Setting of import tolerances, modification of existing maximum residue levels and evaluation of confirmatory data following the Article 12 MRL review for flupyradifurone and DFA

Abstract

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants Bayer CropScience AG and Bayer SAS submitted two requests to the competent national authority in the Netherlands to set import tolerances and to modify existing EU maximum residue levels (MRLs) for the active substance flupyradifurone and its metabolite difluoroacetic acid (DFA) in various crops. The application also included the request to evaluate the confirmatory data related to residues that were identified in the framework of the peer review of flupyradifurone under Regulation (EC) No 1107/2009 as not available. The data submitted in support of intended and authorised uses were found to be sufficient to derive MRL proposals for flupyradifurone and DFA in all crops under consideration except for prickly pear and hops; for grapefruit, pome fruits, grape leaves and witloof, further risk management discussion is recommended to decide on the appropriate MRL. Furthermore, EFSA recommended risk management discussion to examine different options to deal with DFA residues in crops that can be grown in crop rotation. The calculated livestock dietary burdens indicated that existing EU MRLs for flupyradifurone and DFA in animal commodities need to be modified. Adequate analytical methods for enforcement are available to control the residues of flupyradifurone and the DFA in plant and animal matrices. The submitted data are considered sufficient to address the data gaps related to residues which were identified in the framework of the EU pesticides peer review, and thus, the footnotes set for DFA and flupyradifurone MRLs in the Commission Regulation (EU) 2016/1902 can be deleted. Based on the consumer exposure assessment, acute consumer exposure concerns could not be excluded for tomatoes, melons, celery and processed escaroles. Hence, the raising of the existing MRLs for flupyradifurone in these crops is not recommended. For these four crops, MRL proposals for DFA were derived, which reflect the uptake of residues via soil resulting from previous use of flupyradifurone. For the remaining commodities of plant and animal origin, EFSA concludes that the intended EU uses and authorised US and Canadian uses of flupyradifurone and resulting residues of DFA will not result in chronic or acute 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, Bayer CropScience AG and Bayer SAS submitted two applications to the competent national authority in the Netherlands (evaluating Member State, EMS) to set import tolerances and to modify the existing European Union (EU) maximum residue levels (MRLs) for the active substance flupyradifurone and its metabolite difluoroacetic acid (DFA) in a wide range of crops. The EMS drafted two evaluation reports in accordance with Article 8 of Regulation (EC) No 396/2005, which were submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 16 May 2017 (revised and updated in March 2019) and 20 August 2019.

In the context of first approval of flupyradifurone in the EU (EU peer review under Regulation (EC) No 1107/2009), the setting of EU MRLs was requested. During the peer review, EFSA identified some information as unavailable (data gaps) and derived tentative MRLs for those uses which were not fully supported by data. The following data gaps were identified:

1. Field rotational crop studies considering realistic plant back intervals for the crops considered and providing information on the flupyradifurone and DFA residue levels in soil;

2. Animal feeding studies conducted with the DFA metabolite.

As an outcome of the EU pesticide peer review, tentative MRL proposals have been implemented in the MRL legislation for both flupyradifurone and its metabolite DFA, by Commission Regulation (EU) 2016/1902, including footnotes related to data gap number 1, indicating the type of confirmatory data that should be provided by a party having an interest in maintaining the proposed tentative MRL by 6 April 2018. Data gap number 2 was not translated into footnote.

In the framework of the current assessment, the applicant provided information aimed to address the data gaps related to residues identified in the EU pesticides peer review for flupyradifurone.

EFSA assessed the applications and evaluation reports as required by Articles 9 and 10 of the MRL regulation and in accordance with the agreed procedure set out in the working document SANTE/10235/2016. For reasons of efficiency, MRL applications were assessed in one EFSA output.

Based on the conclusions derived by EFSA in the framework of Regulation (EC) No 1107/2009, the data evaluated under a previous MRL assessment and the additional data provided by the EMS in the framework of this application, the following conclusions are derived.

The metabolism of flupyradifurone was investigated following foliar applications of the radiolabelled active substance in fruit crops, pulses/oilseeds and cereals, by soil granule/drench applications in fruit crops, root crops and cereals and by seed dressing in root crops. The EU pesticides peer review concluded that in primary crops, flupyradifurone was expected to be the major component. Following the soil application, significant proportions of difluoroacetic acid (DFA) were observed; the data from residue trials confirmed that DFA is relevant plant metabolite of flupyradifurone.

Studies investigating the effect of processing on the nature of flupyradifurone (hydrolysis studies) demonstrated that the active substance is stable. Studies investigating the effect of processing on the nature of DFA are not available. However, considering the structural similarity of DFA with trifluoroacetic acid (TFA), which is very stable under hydrolysis conditions, EFSA agrees with the applicant and EMS that DFA is unlikely to degrade under standard hydrolytic conditions.

In rotational crops, the major residues identified were flupyradifurone, its metabolites flupyradifurone‐hydroxy, 6‐CNA and their conjugates and DFA. The presence of DFA is mostly the result of its uptake from soil, where DFA is formed as the major metabolite of flupyradifurone.

Based on the metabolic pattern identified in primary and rotational crop metabolism studies, the results of hydrolysis studies, the toxicological significance of metabolites and the capabilities of enforcement analytical methods, the following residue definitions were agreed by the EU pesticides peer review:

• − Residue definition for risk assessment: Sum of flupyradifurone and DFA, expressed as flupyradifurone.
• − Residue definition for enforcement: 1) Flupyradifurone; 2) DFA, expressed as DFA.

The same residue definitions are applicable to rotational crops and processed products. The residue definition for enforcement in Regulation (EC) No 396/2005 is identical with the above‐mentioned residue definition. Most of the import tolerance requests refer to US and Canadian uses, where the established enforcement residue definition is parent flupyradifurone alone.

EFSA concluded that for the crops assessed in this application, metabolism of flupyradifurone in primary and in rotational crops, and the possible degradation in processed products has been 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 of flupyradifurone and of DFA in the crops assessed in this application according to enforcement residue definitions.

The residue data submitted in support of intended European and authorised third country uses under assessment were found to be sufficient to derive MRL proposals for flupyradifurone and DFA in all crops under consideration, except prickly pears and hops. For grapefruit, pome fruit, grape leaves and witloof, further risk management discussion is recommended to decide whether the setting of an MRL is appropriate.

Flupyradifurone exhibits high soil persistency, forming DFA as its soil metabolite. The gradual formation of DFA results in its uptake in rotational crops. Thus, MRL proposals for DFA in annual crops were derived on a basis of residue trials performed after direct treatment of the crop (primary crop treatment), adding contribution of residues that are expected from the soil uptake (see below). Setting of DFA MRLs for imported crops was based on primary crop residue trials and residues taken up via soil, taking into account restrictions on cultivation for succeeding crops in the countries of origin. For those crops for which confirmatory data for DFA and flupyradifurone, MRLs were requested in Commission Regulation (EU) 2016/1902 and for which no uses of flupyradifurone for primary crop treatment have been notified, the MRL proposals were derived on the basis of residues estimated in rotational crops only. Risk management discussions are recommended to examine other risk management options (e.g. plant back restrictions) to reduce the DFA residues in crops that can be grown in crop rotation.

The occurrence of flupyradifurone and DFA residues in rotational crops was investigated in the framework of the EU pesticides peer review and in new studies submitted in the framework of this assessment. The available rotational crop field trials were underdosed compared to the worst‐case plateau concentrations estimated for flupyradifurone in soil resulting from the critical intended EU/authorised US and Canadian uses, but they were within a range where the proportionality principle can be applied. Thus, the DFA residue data were scaled up to estimate the residues taken up from the soil (scaling was applied to all trials with DFA and to the trials in lettuce and barley grain performed with flupyradifurone).

The submitted rotational crop studies addressed the data gap set in Commission Regulation (EU) 2016/1902. It is, however, noted that available rotational crop residue trials do not allow to estimate residues potentially occurring under the theoretical worst‐case scenario, i.e. in crops rotated after three seasonal soil treatments of cucurbits and fruiting vegetables as authorised in the USA and Canada. In reality, such a scenario is unlikely to happen frequently.

Studies investigating the effect of processing on the magnitude of flupyradifurone and DFA residues were submitted on a wide range of crops. Processing factors are summarised in the Appendix B.1.2.3.

An assessment of residues in livestock was performed since several of the crops on which EU uses are intended can be fed to livestock. Moreover, some food crops imported in Europe can also enter feed chain directly or as feed derived from food by‐products. In addition, the applicant requested import tolerances for animal products from the USA and Canada.

Livestock exposure to flupyradifurone and DFA residues was calculated for the EU. The results indicate that the trigger value of 0.004 mg/kg body weight (bw) per day is exceeded for all livestock species, both for flupyradifurone and DFA for relevant livestock diets. Thus, the potential carry‐over of flupyradifurone and DFA residues in animal matrices was further investigated.

The nature of flupyradifurone residues in livestock has been assessed during the EU pesticides peer review of flupyradifurone and the residue definition for enforcement was proposed as 1) flupyradifurone and 2) DFA, expressed as DFA and for risk assessment as the ‘sum of flupyradifurone and DFA, expressed as flupyradifurone’.

The applicant provided livestock feeding studies with flupyradifurone and DFA, respectively, for poultry and ruminants. The studies were used to derive MRL proposals for flupyradifurone and for DFA reflecting the expected dietary burden estimated for EU livestock.

MRL proposals for DFA reflecting the US/Canadian dietary burden were estimated by the EMS. The MRL proposals for DFA and the indicative risk assessment values for US/Canadian livestock took into account DFA residue levels expected in feed (primary crops and rotational crops), as well as residues of flupyradifurone (metabolised to DFA by livestock). The calculations are considered indicative, since only limited information on the use pattern of flupyradifurone in the USA and Canada and possible use restrictions are available. The calculated US/Canadian dietary burden and the related MRLs and risk assessment values for food of animal origin produced in the USA and Canada are therefore affected by an additional, non‐standard uncertainty.

EFSA concluded that the existing EU MRLs for flupyradifurone and DFA should be raised in all animal matrices, except for flupyradifurone in poultry commodities. The data gap identified by the peer review for the livestock feeding studies with DFA was sufficiently addressed.

For the consumer risk assessment of residues in ruminant products, EFSA used input values based on the US/Canadian MRLs for flupyradifurone, adding the estimated DFA residues resulting from metabolism of flupyradifurone to DFA in ruminants (derived from feeding study with flupyradifurone) and the intake of DFA present in feed (estimated from the feeding study with DFA). The approach used by EFSA is considered conservative leading to an overestimation of the exposure, ensuring that consumers are sufficiently protected. For the remaining animal products, the input values for the consumer risk assessment have been derived for the EU following the standard EU approach.

The toxicological profile of flupyradifurone was assessed in the framework of the EU pesticides peer review under Regulation (EC) No 1107/2009 and the data were sufficient to derive an acceptable daily intake (ADI) of 0.064 mg/kg bw per day and an acute reference dose (ARfD) of 0.15 mg/kg bw. The toxicological reference values are also applicable to metabolite DFA.

The consumer risk assessment was performed with revision 3.1 of the EFSA Pesticide Residues Intake Model (PRIMo). EFSA performed two separate consumer exposure calculation scenarios in order to estimate the exposure to flupyradifurone and DFA residues from 1) animal commodities and treated primary crops and 2) rotational crops. The input values in scenario 1 were as derived from the submitted residue trials for plant commodities and risk assessment values derived for animal commodities as described above; for several crops, the risk assessment values were available from previous EFSA assessments. In scenario 2, the input values were derived from rotational crop studies. This information is intended to provide risk managers data to decide on the appropriate risk management options, e.g. setting MRLs covering residues taken up from the soil or setting plant back restrictions.

The estimated long‐term dietary exposure in scenario 1 (consumer exposure due to primary crop treatment) accounted for a maximum of 53% of the ADI (NL toddler diet); for scenario 2 (consumer exposure from the intake of DFA residues taken up by crops from the soil which was previously treated with flupyradifurone), accounted for up to 17% of the ADI (GEMS/Food G06). The combined exposure to flupyradifurone and DFA residues from the intake of food commodities following primary crop treatments, animal commodities and untreated food commodities containing residues due to the uptake via soil accounts for a maximum of 69% of the ADI (Dutch toddler). The overall exposure to flupyradifurone and DFA is unlikely to pose a chronic consumer intake concern.

In the short‐term dietary exposure according to scenario 1, EFSA identified an exceedance of the ARfD for celeries (150%), melons (147%) and for processed escarole (141%). For the remaining crops, the short‐term exposure did not exceed the ARfD and accounted the highest for table grapes (95% of ARfD), escaroles (86%), lettuce (81%). The EMS proposed to perform a refined exposure assessment, using residue concentrations expected in trimmed celery stalks instead of residues expected in whole product (stems and leaves). This refinement is not supported by EFSA since specific consumption data for trimmed celery and untrimmed celery are not available. Hence, the consumption of a large portion of untrimmed celery cannot be excluded.

The exposure scenario 2 (expressed as % of ARfD) was highest for melons (86%), watermelons (69%) and potatoes (55%).

The combined acute exposure to residues from primary treatment (scenario 1) and residues taken up via roots (scenario 2) identified exceedances of the ARfD for melons (233% of ARfD), celeries (161% of ARfD), processed celeries (146% of ARfD) tomatoes (103%) and processed escaroles (154% of ARfD). For peppers, table grapes and unprocessed escaroles, the exposure was close to the ARfD (99%, 95% and 93% of ARfD, respectively). For the remaining commodities of plant and animal origin, the exposure was below 90%.

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

Full details of all endpoints and the consumer risk assessment as well as additional information can be found in Appendices B–E.

