Modification of the existing maximum residue level for quizalofop (resulting from the use of quizalofop‐P‐ethyl) in caraway

Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Nissan Chemical Europe S.A.S. submitted a request to the competent national authority in Finland to modify the existing maximum residue level (MRL) for quizalofop in caraway to accommodate the intended NEU use of quizalop‐P‐ethyl for this commodity. The data submitted in support of the request were found to be sufficient to derive an MRL proposal for caraway. Adequate analytical methods for enforcement are available to control the residues of quizalofop, resulting from the use of quizalofop‐P‐ethyl, on the commodity under consideration at the validated limit of quantification (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 quizalofop‐P‐ethyl 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, Nissan Chemical Europe S.A.S. submitted an application to the competent national authority in Finland (evaluating Member State, EMS) to modify the existing maximum residue level (MRL) for the active substance quizalofop (resulting from the use of quizalofop‐P‐ethyl) in caraway. 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 13 April 2021. To support the intended NEU use of quizalofop‐P‐ethyl in caraway, the EMS proposed to lower the existing MRL from 0.05* to 0.04 mg/kg based on new residues trials and analytical data.

It is noted that several tentative MRL proposals (including one for caraway) have been implemented in the MRL legislation by Commission Regulation (EU) No Reg. (EU) 2019/973 for ‘quizalofop, its salts, its esters (including propaquizafop) and its conjugates’; including footnotes, indicating the type of confirmatory data that should be provided by a party having an interest in maintaining the proposed tentative MRLs by 14 June 2021. In view of the above, EFSA initially put the assessment of the present application on hold to clarify first if such confirmatory data were already submitted to the Rapporteur Member State (RMS) or in the process of being submitted. After a clarification from the RMS and the Commission that such confirmatory data were not available, and considering that the deadline for their submission already expired, EFSA resumed the assessment of the current application and the evaluation report, as required by Article 10 of the MRL regulation on 7 October 2021.

Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC, the data evaluated under previous MRLs assessments, including the review of the existing MRLs for all quizalofop‐P ester variants according to Article 12 of Regulation (EC) No 396/2005 (MRL review), and the additional data provided by the EMS in the framework of this application, the following conclusions are derived.

The metabolism of quizalofop‐P‐ethyl following foliar applications was investigated in the framework of the peer review and the MRL review in crops belonging to the groups of fruit crops, root crops and pulses/oilseeds. Additionally, a new metabolism study in cereals was investigated in a subsequent MRL application. Considering the available metabolism studies of quizalofop‐P‐ethyl as well as metabolism studies of the other ester variants of quizalofop‐P (quizalofop‐P‐tefuryl and propaquizafop), it was concluded that the metabolic patterns of all ester variants in plants were similar with the parent ester rapidly hydrolysed to the corresponding acid (quizalofop) which was always present at harvest. Other phenoxy metabolites than quizalofop were identified at harvest in lower amounts. The MRL review did not propose the inclusion of these metabolites in the residue definition for the time being but recommended to reconsider the toxicological relevance of these phenoxy metabolites under the renewal process.

Studies investigating the effect of processing on the nature of quizalofop‐P‐ethyl (hydrolysis studies) showed no degradation under conditions representative of pasteurisation and baking/brewing/boiling while for conditions simulating sterilisation, quizalofop‐P‐ethyl was partly hydrolysed to quizalofop. Since studies addressing the effect of processing on the nature of quizalofop demonstrated that quizalofop is hydrolytically stable, it was confirmed that the residue definitions for primary crops are also applicable to processed commodities.

From the available rotational crop metabolism studies performed with quizalofop‐P‐ethyl in sugar beets, lettuces, cotton seeds, peanuts and wheat, the MRL review concluded that metabolism in rotational crops proceeds in a similar pathway as in primary crops. No further data were required for the intended use on caraway assessed under this application.

Based on the metabolic pattern identified in metabolism studies with quizalofop‐P‐ethyl, quizalofop‐P‐tefuryl and propaquizafop, the results of hydrolysis studies with quizalofop‐P‐tefuryl and quizalofop‐P‐ethyl, the toxicological significance of metabolites and the capabilities of enforcement analytical methods, the residue definitions for plant products were proposed for all quizalofop ester variants as ‘the sum of quizalofop, its salts, its esters (including propaquizafop) and its conjugates, expressed as quizalofop (any ratio of constituent isomers)’ for both enforcement and risk assessment. These residue definitions are applicable to primary crops (all groups), rotational crops and processed products. The residue definition for enforcement set in Regulation (EC) No 396/2005 is identical with the above‐mentioned residue definition.

EFSA concluded that for the crop assessed in this application, metabolism of quizalofop‐P‐ethyl in primary and in rotational crops, and the possible degradation in processed products has been sufficiently addressed and that the previously derived residue definition is applicable.

A sufficiently validated analytical method based on high‐performance liquid chromatography with tandem mass spectrometry (HPLC‐MS/MS) is available to quantify quizalofop‐P‐ethyl residues in caraway according to the enforcement and risk assessment residue definition. The method enables quantification of residues at or above 0.01 mg/kg in caraway (limit of quantification (LOQ)). As part of the current application, the applicant also provided a new cross‐validation study which was deemed sufficient to demonstrate the extraction efficiency and hydrolysis of conjugates in high water and high oil matrices.

The available residue trials are sufficient to derive an MRL proposal of 0.04 mg/kg for caraway.

Specific studies investigating the magnitude of quizalofop‐P‐ethyl residues in processed commodities are not required for the present application, as significant residues are not expected for caraway and the contribution of caraway to the overall chronic exposure is below 0.01% of the acceptable daily intake (ADI).

The occurrence of quizalofop‐P‐ethyl residues in rotational crops was investigated in the framework of the EU pesticides peer review and the MRL review. Based on available confined rotational crop studies conducted at twice the intended application rate of quizalofop‐P‐ethyl in caraway, it is concluded that no residues are expected in rotational crops if quizalofop‐P‐ethyl is applied on caraway according to the intended good agricultural practice (GAP).

Residues of quizalofop‐P‐ethyl in commodities of animal origin were not assessed since caraway is not fed to livestock.

The toxicological profiles for the different quizalofop‐P‐ester variants (quizalofop‐P‐ethyl, quizalofop‐P‐tefuryl and propaquizafop) were derived in the framework of the EU pesticides peer review. Since all these different ester variants share the same residue definition based on quizalofop, EFSA considered for the consumer risk assessment the lowest toxicological reference values available (respectively, the ADI set for quizalofop‐P‐ethyl and the acute reference dose (ARfD) set for quizalofop‐P‐tefuryl) expressed as ‘quizalofop’, by correcting them by the different molecular weights. Consequently, the resulting values of 0.0083 mg/kg body weight (bw) per day and 0.08 mg/kg bw were used in the chronic and acute dietary exposure assessments, respectively. The metabolites included in the residue definition are deemed of similar toxicity than 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 did not exceed the ARfD for the crop assessed in this application. It should be, however, noted that an establishment of an ARfD to quizalofop‐P‐ethyl was not considered necessary by the peer review (EFSA, 2009) and the ARfD used to evaluate the acute risk was the one set for quizalofop‐P‐tefuryl, recalculated as quizalofop equivalents.

In the framework of the MRL review, a comprehensive long‐term exposure assessment was performed, taking into account the existing uses at EU level of all quizalofop‐P ester variants. EFSA updated the calculation with the STMR value derived from the residue trials submitted in support of this MRL application for caraway and other STMRs derived in another EFSA opinion published after the MRL review. The estimated long‐term dietary intake accounted for 26% of the ADI (NL toddler diet). The contribution of residues expected in caraway to the overall long‐term exposure is below 0.01% of the ADI.

EFSA concluded that the proposed use of quizalofop‐P‐ethyl on caraway will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers’ health.

