	Commodity	Existing EU MRL (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: Deltamethrin (cis‐deltamethrin) (F)
0500030	Maize/corn	2	0.7 Further risk management considerations required	The submitted data are sufficient to derive a MRL proposal for the EU post‐harvest indoor GAP. Risk for consumers unlikely. The current MRL of 2 mg/kg reflects the Codex MRL for a post‐harvest use derived in 2004 for a wider residue definition for enforcement (sum of deltamethrin and its alpha‐R‐ and trans–isomers) which is equivalent to the current tentatively proposed residue definition for risk assessment in the EU. For the existing Codex MRL risk for consumers unlikely (margin of safety regarding the ADI is narrow (99% ADI)). A risk management decision is required whether the current MRL (CXL) of 2 mg/kg shall be maintained, considering the discrepancy regarding the EU and Codex residue definitions or whether it shall be lowered to 0.7 mg/kg.

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

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

Fat soluble.

Crop and/or situation	NEU, SEU, MS or country	F G or I (a)	Pests or group of pests controlled	Preparation		Application				Application rate per treatment				PHI (days) (d)	Remarks
				Type (b)	Conc. a.s. (g/kg)	Method kind	Range of growth stages and 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
Maize/corn	BE, NL, IT, FR	I	Stored grain insects including crawling and flying insects	EC	2.0 g/L	Post‐harvest – spraying	n.a.	1				0.5	g a.i./ton	n.a.
Maize/corn	BE, NL, IT, FR, IE, AT, GR, LU, SE, DK, BG, ES, PT, CY, DE, RO, HU, PL, SK, LV, LT, CZ, HR, SI, EE	I	Stored grain insects including crawling and flying insects	EC	25 g/L	Post‐harvest – spraying	n.a.	1				0.5	g a.i./ton	n.a.
Maize/corn	BE, NL, IT, FR, IE, AT, GR, LU, SE, DK, BG, ES, PT, CY, DE, RO	I	Stored grain insects including crawling and flying insects	UL	6.0 g/L	Post‐harvest – spraying	n.a.	1				0.5	g a.i./ton	n.a.

MRL: maximum residue level; GAP: Good Agricultural Practice; NEU: northern European Union; SEU: southern European Union; MS: Member State; a.s.: active substance; EC: emulsifiable concentrate, UL: ultra‐low volume (ULV) liquid; n.a.: not applicable.

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

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

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.

PHI: minimum preharvest interval.

Primary crops (available studies)	Crop groups	Crop(s)	Application(s)	Sampling (DAT)	Comment/Source
	Fruit crops	Apples	Foliar, 2 x 60 g a.s./ha	28	EFSA (2015)
		Tomatoes	Foliar, 1 x 50 g a.s./ha	4, 14, 28	Study on tomatoes performed in glasshouse (EFSA, 2015).
			Local, 14 μg/tomato		EFSA (2015)
	Cereals/grass	Maize	Foliar, 2 x 110 g a.s./ha	0, 14, 42	EFSA (2015)
	Pulses/oilseeds	Cotton (I)	Local, 3–15 mg/kg leaf	14, 42	Studies I and II on cotton cover the metabolism in leafy vegetables. Study on cotton (I) was performed in open field and in glasshouse. Study on cotton (II) investigated translocation.
		Cotton (II)	Foliar, 0.009 mg/plant	1, 3, 7
			Soil, 0.18 mg/plant
			Hydroponic, 6.7 mg/plant
		Cotton (III)	Foliar, 2 x 224 g a.s/ha	4, 10, 28
Rotational crops (available studies)	Crop groups	Crop(s)	Application(s)	PBI (DAT)	Comment/Source
	Root/tuber crops	Carrots (I)	Bare soil, 10 × 45 g a.s./ha	30, 120	In the study on carrots (II), radishes and spinaches, the crops were cultivated immediately after soil treatment (EFSA, 2015).
		Carrots (II)	Bare soil, 1 × 118 g a.s./ha	0
		Radishes	Bare soil, 1 × 118 g a.s./ha	0
	Leafy crops	Lettuces	Bare soil, 10 × 45 g a.s./ha	30, 120
		Spinaches	Bare soil, 1 × 118 g a.s./ha	0
	Cereal (small grain)	Barley	Bare soil, 10 × 45 g a.s./ha	30, 120
Processed commodities (hydrolysis study)	Conditions			Stable?	Comment/Source
	Pasteurisation (20 min, 90°C, pH 4)			Yes	EFSA (2015)
	Baking, brewing and boiling (60 min, 100°C, pH 5)			Yes	EFSA (2015)
	Sterilisation (20 min, 120°C, pH 6)			No	EFSA (2015)

Plant products (available studies)	Category	Commodity	T (°C)	Stability period		Compounds covered	Comment/Source
				Value	Unit
	High water content	Lettuces	−20	16	Months	cis‐deltamethrin, its alpha‐R‐isomer and trans‐isomer	EFSA (2015)
		Cabbages	−20	24	Months	cis‐deltamethrin, its alpha‐R‐isomer and trans‐isomer	EFSA (2015)
		Tomatoes	−20	24	Months	cis‐deltamethrin, its alpha‐R‐isomer and trans‐isomer	EFSA (2015)
		Maize forage	−23 to −27	13	Months	cis‐deltamethrin and trans‐isomer	EFSA (2022a)
		Maize forage	−23 to −27	Inconclusive	–	alpha‐R‐isomer(a)	EFSA (2022a)
	High oil content	Cotton seed	−12	30	Months	cis‐deltamethrin, its alpha‐R‐isomer and trans‐isomer	EFSA (2015)
	Dry / High starch	Cereals grain	−12	9	Months	cis‐deltamethrin, its alpha‐R‐isomer and trans‐isomer	EFSA (2015)
		Maize grain	−23 to −27	16	Months	cis‐deltamethrin and trans‐deltamethrin	EFSA (2022a)
		Maize grain	−23 to −27	23	Months	alpha‐R‐isomer	EFSA (2022a)
		Maize flour	−23 to −27	15	Months	cis‐deltamethrin, its alpha‐R‐isomer and trans‐isomer	EFSA (2022a)
		Maize starch	−23 to −27	16	Months	cis‐deltamethrin, its alpha‐R‐isomer and trans‐isomer	EFSA (2022a)
	High acid content	Oranges	<−18	25	Months	cis‐deltamethrin, its alpha‐R‐isomer and trans‐isomer	EFSA (2022a)
	Other matrices	Maize stover	−23 to −27	15	Months	cis‐deltamethrin, and trans‐isomer	EFSA (2022a)
		Maize stover	−23 to −27	Inconclusive	–	alpha‐R‐isomer(b)	EFSA (2022a)

