**Suggested citation:** EFSA (European Food Safety Authority) , Brancato A, Brocca D, De Lentdecker C, Erdos Z, Ferreira L, Greco L, Jarrah S, Kardassi D, Leuschner R, Lostia A, Lythgo C, Medina P, Miron I, Molnar T, Pedersen R, Reich H, Sacchi A, Santos M, Stanek A, Sturma J, Tarazona J, Theobald A, Vagenende B and Villamar‐Bouza L, 2018 Reasoned opinion on the modification of the existing maximum residue level for flonicamid in various crops. EFSA Journal 2018;16(9):5410, 25 pp. 10.2903/j.efsa.2018.5410

**Requestor:** European Commission

**Question number:** EFSA‐Q‐2017‐00472; EFSA‐Q‐2017‐00691

Approved: 17 August 2018

Summary {#efs25410-sec-0001}
=======

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted an application to the competent national authority in Germany (evaluating Member State (EMS)) to modify the existing maximum residue level (MRL) for the active substance flonicamid in radishes. The EMS DE 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 1 June 2017. To accommodate for the intended use of flonicamid, the EMS DE proposed to raise the existing MRL from the limit of quantification (LOQ) 0.03\* mg/kg to 0.6 mg/kg.

Furthermore, in accordance with Article 6 of Regulation (EC) No 396/2005, the applicant ISK Biosciences Europe N.V. submitted a request to the competent national authority in the Netherlands (EMS NL) to modify the MRLs for the active substance flonicamid in strawberries, cane fruits, other small fruit and berries, lettuce and other salad plants including endives/scaroles, and pulses (dry beans, lentils, peas and lupins). The EMS NL 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 EFSA on 2 October 2017. To accommodate for the intended uses of flonicamid, the EMS NL proposed to raise the existing MRLs from the limit of quantification (LOQ) of 0.03\* mg/kg to 0.5 mg/kg for strawberries, to 1.0 mg/kg for blackberries and raspberries, to 0.7 mg/kg for other small fruits and berries, to 0.08 mg/kg for outdoor lettuce and other salad plants including escaroles/endives and to 1.0 mg/kg for beans (dry), lentils, peas (dry) and lupins.

EFSA assessed the applications and the evaluation reports as required by Article 10 of the MRL regulation.

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

The metabolism of flonicamid in primary crops was evaluated in the framework of the peer review under Directive 91/414/EEC and the MRL review in the fruit, root and cereal/grass crop groups.

Studies investigating the effect of processing on the nature of residues (standard hydrolysis studies) demonstrated that flonicamid and its main metabolites are stable.

Due to fast degradation of flonicamid and its metabolites in the soil, further investigation of residues in rotational crops is not required. Based on the metabolic pattern identified in metabolism studies, hydrolysis studies, the toxicological significance of metabolites, the residue definition for plant products were proposed as sum of flonicamid, TFNA and TFNG, expressed as flonicamid for enforcement and risk assessment. These residue definitions are applicable to primary crops and processed products.

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

Sufficiently validated analytical methods based on liquid chromatography with tandem mass spectrometry (LC--MS/MS) are available to quantify residues in the crops assessed in this application according to the enforcement residue definition. The methods enable quantification of residues at 0.03 mg/kg in the crops assessed (LOQ).

As some of the crops under consideration are used as feed products, a potential carry‐over into food of animal origin was assessed.

The calculated livestock dietary burden exceeded the trigger value of 0.1 mg/kg dry matter (DM) for all relevant animal species. However, the contribution of flonicamid residues in the crops under consideration in this MRL application to the total livestock exposure was insignificant and therefore a modification of the existing MRLs for commodities of animal origin was considered unnecessary.

The toxicological profile of flonicamid was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.025 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 0.025 mg/kg bw.

The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). This exposure assessment model contains the relevant European food consumption data for different subgroups of the EU population (EFSA, [2007](#efs25410-bib-0001){ref-type="ref"}).

A long‐term consumer intake concern was not identified for any of the European diets incorporated in the EFSA PRIMo. The highest chronic intake was calculated to be 18.4% of the ADI (WHO cluster diet B). The contribution of crops assessed to the total consumer exposure accounted for a maximum of 0.49% of ADI for dry beans (UK toddler).

An acute consumer risk was not identified in relation to the MRL proposals for the crops under consideration. The highest acute consumer exposure was calculated to be 25.8% of the ARfD for radishes, 20.7% of the ARfD for blackberries, 17.5% of the ARfD for escarole and 16.6% for strawberries. For the remaining commodities, the exposure accounted for less than 15% of the ARfD.

EFSA concluded that the proposed use of flonicamid on crops under consideration 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 amend the existing MRLs as reported in the Appendix [B](#efs25410-sec-1002){ref-type="sec"}.

Full details of all endpoints and the consumer risk assessment can be found in Appendices [B](#efs25410-sec-1002){ref-type="sec"}--[D](#efs25410-sec-1004){ref-type="sec"}.

Code[a](#efs25410-note-1006){ref-type="fn"}CommodityExisting EU MRL (mg/kg)Proposed EU MRL (mg/kg)Comment/justification**Enforcement residue definition:** sum of flonicamid, TFNA and TFNG, expressed as flonicamid0152000Strawberries0.03[\*](#efs25410-note-1005){ref-type="fn"}0.5The MRL proposal reflects the intended NEU use. Risk for consumers unlikely0153010Blackberries0.03[\*](#efs25410-note-1005){ref-type="fn"}1.0The MRL proposal reflects the intended NEU use. Risk for consumers unlikely. Extrapolation from data on raspberries0153030Raspberries0.03[\*](#efs25410-note-1005){ref-type="fn"}1.0The MRL proposal reflects the intended NEU use. Risk for consumers unlikely. Extrapolation to the group of cane fruits not possible. Two additional trials are required0154000Other small fruit and berries0.03[\*](#efs25410-note-1005){ref-type="fn"}0.7The MRL proposal reflects the intended NEU use. Risk for consumers unlikely. Extrapolation from data on black currant0213080Radishes0.03[\*](#efs25410-note-1005){ref-type="fn"}0.6The MRL proposal reflects the intended NEU use. Risk for consumers unlikely0251000Lettuce and salad plants0.03[\*](#efs25410-note-1005){ref-type="fn"}0.07The MRL proposal reflects the intended SEU use. Risk for consumers unlikely. Extrapolation to the whole group of lettuce and other salad plants including escaroles/endives0300010Beans (dry)0.03[\*](#efs25410-note-1005){ref-type="fn"}0.8The MRL proposal reflects the intended SEU use and covers the NEU use. Risk for consumers unlikely0300020Lentils0.03[\*](#efs25410-note-1005){ref-type="fn"}0.8Extrapolated from data on beans and peas (dry). The MRL proposal reflects the intended SEU use and covers the NEU use. Risk for consumers unlikely0300030Peas (dry)0.03[\*](#efs25410-note-1005){ref-type="fn"}0.8The MRL proposal reflects the intended SEU use and covers the NEU use. Risk for consumers unlikely0300040Lupins0.03[\*](#efs25410-note-1005){ref-type="fn"}0.8Extrapolated from data on beans and peas (dry). The MRL proposal reflects the intended SEU use and covers the NEU use. Risk for consumers unlikely[^1][^2][^3]