Codea	Commodity	Existing EU MRLb (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition 1: Flupyradifurone
110010	Grapefruit	0.01*	No proposal or 3 Further risk management discussion	Insufficient residue trials in grapefruit data to support the import tolerance request (US GAP). Extrapolation from oranges to grapefruit could be considered by risk managers. US tolerance: 3 mg/kg Risk for consumers unlikely
110020	Oranges		3	The submitted data are sufficient to derive an import tolerance (US GAP). Risk for consumers unlikely
110030	Lemons		1.5
110040	Limes
110050	Mandarins
120000	Tree nuts	0.01*	0.02	The submitted data are sufficient to derive an import tolerance (US/Canadian GAP). Risk for consumers unlikely
130010	Apples	0.4	0.5 or 0.6	The submitted data are sufficient to derive an import tolerance (US/Canadian GAP). The MRL proposal derived from the merged data set of trials in apples and pears is 0.6 mg/kg. Considering that a statistical testing demonstrated that the two data sets belong to different populations, the setting of separate MRLs for pears (0.8 mg/kg) and apples (0.5 mg/kg), with extrapolation to quinces, medlars and loquat should be discussed by risk managers. The US/Canadian MRL is 0.7 mg/kg. Risk for consumers unlikely
130020	Pears		0.8 or 0.6
130030	Quinces		0.5 or 0.6 Further risk management discussion
130040	Medlars
130050	Loquats
151000	Grapes (wine and table grapes)	0.8	3	The submitted data are sufficient to derive an import tolerance (US/Canadian GAP). Risk for consumers unlikely
154010	Blueberries	0.01*	4	The submitted data are sufficient to derive an import tolerance (US/Canadian GAP). Risk for consumers unlikely
161030	Table olives	0.01*	5	The submitted data are sufficient to support the intended SEU uses Risk for consumers unlikely
162040	Prickly pear (cactus fruit)	0.01*	No proposal	Insufficient residue data to support the import tolerance request
211000	Potatoes	0.01*	0.05	The submitted data are sufficient to derive an import tolerance (US/Canadian GAP). Risk for consumers unlikely
212000	Tropical root and tuber vegetables
213000	Other root and tuber vegetables except sugar beet	0.01*	0.9	The submitted data are sufficient to derive an import tolerance (US/Canadian GAP). Risk for consumers unlikely
231010	Tomato	0.7	No proposal	The submitted data suggest an import tolerance of 1 mg/kg (US/Canadian GAP). However, an acute consumer intake concern could not be excluded, considering the residues from primary crop treatment and residues taken up via roots (rotational crop) The US/Canadian MRL is set at a level of 1.5 mg/kg The existing MRL is reflecting an existing EU use, for which no consumer intake concern was identified. A modification of the existing MRL is not proposed
231020	Pepper (including chili pepper)	0.9	No change	The data submitted in support of the import tolerance (US/Canadian GAP) are sufficient to derive an MRL proposal which is at the same level as the existing EU MRL reflecting an EU use. Risk for consumers unlikely
231040	Aubergine (eggplant)	0.7	1.0	The submitted data are sufficient to derive an import tolerance (US/Canadian GAP) by extrapolation from tomatoes. Risk for consumers unlikely
233010	Melon	0.01*	No proposal	Insufficient residue trials in melons data to support the import tolerance request (US/Canadian GAP). For the MRL proposal of 0.4 mg/kg derived from a combined residue data set of melons and cucurbits with edible peel, an acute intake consumer risk could not be excluded
234000	Sweet corn	0.01*	0.05	The submitted data are sufficient to derive an import tolerance (US GAP). Risk for consumers unlikely
241000	Flowering brassica	0.01*	0.6	The submitted data are sufficient to support the intended EU outdoor uses Risk for consumers unlikely
242010	Brussels sprouts	0.01*	0.09	The submitted data are sufficient to support the intended NEU outdoor uses Risk for consumers unlikely
242020	Head cabbage	0.01*	0.3	The submitted data are sufficient to support the intended EU outdoor uses Risk for consumers unlikely
243020	Kales	0.01*	5.0	The submitted data are sufficient to support the intended NEU outdoor use. For the intended SEU use, no residue trials were submitted Risk for consumers unlikely
244000	Kohlrabies	0.01*	0.09	The submitted data are sufficient to support the intended NEU outdoor use Risk for consumers unlikely
251020	Lettuces	5.0	6.0	The submitted data are sufficient to support the intended EU outdoor uses Risk for consumers unlikely
251030	Escaroles	0.03 (ft.1)	0.07	For the intended NEU and SEU outdoor uses, an MRL of 6 mg/kg and 5 mg/kg, respectively, would be required, but for these proposals, an acute consumer intake concerns cannot be excluded MRL required for escaroles grown as rotational crop is 0.07 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
251000 (except 251020 and 251030)	Lettuces and salad plants (except lettuces and escaroles)	0.03 (ft.1)	6.0	The submitted data are sufficient to support the intended EU outdoor uses The data gap identified in the peer review (ft.1) was sufficiently addressed Risk for consumers unlikely
252000	Spinach and similar (leaves)	0.03 (ft.1)	6.0	The submitted data are sufficient to support the intended EU outdoor uses. The data gap identified in the peer review (ft.1) was sufficiently addressed Risk for consumers unlikely
254000	Watercresses	0.03 (ft.1)	0.07	MRL proposal reflecting residues taken up via roots for EU soil plateau concentration. The data gap identified in the peer review (ft.1) was sufficiently addressed Risk for consumers unlikely
256000	Herbs and edible flowers	0.03 (ft.1)	6.0	The submitted data are sufficient to support the intended EU outdoor uses The data gap identified in the peer review (ft.1) was sufficiently addressed Risk for consumers unlikely
253000	Grape leaves and similar species	0.03 (ft.1)	Further risk management considerations required	The data gap identified in the peer review (ft.1) was sufficiently addressed. It is however noted that these crops are unlikely to be affected by residue uptake via crop rotation (vine grape is a permanent crop, witloof is not grown in soil). Hence, risk managers could consider the lowering of the existing MRLs
255000	Witloof/Belgian endives
260010 260030	Beans (with pods) Peas (with pods)	0.01*	0.5	The submitted data are sufficient to support the intended EU outdoor uses Risk for consumers unlikely
260020 260040 260050	Beans (without pods) Peas (without pods) Lupins	0.01*	0.4
270030	Celeries	0.01*	No proposal	The submitted data are sufficient to derive a proposal for an import tolerance of 9 mg/kg (US/Canadian GAP). However, an acute consumer intake concerns could not be excluded
300000	Pulses	0.01*	3.0	The submitted data are sufficient to derive an import tolerance (US/Canadian GAP) which covers the less critical intended EU use Risk for consumers unlikely
401020	Peanuts	0.01*	0.04	The submitted data are sufficient to derive an import tolerance (US/Canadian GAP). Risk for consumers unlikely
401070	Soyabeans	0.01*	1.5
401090	Cotton	0.01*	0.8	The submitted data are sufficient to derive an import tolerance (US GAP) which covers the less critical intended EU use Risk for consumers unlikely
402010	Olives for oil production	0.01*	5	The submitted data are sufficient to support the intended SEU uses Risk for consumers unlikely
500010	Barley	0.01*	3.0	The submitted data are sufficient to derive an import tolerance (US GAP). Risk for consumers unlikely
500080	Sorghum	0.01*	3.0
500090	Wheat	0.01*	1.0
500030	Maize/corn	0.01*	0.02
620000	Coffee	0.05*	1.0	The submitted data are sufficient to derive an import tolerance (Brazilian GAP). Risk for consumers unlikely
640000	Cocoa beans	0.05*	No change	The data submitted in support of import tolerance (Ghana GAP) do not provide evidence that the existing MRL has to be modified
700000	Hops	4.0	No proposal	Insufficient data to support the US import tolerance request
1011010	Swine muscle	0.01*	0.03	MRL proposal based on the calculated EU livestock exposure. Risk for consumers unlikely
1011020	Swine fat	0.01*	0.015
1011030	Swine liver	0.01*	0.08
1011040	Swine kidney	0.01*	0.09
1011050	Swine edible offal	0.01*	0.09
1012010/1015010	Bovine/equine muscle	0.01*	0.3	MRL proposal derived on basis of tolerance established in the USA. The calculated EU livestock exposure results in lower MRL proposals (0.05 mg/kg in muscle, 0.02 mg/kg in fat, 0.3 mg/kg in liver, 0.15 mg/kg in kidney). Risk for consumers unlikely
1012020/1015020	Bovine/equine fat	0.01*	0.2
1012030/1015030	Bovine/equine liver	0.01*	1.0
1012040/1015040	Bovine/equine kidney	0.01*	1.0
1012050/1015050	Bovine/equine edible offal	0.01*	1.0
1013010/1014010	Sheep/goat muscle	0.01*	0.3	MRL proposal derived on basis of tolerance established in the USA. The calculated EU livestock exposure results in lower MRL proposals (0.04 mg/kg in muscle, 0.02 mg/kg in fat, 0.3 mg/kg in liver, 0.15 mg/kg in kidney). Risk for consumers unlikely
1013020/1014020	Sheep/goat fat	0.01*	0.2
1013030/1014030	Sheep/goat liver	0.01*	1.0
1013040/1014040	Sheep/goat kidney	0.01*	1.0
1013050/1014050	Sheep/goat edible offal	0.01*	1.0
1016000	Poultry muscle	0.01*	No change	The calculated livestock dietary burdens do not provide evidence that the existing MRL has to be modified. Risk for consumers unlikely
1016020	Poultry fat	0.01*
1016030	Poultry liver	0.01*
1020010	Milk (cattle)	0.01*	0.15	MRL proposal derived on basis of US tolerance. The calculated EU livestock exposure results in lower MRL proposals (0.03 mg/kg in cattle milk and 0.02 mg/kg in sheep/goat milk). Risk for consumers unlikely
1020020 1020030	Milk (sheep/goat)	0.01*	0.15
1030000	Eggs	0.01*	No change	The calculated livestock dietary burdens do not provide evidence that the existing MRL has to be modified
Enforcement residue definition 2: DFA
110010	Grapefruit	0.02*	No modification or 0.05 Further risk management discussion required	Insufficient residue trials in grapefruit data to support the import tolerance request (US GAP). Extrapolation from oranges to grapefruit could be considered by risk managers Risk for consumers unlikely
110020	Oranges		0.05	The submitted data are sufficient to derive an import tolerance (US GAP). Risk for consumers unlikely
110030	Lemons		0.05
110040	Limes
110050	Mandarins
120000	Tree nuts	0.02*	0.04
130010	Apples	0.03	0.15 or 0.2	The submitted data are sufficient to derive an import tolerance (US/Canadian GAP) The MRL proposal derived from the merged data set of trials in apples and pears is 0.2 mg/kg. Considering that a statistical testing demonstrated that the two data belong to different populations, the separate MRLs for pears (0.3 mg/kg) and apples (0.15 mg/kg), with extrapolation to quinces, medlars and loquat should be discussed by risk managers Risk for consumers unlikely
130020	Pears		0.3 or 0.2
130030	Quinces		0.15 or 0.2 Further risk management discussion required
130040	Medlars
130050	Loquats
151000	Grapes (wine and table grapes)	0.15	No change	The MRL derived for the reported US/Canadian use is lower (0.08 mg/kg) than the existing EU MRL. Hence, no modification of the existing MRL is required
152000	Strawberries	0.03	0.3	MRL proposal for existing EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.03 mg/kg Risk for consumers unlikely
154010	Blueberries	0.02*	0.05	The submitted data are sufficient to derive an import tolerance for US/Canadian use. Risk for consumers unlikely
161030	Table olives	0.02*	0.15	The submitted data are sufficient to support the intended SEU use Risk for consumers unlikely
162040	Prickly pear (cactus fruit)	0.02*	No proposal	Insufficient residue data to support the import tolerance request
211000	Potatoes	0.09 (ft.1)	0.2c	MRL proposal for US/Canadian use reflecting direct treatment and residues taken up via roots Risk for consumers unlikely Direct treatment of the crop with flupyradifurone (primary crop treatment) would require an MRL of 0.03 mg/kg The data gap identified in the peer review (ft.1) was sufficiently addressed
212000	Tropical root and tuber vegetables
213000	Other root and tuber vegetables except sugar beet	0.09 (ft.1)	0.4c	MRL proposal for US/Canadian use reflecting direct treatment and residues taken up via roots. Risk for consumers unlikely Direct treatment of the crop with flupyradifurone (primary crop treatment) would require an MRL of 0.3 mg/kg The data gap identified in the peer review (ft.1) was sufficiently addressed
220000	Bulb vegetables	0.06 (ft.1)	0.15	MRL proposal reflecting residues taken up via roots for EU soil plateau concentration. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
231010	Tomato	0.15 (ft.1)	0.4	For the authorised US/CAN GAP acute consumer intake concern for primary crop use could not be excluded. Therefore, an MRL proposal was derived for existing EU use reflecting direct treatment (foliar application) and residues taken up via roots. Direct treatment of tomatoes with flupyradifurone according to EU GAP would require an MRL of 0.06 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
231020	Pepper (including chili pepper)	0.15 (ft.1)	0.9c	MRL proposal for US/Canadian use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.7 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
231040	Aubergine (eggplant)	0.15 (ft.1)	0.9	MRL proposal for EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.7 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
232000	Cucurbits with edible peel	0.4	0.7	MRL proposal for EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone alone would require an MRL of 0.4 mg/kg Risk for consumers unlikely
233010	Melon	0.15 (ft.1)	0.3	For the authorized US/CAN GAP reflecting direct treatment and residues taken up via roots (MRL proposal of 0.9 mg/kg) an acute consumer intake concern could not be excluded. Therefore, an MRL proposal was derived reflecting the residues taken up via roots in the EU (no primary crop treatment) Direct treatment of the crop with flupyradifurone would require an MRL of 0.15 mg/kg. The data gap identified in the peer review (ft.1) was sufficiently addressed. Risk for consumers unlikely
233020	Pumpkin	0.15 (ft.1)	0.3	MRL proposal reflecting residues taken up via roots in the EU. The data gap identified in the peer review (ft.1) was sufficiently addressed. Risk for consumers unlikely
234000	Sweet corn	0.15 (ft.1)	0.2c	MRL proposal for US/Canadian use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.15 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
241000	Flowering brassica	0.02*	0.7	MRL proposal for EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.5 mg/kg. The submitted data are sufficient to support the MRL proposal. Risk for consumers unlikely
242010	Brussels sprouts	0.02*	0.4	MRL proposal for EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.2 mg/kg. Risk for consumers unlikely
242020	Head cabbage
243020	Kales	0.02*	0.6	MRL proposal for EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.4 mg/kg. Risk for consumers unlikely
244000	Kohlrabies	0.02*	0.4	MRL proposal for EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.2 mg/kg. Risk for consumers unlikely
251020	Lettuces	0.09	0.2	MRL proposal for EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.1 mg/kg. Risk for consumers unlikely
201030	Escaroles	0.04 (ft.1)	0.08	For the use of flupyradifurone (primary crop treatment), an acute consumer intake concern was identified for cooked escaroles from the primary crop treatment and residue soil uptake. Therefore, no MRL proposal was derived for primary crop treatment of escaroles. The MRL proposal is reflecting residues taken up via roots. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
251000 (except 251020 and 251030)	Lettuces and salad plants (except lettuces and escaroles)	0.04 (ft.1)	0.3	MRL proposal for EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.15 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
252000	Spinach and similar (leaves)	0.04 (ft.1)	0.3	MRL proposal for EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.15 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
254000	Watercresses	0.04 (ft.1)	0.08	MRL proposal for EU use reflecting residues taken up via roots. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
256000	Herbs and edible flowers	0.04 (ft.1)	0.3	MRL proposal for EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.15 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
253000	Grape leaves and similar species	0.04 (ft.1)	Further risk management considerations required	The data gap identified in the peer review (ft.1) was sufficiently addressed, noting that these crops are unlikely to be affected by residue uptake via soil (vine grapes are a permanent crop, witloof are not grown in soil). Hence, a modification of the existing MRL is considered not necessary
255000	Witloof/Belgian endives
260010 260030	Beans (with pods) Peas (with pods)	0.4 (ft.1)	0.9	MRL proposal for EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.08 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
260020 260040 260050	Beans (without pods) Peas (without pods) Lupins	0.4 (ft.1)	1.0	MRL proposal for EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.15 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
270000	Stem vegetables, except celery	0.08 (ft.1)	0.2	MRL proposal for EU use reflecting residues taken up via roots. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
270030	Celeries	0.08 (ft.1)	0.2	For the US/Canadian import tolerance request (primary crop treatment), an acute consumer intake concern was identified. Therefore, an MRL proposal was derived reflecting residues taken up via roots (rotational crop). Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
300000	Pulses	0.8 (ft.1)	3.0	MRL proposal for intended EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop in EU with flupyradifurone would require an MRL of 0.3 mg/kg. The direct treatment of the crop according to US/CAN GAP would require an MRL of 2 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
401020	Peanuts	0.05 (ft.1)	0.06c	MRL proposal for US/CA use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.03 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
401070	Soyabeans	0.05 (ft.1)	0.7c	MRL proposal for US/CA use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.6 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
401090	Cotton	0.05 (ft.1)	0.08	MRL proposal for intended EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone in EU would require an MRL of 0.02 mg/kg. The direct treatment of the crop according to US/CAN GAP would require an MRL of 0.03 mg/kg. The data gap identified in the peer review (ft.1) was sufficiently addressed
401000	Oilseeds, except peanuts, cotton, soyabeans	0.05 (ft.1)	0.05	MRL proposal for EU use reflecting residues taken up via roots. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
402010	Olives for oil production	0.02*	0.15	The submitted data are sufficient to support the MRL proposa Risk for consumers unlikely
500010	Barley	0.3 (ft.1)	0.8c	MRL proposal for US/CA use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.6 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
500080	Sorghum		No change	MRL proposal for US/CA use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.07 mg/kg. Risk for consumers unlikely. The data gap identified in the peer review (ft.1) was sufficiently addressed
500090	Wheat		1.5c	MRL proposal for US/CA use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 1 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
500030	Maize/corn		0.1c	MRL proposal for US/CA use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.05 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
620000	Coffee	0.1*	0.2	The submitted data are sufficient to derive an import tolerance. Risk for consumers unlikely
640000	Cocoa beans	0.1*	0.06	The submitted data are sufficient to derive an import tolerance. Risk for consumers unlikely
700000	Hops	0.3	No proposal	Insufficient data to support the import tolerance request
1011010	Swine muscle	0.1 (ft.1)	0.15	MRL proposal based on the calculated EU livestock exposure. Risk for consumers unlikely
1011020	Swine fat	0.1 (ft.1)	0.1
1011030	Swine liver	0.1 (ft.1)	0.09
1011040	Swine kidney	0.15 (ft1)	0.2
1011050	Swine edible offal	0.15 (ft.1)	0.2
1012010/1015010	Bovine/equine muscle	0.1 (ft.1)	0.4	MRL proposal based on the calculated US/Canadian livestock exposure The calculated EU livestock exposure results in lower MRL proposals. Risk for consumers unlikely
1012020/1015020	Bovine/equine fat	0.1 (ft.1)	0.5
1012030/1015030	Bovine/equine liver	0.1 (ft.1)	0.4
1012040/1015040	Bovine/equine kidney	0.15 (ft.1)	0.5
1012050/1015050	Bovine/equine edible offal	0.15 (ft.1)	0.5
1013010/1014010	Sheep/goat muscle	0.1 (ft.1)	0.2	MRL proposal reflects EU livestock dietary burden. Risk for consumers unlikely
1013020/1014020	Sheep/goat fat	0.1 (ft.1)	0.15
1013030/1014030	Sheep/goat liver	0.1(ft.1)	0.15
1013040/1014040	Sheep/goat kidney	0.15 (ft.1)	0.3
1013050/1014050	Sheep/goat edible offal	0.15 (ft.1)	0.3
1016000	Poultry muscle	0.05 (ft.1)	0.15	MRL proposal based on the calculated EU livestock exposure. Risk for consumers unlikely
1016020	Poultry fat	0.03 (ft.1)	0.03
1016030	Poultry liver	0.1 (ft.1)	0.3
1020010	Milk (cattle)	0.03 (ft.1)	0.07	MRL proposal based on the calculated US/Canadian livestock exposure. Risk for consumers unlikely
1020020	Milk (sheep)	0.03 (ft.1)	0.03	MRL proposal based on the calculated EU livestock exposure. Risk for consumers unlikely
1030000	Eggs	0.03 (ft.1)	0.1

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

^*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.

^bMRL according to Commission Regulation (EU) 2016/1902 of 27 October 2016.

^cMRL proposals do not take into account the theoretical worst‐case scenario for uptake of DFA residues via soil in crops growth in rotation after three seasonal soil treatments according to the critical US GAP reported in the framework of this application.

^ft.1The European Food Safety Authority identified some information on rotational crops 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 6 April 2018, or, if that information is not submitted by that date, the lack of it. ((Footnote related to data gap No 1).

Assessment

Flupyradifurone is the ISO common name for 4‐[(6‐chloro‐3‐pyridylmethyl) (2,2‐difluoroethyl) amino]furan‐2(5H)‐one (IUPAC). The chemical structures of the active substance and its main metabolites are reported in Appendix E. Flupyradifurone was evaluated in the framework of Regulation (EC) No 1107/20091 with the Netherlands designated as rapporteur Member State (RMS) for the representative uses of foliar applications on hops and lettuce. The Draft Assessment Report (DAR) also included a proposal to set maximum residue levels (MRL application), in accordance with Article 11 (2) of the Regulation (EC) 1107/2009. The DAR prepared by the RMS has been peer reviewed by EFSA (EFSA, 2015).

Flupyradifurone was approved2 for the use as insecticide on 19 December 2015.

In the framework of the peer review, EFSA identified some information as unavailable (data gaps) relevant both for the representative uses as well as for the crops referred to in the MRL application. The following data gaps were noted:

1. field rotational crop studies considering realistic plant back intervals for the crops considered and providing information on the flupyradifurone and DFA residue levels in soil;

2. animal feeding studies conducted with the DFA metabolite.

MRL proposals for both flupyradifurone and its metabolite difluoroacetic acid (DFA) were implemented in the MRL legislation by Commission Regulation (EU) 2016/4863. For several commodities, footnotes related to data gap number 1 were introduced in the MRL legislation, indicating the type of confirmatory data that should be provided by a party having an interest in maintaining the proposed tentative MRL by 6 April 2018. Data gap number 2 was not implemented as a confirmatory data requirement.4

After completion of the peer review, EFSA has issued one reasoned opinion on the modification of MRLs for flupyradifurone in strawberries, blackberries and raspberries (EFSA, 2016) and the proposals from the reasoned opinion were considered in the Commission Regulation (EU) 2016/19025.

In accordance with Article 6 of Regulation (EC) No 396/2005, on 31 August 2015, Bayer CropScience AG submitted an application (MRL application 1) to the competent national authority in the Netherlands (evaluating Member State, EMS) to modify the existing EU MRLs for flupyradifurone and DFA in support of intended EU uses of flupyradifurone on spinaches, herbs, lettuces and other salad plants; in addition, MRL modifications (import tolerances) were requested for various crops with uses of flupyradifurone authorised in the USA and Canada. The applicant also applied for the import tolerances for commodities 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 European Food Safety Authority (EFSA) on 16 May 2017. The EMS proposed to establish MRLs for flupyradifurone in various crops imported from the United States (USA) and Canada. In order to comply with the enforcement residue definition established in Europe,6 MRL proposals were derived also for difluoroacetic acid (DFA) (in Canada and USA, MRLs are for parent flupyradifurone, but not for DFA).

During its assessment, EFSA identified points related to field rotational crop studies and livestock feeding studies, which needed further clarifications.

In March 2019, the EMS submitted a revised evaluation report, which replaced the previously submitted evaluation report (Netherlands, 2017). In this evaluation report, the EMS also assessed the confirmatory data requested in the DAR which were implemented in the footnotes of the MRL legislation.

EFSA assessed the applications and the new merged evaluation report as required by Articles 9 and 10 of the MRL regulation and in accordance with the agreed procedure set out in the working document SANTE/10235/2016 (European Commission, 2016).

On 20 August 2019, the applicant Bayer SAS submitted second MRL application (MRL application 2) to the competent national authority in the Netherlands to modify the existing EU MRLs for flupyradifurone and DFA in support of the intended EU uses of flupyradifurone on olives, head brassica, flowering brassica, leafy brassica, kohlrabi, legume vegetables, pulses, cotton and to set import tolerance in cocoa beans reflecting authorised uses in Ivory Coast and Ghana. 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 20 August 2019 (Netherlands, 2019).

The MRL proposals by the EMS and the tolerances in place in the country of origin are summarised in Table 1.

Table 1.