However, it should be noted that the MRL review recommended to reconsider the toxicological relevance of the phenoxy metabolites identified in primary and rotational crop metabolism studies under the renewal process, and therefore, the residue definitions and the consumer risk assessment may be reconsidered following the evaluation of this information. In addition, EFSA also highlighted that metabolism studies did not investigate the possible impact of plant metabolism on the isomer ratio of the active substance. Further investigation on this matter would in principle be required. EFSA would therefore recommend reconsidering also this point in the framework of the renewal of approval of the active substance.

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

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

Code( a )	Commodity	Existing EU MRL (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: Quizalofop (sum of quizalofop, its salts, its esters (including propaquizafop) and its conjugates, expressed as quizalofop (any ratio of constituent isomers))
0820030	Caraway	0.05* (Ft)	0.04/Further risk managers’ consideration	The submitted data are sufficient to derive an MRL proposal for the NEU use. Risk for consumers unlikely. EFSA notes that the current MRL for quizalofop in caraway is set as tentative at 0.05* mg/kg, a higher level than the MRL of 0.04 mg/kg proposed in the present application. It is noted that an application to address all the Art.12 confirmatory data set for quizalofop has not been submitted yet and the deadline to provide such data is now expired. Nevertheless, the confirmatory data requirements on residue trials, analytical methods and storage stability for caraway could be considered as sufficiently addressed and the footnote can be removed for this crop. EFSA therefore considers the proposed MRL derived in the context of the present application as acceptable, also taking into account the availability of an enforcement method with an LOQ at 0.01 mg/kg for caraway.

MRL: maximum residue level; NEU: northern Europe; SEU: southern Europe; GAP: Good Agricultural Practice.

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

^*Indicates that the MRL is set at the limit of analytical quantification (LOQ).

(ft): Footnote in Commission Regulation (EU) 2019/973 for caraway: The European Food Safety Authority identified some information on residue trials, analytical methods and storage stability as unavailable for quizalofop‐P‐ethyl. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 14 June 2021, or, if that information is not submitted by that date, the lack of it.

Assessment

The European Food Safety Authority (EFSA) received an application to modify the existing maximum residue level (MRL) for quizalofop (resulting from the use of quizalofop‐P‐ethyl) in caraway. The detailed description of the intended use of quizalofop‐P‐ethyl, which is the basis for the current MRL application, is reported in Appendix A.

Quizalofop‐P‐ethyl is the ISO common name for ethyl (2R)‐2‐[4‐(6‐chloroquinoxalin‐2‐yloxy) phenoxy] propionate (IUPAC). It is an ester variant of quizalofop‐P. Quizalofop‐P is the ISO common name for (R)‐2‐[4‐(6‐chloroquinoxalin‐2‐yloxy)phenoxy]propionic acid (IUPAC). The unresolved isomeric mixture of this substance has the common name quizalofop. Quizalofop‐P belongs to the class of aryloxyphenoxypropionic herbicides which are taken up via leaves and hinder the synthesis of fatty acids by inhibition of the enzyme Acetyl‐CoA carboxylase (ACCase). The chemical structures of the active substance, of other quizalofop ester variants and their main metabolites are reported in Appendix E.

Quizalofop‐P (considered variants quizalofop‐P‐ethyl and quizalofop‐P‐tefuryl) was evaluated in the framework of Directive 91/414/EEC1 with Finland designated as rapporteur Member State (RMS) for the representative uses as a foliar treatment on oilseed rape, sugar/fodder beet, potatoes, peas, beans, linseed and sunflower. The draft assessment report (DAR) prepared by the RMS has been peer reviewed by EFSA (EFSA, 2009). Quizalofop‐P was approved2 for the use as herbicide on 1 December 2009.

The EU MRLs for quizalofop 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 on all quizalofop‐P‐ester variants (quizalofop‐P‐ethyl, quizalofop‐P‐tefuryl and propaquizafop) (EFSA, 2017) and the proposed modifications have been implemented in the MRL legislation. After completion of the MRL review, EFSA has issued one reasoned opinion on the modification of MRLs for quizalofop‐P‐ethyl (EFSA, 2018b). The proposals from these reasoned opinions have been considered in recent MRL regulations.4

In accordance with Article 6 of Regulation (EC) No 396/2005, Nissan Chemical Europe S.A.S. submitted an application to the competent national authority in Finland (evaluating Member State, EMS) to modify the existing maximum residue level (MRL) for quizalofop (resulting from the use of quizalofop‐P‐ethyl) in caraway. 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 13 April 2021. To accommodate for the intended use of quizalofop‐P‐ethyl, the EMS proposed to lower the existing MRL from 0.05* mg/kg (ft) to 0.04 mg/kg based on new residues data supporting the intended NEU use of quizalofop‐P‐ethyl in caraway.

It is noted that several tentative MRL proposals (including one for caraway) have been implemented in the MRL legislation by Commission Regulation (EU) No Reg. (EU) 2019/9736 for ‘quizalofop, its salts, its esters (including propaquizafop) and its conjugates’; including footnotes, indicating the type of confirmatory data that should be provided by a party having an interest in maintaining the proposed tentative MRL by 14 June 2021. In view of the above, EFSA initially put the assessment of the present application on hold in order to clarify first if such confirmatory data were already submitted to the rapporteur Member State (RMS) or were in the process of being submitted. After a clarification from the RMS and the Commission that such confirmatory data were not available, and considering that the deadline for their submission already expired, EFSA resumed the assessment of the current application and the evaluation report, as required by Article 10 of the MRL regulation on 7 October 2021.

EFSA based its assessment on the evaluation report submitted by the EMS (Finland, 2021), the DAR and its addendum (Finland, 2007, 2008) prepared under Council Directive 91/414/EEC, the Commission review report on quizalofop‐P‐ethyl (European Commission, 2010c), the conclusion on the peer review of the pesticide risk assessment of the active substance quizalofop‐P‐ethyl (EFSA, 2009), as well as the conclusions from the reasoned opinion on the MRL review according to Article 12 of Regulation No 396/2005 performed on all quizalofop‐P‐ester variants (quizalofop‐P‐ethyl, quizalofop‐P‐tefuryl and propaquizafop) (EFSA, 2017) and another EFSA opinion on quizalofop‐P‐ethyl (EFSA, 2018b).

For this application, the data requirements established in Regulation (EU) No 544/20117 and the guidance documents applicable at the date of submission of the application to the EMS are applicable (European Commission, 1997a–g, 2000, 2010a,b; 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 546/20118.

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

The evaluation report submitted by the EMS (Finland, 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.

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 quizalofop‐P‐ethyl in primary crops belonging to the groups of fruit crops (tomatoes), root crops (sugar beets and potatoes) and pulses/oilseeds (cotton and soya beans) has been investigated in the framework of the EU pesticides peer review (EFSA, 2009) and the MRL review (EFSA, 2017). Additionally, a new metabolism study in cereals (GM maize, containing the aryloxyalkanoate dioxygenase (aad‐1) gene) was investigated in a subsequent MRL application (EFSA, 2018b). No additional metabolism studies were submitted in the framework of this MRL application.

Additionally, metabolism studies performed with other quizalofop‐P ester variants (quizalofop‐P‐tefuryl and propaquizafop) have been considered in previous assessments and in the MRL review. The metabolic patterns of all three different ester variants in plants were similar with the parent ester rapidly hydrolysed to the corresponding acid (quizalofop), which was always present at harvest. In most cases, the amount of other metabolites than quizalofop was low at harvest, with exception of the metabolites phenoxy acid (PPA), phenoxy propionate (EPP), quizalofop‐phenol (CQOP) and hydroxy‐quizalofop‐phenol (CQOPOH). The MRL review did not propose the inclusion of these metabolites in the residue definition for the time being but recommended to reconsider the toxicological relevance of these phenoxy metabolites under the renewal process.

In the framework of the MRL review, it was also highlighted that metabolism studies did not investigate the possible impact of plant metabolism on the isomer ratio of the active substance. 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 reconsidering this point in the framework of the renewal of approval of the active substance.

