Evaluation of confirmatory data following the Article 12 MRL review for flonicamid

Abstract

The applicant ISK Biosciences Europe N.V, submitted a request to the competent national authority in Finland to evaluate the confirmatory data that were identified for flonicamid in the framework of the maximum residue level (MRL) review under Article 12 of Regulation (EC) No 396/2005 as not available. In order to address the data gaps, the applicant provided method validation data for hops, residue trials on cherries, plums, tomatoes and melons and referred to results from trials in cucumbers and storage stability and hydrolysis studies which have been assessed in previous EFSA outputs. The provided information was considered sufficient to address the confirmatory data gaps for hops, cherries, plums, tomatoes and aubergines, courgettes and cucurbits with inedible peel. EFSA updated the most recent consumer risk assessment for flonicamid and concluded that for the crops under assessment, the long‐term and short‐term dietary intake is unlikely to present a risk to consumer health.

Summary

In 2014, when the European Food Safety Authority (EFSA) reviewed the existing Maximum Residue Levels (MRLs) for flonicamid according to Article 12 of Regulation (EC) No 396/2005, EFSA identified some information as unavailable (data gaps) and derived tentative MRLs for those uses which were not fully supported by data but for which no risk to consumers was identified. The following data gaps were noted:

1. fully validated method of analysis for enforcement of flonicamid and its metabolites TFNG and TFNA in hops;

2. storage stability studies of flonicamid and its metabolites TFNG and TFNA in acidic commodities;

3. four residue trials supporting the northern outdoor good agricultural practice (GAP) on apricots;

4. four additional residue trials supporting the northern outdoor GAP on cherries;

5. three additional residue trials supporting the southern outdoor GAP on plums;

6. eight residue trials supporting the southern outdoor GAP and eight residue trials supporting the EU indoor GAP on tomatoes and aubergines;

7. eight trials supporting the EU indoor GAP on courgettes;

8. four residue trials supporting the southern GAP and eight residue trials supporting the EU indoor GAP on cucurbits with inedible peel;

9. eight residue trials on barley supporting the northern outdoor GAP on barley and oat;

10. a hydrolysis study on the flonicamid metabolites TFNG and TFNA investigating the nature of residues in processed commodities, in particular for wheat and rye which are the main contributors to the chronic exposure.

Tentative MRL proposals have been implemented in the MRL legislation by Commission Regulation (EU) No 2016/71, including footnotes related to data gaps 1, 2, 4, 5, 6, 7, 8, 10, indicating the type of confirmatory data that should be provided by a party having an interest in maintaining the proposed tentative MRL by 27 January 2018.

Data gaps number 3 and 9 were not translated into footnote in the MRL regulation because of other risk management considerations. For apricots in the absence of data, the MRL was set at the limit of quantification (LOQ) of 0.03 mg/kg, whereas for barley and oats, the MRL was set at 0.4 mg/kg on the basis of new intended NEU use which was in parallel assessed by EFSA in the reasoned opinion on the modification of flonicamid MRL in several crops.

To address the data gaps number 1, 4, 5, 6 and 8, the applicant provided a validated analytical method for monitoring of residues of flonicamid in hops and additional residue trials on cherries, plums, tomatoes and melons. Trials on melons, however, covered only the authorised use in the southern Europe; regarding the indoor authorised GAP, no trials were submitted by the applicant who informed to no longer support the indoor authorised use for cucurbits with inedible peel. To address data gap number 7, the applicant used results from indoor trials in cucumbers evaluated in the framework of the 2014 EFSA MRL review. To address data gaps 2 and 10, the applicant referred to studies previously assessed by EFSA in the framework of modification of the existing MRLs for flonicamid in various crops.

In accordance with the agreed procedure set out in the working document SANTE/10235/2016, ISK Biosciences Europe N.V, submitted an application to the competent national authority in Finland (rapporteur Member State, RMS) to evaluate the confirmatory data identified during the MRL review. The RMS assessed the new information in an evaluation report, which was submitted to the European Commission and forwarded to the EFSA on 20 June 2019. When assessing the evaluation report, EFSA identified points which needed further clarifications. On 28 February 2020, the evaluating Member State (EMS) submitted a revised evaluation report which addressed the points for clarification.

The summary table below provides an overview of the assessment of confirmatory data and the recommended MRL modifications to Regulation (EU) No 396/2005.

Codea	Commodity	Existing MRLb	Proposed MRL	Conclusion/recommendation
Enforcement residue definition: Flonicamid (sum of flonicamid, TFNA and TFNG expressed as flonicamid)R
0110000	Citrus fruit	0.15 (ft 1)	0.15	The data gap identified by EFSA concerning storage stability studies on flonicamid and metabolites TFNG and TFNA in acidic commodities has been addressed. The MRL is confirmed. The previous consumer risk assessment was updated using revision 3.1 of EFSA PRIMo and confirmed no consumer intake concerns
0140020	Cherries (sweet)	0.4 (ft 2)	0.4	The data gap identified by EFSA concerning additional residue trials supporting the NEU GAP on cherries has been addressed. The MRL is confirmed. The previous consumer risk assessment was updated using revision 3.1 of EFSA PRIMo and confirmed no consumer intake concerns
0140040	Plums	0.3 (ft 2)	0.3	The data gap identified by EFSA concerning additional residue trials supporting the SEU GAP on plums has been addressed. The MRL is confirmed. The previous consumer risk assessment was updated using revision 3.1 of EFSA PRIMo and confirmed no consumer intake concerns
0231010 0231030	Tomatoes Aubergines/eggplants	0.5 (ft 2)	0.5	The data gap identified by EFSA concerning additional residue trials supporting the SEU GAP in tomatoes and the indoor GAP on tomatoes and aubergines has been addressed. The MRL is confirmed. The previous consumer risk assessment was updated using revision 3.1 of EFSA PRIMo and confirmed no consumer intake concerns
0232030	Courgette	0.5 (ft 2)	0.5	The data gap identified by EFSA concerning additional residue trials supporting the indoor GAP on courgettes has been addressed by extrapolation from residue data on cucumbers assessed in the MRL review. The MRL is confirmed. It was noted, however, that the same data set gives higher MRL in the OECD MRL calculator for cucurbits with edible peel (0.6 mg/kg), requiring further risk management consideration. The previous consumer risk assessment was updated using revision 3.1 of EFSA PRIMo and confirmed no consumer intake concerns
0233000	Cucurbits with inedible peel	0.4 (ft 2)	0.4	The data gap identified by EFSA concerning additional residue trials supporting the SEU GAP in cucurbits with inedible peel has been addressed. The MRL is confirmed. The previous consumer risk assessment was updated using revision 3.1 of EFSA PRIMo and confirmed no consumer intake concerns. The data gap identified by EFSA concerning additional residue trials supporting the indoor GAP on cucurbits with inedible peel has not been addressed; the applicant informed that this use is no longer supported
0500070 0500090	Rye Wheat	2 (ft 3)	2	The data gap identified by EFSA concerning hydrolysis study on flonicamid metabolites TFNG and TFNA has been addressed. The MRL is confirmed. The previous consumer risk assessment was updated using revision 3.1 of EFSA PRIMo and confirmed no consumer intake concerns
0700000	Hops	3 (ft 4)	3	The data gap identified by EFSA concerning a validated analytical method in hops has been addressed. The MRL is confirmed. The previous consumer risk assessment was updated using revision 3.1 of EFSA PRIMo and confirmed no consumer intake concerns