Overview on MRL proposals derived by EMS to be assessed by EFSA

Code	Commodity	Flupyradifurone			Difluoroacetic acid		Origin of proposal
		Existing EU MRLa (mg/kg)	Proposed MRL by the EMS (mg/kg)	MRL in the country of origin (mg/kg)	Existing EU MRLb (mg/kg)	Proposed MRL by the EMS (mg/kg)
110000	Citrus fruit	0.01*	3.0	3.0b	0.02*	0.05	Import tolerance
120000	Tree nuts	0.01*	0.02	0.02b	0.02*	0.04	Import tolerance
130000	Pome fruits	0.4	0.7	0.7b	0.03	0.2	Import tolerance
151000	Grapes (wine and table grapes)	0.8	3.0	3.0b	0.15	0.15	Import tolerance
152000	Strawberries	0.4	No modification required	–	0.03	0.15	EU existing use, considering DFA uptake via soilf
154010	Blueberries	0.01*	4.0	4.0b	0.02*	0.05	Import tolerance
161030	Table olives	0.01*	5.0	–	0.02*	0.15	Intended EU use
162040	Prickly pears/cactus fruits	0.01*	No proposal	0.3b	0.02*	No proposal	Import tolerance
211000	Potato	0.01*	0.05	0.05 (b)	0.09( ft )	0.3	Import tolerancee
212010	Tropical root and tuber vegetables	0.01*	0.9	0.05b	0.09( ft )	0.3	Import tolerancee
213000	Other root and tuber vegetables except sugar beets	0.01*	0.9	0.9b	0.09( ft )	0.3	Import tolerancee
231010	Tomatoes	0.7	1.0	1.5b	0.15( ft )	0.7	Import tolerancee
231020	Sweet peppers/bell peppers	0.9	0.9		0.15( ft )		Import tolerancee
231040	Aubergines/eggplants	0.7	1.0		0.15( ft )		Import tolerancee
220000	Bulb vegetables	0.01*	0.01*	–	0.06( ft )	0.2	Confirmatory data
232000	Cucurbits with edible peel	0.6	0.6	0.4	0.4	0.4	Not assessed since existing EU MRL is higher than requested import tolerancef
233010	Melons	0.01*	0.4	0.4	0.15( ft )	0.7	Import tolerancee
234000	Sweet corn	0.01*	0.05	0.05b	0.15( ft )	0.15	Import tolerancee
241010	Cauliflower	0.01*	0.5	–	0.02*	0.4	Intended EU use
241020	Broccoli	0.01*	0.5	–	0.02*	0.4	Intended EU use
242010	Brussels sprouts	0.01*	0.09	–	0.02*	0.2	Intended EU use
242020	Head cabbages	0.01*	0.2	–	0.02*	0.2	Intended EU use
243020	Kales	0.01*	5.0	–	0.02*	0.4	Intended EU use
244000	Kohlrabies	0.01*	0.09	–	0.02*	0.2	Intended EU use
251020	Lettuces	5.0	5.0	–	0.09	0.09	Intended EU use
251010 251040 251050 251060 251070 251080	Lambs lettuces Cresses Land cresses Roman rocket/rucola Red mustards Baby leaf crops	0.03( ft )	6.0	–	0.04( ft )	0.1	Intended EU use, confirmatory data
251030	Escarole/broadleaved endives	0.03( ft )	0.05	–	0.04( ft )	0.06	Intended EU use, confirmatory data
252000	Spinaches and similar (leaves)	0.03( ft )	6.0	–	0.04( ft )	0.1	Intended EU use, confirmatory data
253000	Grape leaves and similar species	0.03( ft )	0.05	–	0.04( ft )	0.06	Confirmatory data
254000	Water cresses	0.03( ft )	0.05	–	0.04( ft )	0.06	Confirmatory data
255000	Witloof/Belgian endives	0.03( ft )	0.05	–	0.04( ft )	0.06	Confirmatory data
256000	Herbs and edible flowers	0.03( ft )	6.0	–	0.04( ft )	0.1	Intended EU use, confirmatory data
260010	Beans (with pods)	0.01*	0.5d	–	0.4( ft )	0.5d	Intended EU use, confirmatory dataf
260020	Beans without pods	0.01*	0.3d	–
260030	Peas (with pods)	0.01*	0.5d	–
260040	Peas (without pods)	0.01*	0.3d	–
270000	Stem vegetables, except celery	0.01*	0.01*	–	0.08( ft )	0.1	Confirmatory data
70030	Celeries	0.01*	9.0	9b	0.08( ft )	0.3	Import tolerancee
300000	Pulses	0.01*	3.0c/0.4d	3b	0.8( ft )	3c/1.0d	Import tolerance/Intended EU use
401020	Peanuts	0.01*	0.04	0.04b	0.05( ft )	0.15	Import tolerancee
401070	Soyabeans	0.01*	1.5	1.5b	0.05( ft )	0.6	Import tolerancee
401090	Cotton seeds	0.01*	0.8c/0.2d	0.8b	0.05( ft )	0.15c/0.03d	Import tolerance/Intended EU use
401000 (except 401020, 401070, 401090)	Other oilseeds (except soyabeans, peanuts and cotton seeds)	0.01*	0.01*	–	0.05( ft )	0.15c/0.03d	Confirmatory data
402010	Olives for oil production	0.01*	5.0		0.02*	0.15	Intended EU use
500010	Barley	0.01*	3.0	3.0b	0.3( ft )	0.6	Import tolerancee
500030	Maize/corn	0.01*	0.02	0.05b	0.3( ft )	0.2	Import tolerancee
500080	Sorghum	0.01*	3.0	3.0b	0.3( ft )	0.2	Import tolerancee
500090	Wheat	0.01*	1.0	3.0b	0.3( ft )	1.0	Import tolerancee
620000	Coffee beans	0.05*	1.0	1.5	0.1*	0.3	Import tolerance
640000	Cocoa beans	0.05*	0.05*		0.1*	0.1*	Import tolerance (Ivory Coast, Ghana)
700000	Hops	4.0	10	10b	0.3	3.0	Import tolerance
1011010	Swine muscle	0.01*	0.03d	0.01b	0.1	0.15d	Import tolerance
1011020	Swine fat	0.01*	0.015d	0.01b	0.1	0.20d
1011030	Swine liver	0.01*	0.09d	0.04b	0.1	0.10d
1011040	Swine kidney	0.01*	0.15d	0.04b	0.15	0.20d
1011050	Swine edible offal	0.01*	0.15d	0.04b	0.15	0.20d
1012010/1015010	Bovine/equine muscle	0.01*	0.3c	0.3b	0.1	0.20d
1012020/1015020	Bovine/equine fat	0.01*	0.15c	0.2b	0.1	0.30d
1012030/1015030	Bovine/equine liver	0.01*	0.8c	1.0b	0.1	0.15d
1012040/1015040	Bovine/equine kidney	0.01*	0.9c	1.0b	0.15	0.30d
1012050/1015050	Bovine/equine edible offal	0.01*	0.9c	1.0b	0.15	0.30d
1013010/1014010	Sheep/goat muscle	0.01*	0.04d	0.3b	0.1	0.20d
1013020/1014020	Sheep/goat fat	0.01*	0.03d	0.2b	0.1	0.30d
1013030/1014030	Sheep/goat liver	0.01*	0.4d	1.0b	0.1	0.15d
1013040/1014040	Sheep/goat kidney	0.01*	0.20d	1.0b	0.15	0.30d
1013050/1014050	Sheep/goat edible offal	0.01*	0.40d	1.0b	0.15	0.30d
1016000	Poultry muscle	0.01*	0.01*	–	0.05	0.15d
1016020	Poultry fat	0.01*	0.01*	–	0.03	0.04d
1016030	Poultry liver	0.01*	0.01*	–	0.1	0.30d
1020000	Milk	0.01*	0.03d	0.15b	0.03	0.04d
1030000	Eggs	0.01*	0.01*	0.01b	0.03	0.15d

MRL: maximum residue level.

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

^aMRL according to Commission Regulation (EU) 2016/1902 of 27 October 2016.

^bEnvironmental Protection Agency, 40 CFR Part 180, Federal Register/Vol.80, No 15/Friday, January 23, 2015.

^cMRL application from Bayer AG‐Crop Science of 20 February 2019 and Evaluation report (Netherlands, 2017).

^dMRL application from Bayer AG‐Crop Science of June 2019 and Evaluation report (Netherlands, 2019).

^eImport tolerance request covers the less critical EU use for which confirmatory data were requested.

^fUS/Canadian GAPs were reported in the evaluation report, but not assessed by the EMS, since no import of treated commodities is intended.

^ftAccording to Commission Regulation (EU) 2016/1902: The European Food Safety Authority identified some information on rotational crops 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 6 April 2018, or, if that information is not submitted by that date, the lack of it.

For reasons of efficiency, both MRL applications were combined in one EFSA reasoned opinion.

EFSA based its assessment on the evaluation report submitted by the EMS (Netherlands, 2017, 2019), the DAR and its addendum (Netherlands, 2014, 2015) prepared under Regulation (EC) 1107/2009, the conclusion on the peer review of the pesticide risk assessment of the active substance flupyradifurone (EFSA, 2015), the Commission review report on flupyradifurone (European Commission, 2015), as well as the conclusions from a previous EFSA opinion on flupyradifurone (EFSA, 2016).

For this application, the data requirements established in Regulation (EU) No 283/20137 and the guidance documents applicable at the date of submission of the application to the EMS are applicable (European Commission, 2000, 2010a,b, 2017; OECD, 2007a,h, 2008a,b, 2009a,b, 2011, 2013, 2016, 2018). The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation of Plant Protection Products adopted by Commission Regulation (EU) No 546/2011.

The detailed description of the authorised uses in United States, Canada, Brazil, Ivory Coast and Ghana and the intended EU uses, which are the basis for the assessment of the MRL application, is reported in Appendix A. The existing uses for which confirmatory data were requested are reported in EFSA, 2015.

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

Evaluation reports submitted by the EMS (Netherlands, 2017, 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

Flupyradifurone metabolism in primary crops was investigated in the framework of the EU pesticides peer review in four crop groups either by foliar applications (apple, cotton, rice), by soil granule/drench applications (tomato, potato, rice) and by seed treatment (potato). Studies were conducted using ¹⁴C‐flupyradifurone labelled on the pyridinyl and furanone moiety. One study on tomato using soil drench application and a ¹⁴C‐labelling on the difluoroethyl amino group was also submitted (EFSA, 2015).

The metabolism in primary crops was seen to be similar in all plant groups investigated. Flupyridafurone was consistently observed as the major component of the radioactive residues, accounting for ca. 25% to 88% total radioactive residue (TRR) in all plant parts analysed. Besides flupyradifurone, the following metabolites were identified in different plant matrices:

• − the conjugate flupyradifurone‐hydroxy‐glycoside, up to 36% TRR in apple leaves,
• − the conjugate CHMP‐diglycoside, up to 37% TRR (0.06 mg/kg) and the metabolite 6‐CNA in the range of 13% to 22% TRR in tomato fruit, potato tuber and cotton seed at ca. 0.02 mg/kg, both resulting from the cleavage of the molecule at ethylamine bond and containing the pyridinyl moiety.

In tomatoes, following the soil drench application, significant proportions (87% TRR) and levels (0.17 mg/kg) of difluoroacetic acid (DFA) were observed in fruits. Re‐analysing samples from radiolabelled studies for non‐radiolabelled DFA residues, the measured DFA residues (expressed as DFA equivalent), were in the range of 0.04–0.23 mg/kg in apple fruits, potato tuber, cotton seed and rice grain, irrespective of the mode of application.

The peer review concluded that in primary crops, flupyradifurone is not extensively degraded and the metabolism in plants proceed via the hydroxylation of the furanone ring leading to the flupyradifurone‐hydroxy metabolite (M8 metabolite) and its glycoside conjugates and via the cleavage of the parent molecule at the ethylamine bond resulting in the formation of metabolites containing the pyridinyl moiety (CHMP‐diglycoside, 6‐CNA free and conjugated). The furanone counterpart is extensively metabolised and incorporated in natural glycoside or carbohydrate components.

During the current assessment, EFSA requested information on metabolism in genetically modified crops, i.e. data on the nature and magnitude of flupyradifurone in GM crops compared with conventional crops. The applicant analysed different genetically modified crops (maize, cotton, soyabean and potato with genetical modifications to introduce herbicide tolerance, insect resistance, modified product qualities and marker genes inserted to allow monitoring of gene expressions in plant cells). The applicant provided sufficient evidence that, based on the mode of action or structural conformity of targets in the GM crops, the metabolism of flupyradifurone in these GM crops will not be altered.

For the authorised and the intended uses under consideration, it is concluded that the metabolic behaviour in primary crops is addressed.

1.1.2. Nature of residues in rotational crops

The nature of flupyradifurone in rotational crops (turnips, Swiss chard and wheat) was investigated in the framework of the EU pesticides peer review. Flupyradifurone, labelled at ¹⁴C‐pyridinyl and ¹⁴C‐furanone moiety, was applied on a bare soil at an application rate of 436 g/ha. Rotational crops were planted 29, 135 and 296 days after the soil treatment. In rotational crops, flupyradifurone and its metabolites flupyradifurone‐hydroxy, 6‐CNA and their conjugates were found to be the major components of the radioactive residues (EFSA, 2015). These radiolabelled studies did not include the labelling on the difluoroethyl amino group.

Additional field rotational crop studies indicated that DFA is the major component of the residues in rotational crops. The presence of DFA is mostly resulting from the uptake from soil, where this metabolite was identified as a major metabolite (EFSA, 2015).

1.1.3. Nature of residues in processed commodities

The effect of processing on the nature of flupyradifurone was investigated in the framework of the EU pesticides peer review (EFSA, 2015). Standard hydrolysis studies showed that flupyradifurone is hydrolytically stable under standard processing conditions of pasteurisation, baking/brewing/boiling and sterilisation.

The effect of processing on the nature of difluoroacetic acid (DFA) has not been investigated. Considering the similarity of the structures between trifluoroacetic acid (TFA) and DFA, the applicant proposed a read‐across for both acids. The TFA, due to its stability in environment, has been widely studied and is, due to its structure (complete fluoride ion substitution), very stable and thus has no potential for hydrolytic degradation (Lifongo et al., 2010).

EFSA agrees with the EMS that there is sufficient evidence that difluoroacetic acid is stable under standard hydrolysis conditions.

1.1.4. Methods of analysis in plants

The availability of analytical enforcement methods for the determination of flupyradifurone and DFA in plant matrices was investigated in the framework of the EU pesticides peer review (EFSA, 2015). It was concluded that a method (method reference number 01330) using HPLC‐MS/MS is sufficiently validated for the determination of flupyradifurone and DFA residues; LOQs achievable with the method were 0.01 and 0.007 mg/kg8 for flupyradifurone and DFA (expressed as DFA), respectively, in plant matrices with high water (lettuce), high starch (wheat, potato), high acid (oranges) and high oil content (rapeseed). In hops, the validated LOQ for the determination of flupyradifurone is 0.05 mg/kg and for DFA (expressed as DFA), it is 0.03 mg/kg. The validation data for high starch content crop matrix is sufficiently representative to cover high protein content plant matrix (OECD, 2007a, 2007b, 2007c, 2007d, 2007e, 2007f, 2007g, 2007h).

EFSA concludes that a sufficiently validated analytical method is available for the enforcement of flupyradifurone and DFA residues in the crops under consideration.

1.1.5. Storage stability of residues in plants

The storage stability of flupyradifurone and DFA has been investigated in the EU pesticides peer review; on the basis of an interim study report, it was concluded that both compounds are stable for at least 18 months in high water, high acid, high oil, high protein and high starch content matrices when stored frozen at approximately −18°C (EFSA, 2015).

The applicant now submitted the final report of the above‐mentioned study, where stability of flupyradifurone and DFA residues was investigated for longer storage periods of 35 and 52 months. The submitted data confirm freezer storage stability of both compounds at −18°C for 52 months in matrices with high water content (spinach, tomato, sugarcane), high acid content (orange fruit), high oil content (soyabean), high protein content (bean), high starch content (wheat grain) and coffee beans.

The residue trial samples of crops under consideration were stored under conditions for which the stability of flupyradifurone and DFA residues has been demonstrated.

1.1.6. Proposed residue definitions

Based on the metabolic pattern identified in primary and rotational crop metabolism studies, the results of hydrolysis studies, the toxicological significance of metabolites and/or degradation products, the capabilities of enforcement analytical methods, the following residue definitions were agreed by the EU pesticides peer review (EFSA, 2015):

• − Residue definition for risk assessment: Sum of flupyradifurone and DFA, expressed as flupyradifurone.
• − Residue definition for enforcement: 1) Flupyradifurone; 2) DFA, expressed as DFA.

The same residue definitions are applicable to rotational crops and processed products.

The residue definition for enforcement set in Regulation (EC) No 396/2005 is identical with the above‐mentioned residue definition for enforcement.

The enforcement residue definition in the USA and Canada (import tolerance requests) is parent flupyradifurone alone. The same residue definition has been established by the Codex Alimentarius. Information on the residue definition in Brazil, Ghana and Ivory Coast (import tolerance requests for coffee beans and cocoa beans) is not available, but it is likely that in these countries, the Codex residue definitions are used.

EFSA concludes that these residue definitions are appropriate for the crops under consideration and no further information is required.

1.2. Magnitude of residues in plants

1.2.1. Magnitude of residues in primary crops

In support of the intended and authorised uses of flupyradifurone, a wide range of residue trials were submitted. The samples were analysed individually for parent flupyradifurone and its metabolite DFA. Results were expressed according to enforcement and risk assessment residue definitions, currently in force in Europe. The analytical methods used to analyse residue trial samples were sufficiently validated and are considered as fit for purpose (Netherlands, 2017, 2019). It is noted that in the method validation data, the LOQs for the DFA were expressed as parent equivalents.

In most of the trials, duplicate composite samples were collected. In all trials supporting authorised uses in third countries adjuvants were added to the formulation.

In some crops, according to the decline trials, the concentrations of metabolite DFA increase with longer preharvest interval (PHI) intervals, while the concentrations of parent flupyradifurone, generally decline. Thus, from decline trials, the highest individual residue value for flupyradifurone and DFA, irrespective of the PHI, was selected to derive the MRL proposals.

The details of submitted residue trials are reported in Appendix B.1.2.1.

Citrus fruits

GAP USA: 1) foliar application: 1–2 × 0.21 kg/ha, 10‐days interval, PHI 1 day;

2) soil treatment: 1 × 0.41 kg/ha, PHI 30 days

In support of authorised GAPs, the applicant submitted in total 34 GAP compliant residue trials in citrus fruit: 12 on oranges, 8 on lemons, 6 on grapefruit and 8 on mandarins. All trials were performed in the USA in 2010 and 2011.

For the foliar spray treatment, side‐by‐side studies were performed with different water amounts per hectare; hence, one plot received diluted and one plot concentrated application. Generally, both spray patterns gave comparable results. The highest value per trial was selected for the residue data set. Eighteen trials were designed as decline trials. The pulp and peel samples from four trials, analysed at the PHI of 1 day, did not contain quantifiable residues. For the soil treatment, the plot received one drench application 28–30 days prior to harvest. In two trials, mandarins received exaggerated soil application, but, as all residues in these samples were below the LOQ, these trials were not disregarded. Foliar use results in a more critical residue situation in citrus fruits.

The applicant proposed to pool all citrus residue data representing the foliar use, resulting in an MRL proposal of 3 mg/kg for flupyradifurone, which is the same value as the tolerance established in the USA.

This proposal is not supported, as a statistical analysis of the residue data of the different citrus crops demonstrated that the data sets belong to different data populations, except the data on mandarins and lemons where the residues were found to be similar. Moreover, each crop, except grapefruit, is fully supported by individual residue trial data. For grapefruit, two additional trials would be required given that grapefruit is a major crop in the world according to EU guidance document (European Commission, 2017).

Based on a foliar use, an MRL of 3 mg/kg for flupyradifurone and of 0.05 mg/kg for DFA is derived for oranges. For lemons, limes and mandarins, an MRL proposal of 1.5 mg/kg is derived for flupyradifurone and of 0.05 mg/kg for DFA. For grapefruit, the provided data are insufficient to derive an MRL proposal on the basis of grapefruit trials alone. However, risk managers may discuss the possibility to establish the MRL for grapefruits on the basis of the residue trials in grapefruit, complemented by the trials on oranges, considering that oranges and grapefruit are of comparable fruit size. In this case, an MRL proposal of 3 mg/kg for flupyradifurone and of 0.05 mg/kg for DFA would be derived.

Tree nuts

GAP USA, CAN: foliar application 1–2 × 0.21 kg/ha, 14‐days interval, PHI 7 days

In support of the authorised GAP, the applicant submitted in total 10 GAP compliant residue trials on almonds (5) and pecan nuts (5), which were performed in the USA in 2010. In each trial, two separate plots were treated side by side with different concentrations of the a.s. in the spray solution, but with the same application rate per hectare; from these replicates, EFSA selected the higher value to derive the MRL proposals. In all trials, nutmeat and hull were analysed for residues. Only in two trials, residues of flupyradifurone were above the LOQ; DFA was detected above the LOQ in one sample only. The applicant proposes to extrapolate residue data to the whole group of tree nuts. According to EU guidance document (European Commission, 2017), the use is sufficiently supported by residue data.

Residue data are sufficient to derive an MRL proposal of 0.02 mg/kg for flupyradifurone and of 0.04 mg/kg for DFA, based on a combined residue data set.

Pome fruit

GAP USA, Canada: foliar application: 1–2 × 0.21 kg/ha, 10‐days interval, PHI 14 days

In support of the authorised GAP, the applicant submitted in total 23 GAP compliant residue trials on apples (14) and pears (9), which were performed in the USA in 2011. In each trial, two separate plots were treated side by side with different concentrations of the a.s. in the spray solution, but with the same application rate per hectare; from these replicates, EFSA selected the higher value to derive the MRL proposals. Eight trials were designed as decline trials with samples taken 7, 12–14, 21, 28 and 35 days after the last treatment. In five decline trials, highest concentrations of DFA were detected in samples taken at the longest PHI interval of 35 days. Flupyradifurone residues, generally, decrease along time.

The residue situation in pears is slightly more critical than in apples. Since the residue populations according to U‐tests are different, they shall not be merged. The residue data in apples alone could be extrapolated to quinces, medlar and loquats according to EU guidance document (European Commission, 2017) with a resulting MRL proposal of 0.5 mg/kg for flupyradifurone and of 0.15 mg/kg for DFA. For pears, an MRL of 0.8 mg/kg is derived for flupyradifurone and of 0.3 mg/kg for DFA. The tolerance in the USA is established for the whole group at 0.7 mg/kg on a basis of a merged apple and pear residue data set. Risk managers may discuss the possibility to establish the MRL for the whole pome fruit group on the basis of the merged residue data sets of apples and pears. In this case, an MRL proposal of 0.6 mg/kg would be appropriate for flupyradifurone and of 0.2 mg/kg for DFA.

Table and wine grapes

GAP USA: 1) foliar application: 1–2 × 0.21 kg/ha, 10‐days interval, PHI 0 day

GAP USA, Canada: 2) soil treatment: 1 × 0.41 kg/ha, PHI 30 days

In support of the authorised GAP, the applicant submitted in total 13 independent residue trials on grapes representative for the foliar application and 11 trials representative for the soil treatment which were performed in the USA and Canada in 2010. All trials with foliar treatment were designed as decline trials, with samples taken 0, 3, 7 and in two trials also 14, 20–21 day after the last application. The grape samples from trials with soil application were taken 28–‐30 days following the treatment. The foliar use results in a more critical residue situation and was therefore used to derive the MRL proposal of 3 mg/kg for flupyradifurone and 0.08 mg/kg for DFA in table and wine grapes.

Strawberries

The existing EU MRL for flupyradifurone is not to be modified. The applicant and the EMS proposed to raise the existing MRL for DFA from 0.03 mg/kg to 0.15 mg/kg, to account for potential uptake of residues from soil when strawberries are grown in a crop rotation (see Section 1.2.2).