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

1.1.2. Nature of residues in rotational crops

Caraway can be grown in rotation with other crops. According to the soil degradation studies evaluated in the framework of the peer review, quizalofop‐P‐ethyl has a low persistence in soil with a DT₉₀ value under aerobic laboratory conditions of 1.1–3.5 days (Finland, 2007, EFSA, 2009). However, a significantly higher DT₉₀ (603 days) was obtained for the free acid metabolite quizalofop. Therefore, further studies investigating the nature and magnitude of residues in rotational crops are required.

No new studies are submitted with the present application, but the metabolism of quizalofop‐P‐ethyl in rotational crops has been previously investigated in sugar beets, lettuces, cotton seeds, peanuts and wheat sown at 30 and 60 days after bare soil application at 308 g/ha (1.2 N compared to the maximum dose rate authorised for quizalofop‐P‐ethyl) of racemate quizalofop‐P‐ethyl labelled on either the quinoxaline or phenyl rings (Finland, 2007). According to the results of this study, residue levels were not significant (< 0.05 mg eq./kg) regardless of ageing period in soil in all crop parts analysed. It was also concluded that all compounds detected in the rotational crops were also present in primary crops suggesting a similar metabolic pathway between primary and rotational crops.

The same conclusion is also applicable to the present application since it is based on a use with an application rate of 150 g a.s./ha which is lower than the critical GAP considered in the MRL review.

1.1.3. Nature of residues in processed commodities

The effect of processing on the nature of quizalofop was investigated in the framework of the MRL review for the variant quizalofop‐P‐tefuryl (EFSA, 2017) and a new study investigating the effect of processing for the variant quizalofop‐P‐ethyl was submitted with the current application (Finland, 2021).

The standard hydrolysis study investigated in the MRL review, showed that quizalofop is hydrolytically stable under conditions representative for pasteurisation, baking/brewing/boiling and sterilisation (EFSA, 2017).

In the new study provided as part of this MRL application, the hydrolytic stability of quizalofop‐P‐ethyl was investigated with ¹⁴C‐phenoxy and ¹⁴C‐quinoxalin radiolabelled active substance under conditions representative for pasteurisation, baking/brewing/boiling and sterilisation (Finland, 2021). No degradation of quizalofop‐P‐ethyl was detected under conditions representative of pasteurisation, and baking/brewing/boiling while for conditions simulating sterilisation, quizalofop‐P‐ethyl was partly hydrolysed to quizalofop at maximum of 24% applied radioactivity with quizalofop being the remaining 76% of AR. Since quizalofop‐P‐ethyl and quizalofop were the main compounds detected, it was confirmed that the residue definitions for primary crops are also applicable to processed commodities.

1.1.4. Methods of analysis in plants

Analytical methods for the determination of quizalofop residues from the use of the different quizalofop‐P‐ester variants were assessed during the EU peer review and in the framework of the MRL review (EFSA, 2009, 2017).

An analytical method for enforcement of quizalofop‐P‐ethyl (method AN41) was evaluated during the combined MRL review for quizalofop‐P‐ethyl, quizalofop‐P‐tefuryl and propaquizafop (EFSA, 2017). The method was considered as sufficiently validated for residues of quizalofop‐P‐ethyl and quizalofop for dry/high starch/high protein plant matrices (wheat grain and dry beans) and for plant matrices with high acid (oranges), high water (tomatoes) and high oil (cotton seeds) content. The method allows quantifying residues at or above the limit of quantification (LOQ) of 0.01 mg/kg for the total residue (sum of quizalofop‐P‐ethyl and quizalofop). An independent laboratory validation (ILV) for this method was successfully performed for the same four representative plant matrices. However, in the framework of the MRL review, it was noted that extraction efficiency and hydrolysis of conjugates was not demonstrated and that a validated analytical method for enforcement in complex matrices (such as herbal infusions and spices) was not available and it was required (EFSA, 2017).

As part of this application, the applicant provided a cross‐validation study to demonstrate the extraction efficiency and hydrolysis of conjugates. The extraction efficiency was investigated in samples of oilseed rape whole plants (high water content) and seeds (high oil content). An exaggerated application rate (600 g a.s./ha) was applied to oilseed rape to generate treated samples with sufficient incurred residues in the whole plant and in seeds. Different solvents systems used in several analytical methods were applied showing comparable extractions of all analytical methods for the oilseed rape whole plant (high water matrix). Similar extraction was also observed in oilseed rape seeds (high oil matrix) for the enforcement method AN41 compared with the metabolism studies methods RD051/RD2 and the pre‐registration method C43766 (75% of the mean residues detected from the RD051/RD2 and C43766 methods before hydrolysis and 67% after hydrolysis) therefore demonstrating the equivalency of these methods.

Additionally, this new study demonstrates that conjugates are efficiently released upon hydrolysis using the analytical method for enforcement AN41. As shown by the study, higher levels of quizalofop were detected in seeds after hydrolysis with a 39.6% increase compared to the quizalofop levels measured before hydrolysis (average of three trials). This increase following the hydrolysis step is in line with the one observed in the two methods used in metabolism studies RD051/RD2 (average of 39.5% increase of quizalofop after hydrolysis). It is therefore concluded that the enforcement method AN41 will hydrolyse conjugates with the same efficiency as the methods used in the metabolism studies.

Regarding the confirmatory data request of a validated analytical method for enforcement in complex matrices (such as herbal infusions and spices), the EMS is of the opinion that such method is not indispensable within the framework of this application since the analytical method AN41 has been successfully validated in four different matrices and taking into account the insignificant contribution of caraway seeds to the overall dietary exposure. EFSA agrees with the EMS’ view, also considering that caraway seeds are mostly composed of fatty acids and oils, hence the validation of the analytical method AN41 in four different matrices (including high oil matrix) – in addition to caraway being a minor crop with insignificant contribution to the dietary exposure – is sufficient reasons to consider the present analytical method AN41 sufficiently suitable for the crop under assessment.

Regarding the achievable LOQ for caraway, EFSA notes that a validated analytical method for enforcement in complex matrices is still not available. However, additional recovery data were generated for caraway with the enforcement method AN41, which was also used for the analysis of the residue trials, achieving an LOQ of 0.01 mg/kg for this commodity (Finland, 2021). EFSA considered the confirmatory data requirements on analytical methods as sufficiently addressed for caraway.

1.1.5. Storage stability of residues in plants

The storage stability of residues of the different quizalofop‐P‐ester variants, including quizalofop‐P‐ethyl, in plants stored under frozen conditions was investigated in the framework of the MRL review (EFSA, 2017). Stability of quizalofop‐P‐ethyl and quizalofop residues was demonstrated for at least 12 months when stored at −18°C in samples of crops classified as matrices with high water content (snap beans), high acid content (oranges), high oil content (cotton seeds and rape seeds) and dry matrices (wheat grain, GM maize).

EFSA notes that storage stability in complex matrices (such as herbal infusions and spices) has not been demonstrated yet. However, considering that in the available residue trials on caraway, samples of caraway seeds were stored frozen for a maximum of 62 days prior to extraction and storage stability was demonstrated in four different main matrices for at least 12 months (including high oil matrix), it is very unlikely that any degradation would occur in such a short time.

Therefore, the integrity of the caraway seed samples is considered sufficiently demonstrated for the present application. EFSA considered the confirmatory data requirements on storage stability as sufficiently addressed for caraway.

1.1.6. Proposed residue definitions

Based on the metabolic pattern identified in metabolism studies, the results of hydrolysis studies, the toxicological significance of metabolites and the capabilities of enforcement analytical methods, the following residue definition was proposed in the framework of the MRL review, for both enforcement and risk assessment ‘sum of quizalofop, its salts, its esters (including propaquizafop) and its conjugates, expressed as quizalofop (any ratio of constituent isomers)’.