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

^RThe residue definition differs for the following combinations pesticide‐code number: Flonicamid — code 1000000, except code 1040000: Sum of flonicamid and TFNA‐AM, expressed as flonicamid.

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

^bExisting EU MRL and corresponding footnote on confirmatory data.

^{ft 1}The European Food Safety Authority identified some information on storage stability as unavailable. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 27 January 2018, or, if that information is not submitted by that date, the lack of it.

^{ft 2}The European Food Safety Authority identified some information on residue trials as unavailable. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 27 January 2018, or, if that information is not submitted by that date, the lack of it.

^{ft 3}The European Food Safety Authority identified some information on hydrolysis study in processed commodities as unavailable. When reviewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 27 January 2018, or, if that information is not submitted by that date, the lack of it.

^{ft 4}The European Food Safety Authority identified some information on analytical methods as unavailable. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 27 January 2018, or, if that information is not submitted by that date, the lack of it.

Assessment

The review of existing maximum residue levels (MRLs) for the active substance flonicamid according to Article 12 of Regulation (EC) No 396/20051 (MRL review) has been performed in 2014 (EFSA, 2014). The European Food Safety Authority (EFSA) identified some information as unavailable (data gaps) and derived tentative MRLs for those uses not fully supported by data but for which no risk to consumers was identified. The list of GAPs assessed in the framework of the MRL review that were not fully supported by data and for which confirmatory data were requested are listed in Appendix A.

Following the review of existing MRLs, the legal limits have been modified by Commission Regulation (EU) No 2016/712, including footnotes for tentative MRLs that specified the type of information that was identified as missing. Any party having an interest in maintaining the proposed tentative MRL was requested to address the confirmatory data by 27 January 2018.

In accordance with the specific provisions set out in the working document of the European Commission SANTE/10235/2016 (European Commission, 2016) the applicant, ISK Biosciences Europe N.V, submitted an application to the competent national authority in Finland (designated rapporteur Member State, RMS) to evaluate the confirmatory data identified during the MRL review.

The following data gaps were noted:

1. fully validated method of analysis for enforcement of flonicamid and its metabolites TFNG and TFNA in hops;

2. storage stability studies of flonicamid and its metabolites TFNG and TFNA in acidic commodities;

3. four residue trials supporting the northern outdoor GAP on apricots;

4. four additional residue trials supporting the northern outdoor GAP on cherries;

5. three additional residue trials supporting the southern outdoor GAP on plums;

6. eight residue trials supporting the southern outdoor GAP and eight residue trials supporting the EU indoor GAP on tomatoes and aubergines;

7. eight trials supporting the EU indoor GAP on courgettes;

8. four residue trials supporting the southern GAP and eight residue trials supporting the EU indoor GAP on cucurbits with inedible peel;

9. eight residue trials on barley supporting the northern outdoor GAP on barley and oat;

10. a hydrolysis study on the flonicamid metabolites TFNG and TFNA investigating the nature of residues in processed commodities, in particular for wheat and rye which are the main contributors to the chronic exposure.

Data gaps number 3 and 9 were not translated into footnote in the MRL regulation because of other risk management considerations. For apricots in the absence of data, the MRL was set at the LOQ of 0.03 mg/kg, whereas for barley and oats, the MRL was set at 0.4 mg/kg on the basis of new intended NEU use which was in parallel assessed by EFSA in the reasoned opinion on the modification of flonicamid MRL in several crops (EFSA, 2015).

To address the data gaps number 1, 4, 5, 6 and 8, the applicant provided a validated analytical method for monitoring of residues of flonicamid in hops and additional residue trials on cherries, plums, tomatoes and melons. Trials on melons, however, covered only the authorised use in the southern Europe; regarding the indoor authorised GAP, no trials were submitted by the applicant who informed to no longer support the indoor authorised use for cucurbits with inedible peel. To address data gap number 7, the applicant used results from indoor trials in cucumbers evaluated in the framework of the 2014 EFSA MRL review. To address data gaps 2 and 10, the applicant referred to studies previously assessed by EFSA in the framework of modification of the existing MRLs for flonicamid in various crops (EFSA, 2018c,d).

Furthermore, the applicant submitted residue data on peaches, peppers and cucurbits with edible peel intended to address the minor data gaps identified by the MRL review. This information was not further assessed as these data are related to national authorisation in the MS, which does not fall under the remit of EFSA.

The RMS assessed the new information in an evaluation report, which was submitted to the European Commission and forwarded to EFSA on 20 June 2019 (Finland, 2019). EFSA assessed the application as requested by the European Commission in accordance with Article 9 of Regulation (EC) No 396/2005. During the detailed assessment, EFSA identified points which needed further clarifications. On 28 February 2020, the RMS submitted a revised evaluation report which addressed the points for clarification (Finland, 2019).

EFSA based its assessment on the evaluation report submitted by the RMS (Finland, 2019), the reasoned opinion on the MRL review according to Article 12 of Regulation (EC) No 396/2005 (EFSA, 2014) and additional assessments on flonicamid performed after the MRL review (EFSA, 2015, 2018a, 2018c, d, 2019b).

For this application, the data requirements established in Regulation (EU) No 544/20113 and the relevant guidance documents at the date of implementation of the confirmatory data requirements by Regulation (EU) No 2016/71 are applicable. 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 546/20114.

An updated list of end points, including the end points of relevant studies assessed previously and the confirmatory data evaluated in this application, is presented in Appendix B.

The evaluation report submitted by the RMS (Finland, 2019) is considered a supporting document to this reasoned opinion and, thus, is made publicly available as a background document 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

Not relevant for the current assessment.