The EMS reported a lack of confirmation of the initial fortification at the time point zero (EFSA, 2022a).

It is to be noted that at the 23 months' time point the recovery was 70% in one sample and in the other sample recovery was less leading to an average of 67%; furthermore, the previous time point tested in the study was the initial day zero where sample mean recovery was low, 78% (EFSA, 2022a).

Commodity	Region	Residue levels observed in the supervised residue trials (mg/kg)	Comments/Source	Calculated MRL (mg/kg)	HR (mg/kg)	STMR (mg/kg)	CF
Maize/corn	Indoor (Po‐use)	Austria (2022) Maize Mo: 0.265; 0.32; 0.40; 0.402; 0.44 RA: 0.285; 0.34; 0.42; 0.422; 0.46	New data on maize/corn: GAP: 1 × 0.50 g a.s./tonne; PHI = n.a. Underlined values relate to processing trials on maize/corn (Austria, 2021). The residues of the trans‐isomer and alpha‐R‐isomer were analysed and demonstrated to be all below the LOQ of 0.01 mg/kg in all five trials (Austria, 2021).	0.70	0.44	0.40	1
For information purposes, below further considerations on an alternative MRL proposal for maize/corn based on a combined data set of new trials on maize/corn and already assessed GAP‐compliant trials on wheat and barley provided by EMS in the evaluation report (Austria, 2021)
Wheat, barley	Indoor (Po‐use)	EFSA ( 2015 ) Wheat Mo: 0.33; 0.44; 0.45; 0.49 RA: – Barley Mo: 0.32; 0.40; 0.54; 0.58 RA: –	Original information in MRL review: Fall‐back GAP: 1 × 0.5 g a.s./tonne; PHI = n.a. Combined dataset on wheat and barley compliant with the fall‐back GAP for barley, rye, maize and rice (1 × 0.5 g/ton). Residues reported as cis‐deltamethrin. Residue trials stored for 15 months (EFSA,  2015 ). Extrapolation from trials on wheat and barley to rice was proposed in the MRL review (EFSA,  2015 ).	1 tentative (EFSA,  2015 )	0.58	0.45	Not calculated
Wheat, barley, maize	Indoor (Po‐use)	Austria (2021) Combined dataset Maize Mo: 0.265; 0.32; 0.40; 0.402; 0.44 RA: 0.285; 0.34; 0.42; 0.422; 0.46 Wheat Mo: 0.33; 0.44; 0.45; 0.49 RA: – Barley Mo: 0.32; 0.40; 0.54; 0.58 RA: –	Originally proposed by the EMS to combine available residue trials on maize, wheat and barley. Following discussion with EFSA, the EMS supported the approach to base the MRL proposal on trials on maize only as listed. Above in this table. For this post‐harvest use the results of residue trials on maize according to this GAP parameters assessed in previous EFSA opinion available (EFSA, 2020, 2022a); EFSA supported the view of the RMS that the alpha‐R‐isomer and the trans‐isomer of deltamethrin are not expected as demonstrated by relevant data on maize (EFSA, 2020, 2022a). New storage stability data demonstrate the stability of cis‐deltamethrin, its trans‐isomer and alpha‐R‐isomer for at least 16 months in dry commodities (Austria, 2020). Extrapolation to the whole group of cereals (0500000) possible.	0.80	0.58	0.40	1

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

Indicates that the MRL is proposed at the limit of quantification.

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

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

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

Conversion factor to recalculate residues according to the residue definition for monitoring to the residue definition for risk assessment. For the post‐harvest indoor use, a conversion factor of 1 was proposed because provided evidence was considered sufficient to demonstrate that the alpha‐R‐isomer and the trans‐isomer, respectively are not expected above the LOQ of 0.01 mg/kg (EFSA, 2020, 2022a).

MRL proposal is based on ‘Mean + 4SD’ for the post‐harvest use and was calculated to 0.65 mg/kg or 0.78 mg/kg, respectively. Considering the guideline SANCO 10634/2010 Rev 0 (European Commission, 2010), rounding to a MRL proposal of 0.70 mg/kg or 0.80 mg/kg is to be considered.