The same residue definition is applicable to rotational crops and processed products for all groups. The residue definition for enforcement set in Regulation (EC) No 396/2005 is identical with the above‐mentioned residue definition. Taking into account the proposed use assessed in this application, EFSA concluded that this residue definition is appropriate, and no modification is required.

However, EFSA notes that the MRL review recommended to reconsider the toxicological relevance of the phenoxy metabolites identified in primary and rotational crop metabolism studies under the renewal process, and therefore, the above residue definition may be reconsidered following the evaluation of this information. In addition, EFSA highlighted that the metabolism studies did not investigate the possible impact of plant metabolism on the isomer ratio of the active substance. Further investigation on this matter would in principle be required. EFSA would therefore recommend reconsidering also this point in the framework of the renewal of approval of the active substance.

1.2. Magnitude of residues in plants

1.2.1. Magnitude of residues in primary crops

In support of this MRL application, the applicant submitted residue trials performed in caraway seeds. The residue trial samples were analysed for the parent compound and the metabolites included in the residue definitions for enforcement and risk assessment.

According to the assessment of the EMS (Finland, 2021), the methods used were sufficiently validated and fit for purpose. The samples of these residue trials were stored under conditions for which integrity of the samples can be considered as sufficiently demonstrated (see Section 1.1.5).

Caraway

NEU outdoor GAP: 1 × 150 g a.s/ha, BBCH = 11–60, PHI = 56 days

The applicant provided four residue trials conducted in Finland over the period 2015–2016 to determine the residues of quizalofop in caraway after the application of quizalofop‐P‐ethyl according to the intended GAP as reported in Appendix A. All residue trials were considered independent as they were performed in different geographical locations and over two different growing seasons.

EFSA notes that sampling of seeds occurred at 57, 66, 67 and 73 days after the application. Therefore, for three of these trials, the preharvest interval (PHI) is within the ±25% tolerance rule (42–70 days for a PHI of 56 days) while for one trial only (trial number ONE0316‐02), the PHI of 73 days slightly exceeds this tolerance rule. This minor deviation was justified since a PHI of 73 days was considered necessary for this trial to ensure the sampling at harvest matches the maturity of the crop. EFSA agrees to accept this minor deviation and considers the independency and number of trials sufficient to derive an MRL proposal of 0.04 mg/kg for caraway in support of the intended NEU use of quizalofop‐P‐ethyl.

EFSA considered the confirmatory data on residue trials as sufficiently addressed for caraway.

1.2.2. Magnitude of residues in rotational crops

The possible transfer of quizalofop residues to crops that are grown in crop rotation has been assessed in the EU pesticides peer review and in the MRL review (EFSA, 2009, 2017) for the different ester variants of quizalofop‐P, including quizalofop‐P‐ethyl.

The MRL review concluded that significant residues of quizalofop‐P ester variants (including quizalofop‐P‐ethyl) and their metabolites are not expected to be present in rotational crops based on the confined rotational crop studies conducted at 2.8N (propaquizafop), 1.2N (quizalofop‐P‐ethyl) and 2.5N (quizalofop‐P‐tefuryl) and the maximum application rates supported in the framework of the MRL review, provided that these quizalofop ester variants are applied according to the existing GAPs considered in the MRL review.

Since the maximum annual application rate for the crop under consideration (i.e. 150 g a.s./ha) is lower than the application rate tested in the rotational crop study, it is concluded that no residues are expected, provided that the active substance is applied according to the intended GAP.

1.2.3. Magnitude of residues in processed commodities

Specific processing studies for the crop under assessment are not available and are not required since residues in caraway do not exceed the trigger value of 0.1 mg/kg and the contribution of caraway to overall chronic exposure is less than 0.01% of the ADI.

1.2.4. Proposed MRLs

The available data are considered sufficient to derive an MRL proposal for quizalofop in caraway in support of the intended NEU use of quizalofop‐P‐ethyl as well as risk assessment values for the commodity under evaluation (see Appendix B.4).

EFSA notes that the current MRL for quizalofop in caraway is set as tentative at 0.05* mg/kg (Ft) ⁵ , a higher level than the MRL of 0.04 mg/kg proposed in the present application. It is noted that an application to address all the Art.12 confirmatory data set for quizalofop has not been submitted yet and the deadline to provide such data is now expired. Nevertheless, the confirmatory data requirements on residue trials, analytical methods and storage stability for caraway could be considered as sufficiently addressed and the footnote can be removed for this crop. EFSA, therefore, considers the proposed MRL derived in the context of the present application as acceptable, also taking into account the availability of an enforcement method with an LOQ at 0.01 mg/kg for caraway.

In Section 3, EFSA assessed whether residues on this crop resulting from the intended use are likely to pose a consumer health risk.

2. Residues in livestock

Not relevant as caraway seeds are not used for feed purposes.

3. Consumer risk assessment

EFSA performed a dietary risk assessment using revision 3.1 of the EFSA PRIMo (EFSA, 2018a, 2019a). 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 the different quizalofop‐P‐ester variants (quizalofop‐P‐ethyl, quizalofop‐P‐tefuryl and propaquizafop) were derived in the framework of the EU pesticides peer review (EFSA, 2009; European Commission, 2010c). The metabolites included in the risk assessment residue definition were deemed of similar toxicity than the parent active substance. Since all these different ester variants share the same residue definition based on quizalofop, EFSA considered for the consumer risk assessment the lowest toxicological reference values available (respectively, the ADI set for quizalofop‐P‐ethyl and the ARfD set for quizalofop‐P‐tefuryl) expressed as ‘quizalofop’ by correcting them by the different molecular weights. Consequently, the resulting values of 0.0083 mg/kg bw per day and 0.08 mg/kg bw were used in the chronic and acute dietary exposure assessment, respectively.

Short‐term (acute) dietary risk assessment

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

The short‐term exposure did not exceed the ARfD for the crop assessed in this application (see Appendix B.3). It should be, however, noted that an establishment of an ARfD for quizalofop‐P‐ethyl was not considered necessary by the peer review (EFSA, 2009) and the ARfD used in this application to evaluate the acute risk was the one set for quizalofop‐P‐tefuryl, recalculated as quizalofop equivalent (0.08 mg/kg bw).

Long‐term (chronic) dietary risk assessment

In the framework of the MRL review, a comprehensive long‐term exposure assessment was performed, taking into account the existing uses at EU level of all quizalofop‐P ester variants (EFSA, 2017). EFSA updated the calculation with the STMR value derived from the residue trials submitted in support of this MRL application for caraway and other STMRs derived in an EFSA opinion published after the MRL review (EFSA, 2018b). The input values used in the exposure calculations are summarised in Appendix D.1. The estimated long‐term dietary intake accounted for 26% of the ADI (NL toddler diet). The contributions of residues expected in caraway assessed in the present MRL application to the overall long‐term exposure is insignificant. The ADI used in this application to evaluate the chronic risk is based on the lowest ADI of 0.009 mg/kg bw per day derived for quizalofop‐P‐ethyl (EFSA, 2009) and recalculated as quizalofop equivalent (0.0083 mg/kg bw per day).

Based on the risk assessment results, EFSA concluded that the long‐term and short‐term intake of residues occurring in food from the existing uses of quizalofop‐P‐ethyl, quizalofop‐P‐tefuryl and propaquizafop and from the intended use of quizalofop‐P‐ethyl in caraway, is unlikely to present a risk to consumer health.

However, it should be noted that the MRL review recommended to reconsider the toxicological relevance of the phenoxy metabolites identified in primary and rotational crop metabolism studies under the renewal process, and therefore, the residue definitions and the consumer risk assessment may be reconsidered following the evaluation of this information. In addition, EFSA also highlighted that metabolism studies did not investigate the possible impact of plant metabolism on the isomer ratio of the active substance. Further investigation on this matter would in principle be required. EFSA would therefore recommend reconsidering also this point in the framework of the renewal of approval of the active substance.