Blueberries

GAP USA, CAN: foliar application 1–2 × 0.21 kg/ha, 7‐days interval, PHI 3 days

In support of the authorised GAP, the applicant submitted in total 26 GAP compliant residue trials on blueberries. Trials were performed in various countries: USA, Canada, Australia, Chile, New Zealand, United Kingdom, Denmark, Spain and Italy in 2011. Trials were performed on low bush, high bush and rabbit eye blueberries. Seven trials were designed as decline trials with samples taken 0, 1, 3, 7 and 14 days after the last application. In all decline trials, the highest residue concentrations of DFA were measured at the last sampling point 14 days after the treatment. Parent flupyradifurone, generally, reached plateau concentrations at 3–7 days PHI. In two EU trials, blueberries were grown in the field under plastic‐covered tunnels; since residues in these trials were within the same range as in others, these trials were not disregarded.

Residue trials support the MRL proposal of 4 mg/kg for flupyradifurone and of 0.05 mg/kg for DFA in blueberries.

Table olives

See olives for oil production.

Prickly pear/cactus

GAP USA: foliar application 1–2 × 0.21 kg/ha, 7‐days interval, PHI 21 days

In support of the GAP, the applicant submitted in total two GAP compliant, independent trials on prickly pear cactus (fruit and pads were analysed in each trial). Trials were performed in 2011 at two sites in California, USA. At each site trial, two plots were treated, one day apart. The EMS and EFSA are of the opinion that only two independent trials are available, which is insufficient to derive an MRL proposal and to support the authorised use in the USA.

Potatoes; Tropical root and tuber vegetables (cassava, sweet potatoes, yams, arrowroots)

GAP US/CA: foliar application 1–2 × 0.21 kg/ha, 7‐days interval, PHI 7 days

In support of the authorised GAP, the applicant submitted in total 26 GAP compliant residue trials on potatoes. Trials were performed in the USA and Canada in 2010. Four trials were designed as decline trials, with samples analysed 3, 6–7, 14 and 19–21 days following the last treatment. The maximum concentrations of flupyradifurone and the DFA were reached before the last sampling event.

The applicant proposes to extrapolate residue data in potatoes to the whole group of tropical root and tuber vegetables (cassava, sweet potatoes, yams, arrowroots). According to EU guidance document (European Commission, 2017), such extrapolation is acceptable and is fully supported by residue data. An MRL of 0.05 mg/kg for flupyradifurone and of 0.03 mg/kg for DFA is thus derived for potatoes and tropical root and tuber vegetables.

Root and tuber vegetables (except sugar beet): beetroots, carrots, celeriac, horseradish, Jerusalem artichokes, parsnips, parsley roots, radishes, salsifies, swedes/rutabaga and turnips.

GAP US/CA: foliar application 1–2 × 0.21 kg/ha, 7‐ to 10‐days interval, PHI 7 days

In support of the authorised GAP, the applicant submitted in total 10 GAP compliant residue trials on carrots and seven GAP compliant on radish. Trials were performed in the USA and Canada in 2011. Six trials were designed as decline trials, with samples taken 0, 5–7, 12–14, 20–21, 26–28 and 33–35 days after the treatment.

The residue data in carrots suggest an MRL of 0.9 mg/kg; using the trials on radish only, a lower MRL proposal of 0.15 mg/kg is derived for flupyradifurone in radishes. Based on the combined carrot and radish trials, an MRL of 0.7 mg/kg for flupyradifurone and of 0.3 mg/kg for DFA is calculated.

Since an US tolerance for the whole group of root and tuber vegetables is established at 0.9 mg/kg, EFSA accepts the proposal to use carrot residue data and to extrapolate to the whole group of root and tuber vegetables (except sugar beet). For DFA, the MRL proposal, based on carrot data, is 0.3 mg/kg.

Tomatoes, aubergines

GAP US/CA: 1) foliar application 1–2 × 0.21 kg/ha, 7‐days interval, PHI 1 day

2) soil application 1 × 0.41 kg/ha, PHI 45 days

In support of the authorised GAP, the applicant submitted in total two sets of 19 residue trials on tomatoes representative for the foliar use and for the soil application (side‐by‐side trials for the two types of treatments), which were performed in the USA and Canada in 2011. Eight residue trials, respectively, were designed as decline trials, with samples taken 0, 1, 7, 14, 20–21 and 27–28 days after the final treatment for the foliar use and 38–41, 45, 49–50, 60 and 69–70 days after the soil treatment.

In five out of eight decline trials from foliar treatment, the DFA residues increased with time, with the highest residue measured at the last sampling point (PHI interval of 28 days). Hence, for these trials, it cannot be excluded that higher DFA residues might be found at later sampling points. However, since the increase was not consistently observed in all residue trials, the trials were considered valid, despite an additional, non‐standard uncertainty. In harvest trials, the residues of DFA in all samples were below the LOQ. Also in the trials from the soil treatment, residues of DFA increase by time, reaching maximum levels at 60–70 days after the treatment (seven trials).

The proposal of the applicant to extrapolate residue data from tomatoes to aubergines is sufficiently supported by data and is acceptable according to EU guidance documents (European Commission, 2017). The residue data are sufficient to derive an MRL proposal of 1 mg/kg for flupyradifurone (foliar use) and of 0.7 mg/kg for DFA (soil treatment) for tomatoes and aubergines. (See also dietary risk assessment for tomatoes).

Sweet peppers/bell peppers

GAP US/CA: 1) foliar application 1–2 × 0.21 kg/ha, 7‐days interval, PHI 1 day

2) soil application 1 × 0.41 kg/ha, PHI 45 days

In support of the authorised GAP, the applicant submitted two sets of 14 residue trials on sweet peppers (10) and chili peppers (4) representative for the foliar use and for the soil application (side‐by‐side trials for the two types of treatments). Trials were performed in the USA and Canada in 2011. Ten trials were designed as decline trials, with samples taken 0, 1, 7, 13–14, 20–21 and 28 days following the last foliar treatment and 39–40, 44–45, 49–50, 59–63 and 68–70 days after soil application. In five decline trials with foliar treatment, the DFA residues increased with time, with the highest residue measured at the last sampling point. Hence, for these trials, it cannot be excluded that higher DFA residues might be found at later sampling points. However, since the increase was not consistently observed in all residue trials, the trials were considered valid, despite an additional, non‐standard uncertainty. Following soil treatment, in six decline trials, higher residues of DFA were present in samples taken ca. 60 days (three trials) and 70 days (three trials) after the application.

Residue data are sufficient to derive an MRL proposal of 0.9 mg/kg for flupyradifurone based on foliar treatment and of 0.7 mg/kg for DFA, based on the soil treatment of peppers.

Melons

GAP US/CA: 1) foliar application 1–2 × 0.21 kg/ha, 7‐days interval, PHI 1 day

2) soil application 1 × 0.41 kg/ha, PHI 21 days

In support of the authorised GAP, the applicant submitted two sets of five GAP compliant residue trials on melon representative for the foliar and the soil application. Trials were performed in the USA in 2011. All trials were designed as decline trials. The residues of flupyradifurone from soil application and the residues of DFA both from soil and foliar treatment were higher at longer PHI intervals. The plateau concentrations for both compounds were reached within the PHI intervals tested.

The applicant also submitted 17 residue trials on cucumbers (9) and courgettes (summer squash) (8), compliant with the GAP on melons; trials were performed in the USA and Canada in 2011. Side‐by‐side trials for foliar and soil application were performed. Eight cucumber trials and four courgette trials were designed as decline trials with samples analysed at the PHI intervals of 0, 1, 7, 14, 20–21, 28 days for foliar application and at 14, 20–21, 28, 34–35 and 40–42 days for soil treatment. The foliar use trials confirm that plateau concentration of parent compound is reached at the authorised PHI of 1 day, whereas residues of DFA in all decline trials are higher at longer PHI intervals and in five decline trials, no plateau was reached by the latest sampling point at 28‐day PHI. Residue data on courgettes and cucumbers are of a similar data population according to U‐test.

The applicant proposed to combine the residue trials on cucumbers, courgettes and melons to derive an MRL proposal for melons in accordance with the approach used in the USA; based on the pooled residue data sets, an MRL proposal of 0.4 mg/kg for flupyradifurone and of 0.7 mg/kg for DFA is derived. It is noted that the residue trials in melons alone would not be sufficient, since melons are a major crop for import tolerance setting. The merging of residue trials in melons and cucurbits with edible peel is not explicitly mentioned in the EU extrapolation guidance documents. However, considering that the residue data populations on cucumbers/courgettes and melons are similar, the setting of an MRL based on the combined residue data sets is deemed acceptable. The MRL proposals for the foliar use are 0.4 mg/kg for flupyradifurone and 0.7 mg/kg for DFA (See also dietary risk assessment).

Sweet corn

GAP USA: foliar application 1–2 × 0.21 kg/ha, 7‐days interval, PHI 7 days

In support of the authorised GAP, the applicant submitted in total 13 GAP compliant residue trials on maize. Trials were performed in the USA and Canada in 2010. All foliar applications were made at growth stages ranging from BBCH 63 (tip of ear emerging from leaf sheath) to 85 (dough stage: kernel yellowish to yellow (variety dependent) about 55% dry matter).Two trials were designed as decline trials with samples taken at 0, 3, 7, 14 and 21 days after the final treatment. Samples of kernels plus cob (with husk removed), forage and stover were taken in all trials. Residues of DFA increase with time and account for the highest 14–21 days after the last application. The number of submitted decline trials is, however, not sufficient to appropriately assess the uptake of DFA with longer post‐harvest intervals.

The submitted residue trials indicate that an MRL of 0.05 mg/kg for flupyradifurone and of 0.15 mg/kg for DFA would be required to support the authorised use on sweet corn.

Broccoli and cauliflower

GAP NEU/SEU: 2 × 125 g/ha, 10‐days interval, PHI 3 days

In support of the intended GAPs, the applicant provided two sets of eight GAP compliant residue trials representative for NEU and SEU, respectively (four NEU and four SEU trials on cauliflower and four NEU and four SEU trials on broccoli). Trials were performed in various EU countries over growing seasons of 2010, 2011, 2013 and 2016. All trials were designed as decline trials with samples taken 3, 5, 7; in 14 of the 16 trials samples were also taken 10 and 14 days after the last application. The highest concentrations of DFA were observed at the longest tested PHIs.

Residue data are sufficient to support the intended uses. An MRL proposal of 0.6 for flupyradifurone is derived on a basis of SEU use, whereas for the DFA, an MRL proposal of 0.5 mg/kg is derived based on NEU use.

Brussels sprouts

NEU: 2 × 125 g/ha, 10‐days interval, PHI 3 days

In support of the intended GAP, the applicant submitted eight GAP compliant residue trials on Brussels sprouts, which were performed in Germany, the Netherlands, Belgium and France over seasons of 2010 and 2013. All trials were designed as decline trials with samples taken 1, 3–4, 5, 7 and in four trials also 10 and 14 days following the last application. Results confirm that concentrations of DFA increase with longer PHI intervals reaching maximum at the longest PHI tested.

Residue data are sufficient to derive an MRL proposal of 0.09 mg/kg for flupyradifurone and of 0.2 mg/kg for the DFA.

Head cabbage

GAP NEU/SEU: 2 × 125 g/ha, 10‐days interval, PHI 3 days

In support of the intended uses, the applicant submitted in total eight NEU trials and four SEU trials on head cabbage (savoy, red cabbage) that were compliant with the intended GAPs. Trials were performed in the Netherlands, Germany, Belgium, France, Spain and Italy over growing seasons of 2010 and 2013. All trials were designed as decline trials with samples taken 1, 3, 5, 7 and in eight trials also 10 and 14 days after the last application. Results confirm that concentrations of DFA increase with longer PHI intervals.

The SEU use results in a more critical residue situation with regard to concentrations for parent compound and resulting thus in an MRL proposal of 0.3 mg/kg. Residues of DFA occur at the same levels regardless of use, resulting in an MRL proposal of 0.2 mg/kg.

Kale

GAP NEU: 2 × 125 g/ha, 10‐d interval, PHI 3 days

GAP SEU: 1 × 125 g/ha, PHI 3 days

In support of the intended NEU GAP, the applicant provided four GAP compliant trials on curly kale that were performed in Germany, United Kingdom, the Netherlands and Belgium over growing seasons of 2010 and 2013. All trials were designed as residue decline trials, with samples taken 1, 3, 5, 7 and in two trials also 19 and 14 days after the application. Highest concentrations of parent compound occur at the PHI interval of 3 days, whereas DFA residues increase by time.

In support of the SEU GAP, residue trials were not submitted.

Residue data are sufficient to derive an MRL proposal of 5 mg/kg for flupyradifurone and of 0.4 mg/kg for the DFA.

Kohlrabies

GAP NEU: 2 × 125 g/ha, 10‐d interval, PHI 3 days

In support of the intended use, the applicant submitted four GAP compliant residue trials on kohlrabi. Trials were performed in Germany, the Netherlands and Belgium in 2010 and 2013. Trials were designed as decline trials with samples taken 1, 3, 5, 7 and in two trials also 10 and 14 days following the last application. Results indicate that residues of DFA are the highest at the longest PHIs.

Residue data are sufficient to derive an MRL proposal of 0.09 mg/kg for flupyradifurone and of 0.2 mg/kg for the DFA.

Lettuces

GAP NEU/SEU: foliar application 1‐2 × 0.13 kg/ha, 10‐d interval, PHI 3 days

In support of the intended NEU and SEU use, the applicant submitted in total 18 GAP compliant residue trials on lettuce (nine for the NEU and nine for the SEU). Trials were performed in various European countries in 2010 and 2011. All trials were designed as decline trials, with samples taken 0, 1, 3, 4–5, 7, 10 or 14 days after the last application. Three trials from the NEU and three trials from the SEU region were performed on butterhead lettuce type; the remaining six residue trials per each region were performed on open leaf lettuce varieties. To derive the MRL proposal and risk assessment values for lettuce, the residue data on open and head forming lettuce varieties were combined (MRL proposal of 6 mg/kg for flupyradifurone based on SEU trials and of 0.1 mg/kg for the DFA based on NEU trials).

Lamb's lettuce, escarole/broadleaved endive, cress, land cress, Roman rocket/rucola, red mustards, baby leaf crops

Spinaches and similar leaves: spinaches, purslane, chards/beet leaves

Herbs and edible flowers: chervil, chives, celery leaves, parsley, sage, rosemary, thyme, basil and edible flowers, laurel/bay leaves, tarragon

GAP NEU/SEU: foliar application 1–2 × 0.13 kg/ha, 10‐days interval, PHI 3 days

The EMS proposed to use the six trials in open leaf lettuce varieties to derive MRL proposals for lamb`s lettuce, escarole/broadleaved endive, cress, land cress, Roman rocket/rucola, red mustards, baby leaf crops as well as for the groups of spinaches and similar leaves and herbs and edible flowers. According to the EU guidance document (European Commission, 2017), the extrapolation from trials in open leaf lettuces is acceptable. Hence, MRL proposals of 6 mg/kg for flupyradifurone (based on SEU trials) and of 0.15 mg/kg for the DFA (based on NEU trials) are derived (See also dietary risk assessment for escaroles).

Legume vegetables: beans and peas (with pods)

GAP NEU/SEU: 1 × 75 g/ha, PHI 7 days

In support of the intended uses, the applicant provided 16 GAP compliant residue trials (eight NEU and eight SEU) on peas with pods representing NEU and SEU use. The trials were performed in Germany, France, Belgium, the Netherlands, Spain and Italy over growing seasons of 2012 and 2013.

The trials on peas provide information on residues at the intended PHI as well as at the PHI of 14 days. In all trials, the concentrations of DFA were the highest at the longest PHI. Residue data are sufficient to derive an MRL of 0.5 mg/kg for flupyradifurone and of 0.08 mg/kg for DFA. The proposed extrapolation of residue data from peas (with pods) to beans (with pods) is acceptable.

Legume vegetables: beans and peas (without pods), lentils

GAP NEU/SEU: 1 × 75 g/ha, PHI of 3 days

In support of the intended uses, the applicant provided eight GAP compliant residue trials on peas (without pods) representing NEU use and eight GAP compliant trials on peas (without pods) representing SEU use. The trials were performed in Germany, France, Belgium, the Netherlands, Spain and Italy over growing seasons of 2012 and 2013.

The trials on peas (without pods) were all designed as reverse decline trials and provide information on residues in peas at the PHI intervals of 3, 7, 10, 14 and 21 days. Flupyradifurone residues increased with time, with the highest residue measured at PHI interval of 7–10 days. Also residues of DFA increase with time, but the plateau concentrations have been reached within PHIs tested. The residue data are sufficient to support the use and to derive an MRL proposal of 0.4 mg/kg for flupyradifurone and of 0.15 mg/kg for DFA in peas (without pods) based on SEU trials. Extrapolation to beans (without pods) and lentils is acceptable.

Celeries

GAP US/CA: foliar application 1‐2 × 0.21 kg/ha, 7‐days interval, PHI 1 day

In support of the authorised GAP, the applicant submitted 10 GAP compliant residue trials on celeries. Trials were performed in the USA and Canada over growing seasons of 2011/2012. Four trials were designed as decline trials with samples taken 0, 1, 6–7, 14, 21 and 28 days after the last treatment. In all trials, both trimmed and untrimmed stems were analysed. Since the EU MRL for celeries refers to the whole product (untrimmed stems, including the leaves), the residue concentrations measured in the untrimmed product were used to derive the MRL proposal and the risk assessment values.

Residue data are sufficient to derive an MRL proposal of 9 mg/kg for flupyradifurone and of 0.06 mg/kg for the DFA for celery in support of the authorised use (See also dietary risk assessment).

Pulses: beans, lentils, peas, lupins

GAP US/CA: foliar application 1‐2 × 0.21 kg/ha, 10‐days interval, PHI 7 days

In support of the authorised use, the applicant submitted 10 GAP compliant trials on peas and 10 GAP compliant trials on beans. Trials were performed in the USA and Canada in 2011. Four trials per crop were designed as decline trials, with samples taken 0, 7, 12–14, 21, 28 and 33–35 days after the last treatment. In all trials, samples of dry seed, green material (vine, forage) and hay were taken. Generally, the residues both of flupyradifurone and the DFA levelled off by the last sampling point.

The applicant proposes to extrapolate available residue data to the remaining crops of pulses group: lentils and lupins. In peas, the foliar treatment results in a more critical residue situation, and thus, the residue data set on peas was used to derive an MRL proposal of 3 mg/kg for flupyradifurone and of 2 mg/kg for DFA for pulses.

GAP NEU/SEU: 1 × 75 g/ha, PHI 7 days

In support of the intended use, the applicant submitted eight GAP compliant trials on peas supporting the SEU use and eight GAP compliant trials on peas supporting the NEU use. Trials were performed in Germany, France, Belgium, the Netherlands, Spain and Italy in 2012 and 2013. All trials were designed as reverse decline trials and provide information on residues in the crops 7, 14, 20–22, 28–30, 34–39, 42–46 and 53 days after the last treatment. In all trials, parent flupyradifurone was higher at later PHI intervals; however, the plateau concentration was accounted for. Similarly, the DFA residues increase by time and 30–42 days after the last treatment reach its highest concentration.

Residue data are sufficient to support the use and the proposed extrapolation to beans, lupins and lentils. The SEU use results in a more critical residue situation, requiring an MRL of 0.4 mg/kg for flupyradifurone and of 0.3 mg/kg for the DFA. However, the authorised use in the USA and Canada results in a higher MRL proposal.

Peanuts

GAP US/CA: foliar application 1‐2 × 0.21 kg/ha, 10‐days interval, PHI 7 days

In support of the authorised GAP, the applicant submitted in total 12 residue trials on peanuts, which were performed in the USA in 2010. One trial was disregarded as it was incompliant with the GAP since the sample was taken at the PHI of 3 days, instead of 7 days. Four trials were designed as decline trials, with samples collected 0, 3, 7–8, 14 and 21 days after the last application. Once collected, peanuts were allowed to dry for 4–17 days prior to sampling selection. All trials provide information on residues in shelled peanuts (nutmeat) and peanut hay.

Residue data are sufficient to derive an MRL proposal of 0.04 mg/kg for flupyradifurone and of 0.03 mg/kg for DFA in support of the authorised use on peanuts.

Soyabeans

GAP US/CA: foliar application 1‐2 × 0.21 kg/ha, 10‐days interval, PHI 21 days

In support of the authorised GAP, the applicant submitted in total 20 GAP compliant residue trials on soya. Trials were performed in the USA and Canada in 2010 and 2011. Four trials were designed as decline trials, with bean samples taken 8–10, 14–15, 21, 28, 35 days after the last application; only in one decline trial residues of both compounds in soya beans were higher at a longer PHI of 28 days. All trials provide information on residues in soyabean seed, hay and forage.

A sufficient number of residue trials have been submitted to derive an MRL proposal of 1.5 mg/kg for flupyradifurone and of 0.6 mg/kg for the DFA in soyabean in support of the authorised use.

Cotton

GAP USA: foliar application 1‐2 × 0.21 kg/ha, 10‐days interval, PHI 14 days

In support of the authorised GAP, the applicant submitted 12 GAP compliant residue trials on cotton, which were performed in the USA in 2010. One trial was disregarded as GAP incompliant, considering that samples were taken at the PHI of 19 days. Four trials were designed as decline trials, with seed samples taken 6–7, 13–14, 19–21 and 27–28 days after the last application. All seed cotton samples were ginned to generate cotton seed samples (undelinted seed); in four trials gin by‐products were analysed for residues.

