Setting of import tolerances for flonicamid in various crops and products of animal origin

Abstract

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 Finland to set an import tolerance for the active substance flonicamid in various crops and products of animal origin on the basis of the authorised use of flonicamid in the USA. The data submitted in support of the request were found to be sufficient to derive maximum residue level (MRL) proposals for all crops under assessment. Based on the results of the feeding studies and the updated animal burden calculations, no need for new MRL proposals on products of animal origin was identified. Adequate analytical methods for enforcement are available to control the residues of flonicamid in plant and animal matrices. EFSA updated the most recent consumer risk assessment for flonicamid and concluded that the authorised USA uses of flonicamid will not result in acute or chronic consumer exposure exceeding the toxicological reference values and, therefore, is unlikely to pose a risk to consumers’ health.

Summary

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 Finland (evaluating Member State, EMS) to set import tolerances for the active substance flonicamid in various crops and products of animal origin on the basis of authorised use of flonicamid in the USA. The EMS drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 11 December 2019. The EMS proposed to raise MRLs for almonds, potatoes, beans and peas (with and without pods), pulses and hops; the EMS did not propose to modify the existing MRLs for other tree nuts (except almonds), basil and edible flowers as well as for the commodities of animal origin.

EFSA assessed the application and the evaluation report 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, including the MRL review according to Article 12 of the Regulation (EU) 396/2005 (MRL review) and the additional data provided by the EMS in the framework of this application, the following conclusions are derived.

The metabolism of flonicamid has been investigated in fruit (peach, pepper), root (potato) and cereals/grass (wheat) crop groups. Parent flonicamid and the two metabolites 4‐trifluoromethylnicotinic acid (TFNA) and N‐(4‐trifluoromethylnicotinoyl) glycine (TFNG) were found to be the main residues. Studies investigating the effect of processing on the nature of flonicamid (hydrolysis studies) demonstrated that the active substance and its metabolites are hydrolytically stable under the representative conditions.

As the authorised uses of flonicamid are on imported crops, investigations of residues in rotational crops are not required.

Based on the metabolic pattern identified in metabolism studies, the results of hydrolysis studies, the toxicological significance of metabolites and degradation products, the residue definition for plant products was proposed as ‘sum of flonicamid, TFNA and TFNG, expressed as flonicamid’ for enforcement and risk assessment. This residue definition is applicable to primary crops, rotational crops and processed products.

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

Sufficiently validated analytical methods based on high‐performance liquid chromatography with tandem mass spectrometry (HPLC‐MS/MS) are available to quantify residues in the crops assessed in this application according to the enforcement residue definition. The methods allow quantifying residues for each analyte included in the residue definition at the limit of quantification (LOQ) of 0.01 mg/kg (combined LOQ of 0.03 mg/kg) for high water, high acid, high oil, dry commodities and fresh hops and at the LOQ of 0.05 mg/kg (combined LOQ of 0.15 mg/kg) for dried hops.

The available residue trials are sufficient to derive MRL proposals for tree nuts (except coconuts), potatoes, beans (with and without pods), peas (with and without pods), pulses and hops. For basil and edible flowers (covering mint), the trials were also sufficient but did not suggest the modification of the MRL in place.

The processing factors (PF) derived for potato chips and potato flakes from the studies submitted under current assessment were not robust enough to be included in Annex VI of Regulation (EC) No 396/2005.

Among the crops under assessment, potatoes and pulses may be used for feed purposes. Since import of these commodities in Europe is applied for, these crops or their by‐products can enter the EU livestock feed chain. Thus, a potential carry‐over of flonicamid residues into food of animal origin was assessed. The calculated EU livestock dietary burden exceeded the trigger value of 0.1 mg/kg dry matter (DM) for all relevant animal species, but the calculated exposure was significantly lower than the livestock exposure calculated by the JMPR, based on which the existing EU MRLs for flonicamid in commodities of animal origin were recently set.

The toxicological profile of flonicamid was assessed in the framework of the EU pesticides peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.025 mg/kg body weight (bw) per day and an acute reference dose (ARfD) of 0.025 mg/kg bw. The metabolites included in the residue definition are of similar toxicity as the parent active substance.

The consumer risk assessment was performed with revision 3.1 of the EFSA Pesticide Residues Intake Model (PRIMo). The short‐term exposure assessment was performed only with regard to the commodities assessed in the present MRL application in accordance with the internationally agreed methodology. The short‐term exposure was below the ARfD for all commodities and accounted the highest for peas (without pods) (96% of ARfD), beans (without pods) (93% of ARfD), potatoes (68% of ARfD), peas (with pods) (66% of ARfD) and beans (with pods) (64% of ARfD).

The long‐term exposure assessment performed in the most recent EFSA reasoned opinion published after the MRL review was updated with the risk assessment values derived from the residue trials submitted in support of the present MRL application. The highest estimated long‐term dietary intake was 30% of the ADI (NL toddler). The contribution of residues of flonicamid in the crops under consideration to the overall long‐term exposure was individually less than 3% of ADI.

Based on the consumer exposure assessment, EFSA concludes that the authorised USA uses of flonicamid will not result in acute or chronic 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 summary table below.

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

Codea	Commodity	Existing EU MRL (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition (plant commodities): Flonicamid (sum of flonicamid, TFNA and TFNG, expressed as flonicamid)
0120000	Tree nuts (except coconuts and pistachios)	0.06*	0.07	The submitted data are sufficient to derive an import tolerance based on the authorised US GAP. Risk for consumers unlikely
0120100	Pistachios	0.06*	0.3	The submitted data are sufficient to derive an import tolerance based on the authorised US GAP. Risk for consumers unlikely
0211000	Potatoes	0.09	0.2	The submitted data are sufficient to derive an import tolerance based on the authorised US GAP. Risk for consumers unlikely
0256080	Basil and edible flowers (Mint)	6	No change	The submitted data do not provide evidence that the existing MRL has to be modified
0260010	Beans (with pods)	1.5	3.0	The submitted data are sufficient to derive an import tolerance based on the authorised US GAP. Risk for consumers unlikely
0260020	Beans (without pods)	0.03*	5.0	The submitted data are sufficient to derive an import tolerance based on the authorised US GAP. Risk for consumers unlikely
0260030	Peas (with pods)	1.5	3.0	The submitted data are sufficient to derive an import tolerance based on the authorised US GAP. Risk for consumers unlikely
0260040	Peas (without pods)	0.7	5.0	The submitted data are sufficient to derive an import tolerance based on the authorised US GAP. Risk for consumers unlikely
0300000	Pulses	0.8	2.0	The submitted data are sufficient to derive an import tolerance based on the authorised US GAP. Risk for consumers unlikely
0700000	Hops	3 (ft)b	20	The submitted data are sufficient to derive an import tolerance based on the US GAP. Risk for consumers unlikely
Enforcement residue definition (animal commodities): Sum of flonicamid and TFNA‐AM expressed as flonicamid
1011010 1012010 1013010 1014010 1015010	Swine, Bovine, Sheep, Goat, Horse: meat	0.15	No change	The submitted data do not provide evidence that the existing MRL has to be modified
1011020 1012020 1013020 1014020 1015020	Swine, Bovine, Sheep, Goat, Horse: fat	0.05	No change	The submitted data do not provide evidence that the existing MRL has to be modified
1011030 1012030 1013030 1014030 1015030	Swine, Bovine, Sheep, Goat, Horse: liver	0.2	No change	The submitted data do not provide evidence that the existing MRL has to be modified
1011040 1012040 1013040 1014040 1015040	Swine, Bovine, Sheep, Goat, Horse: kidney	0.2	No change	The submitted data do not provide evidence that the existing MRL has to be modified
1011050 1012050 1013050 1014050 1015050	Swine, Bovine, Sheep, Goat, Horse: edible offal	0.2	No change	The submitted data do not provide evidence that the existing MRL has to be modified
1020000	Milk	0.15	No change	The submitted data do not provide evidence that the existing MRL has to be modified

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

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

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

^bAn analytical method for the determination of residues of flonicamid in hops was submitted and evaluated by EFSA (2020) in response to confirmatory data identified in the framework of the EFSA MRL review on flonicamid (EFSA, 2014) and footnote (ft) implemented in Reg. (EC) No 396/2005 for flonicamid in hops.