1.1.2. Nature of residues in rotational crops

Not relevant for the current assessment.

1.1.3. Nature of residues in processed commodities

In order to address the data gap number 10,5 the applicant referred to a hydrolysis study with flonicamid metabolites TFNG and TFNA which was submitted in the framework of an Article 10 MRL application and assessed by EFSA in 2018 (EFSA, 2018c). Details of the study are presented in Appendix B.1.1.1.

EFSA concluded that the data gap identified in the framework of the MRL review was addressed and the footnote in the legislation can be deleted (EFSA, 2018b).

1.1.4. Methods of analysis in plants

In order to address data gap number 1,6 the applicant submitted a method validation package and internal laboratory validation (ILV) data for the monitoring of flonicamid and its metabolites in hops. Analysis of residues of flonicamid, TFNA and TFNG is performed by high‐performance liquid chromatography with mass spectrometric detection (HPLC‐MS/MS). The quantified residues are expressed as flonicamid equivalents. The validated LOQs were at the level of 0.01 mg/kg per residue in fresh hops (combined LOQ of 0.03 mg/kg) and at the level of 0.05 mg/kg per residue in dried hops (combined LOQ of 0.15 mg/kg). No confirmatory method was needed as the primary method is highly selective.

EFSA noted that in the ILV validation package, some of the measured recoveries for parent flonicamid were lower than 70% (51–72%). Based, however, on the complexity of the matrix and that recoveries for metabolites TFNA (74%) and TFNG (68%) in dried hops were above or slightly below the 70% requirement, these results were considered acceptable. Therefore, the analytical method can be considered to be fully validated as enforcement method in terms of specificity, linearity, accuracy and precision based on the provisions of the SANCO/825/00 rev 8.1 guidance document (European Commission, 2010).

Details on the analytical method are presented in Appendix B.1.1.1.

EFSA concludes that the data gap identified in the framework of the MRL review is addressed.

1.1.5. Storage stability of residues in plants

In order to address the data gap number 2,7 the applicant referred to a storage stability study on flonicamid metabolites TFNG and TFNA in commodities with high acid content (oranges) which was provided in the framework of an MRL application and assessed by EFSA (EFSA, 2018b). Details are presented in Appendix B.1.1.2.

EFSA concluded that the data gap identified in the framework of the MRL review was addressed and the footnote in the legislation can be deleted (EFSA, 2018b).

1.1.6. Proposed residue definitions

The previously derived residue definitions are still applicable.

1.2. Magnitude of residues in plants

In the framework of the current assessment, the applicant provided residue information to address the confirmatory data requirement for cherries, plums, tomatoes, courgettes and melons. Details on the trials are presented in Appendix B.1.2.1.

The submitted residue trial samples were analysed in accordance with the applicable residue definitions for enforcement and risk assessment. The analytical methods used to determine residues of flonicamid and its metabolites in the crops under evaluation were considered sufficiently validated and fit for purpose. Samples were stored under conditions ensuring stability of flonicamid, TFNA and TFNG (Finland, 2019).

Cherries

Authorised GAP (EFSA, 2014 ): NEU, 2 × 70 g a.s./ha, PHI: 14 days

In order to address the data gap number 4,8 the applicant submitted four new outdoor residue trials on cherries which were performed in northern Europe and were compliant with the authorised NEU GAP as reported in the framework of the MRL review (EFSA, 2014; Finland, 2019). Results derived from cherries without stones were re‐calculated to the whole fruit by taking into account the weight ratio of cherries without stones to cherries with stones.

The new residue trials on cherries (4) were combined with the residue trials on cherries (4 trials) as reported in the MRL review (EFSA, 2014). Merged residue data set confirms the existing tentative MRL of 0.4 mg/kg.

EFSA concludes that the data gap identified in the framework of the MRL review is addressed and that the footnote can be deleted.

Plums

Authorised GAP (EFSA, 2014 ): SEU, 2 × 70 g a.s./ha, PHI 14 days

In order to address the data gap number 5,9 the applicant submitted three new outdoor residue trials on plums which were performed in the southern Europe and were compliant with the authorised SEU GAP as reported in the framework of the EFSA MRL review (EFSA, 2014; Finland, 2019).

To confirm the MRL proposal for flonicamid on plums, the results from the new trials (3) were combined with the results from previously submitted trials (5) in plums from the southern Europe (EFSA, 2014). Merged residue data set confirms the existing tentative MRL of 0.3 mg/kg.

EFSA concluded that the data gap identified in the framework of the MRL review is addressed and that the footnote can be deleted.

Tomatoes and aubergines

Trials supporting the outdoor GAP (SEU) for tomatoes

Authorised GAP (EFSA, 2014 ): SEU, outdoor, 3 × 50 g/ha, PHI 1 day

Adjusted GAP (Finland, 2019 ): SEU, outdoor, 3 × 60 g/ha, PHI 1 day

In order to address the data gap number 6,10 the applicant submitted four new outdoor residue trials on tomatoes compliant with the adjusted GAP in Southern Europe. Since the application rate in the adjusted GAP is within the 25% of the acceptable deviation, the submitted trials were considered acceptable to support the authorised SEU GAP for flonicamid on tomatoes.

Four residue trials evaluated in the framework of the MRL review were also considered (EFSA, 2014). These older trials were overdosed in terms of the application rate but were acceptable as the higher application rate was the only deviation from the authorised GAP for these trials (3 × 80 g/ha instead of 3 × 60 g/ha as in the adjusted GAP).

EFSA applied the proportionality approach and all available residue trials on tomatoes were scaled to the adjusted application rate of 60 g a.s./ha before proceeding with the MRL calculation (EFSA, 2018b). A combined residue data set suggests a lower MRL proposal (0.2 mg/kg) than the existing tentative EU MRL of tomatoes (0.5 mg/kg) which is based on indoor use.

Trials supporting the indoor GAP for tomatoes and aubergines

Authorised GAP (EFSA, 2014 ): Indoor, 3 ×  50 g/ha, PHI 1 day

Adjusted GAP (Finland, 2019 ): Indoor, 3 ×  60 g/ha, PHI 1 day

In order to address the data gap number 6¹², the applicant submitted four new indoor trials on tomatoes supporting the adjusted indoor GAP in tomatoes and aubergines. The submitted trials were considered acceptable to support the authorised indoor use of flonicamid in tomatoes and aubergines.