Processed commodity	Number of valid studies (a)	Processing Factor (PF)		CFP (b)	Comment/Source
		Individual values	Median PF
Maize, aspirated grain fractions	2	179.2; 131.3	155.3	1.01	Residues of the alpha‐R‐ and trans‐isomers are each below < 0.01 mg/kg in both trials in the raw agricultural and processed commodity (Austria (2021)).
Maize, bran, dry milled	2	3.2; 1.7	2.4	1.03
Maize, flour, dry milled	2	3.7; 3.1	3.4	1.02
Maize, germ, dry milled	2	0.9; 0.6	0.7	1.09
Maize, grit, dry milled	2	0.2; 0.3	0.2	1.26
Maize, meal, dry milled	2	1.6; 1.4	1.5	1.04
Maize, middlings, dry milled	2	0.2; 0.2	0.2	1.29
Maize, refined oil, dry milled	2	7.5; 4.5	6.0	1.05	Residues of the alpha‐R‐isomer: 0.094 mg/kg and 0.055 mg/kg; trans‐isomer are 2 × < 0.01 mg/kg (Austria, 2021).
Maize, gluten, wet milled	2	0.4; 0.7	0.5	1.14	Residues of the alpha‐R‐ and trans‐isomers are each below < 0.01 mg/kg in both trials in the raw agricultural and processed commodity (Austria (2021))
Maize, gluten feed meal, wet milled	2	0.8; 1.9	1.4 (tentative)	1.06	Residues of the alpha‐R‐ and trans‐isomers are each below < 0.01 mg/kg in both trials in the raw agricultural and processed commodity (Austria (2021)). This PF is considered as tentative because the difference between the two studies is 58% which exceeds 50% (OECD, 508). A third study would be needed to derive a robust PF.
Maize, germ, wet milled	2	0.3; 0.3	0.3	1.22	Residues of the alpha‐R‐ and trans‐isomers are each below < 0.01 mg/kg in both trials in the raw agricultural and processed commodity (Austria (2021))
Maize, refined oil, wet milled	2	1.6; 0.8	1.2	1.06	Residues of the alpha‐R‐isomer: 0.013 mg/kg and < 0.01 mg/kg; trans‐isomer: 2 × < 0.01 mg/kg (Austria, 2021).
Maize, starch, wet milled	2	< 0.04; < 0.03	< 0.04	1.00	Residues of cis‐deltamethrin in starch were < 0.01 mg/kg in both trials. Residues of the alpha‐R‐ and trans‐isomers are each below < 0.01 mg/kg in both trials in the raw agricultural and processed commodity (Austria (2021)).
A processing study on orange is provided and mentioned for completeness (Austria, 2021). Additional processing factors were derived during the MRL review (EFSA, 2015).

PF: processing factor = ratio of the residue level according to the residue definition for enforcement in the processed commodity and the residue level identified in the raw agricultural commodity according to the residue definition for enforcement

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

Conversion factor for risk assessment based on the ratio of the residue level identified in the processed commodity according to the residue definition for risk assessment and the residue level identified in the processed commodity according to the residue definition for enforcement (EFSA, 2016). In case that residues of isomers were below the LOQ of 0.01 mg/kg, the LOQ was added for each isomer to the residue level according to the residue definition for risk assessment unless the parent cis‐deltamethrin was as well below the LOQ (see maize, starch).

Livestock (available studies)	Animal	Dose (mg/kg bw per day)	Duration (days)	Comment/Source
	Lactating ruminants	10	3	Lactating cows were orally dosed with [−gem‐dimethyl‐14C]‐deltamethrin or [14C‐benzyl]‐deltamethrin (EFSA, 2015)
	Laying hen	5	3	Poultry were fed deltamethrin labelled on both the benzyl and dimethyl rings [14C‐benzyl]‐label and [gem‐dimethyl‐14C]‐label (EFSA, 2015)
	Pig	–	–
	Fish	–	–

Code (a)	Commodity	Existing EU MRL (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: Deltamethrin (cis‐deltamethrin) (F)
0500030	Maize/corn	2	0.7 Further risk management considerations required	The submitted data are sufficient to derive a MRL proposal for the EU post‐harvest indoor GAP. Risk for consumers unlikely. The current MRL of 2 mg/kg reflects the Codex MRL for a post‐harvest use derived in 2004 for a wider residue definition for enforcement (sum of deltamethrin and its alpha‐ R‐ and trans‐isomers) which is equivalent to the current tentatively proposed residue definition for risk assessment in the EU. For the existing Codex MRL risk to consumers unlikely (margin of safety regarding the ADI is narrow (99% ADI)). A risk management decision is required whether the current MRL (CXL) of 2 mg/kg shall be maintained, considering the discrepancy regarding the EU and Codex residue definitions or whether it shall be lowered to 0.7 mg/kg.

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

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

Fat soluble.