(ft): 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 European Food Safety Authority (EFSA) received an application to modify the existing maximum residue level (MRL) for flonicamid in various crops and products of animal origin. The detailed description of the authorised uses of flonicamid in the USA, which are the basis for the current MRL application, is reported in Appendix A.

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.

Flonicamid was evaluated in the framework of Directive 91/414/EEC1 with France designated as rapporteur Member State (RMS) for the representative uses as foliar spray applications on potatoes, wheat, apples and pears in northern and southern European Union (EU) and on peaches in the southern EU. The draft assessment report (DAR) prepared by the RMS has been peer reviewed by EFSA (2010). Flonicamid was approved2 for the use as insecticide on 1 September 2010.

The EU MRLs for flonicamid are established in Annex II of Regulation (EC) No 396/20053. The review of existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (MRL review) has been performed (EFSA, 2014) 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 (EFSA, 2015, 2016a, 2017, 2018b,c, 2019b, 2020). Proposals from these reasoned opinions have been considered in recent MRL regulations.4 Certain Codex maximum residue limits (CXLs) have been taken over in the EU MRL legislation.5

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 Finland (evaluating Member State, EMS) to set import tolerances for the active substance flonicamid in various crops and products of animal origin. The EMS drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the EFSA on 11 December 2019. The EMS proposed to raise MRLs for almonds, potatoes, beans and peas (with and without pods), pulses and hops; the EMS did not propose to modify the existing MRLs for other tree nuts (except almonds), basil and edible flowers as well as for the commodities of animal origin.

EFSA based its assessment on the evaluation report submitted by the EMS (Finland, 2019), the draft assessment report (DAR) (and its addendum) (France, 2005, 2009) prepared under Council Directive 91/414/EEC, the Commission review report on flonicamid (European Commission, 2010a), the conclusion on the peer review of the pesticide risk assessment of the active substance flonicamid (EFSA, 2010), as well as the conclusions from previous EFSA opinions on flonicamid (EFSA, 2015, 2016a,b, 2017, 2018b,c, 2019b, 2020).

For this application, the data requirements established in Regulation (EU) No 544/20116 and the guidance documents applicable at the date of submission of the application to the EMS are applicable (European Commission, 1997a, 1997b, 1997c, 1997d, 1997e, 1997f, 1997g, 2000, 2010b, 2010c, 2017; OECD, 2011, 2013). The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation of Plant Protection Products adopted by Commission Regulation (EU) No 546/20117.

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

The evaluation report submitted by the EMS (Finland, 2019) and the exposure calculations using the EFSA Pesticide Residues Intake Model (PRIMo) are considered as supporting documents to this reasoned opinion and, thus, are made publicly available as background documents to this reasoned opinion.

1. Residues in plants

1.1. Nature of residues and methods of analysis in plants

1.1.1. Nature of residues in primary crops

The metabolism of flonicamid in primary crops belonging to the group of fruit crops (peach, pepper), root crops (potato) and cereals/grass (wheat) has been investigated in the framework of the EU pesticides peer review and the MRL review (EFSA, 2010, 2014).

In the crops tested, parent compound and the two metabolites 4‐trifluoromethylnicotinic acid (TFNA) and N‐(4‐trifluoromethylnicotinoyl) glycine (TFNG) were found to be the main residues.

For the authorised uses under consideration, the metabolic behaviour in primary crops is sufficiently addressed.

1.1.2. Nature of residues in rotational crops

Investigations of residues in rotational crops are not required for imported crops. In any case, the need for trials on rotational crops is not triggered for flonicamid as, based on soil degradation studies evaluated in the framework of the peer review (EFSA, 2010), the DT₉₀ value of flonicamid and its metabolites ranged from 1.5 to 8.7 days, which is far below the trigger value of 100 days (European Commission, 1997c).

1.1.3. Nature of residues in processed commodities

Standard hydrolysis studies investigating the nature of residues in processed commodities and simulating processing conditions representative of pasteurisation, boiling and sterilisation were assessed in the EU pesticides peer review, the MRL review and in a previous MRL application (EFSA, 2010, 2014, 2018b). It was concluded that the parent compound flonicamid and its metabolites are hydrolytically stable under the representative conditions.

1.1.4. Methods of analysis in plants

Analytical methods for the determination of flonicamid residues and metabolites (TFNG and TFNA) in plant commodities were assessed during the EU pesticides peer review, the MRL review and the recently evaluated Art. 12 confirmatory data (EFSA, 2010, 2014, 2020). Sufficiently validated methods are available for the monitoring of residues of flonicamid and its metabolites in high water, high acid, high oil, dry commodities, fresh and dried hops, based on HPLC‐MS/MS. The methods allow quantifying residues for each analyte included in the residue definition at the individual LOQ of 0.01 mg/kg (combined LOQ of 0.03 mg/kg) for high water, high acid, high oil, dry commodities and fresh hops and at the LOQ of 0.05 mg/kg (combined LOQ of 0.15 mg/kg) for dried hops (EFSA, 2010, 2014, 2020).

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

1.1.5. Storage stability of residues in plants

The storage stability of flonicamid and metabolites TFNA and TFNG in plants stored under frozen conditions was investigated in the framework of the EU pesticides peer review and previous MRL applications (EFSA, 2010, 2015, 2018b).

According to the studies available, flonicamid and metabolites are stable for up to 18 months when stored at −18°C in high water content and dry commodities, up to 12 months when stored at −20°C in high oil and high protein content commodities and up to 6 months when stored at −18°C in high acid content commodities.

Additional information on the stability of residues in frozen samples from commodities of high water content (spinach, tomatoes), high oil content (cotton seed) and high starch content (potato tuber, wheat grain) was submitted by the applicant (Finland, 2019). Based on these studies, flonicamid and its metabolites TFNA and TFNG were found to be stable for up to 23 months at −18°C in spinach and tomatoes, cotton seed, potato tuber and wheat grain.

Information on the storage stability of residues of flonicamid in processed apple (juice), cotton seed (oil) and processed cereals also became available (Finland, 2019). Results from these studies showed that residues of flonicamid are stable for up to 23 months in apple juice, cotton oil and processed cereals when stored at −18°C.

In mint oil, flonicamid and metabolites TFNA and TFNG were found to degrade more than 50% when stored for a year at −18°C.

Details on storage stability data are presented in Appendix B.1.1.2.

1.1.6. Proposed residue definitions

Based on the metabolic pattern identified in metabolism studies, the results of hydrolysis studies, the toxicological significance of metabolites and degradation products, the following residue definition for plant commodities was proposed in the framework of the MRL Review (EFSA, 2014):

• Residue definition for enforcement and for risk assessment: sum of flonicamid and the metabolites 4‐(trifluoromethyl) nicotinic acid (TFNA) and N‐[4‐(trifluoromethyl)nicotinoyl] glycine (TFNG), expressed as flonicamid.

TThe residue definition for enforcement set in Regulation (EC) No 396/2005 is identical with the above‐mentioned residue definition. Taking into account the available information for the uses assessed in this application, EFSA concluded that the existing residue definition is appropriate, and no modification is required.