Four residue trials evaluated in the framework of the MRL review were also considered (EFSA, 2014). These older trials were overdosed in terms of the application rate but were acceptable as the higher application rate was the only deviation from the authorised GAP for these trials (3 × 80 g/ha instead of 3 × 60 g/ha as in the adjusted GAP).

EFSA used the proportionality approach and all available residue trials on tomatoes were scaled to the adjusted application rate of 60 g a.s./ha before proceeding with the MRL calculation (EFSA, 2018b). A combined residue data set confirms the existing tentative EU MRL of tomatoes (0.5 mg/kg).

Despite no residue trials on aubergines were available, an extrapolation from tomatoes to aubergines is acceptable according to the European Commission Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs (European Commission, 2017).

EFSA concluded that the data gap identified in the framework of the MRL review is addressed and that the footnote can be deleted.

Courgettes

Authorised GAP (EFSA, 2014 ): Indoor, 3 ×  50 g/ha, PHI 1 day

Adjusted GAP (Finland, 2019 ): Indoor, 3 ×  80 g/ha, PHI 1 day

In order to address the data gap number 7,11 the applicant did not perform new indoor trials on courgettes but used results from eight indoor trials in cucumbers which were evaluated in the MRL review and are compliant with the adjusted GAP for courgettes (EFSA, 2014). It is noted that these residue trials were used to derive the existing EU MRL of 0.5 mg/kg in cucumbers and gherkins. An extrapolation from cucumbers to courgettes is acceptable according to the European Commission Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs (European Commission, 2017).

Although derived from the same cucumber data set as assessed in the MRL review, the estimated MRL was found to be higher than the one proposed by EFSA in 2014 (0.6 mg/kg instead of 0.5 mg/kg). This new proposal, however, is not related to the results of the trials per se but to the calculation mode of the 2015 OECD calculator which rounds the MRLs up.

According to the Commission working document on the evaluation of data submitted to confirm MRLs following the review of existing MRLs, however, ‘if the adjusted GAP leads to a higher MRL proposal, it should be evaluated following the standard procedures for setting new or modified MRLs’ (European Commission 2016). Based on the above, additional risk management considerations are required in order to derive a permanent MRL for courgettes.

EFSA notes that since the same data set was used to derive an MRL for cucumbers and gherkins in the framework of the MRL review, risk managers may consider applying the calculated MRL for courgettes to all group of cucurbits with edible peel.

EFSA concluded that the data gap identified in the framework of the MRL review is addressed and that the footnote can be deleted.

Cucurbits with inedible peel (melons, watermelons, pumpkins)

Authorised GAP (EFSA, 2014 ): SEU, outdoor 3 ×  50 g/ha, PHI 1 day

In order to address the data gap number 8,12 the applicant submitted eight new outdoor residue trials on melons which were performed in the southern Europe and were compliant with the authorised GAP in the SEU (EFSA, 2014; Finland, 2019). Results derived from melon peel and melon pulp were combined and re‐calculated to the whole fruit by taking into account the weight ratio of the melon peel to the melon pulp. An extrapolation of residue data from melons to the remaining crops of the group of cucurbits with inedible peel (watermelon and pumpkin) is acceptable according to the European Commission Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs (European Commission, 2017).

In the presence of sufficient number of GAP compliant trials in melons, results from four overdosed melon trials evaluated in the framework of the MRL review were not considered in the present assessment (3 × 80 g/ha instead of 3 × 50 g/ha as in authorised use) (EFSA, 2014).

Based on the submitted residue trials on melons, the tentative MRL of 0.4 mg/kg set for flonicamid in cucurbits with inedible peel was confirmed.

EFSA concluded that the data gap identified in the framework of the MRL review is addressed and that the footnote could be deleted.

Authorised GAP (EFSA, 2014 ): Indoor, 3 ×  50 g/ha, PHI 1 day

In order to address the data gap number 8¹², no new data were submitted. The applicant informed that this use is no longer supported (Finland, 2019). In the absence of such data, Member States are recommended to withdraw or modify the relevant authorisations for indoor uses of flonicamid in cucurbits with inedible peel.

2. Residues in livestock

The confirmatory data assessed in this evaluation do not have an impact on pesticide residues expected in livestock. Thus, the previous assessment of residues in livestock (EFSA, 2018d) is still valid.

3. Consumer risk assessment

The consumer exposure assessment which was performed in the framework of the MRL review using revision 2 of the EFSA PRIMo model (EFSA, 2014) was now updated with the new risk assessment values derived from the available residue trials on cherries, plums, tomatoes, cucumbers and cucurbits with inedible peel, using revision 3.1 of the EFSA PRIMo (EFSA, 2017, 2019a). This exposure assessment model contains food consumption data for different subgroups of the EU population and allows the acute and chronic exposure assessment to be performed in accordance with the internationally agreed methodology for pesticide residues (FAO, 2016).

The contributions of commodities for which no GAP was reported in the framework of the MRL review (EFSA, 2014) or in subsequent EFSA assessments were not included in the exposure calculation.

3.1. Short‐term (acute) dietary risk assessment

The estimation of the acute dietary exposure was based on the highest residue (HR) derived from supervised field trials submitted under the current assessment (Finland, 2019). For remaining commodities, the highest residue values as derived in the framework of the MRL review (EFSA, 2014) and in other EFSA outputs that have been issued after the MRL review (EFSA, 2015, 2016, 2018b 2018c, d, 2019b), were used as input values. The complete list of input values is reported in Appendix D.

The international estimated short‐term intake (IESTI) accounted for 85% of the acute reference dose (ARfD) in melons, 79% of the ARfD in tomatoes, 68% of the ARfD in watermelons, 63% of the ARfD in courgettes, 34% of the ARfD in aubergines/eggplants, 22% of the ARfD in plums, 15% of the ARfD in pumpkins and 9% of the ARfD in cherries.

EFSA concluded that for the crops under assessment, the short‐term exposure to residues of flonicamid does not exceed the ARfD set for the active substance, and therefore, is unlikely to pose a risk to consumers’ health.

3.2. Long‐term (chronic) dietary risk assessment

EFSA updated the previous exposure assessment (EFSA, 2019b), with the supervised trials median residue value (STMR) derived from trials submitted under the current assessment (Finland, 2019). The complete list of input values is reported in Appendix D.