Code	Commodity	Existing/proposed MRL	Source/type of MRL	Chronic risk assessment(1)		Acute risk assessment(2)
				Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Risk assessment residue definition: Sum of cis‐deltamethrin and its alpha‐R‐isomer and trans‐isomer
500030	Maize/corn	0.70	Proposed	0.40	STMR‐RAC× CF(1)	0.44	HR‐RAC × CF(1)
110010	Grapefruits	0.02	CXL (2004)	0.01	STMR‐RAC	0.01	HR‐RAC
110020	Oranges	0.02	CXL (2004)	0.01	STMR‐RAC	0.01	HR‐RAC
110030	Lemons	0.02	CXL (2004)	0.01	STMR‐RAC	0.01	HR‐RAC
110040	Limes	0.02	CXL (2004)	0.01	STMR‐RAC	0.01	HR‐RAC
110050	Mandarins	0.02	CXL (2004)	0.01	STMR‐RAC	0.01	HR‐RAC
120010	Almonds	0.02*	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.02	HR‐RAC × CF(1)
120020	Brazil nuts	0.02*	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.02	HR‐RAC × CF(1)
120030	Cashew nuts	0.02*	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.02	HR‐RAC × CF(1)
120040	Chestnuts	0.02*	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.02	HR‐RAC × CF(1)
120050	Coconuts	0.02*	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.02	HR‐RAC × CF(1)
120060	Hazelnuts/cobnuts	0.02*	CXL (2004)	0.02	STMR‐RAC	0.02	HR‐RAC
120070	Macadamia	0.02*	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.02	HR‐RAC × CF(1)
120080	Pecans	0.02*	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.02	HR‐RAC × CF(1)
120090	Pine nut kernels	0.02*	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.02	HR‐RAC × CF(1)
120100	Pistachios	0.02*	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.02	HR‐RAC × CF(1)
120110	Walnuts	0.02*	CXL (2004)	0.02	STMR‐RAC	0.02	HR‐RAC
130010	Apples	0.2	CXL (2004)	0.03	STMR‐RAC	0.08	HR‐RAC
130020	Pears	0.09	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.07	HR‐RAC × CF(1)
130030	Quinces	0.1	EFSA (2022a)	0.03	STMR‐RAC × CF(1)	0.08	HR‐RAC × CF(1)
130040	Medlar	0.1	EFSA (2022a)	0.03	STMR‐RAC × CF(1)	0.08	HR‐RAC × CF(1)
130050	Loquats/Japanese medlars	0.1	EFSA (2022a)	0.03	STMR‐RAC × CF(1)	0.08	HR‐RAC × CF(1)
140010	Apricots	0.15	EFSA (2022a)	0.03	STMR‐RAC × CF(1)	0.08	HR‐RAC × CF(1)
140020	Cherries (sweet)	0.1	EFSA (2022a)	0.04	STMR‐RAC × CF(1)	0.05	HR‐RAC × CF(1)
140030	Peaches	0.15	EFSA (2022a)	0.03	STMR‐RAC × CF(1)	0.08	HR‐RAC × CF(1)
140040	Plums	0.1	EFSA (2022a)	0.01	STMR‐RAC × CF(1)	0.06	HR‐RAC × CF(1)
151010	Table grapes	0.2	CXL (2004)	0.04	STMR‐RAC	0.09	HR‐RAC
151020	Wine grapes	0.2	CXL (2004)	0.04	STMR‐RAC	0.09	HR‐RAC
152000	Strawberries	0.2	CXL (2004)	0.02	STMR‐RAC	0.1	HR‐RAC
153010	Blackberries	0.08	EFSA (2022a)	0.03	STMR‐RAC × CF(1)	0.04	HR‐RAC × CF(1)
153020	Dewberries	0.08	EFSA (2022a)	0.03	STMR‐RAC × CF(1)	0.04	HR‐RAC × CF(1)
153030	Raspberries (red and yellow)	0.08	EFSA (2022a)	0.03	STMR‐RAC × CF(1)	0.04	HR‐RAC × CF(1)
154010	Blueberries	0.6	EFSA (2022a)	0.08	STMR‐RAC × CF(1)	0.3	HR‐RAC × CF(1)
154020	Cranberries	0.6	EFSA (2022a)	0.08	STMR‐RAC × CF(1)	0.3	HR‐RAC × CF(1)
154030	Currants (red black and white)	0.6	EFSA (2022a)	0.08	STMR‐RAC × CF(1)	0.3	HR‐RAC × CF(1)
154040	Gooseberries (green red and yellow)	0.6	EFSA (2022a)	0.08	STMR‐RAC × CF(1)	0.3	HR‐RAC × CF(1)
154050	Rose hips	0.6	EFSA (2022a)	0.08	STMR‐RAC × CF(1)	0.3	HR‐RAC × CF(1)
154060	Mulberries (black and white)	0.6	EFSA (2022a)	0.08	STMR‐RAC × CF(1)	0.3	HR‐RAC × CF(1)
154070	Azarole/Mediteranean medlar	0.6	EFSA (2022a)	0.08	STMR‐RAC × CF(1)	0.3	HR‐RAC × CF(1)
154080	Elderberries	0.6	EFSA (2022a)	0.08	STMR‐RAC × CF(1)	0.3	HR‐RAC × CF(1)
161030	Table olives	1	EFSA (2015)	0.21	STMR‐RAC	0.31	HR‐RAC
163030	Mangoes	0.05	Proposed (EFSA 2022b)	0.03	STMR‐pulp	0.03	HR‐pulp
163040	Papayas	0.1	Proposed (EFSA 2022b)	0.03	STMR‐pulp	0.03	HR‐pulp
211000	Potatoes	0.01*	CXL (2004)	0.01	STMR‐RAC	0.01	HR‐RAC
213010	Beetroots	0.02*	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.02	HR‐RAC × CF(1)
213020	Carrots	0.02	CXL (2004)	0.01	STMR‐RAC	0.02	HR‐RAC
213030	Celeriacs/turnip rooted celeries	0.02*	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.02	HR‐RAC × CF(1)
213040	Horseradishes	0.02*	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.02	HR‐RAC × CF(1)