1.2. Magnitude of residues in plants

1.2.1. Magnitude of residues in primary crops

In support of the MRL application, the applicant submitted results from residue trials on the following commodities: almonds, pecans, pistachios, potatoes, fresh beans and peas (with and without pods), beans and peas (dry), mint and hops.

Samples taken in the context of the available trials were analysed for the parent compound and the metabolites included in the residue definitions for enforcement and risk assessment, expressed as flonicamid equivalents.

In the framework of this application, additional method validation data were submitted in support of the residue trials available for flonicamid residues in high water (peach), dry (wheat straw) and high starch content (potato) commodities (Finland, 2019). Additionally, an internal laboratory validation study on high oil content matrices (cotton seed) became available, in support of the crop field trials on hops. All methods, based on HPLC‐MS/MS, were found to be sufficiently validated to support the determination of residues of flonicamid in the crops under assessment.

Samples were stored under conditions ensuring stability of flonicamid, TFNA and TFNG (Finland, 2019).

All studies concern field trials performed on crops growing in the USA (Finland, 2019).

1.2.1.1. Tree nuts

Authorised good agricultural practice (GAP) in the USA (Finland, 2019): 3 appl. × 100 g a.s./ha, preharvest interval (PHI): 40 days

In support of the authorised use on tree nuts in the USA, the applicant submitted five residue trials on almonds, five trials on pecans and two trials on pistachios, which were performed in the USA over the growing seasons of 2011 and 2014. In one of the pecan trials, the sample was taken at the PHI of 20 instead of 40 days as in the authorised GAP; the data from this trial were disregarded. Remaining trials were compliant with the authorised GAP.

EFSA noted that only one trial was a decline trial (almond trial) as the requirement for 50% decline trials is not mandatory in the USA. Considering, however, that tree nuts are minor crop in the EU and worldwide and that the results from the decline trial did not indicate an increase of flonicamid residues after 20, 30, 40 and 50 days following the product's last treatment, the trials were considered acceptable.

The applicant proposes to combine available residue trials on almonds, pecan nuts and pistachios and extrapolate to the whole group of tree nuts. In its evaluation report, the EMS does not support the extrapolation from trials on pistachios and makes reference to the European Commission Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs, according to which ‘trials on pistachios (0120100) cannot be used for extrapolation purposes if last application took place at a growth stage where pistachios were already open’ (European Commission, 2017). Therefore, results from pistachios could not be used to derive MRL proposals for almonds and pecans.

On the other hand, results from trials on almonds and pecans were relevant and could be used to derive an MRL proposal for pistachios (European Commission, 2017).

Based on the above,

• results from five trials on almonds and four trials on pecans were combined to derive an MRL proposal of 0.07 mg/kg for flonicamid in these commodities and, by extrapolation, to the whole group of tree nuts (except coconuts and pistachios) (European Commission, 2017).

• results from five trials on almonds, four trials on pecans and two trials on pistachios were combined and used to derive an MRL proposal of 0.3 mg/kg for flonicamid in pistachios (European Commission, 2017).

The tolerance of flonicamid in the USA8 is set at 0.15 mg/kg for tree nuts (except pistachios) and at 0.6 mg/kg for pistachios.

1.2.1.2. Potatoes

Authorised GAP in the USA (Finland, 2019): 3 appl. × 100 g a.s./ha, PHI: 7 days

In support of the authorised use on potatoes, the applicant submitted 17 GAP compliant outdoor residue trials on this commodity. All trials were performed in the USA over the growing season of 2001 except one which was performed in 2002. Two trials were experimental replicates and the mean value of the trial data was selected. Therefore, 16 was the number of results used to derive an MRL proposal for this commodity.

EFSA noted that only two from these studies were decline trials as the requirement for 50% decline trials is not mandatory in the USA. The effect of time on the level of residues present in these two decline trials was investigated and showed to clearly decrease over time. This information was considered sufficient to proceed with the present assessment.

The number of submitted trials is sufficient to derive an MRL proposal of 0.2 mg/kg for flonicamid in potatoes. The tolerance of flonicamid in USA9 is set at 0.2 mg/kg.

1.2.1.3. Mint

Authorised GAP in the USA (Finland, 2019): 3 appl. × 100 g a.s./ha, PHI: 7 days

In support of the authorised use on mint (subgroup of ‘basil and edible flowers’), the applicant submitted five GAP compliant outdoor residue trials on this commodity. All trials were performed in the USA over the growing season of 2011. EFSA noted that no decline trials were carried out on mint. Nevertheless, the effect of time on the level of residues of flonicamid in fresh herbs was investigated in previously evaluated trials which showed that levels of flonicamid residues clearly decline from a PHI of 7 days to 14 days (EFSA, 2016a). This information was considered sufficient to proceed with the present assessment.

The number of submitted trials is sufficient to derive an MRL proposal of 6 mg/kg for flonicamid in mint.10 The tolerance of flonicamid in USA11 is set at 7 mg/kg.

1.2.1.4. Fresh beans and peas

Beans and peas (with pods)

Authorised GAP in the USA (Finland, 2019): 3 appl. × 100 g a.s./ha, PHI: 7 days

In support of the authorised use on beans (with pods) and peas (with pods), the applicant submitted seven outdoor residue trials on beans (with pods) and five outdoor trials on peas (with pods). All trials were performed in the USA over the growing season of 2012, except from one trial in peas (with pods) which was performed in 2013. In one of the bean and one of the pea trials, the samples were taken at the PHIs of 10 and 4 instead of 7 days as in the authorised GAP; the data from these trials were disregarded. Remaining trials were compliant with the authorised GAP.

EFSA noted that only one out of the 10 available trials on beans, peas (with pods) was a decline trial as the requirement for 50% decline trials is not mandatory in the USA. In this trial, residues appear to remain stable over time (day 1 to day 10) although a slight increase was documented from PHI 10 (0.72 mg/kg) to 15 (0.86 mg/kg) but still within the same order of magnitude. Additional information on the effect of time on the level of residues of flonicamid in beans and peas (with pods) was retrieved from previously evaluated trials which showed similar levels of residues for PHIs of 7 days and 14 days (EFSA, 2017). This information was considered sufficient to proceed with the present assessment.

Beans with pods are major crop in the world, for which at least eight GAP compliant residue trials need to be submitted (European Commission, 2017). In this respect, the EMS and the applicant proposed to combine the residue data on beans and peas in order to derive an MRL for both crops with pods. As the residue data on beans with pods and peas with pods are of the same population according to statistical tests, the incomplete residue data set on beans can be completed with additional trials on peas with pods.

A combined residue data set indicates than an MRL of 3 mg/kg would be required to support the authorised use on beans (with pods) and peas (with pods) in the USA. The tolerance of flonicamid in USA12 is set at 4 mg/kg.

Beans and peas (without pods)

Authorised GAP in the USA (Finland, 2019): 3 appl. × 100 g a.s./ha, PHI: 7 days

In support of the authorised use on beans (without pods) and peas (without pods), the applicant submitted six outdoor trials on beans (without pods) and six outdoor trials on peas (without pods). All trials were performed in the USA over the growing season of 2012. One of the pea trials was performed with four applications instead of 3 as in the authorised GAP; the data from this trial were disregarded. Remaining trials were compliant with the authorised GAP.

EFSA noted that no decline trials were carried out on beans and peas (without pods). Nevertheless, the information retrieved from previously evaluated trials on beans and peas (with pods) was considered equally relevant to support that residues of flonicamid in beans and peas (without pods) would not be expected to increase over time (EFSA, 2017). This information was considered sufficient to proceed with the present assessment.

Peas without pods are major crop in the world, for which at least eight GAP compliant residue trials need to be submitted (European Commission, 2017). In this respect, the EMS and the applicant proposed to combine the residue data on beans and peas in order to derive an MRL for both crops without pods. As the residue data on beans without pods and peas without pods are of the same population according to statistical tests, the incomplete residue data set on peas can be completed with additional trials on beans without pods.