A sufficient number of residue trials have been submitted to derive an MRL proposal of 0.8 mg/kg for flupyradifurone and of 0.03 mg/kg for the DFA in cotton seed in support of the authorised use in the USA.

GAP SEU: 1 × 125 g/ha, PHI 21 days

In support of the intended use, the applicant submitted eight GAP compliant residue trials on cotton, which were performed in Spain and Greece in 2014 and 2015. All trials were decline trials, with samples of seeds taken 21, 28 and 35 days after the last treatment. The samples of gin by‐products were taken and analysed for residues from three trials. Residues of DFA in all except one trial were below the LOQ. The residue data are sufficient to support the use and to derive an MRL proposal of 0.2 mg/kg for flupyradifurone and of 0.02 mg/kg for the DFA.

The authorised use of flupyradifurone is more critical, and therefore, the final MRL proposal is based on import tolerance in cotton.

Olives for oil production/Table olives

GAP SEU: 1 × 150 g/ha, PHI 14 days

In support of the intended use, the applicant submitted eight GAP compliant residue trials on olives. Trials were performed in Spain and Italy in 2014 and 2015. All trials were decline trials with samples analysed 7, 14, 21, 28 and 35 days following the last application. In six trials, the concentration of DFA was the highest at the longest investigated PHI interval. The residues of parent flupyradifurone level off at 14–21 days following the application.

Residue data are sufficient to derive an MRL proposal of 5 mg/kg for flupyradifurone and of 0.15 mg/kg for DFA in table olives and olives for oil production.

Barley

GAP USA: foliar application 1‐2 × 0.21 kg/ha, 7‐days interval, PHI 21 days

In support of the authorised GAP, the applicant submitted in total 20 GAP compliant residue trials on barley, which were performed in the USA and Canada in 2010 and 2011. All trials provide information on residues in barley grain, straw and hay. Four of the trials were designed as decline trials with grain samples taken 10, 15, 20–21, 28 and 35 days after the last application indicating that in grain maximum concentrations of flupyradifurone and DFA occur at the PHI of 20–29 days.

A sufficient number of residue trials have been submitted to derive an MRL proposal of 3 mg/kg for flupyradifurone and of 0.6 mg/kg for the DFA in barley grain in support of the authorised use in the USA.

Maize

GAP USA: foliar application 1‐2 × 0.21 kg/ha, 7‐days interval, PHI 21 days

In support of the authorised GAP, the applicant submitted 20 GAP compliant residue trials on maize, which were performed in the USA and Canada in 2010. In all trials, samples of maize kernels, stover and forage were collected.

Four of the trials were designed as decline trials with grain samples taken 10, 13–15, 19–22, 26–28 and 33–35 days after the last application. Only in one kernel sample residues of flupyradifurone and the DFA were above the LOQ. A sufficient number of residue trials have been submitted to derive an MRL proposal of 0.02 mg/kg for flupyradifurone and of 0.05 mg/kg for the DFA in maize grain in support of the authorised use in the USA.

Sorghum

GAP USA: foliar application 1‐2 × 0.21 kg/ha, 7‐days interval, PHI 21 days

In support of the authorised GAP, the applicant submitted nine GAP compliant residue trials on sorghum, which were performed in the USA in 2010. In all trials, samples of sorghum grain, forage and stover were collected. One trial was designed as decline trial with grain samples taken 10, 13, 19, 26 and 33 days after the last application, indicating that higher residues of flupyradifurone and the DFA occur at a longer PHI of 26 and 33 days, respectively.

A sufficient number of residue trials have been submitted to derive an MRL proposal of 3 mg/kg for flupyradifurone and of 0.07 mg/kg for the DFA in sorghum grain in support of the authorised use in the USA.

Wheat

GAP USA: foliar application 1‐2 × 0.21 kg/ha, 7‐days interval, PHI 21 days

In support of the authorised GAP, the applicant submitted in total 29 GAP compliant residue trials on wheat, which were performed in the USA and Canada in 2010 and 2011. In all trials, samples of wheat grain, forage, straw and hay were collected. Four of the trials were designed as decline trials with grain samples taken 9–10, 14–15, 20–21, 28 and 34–35 days after the last application. In three of the decline trials, higher residues of flupyradifurone and DFA occur at longer PHI intervals of 27–35 days.

A sufficient number of residue trials have been submitted to derive an MRL proposal of 1 mg/kg for flupyradifurone and of 1 mg/kg for the DFA in wheat grain in support of the authorised use in the USA.

Coffee beans

GAP Brazil: soil application (drench): 1 × 0.6 kg/ha (50 mL/plant) + foliar application: 1–3 × 0.2 kg/ha, 14‐day interval, PHI 21 days

In support of the authorised GAP, the applicant submitted 13 GAP compliant residue trials on coffee. Trials were performed in Guatemala, Mexico and Brazil in 2011 and 2012. The drench treatment was done 86–91 days prior foliar applications which were performed three times with 12‐ to 15‐day interval. All trials were designed as decline trials with coffee cherries sampled 0, 7, 13–14, 19–22, 28 and 33–35 days after the last application. Coffee cherries from Guatemala and Mexico trials were washed, overnight fermented, mucilage removed and then air‐dried for 8–10 days to reach commercial dryness. Coffee cherries from Brazilian trials were dried for 1–3 weeks and then husked. The dried green coffee beans were then analysed for residues. In three trials, highest concentrations of flupyradifurone and DFA were identified at the longest PHI interval of 33–35 days.

A sufficient number of residue trials have been submitted to derive an MRL proposal of 1 mg/kg for flupyradifurone and of 0.2 mg/kg for the DFA in coffee beans in support of the authorised use in Brazil.

Cocoa beans

GAP Ghana: 4 × 15 g/ha, 30‐days interval, PHI 7 days

GAP Ivory Coast: 2 × 18.75 g/ha, PHI not indicated

The applicant submitted nine residue trials on cocoa from Ivory Coast and Ghana, performed over growing seasons of 2014 and 2015. The use pattern in residue trials supports the GAP authorised in Ghana; the application rates were higher than in the authorised GAP, but within upper limit of acceptable 25% deviation. Cocoa pods were collected at 3, 7, 9–11, 13–15, 20–22, 25–28 and 58–63 days after the last application. Pods were cracked and pulp with beans were wrapped in banana leaves and left into ambient temperature for fermentation process (6–7 days). Afterwards beans were dried. Residues of flupyradifurone in all bean samples were below the LOQ, whereas DFA concentrations increased by time and did not level off by the longest post‐harvest intervals of ca. 58 days.

Sufficient number of residue trials has been submitted to derive an MRL proposal of 0.01* mg/kg for flupyradifurone and of 0.06 mg/kg for the DFA in cocoa beans in support of the authorised use in Ghana. The applicant informed that no tolerance for flupyradifurone is established in Ghana of Ivory Coast.

Hops

GAP US/CA: foliar application 1 × 0.154 kg/ha, PHI 21 days

In support of the authorised GAP, the applicant submitted three GAP compliant residue trials on hops which were performed in the USA in 2011. Fresh hop cones were harvested 21 days after the last application, kiln dried on the day of harvest and dried hop cones were analysed for residues. The EMS and the applicant, on the basis of the available residue data set, propose to set the tolerance at 10 mg/kg for flupyradifurone and of 3 mg/kg for DFA in hops. However, at least four GAP compliant residue trials are required according to EU guidance documents (European Commission, 2017). Thus, three trials are not sufficient to derive an MRL proposal.

There are eight European residue trials on hops that have been performed according to the same GAP and were assessed by EFSA during the EU pesticides peer review. These trials, however, indicated a less critical residue situation. An MRL of 4 mg/kg for flupyradifurone and of 0.3 mg/kg for DFA was derived in support of the EU use (EFSA, 2015).

Feed items

For certain crops used as feed items in the USA and Canada, residue data were provided (hay, straw, stover, forage of cereals, oilseeds and pulses) and details of submitted residue trials are reported in Appendix B.1.2.1.

1.2.2. Magnitude of residues in rotational crops

The fate and magnitude of flupyradifurone in soil were investigated in the framework of the EU pesticides peer review (EFSA, 2015). According to soil degradation studies, parent flupyradifurone exhibited moderate to high persistence in the soil with the maximum DT90_field value of more than 1000 days. The relevant soil metabolites of flupyradifurone (6‐CNA and DFA) exhibited very low to moderate and moderate to medium persistence with maximum DT90_lab values of 121 days and 244 days, respectively (EFSA, 2015). The 6‐CNA metabolite was not identified by the peer review experts as relevant residue in rotational crops and was thus not further considered in this assessment.

Given the soil persistence of flupyradifurone, its residues may accumulate in the soil and be metabolised to compounds that are taken up by crops in addition to residues that result from the primary crop treatment. Thus, the magnitude of residue uptake in rotational crops via soil has to be investigated for the EU uses considered in this application and for the imported crops for which import tolerances have been requested.9

Rotational crop field trials

A wide range of rotational crop field studies were submitted for the EU pesticides peer review. Rotational crops were planted 25–30 days after the soil treatment at 125–200 g/ha or planted after the harvest of lettuce, treated at 200 g/ha (plant back intervals (PBIs) of 61–145 days and 266–329 days) (EFSA, 2015). The experts of the EU pesticides peer review derived MRL proposals for DFA and flupyradifurone on the basis of the trials with a dose rate of 200 g/ha. The highest residues were identified in rotational crops planted at 30‐day PBI. Provisional MRL proposals for flupyradifurone and DFA were derived for a range of crops according to Commission Regulation (EU) 2016/486, including a footnote which specified that information on rotational crops was unavailable and requesting that interested parties should provide the missing information by 6 April 2018. The MRL proposals were considered provisional since sufficient information was not provided to conclude whether the rotational crop field trials were conducted at rates reflecting the expected plateau concentrations in soil reached following several years of consecutive applications of flupyradifurone. Moreover, the peer review experts concluded that most of the available studies were conducted with a single plant back interval of 30 days, which seems an unrealistic situation for several crops (EFSA, 2015).

In order to address the data gap, the applicant now submitted rotational crop field trials performed in Europe. In these studies, a range of rotational crops (potatoes, oilseed rape, barley, maize strawberries, cauliflower and broccoli) was grown following the soil treatment at 300 g/ha or 175–185 g/ha; the crops were planted at different PBIs (PBI for potatoes, oilseed rape, barley: 107–204 days and 273–365 days; PBI for strawberries, cauliflower and broccoli: 21–30 days, 107–204 days, 273–365 days). The samples taken at immature and mature growth stage were analysed for flupyradifurone and DFA residues (Netherlands, 2017).

The residue concentration in soil (0–20 cm) was determined in all trials on the day of the planting/sowing of the crop and at all PBIs. Residues of DFA in all soil samples were below the LOQ of 0.005 mg/kg, whereas parent flupyradifurone ranged from < 0.005 to 0.10 mg/kg soil at PBI 21–30 days, at PBI 129–181 days, the residues accounted for up to 0.07 mg/kg soil. In soil samples taken at PBI of 319–363 days, the residue accounted for up to 0.06 mg/kg soil. The geometrical mean soil concentrations of flupyradifurone ranged from 0.016 mg/kg to 0.039 mg/kg. The results indicate that mean soil residues are at the same order of magnitude for the two application rates tested (175 or 300 g/ha). The summary of soil residue data is given in Table E.2, Appendix E.

Table E.2.

Soil residues (mg/kg) in the rotational crop field trials submitted in the framework of the current assessment (Netherlands, 2017)

	PBI 21–30 days		PBI 129–181 days		PBI 319–363 days
	FL	DFA, as DFA	FL	DFA, as DFA	FL	DFA, as DFA
Bare soil 300 g/ha
	< 0.005	< 0.005	0.019	< 0.005	0.014	< 0.005
	< 0.005	< 0.005	0.061	< 0.005	0.026	< 0.005
	0.053	< 0.005	0.035	< 0.005	0.007	< 0.005
	0.008	< 0.005	0.03	< 0.005	< 0.005	< 0.005
	0.1	< 0.005	< 0.005	< 0.005	0.039	< 0.005
	0.046	< 0.005	< 0.005	< 0.005	0.007	< 0.005
	0.079	< 0.005	0.067	< 0.005	0.031	< 0.005
	0.069	< 0.005	0.022	< 0.005	0.024	< 0.005
	–	–	0.051	< 0.005	0.064	< 0.005
	–	–	0.039	< 0.005	0.019	< 0.005
	–	–	0.074	< 0.005	< 0.005	< 0.005
	–	–	0.067	< 0.005	–	–
Bare soil 175 g/ha
	–	–	0.046	< 0.005	0.019	< 0.005
	–	–	0.016	< 0.005	0.015	< 0.005
	–	–	0.032	< 0.005	0.023	< 0.005
	–	–	0.04	< 0.005	0.034	< 0.005
	–	–	0.024	< 0.005	0.017	< 0.005
	–	–	0.036	< 0.005	0.017	< 0.005
	–	–	0.02	< 0.005	0.018	< 0.005
	–	–	0.035	< 0.005	0.036	< 0.005
	–	–	0.041	< 0.005	0.025	< 0.005
	–	–	0.029	< 0.005	0.022	< 0.005
	–	–	0.018	< 0.005	0.011	< 0.005
	–	–	0.028	< 0.005	0.019	< 0.005
Overall geomean	0.027	–	0.029	–	0.018	–
Overall mean	0.046	–	0.035	–	0.022	–
Highest residue	0.10	–	0.074	–	0.064	–
Application on bare soil, 300 g/ha
	< 0.005	< 0.005	0.019	< 0.005	0.014	< 0.005
	< 0.005	< 0.005	0.061	< 0.005	0.026	< 0.005
	0.053	< 0.005	0.035	< 0.005	0.007	< 0.005
	0.008	< 0.005	0.03	< 0.005	< 0.005	< 0.005
	0.1	< 0.005	< 0.005	< 0.005	0.039	< 0.005
	0.046	< 0.005	< 0.005	< 0.005	0.007	< 0.005
	0.079	< 0.005	0.067	< 0.005	0.031	< 0.005
	0.069	< 0.005	0.022	< 0.005	0.024	< 0.005
	–	–	0.051	< 0.005	0.064	< 0.005
	–	–	0.039	< 0.005	0.019	< 0.005
	–	––	0.074	< 0.005	< 0.005	< 0.005
	–	–	0.067	< 0.005	–	–
Geomean	0.028	< 0.005	0.03	< 0.005	0.016	< 0.005
Mean	0.046	< 0.005	0.04	< 0.005	0.022	< 0.005
Highest residue	0.1	< 0.005	0.074	< 0.005	0.064	< 0.005
Application on bare soil, 175 g/ha
	–	–	0.046	< 0.005	0.019	< 0.005
	–	–	0.016	< 0.005	0.015	< 0.005
	–	–	0.032	< 0.005	0.023	< 0.005
	–	–	0.04	< 0.005	0.034	< 0.005
	–	–	0.024	< 0.005	0.017	< 0.005
	–	–	0.036	< 0.005	0.017	< 0.005
	–	–	0.02	< 0.005	0.018	< 0.005
	–	–	0.035	< 0.005	0.036	< 0.005
	–	–	0.041	< 0.005	0.025	< 0.005
	–	–	0.029	< 0.005	0.022	< 0.005
	–	–	0.018	< 0.005	0.011	< 0.005
	–	–	0.028	< 0.005	0.019	< 0.005
Geomean	–	–	0.029	< 0.005	0.02	< 0.005
Mean	–	–	0.03	< 0.005	0.021	< 0.005
Highest residue	–	–	0.043	< 0.005	0.036	< 0.005
Overall geomean	0.027	–	0.029	< 0.005	0.018	< 0.005
Overall mean	0.046	–	0.035	< 0.005	0.022	< 0.005

FL: flupyradifurone; PBI: Plant‐back interval.

In rotational crops, parent flupyradifurone was below the LOQ of 0.01 mg/kg in all edible plant matrices at all PBIs (except one barley grain sample containing residues at the LOQ of 0.01 mg/kg). DFA residues were present in all edible plant matrices at all plant back intervals, indicating that DFA is gradually formed in the soil from flupyradifurone and taken up by the crops. The summary of residue data in rotational crops is given in Table E.1, Appendix E.

Table E.1.

Summary of rotational crop field trials submitted in the framework of the current assessment (Netherlands, 2017)