213050	Jerusalem artichokes	0.02*	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.02	HR‐RAC × CF(1)
213060	Parsnips	0.02*	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.02	HR‐RAC × CF(1)
213070	Parsley roots/Hamburg roots parsley	0.02*	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.02	HR‐RAC × CF(1)
213080	Radishes	0.02*	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.02	HR‐RAC × CF(1)
213090	Salsifies	0.02*	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.02	HR‐RAC × CF(1)
213100	Swedes/rutabagas	0.02*	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.02	HR‐RAC × CF(1)
213110	Turnips	0.02*	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.02	HR‐RAC × CF(1)
220010	Garlic	0.06	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.04	HR‐RAC × CF(1)
220020	Onions	0.06	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.04	HR‐RAC × CF(1)
220030	Shallots	0.06	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.04	HR‐RAC × CF(1)
220040	Spring onions/green onions and Welsh onions	0.3	EFSA (2022a)	0.06	STMR‐RAC × CF(1)	0.13	HR‐RAC × CF(1)
231010	Tomatoes	0.1	Proposed (EFSA 2022a)	0.03	STMR‐RAC × CF(1)	0.07	HR‐RAC × CF(1)
231020	Sweet peppers/bell peppers	0.15	EFSA (2022a)	0.03	STMR‐RAC × CF(1)	0.07	HR‐RAC × CF(1)
231030	Aubergines/egg plants	0.4	EFSA (2022a)	0.06	STMR‐RAC × CF(1)	0.2	HR‐RAC × CF(1)
231040	Okra/lady's fingers	0.15	Proposed (EFSA 2022a)	0.03	STMR‐RAC × CF(1)	0.07	HR‐RAC × CF(1)
232010	Cucumbers	0.2	CXL (2004)	0.02	STMR‐RAC	0.09	HR‐RAC
232020	Gherkins	0.2	CXL (2004)	0.02	STMR‐RAC	0.09	HR‐RAC
232030	Courgettes	0.2	CXL (2004)	0.02	STMR‐RAC	0.09	HR‐RAC
232990	Other cucurbits ‐ edible peel	0.2	CXL (2004)	0.02	STMR‐RAC
233010	Melons	0.02*	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.02	HR‐RAC × CF(1)
233020	Pumpkins	0.2	CXL (2004)	0.02	STMR‐RAC	0.09	HR‐RAC
233030	Watermelons	0.02*	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.02	HR‐RAC × CF(1)
234000	Sweet corn	0.02*	CXL (2004)	0.02	STMR‐RAC	0.02	HR‐RAC
241010	Broccoli	0.1	CXL (2004)	0.02	STMR‐RAC	0.04	HR‐RAC
241020	Cauliflowers	0.1	CXL (2004)	0.02	STMR‐RAC	0.04	HR‐RAC
241990	Other flowering brassica	0.1	CXL (2004)	0.02	STMR‐RAC
242010	Brussels sprouts	0.01*	EFSA (2022a)	0.01	STMR‐RAC × CF(1)	0.01	HR‐RAC × CF(1)
242020	Head cabbages	0.01*	EFSA (2022a)	0.01	STMR‐RAC × CF(1)	0.01	HR‐RAC × CF(1)
243010	Chinese cabbages/pe‐tsai	0.2	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.11	HR‐RAC × CF(1)
243020	Kales	0.15	EFSA (2018a)	0.063	STMR‐RAC × CF(1.25)	0.163	HR‐RAC CF(1.25)
244000	Kohlrabies	0.01*	EFSA (2022a)	0.01	STMR‐RAC × CF(1)	0.01	HR‐RAC × CF(1)
251010	Lamb's lettuce/corn salads	2	CXL (2006)	0.125	STMR‐RAC	1	HR‐RAC
251040	Cress and other sprouts and shoots	2	CXL (2006)	0.125	STMR‐RAC	1	HR‐RAC
251050	Land cress	2	CXL (2006)	0.125	STMR‐RAC	1	HR‐RAC
251060	Roman rocket/rucola	2	CXL (2006)	0.125	STMR‐RAC	1	HR‐RAC
251070	Red mustards	2	CXL (2006)	0.125	STMR‐RAC	1	HR‐RAC
251080	Baby leaf crops (including brassica species)	2	CXL (2006)	0.125	STMR‐RAC	1	HR‐RAC
253000	Grape leaves and similar species	2	CXL (2006)	0.125	STMR‐RAC	1	HR‐RAC
254000	Watercress	2	CXL (2006)	0.125	STMR‐RAC	1	HR‐RAC
255000	Witloofs/Belgian endives	0.02*	EFSA (2015)	0.026	STMR‐RAC × CF(1.3)	0.026	HR‐RAC × CF(1.3)
256010	Chervil	2	CXL (2006)	0.125	STMR‐RAC	1	HR‐RAC
256020	Chives	1.5	EFSA (2022a)	0.111	STMR‐RAC × CF(1.3)	1.3	HR‐RAC × CF(1.3)
256030	Celery leaves	1.5	EFSA (2022a)	0.111	STMR‐RAC × CF(1.3)	1.3	HR‐RAC × CF(1.3)
256040	Parsley	1.5	EFSA (2022a)	0.111	STMR‐RAC × CF(1.3)	1.3	HR‐RAC × CF(1.3)
256050	Sage	1.5	EFSA (2022a)	0.111	STMR‐RAC × CF(1.3)	1.3	HR‐RAC × CF(1.3)
256060	Rosemary	1.5	EFSA (2022a)	0.111	STMR‐RAC × CF(1.3)	1.3	HR‐RAC × CF(1.3)
256070	Thyme	1.5	EFSA (2022a)	0.111	STMR‐RAC × CF(1.3)	1.3	HR‐RAC × CF(1.3)
256080	Basil and edible flowers	1.5	EFSA (2022a)	0.111	STMR‐RAC × CF(1.3)	1.3	HR‐RAC × CF(1.3)
256090	Laurel/bay leaves	1.5	EFSA (2022a)	0.111	STMR‐RAC × CF(1.3)	1.3	HR‐RAC × CF (1.3)
256100	Tarragon	1.5	EFSA (2022a)	0.111	STMR‐RAC × CF(1.3)	1.3	HR‐RAC × CF (1.3)
256990	Other herbs	1.5	EFSA (2022a)	0.111	STMR‐RAC × CF(1.3)