A combined residue data set indicates than an MRL of 5 mg/kg would be required to support the authorised use on beans (without pods) and peas (without pods) in the USA. The tolerance of flonicamid in USA12 is set at 6 mg/kg.

1.2.1.5. Pulses

Authorised GAP in the USA (Finland, 2019): 3 appl. × 100 g a.s./ha, PHI: 7 days

In support of the authorised use on pulses, the applicant submitted 10 outdoor trials on dry beans and 5 outdoor trials on dry peas. Trials were performed in the USA over the growing seasons of 2010 and 2011 for dry beans and 2012 for dry peas. One of the bean trials was performed with four applications instead of 3 as in the authorised GAP; the data from this trial were disregarded. Remaining trials were compliant with the authorised GAP.

EFSA noted that no decline trials were performed on dried beans or peas, as the requirement for 50% declined trials is not mandatory in the US. Information on the effect of time on the level of residues of flonicamid in beans and peas (dried) was retrieved from previously evaluated trials and found to decline over time (EFSA, 2018b). This information was considered sufficient to proceed with the present assessment.

Dried beans and peas are major crops in the world, for which at least eight GAP compliant residue trials need to be submitted (European Commission, 2017). The EMS and the applicant proposed to combine the residue data on beans and peas in order to derive MRL for all pulses. As the residue data on beans and peas are of the same population according to statistical tests, the incomplete residue data set on peas can be completed with additional results from beans (and vice versa).

A combined residue data set indicates than an MRL of 2 mg/kg would be required to support the authorised use on pulses in the USA. The tolerance of flonicamid in USA12 is set at 3 mg/kg.

1.2.1.6. Hops

Authorised GAP in the USA (Finland, 2019): 3 appl. × 100 g a.s./ha, PHI: 10 days

In support of the authorised use on hops, the applicant submitted four GAP compliant outdoor trials on this commodity. All trials were performed in the USA over the growing season of 2003, except from one in 2014. EFSA noted that no decline trials were performed on hops. Information on the effect of time on the level of residues of flonicamid in hops was retrieved from previously evaluated trials. The results from these trials indicated that residues of flonicamid in hops do not increase over time (until PHI 28) (EFSA, 2014). This information was considered sufficient to proceed with the present assessment.

The number of trials is sufficient to derive an MRL proposal of 20 mg/kg in hops. The tolerance of flonicamid in USA8 is set at 20 mg/kg.

1.2.2. Magnitude of residues in rotational crops

The soil degradation studies evaluated in the framework of the peer review (EFSA, 2010) demonstrated that the DT₉₀ value of flonicamid and its metabolites ranged from 1.5 to 8.7 days which is far below the trigger value of 100 days (European Commission, 1997c). Thus, further studies on rotational crops are not required.

1.2.3. Magnitude of residues in processed commodities

Studies investigating the effect of processing on the magnitude of residues of flonicamid and its metabolites in processed commodities were assessed in the framework of the peer review and the Article 12 MRL review (EFSA, 2010, 2014).

Additional data from studies on processed potatoes and processed mint were submitted by the applicant for the current assessment (Finland, 2019).

1.2.3.1. Potato chips and potato flakes

Results from studies carried out on potatoes showed higher levels of flonicamid in processed than in raw potatoes and suggested that residues of flonicamid concentrate in potato chips and potato flakes. The processing factors estimated for potato chips and potato flakes can only be considered indicative as they originate from one trial only.

1.2.3.2. Mint oil

Results from two studies carried out on mint suggest that residues of flonicamid would not be expected to concentrate in mint oil. However, since residues of flonicamid and metabolites TFNA and TFNG were found to considerably degrade in mint oil after a year of storage at −18°C (> 50%) and samples of mint oil before analysis were stored for this period of time, this result is not considered valid and cannot be used to derive a processing factor for flonicamid in mint oil.

A resume of the processing studies and estimated processing factors is presented in Appendix B.1.2.3.

1.2.4. Proposed MRLs

The available data are considered sufficient to derive MRL proposals as well as risk assessment values for the commodities under evaluation (see Appendix B.1.2.1). In Section 3, EFSA assessed whether residues on these crops resulting from the intended uses are likely to pose a consumer health risk.

2. Residues in livestock

Among the crops under assessment, potatoes and pulses may be used for feed purposes. Since import of these commodities in Europe is applied for, these crops or their by‐products can enter the EU livestock feed chain. Hence, it was necessary to update the previous dietary burden calculation for livestock to estimate whether the residues of flonicamid in imported potatoes and pulses and their by‐products would have an impact on the levels of residues expected in food of animal origin (EFSA, 2018c).

In the framework of the present assessment, the applicant applied for MRLs in commodities of animal origin, which are lower than the existing EU MRLs for flonicamid. This may be explained by the fact that the current application (2018) was submitted in parallel with the publication of Regulation (EU) 2018/68713, implementing higher Codex MRLs for flonicamid in animal commodities (EFSA, 2016b).

The input values for the exposure calculations for livestock are presented in Appendix D.1.

The results of the dietary burden calculation presented in Appendix B.2. showed that the exposure to flonicamid residues exceeds the trigger value of 0.1 mg/kg DM in all species. However, the calculated dietary burdens are significantly lower than the dietary burdens calculated for Australian cattle and EU poultry by the JMPR (FAO, 2016b), based on which the existing EU MRLs are currently set. Nevertheless, the nature and magnitude of flonicamid residues in livestock were assessed further.

2.1. Nature of residues and methods of analysis in livestock

Metabolism studies in goat and poultry have been assessed in the framework of the EU pesticides peer review and the MRL review (EFSA, 2010, 2014). The residue definitions for enforcement and risk assessment in all commodities of animal origin were defined as the ‘sum of flonicamid and TFNA‐AM, expressed as flonicamid’. Validated analytical methods for enforcement of the proposed residue definition are available. In the framework of the peer review, the residues of flonicamid and TFNA‐AM were considered not to be fat soluble.

EFSA concluded that the metabolism of flonicamid in livestock was sufficiently elucidated.

2.2. Magnitude of residues in livestock

Feeding studies with lactating cows and laying hens were assessed in the framework of the EU pesticides peer review and MRL review (EFSA, 2010, 2014).

The data from the available feeding studies were compared with the updated dietary burdens that took into consideration additional contribution of flonicamid residues in potatoes and pulses according to the authorised use in the USA. Results indicate that there is no need to modify the existing EU MRLs for flonicamid in commodities of animal origin.

3. Consumer risk assessment

EFSA performed a dietary risk assessment for the agreed residue definitions for risk assessment using revision 3.1 of the EFSA PRIMo (EFSA, 2018a, 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, 2016a).

The toxicological reference values for flonicamid used in the risk assessment (i.e. ADI and ARfD values) were derived in the framework of the EU pesticides peer review (EFSA, 2010). The metabolites included in the risk assessment residue definition were considered to be of similar toxicity as the parent compound.

The input values used in the exposure calculations are summarised in Appendix D.2.

Short‐term (acute) dietary risk assessment

The short‐term risk assessment was performed only with regard to the commodities assessed in the present MRL application: tree nuts (except coconuts), potatoes, basil and edible flowers, beans (with and without pods), peas (with and without pods), beans (dry), peas (dry) and hops. The estimation of the exposure is based on the highest residue (HR) derived from the supervised field trials submitted on the above‐mentioned commodities.

For the crops under assessment, the short‐term exposure did not exceed the ARfD and accounted for peas (without pods) (96% of ARfD), beans (without pods) (93% of ARfD), potatoes (68% of ARfD), peas (with pods) (66% of ARfD), beans (with pods) (64%), beans (dry) (29% of ARfD), peas (dry) (10% of ARfD), basil and edible flowers (8% of ARfD), pistachios (4% of ARfD), hops (2% of ARfD) and tree nuts (except pistachios and coconuts) (≤ 1% of ARfD).