Crop	Growth stage at sampling	PBI 21–30				PBI 107–204				PBI 273–365
		FL	DFA, as FL	Sum, as FL	DFA, as DFA	FL	DFA, as FL	Sum, as FL	DFA, as DFA	FL	DFA, as FL	Sum, as FL	DFA, as DFA
Bare soil 300 g/ha
Potato (tuber)	BBCH 45	–	–	–	–	< 0.01	0.036	0.046	0.012	< 0.01	< 0.02	< 0.03	< 0.007
		–	–	–	–	< 0.01	0.13	0.14	0.042	< 0.01	0.054	0.064	0.018
		–	–	–	–	< 0.01	0.26	0.27	0.088	< 0.01	0.057	0.067	0.019
		–	–	–	–	< 0.01	0.049	0.059	0.016	< 0.01	0.033	0.043	0.011
	BBCH 49 (mature)	–	–	–	–	< 0.01	0.034	0.044	0.011	< 0.01	< 0.02	< 0.03	< 0.007
		–	–	–	–	< 0.01	0.084	0.094	0.028	< 0.01	0.042	0.052	0.014
		–	–	–	–	< 0.01	0.21	0.22	0.071	< 0.01	0.044	0.054	0.015
		–	–	–	–	< 0.01	0.069	0.079	0.023	< 0.01	0.037	0.047	0.012
	STMR (mg/kg)	–	–	–	–	–	–	0.11	0.033	–	–	0.056	0.015
	HR (mg/kg)	–	–	–	–	–	–	0.27	0.088	–	–	0.067	0.019
Strawberry	BBCH 85	< 0.01	0.17	0.18	0.056	< 0.01	0.12	0.13	0.04	< 0.01	0.073	0.083	0.024
		< 0.01	0.25	0.26	0.083	< 0.01	0.37	0.38	0.12	< 0.01	0.078	0.088	0.026
		< 0.01	0.027	0.037	0.009	< 0.01	< 0.02	< 0.03	< 0.007	< 0.01	< 0.02	< 0.03	< 0.007
		< 0.01	0.23	0.24	0.078	< 0.01	0.21	0.22	0.068	< 0.01	0.051	0.061	0.017
	BBCH 87 (mature)	< 0.01	0.21	0.22	0.068	< 0.01	0.14	0.15	0.046	< 0.01	0.069	0.079	0.023
		< 0.01	0.3	0.31	0.098	< 0.01	0.37	0.38	0.12	< 0.01	0.23	0.24	0.076
		< 0.01	< 0.02	< 0.03	< 0.007	< 0.01	0.035	0.045	0.012	< 0.01	< 0.02	< 0.03	< 0.007
		< 0.01	0.36	0.37	0.12	< 0.01	0.18	0.19	0.059	< 0.01	< 0.02	< 0.03	< 0.007
	STMR (mg/kg)	–	–	0.265	0.083	–	–	0.185	0.057	–	–	0.072	0.021
	HR (mg/kg)	–	–	0.37	0.12	–	–	0.38	0.12	–	–	0.24	0.076
Cauliflower	BBCH 45	< 0.01	0.075	0.085	0.025	< 0.01	0.045	0.055	0.015	< 0.01	0.021	0.031	0.007
		< 0.01	0.18	0.19	0.059	< 0.01	0.15	0.16	0.048	< 0.01	0.12	0.13	0.041
	BBCH 49 (mature)	< 0.01	0.07	0.08	0.023	< 0.01	0.036	0.046	0.012	< 0.01	0.023	0.033	0.008
		< 0.01	0.2	0.21	0.065	< 0.01	0.11	0.12	0.035	< 0.01	0.098	0.11	0.033
Broccoli	BBCH 45	< 0.01	0.13	0.14	0.042	< 0.01	0.087	0.097	0.029	< 0.01	0.047	0.057	0.016
		< 0.01	0.17	0.18	0.056	< 0.01	0.18	0.19	0.061	< 0.01	0.053	0.063	0.018
	BBCH 49 (mature)	< 0.01	0.062	0.072	0.021	< 0.01	0.11	0.12	0.037	< 0.01	0.068	0.078	0.023
		< 0.01	0.16	0.17	0.054	< 0.01	0.17	0.18	0.058	< 0.01	0.046	0.056	0.015
	STMR (mg/kg)	–	–	0.16	0.049	–	–	0.14	0.043	–	–	0.067	0.021
	HR (mg/kg)	–	–	0.21	0.065	–	–	0.19	0.061	–	–	0.13	0.041
Bare soil 175 g/ha
Barley grain	BBCH 89	–	–	–	–	< 0.01	0.14	0.15	0.047	< 0.01	0.12	0.13	0.04
		–	–	–	–	< 0.01	0.11	0.12	0.038	< 0.01	0.075	0.085	0.025
		–	–	–	–	< 0.01	0.26	0.27	0.088	< 0.01	0.17	0.18	0.056
		–	–	–	–	< 0.01	0.37	0.38	0.12	< 0.01	0.26	0.27	0.088
	STMR (mg/kg)	–	–	–	–	–	–	0.21	0.068	–	–	0.155	0.048
	HR (mg/kg)	–	–	–	–	–	–	0.38	0.12	–	–	0.27	0.088
Barley straw	BBCH 89	–	–	–	–	< 0.01	< 0.1	< 0.11	< 0.03	< 0.01	< 0.1	< 0.11	< 0.03
		–	–	–	–	< 0.01	< 0.1	< 0.11	< 0.03	< 0.01	< 0.1	< 0.11	< < 0.03
		–	–	–	–	0.018	< 0.1	0.12	< 0.03	< 0.01	< 0.1	< 0.11	< 0.03
		–	–	–	–	0.032	0.11	0.14	0.036	0.019	< < 0.1	0.12	< 0.03
	STMR (mg/kg)	–	–	–	–	–	–	0.115	0.03	–	–	0.11	< 0.03
	HR (mg/kg)	–	–	–	–	–	–	0.14	0.036	–	–	0.12	< < 0.03
Barley forage	BBCH 75	–	–	–	–	< 0.01	0.041	0.051	0.014	< 0.01	0.06	0.07	0.02
		–	–	–	–	< 0.01	0.024	0.034	0.008	< 0.01	< 0.02	< 0.03	< 0.007
		–	–	–	–	< 0.01	0.083	0.093	0.028	< 0.01	0.074	0.084	0.025
		–	–	–	–	0.013	0.13	0.15	0.045	< 0.01	0.081	0.091	0.027
	STMR (mg/kg)	–	–	–	–	–	–	0.072	0.021	–	–	0.077	0.023
	HR (mg/kg)	–	–	–	–	–	–	0.15	0.045	–	–	0.09	0.027
Rape seed	BBCH 89	–	–	–	–	< 0.01	0.027	0.037	0.0091	< 0.01	0.02	< 0.03	0.007
		–	–	–	–	< 0.01	0.043	0.053	0.014	< 0.01	0.023	0.033	0.007
		–	–	–	–	< 0.01	0.067	0.077	0.022	< 0.01	0.04	0.05	0.013
	STMR (mg/kg)	–	–	–	–	–	–	0.053	0.014	–	–	0.033	0.007
	HR (mg/kg)	–	–	–	–	–	–	0.077	0.022	–	–	0.05	0.013
Rape forage	BBCH 59	–	–	–	–	< 0.01	0.045	0.055	0.015	< 0.01	0.023	0.033	0.0076
		–	–	–	–	< 0.01	0.029	0.039	0.0097	< 0.01	0.02	< 0.03	0.007
		–	–	–	–	< 0.01	0.17	0.18	0.056	< 0.01	0.13	0.14	0.044
		–	–	–	–	< 0.01	0.25	0.26	0.085	0.01	0.14	0.15	0.046
	STMR (mg/kg)	–	–	–	–			0.118	0.036	–	–	0.087	0.026
	HR (mg/kg)	–	–	–	–			0.26	0.085	–	–	0.15	0.046
Maize grain	BBCH 89	–	–	–	–	< 0.01	< 0.02	< 0.03	< 0.007	< 0.01	< 0.02	< 0.03	< 0.007
		–	–	–	–	< 0.01	0.1	0.11	0.035	< 0.01	0.058	0.068	0.019
		–	–	–	–	< 0.01	0.063	0.073	0.021	< 0.01	0.04	0.05	0.013
		–	–	–	–	< 0.01	0.11	0.12	0.037	< 0.01	0.089	0.099	0.03
	STMR (mg/kg)	–	–	–	–	–	–	0.092	0.028	–	–	0.059	0.016
	HR (mg/kg)	–	–	–	–	–	–	0.12	0.037	–	–	0.099	0.03
Maize stover	BBCH 89	–	–	–	–	< 0.01	< 0.02	< 0.03	< 0.007	< 0.01	< 0.02	< 0.03	< 0.007
		–	–	–	–	< 0.01	0.022	0.032	0.007	< 0.01	< 0.02	< 0.03	< 0.007
		–	–	–	–	0.02	0.043	0.063	0.014	< 0.01	< 0.02	< 0.03	< 0.007
		–	–	–	–	0.02	0.066	0.086	0.022	0.01	0.025	0.035	0.008
	STMR (mg/kg)	–	–	–	–	–	–	0.048	0.011	–	–	0.03	0.007
	HR (mg/kg)	–	–	–	–	–	–	0.086	0.022	–	–	0.035	0.008
Maize forage	BBCH 85	–	–	–	–	< 0.01	< 0.02	< 0.03	< 0.007	< 0.01	< 0.02	< 0.03	< 0.007
		–	–	–	–	< 0.01	0.045	0.055	0.015	< 0.01	0.022	0.032	0.007
		–	–	–	–	< 0.01	0.034	0.044	0.011	< 0.01	0.024	0.034	0.008
		–	–	–	–	0.03	0.061	0.091	0.02	0.012	0.026	0.039	0.009
	STMR (mg/kg)	–	–	–	–	–	–	0.05	0.013	–	–	0.033	0.008
	HR (mg/kg)	–	–	–	–	–	–	0.09	0.02	–	–	0.039	0.009

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

All available rotational crop field trials have been performed with lower application rates (175–300 g/ha) than the maximum authorised or intended seasonal application of flupyradifurone in North America (410 g/ha) and EU (250 g/ha). According to the OECD guidance document on residues in rotational crops, the application rate in the rotational crop field studies should be the maximum seasonal application rate (on the primary crop) plus the application rate corresponding to residues in the soil from the long‐term use of the active substance (soil plateau levels) (OECD, 2018). In case the rotational crop field trials were performed with application rates not matching the calculated soil plateau levels, the guidance document suggests to use the proportionality principle which allows scaling of residues found in rotational crops, provided that scaling factors are within a range for applying proportionality principle (0.3× and 4×).

Thus, in order to estimate the residues expected in rotational crops, scaling factors were derived calculating the ratio of the expected flupyradifurone soil plateau concentrations for the critical EU and US/Canadian uses and the residue concentrations measured in the soil at the different plant back intervals (Table E.1).

Soil plateau concentrations in soil for intended EU uses

The worst‐case long‐term flupyradifurone soil plateau concentration (C_min) for authorised and intended EU application rates (2 × 125 g/ha) was estimated in the framework of the EU pesticides peer review (EFSA, 2015) as 0.062 mg/kg (DT₅₀ 462 days, indoor application on lettuce at 2 × 0.125 kg/ha, crop interception 25%, residue distribution over 20 cm soil). Since the determined geometrical mean soil concentration of flupyradifurone in soil from the rotational crop residue trials was 0.029 mg/kg (highest, at the PBI of 107–204 days, after application of 300 g flupyradifurone/ha), the residue trials are considered underdosed; a scaling factor of 2.06 was derived.

Soil plateau concentrations in soil for authorised foliar uses in the USA/Canada (import tolerances)

The worst‐case long‐term flupyradifurone soil plateau concentration (C_min) from critical authorised uses in North America (410 g/ha) was estimated by EFSA using the EU soil dissipation data. The following input parameters were used: DT₅₀ 462 days, application of 2 × 210 g/ha, interval between applications 7 days, crop interception 70%, residue distribution over 20 cm soil; the method of the calculation: Double First Order in Parallel (DFOP). The C_min was calculated at 0.0416 mg/kg. Since the determined geometrical mean soil concentration of flupyradifurone in soil is 0.029 mg/kg, the residue trials are underdosed. Hence, a scaling factor of 1.4 is derived.

Soil plateau concentrations in soil for authorised soil uses in the USA/Canada (import tolerances)

Among the crops for which import tolerances were requested under the current application, a soil treatment is authorised for tomatoes, aubergines (fruiting vegetables) and melons (cucurbits). The soil application takes place 45 days before harvest and, according to the U.S. EPA Registration notice,10 three crop rotations per year are allowed, thus resulting in the maximum annual application rate of 1230 g/ha. For this application rate, EFSA calculated the worst‐case long‐term plateau concentration using EU soil dissipation data as considered by the EU pesticides peer review. The following input parameters were used: DT₅₀ of 462 days, three crop rotations at 1 × 410 g/ha, interval between applications 105 days, crop interception 0%, residue distribution over 20 cm soil; the method of the calculation: DFOP. The calculated background concentration (C_min) of flupyradifurone after many years of use over 20 cm was estimated as 0.35 mg/kg. The data indicate that, when considering the geometrical mean soil concentration of flupyradifurone as estimated from residue trials (0.03 mg/kg), the residue trials have been significantly underdosed (0.09 N), which is outside the range where scaling is considered appropriate. Thus, in order to estimate residues in crops that are grown in soil containing residues at the plateau level from multi‐year use of flupyradifurone at an annual application rate of 1,230 g/ha, rotational crop trials at higher dose rates would be required. However, it is noted that in reality, such a scenario is not expected to happen frequently.

To estimate the magnitude of flupyradifurone and DFA residues in rotational crops grown in European and North American soils containing flupyradifurone residues at estimated plateau levels from the critical use patterns (250 g/ha for EU and 410 g/ha for USA/Canada), the residue concentrations measured in the rotational crop residue trials were multiplied by the scaling factors of 2.06 and 1.4, respectively. The derived scaling factors are within a range where the scaling of residue levels is still possible according to the proportionality principle (i.e. between 0.3 × and 4 × the plateau soil concentration). It is noted that residue values below the LOQ were not scaled up. An overview of scaled DFA residue concentrations (expressed as DFA)11 is presented in Tables E.3, Appendix E.

Table E.3.

Residues of DFA, expressed as DFA, (scaled) in rotational crops (mg/kg)

Crop	PBI	EU pesticides peer review trials (Netherlands, 2014; EFSA, 2015)		Residue trials submitted under current assessment (Netherlands, 2019)		EU pesticides peer review trials (Netherlands, 2014; EFSA, 2015)		Residue trials submitted under current assessment (Netherlands, 2017)
		Scaled to Cmin b (0.062 mg/kg) from critical intended EU uses (2.06 x)				Scaled to Cmin b (0.042 mg/kg) from US/CA authorised uses (1.4 x)
		STMR a	HR a	STMR	HR	STMR a	HR a	STMR	HR
Potato tuber		0.08	0.17	0.05	0.18	0.05	0.12	0.04	0.12
Carrot/turnip		0.04	0.07	–	–	0.03	0.05	–	–
Leek		0.05	0.16	–	–	0.03	0.11	–	–
Onion		0.04	0.11	–	–	0.03	0.07	–	–
Barley grain	2nd rotation	0.23	0.43	0.14	0.25	0.15	0.29	0.09	0.17
Maize seed	2nd rotation	–	–	0.06	0.08	–		0.04	0.05
Lettuce head	1st rotation	0.02	0.08	–	–	0.02	0.05	–	–
Cauliflower/broccoli	1st rotation	–	–	0.10	0.13	–	–	0.07	0.09
Rape seed	2nd rotation	0.05	0.10	0.03	0.05	0.04	0.07	0.02	0.03
Dry peas		1.06	1.58	–	–	0.72	1.07	–	–
Bean with pods		0.33	0.76	–	–	0.22	0.51	–	–
Cucumber		0.21	0.28	–	–	0.14	0.19	–	–
Strawberry	1st rotation	–	–	0.11	0.25	–	–	0.10	0.17
Barley straw	2nd rotation	0.06	0.23	0.06	0.07	0.13	0.16	0.04	0.05
Barley forage	2nd rotation	–	–	0.04	0.09	–	–	0.03	0.06
Rape forage	2nd rotation	–	–	0.07	0.18	–	–	0.05	0.12
Maize stover	2nd rotation	–	–	0.02	0.05	–	–	0.01	0.03
Maize forage	2nd rotation	–	–	0.03	0.04	–	–	0.02	0.03

STMR: supervised trials median residue; HR: highest residue; PBI: plant back interval; C_min: soil plateau concentration.

^aAt the PBI of 30 days; first rotation.

^bWorst case background/plateau soil residue concentrations estimated from the critical seasonal application rate.

The highest residues of flupyradifurone observed in rotational crop edible matrices – lettuce at 0.03 mg/kg and barley grain at 0.01 mg/kg – were also scaled up in order to estimate magnitude of uptake of flupyradifurone in respective rotational crop groups (leafy vegetables and cereals).

EFSA concludes that the confirmatory data requirement number 1 has been addressed.

1.2.3. Magnitude of residues in processed commodities

In the framework of the current application, the applicant submitted a wide range of studies where the effect of processing on the magnitude of flupyradifurone and DFA was investigated in processed products of oranges, soyabean, potato, barley, wheat, maize, cotton, peanut, coffee (Netherlands, 2017), melons, mustard greens, broccoli, carrots, courgettes, peas, olives, cocoa beans (Netherlands, 2019). The raw and processed commodities were analysed for flupyradifurone and DFA individually and results were presented according to currently applicable enforcement and risk assessment residue definitions. The processing factors give the ratio of residues in processed products to residues in unprocessed products. Separate PF were calculated for parent flupyradifurone (PF_F), for DFA (PF_DFA) and for the sum of flupyradifurone and DFA, expressed as DFA (PF_sum). Hence, the PF_F and PF_DFA are intended for enforcement purpose, while PF_sum is to be used for risk assessment purposes. An overview of derived processing factors is presented in Appendix B.1.2.3.

Oranges

Oranges from two SEU trials (1 × 125‐144 g/ha, PHI 29 days) and from two USA trials (2 × 589–1,000 g/ha, PHI 1 day) were processed into juice, marmalade and oil and a number of other processed products. Due to different GAPs, the US and SEU processing studies were considered separately.

Residues in the raw agricultural commodity (RAC, unwashed oranges) ranged from 0.12 to 0.52 mg/kg for flupyradifurone and from < 0.017 to 0.03 mg/kg for the DFA. Various processing by‐products were analysed for residues, but only the data in juice, marmalade, oil, dry and wet pomace were considered for deriving processing factors. It is noted that washing does not have an impact on total residue levels in oranges. A concentration of total residues by an average factor of 4.2 is observed in dry pomace and of 1.3 in wet pomace. A reduction of total residues is expected in juice, marmalade and oil. The results for dry pomace from two SEU trials were not considered for deriving processing factor, as data on the validation of analytical method for the determination of residues in dry pomace were not provided.

In four residue trials submitted in support of the import tolerance request, the samples of pulp and peel were also analysed from samples taken at the PHI of 1 day. These data were combined with the US processing study to derive PF_sum of 0.6. The median processing factor of 0.4 was derived from SEU processing studies (PF_sum 0.2) and US processing studies/residue trials (PF_sum 0.6) to be applied in the consumer exposure refinement.

Chilli peppers

From four residue trials in chilli peppers, samples of dried chilli peppers were analysed. The total residues in dried specimen were approximately five times the concentration measured in fresh chilli peppers. Hence, the default processing factor usually applied to chilli peppers is confirmed.

Soyabean

Two trials from the USA were available where soya was treated twice at an application rate ranging from 997 to 1,000 g/ha. Samples of soyabean were collected 19–21 days after the last application and processed into meal, aspirated grain fraction, milk and defatted flour. Residues in raw agricultural commodity (RAC, soyabean) ranged from 0.4 to 0.7 mg/kg for flupyradifurone and from 0.017 to 0.1 mg/kg for the DFA. A concentration of total residues occurs 12‐fold in aspirated grain fraction; in defatted flour and meal, a slight increase was observed (by a factor of 1.1). In refined oil, none of the compounds were present above the LOQs.

Potato

Two trials from the USA were available where potatoes were treated twice at application rates ranging from 581 to 1,010 g/ha. Samples of mature potato were collected at the 6‐ to 7‐day PHI and processed into chips, flakes, starch and cooked potatoes. Although residues of flupyradifurone and of DFA were below the LOQs in RAC (unwashed potato) from both trials, some concentration of residues was observed in peeled potato, potato chips and flakes from one trial.

Additional two trials from NEU were provided where potatoes were treated once at 100 g/ha and harvested 14 days after the last application. Samples were stored at 4–8°C before processing into starch, flakes, chips and cooked potatoes. Various intermediate products – dried pulp, waste – were analysed for residues. Residues of flupyradifurone in all RAC samples were below the LOQ; therefore, these data are not considered for deriving processing factors. Low residues of DFA were observed in RAC, with a concentration in flakes and chips. In dried pulp, starch and waste, no concentration of DFA residues occur.

Barley

Two trials from NEU were provided where spring barley was treated once at 460 g/ha. Samples of mature grain were collected 20–22 days after the last application and processed into beer and pearl barley. A reduction of total residues of flupyradifurone and the DFA was observed in all processing products – beer, pearl barley, brewer`s grain – except in the pearl barley rub‐off. Residues of DFA individually concentrate only in malt sprouts (12x).

Wheat

Two trials from NEU were provided where wheat was treated once at 460 g/ha. Samples of mature grain were collected 20–22 days after the last application and processed into semolina, white flour, whole meal flour, white bread, whole meal bread and wheat germ.

Two trials from the USA were provided where wheat was treated twice at an application rate of 1,000 g/ha. Samples of grain were collected 19–21 days after the last application and processed into white flour, whole meal flour, bread, germ, fresh and dry pasta, cooked pasta, gluten and starch.

The residue data from processing studies on germ, flour (whole meal and white), bread (whole meal and white) were consistent in the USA and EU trials and were therefore combined.

Reduction of total residues is observed in semolina, white flour, pasta, starch, gluten, white bread and whole meal bread. Residues concentrate in aspirated grain fraction, whole meal flour, in bran and in germ.

Maize

Two trials from the USA were provided where maize was treated twice at application rates ranging from 603 to 1,000 g/ha. Samples of mature maize kernels were collected at the PHI of 21 days and processed into aspirated grain fraction, flour, germ, meal and oil. Two different milling processes – wet and dry – were applied to derive germ, meal (dry only) and refined oil. Parent flupyradifurone ranged from 0.012 to 0.03 mg/kg in dry seeds and a concentration was observed only in aspirated grain fraction and bran. In germs, a slight residue reduction was observed and in the remaining processed commodities in all samples parent flupyradifurone was below the LOQ. Residues of the DFA were below the LOQ in the RAC (maize seeds) as well as in all processed commodities; therefore, processing factors for enforcement cannot be derived. However, considering that trials were significantly overdosed with respect to the authorised GAP, for risk assessment purposes, it can be concluded that no concentration of DFA residues will occur in processed maize commodities derived from maize treated at the authorised GAP.

Cotton

Two trials from the USA were provided where cotton was treated twice at application rates ranging from 596 to 1,000 g/ha. Samples of cotton seed were collected 13–14 days after the last application and, after ginning, undelinted seed (RAC) was processed into meal and oil. Bran and hulls were also analysed for residues. Residues of flupyradifurone were below the LOQ in crude and refined oil and a reduction of residues was observed in meal and hull. The residues of DFA were below the LOQ in the RAC and in all processed commodities (exception one meal sample); therefore, processing factors for enforcement cannot be derived.

Peanut

Two field trials from the USA were provided where peanuts were treated twice at application rates ranging from 592 to 1,000 g/ha. Samples of unshelled peanuts were collected 7 days following the last application and, once shelled (peanut nutmeat, RAC), were processed into meal, refined oil, peanut butter and roasted peanuts. Concentration of flupyradifurone and DFA residues was observed in peanut meal only.

Coffee beans

Two field trials from Brazil and Mexico were submitted where coffee plants received one drench (1.2 kg/ha) and three foliar applications (0.4 kg/ha). Coffee cherries were sampled 14 days after the last application and were dried (either air drying for 10 days or oven drying for 4 days (50°C) followed by air drying for 8 days) to obtain RAC, green, dry coffee beans. Green coffee beans were roasted or processed into instant coffee. Data indicate residue concentration, in particular of the DFA, in instant coffee. In roasted beans, a reduction of residues occurs.

Melons

Samples of melon pulp derived from residue trials were analysed for residues only at the authorised PHI interval of 1 day and a peeling factor of 0.1 was derived for parent flupyradifurone. However, since residues of DFA are higher at longer PHI intervals at which no residue data in pulp were provided, no peeling factors can be derived to estimate the magnitude of DFA and total residues in melon pulp.

Mustard greens

One field trial from the USA was submitted where mustard greens were treated twice at an application rate of 205 g/ha. Mustard leaves were collected 1 day after the last application, washed for 30 s three times, allowed to dry for 2 min and then cooked for 10 min. Data indicate reduction of residues by cooking.

Broccoli

One field trial from the USA was submitted where broccoli was treated twice at an application rate of 205 g/ha. Broccoli curds were collected 1 day after the last application, washed for 30 s three times, allowed to dry for 2 min and then cooked for 10 min. Data indicate reduction of residues by cooking.