In the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005, EFSA identified that hydrolysis studies on the flonicamid metabolites TFNG and TFNA investigating the nature of residues in processed commodities are missing. Since this information was provided in the current application, the footnote to the MRL for wheat and rye established in the MRL regulation related to this data gap can be deleted.

Furthermore, it is noted that the footnote included in the current MRL legislation related to the citrus fruits requesting the submission of information on storage stability can be deleted since data demonstrating stability of flonicamid during storage were provided with the current applications.

Assessment {#efs25410-sec-0003}
==========

The detailed description of the intended uses of flonicamid, which is the basis for the current maximum residue level (MRL) application, is reported in Appendix [A](#efs25410-sec-1001){ref-type="sec"}.

Flonicamid is the ISO common name for *N*‐cyanomethyl‐4‐(trifluoromethyl)nicotinamide (IUPAC). The chemical structures of the active substance and its main metabolites are reported in Appendix [E](#efs25410-sec-1005){ref-type="sec"}.

Flonicamid was evaluated in the framework of Directive 91/414/EEC[1](#efs25410-note-1007){ref-type="fn"} with France designated as rapporteur Member State (RMS) for the representative uses as a foliar spray applications on potatoes, wheat, apples and pears in all the European Union (EU) countries and on peaches in southern Europe (SEU). The draft assessment report (DAR) prepared by the RMS has been peer reviewed by the European Food Safety Authority (EFSA, [2010](#efs25410-bib-0002){ref-type="ref"}). Flonicamid was approved[2](#efs25410-note-1008){ref-type="fn"} for the use as insecticide on 1 September 2010.

The EU MRLs for flonicamid are established in Annex II of Regulation (EC) No 396/2005[3](#efs25410-note-1009){ref-type="fn"}. The review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (MRL review) has been performed (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"}) 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 flonicamid. The proposals from these reasoned opinions have been considered in several regulations[4](#efs25410-note-1010){ref-type="fn"} for EU MRL legislation.

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Dienstleistungszentrum Ländlicher Raum submitted an application to the competent national authority in Germany (evaluating Member State, EMS DE) to modify the existing MRL for the active substance flonicamid in radishes. The EMS DE 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 1 June 2017. To accommodate for the intended use of flonicamid, the EMS DE proposed to raise the existing MRL from the limit of quantification (LOQ) 0.03 mg/kg to 0.6 mg/kg.

In accordance with Article 6 of Regulation (EC) No 396/2005, ISK Biosciences Europe N.V. submitted an application to the competent national authority in the Netherlands (EMS NL) to modify the existing MRL for the active substance flonicamid in strawberries, cane fruits, other small fruit and berries, lettuces and other salad plants including escaroles/endives, beans (dry), lentils, peas (dry) and lupins. The EMS NL 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 2 October 2017. To accommodate for the intended uses of flonicamid, the EMS NL proposed to raise the existing MRLs from the LOQ of 0.03\* mg/kg to 0.5 mg/kg for strawberries, to 1.0 mg/kg for blackberries and raspberries, to 0.7 mg/kg for other small fruits and berries, to 0.07 mg/kg for outdoor lettuces and to 1.0 mg/kg for pulses (i.e. dry beans, lentils, peas and lupins).

EFSA identified points which needed further clarification, which were requested from the EMS NL. On 8 January 2018, the EMS NL submitted a revised evaluation report, and on July 2018 EMS NL submitted another revised evaluation report, which replaced the previously submitted evaluation reports.

EFSA based its assessment on the evaluation report submitted by the EMS DE (Germany, [2017](#efs25410-bib-0023){ref-type="ref"}), EMS NL (Netherlands, [2017](#efs25410-bib-0024){ref-type="ref"}), the draft assessment report (DAR) (and its addendum) (France, [2005](#efs25410-bib-0021){ref-type="ref"}, [2009](#efs25410-bib-0022){ref-type="ref"}) prepared under Council Directive 91/414/EEC, the Commission review report on flonicamid (European Commission, [2010a](#efs25410-bib-0015){ref-type="ref"}), the conclusion on the peer review of the pesticide risk assessment of the active substance flonicamid (EFSA, [2010](#efs25410-bib-0002){ref-type="ref"}), as well as the conclusions from previous EFSA opinions on flonicamid including the Article 12 MRL review (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"}, [2015](#efs25410-bib-0004){ref-type="ref"}, [2016](#efs25410-bib-0005){ref-type="ref"}, [2017](#efs25410-bib-0006){ref-type="ref"}).

For this application, the data requirements established in Regulation (EU) No 544/2011 and the guidance documents applicable at the date of submission of the application to the EMS are applicable (European Commission, [1997a](#efs25410-bib-0007){ref-type="ref"},[b](#efs25410-bib-0008){ref-type="ref"},[c](#efs25410-bib-0009){ref-type="ref"},[d](#efs25410-bib-0010){ref-type="ref"},[e](#efs25410-bib-0011){ref-type="ref"},[f](#efs25410-bib-0012){ref-type="ref"},[g](#efs25410-bib-0013){ref-type="ref"}, [2000](#efs25410-bib-0014){ref-type="ref"}, [2010b](#efs25410-bib-0016){ref-type="ref"},[c](#efs25410-bib-0017){ref-type="ref"}, [2017](#efs25410-bib-0018){ref-type="ref"}; OECD, [2011](#efs25410-bib-0025){ref-type="ref"}, [2013](#efs25410-bib-0026){ref-type="ref"}). The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation of Plant Protection Products adopted by Commission Regulation (EU) No 546/2011.