260010	Beans (with pods)	0.2	CXL (2004)	0.01	STMR‐RAC	0.14	HR‐RAC
260020	Beans (without pods)	0.2	CXL (2004)	0.01	STMR‐RAC	0.14	HR‐RAC
260030	Peas (with pods)	0.2	CXL (2004)	0.01	STMR‐RAC	0.14	HR‐RAC
260040	Peas (without pods)	0.2	CXL (2004)	0.01	STMR‐RAC	0.14	HR‐RAC
260050	Lentils (fresh)	0.2	CXL (2004)	0.01	STMR‐RAC	0.14	HR‐RAC
270010	Asparagus	0.01*	EFSA (2015)	0.01	STMR‐RAC	0.01	HR‐RAC
270030	Celeries	0.3	EFSA (2017a, b)	0.075	STMR‐RACCF(1.25)	0.2	HR‐RAC × CF(1.25)
270040	Florence fennels	0.3	EFSA (2017a, b)	0.075	STMR‐RACCF(1.25)	0.2	HR‐RAC × CF(1.25)
270060	Leeks	0.3	EFSA (2022a)	0.06	STMR‐RACCF(1)	0.13	HR‐RAC × CF(1)
270070	Rhubarbs	0.3	EFSA (2017a, b)	0.075	STMR‐RACCF(1.25)	0.2	HR‐RAC × CF(1.25)
280010	Cultivated fungi	0.05	CXL (2004)	0.02	STMR‐RAC	0.03	HR‐RAC
300010	Beans	1	CXL (2004)	0.5	STMR‐RAC	0.85(a)	HR‐RAC
300020	Lentils	1	CXL (2004)	0.5	STMR‐RAC	0.85(a)	HR‐RAC
300030	Peas	1	CXL (2004)	0.5	STMR‐RAC	0.85(a)	HR‐RAC
300040	Lupins/lupini beans	1	CXL (2004)	0.5	STMR‐RAC	0.85(a)	HR‐RAC
401010	Linseeds	0.02*	EFSA (2015)	0.02	STMR‐RACCF(1)	0.02	STMR‐RAC × CF (1)
401030	Poppy seeds	0.2	EFSA (2015)	0.05	STMR‐RACCF(1)	0.05	STMR‐RAC × CF (1)
401040	Sesame seeds	0.02*	EFSA (2015)	0.01	STMR‐RACCF(1)	0.01	STMR‐RAC × CF (1)
401050	Sunflower seeds	0.05	CXL (2004)	0.05	STMR‐RAC	0.05	STMR‐RAC
401060	Rapeseeds/canola seeds	0.2	CXL (2017)	0.07	STMR‐RAC	0.07	STMR‐RAC
401080	Mustard seeds	0.07*	EFSA (2015)	0.05	STMR‐RAC × CF(1)	0.05	STMR‐RAC × CF (1)
401090	Cotton seeds	0.02*	EFSA (2015)	0.01	STMR‐RAC × CF(1)	0.01	STMR‐RAC × CF (1)
401100	Pumpkin seeds	0.02*	EFSA (2015)	0.01	STMR‐RAC × CF(1)	0.01	STMR‐RAC × CF (1)
401110	Safflower seeds	0.02*	EFSA (2015)	0.01	STMR‐RAC × CF(1)	0.01	STMR‐RAC × CF (1)
401120	Borage seeds	0.2	EFSA (2015)	0.05	STMR‐RAC × CF(1)	0.05	STMR‐RAC × CF(1)
401130	Gold of pleasure seeds	0.07*	EFSA (2015)	0.05	STMR‐RAC × CF(1)	0.05	STMR‐RAC × CF (1)
401140	Hemp seeds	0.2	EFSA (2015)	0.05	STMR‐RAC × CF(1)	0.05	STMR‐RAC × CF (1)
401150	Castor beans	0.2	EFSA (2015)	0.05	STMR‐RAC × CF(1)	0.05	STMR‐RAC × CF(1)
402010	Olives for oil production	0.6	EFSA (2022a)	39	STMR‐RAC × CF(1)	0.239	STMR‐RAC × CF (1)
500010	Barley	2	CXL (2004)	0.7	STMR‐RAC	1.1(a)	HR‐RAC
500020	Buckwheat and other pseudo‐cereals	2	CXL (2004)	0.7	STMR‐RAC	1.1(a)	HR‐RAC
500040	Common millet/proso millet	2	CXL (2004)	0.7	STMR‐RAC	1.1(a)	HR‐RAC
500050	Oat	2	CXL (2004)	0.7	STMR‐RAC	1.1(a)	HR‐RAC
500060	Rice	1	EFSA (2022a)	0.45	STMR‐RAC × CF(1)	0.58(a)	HR‐RAC
500070	Rye	2	CXL (2004)	0.7	STMR‐RAC	1.1(a)	HR‐RAC
500080	Sorghum	2	CXL (2004)	0.7	STMR‐RAC	1.1(a)	HR‐RAC
500090	Wheat	1	EFSA (2022a)	0.45	STMR‐RAC × CF(1)	0.58(a)	HR‐RAC
610000	Tea (dried leaves of Camellia sinensis)	5	CXL (2004)	2.2	STMR‐RAC	2.2	STMR‐RAC
631010	Chamomille	9	EFSA (2022a)	0.78	STMR‐RAC × CF(1.3)	9.1	HR‐RAC × CF (1.3)
631020	Hybiscus/roselle	9	EFSA (2022a)	0.78	STMR‐RAC × CF(1.3)	9.1	HR‐RAC × CF (1.3)
631030	Rose	9	EFSA (2022a)	0.78	STMR‐RAC × CF(1.3)	9.1	HR‐RAC × CF (1.3)
631040	Jasmine	9	EFSA (2022a)	0.78	STMR‐RAC × CF(1.3)	9.1	HR‐RAC × CF (1.3)
631050	Lime/linden	9	EFSA (2022a)	0.78	STMR‐RAC × CF(1.3)	9.1	HR‐RAC × CF (1.3)
631990	Other herbal infusions (dried flowers)	9	EFSA (2022a)	0.78	STMR‐RAC × CF(1.3)
632010	Strawberry leaves	9	EFSA (2022a)	0.78	STMR‐RAC × CF(1.3)	9.1	HR‐RAC × CF (1.3)
632020	Rooibos	9	EFSA (2022a)	0.78	STMR‐RAC × CF(1.3)	9.1	HR‐RAC × CF (1.3)
632030	Mate/maté	9	EFSA (2022a)	0.78	STMR‐RAC × CF(1.3)	9.1	HR‐RAC × CF (1.3)
632990	Other herbal infusions (dried leaves)	9	EFSA (2022a)	0.78	STMR‐RAC × CF(1.3)
633010	Valerian root	0.3	EFSA (2022a)	0.07	STMR‐RAC × CF(1)	0.14	HR‐RAC × CF (1)
633020	Ginseng root	0.3	EFSA (2022a)	0.07	STMR‐RAC × CF(1)	0.14	HR‐RAC × CF (1)
633990	Other herbal infusions (dried roots)	0.3	EFSA (2022a)	0.07	STMR‐RAC × CF(1)
650000	Carobs/Staint John's bread	0.70	EFSA (2020)	0.365	STMR‐RAC × CF(1)	0.405	HR‐RAC × CF (1)
820010	Allspice/pimento	0.03	CXL (2011)	0.03	STMR‐RAC	0.03	HR‐RAC
820020	Sichuan pepper	0.03	CXL (2011)	0.03	STMR‐RAC	0.03	HR‐RAC
820030	Caraway	0.03	CXL (2011)	0.03	STMR‐RAC	0.03	HR‐RAC