The estimated long‐term exposure to flonicamid accounted for up to 28% of the acceptable daily intake (ADI) (NL toddler diet). The contribution of residues expected in (i) cherries is up to the 0.2% of the ADI (DE child), (ii) plums is up to the 0.1% of the ADI (GEMS/Food G15), (iii) tomatoes is up to the 1.6% of the ADI (GEMS/Food G06), (iv) aubergines is up to the 0.2% of the ADI (GEMS/Food G06), (v) courgettes is up to 0.3% of the ADI (FR infant), (vi) melons is up to 0.20% of the ADI (IE adult), (vii) pumpkins is up to 0.06% of the ADI (GEMS/Food G06) and (viii) watermelons is 0.27% of the ADI (GEMS/Food G06).

EFSA concluded that based on the existing uses and results from new trials submitted in the framework of the present application, the long‐term exposure to residues of flonicamid does not exceed the ADI set for the active substance, and therefore, is unlikely to pose a risk to consumers’ health.

4. Conclusion and Recommendations

To address data gaps identified in the framework of the MRL review, the applicant submitted an analytical method on hops (data gap number 1) and additional residue trials to support the use of flonicamid in cherries, plums, tomatoes and aubergines, courgettes and cucurbits with inedible peel (data gaps number 4–8). The data gaps were sufficiently addressed, and the respective footnotes can be deleted.

To address data gaps 2 and 10, the applicant referred to studies previously assessed by EFSA in the framework of modification of the existing MRLs for flonicamid in various crops. Data gaps number 3 and 9 were not translated into footnotes in the MRL regulation because of other risk management considerations.

EFSA concluded that for the crops under assessment, the short‐term exposure to residues of flonicamid does not exceed the ARfD set for the active substance, and therefore, is unlikely to pose a risk to consumers’ health. Based on the existing uses and results from new trials submitted in the framework of the present application, the long‐term exposure to residues of flonicamid does not exceed the ADI set for the active substance, and therefore, is unlikely to pose a risk to consumers’ health.

The overview of the assessment of confirmatory data and the recommended MRL modifications are summarised in Appendix B.4.

Abbreviations

a.s.

active substance

ADI

acceptable daily intake

AR

applied radioactivity

ARfD

acute reference dose

BBCH

growth stages of mono‐ and dicotyledonous plants

Bw

body weight

CXL

Codex maximum residue limit

DAT

days after treatment

DT₉₀

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

Dw

dry weight

EC

emulsifiable concentrate

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

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

HR

highest residue

IEDI

international estimated daily intake

IESTI

international estimated short‐term intake

ILV

independent laboratory validation

ISO

International Organisation for Standardisation

IUPAC

International Union of Pure and Applied Chemistry

JMPR

Joint FAO/WHO Meeting on Pesticide Residues

K_oc

organic carbon adsorption coefficient

LC

liquid chromatography

LOAEL

lowest observed adverse effect level

LOD

limit of detection

LOQ

limit of quantification

MRL

maximum residue level

MS

Member States

MS

mass spectrometry detector

MS/MS

tandem mass spectrometry detector

NEU

northern Europe

OECD

Organisation for Economic Co‐operation and Development

PAFF

Standing Committee on Plants, Animals, Food and Feed

PBI

plant back interval

PHI

preharvest interval

PRIMo

(EFSA) Pesticide Residues Intake Model

RA

risk assessment

RD

residue definition

RMS

rapporteur Member State

SANCO

Directorate‐General for Health and Consumers

SEU

southern Europe

STMR

supervised trials median residue

WG

water‐dispersible granule

Appendix A – Summary of GAPs assessed in the evaluation of confirmatory data

A.1. Summary of the authorised/adjusted GAPs relevant for the assessment of confirmatory data

Code	Crop and/or situation	NEU, SEU, MS or country	F, G or Ia	Pests controlled	Active substance (a.s.)	Formulation typeb	a.s. conc. in formulation (g/kg or g/L)	Appl. method	Growth stagec	No of appl.	Interval (days) Minim.	Water amount (L/ha)	Max. appl. Rate (g a.s./ha)	PHI (days)d	Comments
Authorised GAP (EFSA, 2014)
0140020	Cherries (sweet)	NEU	F	Aphid	Flonicamid	WG	500	Foliar treatment	–	2	21		70	14
Authorised GAP (EFSA, 2014)
0140040	Plums	SEU	F	Aphid	Flonicamid	WG	500	Foliar treatment	–	2	21		70	14
Authorised GAP (EFSA, 2014)
	Tomatoes	SEU	F	Aphid	Flonicamid	WG	500	Foliar treatment	–	3	7		50	1
		NEU/SEU	G	Aphid	Flonicamid	WG	500	Foliar treatment	–	3	10		50	1
Adjusted GAP (Finland, 2019)
0231010	Tomatoes	SEU	F	Aphid	Flonicamid	WG	500	Foliar treatment	–	3	7		60	1	This GAP shall substitute the authorised GAP
		NEU/SEU	G	Aphid	Flonicamid	WG	500	Foliar treatment	–	3	7		60	1
Authorised GAP (EFSA, 2014)
0231030	Aubergines/eggplants	NEU/SEU	G	Aphid	Flonicamid	WG	500	Foliar treatment	–	3	10		50	1
Adjusted GAP (Finland, 2019)
0231030	Aubergines/eggplants	NEU/SEU	G	Aphid	Flonicamid	WG	500	Foliar treatment	–	3	7		60	1	This GAP shall substitute the authorised GAP
Authorised GAP (EFSA, 2014)
0233010	Melons	SEU	F	Aphid	Flonicamid	WG	500	Foliar treatment	–	3	7		50	1
0233020	Pumpkins	SEU	F	Aphid	Flonicamid	WG	500	Foliar treatment	–	3	7		50	1
0233030	Watermelons	SEU	F	Aphid	Flonicamid	WG	500	Foliar treatment	–	3	7		50	1
0233010	Melons	NEU/SEU	G	Aphid	Flonicamid	WG	500	Foliar treatment	–	3	7		50	1
0233020	Pumpkins	NEU/SEU	G	Aphid	Flonicamid	WG	500	Foliar treatment	–	3	7		50	1
0233030	Watermelons	NEU/SEU	G	Aphid	Flonicamid	WG	500	Foliar treatment	–	3	7		50	1
Authorised GAP (EFSA, 2014)
0232030	Courgette	NEU/SEU	G	Aphid	Flonicamid	WG	500	Foliar treatment	–	3	7		50	1
Adjusted GAP (Finland, 2019)
0232030	Courgette	NEU/SEU	G	Aphid	Flonicamid	WG	500	Foliar treatment	–	3	7		80	1	This GAP shall substitute the authorised GAP

NEU: northern European Union; SEU: southern European Union; MS: Member State; a.s.: active substance; WG: water‐dispersible granule.