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 caraway.

EFSA concluded that the proposed use of quizalofop‐P‐ethyl on caraway will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers’ health.

However, it should be noted that the MRL review recommended to reconsider the toxicological relevance of the phenoxy metabolites identified in primary and rotational crop metabolism studies under the renewal process, and therefore, the residue definitions and the consumer risk assessment may be reconsidered following the evaluation of this information. In addition, EFSA also highlighted that metabolism studies did not investigate the possible impact of plant metabolism on the isomer ratio of the active substance. Further investigation on this matter would in principle be required. EFSA would therefore recommend reconsidering also this point in the framework of the renewal of approval of the active substance.

EFSA considered the confirmatory data requirements on residue trials, analytical methods and storage stability could be considered as sufficiently addressed for caraway and the related footnote in Regulation can be removed for this crop.

The MRL recommendations are summarised in Appendix B.4.

Abbreviations

a.s.

active substance

ADI

acceptable daily intake

ARfD

acute reference dose

BBCH

growth stages of mono‐ and dicotyledonous plants

Bw

body weight

CAC

Codex Alimentarius Commission

CAS

Chemical Abstract Service

CCPR

Codex Committee on Pesticide Residues

CEN

European Committee for Standardisation (Comité Européen de Normalisation)

CF

conversion factor for enforcement to risk assessment residue definition

DAR

draft assessment report

DAT

days after treatment

DT₉₀

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

EMS

evaluating Member State

Eq

residue expressed as a.s. equivalent

EURL

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

FAO

Food and Agriculture Organization of the United Nations

GAP

Good Agricultural Practice

GC

gas chromatography

GC‐MS

gas chromatography with mass spectrometry

HPLC

high performance liquid chromatography

HPLC‐MS

high performance liquid chromatography with mass spectrometry

HPLC‐MS/MS

high performance liquid chromatography with tandem mass spectrometry

HPLC‐UVD

high performance liquid chromatography with ultra‐violet detector

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

LOQ

limit of quantification

MRL

maximum residue level

MS

Member States

MS

mass spectrometry detector

MS/MS

tandem mass spectrometry detector

MW

molecular weight

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

RPF

relative potency factor

SANCO

Directorate‐General for Health and Consumers

SC

suspension concentrate

SCPAFF

Standing Committee on Plants, Animals, Food and Feed (formerly: Standing Committee on the Food Chain and Animal Health; SCFCAH)

SEU

southern Europe

SG

water‐soluble granule

SL

soluble concentrate

SP

water‐soluble powder

STMR

supervised trials median residue

WHO

World Health Organization

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

1.

Crop and/or situation	NEU, SEU, MS or country	F, G or I b , 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 (min)	g a.s./hL min–max	Water L/ha min–max	Rate	Unit
Caraway	NEU	F	Annual and perennial grasses	EC	50 g/L	Foliar treatment – broadcast spraying	BBCH 11–60	1	n.a.	25–75	200–300	0.075–0.150	kg a.i./ha	56

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.

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

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

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

^dPHI – minimum preharvest interval.

Appendix B – List of end points

B.1 Residues in plants

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

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

Primary crops (available studies)	Crop groups	Crop(s)	Application(s)	Sampling (DAT) a	Comment/Source
	Fruit crops	Tomatoes b	Foliar, 1 × 167–173 g a.s./ha	0, 12 and 105	(EFSA, 2017; EFSA, 2018b for a study in GM maize)
	Root crops	Sugar beets b	Foliar, 1 × 280 g a.s./ha	31, 60 and 90
		Sugar beets c	Foliar, 1 × 6 g a.s./ha	28
		Potatoes c	Foliar, 1 × 6 g a.s./ha	14
		Sugar beets d	Foliar, 1 × 316 g a.s./ha	31
	Pulses/oilseeds	Cotton e	Foliar, 1 × 260 g a.s./ha	0, 7, 21 and 42
		Soya beans e	Foliar, 1 × 273–287 g a.s./ha	0, 7, 21 and 42
		Soya beans f	Foliar, 1 × 280 g a.s./ha	0, 7, 14, 29 and 63
		Soya beans g	Foliar, 1 × 340 g a.s./ha (R/S); 1 × 160 g a.s./ha (R + S)	1, 14 and 105
	Cereals	GM maize b (aad‐1 gene)	1 × 98 g a.s./ha	48 (forage); 72 (grain, cobs, stover/fodder)

Rotational crops (available studies)	Crop groups	Crop(s)	Application(s)	PBI (DAT)	Comment/Source
	Root/tuber crops	Sugar beets e	Bare soil, 308 g a.s./ha	30, 60	EFSA (2017)
	Leafy crops	Lettuces e	Bare soil, 308 g a.s./ha	30, 60
	Pulses and oilseeds	Cotton seeds e Peanuts e	Bare soil, 308 g a.s./ha	30, 60
	Cereal (small grain)	Wheat e	Bare soil, 308 g a.s./ha	30, 60

Processed commodities (hydrolysis study)	Conditions	Stable?	Comment/Source
	Pasteurisation (20 min, 90°C, pH 4)	Yes	Finland (2021)
	Baking, brewing and boiling (60 min, 100°C, pH 5)	Yes
	Sterilisation (20 min, 120°C, pH 6)	No (quizalofop‐P‐ethyl was partly hydrolysed to quizalofop)
	A standard hydrolysis study performed with quizalofop‐P‐terfuryl was assessed in the framework of the MRL review demonstrating that quizalofop is not expected to degrade hydrolytically under conditions representative of three different processing practices (EFSA, 2017). A new study performed with quizalofop‐P‐ethyl was also submitted with this application. As quizalofop‐P‐ethyl and quizalofop were the main compounds detected in the buffer solutions in conditions simulating pasteurisation, baking/brewing/boiling and sterilisation, it can be concluded that the residue definitions for primary crops are also applicable to processed commodities

^aDAT: days after treatment.

^bPhenyl‐ and quinoxaline‐labelled quizalofop‐P‐ethyl (R‐enantiomer).

^cPhenyl‐labelled quizalofop‐ethyl (Racemate (R/S)). Study results used for information only considering the low application rate.

^dPhenyl‐labelled quizalofop‐P‐ethyl (R‐enantiomer). Residues analysed in foliage only.

^ePhenyl‐ and quinoxaline‐labelled quizalofop‐ethyl (racemate (R/S)).

^fPhenyl‐ and quinoxaline‐labelled quizalofop‐ethyl (racemate (R/S) and R‐enantiomer).

^gQuinoxaline‐labelled quizalofop‐ethyl (racemate (R/S) and R‐ and S‐enantiomer).

B.1.1.2 Stability of residues in plants

Plant product (available studies)	Category	Commodity	T (°C)	Stability period		Compounds covered	Comment/Source
				Value	Unit
	High water content	Snap beans	–20	28 a	Months	quizalofop‐P‐ethyl and quizalofop‐P	Since conjugates may only degrade to the acid form, the reported storage stability studies are expected to cover all compounds included in the residue definition, including conjugates. (EFSA, 2017)
	High oil content	Cotton seeds Rape seeds	–20	28 a	Months
	Dry/High starch	Wheat grain	–18	12 a	Months
		GM maize grain	–20	13 a	Months
	High acid content	Oranges	–18	12 a	Months
	Processed products	GM maize oil	–20	13 b	Months
		GM maize flour	–20	13 a	Months
		GM maize starch	–20	13 b	Months
	Others	GM maize stover	–20	13 a	Months
		GM maize forage	–20	13 a	Months

GM: genetically modified.

^aStorage stability refers to the total residues of quizalofop‐P‐ethyl and quizalofop.

^bStorage stability demonstrated individually for quizalofop‐P‐ethyl and quizalofop.