A selected list of end points of the studies assessed by EFSA in the framework of these MRL applications, including the end points of relevant studies assessed previously, is presented in Appendix [B](#efs25410-sec-1002){ref-type="sec"}.

The evaluation report submitted by the EMS DE (Germany, [2017](#efs25410-bib-0023){ref-type="ref"}) and EMS NL (Netherlands, [2017](#efs25410-bib-0024){ref-type="ref"}) 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 {#efs25410-sec-0004}
=====================

1.1. Nature of residues and methods of analysis in plants {#efs25410-sec-0005}
---------------------------------------------------------

### 1.1.1. Nature of residues in primary crops {#efs25410-sec-0006}

The metabolism of flonicamid in primary crops was evaluated in the framework of the peer review under Directive 91/414/EEC (EFSA, [2010](#efs25410-bib-0002){ref-type="ref"}) and reviewed in the Article 12 MRL review (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"}) in the fruit, root/tuber and cereal crop groups.

### 1.1.2. Nature of residues in rotational crops {#efs25410-sec-0007}

The crops under consideration can be grown in rotation with other plants and therefore the possible occurrence of residues in succeeding crops resulting from the use on primary crops should be assessed. The soil degradation studies demonstrated that the degradation rate of flonicamid and its metabolites is rapid, with a maximum DT~90~ of 1.5--8.7 days (EFSA, [2010](#efs25410-bib-0002){ref-type="ref"}), which is far below the trigger value of 100 days (European Commission, [1997c](#efs25410-bib-0009){ref-type="ref"}). Thus, further studies on rotational crops are not required.

### 1.1.3. Nature of residues in processed commodities {#efs25410-sec-0008}

Standard hydrolysis studies simulating processing conditions representative of pasteurisation, boiling and sterilisation were assessed in the conclusion of the peer review and the MRL review (EFSA, [2010](#efs25410-bib-0002){ref-type="ref"}, [2014](#efs25410-bib-0003){ref-type="ref"}). It was concluded that the parent compound flonicamid is hydrolytically stable under the representative conditions.

Hydrolysis studies investigating the effect of processing on the nature of the two metabolites TFNA and TFNG were requested as confirmatory data in the framework of the MRL review (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"}); this information was submitted with the current application (Netherlands, [2017](#efs25410-bib-0024){ref-type="ref"}). It is concluded that the two metabolites are hydrolytically stable under the representative conditions.

Therefore, the footnote included in the current MRL legislation related to rye and wheat requesting the submission of hydrolysis studies for the two metabolites can be deleted. The previously derived conclusion that the residue definition for primary crops is also applicable for processed commodities is confirmed.

### 1.1.4. Methods of analysis in plants {#efs25410-sec-0009}

Analytical methods for the determination of flonicamid residues and its metabolites (TFNG and TFNA) in plant commodities were assessed during the EU pesticides peer review and the MRL review (EFSA, [2010](#efs25410-bib-0002){ref-type="ref"}, [2014](#efs25410-bib-0003){ref-type="ref"}).

Sufficiently validated methods to control residues of flonicamid and its metabolites in high water, high acid and high oil content matrices and in dry commodities were provided. The methods allow quantifying residues for each analyte included in the residue definition individually at the LOQ of 0.01 mg/kg (combined LOQ of 0.03 mg/kg) (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"}).

EFSA concludes that sufficiently validated analytical methods are available for enforcing the proposed MRL for flonicamid in the crops under consideration.

### 1.1.5. Stability of residues in plants {#efs25410-sec-0010}

The storage stability of flonicamid and its metabolites was investigated in the framework of the EU pesticides peer review in high water content and in dry commodities and according to these studies flonicamid and its metabolites are stable for up to 18 months when stored at −18°C (EFSA [2010](#efs25410-bib-0002){ref-type="ref"}).

In a previous MRL application, storage stability was investigated in high oil content and in high protein content commodities and according to these studies flonicamid and its metabolites are stable for up to 12 months when stored at −20°C (EFSA, [2015](#efs25410-bib-0004){ref-type="ref"}).

Additionally, storage stability of flonicamid and its metabolites TFNA and TFNG in whole fruit orange samples was submitted with this application to address high acid commodities and according to this study flonicamid and its metabolites are stable for up to 6 months when stored at −18°C (Netherlands, [2017](#efs25410-bib-0024){ref-type="ref"}).

EFSA concludes that the storage stability data cover the storage time for the supervised residue trials of the crops under consideration and the residue data are valid with regard to storage stability. Furthermore, EFSA recommends deleting the footnote included in the current MRL legislation related to the citrus fruits requesting the submission of information on storage stability.

### 1.1.6. Proposed residue definitions {#efs25410-sec-0011}

Based on the metabolic pattern identified in metabolism studies and in processing studies, the Article 12 MRL review (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"}) concluded on a reside definition for enforcement and for risk assessment as the sum of flonicamid and the metabolites TFNA and TFNG expressed as flonicamid.

The available information for the uses assessed in this application is sufficient to conclude that the previously derived residue definitions are applicable for the crops under assessment.

1.2. Magnitude of residues in plants {#efs25410-sec-0012}
------------------------------------

### 1.2.1. Magnitude of residues in primary crops {#efs25410-sec-0013}

All samples of the supervised residue trials submitted with the MRL applications were analysed individually and the total residue was calculated as sum of flonicamid and its metabolites TFNA and TFNG, expressed as flonicamid. According to the EMS DE and EMS NL, the analytical methods used to analyse the residue trial samples have been sufficiently validated and were proven to be fit for the purpose. The samples of these residue trials were stored under conditions for which integrity of the samples has been demonstrated. (Germany, [2017](#efs25410-bib-0023){ref-type="ref"}; Netherlands, [2017](#efs25410-bib-0024){ref-type="ref"}).

*Radishes*

Five outdoor residue trials on radishes compliant with the intended northern Europe (NEU) Good Agricultural Practice (GAP) were submitted. The number of trials is sufficient for setting a MRL for a minor crop.