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

^bCropLife International Technical Monograph no 2, 6th Edition. Revised May 2008. 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)	Comment/Source
	Fruit crops	Peach	Foliar: 2 × 100 and 2 × 500 g/ha	21	Radiolabelled active substance: 3‐14C‐phenyl (EFSA, 2010, 2014)
		Pepper	Foliar: 1 × 100 g/ha	7, 14
	Root crops	Potato	Foliar: 2 × 100 and 2 × 500 g/ha	14
	Cereals/grass	Wheat	Foliar: 2 × 100 and 2 × 500 g/ha	21

Rotational crops (available studies)	Crop groups	Crop(s)	Application(s)	PBI (DAT)	Comment/Source
	–	–	–	–	Not triggered (EFSA, 2010)

Processed commodities (hydrolysis study)	Conditions	Stable?	Comment/Source
	Pasteurisation (20 min, 90°C, pH 4)	Yes	Parent flonicamid (EFSA, 2010) TFNG and TFNA (EFSA, 2018c)
	Baking, brewing and boiling (60 min, 100°C, pH 5)	Yes
	Sterilisation (20 min, 120°C, pH 6)	Yes
	Other processing conditions	–	–

B.1.1.2. Storage stability of residues in plants

Plant products (available studies)	Category	Commodity	T (°C)	Stability period		Compounds covered	Comment/Source
				Value	Unit
	High water content	Apple, potatoes	−18	18	Months	Parent and its metabolites TFNG, TFNA, TFNA‐AM	EFSA (2010)
	High oil content	Rape seed	−20	12	Months	Parent and its metabolites TFNG, TFNA	EFSA (2015)
	High protein content	Beans	−20	12	Months	Parent and its metabolites TFNG, TFNA	EFSA (2015)
	Dry/High starch	Wheat grain, wheat straw	−18	18	Months	Parent and its metabolites TFNG, TFNA, TFNA‐AM	EFSA (2010)
	High acid content	Orange (whole fruit)	−18	6	Months	Parent and its metabolites TFNG, TFNA	EFSA (2018c)
	Processed products	–	–	–	–	–	–
	Others	–	–	–	–	–	–

B.1.2. Magnitude of residues in plants

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

Commodity	Region/Indoora	Residue levels observed in the supervised residue trialsb (mg/kg)	Comments/Source	Calculated MRL (mg/kg)	HRc (mg/kg)	STMRd (mg/kg)
Cherries (sweet)	NEU	Residue trials (EFSA, 2014): 0.1; 0.11; 0.12; 0.17 Residue trials supporting authorised GAP (Finland, 2019): 0.07; 0.16; 0.14; 0.18	Residue trials on cherries (sweet) compliant with the authorised GAP	0.4	0.18	0.13
Plums	SEU	Residue trials (EFSA, 2014): 0.04; 0.05; 0.09; 0.11; 0.13 Residue trials supporting authorised GAP (Finland, 2019): 0.03; 0.05; 0.06	Residue trials on plums compliant with the authorised GAP	0.3	0.13	0.06
Tomatoes	SEU	Residue trials (EFSA, 2014): Unscaled: 2 × 0.05; 0.10; 0.15 Scaled: 2 × 0.04; 0.08; 0.11 Residue trials supporting adjusted GAP (Finland, 2019): Unscaled: 3 × 0.05; 0.06 Scaled: 3 × 0.05; 0.06	New trials on tomatoes compliant with the adjusted SEU GAP. Trials assessed by the MRL review were overdosed (3 × 80 g a.s./ha instead of 3 × 60 g a.s./ha) (EFSA, 2014). New and old trials were combined (U test, 5%) and scaled based on proportionality to align with the adjusted SEU GAP for tomatoes (EFSA, 2018b)	0.2	0.11	0.05
Tomatoes Aubergines/Eggplants	Indoor	Residue trials (EFSA, 2014): Unscaled: 2 × 0.07; 0.08; 0.11; 0.17; 0.19; 0.22; 0.24 Scaled: 2 × 0.05; 0.06; 0.08; 0.13; 0.14; 0.17; 0.19 Residue trials supporting adjusted GAP (Finland, 2019): Unscaled: 2 × 0.07; 0.20; 0.34 Scaled: 2 × 0.07; 0.20; 0.34	New trials on tomatoes compliant with the adjusted indoor GAP. The trials assessed by the MRL review were overdosed (3 × 80 g a.s./ha instead of 3 × 60 g a.s./ha) (EFSA, 2014). New and old indoor trials were combined (U test, 5%) and scaled based on proportionality to align with the adjusted GAP (EFSA, 2018b). Extrapolation from tomatoes to aubergines possible	0.5	0.34	0.11
Courgettes	Indoor	Residue trials (EFSA, 2014): 0.08; 0.11; 0.14; 2 × 0.15; 0.16; 0.24; 0.34	Results from trials on cucumbers compliant with the adjusted GAP. Extrapolation from cucumbers to courgettes and whole group of cucurbits with edible peel possible Based on the same data set, the MRL review derived an MRL proposal of 0.5 mg/kg for cucurbits with edible peel, as implemented in Regulation (EU) No 2016/71	0.6	0.34	0.15
Cucurbits with inedible peel (melons, pumpkins, watermelons)	SEU	Residue trials supporting authorised GAP (Finland, 2019): Whole fruit: 0.03; 0.07; 2 × 0.10; 0.13; 0.14; 0.20; 0.23	New trials on melons compliant with the authorised GAP. Extrapolation to the whole group of cucurbits with inedible peel possible	0.4	0.23	0.12
		Pulp: 0.03; 2×0.04; 2×0.06; 0.08; 0.11; 0.14		–	0.14	0.06
	Indoor	–	Residue trials supporting the authorised indoor GAP have not been submitted. The applicant does not want to support this use	–	–	–

MRL: maximum residue level; GAP: Good Agricultural Practice; a.s.: active substance.

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

^bHighest residue generated from the sum of flonicamid and metabolites TFNA and TFNG, expressed as flonicamid. 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.

^dSupervised trials median residue according to the residue definition for monitoring.

B.1.2.2. Residues in rotational crops

B.1.2.3. Processing factors

Not relevant.

B.2. Residues in livestock

Not relevant.