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)
Caraway seeds	NEU	Mo/RA: 2 × < 0.01; 2 × 0.02	Residue trials on caraway compliant with GAP. MRLOECD = 0.04	0.04	0.02	0.02

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

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

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

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

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

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 and not required.

B.2 Residues in livestock

Not relevant.

B.3 Consumer risk assessment

B.4 Recommended MRLs

Code( a )	Commodity	Existing EU MRL (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition: Quizalofop (sum of quizalofop, its salts, its esters (including propaquizafop) and its conjugates, expressed as quizalofop (any ratio of constituent isomers))
0820030	Caraway	0.05* (Ft)	0.04/Further risk managers’ considerations	The submitted data are sufficient to derive an MRL proposal for the NEU use. Risk for consumers unlikely. EFSA notes that the current MRL for quizalofop in caraway is set as tentative at 0.05* mg/kg, a higher level than the MRL of 0.04 mg/kg proposed in the present application. It is noted that an application to address all the Art.12 confirmatory data set for quizalofop has not been submitted yet and the deadline to provide such data is now expired. Nevertheless, the confirmatory data requirements on residue trials, analytical methods and storage stability for caraway could be considered as sufficiently addressed and the footnote can be removed for this crop. EFSA therefore considers the proposed MRL derived in the context of the present application as acceptable, also taking into account the availability of an enforcement method with an LOQ at 0.01 mg/kg for caraway.

MRL: maximum residue level; NEU: northern Europe; SEU: southern Europe; GAP: Good Agricultural Practice.

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

^*Indicates that the MRL is set at the limit of analytical quantification (LOQ).

Appendix C – Pesticide Residue Intake Model (PRIMo)

1.