*Strawberries*

Eight outdoor residue trials compliant with the intended NEU GAP were submitted. The number of trials is sufficient for setting an MRL for a major crop.

*Raspberries, blackberries*

Four outdoor residue trials on raspberries compliant with the intended NEU GAP were submitted.

It is possible to extrapolate from raspberries to blackberries, as there are enough residue trials for the MRL setting.

*Other small fruit and berries*

Six outdoor residue trials on blackcurrants performed according to the requested GAP were submitted. Blackcurrants are part of the subgroup of other small fruit and berries which encompasses only minor crops. Therefore, in accordance to EU guidance document (European Commission, [2017](#efs25410-bib-0018){ref-type="ref"}), the number of trials on blackcurrants is also sufficient for extrapolation to the whole subgroup of other small fruits and berries.

*Lettuce and other salad plants*

Eight residue trials compliant with SEU GAP in lettuce have been provided. Although it was not specified whether the trials were performed in open leaf or head forming varieties, they were accepted to be extrapolated to the whole crop group, because the variety is not considered relevant for type of application (drenching before transplanting).

*Dry peas, dry beans, other pulses*

The applicant provided four NEU trials in peas and four SEU trials in chick peas; the trials were compliant with the intended GAP in terms of application rate. The samples in the NEU trials were taken 20--32 days after the treatment; the preharvest interval (PHI) in the SEU trials ranged from 28 to 65 days. It is noted that the PHI was not specified in the GAP.

In addition, four NEU trials and four SEU trials in dry beans compliant with the intended GAP in terms of application rate were provided. The samples in the NEU trials were taken 37--63 days after the treatment; the PHI in the SEU trials ranged from 40 to 67 days.

Trials with dry peas and beans in NEU have been pooled for MRL calculations. Similarly, trials with dry peas and beans in SEU have been pooled to calculate a MRL proposal.

In accordance to EU guidance document (European Commission, [2017](#efs25410-bib-0018){ref-type="ref"}), trials with dry peas and dry beans can be extrapolated to each of the other pulses.

### 1.2.2. Magnitude of residues in rotational crops {#efs25410-sec-0014}

The soil degradation studies demonstrated that the degradation rate of flonicamid and its metabolites is rapid, with a maximum DT~90~ of 1.5--8.7 days (EFSA, [2010](#efs25410-bib-0002){ref-type="ref"}), which is far below the trigger value of 100 days (European Commission, [1997c](#efs25410-bib-0009){ref-type="ref"}). Thus, further studies on rotational crops are not required.

### 1.2.3. Magnitude of residues in processed commodities {#efs25410-sec-0015}

EFSA considers that there is no need to investigate, for the crops assessed under this application, the magnitude of residues in processed commodities considering that the standard hydrolysis studies have demonstrated that flonicamid and its metabolites are stable under the representative conditions (EFSA, [2010](#efs25410-bib-0002){ref-type="ref"}, [2014](#efs25410-bib-0003){ref-type="ref"}; Netherlands, [2017](#efs25410-bib-0024){ref-type="ref"}) and considering that the expected residues in the crops concerned contribute to the overall long‐term exposure to a low extent (maximum contribution for dry beans accounting 0.49% of the acceptable daily intake (ADI)).

### 1.2.4. Proposed MRLs {#efs25410-sec-0016}

EFSA proposes to amend the existing MRLs as reported in the Appendix [B](#efs25410-sec-1002){ref-type="sec"}.

2. Residues in livestock {#efs25410-sec-0017}
========================

Beans dry, lupins and peas may be used for feed purposes. When these crops were added as input values for the exposure calculation in livestock, they had no major impact on the overall dietary burden, compared with the result of the dietary burden calculation performed in 2017, where the current MRLs for animal products were derived (EFSA, [2017](#efs25410-bib-0006){ref-type="ref"}).

Therefore, EFSA concludes that there is no need to modify the existing EU MRLs in products of animal origin.

The input values for the exposure calculations for livestock are presented in Appendix [D.1](#efs25410-sec-0038){ref-type="sec"}. The results of the dietary burden calculation are presented in Appendix [B](#efs25410-sec-1002){ref-type="sec"}.

3. Consumer risk assessment {#efs25410-sec-0018}
===========================

EFSA performed a dietary risk assessment using revision 2 of the EFSA PRIMo (EFSA, [2007](#efs25410-bib-0001){ref-type="ref"}). This exposure assessment model contains food consumption data for different subgroups of the EU population and allows the acute and chronic exposure assessment to be performed in accordance with the internationally agreed methodology for pesticide residues (EFSA, [2007](#efs25410-bib-0001){ref-type="ref"}).

The toxicological reference values for flonicamid used in the risk assessment (i.e. ADI and acute reference dose (ARfD) values) were derived in the framework of the EU pesticides peer review (EFSA, [2010](#efs25410-bib-0002){ref-type="ref"}). The metabolites included in the risk assessment residue definition were considered to be not more toxic than the parent compound.

*Short‐term (acute) dietary risk assessment*

The short‐term exposure assessment was performed only with regard to the commodities under consideration in accordance with the internationally agreed methodology. The calculations were based on the risk assessment values derived from the supervised field trials, i.e. the supervised trials median residue (STMR) for pulses and the highest residue (HR) for the remaining commodities (Appendix [D.2](#efs25410-sec-0039){ref-type="sec"}).

An acute consumer risk was not identified in relation to the MRL proposals for the crops under consideration. The highest acute consumer exposure was calculated to be 25.8% of the ARfD for radishes, 20.7% of the ARfD for blackberries, 17.5% of the ARfD for escarole and 16.6% for strawberries. For the remaining commodities, the exposure accounted for less than 15% of the ARfD.

*Long‐term (chronic) dietary risk assessment*

In the framework of the review of the existing MRLs for flonicamid according to Article 12 of Regulation (EC) No 396/2005, a comprehensive long‐term exposure assessment was performed taking into account the existing uses at the EU level and sufficiently supported import tolerances or Codex MRL (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"}).

EFSA updated this risk assessment with the relevant STMR values derived from the residue trials conducted on the crops under consideration in this MRL application. In addition, STMR values derived in EFSA opinions published after the MRL review (EFSA, [2015](#efs25410-bib-0004){ref-type="ref"}, [2016](#efs25410-bib-0005){ref-type="ref"}, [2017](#efs25410-bib-0006){ref-type="ref"}) were included in the dietary exposure assessment.