B.3. Consumer risk assessment

B.4. Recommended MRLs

Codea	Commodity	Existing MRLb	Proposed MRL	Conclusion/recommendation
Enforcement residue definition: Flonicamid (sum of flonicamid, TFNA and TFNG expressed as flonicamid)R
0110000	Citrus fruit	0.15 (ft 1)	0.15	The data gap identified by EFSA concerning storage stability studies on flonicamid and metabolites TFNG and TFNA in acidic commodities has been addressed. The MRL is confirmed. The previous consumer risk assessment was updated using revision 3.1 of EFSA PRIMo and confirmed no consumer intake concerns
0140020	Cherries (sweet)	0.4 (ft 2)	0.4	The data gap identified by EFSA concerning additional residue trials supporting the NEU GAP on cherries has been addressed. The MRL is confirmed. The previous consumer risk assessment was updated using revision 3.1 of EFSA PRIMo and confirmed no consumer intake concerns
0140040	Plums	0.3 (ft 2)	0.3	The data gap identified by EFSA concerning additional residue trials supporting the SEU GAP on plums has been addressed. The MRL is confirmed. The previous consumer risk assessment was updated using revision 3.1 of EFSA PRIMo and confirmed no consumer intake concerns
0231010 0231030	Tomatoes Aubergines/eggplants	0.5 (ft 2)	0.5	The data gap identified by EFSA concerning additional residue trials supporting the SEU GAP in tomatoes and the indoor GAP on tomatoes and aubergines has been addressed. The MRL is confirmed. The previous consumer risk assessment was updated using revision 3.1 of EFSA PRIMo and confirmed no consumer intake concerns
0232030	Courgette	0.5 (ft 2)	0.5	The data gap identified by EFSA concerning additional residue trials supporting the indoor GAP on courgettes has been addressed by extrapolation from residue data on cucumbers assessed in the MRL review. The MRL is confirmed. It was noted, however, that the same data set gives higher MRL in the OECD MRL calculator for cucurbits with edible peel (0.6 mg/kg), requiring further risk management consideration. The previous consumer risk assessment was updated using revision 3.1 of EFSA PRIMo and confirmed no consumer intake concerns
0233000	Cucurbits with inedible peel	0.4 (ft 2)	0.4	The data gap identified by EFSA concerning additional residue trials supporting the SEU GAP in cucurbits with inedible peel has been addressed. The MRL is confirmed. The previous consumer risk assessment was updated using revision 3.1 of EFSA PRIMo and confirmed no consumer intake concerns. The data gap identified by EFSA concerning additional residue trials supporting the indoor GAP on cucurbits with inedible peel has not been addressed; the applicant informed that this use is no longer supported
0500070 0500090	Rye Wheat	2 (ft 3)	2	The data gap identified by EFSA concerning hydrolysis study on flonicamid metabolites TFNG and TFNA has been addressed. The MRL is confirmed. The previous consumer risk assessment was updated using revision 3.1 of EFSA PRIMo and confirmed no consumer intake concerns
0700000	Hops	3 (ft 4)	3	The data gap identified by EFSA concerning a validated analytical method in hops has been addressed. The MRL is confirmed. The previous consumer risk assessment was updated using revision 3.1 of EFSA PRIMo and confirmed no consumer intake concerns

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

^RThe residue definition differs for the following combinations pesticide‐code number: Flonicamid — code 1000000, except code 1040000: Sum of flonicamid and TFNA‐AM, expressed as flonicamid.

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

^bExisting EU MRL and corresponding footnote on confirmatory data.

^{ft 1}The European Food Safety Authority identified some information on storage stability as unavailable. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 27 January 2018, or, if that information is not submitted by that date, the lack of it.

^{ft 2}The European Food Safety Authority identified some information on residue trials as unavailable. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 27 January 2018, or, if that information is not submitted by that date, the lack of it.

^{ft 3}The European Food Safety Authority identified some information on hydrolysis study in processed commodities as unavailable. When reviewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 27 January 2018, or, if that information is not submitted by that date, the lack of it.

^{ft 4}The European Food Safety Authority identified some information on analytical methods as unavailable. When re‐viewing the MRL, the Commission will take into account the information referred to in the first sentence, if it is submitted by 27 January 2018, or, if that information is not submitted by that date, the lack of it.

Appendix C – Pesticide Residue Intake Model (PRIMo)

1.