Long‐term (chronic) dietary risk assessment

In the framework of the MRL review, a comprehensive long‐term exposure assessment was performed, taking into account the existing uses at EU level and the acceptable CXLs (EFSA, 2014). EFSA updated the calculation with the relevant STMR values derived from the residue trials submitted in support of this MRL application for the above‐mentioned crops and products of animal origin (Finland, 2019). STMRs derived in EFSA opinions published after the MRL review (EFSA, 2015, 2016a,b, 2017, 2018b,c, 2019b, 2020) were also considered in the estimation of the long‐term exposure. The contributions of commodities for which no GAP was reported in the framework of the MRL review (EFSA, 2014) and in subsequent EFSA flonicamid assessments were not included in the calculation.

The estimated long‐term exposure to flonicamid residues accounted for up to 30% of the ADI (NL toddler). The contribution of residues expected in (i) beans (with pods) is up to the 2.8% of the ADI, (ii) potatoes is up to the 1.3% of the ADI, (iii) peas (without pods) is up to the 1.3% of the ADI, (iv) beans (dry) is up to the 1.2% of the ADI and (v) for all other assessed crops is less than 1% of the ADI.

Based on the consumer exposure assessment, EFSA concludes that the existing EU uses and the authorised uses of flonicamid in the USA will not result in acute or chronic consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers’ health.

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

4. Conclusion and Recommendations

The data submitted in support of this MRL application were found to be sufficient to derive MRL proposals for all crops under assessment on the basis of authorised uses of flonicamid in the USA.

The livestock exposure to flonicamid residues from the intake of potatoes and pulses treated according to authorised uses would not require modification of the existing EU MRLs for flonicamid in commodities of animal origin.

EFSA updated the most recent consumer risk assessment for flonicamid and concluded that the authorised USA uses of flonicamid will not result in acute or chronic 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.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

CAS

Chemical Abstract Service

CCPR

Codex Committee on Pesticide Residues

CF

conversion factor for enforcement to risk assessment residue definition

CIRCA

(EU) Communication & Information Resource Centre Administrator

CS

capsule suspension

CV

coefficient of variation (relative standard deviation)

DAR

draft assessment report

DAT

days after treatment

DM

dry matter

DS

powder for dry seed treatment

DT₉₀

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

EC

emulsifiable concentrate

EDI

estimated daily intake

EMS

evaluating Member State

FAO

Food and Agriculture Organization of the United Nations

GAP

Good Agricultural Practice

GS

growth stage

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

LC

liquid chromatography

LOQ

limit of quantification

MRL

maximum residue level

MS

Member States

MS

mass spectrometry detector

MS/MS

tandem mass spectrometry detector

MW

molecular weight

NEU

northern Europe

OECD

Organisation for Economic Co‐operation and Development

PBI

plant back interval

PF

processing factor

PHI

preharvest interval

PRIMo

(EFSA) Pesticide Residues Intake Model

RA

risk assessment

RAC

raw agricultural commodity

RD

residue definition

RMS

rapporteur Member State

SANCO

Directorate‐General for Health and Consumers

SC

suspension concentrate

SEU

southern Europe

SG

water‐soluble granule

SL

soluble concentrate

STMR

supervised trials median residue

UV

ultraviolet (detector)

WHO

World Health Organization

WP

wettable powder

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

1.

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
0120010	Almonds	Non‐EU	F	Aphid	Flonicamid	SG	500	Foliar treatment	76–89	3	7	475	100	40
0120020	Brazil nuts	Non‐EU	F	Aphid	Flonicamid	SG	500	Foliar treatment	76–89	3	7	475	100	40
0120030	Cashew nuts	Non‐EU	F	Aphid	Flonicamid	SG	500	Foliar treatment	76–89	3	7	475	100	40
0120040	Chestnuts	Non‐EU	F	Aphid	Flonicamid	SG	500	Foliar treatment	76–89	3	7	475	100	40
0120060	Hazelnuts	Non‐EU	F	Aphid	Flonicamid	SG	500	Foliar treatment	76–89	3	7	475	100	40
0120070	Macadamias	Non‐EU	F	Aphid	Flonicamid	SG	500	Foliar treatment	76–89	3	7	475	100	40
0120080	Pecans	Non‐EU	F	Aphid	Flonicamid	SG	500	Foliar treatment	76–89	3	7	475	100	40
0120090	Pine nut kernels	Non‐EU	F	Aphid	Flonicamid	SG	500	Foliar treatment	76–89	3	7	475	100	40
0120100	Pistachios	Non‐EU	F	Aphid	Flonicamid	SG	500	Foliar treatment	76–89	3	7	475	100	40
0120110	Walnuts	Non‐EU	F	Aphid	Flonicamid	SG	500	Foliar treatment	76–89	3	7	475	100	40
0211000	Potatoes	Non‐EU	F	Aphid	Flonicamid	SG	500	Foliar treatment	40–99	3	7	95	100	7
0256080	Basil and edible flowers (Mint)	Non‐EU	F	Aphid	Flonicamid	SG	500	Foliar treatment	49–69	3	14	190	100	7
0260010	Beans (with pods)	Non‐EU	F	Aphid	Flonicamid	SG	500	Foliar treatment	60–89	3	7	95	100	7
0260020	Beans (without pods)	Non‐EU	F	Aphid	Flonicamid	SG	500	Foliar treatment	60–89	3	7	95	100	7
0260030	Peas (with pods)	Non‐EU	F	Aphid	Flonicamid	SG	500	Foliar treatment	60–89	3	7	95	100	7
0260040	Peas (without pods)	Non‐EU	F	Aphid	Flonicamid	SG	500	Foliar treatment	60–89	3	7	95	100	7
0300010	Beans	Non‐EU	F	Aphid	Flonicamid	SG	500	Foliar treatment	60–89	3	7	95	100	7
0300020	Lentils	Non‐EU	F	Aphid	Flonicamid	SG	500	Foliar treatment	60–89	3	7	95	100	7
0300030	Peas	Non‐EU	F	Aphid	Flonicamid	SG	500	Foliar treatment	60–89	3	7	95	100	7
0300040	Lupins/lupini beans	Non‐EU	F	Aphid	Flonicamid	SG	500	Foliar treatment	60–89	3	7	95	100	7
0700000	Hops	Non‐EU	F	Aphid	Flonicamid	SG	500	Foliar treatment	65–87	3	7	475	100	10