The input values used for the dietary exposure calculation are summarised in Appendix [D](#efs25410-sec-1004){ref-type="sec"}.

A long‐term consumer intake concern was not identified for any of the European diets incorporated in the EFSA PRIMo. The highest chronic intake was calculated to be 18.4% of the ADI (WHO cluster diet B). The contribution of crops assessed to the total consumer exposure accounted for a maximum of 0.49% of ADI for dry beans (UK toddler).

EFSA concludes that the intended uses of flonicamid on the commodities under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a health concern to consumers.

4. Conclusion and Recommendations {#efs25410-sec-0019}
=================================

The data submitted in support of these MRL applications were found to be sufficient to derive MRL proposals for radishes, strawberries, raspberries, blackberries, and other small fruits and berries, lettuce and other salad plants (including escaroles/endives), and pulses (dry peas, beans, lupins, and lentils).

EFSA concluded that the proposed uses of flonicamid will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers' health.

The MRL recommendations are summarised in Appendix [B](#efs25410-sec-1002){ref-type="sec"}.

Abbreviations {#efs25410-sec-0020}
=============

a.s.active substanceADIacceptable daily intakeARapplied radioactivityARfDacute reference doseBBCHgrowth stages of mono‐ and dicotyledonous plantsbwbody weightCFconversion factor for enforcement to risk assessment residue definitionDARdraft assessment reportDATdays after treatmentDMdry matterDT~90~period required for 90% dissipation (define method of estimation)EMSevaluating Member StateFAOFood and Agriculture Organization of the United NationsGAPGood Agricultural PracticeHRhighest residueIEDIinternational estimated daily intakeIESTIinternational estimated short‐term intakeInChIKeyInternational Chemical Identifier KeyISOInternational Organisation for StandardisationIUPACInternational Union of Pure and Applied ChemistryLCliquid chromatographyLOQlimit of quantificationMomonitoringMRLmaximum residue levelMS/MStandem mass spectrometry detectorNEUnorthern EuropeOECDOrganisation for Economic Co‐operation and DevelopmentPBIplant‐back intervalPFprocessing factorPHIpreharvest intervalPRIMo(EFSA) Pesticide Residues Intake ModelRArisk assessmentRDresidue definitionRMSrapporteur Member StateSANCODirectorate‐General for Health and ConsumersSEUsouthern EuropeSMILESsimplified molecular‐input line‐entry systemSTMRsupervised trials median residueWGwater‐dispersible granuleWHOWorld Health Organization

Appendix A -- Summary of intended GAP triggering the amendment of existing EU MRLs {#efs25410-sec-1001}
==================================================================================

 {#efs25410-sec-0021}

Crop and/or situationNEU, SEU, MS or countryF G or I[a](#efs25410-note-1012){ref-type="fn"}Pests or Group of pests controlledPreparationApplicationApplication rate per treatmentPHI (days)[d](#efs25410-note-1015){ref-type="fn"}RemarksType[b](#efs25410-note-1013){ref-type="fn"}Conc. a.s.Method kindRange of growth stages & season[c](#efs25410-note-1014){ref-type="fn"}Number min--maxInterval between application (min)g a.s./hL min--maxWater L/ha min--maxRateUnitRadishesNEUFAphidsWG500 g/kgSprayingBBCH 122--13.3360080g/ha7--StrawberriesNEUFAphidsWG500 g/kgSprayingBBCH 11‐89 (April--August)27140200--1,20070g/ha3RaspberriesNEUFAphidsWG500 g/kgSprayingBBCH 11‐89 (April--August)27140200--1,20070g/ha3BlackberriesNEUFAphidsWG500 g/kgSprayingBBCH 11‐89 (April--August)27140200--1,20070g/ha3Other small fruits and berriesNEUFAphidsWG500 g/kgSprayingBBCH 11‐89 (April--August)27140200--1,20070g/ha10Lettuce and other salad plantsSEUFWhite flyWG500 g/kgDrenchingPretransplant (1)1--(2)(2)(2)49(1) Pretransplant, maximum 1 day before the planned transplant date. Clods are dipped in solution to deliver concentration of(2) 1 mg a.s./plantEndiveSEUFWhite flyWG500 g/kgDrenchingPretransplant (1)1--(2)(2)(2)49(1) Pretransplant, maximum 1 day before the planned transplant date. Clods are dipped in solution to deliver concentration of(2) 1 mg a.s./plantPeas (dry)NEUSEUFAphidsWG500 g/kgSprayingBBCH 711--140200--60070g/ha--Determined by growth stageBeans (dry)NEUSEUFAphidsWG500 g/kgSprayingBBCH 711--140200--60070g/ha--Determined by growth stageLupinsNEUSEUFAphidsWG500 g/kgSprayingBBCH 711--140200--60070g/ha--Determined by growth stageLentilsNEUSEUFAphidsWG500 g/kgSprayingBBCH 711--140200--60070g/ha--Determined by growth stage[^4][^5][^6][^7][^8]

Appendix B -- List of end points {#efs25410-sec-1002}
================================

B.1.. Residues in plants {#efs25410-sec-0022}
------------------------

### B.1.1.. Nature of residues and methods of analysis in plants {#efs25410-sec-0023}

#### B.1.1.1.. Metabolism studies, methods of analysis and residue definitions in plants {#efs25410-sec-0024}

Primary crops (available studies)Crop groupsCrop(s)Application(s)Sampling (DAT)Comment/SourceFruit cropsPeachFoliar: 2 × 100 and 2 × 500 g/ha21Radiolabelled active substance: 3‐^14^C‐phenyl (EFSA, [2010](#efs25410-bib-0002){ref-type="ref"}, [2014](#efs25410-bib-0003){ref-type="ref"})PepperFoliar: 1 × 100 g/ha7, 14Root cropsPotatoFoliar: 2 × 100 and 2 × 500 g/ha14Cereals/grassWheatFoliar: 2 × 100 and 2 × 500 g/ha21**Rotational crops** (available studies)**Crop groupsCrop(s)Application(s)PBI** (DAT)**Comment/Source**--------Not triggered (EFSA, [2010](#efs25410-bib-0002){ref-type="ref"})**Processed commodities**(hydrolysis study)**ConditionsStable?Comment/Source**Pasteurisation (20 min, 90°C, pH 4)YesParent flonicamid: (EFSA, [2010](#efs25410-bib-0002){ref-type="ref"}) TFNG and TFNA: (Netherlands, [2017](#efs25410-bib-0024){ref-type="ref"})Baking, brewing and boiling (60 min, 100°C, pH 5)YesSterilisation (20 min, 120°C, pH 6)YesOther processing conditions--