PRIMo rev.3.113

Appendix D – Input values for the exposure calculations

D.1. Consumer risk assessment

Commodity	Chronic risk assessment		Acute risk assessment
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Cherries	0.13	STMR	0.18	HR
Plums	0.06	STMR	0.13	HR
Tomatoes	0.11	STMR	0.34	HR
Aubergines (egg plants)	0.11	STMR	0.34	HR
Courgettes	0.15	STMR	0.34	HR
Cucumbers, gherkins	0.15	STMR	0.34	HR
Cucurbits ‐ inedible peel	0.06	STMR (melon pulp)	0.14	HR (melon pulp)
Hops (dried)	0.61	STMR	1.29	HR
Citrus fruit	0.04	STMR (EFSA, 2018c)	0.07	HR (EFSA, 2018c)
Rye	0.35	STMR (EFSA, 2018c)	0.35	STMR (EFSA, 2018c)
Wheat	0.35	STMR (EFSA, 2018c)	0.35	STMR (EFSA, 2018c)
Strawberries	0.14	STMR (EFSA, 2019b)	0.45	HR (EFSA, 2019b)
Blueberries	0.23	STMR (EFSA, 2019b)	0.46	HR (EFSA, 2019b)
Cranberries	0.23	STMR (EFSA, 2019b)	0.46	HR (EFSA, 2019b)
Currants	0.23	STMR (EFSA, 2019b)	0.46	HR (EFSA, 2019b)
Gooseberries	0.23	STMR (EFSA, 2019b)	0.46	HR (EFSA, 2019b)
Pome fruit	0.06	STMR (EFSA, 2014)	0.19	HR (EFSA, 2014)
Apricots	0.10	STMR (EFSA, 2018b, 2018c, d, 2019b)	0.127	HR (EFSA, 2018b, 2018c, d, 2019b)
Peaches	0.08	STMR (EFSA, 2014)	0.3	HR (EFSA, 2014)
Blackberries	0.36	STMR (EFSA, 2018c)	0.48	HR (EFSA, 2018c)
Raspberries	0.36	STMR (EFSA, 2018c)	0.48	HR (EFSA, 2018c)
Potatoes	0.03	STMR (EFSA, 2014)	0.06	HR (EFSA, 2014)
Beetroots	0.05	STMR (EFSA, 2018c)	0.15	HR (EFSA, 2018c)
Carrots	0.05	STMR (EFSA, 2018c)	0.15	HR (EFSA, 2018c)
Celeriacs	0.05	STMR (EFSA, 2018c)	0.15	HR (EFSA, 2018c)
Horseradishes	0.05	STMR (EFSA, 2018c)	0.15	HR (EFSA, 2018c)
Jerusalem artichokes	0.05	STMR (EFSA, 2018c)	0.15	HR (EFSA, 2018c)
Parsnips	0.05	STMR (EFSA, 2018c)	0.15	HR (EFSA, 2018c)
Parsley root	0.05	STMR (EFSA, 2018c)	0.15	HR (EFSA, 2018c)
Radishes	0.22	STMR (EFSA, 2018c)	0.29	HR (EFSA, 2018c)
Salsifies	0.05	STMR (EFSA, 2018c)	0.15	HR (EFSA, 2018c)
Swedes	0.05	STMR (EFSA, 2018c)	0.15	HR (EFSA, 2018c)
Turnips	0.05	STMR (EFSA, 2018c)	0.15	HR (EFSA, 2018c)
Peppers	0.06	STMR (EFSA, 2015)	0.15	HR (EFSA, 2015)
Cucumbers	0.15	STMR (EFSA, 2014)	0.34	HR (EFSA, 2014)
Gherkins	0.15	STMR (EFSA, 2014)	0.34	HR (EFSA, 2014)
Other cucurbits ‐ edible peel	0.15	STMR (EFSA, 2014)	0.34	HR (EFSA, 2014)
Brussels sprouts	0.07	STMR (EFSA, 2015)	0.32	HR (EFSA, 2015)
Head cabbage	0.14	STMR (EFSA, 2017, 2018c,d, 2019b)	0.23	HR (EFSA, 2018b, 2018c, d, 2019b)
Lettuce and other salad plants including Brassicaceae	0.03	STMR (EFSA, 2018c)	0.05	HR (EFSA, 2018c)
Herbs	0.71	STMR (EFSA, 2016)	3	HR (EFSA, 2016)
Beans (with pods)	0.34	STMR (EFSA, 2018b, 2018c, d, 2019b)	0.67	STMR (EFSA, 2018b, 2018c, d, 2019b)
Peas (with pods)	0.34	STMR (EFSA, 2018b, 2018c, d, 2019b	0.67	STMR (EFSA, 2018b, 2018c, d, 2019b)
Peas (without pods)	0.20	STMR (EFSA, 2015)	0.35	STMR (EFSA, 2015)
Beans (dry)	0.16	STMR (EFSA, 2018c)	0.16	STMR (EFSA, 2018c)
Lentils	0.16	STMR (EFSA, 2018c)	0.16	STMR (EFSA, 2018c)
Peas (dry)	0.16	STMR (EFSA, 2018c)	0.16	STMR (EFSA, 2018c)
Lupins	0.16	STMR (EFSA, 2018c)	0.16	STMR (EFSA, 2018c)
Cotton seed	0.04	STMR (EFSA, 2015)	0.04	STMR (EFSA, 2015)
Barley	0.17	STMR (EFSA, 2015)	0.17	STMR (EFSA, 2015)
Oats	0.17	STMR (EFSA, 2015)	0.17	STMR (EFSA, 2015)
Sugar beet (root)	0.03	STMR (EFSA, 2018b, 2018c, d, 2019b)	0.03	STMR (EFSA, 2018b, 2018c, d, 2019b)
Swine, Bovine, Sheep, Goat, Horse: meat	0.06	STMR (FAO, 2016)	0.102	HR (FAO, 2016)
Swine, Bovine, Sheep, Goat, Horse: fat	0.02	STMR (FAO, 2016)	0.03	HR (FAO, 2016)
Swine, Bovine, Sheep, Goat, Horse: liver	0.10	STMR (FAO, 2016)	0.17	HR (FAO, 2016)
Swine, Bovine, Sheep, Goat, Horse: kidney	0.10	STMR (FAO, 2016)	0.17	HR (FAO, 2016)
Swine, Bovine, Sheep, Goat, Horse: edible offal	0.10	STMR (FAO, 2016)	0.17	HR (FAO, 2016)
Poultry: meat	0.04	STMR (FAO, 2016)	0.076	HR (FAO, 2016)
Poultry: fat	0.04	STMR (FAO, 2016)	0.04	HR (FAO, 2016)
Poultry: liver	0.04	STMR (FAO, 2016)	0.09	HR (FAO, 2016)
Poultry: kidney	0.04	STMR (FAO, 2016)	0.09	HR (FAO, 2016)
Poultry: edible offal	0.04	STMR (FAO, 2016)	0.09	HR (FAO, 2016)
Milk and cream	0.05	STMR (FAO, 2016)	0.05	STMR (FAO, 2016)
Bird's eggs	0.08	STMR (EFSA, 2018c)	0.12	HR (EFSA, 2018c)

STMR: supervised trials median residue; HR: highest residue.

Appendix E – Used compound codes

1.

Code/trivial name	Chemical name/SMILES notation/InChIKeya	Structural formula
flonicamid	N‐cyanomethyl‐4‐(trifluoromethyl)nicotinamide O=C(NCC#N)c1cnccc1C(F)(F)F RLQJEEJISHYWON‐UHFFFAOYSA‐N
TFNA	4‐(trifluoromethyl)nicotinic acid or 4‐(trifluoromethyl)pyridine‐3‐carboxylic acid OC(=O)c1cnccc1C(F)(F)F LMRJHNFECNKDKH‐UHFFFAOYSA‐N
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
TFNA‐AM	4‐(trifluoromethyl)nicotinamide or 4‐(trifluoromethyl)pyridine‐3‐carboxamide O=C(N)c1cnccc1C(F)(F)F JUIWZYBJXUPIKF‐UHFFFAOYSA‐N

SMILES: simplified molecular‐input line‐entry system; InChiKey: International Chemical Identifier Key.

^aACD/ChemSketch, Advanced Chemistry Development, Inc., ACD/Labs Release: 12.00 Product version: 12.00 (Build 29305, 25 November 2008).

Suggested citation: EFSA (European Food Safety Authority) Anastassiadou M, Bernasconi G, Brancato A, Carrasco Cabrera L, Greco L, Jarrah S, Kazocina A, Leuschner R, Magrans JO, Miron I, Nave S, Pedersen R, Reich H, Rojas A, Sacchi A, Santos M, Stanek A, Theobald A, Vagenende B and Verani A, 2020. Reasoned Opinion on the evaluation of confirmatory data following the Article 12 MRL review for flonicamid. EFSA Journal 2020;18(5):6117, 29 pp. 10.2903/j.efsa.2020.6117