NEU: northern European Union; SEU: southern European Union; MS: Member State; a.s.: active substance; SG: water‐soluble 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, 2018b)
	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 metabolites TFNG, TFNA, TFNA‐AM	EFSA (2010)
		Spinach, tomatoes	−18	23	months	Parent and metabolites TFNG, TFNA	Finland (2019)
	High oil content	Rape seed	−20	12	months	Parent and metabolites TFNG, TFNA	EFSA (2015)
		Cotton seed	−18	23	months	Parent and metabolites TFNG, TFNA	Finland (2019)
	High protein content	Beans	−20	12	months	Parent and metabolites TFNG, TFNA	EFSA (2015)
	Dry/High starch	Wheat grain, wheat straw	−18	18	months	Parent and metabolites TFNG, TFNA, TFNA‐AM	EFSA (2010)
		Potato tuber, wheat grain	−18	23	months	Parent and metabolites TFNG, TFNA	Finland (2019)
	High acid content	Orange (whole fruit)	−18	6	months	Parent and metabolites TFNG, TFNA	EFSA (2018b)
	Processed products	Apple juice, cotton oil and processed cereals	−18	23	months	Parent and metabolites TFNG, TFNA	Finland (2019)
		Mint oil	−18	–	–	Parent and metabolites TFNG, TFNA	Flonicamid and metabolites TFNG, TFNA degrade more than 50% within a year (Finland, 2019)
	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)	CFe
Almonds, pecans	USA/Outdoor	Almonds: < 0.03; 0.03; 0.03; 0.04; 0.06 Pecans: 4 × < 0.03	Residue trials on almonds (5) and pecans (4) compliant with the GAP. The residue data on almonds and pecans were combined. An extrapolation to the whole group of tree nuts (except coconut) possible	0.07	0.06	0.03	–
Pistachios	USA/Outdoor	Almonds: < 0.03; 0.03; 0.03; 0.04; 0.06 Pecans: 4 × < 0.03 Pistachios: 0.13; 0.186	Residue trials on almonds (5), pecans (4) and pistachios (2) compliant with the GAP. Extrapolation to pistachios possible	0.3	0.19	0.03	–
Potatoes	USA/Outdoor	2 × 0.043; 0.044; 2 × 0.045; 0.046; 2 × 0.054; 0.063; 0.064; 0.065; 0.066; 0.070; 0.080; 0.102; 0.113	Residue trials on potatoes (16) compliant with the GAP	0.2	0.11	0.06	–
Mint (basil and edible flowers)	USA/Outdoor	0.6833; 1.937; 2.112; 2.294; 2.605	Residue trials on mint (5) compliant with the GAP	6.0	2.61	2.11	–
Beans, peas with pods	USA/Outdoor	Beans with pods: 0.671; 0.736; 0.833; 0.864; 1.04; 1.41Peas with pods: 0.372; 0.593; 1.07; 2.03	Residue trials on beans with pods (6) and peas with pods (4) compliant with the GAP. Beans with pods are a major crop for which a least eight GAP compliant trials shall be submitted. Since residues in beans and peas are of the same data population, the incomplete residue data set on beans is completed with additional trials on peas with pods, considered equivalent to trials on beans with pods. Thus, results from trials on beans and peas combined to derive an MRL proposal	3.0	2.03	0.85	–
Beans, peas without pods	USA/Outdoor	Beans without pods: 0.122; 0.260; 0.321; 0.410; 0.594; 0.913 Peas without pods: 0.470; 0.546; 0.623; 1.78; 2.94	Residue trials on beans without pods (6) and peas without pods (5) compliant with the GAP.Peas without pods are a major crop for which a least eight GAP compliant trials shall be submitted. Since residues in beans and peas are of the same data population, the incomplete residue data set on peas is completed with additional trials on beans without pods, considered equivalent to trials on peas without pods. Thus, results from trials on beans and peas combined to derive an MRL proposal	5.0	2.94	0.55	–
Pulses (beans and peas)	USA/Outdoor	Dry beans: 4 × < 0.06; 0.084; 0.297; 0.355; 0.868; 1.252 Dry peas: 0.435; 0.459; 0.836; 0.841; 0.918	Residue trials on dry beans (9) and peas (5) compliant with the GAP. Residue data are of the same data population and were combined to derive an MRL proposal	2.0	1.25	0.39	–
Hops (dry)	USA/Outdoor	1.06; 1.81; 3.23; 10.13	Residue trials on hops (dry) (4) compliant with the GAP	20	10.13	2.52	–

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

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

^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.

^eConversion factor to recalculate residues according to the residue definition for monitoring to the residue definition for risk assessment.

B.1.2.2. Residues in rotational crops

B.1.2.3. Processing factors

Processed commodity	Number of valid studiesa	Processing Factor (PF)		Comment/Source
		Individual values	Median PF
Potato (wet peel)	1	0.034; 0.033	0.034	Tentativeb (Finland, 2019)
Potato chips	1	1.52; 1.63	1.6	Tentativeb (Finland, 2019)
Potato flakes	1	2.85; 3.11	3.0	Tentativeb (Finland, 2019)
Mint oil	2	< 0.03; < 0.09	< 0.06	–c (Finland, 2019)

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

^bA tentative PF is derived based on a limited data set: results on potatoes based on one study only.

^cNo PF was derived as residues in mint oil unstable after storage (Finland, 2019).

B.2. Residues in livestock

Dietary burden calculation according to OECD, 2013.

Relevant groups (sub groups)	Dietary burden expressed in				Most critical subgroupa	Most critical commodityb	Trigger exceeded(Y/N)	Previous assessment (EFSA, 2018c)	FAO, 2016b; EFSA, 2017
	mg/kg bwper day		mg/kg DM					mg/kg DM
	Median	Max	Median	Max				Max burden
Cattle (all)	0.131	0.143	4.39	4.91	Dairy cattle	Potato	process waste	2.91	27.7
Cattle (dairy only)	0.131	0.143	3.41	3.73	Dairy cattle	Potato	process waste	2.23	22.2
Sheep (all)	0.144	0.158	4.33	4.74	Ram/Ewe	Potato	process waste	2.74	27.7
Sheep (ewe only)	0.144	0.158	4.33	4.74	Ram/Ewe	Potato	process waste	2.74	27.7
Swine (all)	0.056	0.066	2.41	2.87	Swine (breeding)	Potato	process waste	2.15	27.7
Poultry (all)	0.062	0.071	0.91	1.04	Poultry layer	Wheat	milled bypdts	1.04	2.8
Poultry(layer only)	0.062	0.071	0.91	1.04	Poultry layer	Wheat	milled bypdts	1.04	2.8

bw: body weight; DM: dry matter.

^aWhen 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’.

^bThe most critical commodity is the major contributor identified from the maximum dietary burden expressed as ‘mg/kg bw per day’.

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

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

Livestock (available studies)	Animal	Dose(mg/kg bw per day)	Duration(days)	Comment/Source
	Laying hen	0.78	5	3‐14C‐phenyl (EFSA, 2014)
	Lactating goat	1.69	5	3‐14C‐phenyl (EFSA, 2014)

B.2.1.2. Stability of residues in livestock

Animal products (available studies)	Animal	Commodity	T (°C)	Stability period		Compounds covered	Comment/Source
				Value	Unit
	Hen	muscle, fat, eggs	−18	8	Months	Parent and metabolites TFNA, TFNA‐AM, OH‐TFNA‐AM, TFNG	EFSA (2010)
	Goat	muscle, fat, milk	−18	9	Months	Parent and metabolites TFNA, TFNA‐AM, OH‐TFNA‐AM, TFNG	EFSA (2010)

B.2.2. Magnitude of residues in livestock

B.2.2.1. Summary of the residue data from livestock feeding studies

Animal commodity	Residues at the closestfeeding level (mg/kg)		Estimated value at 1N		MRL proposal(mg/kg)	CF
	Mean	Highest	STMR(mg/kg)	HR(mg/kg)
Cattle (all)Closest feeding level (0.086 mg/kg bw; 1.0 N rate)
Muscle	0.04	0.04	0.04	0.04	0.05	n.a.
Fat	0.02	0.02	0.02	0.02	0.03	n.a.
Liver	0.06	0.06	0.06	0.06	0.06	n.a.
Kidney	0.06	0.06	0.06	0.06	0.06	n.a.
Cattle (dairy only) Closest feeding level (0.086 mg/kg bw; 1.0 N rate)
Milk	0.02	0.02	0.03	0.03	0.03	n.a.
Sheep (all) Closest feeding level (0.086 mg/kg bw; 0.9 N rate)
Muscle	0.04	0.04	0.04	0.04	0.05	n.a.
Fat	0.02	0.02	0.02	0.02	0.03	n.a.
Liver	0.06	0.06	0.06	0.06	0.06	n.a.
Kidney	0.06	0.06	0.06	0.06	0.06	n.a.
Sheep (ewe only) Closest feeding level (0.086 mg/kg bw; 0.9 N rate)
Milk	0.02	0.02	0.03	0.03	0.03	n.a.
Swine (all) Closest feeding level (0.086 mg/kg bw; 1.4 N rate)
Muscle	0.04	0.04	0.04	0.04	0.04	n.a.
Fat	0.02	0.02	0.02	0.02	0.03	n.a.
Liver	0.06	0.06	0.06	0.06	0.06	n.a.
Kidney	0.06	0.06	0.06	0.06	0.06	n.a.
Poultry (all) Closest feeding level (0.017 mg/kg bw; 0.2 N rate)
Muscle	0.02	0.02	0.04	0.04	0.04	n.a.
Fat	0.02	0.02	0.03	0.03	0.03	n.a.
Liver	0.02	0.02	0.04	0.04	0.04	n.a.
Poultry (layer only)Closest feeding level (0.017 mg/kg bw; 0.2 N rate)
Eggs	0.02	0.02	0.08	0.09	0.1	n.a.