![](EFS2-16-e05410-g002.jpg "image")

#### B.1.1.2.. Stability of residues in plants {#efs25410-sec-0025}

Plant products (available studies)CategoryCommodityT (°C)Stability periodCompounds coveredComment/SourceValueUnitHigh water contentApple, potato−1818MonthsParent and its metabolites TFNG, TFNA, TFNA‐AMEFSA ([2010](#efs25410-bib-0002){ref-type="ref"})High oil contentRape seed−2012MonthsParent and its metabolites TFNG, TFNAEFSA ([2015](#efs25410-bib-0004){ref-type="ref"})Dry/High starchWheat−1818MonthsParent and its metabolites TFNG, TFNA, TFNA‐AMEFSA ([2010](#efs25410-bib-0002){ref-type="ref"})High acid contentOrange (whole fruit)−186MonthsParent and its metabolites TFNG, TFNANetherlands ([2017](#efs25410-bib-0024){ref-type="ref"})High protein contentBean−2012MonthsParent and its metabolites TFNG, TFNAEFSA ([2015](#efs25410-bib-0004){ref-type="ref"})

### B.1.2.. Magnitude of residues in plants {#efs25410-sec-0026}

#### B.1.2.1.. Summary of residues data from the supervised residue trials {#efs25410-sec-0027}

CommodityRegion/Indoor[a](#efs25410-note-1018){ref-type="fn"}Residue levels observed in the supervised residue trials (mg/kg)Comments/SourceCalculated MRL (mg/kg)HR[b](#efs25410-note-1019){ref-type="fn"} (mg/kg)STMR[c](#efs25410-note-1020){ref-type="fn"} (mg/kg)CF[d](#efs25410-note-1021){ref-type="fn"}Radishes (2 × 80 g/ha, PHI 7 days)NEU0.053, 0.183, 0.217, 0.224, 0.294MRL~OECD~: 0.58/0.6**0.60.290.22**--Strawberries (2 × 70 g/ha, PHI 3 days)NEU0.06, 0.077, 0.079, 0.087, 0.145, 0.164, 0.177, 0.266MRL~OECD~: 0.41/0.5**0.5**0.2660.12--Raspberries, blackberries(2 × 70 g/ha, PHI 3 days)NEURaspberries: 0.118, 0.285, 0.426, 0.483MRL~OECD~: 0.98/1.0 Extrapolation from raspberries to blackberries**1.0**0.480.36--Other small fruit and berries (2 × 70 g/ha, PHI 10 days)NEUBlack currants: 0.067, 0.153, 0.156, 0.192, 0.256, 0.370MRL~OECD~: 0.61/0.70 Extrapolation from black currant to whole group of other small fruits and berries**0.7**0.370.17--Lettuce and other salad plants (1 mg/plant, PHI 49 days)SEULettuce (variety not specified): 4 × \< 0.03, 0.03, 2 × 0.04, 0.05MRL~OECD~: 0.07/0.07 Extrapolation from lettuce to other salad plants including escaroles/endives**0.07**0.050.03--Peas and beans dry (70 g/ha, PHI determined by growth stage)NEUPeas: 0.097, 0.177, 0.259, 0.404 Beans: 0.136, 0.140, 0.142, 0.176MRL~OECD~: 0.58/0.6 Extrapolation to lentils and lupins**0.6**0.400.16--SEUPeas: \< 0.03, 0.071, 0.085, 0.136 Beans: 0.190, 0.269, 0.377, 0.415MRL~OECD~: 0.77/0.8 Extrapolation to lentils and lupins**0.8**0.420.16--[^9][^10][^11][^12][^13][^14]

#### B.1.2.2.. Residues in rotational crops {#efs25410-sec-0028}

![](EFS2-16-e05410-g003.jpg "image")

#### B.1.2.3.. Processing factors {#efs25410-sec-0029}

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

B.2.. Residues in livestock {#efs25410-sec-0030}
---------------------------

Relevant groups (subgroups)Dietary burden expressed inMost critical subgroup[a](#efs25410-note-1023){ref-type="fn"}Most critical commodity[b](#efs25410-note-1024){ref-type="fn"}Trigger exceeded(Y/N)Previous assessment Maximum burden (mg/kg bw) (EFSA, [2017](#efs25410-bib-0006){ref-type="ref"})mg/kg bw per daymg/kg DMMedianMaximumMedianMaximumCattle (all diets)0.0720.0772.352.47Dairy cattlePotato process wasteY2.47Cattle (dairy only)0.0720.0771.862.00Dairy cattlePotato process wasteY2.00Sheep (all diets)0.0760.0772.272.30Ram/EwePotato process wasteY2.30Sheep (ewe only)0.0760.0772.272.30Ram/EwePotato process wasteY2.30Swine (all diets)0.0480.0481.641.70Swine finishingWheat milled by‐productsY1.70Poultry (all diets)0.0610.0630.890.92Poultry layerWheat milled by‐productsY0.92Poultry (layer only)0.0610.0630.890.92Poultry layer onlyWheat milled by‐productsY0.92[^15][^16][^17]

### B.2.1.. Nature of residues and methods of analysis in livestock {#efs25410-sec-0031}

#### B.2.1.1.. Metabolism studies, methods of analysis and residue definitions in livestock {#efs25410-sec-0032}

Livestock (available studies)AnimalDose (mg/kg bw per day)Duration (days)Comment/SourceLaying hens0.7853‐^14^C‐phenyl (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"})Lactating ruminants1.695Goat, 3‐^14^C‐phenyl (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"})[^18]

![](EFS2-16-e05410-g004.jpg "image")

#### B.2.1.2.. Stability of residues in livestock {#efs25410-sec-0033}

Animal products (available studies)AnimalCommodityT (°C)Stability periodCompounds coveredComment/SourceValueUnitHenMuscle, fat, eggs−188MonthsParent and metabolites TFNA, TFNA‐AM, OH‐TFNA‐AM, TFNGEFSA ([2010](#efs25410-bib-0002){ref-type="ref"})GoatMuscle, fat, milk−189MonthsParent and metabolites TFNA, TFNA‐AM, OH‐TFNA‐AM, TFNGEFSA ([2010](#efs25410-bib-0002){ref-type="ref"})

### B.2.2.. Magnitude of residues in livestock {#efs25410-sec-0034}

Not relevant.