Carrots

Carrot samples from three trials were washed and cooked to see the effect of processing on the magnitude of residues; cooking reduces the total residues for an average of 15%.

Courgettes

Similar results as for cooked broccoli and carrots were reported for cooked courgettes.

Peas (green)

Two trials from NEU were submitted, where peas were treated at the application rate of 75 g/ha (1N the intended GAP) and green seeds were collected 17–18 days after the treatment and processed into cooked peas and canned peas. Peas were cooked in a saucepan for 15 min and then analysed for residues. Canned peas were washed, blanched and then sterilised. Reduction of residues is observed under both processing conditions. Data from one trial were not considered as residues of flupyradifurone and the DFA were below the LOQs in raw commodity.

Olives

Two field trials from SEU were submitted where olives were treated once at 150 g/ha (1N the intended SEU GAP). Olives were collected 14 days after treatment to be processed into oil. Samples of crude oil, refined oil and solvent extracted refined oil were analysed for residues. In one trial, residues of DFA (affecting also total residue data) were detected in control sample of crude oil, thus for crude oil, only one study is considered valid. In one trial, residues of DFA were below the LOQ in RAC. In none of the samples of refined oil residues above LOQs were detected, with the exception of one sample of crude oil were flupyradifurone was quantified (PF_F of 0.13).

Cocoa beans

Two residue trials from Ivory Coast were submitted where cocoa was treated four times at an application rate of 93.75 g/ha. Samples of cocoa pods (BBCH 89) were collected at the PHI of 7 days. Beans were wrapped into banana leaves and left to ferment for 6–7 days. Fermented beans were air‐dried and processed into roasted beans, cocoa powder and chocolate. Beans were broken in a roller mill to produce nibs and shells. Nibs were roasted for 20 min at 125°C in air convection drying cabinet. Roasted nibs were milled to produce cocoa liquor, which afterwards was split into two fractions – one for cocoa powder extraction and the other for chocolate production. Only in one out of four dry bean samples (=RAC) parent flupyradifurone was detected above the LOQ, at 0.01 mg/kg (confirming the residue trial data), whereas DFA was present at an average level of 0.026 mg/kg. Results indicate reduction of DFA residues in roasted beans and in chocolate. Concentration of flupyradifurone residues is observed in cacao powder and in chocolate, the latter requiring additional trials to confirm this observation.

1.2.4. Proposed MRLs

The available data are considered sufficient to derive MRL proposals for flupyradifurone and the DFA as well as the risk assessment values for the commodities under evaluation, except for prickly pears and hops. For melons, the number of residue trials is not sufficient. However, the data set can be complemented by residue trials in cucurbits (edible peel) which were performed according the GAP for melons and where residues were found to occur in the same order of magnitude as in melons (see Section 1.2.1). For grapefruit, the non‐standard extrapolation from oranges should be discussed by risk managers. For pome fruit, EFSA proposed two options: 1) MRL proposal derived from the merged data set on apples and pears; 2) separate MRL proposals for pears and apples (extrapolation of apples to other pome fruit).

For several annual crops, soil uptake of DFA residues is significant, compared to residues resulting from the primary crop treatment and therefore have to be taken into consideration for the consumer exposure assessment and when setting MRLs for DFA. In order to estimate MRLs for the DFA in crops on which the use of flupyradifurone was sufficiently supported by residue data, the highest DFA residues estimated in the respective rotational crop at EU or US/Canadian flupyradifurone soil plateau concentrations were added to the MRLs calculated for primary treatment; the result was then rounded up to the next MRL class.12 The calculations were performed for EU and US/Canadian uses separately, taking into account the expected residues taken up via soil in the corresponding geographical zone.

For those crops for which confirmatory data on rotational crops were requested (footnotes added to the DFA MRLs in Commission Regulation (EU) 2016/1902) and on which no use of flupyradifurone has been reported, the MRL proposals for DFA were derived on the basis of residues estimated in rotational crop trials. In Table E.4, Appendix E, the calculations of the MRL proposals as outlined in this paragraph are presented.

Table E.4.

MRL proposals for DFA for plant products (in mg/kg)

Crop under assessment	Origin of the GAP	MRL proposal (primary crop treatment)	HR (representative rotational crop at EU plateau soil concentration for flupyradifurone)	HR in rotational crops (at US/CA plateau soil concentration flupyradifurone	MRL primary crop + HR for RC	MRL proposala
Strawberries	EU	0.03	0.25 (strawberries)	–	0.28	0.3
Potatoes	US/CA	0.03	–	0.12 (potato)	0.15	0.2
Tropical root and tuber vegetables	US/CA	0.03	–	0.12 (potato)	0.15	0.2
Root and tuber vegetables (except sugar beet)	US/CA	0.3	–	0.05 (carrot)	0.35	0.4
Bulb vegetables	Nso primary crop use	–	0.11 (onion)	–	0.11	0.15
Tomatoes	US/CA	0.7	–	0.19 (cucumber)	0.89	0.9
Tomatoes	EU use (EFSA, 2015)	0.06	0.28 (cucumber)	–	0.34	0.4 (fall‐back MRL)
Peppers	US/CA	0.7	–	0.19 (cucumber)	0.89	0.9
Aubergines	US/CA	0.7	–	0.19 (cucumber)	0.89	0.9
Cucurbits edible peel	EU (EFSA, 2015)	0.4	0.28 (cucumber)	–	0.68	0.7
Melons	US/CA	0.7	–	0.19 (cucumber)	0.89	0.9
Melons	EU	–	0.28 (cucumber)	–	0.43	0.3
Pumpkins	EU	–	0.28 (cucumber)	–	0.28	0.3
Sweet corn	US/CA	0.15	–	0.05 (maize)	0.2	0.2
Broccoli, cauliflower	EU	0.5	0.13 (broccoli, cauliflower)	–	0.63	0.7
Brussels sprouts	EU	0.2	0.13 (broccoli, cauliflower)	–	0.33	0.4
Head cabbage	EU	0.2	0.13 (broccoli, cauliflower)	–	0.33	0.4
Kale	EU	0.4	0.13 (broccoli, cauliflower)	–	0.53	0.6
Kohlrabi	EU	0.2	0.13 (broccoli, cauliflower)	–	0.33	0.4
Lettuce	EU	0.1	0.08 (lettuce)	–	0.18	0.2
Lettuce and other salad plants (except lettuce); Spinach and similar;Herbs and edible flowers	EU	0.15	0.08 (lettuce)	–	0.23	0.3
Watercress	No primary crop use	–	0.08 (lettuce)	–		0.08
Legumes with pods	EU	0.08	0.76 (beans with pods)	–	0.86	0.9
Legumes without pods	EU	0.15	0.76 (beans with pods)	–	0.91	1.0
Celeries	US/CA	0.06	–	0.11 (leek)	0.17	0.2
Celeries	EU	–	0.16 (leek)	–	0.16	0.2 (fall back MRL)
Stem vegetables, except celery	No primary crop use	–	0.16(leek)	–	0.16	0.2
Pulses	US/CA	2	–	1.07 (dry peas)	3.07	3
Pulses	EU	0.3	1.58 (dry peas)	–	1.88	2
Peanuts	US/CA	0.03	–	0.03 (rape seed)	0.06	0.06
soyabean seed	US/CA	0.6	–	0.03 (rape seed)	0.63	0.7
Cotton seed	US/CA	0.03	–	0.03 (rape seed)	0.06	0.06
Cotton seed	EU	0.02	0.05 (rape seed)	–	0.07	0.08
Oilseeds, except cotton, peanuts and soyabean	No primary crop use	–	0.05 (rape seed)	–	0.05	0.05
Barley grain	US/CA	0.6	–	0.17 (barley)	0.77	0.8
Sorghum grain	US/CA	0.07	–	0.17 (barley)	0.24	0.3
Wheat grain	US/CA	1	–	0.17 (barley)	1.17	1.5
Maize grain	US/CA	0.05	–	0.05 (maize)	0.1	0.1
Cereals, except wheat, sorghum, wheat and maize	No primary crop use	–	0.25 (barley)	–	0.25	0.3

HR: highest residue; MRL: maximum residue level.

^aThe MRL proposals representing the critical GAP for the commodity under assessment is highlighted in bold.

The data gap set in Commission Regulation (EU) 2016/1902 for flupyradifurone (leafy vegetables) was addressed; the MRL proposals for lettuces and salad plants (except escaroles), spinach and similar and herbs and edible flowers are based on the primary crop treatment (intended EU uses); residues from uptake of flupyradifurone via the root are insignificant in comparison to residues following direct treatment. For escaroles and water cress, MRL proposals are based on rotational crop studies, taking into account the calculated EU soil plateau.

MRL calculation of MRL proposals for DFA is summarised in Table E.4 in Appendix E. It is noted that the OECD guidance document on rotational crops (OECD, 2018) provides several risk management options for active substances that are likely to lead to residues in rotational crops. One option is the setting of MRLs considering the contribution of residues taken up via the roots. However, risk managers should also discuss the appropriateness of other options described in the OECD guidance document (e.g. plant back restrictions could be imposed to avoid or limit residues in succeeding crops).

The appropriateness of the calculated MRL proposals with regard to consumer health risks is assessed in Section 3.

2. Residues in livestock

Several of the crops on which EU uses are intended (head cabbage, kale, pulses, cotton) can be fed to livestock. Moreover, some food crops imported to Europe can also enter livestock feed chain directly as feed (cereals, oilseeds, pulses) or their by‐products can be used for feed purpose (pomace, meal etc.). EU livestock can be exposed to residues of flupyradifurone (mainly via primary crops) and to DFA residues (mainly from residues in rotational crops but also from primary crops as metabolite of flupyradifurone).

The applicant has also applied for setting import tolerances for animal products imported from the USA and Canada, due to exposure of US/Canadian livestock to residues via feed which result in flupyradifurone and DFA residues in US/Canadian livestock.

Thus, EFSA and the EMS estimated livestock exposure and potential carry‐over of flupyradifurone and DFA residues into livestock matrices. The approaches taken for the assessment of animal products produced in the EU and in US/Canadian are described below.

a) EU scenario: livestock dietary exposure to flupyradifurone and DFA (for the estimation of residues in food of animal origin produced in Europe)

EFSA calculated the EU livestock dietary exposure to residues from the intake of primary and rotational crops grown in the EU as well as from the commodities for which import tolerances were requested that can be used for feed purposes (either unprocessed products such as cereals, oilseeds, pulses or as food by‐products (pomace, meal etc.)).

The livestock exposure was calculated separately for flupyradifurone and the DFA according to the OECD methodology using the EFSA Animal model 2017. The input values for flupyradifurone were as estimated in primary crops from the submitted residue trials. DFA is a major metabolite found in rotational crops; to calculate livestock exposure to DFA, the following approaches were considered for the choice of input values:

• − For feed crops on which the use of flupyradifurone is intended in Europe and no import is expected (head cabbage, kale), DFA residues in primary crop (reflecting the EU intended use, see Appendix B, B.1.2.1) were added to residue levels of DFA estimated in the respective rotational crop when grown in the soil with flupyradifurone residues at EU plateau level (C_min) (see Table E.3, Appendix E);
• − For crops for which an import tolerance was requested for USA/Canada uses and for which also EU uses are intended (i.e. pulses, cotton), the DFA residues in primary crop (EU and US/Canadian use, respectively) were added to residue levels of DFA estimated in the respective rotational crop when grown in the soil with flupyradifurone residues at EU or US/Canadian plateau levels (C_min). The highest supervised trials median residue (STMR) and HR (either EU or US/CA) were selected as input value.
• − For feed items for which US/Canadian uses of flupyradifurone were reported and which are expected to be exported to the EU, but which might be grown also in Europe as rotational crops (carrot, potatoes, swedes, turnips, soyabean, peanuts, maize, barley, sorghum and wheat), the DFA residues in primary crop (US/Canadian use) were added to residue levels of DFA estimated in the respective rotational crop when grown in the soil with flupyradifurone residues at US/Canadian plateau levels (C_min). These values were then compared with the estimated DFA residues in the relevant rotational crop when grown in EU soils containing flupyradifurone at plateau concentrations. The highest value of the STMR and of the HR was selected as input value.
• − For the remaining feed crops, it was assumed that these crops are grown in EU soils containing residues at the EU soil plateau level (C_min). The STMR and HR values as estimated from the respective rotational crop were used as input values.

The input values for the EU dietary burden calculation are summarised in Appendix D.1.a).

b) US scenario: Livestock exposure to flupyradifurone and DFA residues in North America (for the estimation of residues in imported commodities of animal origin)

The EMS performed a calculation estimating the DFA exposure of US/Canadian livestock, taking into account DFA residue levels expected in US feed (primary crops and rotational crops). Hence, the EMS compared the DFA residues in primary feed crops with the estimated DFA residues in rotational crops and the highest value was chosen for the dietary burden calculation.13

The input values for the US/Canadian dietary burden calculation are summarised in Appendix D.1.b. The calculations are considered indicative, since only limited information on the use pattern of flupyradifurone in the USA and Canada and possible use restrictions or import of feed to the USA/Canada containing residues of DFA and flupyradifurone are available. Although the calculated US/Canadian dietary burden for DFA is affected by an additional, non‐standard uncertainty, it is considered appropriate to be used for an estimation of the expected residues in food of animal origin, considering the overall conservatism of the approach.

Considering the lack of detailed information on residues in feed used in the USA/Canada, EFSA did not perform a dietary burden for flupyradifurone to be used for estimating the expected residues in US/Canadian livestock. Instead EFSA used a simplified approach: instead of performing a re‐assessment of the MRLs required for US livestock, EFSA relied on the US/Canadian MRLs as established in the Federal Register for risk assessment. Hence, to derive the MRL proposals for US/Canadian livestock, EFSA compared the estimated EU MRL proposals derived for flupyradifurone with the existing US/Canadian MRLs to decide on the appropriate EU MRLs animal products.

The results of the dietary burden calculations (EU scenario for flupyradifurone and DFA, US scenario calculating dietary burden for US livestock for DFA) which are presented in Appendix B, Section B.2. demonstrated significant exposure to flupyradifurone and DFA, exceeding the trigger value of 0.004 mg/kg bw per day for all livestock species. It was noted that the exposure to DFA residues for EU dairy cattle and poultry is lower than the indicative exposure calculated for US/Canadian livestock.

Considering the results of livestock dietary burden calculations, the nature and magnitude of flupyradifurone and DFA in animal matrices were further investigated.

2.1. Nature of residues and methods of analysis in livestock

The nature of flupyradifurone residues in livestock was investigated in the framework of the EU pesticides peer review (EFSA, 2015). ¹⁴C‐flupyradifurone labelled on pyridinyl or furanone moiety was administered to goats or hens at the dose rate of ca. 1 mg/kg bw.

In goats, the degradation of the parent compound was limited, flupyradifurone accounting for 24–35% in milk and kidney and up to 81–99% in fat. The metabolism was more extensive in hens; low amounts of flupyradifurone were detected in any poultry matrices in the ¹⁴C‐furanone study (< 3% TRR) and was in the range of 1% (liver) to 20% TRR (eggs) in the ¹⁴C‐pyridinyl study. The main components identified in hens were the flupyradifurone‐hydroxy metabolites (18% TRR in eggs) and its sulfate conjugate in fat and liver (16–23% TRR) and the acetyl‐AMCP metabolite in egg, fat and muscle (23–40% TRR) (EFSA, 2015).

The animal feeding studies with flupyradifurone alone revealed that DFA is a major marker of the residues in poultry matrices and to a lesser extent, in ruminant matrices.

Based on these studies, the residue definitions were proposed as ‘Sum of flupyradifurone and DFA, expressed as flupyradifurone’ for risk assessment. For enforcement, to align with the residue definition set for plants, two separate residue definitions were established: 1) flupyradifurone and 2) DFA, expressed as DFA (EFSA, 2015).

The metabolic pathway of flupyradifurone and DFA in rats and ruminants proceeds in a similar pathway, and therefore, the metabolism study in swine is not necessary. Flupyradifurone and DFA are considered not fat soluble.

2.2. Magnitude of residues in livestock

The magnitude of flupyradifurone in livestock was investigated in the framework of the EU pesticides peer review (EFSA, 2015). Lactating cows were dosed with flupyradifurone alone for 29 consecutive days at dose rates of 0.18, 0.9, 1.84 and 4.9 mg/kg bw per day. Laying hens were dosed with flupyradifurone alone at 0.1, 0.45, 1.31 and 4.5 mg/kg bw per day. Animal matrices were analysed for flupyradifurone and DFA individually and total residues were expressed as the sum of flupyradifurone and DFA.

Since residues in rotational crops mainly consist of DFA, the EU pesticides peer review experts set a data gap for feeding studies where animals are dosed with the DFA. Provisionally and pending the submission of the requested data, the peer review derived MRLs for animal products from the feeding studies conducted with the parent flupyradifurone alone and considering a transfer factor approach proposed by the applicant (EFSA, 2015).

In the framework of the current assessment, the applicant submitted a new livestock feeding study with DFA where the magnitude of residues was investigated in laying hens and dairy cows, at levels covering the highest dietary burdens calculated in this assessment (Netherlands, 2017).

Poultry feeding study

The difluoroacetic acid was administered to laying hens in the form of a salt (sodium difluoroacetate14) at an actual average dose rates corresponding to 0.018 (1N dose group), 0.054 (3N dose group) and 0.181 mg DFA/kg bw per day (10× dose group). The control group and the two lowest dose groups consisted of 12 hens, whereas the highest dose group (10N) consisted of 28 hens. The duration of the study was 29 days. Eggs were collected twice a day. On day 29 of the study, all animals from 1N and 3N dose groups and 12 hens of 10N dose group were sacrificed. Six hens from control group and the remaining birds from 10N dose group entered depuration phase of the study, which lasted up to 50 days from the start of the study. The samples of eggs and tissues prior to analysis were stored frozen at −18°C and were analysed within 30 days of collection.

The stability of DFA residues during the storage of samples for 24 and 48 h was investigated in a separate experiment, by spiking control samples at a level of 0.1 mg/kg DFA. The stability of DFA was confirmed when tissue and egg samples are stored at temperature range −2.5 to −18°C for up to 2 days. The analytical method used to analyse samples was sufficiently validated at the LOQ of 0.01 mg/kg in all tissues and eggs.

Plateau of DFA residues in eggs was reached 7 days after the first dosing and was below the LOQ of 0.01 mg/kg 14 days after the dose cessation. Higher residues were observed in egg white (mean of 0.12 mg/kg from 10N dose group) than in egg yolk (0.25 mg/kg). In muscle, residues were detected in all samples in all dose groups, with a mean residue level of 0.388 mg/kg in 10N dose group; 21 days after the dose cessation, residues were not detected any more in muscle. Residues in fat at the 1N dose group were below the LOQ (but above the limit of detection (LOD)) and in the 10N dose group on average accounted for 0.07 mg/kg. Residues in liver were present in all dose groups, mean values ranging from 0.052 mg/kg in 1N dose group to 0.8 mg/kg in the highest dose group. According to depuration study, no accumulation of DFA residues occurred in tissues.

Ruminant feeding study

The difluoroacetic acid was administered to 15 dairy cows in form of a salt (sodium difluoroacetate) at an actual average dose rates corresponding to 0.032 (1N dose group), 0.17 (5N dose group) and 0.33 mg DFA/kg bw per day (10N dose group). Control group consisted of two cows, 1N and 5N dose group of three cows and 10N dose group of 7 cows. The duration of the study was 29 days. Samples of tissues and milk were collected, homogenised with dry ice and frozen prior to analysis, which took place within 30 days of sampling. The analytical method used to analyse samples was sufficiently validated at the LOQ of 0.01 mg/kg in all tissues and milk.

In milk, the highest residues were found in the samples taken on the 25th day of the study (0.23 mg/kg 10N dose study), the plateau was observed on days 7–14 post dose administration. Ten days after the dose cessation, the residues in milk decreased below the LOQ. Milk samples taken on day 25 from the 10N dose group were separated into cream and whey and indicated no preferential accumulation of DFA residues in neither aqueous nor fatty phase. In all tissue samples from all dose groups, average residues were always above the LOQ. Fat sample consisted of mesenteric, perirenal and sub‐cutaneous fat; higher residues were observed in subcutaneous fat. In tissue samples from 10N dose group, the average residues accounted for 0.68 mg/kg in liver, 1.1 mg/kg in kidney, 0.67 mg/kg in muscle and 0.52 mg/kg in fat. In all tissues, residues decreased below the LOQ of 0.01 gm/kg 14 days after the cessation of dose administration.

The calculated dietary burdens for flupyradifurone and DFA were then compared to the results of the livestock feeding studies with flupyradifurone and DFA, respectively, to estimate the magnitude of residues expected in animal matrices.

For flupyradifurone, the MRL proposals for swine and poultry products derived for the EU scenario were higher than the US tolerances while for ruminants, the US tolerances were higher than the MRL calculated for the EU scenario.