820040	Cardamom	0.03	CXL (2011)	0.03	STMR‐RAC	0.03	HR‐RAC
820050	Juniper berry	0.03	CXL (2011)	0.03	STMR‐RAC	0.03	HR‐RAC
820060	Peppercorn (black green and white)	0.03	CXL (2011)	0.03	STMR‐RAC	0.03	HR‐RAC
820070	Vanilla pods	0.03	CXL (2011)	0.03	STMR‐RAC	0.03	HR‐RAC
820080	Tamarind	0.03	CXL (2011)	0.03	STMR‐RAC	0.03	HR‐RAC
820990	Other spices (fruits)	0.03	CXL (2011)	0.03	STMR‐RAC
840010	Liquorice	0.5	CXL (2011)	0.05	STMR‐RAC	0.33	HR‐RAC
840020	Ginger	0.5	CXL (2011)	0.05	STMR‐RAC	0.33	STMR‐RAC
840030	Turmeric/curcuma	0.5	CXL (2011)	0.05	STMR‐RAC	0.33	HR‐RAC
840040	Horseradish root spices	0.5	CXL (2011)	0.05	STMR‐RAC	0.33	HR‐RAC
900010	Sugar beet roots	0.02*	EFSA (2022a)	0.02	STMR‐RAC × CF(1)	0.02	HR‐RAC × CF (1)
900030	Chicory roots	0.04	EFSA (2022a)	0.01	STMR‐RAC × CF(1)	0.02	HR‐RAC × CF (1)
1011010	Swine: Muscle/meat	0.03	EFSA (2015)	0.055	STMR‐RAC	0.061	HR‐RAC
1011020	Swine: Fat tissue	0.5	EFSA (2015)	0.155	STMR‐RAC	0.186	HR‐RAC
1011030	Swine: Liver	0.03*	EFSA (2015)	0.03	STMR‐RAC	0.03	HR‐RAC
1011040	Swine: Kidney	0.03*	EFSA (2015)	0.03	STMR‐RAC	0.03	HR‐RAC
1011050	Swine: Edible offals (other than liver and kidney)	0.5	EFSA (2015)	0.155	STMR‐RAC	0.186	HR‐RAC
1012010	Bovine: Muscle/meat	0.03	EFSA (2015)	0.055	STMR‐RAC	0.061	HR‐RAC
1012020	Bovine: Fat tissue	0.5	EFSA (2015)	0.155	STMR‐RAC	0.186	HR‐RAC
1012030	Bovine: Liver	0.03*	EFSA (2015)	0.03	STMR‐RAC	0.03	HR‐RAC
1012040	Bovine: Kidney	0.03*	EFSA (2015)	0.03	STMR‐RAC	0.03	HR‐RAC
1012050	Bovine: Edible offals (other than liver and kidney)	0.5	EFSA (2015)	0.155	STMR‐RAC	0.186	HR‐RAC
1013010	Sheep: Muscle/meat	0.03	EFSA (2015)	0.055	STMR‐RAC	0.061	HR‐RAC
1013020	Sheep: Fat tissue	0.5	EFSA (2015)	0.155	STMR‐RAC	0.186	HR‐RAC
1013030	Sheep: Liver	0.03*	EFSA (2015)	0.03	STMR‐RAC	0.03	HR‐RAC
1013040	Sheep: Kidney	0.03*	EFSA (2015)	0.03	STMR‐RAC	0.03	HR‐RAC
1013050	Sheep: Edible offals (other than liver and kidney)	0.5	EFSA (2015)	0.155	STMR‐RAC	0.186	HR‐RAC
1014010	Goat: Muscle/meat	0.03	EFSA (2015)	0.055	STMR‐RAC	0.061	HR‐RAC
1014020	Goat: Fat tissue	0.5	EFSA (2015)	0.155	STMR‐RAC	0.186	HR‐RAC
1014030	Goat: Liver	0.03*	EFSA (2015)	0.03	STMR‐RAC	0.03	HR‐RAC
1014040	Goat: Kidney	0.03*	EFSA (2015)	0.03	STMR‐RAC	0.03	HR‐RAC
1014050	Goat: Edible offals (other tha liver and kindey)	0.5	EFSA (2015)	0.155	STMR‐RAC	0.186	HR‐RAC
1015010	Equine: Muscle/meat	0.03	EFSA (2015)	0.055	STMR‐RAC	0.061	HR‐RAC
1015020	Equine: Fat tissue	0.5	EFSA (2015)	0.155	STMR‐RAC	0.186	HR‐RAC
1015030	Equine: Liver	0.03*	EFSA (2015)	0.03	STMR‐RAC	0.03	HR‐RAC
1015040	Equine: Kidney	0.03*	EFSA (2015)	0.03	STMR‐RAC	0.03	HR‐RAC
1015050	Equine: Edible offals (other than liver and kidney)	0.5	EFSA (2015)	0.155	STMR‐RAC	0.186	HR‐RAC
1016010	Poultry: Muscle/meat	0.02*	EFSA (2015)	0.022	STMR‐RAC	0.027	HR‐RAC
1016020	Poultry: Fat tissue	0.1	EFSA (2015)	0.038	STMR‐RAC	0.09	HR‐RAC
1016030	Poultry: Liver	0.02*	EFSA (2015)	0.02	STMR‐RAC	0.02	HR‐RAC
1016040	Poultry: Kidney	0.02*	EFSA (2015)	0.02	STMR‐RAC	0.02	HR‐RAC
1016050	Poultry: Edible offals (other than liver and kidney)	0.02*	EFSA (2015)	0.02	STMR‐RAC	0.02	HR‐RAC
1017010	Other farmed animals: Muscle/meat	0.03	EFSA (2015)	0.155	STMR‐RAC	0.061	HR‐RAC
1017020	Other farmed animals: Fat tissue	0.5	EFSA (2015)	0.155	STMR‐RAC	0.186	HR‐RAC
1017030	Other farmed animals: Liver	0.03*	EFSA (2015)	0.03	STMR‐RAC	0.03	HR‐RAC
1017040	Other farmed animals: Kidney	0.03*	EFSA (2015)	0.03	STMR‐RAC	0.03	HR‐RAC
1017050	Other farmed animals: Edible offals (other than liver and kidney)	0.5	EFSA (2015)	0.155	STMR‐RAC	0.186	HR‐RAC
1020010	Milk: Cattle	0.05	EFSA (2015)	0.017	STMR‐RAC	0.017	STMR‐RAC
1020020	Milk: Sheep	0.05	EFSA (2015)	0.017	STMR‐RAC	0.017	STMR‐RAC
1020030	Milk: Goat	0.05	EFSA (2015)	0.017	STMR‐RAC	0.017	STMR‐RAC
1020040	Milk: Horse	0.05	EFSA (2015)	0.017	STMR‐RAC	0.017	STMR‐RAC
1030010	Eggs: Chicken	0.02*	EFSA (2015)	0.02	STMR‐RAC	0.02	HR‐RAC
1030020	Eggs: Duck	0.02*	EFSA (2015)	0.02	STMR‐RAC	0.02	HR‐RAC
1030030	Eggs: Goose	0.02*	EFSA (2015)	0.02	STMR‐RAC	0.02	HR‐RAC
1030040	Eggs: Quail	0.02*	EFSA (2015)	0.02	STMR‐RAC	0.02	HR‐RAC
1030990	Eggs: Others	0.02*	EFSA (2015)	0.02	STMR‐RAC