B.3.. Consumer risk assessment {#efs25410-sec-0035}
------------------------------

![](EFS2-16-e05410-g005.jpg "image")

B.4.. Recommended MRLs {#efs25410-sec-0036}
----------------------

Code[a](#efs25410-note-1028){ref-type="fn"}CommodityExisting EU MRL (mg/kg)Proposed EU MRL (mg/kg)Comment/justification**Enforcement residue definition:** sum of flonicamid, TFNA and TFNG, expressed as flonicamid0152000Strawberries0.03[\*](#efs25410-note-1027){ref-type="fn"}0.5The MRL proposal reflects the intended NEU use. Risk for consumers unlikely0153010Blackberries0.03[\*](#efs25410-note-1027){ref-type="fn"}1.0The MRL proposal reflects the intended NEU use. Risk for consumers unlikely. Extrapolation from data on raspberries0153030Raspberries0.03[\*](#efs25410-note-1027){ref-type="fn"}1.0The MRL proposal reflects the intended NEU use. Risk for consumers unlikely. Extrapolation to the group of cane fruits not possible. Two additional trials are required0154000Other small fruit and berries0.03[\*](#efs25410-note-1027){ref-type="fn"}0.7The MRL proposal reflects the intended NEU use. Risk for consumers unlikely. Extrapolation from data on black currant0213080Radishes0.03[\*](#efs25410-note-1027){ref-type="fn"}0.6The MRL proposal reflects the intended NEU use. Risk for consumers unlikely0251000Lettuce and salad plants0.03[\*](#efs25410-note-1027){ref-type="fn"}0.07The MRL proposal reflects the intended SEU use. Risk for consumers unlikely Extrapolation to the whole group of lettuce and other salad plants including escaroles/endives0300010Beans (dry)0.03[\*](#efs25410-note-1027){ref-type="fn"}0.8The MRL proposal reflects the intended SEU use and covers the NEU use. Risk for consumers unlikely0300020Lentils0.03[\*](#efs25410-note-1027){ref-type="fn"}0.8Extrapolated from data on beans and peas (dry). The MRL proposal reflects the intended SEU use and covers the NEU use. Risk for consumers unlikely0300030Peas (dry)0.03[\*](#efs25410-note-1027){ref-type="fn"}0.8The MRL proposal reflects the intended SEU use and covers the NEU use. Risk for consumers unlikely0300040Lupins0.03[\*](#efs25410-note-1027){ref-type="fn"}0.8Extrapolated from data on beans and peas (dry). The MRL proposal reflects the intended SEU use and covers the NEU use. Risk for consumers unlikely[^19][^20][^21]

Appendix C -- Pesticide Residue Intake Model (PRIMo) {#efs25410-sec-1003}
====================================================

 {#efs25410-sec-0037}

Appendix D -- Input values for the exposure calculations {#efs25410-sec-1004}
========================================================

D.1.. Livestock dietary burden calculations {#efs25410-sec-0038}
-------------------------------------------

Feed commodityMedian dietary burdenMaximum dietary burdenInput value (mg/kg)CommentInput value (mg/kg)Comment**Risk assessment residue definition: Flonicamid, TFNG and TFNA expressed as flonicamid**Dry peas, beans and lupins0.16STMR0.16STMRLupins, meal0.18STMR x PF (1.1)0.18STMR x PF (1.1)Cabbages0.14STMR (EFSA, [2017](#efs25410-bib-0006){ref-type="ref"})0.23HR (EFSA, [2017](#efs25410-bib-0006){ref-type="ref"})Sugar beet tops0.085STMR (EFSA, [2017](#efs25410-bib-0006){ref-type="ref"})0.2HR (EFSA, [2017](#efs25410-bib-0006){ref-type="ref"})Sugar beet, dry pulps1.53STMR x PF (18) (EFSA, [2017](#efs25410-bib-0006){ref-type="ref"})1.53STMR x PF (18) (EFSA, [2017](#efs25410-bib-0006){ref-type="ref"})Sugar beet, ensiled pulps0.26STMR x PF (3) (EFSA, [2017](#efs25410-bib-0006){ref-type="ref"})0.26STMR x PF (3) (EFSA, [2017](#efs25410-bib-0006){ref-type="ref"})Sugar beet, molasses2.38STMR x PF (28) (EFSA, [2017](#efs25410-bib-0006){ref-type="ref"})2.38STMR x PF (28) (EFSA, [2017](#efs25410-bib-0006){ref-type="ref"})Citrus, dried pulps0.4STMR x PF (10) (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"})0.4STMR x PF (10) (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"})Apple pomaces0.3STMR x PF (5) (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"})0.3STMR x PF (2.5) (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"})Wheat/Rye grains0.35STMR (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"})0.35STMR (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"})Wheat milled by‐products2.45STMR x PF (7) (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"})2.45STMR x PF (7) (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"})Wheat/Rye straw0.18STMR (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"})0.48HR (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"})Barley/Oat grains0.14STMR (EFSA, [2015](#efs25410-bib-0004){ref-type="ref"})0.18HR (EFSA, [2015](#efs25410-bib-0004){ref-type="ref"})Barley/Oat straw0.05STMR (EFSA, [2015](#efs25410-bib-0004){ref-type="ref"})0.07HR (EFSA, [2015](#efs25410-bib-0004){ref-type="ref"})Potatoes0.03STMR (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"})0.06HR (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"})Potato process waste0.6STMR x PF (20) (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"})0.6STMR x PF (20) (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"})Potato dry pulp1.14STMR x PF (38) (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"})1.14STMR x PF (38) (EFSA, [2014](#efs25410-bib-0003){ref-type="ref"})Cotton meal0.05STMR x PF (1.3) (EFSA, [2015](#efs25410-bib-0004){ref-type="ref"})0.05STMR x PF (1.3) (EFSA, [2015](#efs25410-bib-0004){ref-type="ref"})Cotton (undelinted seed)0.14STMR (EFSA, [2015](#efs25410-bib-0004){ref-type="ref"})0.14STMR (EFSA, [2015](#efs25410-bib-0004){ref-type="ref"})[^22]