Appendix D – Input values for the exposure calculations

D.1 Consumer risk assessment

Commodity	Existing/proposed MRL (mg/kg)	Source	Chronic risk assessment		Acute risk assessment
			Input value (mg/kg)	Comment	Input value (mg/kg)	Comment a
Risk assessment residue definition: Quizalofop (sum of quizalofop, its salts, its esters (including propaquizafop) and its conjugates, expressed as quizalofop (any ratio of constituent isomers))
Grapefruits	0.02*	EFSA (2017)	0.01	STMR‐RAC	0.01	HR‐RAC
Oranges	0.02*	EFSA (2017)	0.01	STMR‐RAC	0.01	HR‐RAC
Lemons	0.02*	EFSA (2017)	0.01	STMR‐RAC	0.01	HR‐RAC
Limes	0.02*	EFSA (2017)	0.01	STMR‐RAC	0.01	HR‐RAC
Mandarins	0.02*	EFSA (2017)	0.01	STMR‐RAC	0.01	HR‐RAC
Other citrus fruit	0.02*	EFSA (2017)	0.01	STMR‐RAC
Almonds	0.01*	EFSA (2017)	0.01	STMR‐RAC	0.01	HR‐RAC
Brazil nuts	0.01*	EFSA (2017)	0.01	STMR‐RAC	0.01	HR‐RAC
Cashew nuts	0.01*	EFSA (2017)	0.01	STMR‐RAC	0.01	HR‐RAC
Chestnuts	0.01*	EFSA (2017)	0.01	STMR‐RAC	0.01	HR‐RAC
Coconuts	0.01*	EFSA (2017)	0.01	STMR‐RAC	0.01	HR‐RAC
Hazelnuts/cobnuts	0.01*	EFSA (2017)	0.01	STMR‐RAC	0.01	HR‐RAC
Macadamia	0.01*	EFSA (2017)	0.01	STMR‐RAC	0.01	HR‐RAC
Pecans	0.01*	EFSA (2017)	0.01	STMR‐RAC	0.01	HR‐RAC
Pine nut kernels	0.01*	EFSA (2017)	0.01	STMR‐RAC	0.01	HR‐RAC
Pistachios	0.01*	EFSA (2017)	0.01	STMR‐RAC	0.01	HR‐RAC
Walnuts	0.01*	EFSA (2017)	0.01	STMR‐RAC	0.01	HR‐RAC
Other tree nuts	0.01*	EFSA (2017)	0.01	STMR‐RAC
Apples	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Pears	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Quinces	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Medlar	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Loquats/Japanese medlars	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Other pome fruit	0.02*	EFSA (2017)	0.02	STMR‐RAC
Apricots	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Cherries (sweet)	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Peaches	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Plums	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Other stone fruit	0.02*	EFSA (2017)	0.02	STMR‐RAC
Table grapes	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Wine grapes	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Strawberries	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Blackberries	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Dewberries	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Raspberries (red and yellow)	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Kumquats	0.01*	EFSA (2017)	0.01	STMR‐RAC	0.01	HR‐RAC
Potatoes	0.1	EFSA (2017)	0.04	STMR‐RAC	0.08	HR‐RAC
Beetroots	0.06	EFSA (2017)	0.04	STMR‐RAC	0.05	HR‐RAC
Carrots	0.2	EFSA (2017)	0.06	STMR‐RAC	0.1	HR‐RAC
Celeriacs/turnip‐rooted celeries	0.08	EFSA (2017)	0.02	STMR‐RAC	0.06	HR‐RAC
Horseradishes	0.08	EFSA (2017)	0.02	STMR‐RAC	0.06	HR‐RAC
Jerusalem artichokes	0.08	EFSA (2017)	0.02	STMR‐RAC	0.06	HR‐RAC
Parsnips	0.2	EFSA (2017)	0.06	STMR‐RAC	0.1	HR‐RAC
Parsley roots/Hamburg roots parsley	0.2	EFSA (2017)	0.06	STMR‐RAC	0.1	HR‐RAC
Radishes	0.2	EFSA (2017)	0.06	STMR‐RAC	0.1	HR‐RAC
Salsifies	0.2	EFSA (2017)	0.06	STMR‐RAC	0.1	HR‐RAC
Swedes/rutabagas	0.06	EFSA (2017)	0.04	STMR‐RAC	0.05	HR‐RAC
Turnips	0.08	EFSA (2017)	0.03	STMR‐RAC	0.04	HR‐RAC
Other root and tuber vegetables	0.2	EFSA (2017)	0.06	STMR‐RAC
Garlic	0.04	EFSA (2017)	0.04	STMR‐RAC	0.04	HR‐RAC
Onions	0.04	EFSA (2017)	0.04	STMR‐RAC	0.04	HR‐RAC
Shallots	0.04	EFSA (2017)	0.04	STMR‐RAC	0.04	HR‐RAC
Tomatoes	0.05	EFSA (2017)	0.01	STMR‐RAC	0.05	HR‐RAC
Aubergines/egg plants	0.05	EFSA (2017)	0.01	STMR‐RAC	0.05	HR‐RAC
Broccoli	0.4	EFSA (2017)	0.06	STMR‐RAC	0.26	HR‐RAC
Cauliflowers	0.4	EFSA (2017)	0.06	STMR‐RAC	0.26	HR‐RAC
Other flowering brassica	0.4	EFSA (2017)	0.06	STMR‐RAC
Head cabbages	0.6	EFSA (2017)	0.05	STMR‐RAC	0.2	HR‐RAC
Lamb's lettuce/corn salads	0.2	EFSA (2017)	0.2	STMR‐RAC	0.2	HR‐RAC
Lettuces	0.2	EFSA (2017)	0.2	STMR‐RAC	0.2	HR‐RAC
Escaroles/broad‐leaved endives	0.2	EFSA (2017)	0.2	STMR‐RAC	0.2	HR‐RAC
Cress and other sprouts and shoots	0.2	EFSA (2017)	0.2	STMR‐RAC	0.2	HR‐RAC
Land cress	0.2	EFSA (2017)	0.2	STMR‐RAC	0.2	HR‐RAC
Roman rocket/rucola	0.2	EFSA (2017)	0.2	STMR‐RAC	0.2	HR‐RAC
Red mustards	0.2	EFSA (2017)	0.2	STMR‐RAC	0.2	HR‐RAC
Baby leaf crops (including brassica species)	0.2	EFSA (2017)	0.2	STMR‐RAC	0.2	HR‐RAC
Other lettuce and other salad plants	0.2	EFSA (2017)	0.2	STMR‐RAC
Spinaches	0.2	EFSA (2017)	0.02	STMR‐RAC	0.12	HR‐RAC
Chards/beet leaves	0.04	EFSA (2017)	0.04	STMR‐RAC	0.04	HR‐RAC
Chervil	0.2	EFSA (2017)	0.05	STMR‐RAC	0.12	HR‐RAC
Chives	0.2	EFSA (2017)	0.05	STMR‐RAC	0.12	HR‐RAC
Celery leaves	0.2	EFSA (2017)	0.05	STMR‐RAC	0.12	HR‐RAC
Parsley	0.2	EFSA (2017)	0.05	STMR‐RAC	0.12	HR‐RAC
Sage	0.2	EFSA (2017)	0.05	STMR‐RAC	0.12	HR‐RAC
Rosemary	0.2	EFSA (2017)	0.05	STMR‐RAC	0.12	HR‐RAC
Thyme	0.2	EFSA (2017)	0.05	STMR‐RAC	0.12	HR‐RAC
Basil and edible flowers	0.2	EFSA (2017)	0.05	STMR‐RAC	0.12	HR‐RAC
Laurel/bay leaves	0.2	EFSA (2017)	0.05	STMR‐RAC	0.12	HR‐RAC
Tarragon	0.2	EFSA (2017)	0.05	STMR‐RAC	0.12	HR‐RAC
Other herbs	0.2	EFSA (2017)	0.05	STMR‐RAC
Beans (with pods)	0.3	EFSA (2017)	0.02	STMR‐RAC	0.17	HR‐RAC
Beans (without pods)	0.2	EFSA (2017)	0.04	STMR‐RAC	0.07	HR‐RAC
Peas (with pods)	0.03	EFSA (2017)	0.01	STMR‐RAC	0.02	HR‐RAC
Peas (without pods)	0.2	EFSA (2017)	0.03	STMR‐RAC	0.11	HR‐RAC
Lentils (fresh)	0.2	EFSA (2017)	0.03	STMR‐RAC	0.11	HR‐RAC
Florence fennels	0.01*	EFSA (2017)	0.01	STMR‐RAC	0.01	HR‐RAC
Beans	0.2	EFSA (2017)	0.05	STMR‐RAC	0.05	STMR‐RAC
Lentils	0.2	EFSA (2017)	0.05	STMR‐RAC	0.05	STMR‐RAC
Peas	0.2	EFSA (2017)	0.05	STMR‐RAC	0.05	STMR‐RAC
Linseeds	0.3	EFSA (2017)	0.1	STMR‐RAC	0.1	STMR‐RAC
Poppy seeds	0.7	EFSA (2017)	0.2	STMR‐RAC	0.2	STMR‐RAC
Sunflower seeds	0.8	EFSA (2017)	0.12	STMR‐RAC	0.12	STMR‐RAC
Rapeseeds/canola seeds	2	EFSA (2017)	0.23	STMR‐RAC	0.23	STMR‐RAC
Soya beans	0.2	EFSA (2017)	0.04	STMR‐RAC	0.04	STMR‐RAC
Mustard seeds	0.7	EFSA (2017)	0.2	STMR‐RAC	0.2	STMR‐RAC
Cotton seeds	0.1	EFSA (2017)	0.04	STMR‐RAC	0.04	STMR‐RAC
Maize/corn	0.02	EFSA (2018b)	0.02	STMR‐RAC	0.02	STMR‐RAC
Rice	0.05*	EFSA (2017)	0.05	STMR‐RAC	0.05	STMR‐RAC
Chamomille	0.8	EFSA (2017)	0.03	STMR‐RAC	0.46	HR‐RAC
Hibiscus/roselle	0.8	EFSA (2017)	0.03	STMR‐RAC	0.46	HR‐RAC
Rose	0.8	EFSA (2017)	0.03	STMR‐RAC	0.46	HR‐RAC
Jasmine	0.8	EFSA (2017)	0.03	STMR‐RAC	0.46	HR‐RAC
Lime/linden	0.8	EFSA (2017)	0.03	STMR‐RAC	0.46	HR‐RAC
Other herbal infusions (dried flowers)	0.8	EFSA (2017)	0.03	STMR‐RAC
Strawberry leaves	0.8	EFSA (2017)	0.03	STMR‐RAC	0.46	HR‐RAC
Rooibos	0.8	EFSA (2017)	0.03	STMR‐RAC	0.46	HR‐RAC
Mate/maté	0.8	EFSA (2017)	0.03	STMR‐RAC	0.46	HR‐RAC
Other herbal infusions (dried leaves)	0.8	EFSA (2017)	0.03	STMR‐RAC
Anise/aniseed	0.05*	EFSA (2017)	0.05	STMR‐RAC	0.05	HR‐RAC
Black caraway/black cumin	0.05*	EFSA (2017)	0.05	STMR‐RAC	0.05	HR‐RAC
Celery seed	0.05*	EFSA (2017)	0.05	STMR‐RAC	0.05	HR‐RAC
Coriander seed	0.05*	EFSA (2017)	0.05	STMR‐RAC	0.05	HR‐RAC
Cumin seed	0.05*	EFSA (2017)	0.05	STMR‐RAC	0.05	HR‐RAC
Dill seed	0.05*	EFSA (2017)	0.05	STMR‐RAC	0.05	HR‐RAC
Fennel seed	0.05*	EFSA (2017)	0.05	STMR‐RAC	0.05	HR‐RAC
Fenugreek	0.05*	EFSA (2017)	0.05	STMR‐RAC	0.05	HR‐RAC
Nutmeg	0.05*	EFSA (2017)	0.05	STMR‐RAC	0.05	HR‐RAC
Other spices (seeds)	0.05*	EFSA (2017)	0.05	STMR‐RAC
Allspice/pimento	0.05*	EFSA (2017)	0.05	STMR‐RAC	0.05	HR‐RAC
Sichuan pepper	0.05*	EFSA (2017)	0.05	STMR‐RAC	0.05	HR‐RAC
Caraway	0.04	Proposed	0.02	STMR‐RAC	0.02	HR‐RAC
Cardamom	0.05*	EFSA (2017)	0.05	STMR‐RAC	0.05	HR‐RAC
Juniper berry	0.05*	EFSA (2017)	0.05	STMR‐RAC	0.05	HR‐RAC
Peppercorn (black, green and white)	0.05*	EFSA (2017)	0.05	STMR‐RAC	0.05	HR‐RAC
Vanilla pods	0.05*	EFSA (2017)	0.05	STMR‐RAC	0.05	HR‐RAC
Tamarind	0.05*	EFSA (2017)	0.05	STMR‐RAC	0.05	HR‐RAC
Other spices (fruits)	0.05*	EFSA (2017)	0.05	STMR‐RAC
Sugar beet roots	0.06	EFSA (2017)	0.04	STMR‐RAC	0.05	HR‐RAC
Chicory roots	0.08	EFSA (2017)	0.02	STMR‐RAC	0.06	HR‐RAC
Swine: Muscle/meat	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Swine: Fat tissue	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Swine: Liver	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Swine: Kidney	0.1	EFSA (2017)	0.07	STMR‐RAC	0.1	HR‐RAC
Swine: Edible offals (other than liver and kidney)	0.1	EFSA (2017)	0.07	STMR‐RAC	0.1	HR‐RAC
Bovine: Muscle/meat	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Bovine: Fat tissue	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Bovine: Liver	0.03	EFSA (2017)	0.02	STMR‐RAC	0.03	HR‐RAC
Bovine: Kidney	0.3	EFSA (2017)	0.16	STMR‐RAC	0.22	HR‐RAC
Bovine: Edible offals (other than liver and kidney)	0.3	EFSA (2017)	0.16	STMR‐RAC	0.22	HR‐RAC
Sheep: Muscle/meat	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Sheep: Fat tissue	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Sheep: Liver	0.03	EFSA (2017)	0.03	STMR‐RAC	0.03	HR‐RAC
Sheep: Kidney	0.3	EFSA (2017)	0.17	STMR‐RAC	0.24	HR‐RAC
Sheep: Edible offals (other than liver and kidney)	0.3	EFSA (2017)	0.17	STMR‐RAC	0.24	HR‐RAC
Goat: Muscle/meat	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Goat: Fat tissue	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Goat: Liver	0.03	EFSA (2017)	0.03	STMR‐RAC	0.03	HR‐RAC
Goat: Kidney	0.3	EFSA (2017)	0.17	STMR‐RAC	0.24	HR‐RAC
Goat: Edible offals (other than liver and kidney)	0.3	EFSA (2017)	0.17	STMR‐RAC	0.24	HR‐RAC
Equine: Muscle/meat	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Equine: Fat tissue	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Equine: Liver	0.03	EFSA (2017)	0.02	STMR‐RAC	0.03	HR‐RAC
Equine: Kidney	0.3	EFSA (2017)	0.16	STMR‐RAC	0.22	HR‐RAC
Equine: Edible offals (other than liver and kidney)	0.3	EFSA (2017)	0.16	STMR‐RAC	0.22	HR‐RAC
Poultry: Muscle/meat	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Poultry: Fat tissue	0.04	EFSA (2017)	0.03	STMR‐RAC	0.03	HR‐RAC
Poultry: Liver	0.04	EFSA (2017)	0.03	STMR‐RAC	0.03	HR‐RAC
Poultry: Kidney	0.04	EFSA (2017)	0.03	STMR‐RAC	0.03	HR‐RAC
Poultry: Edible offals (other than liver and kidney)	0.04	EFSA (2017)	0.03	STMR‐RAC	0.03	HR‐RAC
Other farmed animals: Muscle/meat	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Other farmed animals: Fat tissue	0.02*	EFSA (2017)	0.02	STMR‐RAC	0.02	HR‐RAC
Other farmed animals: Liver	0.03	EFSA (2017)	0.02	STMR‐RAC	0.03	HR‐RAC
Other farmed animals: Kidney	0.3	EFSA (2017)	0.16	STMR‐RAC	0.22	HR‐RAC
Other farmed animals: Edible offals (other than liver and kidney)	0.3	EFSA (2017)	0.16	STMR‐RAC	0.22	HR‐RAC
Milk: Cattle	0.015	EFSA (2017)	0.01	STMR‐RAC	0.01	STMR‐RAC
Milk: Sheep	0.015	EFSA (2017)	0.01	STMR‐RAC	0.01	STMR‐RAC
Milk: Goat	0.015	EFSA (2017)	0.01	STMR‐RAC	0.01	STMR‐RAC
Milk: Horse	0.015	EFSA (2017)	0.01	STMR‐RAC	0.01	STMR‐RAC
Milk: Others	0.015	EFSA (2017)	0.01	STMR‐RAC	0.01	STMR‐RAC
Eggs: Chicken	0.01*	EFSA (2017)	0.01	STMR‐RAC	0.01	HR‐RAC
Eggs: Duck	0.01*	EFSA (2017)	0.01	STMR‐RAC	0.01	HR‐RAC
Eggs: Goose	0.01*	EFSA (2017)	0.01	STMR‐RAC	0.01	HR‐RAC
Eggs: Quail	0.01*	EFSA (2017)	0.01	STMR‐RAC	0.01	HR‐RAC
Eggs: Others	0.01*	EFSA (2017)	0.01	STMR‐RAC