STMR: supervised trials median residue; HR: highest residue; MRL: maximum residue level; CF: conversion factor; bw: body weight; n.a.: not applicable.

B.3. Consumer risk assessment

B.4. Recommended MRLs

Codea	Commodity	ExistingEU MRL(mg/kg)	ProposedEU MRL(mg/kg)	Comment/justification
Enforcement residue definition (plant commodities): Flonicamid (sum of flonicamid, TFNA and TFNG, expressed as flonicamid)
0120000	Tree nuts (except coconuts and pistachios)	0.06*	0.07	The submitted data are sufficient to derive an import tolerance based on the authorised US GAP. Risk for consumers unlikely
0120100	Pistachios	0.06*	0.3	The submitted data are sufficient to derive an import tolerance based on the authorised US GAP. Risk for consumers unlikely
0211000	Potatoes	0.09	0.2	The submitted data are sufficient to derive an import tolerance based on the authorised US GAP. Risk for consumers unlikely
0256080	Basil and edible flowers (Mint)	6	No change	The submitted data do not provide evidence that the existing MRL has to be modified
0260010	Beans (with pods)	1.5	3.0	The submitted data are sufficient to derive an import tolerance based on the authorised US GAP. Risk for consumers unlikely
0260020	Beans (without pods)	0.03*	5.0	The submitted data are sufficient to derive an import tolerance based on the authorised US GAP. Risk for consumers unlikely
0260030	Peas (with pods)	1.5	3.0	The submitted data are sufficient to derive an import tolerance based on the authorised US GAP. Risk for consumers unlikely
0260040	Peas (without pods)	0.7	5.0	The submitted data are sufficient to derive an import tolerance based on the authorised US GAP. Risk for consumers unlikely
0300000	Pulses	0.8	2.0	The submitted data are sufficient to derive an import tolerance based on the authorised US GAP. Risk for consumers unlikely
0700000	Hops	3 (ft)b	20	The submitted data are sufficient to derive an import tolerance based on the US GAP. Risk for consumers unlikely
Enforcement residue definition (animal commodities): Sum of flonicamid and TFNA‐AM expressed as flonicamid
10110101012010101301010140101015010	Swine,Bovine,Sheep,Goat,Horse: meat	0.15	No change	The submitted data do not provide evidence that the existing MRL has to be modified.
10110201012020101302010140201015020	Swine,Bovine,Sheep,Goat,Horse: fat	0.05	No change	The submitted data do not provide evidence that the existing MRL has to be modified.
10110301012030101303010140301015030	Swine,Bovine,Sheep,Goat,Horse: liver	0.2	No change	The submitted data do not provide evidence that the existing MRL has to be modified.
10110401012040101304010140401015040	Swine,Bovine,Sheep,Goat,Horse: kidney	0.2	No change	The submitted data do not provide evidence that the existing MRL has to be modified.
10110501012050101305010140501015050	Swine,Bovine,Sheep,Goat,Horse: edible offal	0.2	No change	The submitted data do not provide evidence that the existing MRL has to be modified.
1020000	Milk	0.15	No change	The submitted data do not provide evidence that the existing MRL has to be modified.

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

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

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

^bAn analytical method for the determination of residues of flonicamid in hops was submitted and evaluated by EFSA (EFSA, 2020) in response to confirmatory data identified in the framework of the EFSA MRL review on flonicamid (EFSA, 2014) and footnote (ft) implemented in Reg. (EC) No 396/2005 for flonicamid in hops.

(ft): 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.3.114

Appendix D – Input values for the exposure calculations

D.1. Livestock dietary burden calculations

Feed commodity	Median dietary burden		Maximum dietary burden
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Risk assessment residue definition: Sum of flonicamid and TFNA‐AM expressed as flonicamid
Barley (straw)	0.05	STMR (EFSA, 2015)	0.07	HR (EFSA, 2015)
Beet, sugar (tops)	0.09	STMR (EFSA, 2017)	0.20	HR (EFSA, 2017)
Cabbage, heads (leaves)	0.14	STMR (EFSA, 2017)	0.23	HR (EFSA, 2017)
Oat (straw)	0.05	STMR (EFSA, 2015)	0.07	HR (EFSA, 2015)
Rye (straw)	0.18	STMR (EFSA, 2014)	0.48	HR (EFSA, 2014)
Triticale (straw)	0.18	STMR (EFSA, 2014)	0.48	HR EFSA, 2014)
Turnip tops (leaves)	0.07	STMR (EFSA, 2018c)	0.29	HR (EFSA, 2018c)
Wheat (straw)	0.18	STMR (EFSA, 2014)	0.48	HR (EFSA, 2014)
Carrot (culls)	0.05	STMR (EFSA, 2018c)	0.15	HR (EFSA, 2018c)
Potato (culls)	0.06	STMR	0.11	HR
Swede (roots)	0.05	STMR (EFSA, 2018c)	0.15	HR (EFSA, 2018c)
Turnip (roots)	0.05	STMR (EFSA, 2018c)	0.15	HR (EFSA, 2018c)
Barley (grain)	0.14	STMR (EFSA, 2015)	0.14	STMR (EFSA, 2015)
Bean (seed, dry)	0.39	STMR	0.39	STMR
Cotton (undelinted seed)	0.14	STMR (EFSA, 2015)	0.14	STMR (EFSA 2015)
Lupin (seed)	0.39	STMR	0.39	STMR
Oat (grain)	0.14	STMR (EFSA, 2015)	0.14	STMR (EFSA, 2015)
Pea (seed, dry)	0.39	STMR	0.39	STMR
Rye (grain)	0.35	STMR (EFSA, 2014)	0.35	STMR (EFSA, 2014)
Triticale (grain)	0.35	STMR (EFSA, 2014)	0.35	STMR (EFSA, 2014)
Wheat (grain)	0.35	STMR (EFSA, 2014)	0.35	STMR (EFSA, 2014)
Apple (pomace, wt)	0.30	0.06 STMR × 5 PFa (EFSA, 2014)	0.30	0.06 STMR × 5 PFa (EFSA, 2014)
Beet, sugar (dried pulp)	1.62	0.09 STMR × 18 PFa (EFSA, 2017)	1.62	0.09 STMR × 18 PFa (EFSA, 2017)
Beet, sugar (ensiled pulp)	0.27	0.09 STMR × 3 PFa (EFSA, 2017)	0.27	0.09 STMR × 3 PFa (EFSA, 2017)
Beet, sugar (molasses)	2.52	0.09 STMR × 28 PFa (EFSA, 2017)	2.52	0.09 STMR × 28 PFa (EFSA, 2017)
Brewer's grain	0.46	0.14 STMR × 3.3 PFa (EFSA, 2014)	0.46	0.14 STMR × 3.3 PFa (EFSA, 2014)
Citrus (dried pulp)	0.40	0.04 STMR × 10 PFa (EFSA, 2014)	0.40	0.04 STMR × 10 PFa (EFSA, 2014)
Cotton (meal)	0.05	0.04 STMR × 1.3 PFa (EFSA, 2015)	0.05	0.04 STMR × 1.3 PFa (EFSA, 2015)
Distiller's grain (dried)	1.16	0.35 STMR × 3.3 PFa (EFSA, 2014)	1.16	0.35 STMR × 3.3 PFa (EFSA, 2014)
Lupin seed (meal)	0.43	0.39 STMR × 1.1 PFa	0.43	0.39 STMR × 1.1 PFa
Potato (process waste)	1.20	0.06 STMR × 20 PFa	1.20	0.06 STMR × 20 PFa
Potato (dried pulp)	2.28	0.06 STMR × 38 PFa	2.28	0.06 STMR × 38 PFa
Wheat gluten (meal)	0.63	0.35 STMR × 1.8 PFa (EFSA, 2014)	0.63	0.35 STMR × 1.8 PFa (EFSA, 2014)
Wheat (milled by‐product)	2.45	0.35 STMR × 7 PFa (EFSA, 2014)	2.45	0.35 STMR × 7 PFa (EFSA, 2014)