STMR‐RAC: supervised trials median residue in raw agricultural commodity; HR‐RAC: highest residue in raw agricultural commodity; CF: conversion factor for risk assessment; CXL: Codex MRL in place [https://www.fao.org/fao-who-codexalimentarius/codex-texts/dbs/pestres/pesticide-detail/en/?p_id=135].

For animal commodities: Consumption figures in the EFSA PRIMo are expressed as meat. Since the a.s. is a fat‐soluble pesticide, STMR and HR residue values were calculated considering a 80%/90% muscle and 20%/10% fat content for mammal/poultry meat respectively (FAO, 2016).

Indicates that the value is at the limit of analytical quantification (LOQ).

It is noted that in the refined mode calculation mode for post‐harvest uses of bulk materials, the EFSA PRIMo rev. 3.1 model, performs the calculations erroneously with the STMR value, rather than automatically selecting the HR value. Hence, the input values in the column ‘acute RA input value’ were updated manually by unprotecting the worksheet to force the calculation to be performed with the HR value.

Code/trivial name (a)	IUPAC name/SMILES notation/InChiKey (b)	Structural formula (c)
Deltamethrin (cis‐deltamethrin)	(S)‐α‐cyano‐3‐phenoxybenzyl (1R,3R)‐3‐(2,2‐dibromovinyl)‐2,2‐dimethylcyclopropanecarboxylate or (S)‐α‐cyano‐3‐phenoxybenzyl (1R)‐cis‐3‐(2,2‐dibromovinyl)‐2,2‐dimethylcyclopropanecarboxylate Br/C(Br) = C/[C@H]1[C@@H](C(=O)O[C@H](C#N)c2cccc(Oc3ccccc3)c2)C1(C)C OWZREIFADZCYQD‐NSHGMRRFSA‐N
trans‐isomer	(S)‐cyano(3‐phenoxybenzyl) (1R,3S)‐3‐(2,2‐dibromovinyl)‐2,2‐dimethylcyclopropanecarboxylate Br/C(Br) = C/[C@@H]1[C@@H](C(=O)O[C@H](C#N)c2cccc(Oc3ccccc3)c2)C1(C)C OWZREIFADZCYQD‐GGPKGHCWSA‐N
alpha‐R‐isomer	(R)‐α‐cyano‐3‐phenoxybenzyl (1R,3R)‐3‐(2,2‐dibromovinyl)‐2,2‐dimethylcyclopropanecarboxylate Br/C(Br) = C/[C@H]1[C@@H](C(=O)O[C@@H](C#N)c2cccc(Oc3ccccc3)c2)C1(C)C OWZREIFADZCYQD‐BJLQDIEVSA‐N

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

The metabolite name in bold is the name used in the conclusion.

ACD/Name 2020.2.1 ACD/Labs 2020 Release (File version N15E41, Build 116,563, 15 June 2020).

ACD/ChemSketch 2020.2.1 ACD/Labs 2020 Release (File version C25H41, Build 121,153, 22 March 2021).