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

^aInput values for the commodities which are not under consideration for the acute risk assessment are reported in grey.

Appendix E – Used compound codes

1.

Code/trivial name a	Chemical name/SMILES notation/ InChiKey b	Structural formula c
Quizalofop‐P‐ethyl	ethyl (2R)‐2‐[4‐(6‐chloroquinoxalin‐2‐yloxy)phenoxy]propionate O = C(OCC)[C@@H](C)Oc1ccc(cc1)Oc2cnc3cc(Cl)ccc3n2 OSUHJPCHFDQAIT‐GFCCVEGCSA‐N
Quizalofop‐P‐tefuryl	(RS)‐tetrahydrofurfuryl (R)‐2‐[4‐(6‐chloroquinoxalin‐2‐yloxy)phenoxy]propionate O = C(OCC1CCCO1)[C@@H](C)Oc4ccc(Oc2cnc3cc(Cl)ccc3n2)cc4 BBKDWPHJZANJGB‐IKJXHCRLSA‐N
Propaquizafop	2‐isopropylideneaminooxyethyl (R)‐2‐[4‐(6‐chloroquinoxalin‐2‐yloxy)phenoxy]propionate C/C(C)=N\OCCOC(=O)[C@@H](C)Oc1ccc(cc1)Oc2cnc3cc(Cl)ccc3n2 FROBCXTULYFHEJ‐OAHLLOKOSA‐N
Quizalofop‐P	(R)‐2‐[4‐(6‐chloroquinoxalin‐2‐yloxy)phenoxy]propionic acid O = C(O)[C@@H](C)Oc1ccc(cc1)Oc2cnc3cc(Cl)ccc3n2 ABOOPXYCKNFDNJ‐SNVBAGLBSA‐N
Quizalofop	(RS)‐2‐[4‐(6‐chloroquinoxalin‐2‐yloxy)phenoxy]propionic acid O = C(O)C(C)Oc1ccc(cc1)Oc2cnc3cc(Cl)ccc3n2 ABOOPXYCKNFDNJ‐UHFFFAOYSA‐N
Phenoxy propionate (EPP)	2‐(4‐hydroxyphenoxy)‐2‐methylbutanoate [O‐]C(=O)C(C)(CC)Oc1ccc(O)cc1 CFECBIHTYUULLL‐UHFFFAOYSA‐M
Phenoxy acid Hydroxyphenoxypropionic acid (PPA)	(R)‐2‐(4‐hydroxyphenoxy)propionic acid C[C@@H](Oc1ccc(O)cc1)C(=O)O AQIHDXGKQHFBNW‐ZCFIWIBFSA‐N
Quizalofop‐phenol Hydroxy ether (CQOP)	4‐(6‐chloroquinoxalin‐2‐yloxy)phenol Oc1ccc(cc1)Oc2cnc3cc(Cl)ccc3n2 UVYFSLAJRJHGJB‐UHFFFAOYSA‐N
Hydroxy‐quizalofop‐phenol (CQOPOH) Dihydroxy ether	7‐chloro‐3‐(4‐hydroxyphenoxy)quinoxalin‐2(1H)‐one Oc1ccc(cc1)Oc2nc3ccc(Cl)cc3nc2O SUDISTHTCZHOSE‐UHFFFAOYSA‐N

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

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

^bACD/Name 2020.2.1 ACD/Labs 2020 Release (File version N15E41, Build 116563, 15 Jun 2020).

^cACD/ChemSketch 2020.2.1 ACD/Labs 2020 Release (File version C25H41, Build 121153, 22 Mar 2021).

Suggested citation: EFSA (European Food Safety Authority) , Bellisai G, Bernasconi G, Brancato A, Carrasco Cabrera L, Ferreira L, Giner G, Greco L, Jarrah S, Leuschner R, Oriol Magrans J, Miron I, Nave S, Pedersen R, Reich H, Ruocco S, Santos M, Pia Scarlato A, Theobald A, Vagenende B and Verani A, 2021. Reasoned Opinion on the modification of the existing maximum residue level for quizalofop (resulting from the use of quizalofop‐P‐ethyl) in caraway. EFSA Journal 2021;19(12):6957, 32 pp. 10.2903/j.efsa.2021.6957