STMR: supervised trials median residue; HR: highest residue; PF: processing factor.

^aFor apple pomace, Beet sugar (dried pulp), Beet sugar (ensiled pulp), Beet sugar (molasses), Brewer's grain, Citrus (dried pulp), Cotton (meal), Distiller's grain (dried), Lupin seed (meal), Potato (process waste), Potato (dried pulp), Wheat gluten (meal), Wheat (milled by‐product), in the absence of processing factors supported by data, default processing factors of 5, 18, 3, 28, 3.3, 10, 1.3, 3.3, 1.1, 20, 38, 1.8, 7 were, respectively, included in the calculation to consider the potential concentration of residues in these commodities.

D.2. Consumer risk assessment

Commodity	Chronic risk assessment		Acute risk assessment
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Tree nuts, except pistachios and coconuts	0.03	STMR	0.06	HR
Pistachios	0.03	STMR	0.19	HR
Potatoes	0.06	STMR	0.11	HR
Basil and edible flowers (mint)	2.11	STMR	2.61	HR
Beans (with pods)	0.85	STMR	1.41	HR
Peas (with pods)	0.85	STMR	2.03	HR
Beans (without pods)	0.55	STMR	2.94	HR
Peas (without pods)	0.55	STMR	2.94	HR
Pulses (dry)	0.39	STMR	1.25	HR
Hops (dried)	2.52	STMR	10.13	HR
Citrus fruit	0.04	STMR (EFSA, 2018a)	–	Acute risk assessment performed only for the crops under consideration
Cherries	0.13	STMR (EFSA, 2020)	–
Plums	0.06	STMR (EFSA, 2020)	–
Strawberries	0.14	STMR (EFSA, 2019b)	–
Blueberries	0.23	STMR (EFSA, 2019b)	–
Cranberries	0.23	STMR (EFSA, 2019b)	–
Currants	0.23	STMR (EFSA, 2019b)	–
Gooseberries	0.23	STMR (EFSA, 2019b)	–
Pome fruit	0.06	STMR (EFSA, 2014)	–
Apricots	0.10	STMR (EFSA, 2017)	–
Peaches	0.08	STMR (EFSA, 2014)	–
Blackberries	0.36	STMR (EFSA, 2018a)	–
Raspberries	0.36	STMR (EFSA, 2018a)	–
Beetroots	0.05	STMR (EFSA, 2018c)	–
Carrots	0.05	STMR (EFSA, 2018c)	–
Celeriacs	0.05	STMR (EFSA, 2018c)	–
Horseradishes	0.05	STMR (EFSA, 2018c)	–
Jerusalem artichokes	0.05	STMR (EFSA, 2018c)	–
Parsnips	0.05	STMR (EFSA, 2018c)	–
Parsley root	0.05	STMR (EFSA, 2018c)	–
Radishes	0.22	STMR (EFSA, 2018b)	–
Salsifies	0.05	STMR (EFSA, 2018c)	–
Swedes	0.05	STMR (EFSA, 2018c)	–
Turnips	0.05	STMR (EFSA, 2018c)	–
Tomatoes	0.11	STMR (EFSA, 2020)	–
Peppers	0.06	STMR (EFSA, 2015)	–
Aubergines (egg plants)	0.11	STMR (EFSA, 2020)	–
Cucumbers	0.15	STMR (EFSA, 2014)	–
Gherkins	0.15	STMR (EFSA, 2014)	–
Courgettes	0.15	STMR (EFSA, 2020)	–
Other cucurbits – edible peel	0.15	STMR (EFSA, 2014)	–
Cucurbits – inedible peel	0.06	STMR (melon pulp) (EFSA, 2020)	–
Brussels sprouts	0.07	STMR (EFSA, 2015)	–
Head cabbage	0.14	STMR (EFSA, 2017)	–
Lettuce and other salad plants including Brassicacea	0.03	STMR (EFSA, 2018b)	–
Herbs	0.71	STMR (EFSA, 2016a)	–
Cotton seed	0.04	STMR (EFSA, 2015)	–
Barley	0.17	STMR (EFSA, 2015)	–
Oats	0.17	STMR (EFSA, 2015)	–
Rye	0.35	STMR (EFSA, 2018b)	–
Wheat	0.35	STMR (EFSA, 2018b)	–
Sugar beet (root)	0.03	STMR (EFSA, 2017)	–
Swine, Bovine, Sheep, Goat, Horse: meat	0.06	STMR (FAO, 2016b)	–
Swine, Bovine, Sheep, Goat, Horse: fat	0.02	STMR (FAO, 2016b)	–
Swine, Bovine, Sheep, Goat, Horse: liver	0.10	STMR (FAO, 2016b)	–
Swine, Bovine, Sheep, Goat, Horse: kidney	0.10	STMR (FAO, 2016b)	–
Swine, Bovine, Sheep, Goat, Horse: edible offal	0.10	STMR (FAO, 2016b)	–
Poultry: meat	0.04	STMR (FAO, 2016b)	–
Poultry: fat	0.04	STMR (FAO, 2016b)	–
Poultry: liver	0.04	STMR (FAO, 2016b)	–
Poultry: kidney	0.04	STMR (FAO, 2016b)	–
Poultry: edible offal	0.04	STMR (FAO, 2016b)	–
Milk and cream	0.05	STMR (FAO, 2016b)	–
Bird's eggs	0.08	STMR (EFSA, 2018c)	–

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

Appendix E – Used compound codes

1.

Code/trivial namea	IUPAC name/SMILES notation/InChiKeyb	Structural formulac
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)pyridine‐3‐carboxamide or 4‐(trifluoromethyl)nicotinamide O=C(N)c1cnccc1C(F)(F)F JUIWZYBJXUPIKF‐UHFFFAOYSA‐N
OH‐TFNA‐AM	6‐oxo‐4‐(trifluoromethyl)‐1,6‐dihydropyridine‐3‐carboxamide or 6‐hydroxy‐4‐(trifluoromethyl)nicotinamide FC(F)(F)c1cc(O)ncc1C(N)=O JZASIHOQMPWGMF‐UHFFFAOYSA‐N

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

^bACD/Name 2019.1.1 ACD/Labs 2019 Release (File version N05E41, Build 110555, 18 Jul 2019).

^cACD/ChemSketch 2019.1.1 ACD/Labs 2019 Release (File version C05H41, Build 110712, 24 Jul 2019).

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 setting of import tolerances for flonicamid in various crops and products of animal origin. EFSA Journal 2020;18(6):6136, 37 pp. 10.2903/j.efsa.2020.6136