D.2.. Consumer risk assessment {#efs25410-sec-0039}
------------------------------

CommodityChronic risk assessmentAcute risk assessmentInput value (mg/kg)CommentInput value (mg/kg)CommentStrawberries0.12STMR0.27HRBlackberries0.36STMR0.48HRRaspberries0.36STMR0.48HROther small fruits and berries0.17STMR0.37HRRadishes0.22STMR0.29HRLettuce and other salad plants (including escaroles/endives)0.03STMR0.05HRBeans (dry), peas (dry), Lupins, Lentils0.16STMR0.16STMROther commodities of plant and animal originSTMRSee table 7 (EFSA, [2017](#efs25410-bib-0006){ref-type="ref"})Acute risk assessment undertaken only with regard to the crop under consideration[^23]

Appendix E -- Used compound codes {#efs25410-sec-1005}
=================================

 {#efs25410-sec-0040}

Code/trivial nameChemical name/SMILES notation/InChIKey[a](#efs25410-note-1032){ref-type="fn"}Structural formula[b](#efs25410-note-1033){ref-type="fn"}flonicamid*N*‐cyanomethyl‐4‐(trifluoromethyl)nicotinamideO=C(NCC\#N)c1cnccc1C(F)(F)F RLQJEEJISHYWON‐UHFFFAOYSA‐N![](EFS2-16-e05410-g006.jpg "image")TFNA4‐(trifluoromethyl)nicotinic acid or 4‐(trifluoromethyl)pyridine‐3‐carboxylic acid OC(=O)c1cnccc1C(F)(F)F LMRJHNFECNKDKH‐UHFFFAOYSA‐N![](EFS2-16-e05410-g007.jpg "image")TFNG*N*‐\[4‐(trifluoromethyl)nicotinoyl\]glycine or *N*‐\[4‐(trifluoromethyl)pyridine‐3‐carbonyl\]glycine O=C(NCC(=O)O)c1cnccc1C(F)(F)F AXMBYGGSBXWTEY‐UHFFFAOYSA‐N![](EFS2-16-e05410-g008.jpg "image")TFNA‐AM4‐(trifluoromethyl)nicotinamide or 4‐(trifluoromethyl)pyridine‐3‐carboxamide O=C(N)c1cnccc1C(F)(F)F JUIWZYBJXUPIKF‐UHFFFAOYSA‐N![](EFS2-16-e05410-g009.jpg "image")[^24][^25][^26]

Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. OJ L 230, 19.8.1991, p. 1--32.

Commission Directive 2010/29/EU of 27 April 2010 amending Council Directive 91/414/EEC to include flonicamid (IKI‐220) as active substance, OJ L 106, 28.4.2010, p. 9--11.

Regulation (EC) No 396/2005 of the Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC. OJ L 70, 16.3.2005, p. 1--16.

For an overview of all MRL Regulations on this active substance, please consult: <http://ec.europa.eu/food/plant/pesticides/eupesticides-database/public/?event=pesticide.residue.selection&language=EN>

[^1]: MRL: maximum residue level; NEU: northern Europe; SEU: southern Europe.

[^2]: \*Indicates that the MRL is set at the limit of analytical quantification (LOQ).

[^3]: Commodity code number according to Annex I of Regulation (EC) No 396/2005.

[^4]: GAP: Good Agricultural Practice; MRL: maximum residue level; NEU: northern European Union; SEU: southern European Union; MS: Member State; a.s.: active substance; WG: water‐dispersible granule; BBCH: growth stages of mono‐ and dicotyledonous plants.

[^5]: Outdoor or field use (F), greenhouse application (G) or indoor application (I).

[^6]: CropLife International Technical Monograph no 2, 6th Edition. Revised May 2008. Catalogue of pesticide formulation types and international coding system.

[^7]: Growth stage range from first to last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISBN 3‐8263‐3152‐4), including, where relevant, information on season at time of application.

[^8]: PHI: minimum preharvest interval.

[^9]: MRL: maximum residue level; OECD: Organisation for Economic Co‐operation and Development.

[^10]: \*Indicates that the MRL is proposed at the limit of quantification.

[^11]: NEU: Outdoor trials conducted in northern Europe, SEU: Outdoor trials conducted in southern Europe, Indoor: indoor EU trials or Country code: if non‐EU trials.

[^12]: Highest residue: The highest residue for risk assessment refers to the whole commodity and not to the edible portion.

[^13]: Supervised trials median residue: The median residue for risk assessment refers to the whole commodity and not to the edible portion.

[^14]: Conversion factor to recalculate residues according to the residue definition for monitoring to the residue definition for risk assessment.

[^15]: bw: body weight; DM: dry matter.

[^16]: When one group of livestock includes several subgroups (e.g. poultry 'all' including broiler, layer and turkey), the result of the most critical subgroup is identified from the maximum dietary burdens expressed as 'mg/kg bw per day'.

[^17]: The most critical commodity is the major contributor identified from the maximum dietary burden expressed as 'mg/kg bw per day'.

[^18]: bw: body weight.

[^19]: MRL: maximum residue level; NEU: northern Europe; SEU: southern Europe.

[^20]: \*Indicates that the MRL is set at the limit of analytical quantification (LOQ).

[^21]: Commodity code number according to Annex I of Regulation (EC) No 396/2005.

[^22]: STMR: supervised trials median residue; HR: highest residue; PF: processing factor.

[^23]: STMR: supervised trials median residue; HR: highest residue.

[^24]: SMILES: simplified molecular‐input line‐entry system; InChIKey: International Chemical Identifier Key.

[^25]: ACD/Name 2017.2.1 ACD/Labs 2017 Release (File version N40E41, Build 96719, 6 September 2017).

[^26]: ACD/ChemSketch 2017.2.1 ACD/Labs 2017 Release (File version C40H41, Build 99535, 14 February 2018).