To derive the MRL proposals for DFA, the results of the feeding study with DFA and the DFA residues measured in the feeding study with flupyradifurone had to be summed up, taking into account that DFA is formed in animal metabolism after intake of flupyradifurone.

The detailed calculations are presented in Appendix B.2.2.1, whereas summary overview is given in Table E.5 of Appendix E.

Table E.5.

Summary of risk assessment values and MRL proposals for commodities of animal origin

Commodity	EU intake (DFA, expressed as DFA)			US/CA intake (DFA, expressed as DFA) (Netherlands, 2019)			Risk assessment valuesa DFA, expressed as flupyradifurone		EU intake (flupyradifurone)			US/CA MRL flupyradifurone	Input value for RA (flupyradifurone and DFA, expressed as flupyradifurone)
	STMR	HR	MRL proposal	STMR	HR	MRL proposal	STMR	HR	STMR	HR	MRL proposal	MRL	STMRb	HRc
Cattle muscle	0.08	0.16	0.2	0.268	0.308	0.4	0.80	0.92	0.02	0.04	0.05	0.3	1.10	1.22
Cattle fat	0.05	0.13	0.15	0.277	0.426	0.5	0.83	1.28	0.007	0.02	0.02	0.2	1.03	1.48
Cattle liver	0.06	0.12	0.15	0.248	0.303	0.4	0.74	0.91	0.05	0.28	0.3	1	1.74	1.91
Cattle kidney	0.13	0.21	0.3	0.414	0.462	0.5	1.24	1.39	0.06	0.15	0.15	1	2.24	2.39
Cattle milk	0.02	0.03	0.03	0.063	0.063	0.07	0.19	0.19	0.01	0.02	0.03	0.15	0.34	–
Sheep muscle	0.08	0.18	0.20	N.C.	n.c.	n.c.	0.24	0.54	0.01	0.04	0.04	0.3	0.54	0.84
Sheep fat	0.06	0.15	0.15	n.c.	n.c.	n.c.	0.18	0.45	0.005	0.02	0.02	0.2	0.38	0.65
Sheep liver	0.07	0.13	0.15	n.c.	n.c.	n.c.	0.21	0.39	0.04	0.27	0.3	1	1.21	1.39
Sheep kidney	0.13	0.24	0.30	n.c.	n.c.	n.c.	0.39	0.72	0.04	0.14	0.15	1	1.39	1.72
Sheep milk	0.01	0.02	0.03	n.c.	n.c.	n.c.	0.03	0.06	0.01	0.02	0.02	0.15	0.18	0.21
Swine muscle	0.05	0.12	0.15	0.042	0.052	0.06	0.15	0.36	0.01	0.02	0.03	0.01	0.16	0.38
Swine fat	0.03	0.10	0.10	0.044	0.073	0.08	0.13	0.30	0.003	0.01	0.015	0.01	0.14	0.31
Swine liver	0.04	0.09	0.09	0.034	0.039	0.04	0.12	0.27	0.02	0.08	0.08	0.04	0.14	0.35
Swine kidney	0.07	0.16	0.20	0.06	0.067	0.07	0.21	0.48	0.02	0.09	0.09	0.04	0.23	0.57
Poultry muscle	0.073	0.12	0.15	0.102	0.109	0.15	0.31	0.37	0.01	0.01	0.01	–	0.32	0.38
Poultry fat	0.018	0.03	0.03	0.025	0.028	0.03	0.08	0.08	0.01	0.01	0.01	–	0.09	0.09
Poultry liver	0.223	0.23	0.3	0.185	0.198	0.2	0.67	0.68	0.01	0.01	0.01	–	0.68	0.69
Eggs	0.06	0.10	0.10	0.08	0.09	0.1	0.24	0.30	0.01	0.01	0.01	–	0.25	0.31

STMR: supervised trials median residue; HR: highest residue; MRL: maximum residue level; RA: risk assessment; n.c.: calculated.

^aHighest value among EU and US/Canadian feed intake selected.

^bSTMR value refers to the sum of highest STMR value estimated for DFA (expressed as flupyradifurone) for the EU or US/Canadian feed intakes AND the highest STMR value for flupyradifurone for the EU or US/Canadian feed intakes. For commodities of cattle, sheep/goat the tolerance in the USA and Canada is higher that MRL proposal derived for EU diet but no STMR value is available for flupyradifurone; in this case the tolerance was used to estimate input values (STMR) for the risk assessment in these matrices.

^cHR value refers to the sum of highest HR value estimated for DFA (expressed as flupyradifurone) for the EU or US/Canadian feed intakes AND the highest HR value for flupyradifurone for the EU or US/Canadian feed intakes. For commodities of cattle, sheep/goat the tolerance in the USA and Canada is higher that MRL proposal derived for EU diet but no HR value is available for flupyradifurone; in this case the tolerance was used to estimate input values (HR) for the risk assessment in these matrices.

Values in bold indicate highest MRL proposal amongst EU and NA livestock dietary burdens.

EFSA concluded that the existing EU MRLs for flupyradifurone and DFA should be raised in all animal matrices, except for flupyradifurone in poultry commodities.

The data gap identified by the peer review for the livestock feeding studies with DFA is sufficiently addressed.

3. Consumer risk assessment

The consumer risk assessment was performed with revision 3.1 of the EFSA Pesticide Residues Intake Model (PRIMo). This exposure assessment model contains the relevant European food consumption data for different subgroups of the EU population (EFSA, 2018, 2019).

The toxicological reference values for flupyradifurone used in the risk assessment (i.e. ADI and ARfD values) were derived in the framework of the EU pesticides peer review (European Commission, 2015). The peer review also assessed toxicological studies submitted for metabolite DFA and concluded that the reference values of parent are applicable to DFA (EFSA, 2015). The risk assessment residue definition refers to the sum of flupyradifurone and the DFA, expressed as DFA.

EFSA performed two separate consumer exposure calculations in order to estimate the exposure from primary crops (including also animal products) and rotational crops, to provide risk managers additional information to decide on risk management options as regards residues in rotational crops, e.g. whether MRLs should be established to cover residues in rotational crops or whether other restrictions would be appropriate to avoid residues in untreated crops.

Scenario 1: Exposure to residues resulting from treated primary crops and animal commodities exposed to residues on primary treated crops.

In order to calculate chronic and acute consumer exposure to residues of flupyradifurone and DFA, the STMR and HR values, respectively, as derived from submitted residue trials (Table B.1.2.1) were used as input values. For strawberries, raspberries, blackberries, cucurbits (edible peel), watermelon pulp and hops, the risk assessment values were as derived in the previous EFSA assessments (EFSA, 2015, 2016). For citrus fruits, the peeling factor of 0.4 was applied to refine the exposure calculation. For remaining commodities of plant origin, no input values were used in the consumer exposure calculation as no uses of flupyradifurone are authorised on other crops in EU.

For the consumer risk assessment of residues in ruminant products, EFSA used input values based on the US/Canadian MRLs for flupyradifurone, adding the estimated DFA residues resulting from metabolism of flupyradifurone to DFA in ruminants (derived from feeding study with flupyradifurone) and the intake of DFA present in feed (estimated from the feeding study with DFA). DFA residues were recalculated to flupyradifurone using a molecular weight conversion factor.¹¹ The approach used by EFSA is conservative leading to an overestimation of the exposure, ensuring that consumers are sufficiently protected. For the remaining animal products, the input values for the consumer risk assessment have been derived for the EU following the standard EU approach. The background for the identification of input values for scenario 1 are reported in Table E.5, Appendix E.

Scenario 2: Exposure to residues from the intake of plant commodities that are grown as rotational crops (untreated)

In scenario 2, the input values were derived from rotational crop studies, where the main residue was DFA (expressed as flupyradifurone); in lettuce and barley also low concentrations of flupyradifurone were identified from soil uptake. For annual crops for which import tolerances were requested and which therefore can enter the EU market, the DFA residue values were calculated considering the respective rotational crop field trials, scaled to reflect the US/Canadian flupyradifurone soil plateau concentrations. This residue concentration was then compared with the DFA residues in the same crop reflecting EU flupyradifurone soil plateau concentrations. The highest DFA value was selected as input value for the exposure calculation.

For the remaining annual crops, the STMR and HR values for DFA were calculated for the EU soil plateau concentrations (recalculated to flupyradifurone using the molecular weight conversion factor) (Table E.3, Appendix E). For cereals and leafy crops, the residues of flupyradifurone identified in the rotational crop studies in barley and lettuce were added.

An overview of input values for consumer exposure assessment is provided in Appendix D.2.

The calculated exposures were then compared with the toxicological reference values as derived for flupyradifurone.

The estimated long‐term dietary exposure in scenario 1 (consumer exposure due to primary crop treatment) accounted for a maximum of 53% of the ADI (NL toddler diet); for scenario 2 (consumer exposure from the intake of DFA residues taken up by crops from the soil which was previously treated with flupyradifurone), accounted for up to 17% of the ADI (GEMS/Food G06). The combined exposure to flupyradifurone and DFA residues from the intake of food commodities following primary crop treatments, animal commodities and untreated food commodities containing residues due to the uptake via soil accounts for a maximum of 69% of the ADI (Dutch toddler). The overall exposure to flupyradifurone and DFA is unlikely to pose a chronic consumer intake concern.

In the short‐term dietary exposure according to scenario 1 EFSA identified an exceedance of the ARfD for celeries (150%), melons (147%) and for processed escarole (141%). For the remaining crops, the short‐term exposure did not exceed the ARfD and accounted the highest for table grapes (95% of ARfD), escaroles (86%), lettuce (81%). The EMS proposed to perform a refined exposure assessment, using residue concentrations expected in trimmed celery stalks instead of residues expected in whole product (stems and leaves). This refinement is not supported by EFSA since specific consumption data for trimmed celery and untrimmed celery are not available. Hence, the consumption of a large portion of untrimmed celery cannot be excluded.

The exposure scenario 2 (expressed as % of ARfD) was highest for melons (86%), watermelons (69%) and potatoes (55%).

The combined exposure to residues from primary treatment (scenario 1) and residues taken up via roots (scenario 2) identified exceedances of the ARfD for melons (233% of ARfD), celeries (161% of ARfD), processed celeries (146% of ARfD), tomatoes (103%) and processed escaroles (154% of ARfD). For peppers, table grapes and unprocessed escaroles, the exposure was close to the ARfD (99%, 95% and 93% of ARfD, respectively). For the remaining commodities of plant and animal origin, the exposure was below 90%.

For melons, celeries, tomatoes and escaroles, an acute risk assessment was performed for alternative MRL proposal, i.e. assuming no primary crop use for melons,15 escaroles and celeries; for tomatoes, the HR for the EU primary crop use assessed in the framework of the peer review (EFSA, 2015) was added to the HR estimated for tomatoes grown as rotational crops. For these alternative scenarios, the exposure did not lead to an exceedance of the ARfD.

The results of the consumer exposure assessment are presented in more detail in Appendix B.3.

4. Conclusion and Recommendations

The data submitted in support of intended and authorised uses were found to be sufficient to derive MRL proposals for flupyradifurone and DFA in all crops under consideration except for prickly pear and hops; for grapefruit, pome fruits, grape leaves and witloof, further risk management discussion is recommended to decide on the appropriate MRL. EFSA also derived MRL proposals for primary crop treatment only which should provide the necessary background information to risk managers to decide on possible risk mitigation measures to address residues expected in rotational crops.

For various commodities of animal origin, the MRL proposals were derived on the basis of estimated livestock exposure to flupyradifurone and DFA residues from the intended and authorised uses of flupyradifurone.

The data gaps identified by the EU pesticides peer review related to 1) field rotational crop studies considering realistic plant back intervals for the crops considered and providing information on the flupyradifurone and DFA residue levels in soil and 2) animal feeding studies conducted with the DFA metabolite are sufficiently addressed and the confirmatory data gap as set for DFA and flupyradifurone MRLs in the Commission Regulation (EU) 2016/1902 can be deleted.

Consumer exposure calculation indicates no chronic consumer intake concerns related to flupyradifurone and DFA residues in commodities of plant and animal origin. Acute consumer exposure concerns could not be excluded for melons, celery (processed and unprocessed), tomatoes and processed escarole. Fall‐back MRL proposals were derived for celery, tomatoes and escaroles for which no acute intake concern was identified. The fall‐back MRL proposals for melons, celery and escaroles reflect the uptake via roots (no primary crop treatment); for tomatoes, it reflects the EU use (assessed previously (EFSA, 2015)) plus the uptake via roots.

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

CAC

Codex Alimentarius Commission

CAS

Chemical Abstract Service

CF

conversion factor for enforcement to risk assessment residue definition

CV

coefficient of variation (relative standard deviation)

DALA

days after last application

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

FID

flame ionisation detector

GAP

Good Agricultural Practice

GC

gas chromatography

GC‐FID

gas chromatography with flame ionisation detector

GC‐MS

gas chromatography with mass spectrometry

GC‐MS/MS

gas chromatography with tandem mass spectrometry

GS

growth stage

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

ISO

International Organisation for Standardisation

IUPAC

International Union of Pure and Applied Chemistry

LC

liquid chromatography

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

MW

molecular weight

NEU

northern Europe

OECD

Organisation for Economic Co‐operation and Development

PBI

plant back interval

PF

processing factor

PHI

preharvest interval

P_ow

partition coefficient between n‐octanol and water

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

SL

soluble concentrate

SP

water‐soluble powder

STMR

supervised trials median residue

TAR

total applied radioactivity

TRR

total radioactive residue

UV

ultraviolet (detector)

WHO

World Health Organization

WP

wettable powder

Appendix A – Summary of GAPs triggering the amendment of existing EU MRLs

1.

Crop and/or situation	NEU, SEU, MS or country	F G or Ia	Pests or group of pests controlled	Preparation		Application				Application rate per treatment			PHI (days)d	Remarks
				Typeb	Conc. a.s. (g/L)	Method kind	Range of growth stages & seasonc	No min–max	Interval between application (min)	g a.s./hL (min–max)	Rate	Unit
Grapefruits	USA	F	Aphids, whiteflies, scales, Scirothrips, Asian citrus psyllid	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	1	Max 0.410 Kg a.s./ha
Grapefruits	USA	F	Asian citrus psyllid, aphids	SL	200.0	Soil treatment – general (see also comment field)		1		0.31	0.41	kg a.i./ha	30	Max 0.410 Kg a.s./ha
Oranges	USA	F	Aphids, whiteflies, scales, Scirothrips, Asian citrus psyllid	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	1	Max 0.410 Kg a.s./ha
Oranges	USA	F	Asian citrus psyllid, aphids	SL	200.0	Soil treatment – general (see also comment field)		1		0.31	0.41	kg a.i./ha	30	Max 0.410 Kg a.s./ha
Lemons	USA	F	Aphids, whiteflies, scales, Scirothrips, Asian citrus psyllid	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	1	Max 0.410 Kg a.s./ha
Lemons	USA	F	Asian citrus psyllid, aphids	SL	200.0	Soil treatment – general (see also comment field)		1		0.31	0.41	kg a.i./ha	30	Max 0.410 Kg a.s./ha
Limes	USA	F	Aphids, whiteflies, scales, Scirothrips, Asian citrus psyllid	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	1	Max 0.410 Kg a.s./ha
Limes	USA	F	Asian citrus psyllid, aphids	SL	200.0	Soil treatment – general (see also comment field)		1		0.31	0.41	kg a.i./ha	30	Max 0.410 Kg a.s./ha
Mandarins	USA	F	Aphids, whiteflies, scales, Scirothrips, Asian citrus psyllid	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	1	Max 0.410 Kg a.s./ha
Mandarins	USA	F	Asian citrus psyllid, aphids	SL	200.0	Soil treatment – general (see also comment field)		1		0.31	0.41	kg a.i./ha	30	Max 0.410 Kg a.s./ha
Almonds	USA, CA	F	Aphids, whitefly	SL	200.0	Foliar treatment – broadcast spraying		1–2	14	0.12	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Brazil nuts	USA, CA	F	Aphids, whitefly	SL	200.0	Foliar treatment – broadcast spraying		1–2	14	0.12	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Cashew nuts	USA, CA	F	Aphids, whitefly	SL	200.0	Foliar treatment – broadcast spraying		1–2	14	0.12	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Chestnuts	USA, CA	F	Aphids, whitefly	SL	200.0	Foliar treatment – broadcast spraying		1–2	14	0.12	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Coconuts	USA, CA	F	Aphids, whitefly	SL	200.0	Foliar treatment – broadcast spraying		1–2	14	0.12	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Hazelnuts/cobnuts	USA, CA	F	Aphids, whitefly	SL	200.0	Foliar treatment – broadcast spraying		1–2	14	0.12	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Macadamia	USA, CA	F	Aphids, whitefly	SL	200.0	Foliar treatment – broadcast spraying		1–2	14	0.12	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Pecans	USA, CA	F	Aphids, whitefly	SL	200.0	Foliar treatment – broadcast spraying		1–2	14	0.12	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Pine nut kernels	USA, CA	F	Aphids, whitefly	SL	200.0	Foliar treatment – broadcast spraying		1–2	14	0.12	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Pistachios	USA, CA	F	Aphids, whitefly	SL	200.0	Foliar treatment – broadcast spraying		1–2	14	0.12	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Walnuts	USA, CA	F	Aphids, whitefly	SL	200.0	Foliar treatment – broadcast spraying		1–2	14	0.12	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Apples	USA, CA	F	Aphids, leafhoppers, psyllids, scales	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	14	Max 0.410 Kg a.s./ha
Pears	USA, CA	F	Aphids, leafhoppers, psyllids, scales	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	14	Max 0.410 Kg a.s./ha
Quinces	USA, CA	F	Aphids, leafhoppers, psyllids, scales	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	14	Max 0.410 Kg a.s./ha
Medlar	USA, CA	F	Aphids, leafhoppers, psyllids, scales	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	14	Max 0.410 Kg a.s./ha
Loquats/Japanese medlars	USA, CA	F	Aphids, leafhoppers, psyllids, scales	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	14	Max 0.410 Kg a.s./ha
Table grapes	USA	F	Leafhopper, mealy‐bug	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	0	Max 0.410 Kg a.s./ha
Table grapes	USA, CA	F	Mealybug, leafhopper	SL	200.0	Soil treatment – general (see also comment field)		1		0.31	0.41	kg a.i./ha	30	Max 0.410 Kg a.s./ha
Wine grapes	USA	F	Leafhopper, mealy‐bug	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	0	Max 0.410 Kg a.s./ha
Wine grapes	USA, CA	F	Mealybug, leafhopper	SL	200.0	Soil treatment – general (see also comment field)		1		0.31	0.41	kg a.i./ha	30	Max 0.410 Kg a.s./ha
Strawberries	USA	F	Aphids, whitefly	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	0	Max 0.410 Kg a.s./ha; EMS confirmed that no MRL modification was requested.
Blueberries	USA, CA	F	Aphids, flies (maggots)	SL	200.0	Foliar treatment – broadcast spraying		1–2	7	0.12	0.21	kg a.i./ha	3	Max 0.410 Kg a.s./ha IR/PMC
Table olives	SEU		Olive fruit fly, meadow froghopper	SL	200.0	Foliar treatment – broadcast spraying	55–85	1		500–1,200 L/ha	150.00	g a.i./ha	14
Prickly pears/cactus fruits	USA	F	Aphids	SL	200.0	Foliar treatment – broadcast spraying		1–2	7	0.12	0.21	kg a.i./ha	21	Max 0.410 Kg a.s./ha IR‐4
Potatoes	USA, CA	F	Aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	7	0.10	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Cassava roots/manioc	USA, CA	F	Aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	7	0.10	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Sweet potatoes	USA, CA	F	Aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	7	0.10	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Yams	USA, CA	F	Aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	7	0.10	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Arrowroots	USA, CA	F	Aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	7	0.10	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Beetroots	USA, CA	F	Aphids, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.10	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Beetroots	USA, CA	F	Aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	7	0.10	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Carrots	USA, CA	F	Aphids, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.10	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Celeriacs/turnip rooted celeries	USA, CA	F	Aphids, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.10	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Horseradishes	USA, CA	F	Aphids, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.10	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Jerusalem artichokes	USA, CA	F	Aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	7	0.10	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Parsnips	USA, CA	F	Aphids, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.10	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Parsley roots/Hamburg roots parsley	USA, CA	F	Aphids, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.10	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Radishes	USA, CA	F	Aphids, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.10	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Salsifies	USA, CA	F	Aphids, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.10	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Swedes/rutabagas	USA, CA	F	Aphids, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.10	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Turnips	USA, CA	F	Aphids, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.10	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Tomatoes	USA, CA	F	Aphis, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	7	0.12	0.21	kg a.i./ha	1	Max 0.410 Kg a.s./ha
Tomatoes	USA, CA	F	Aphids, leafhopper, whitefly	SL	200.0	Soil treatment – general (see also comment field)		1		0.31	0.41	kg a.i./ha	45	Max 0.410 Kg a.s./ha
Sweet peppers/bell peppers	USA, CA	F	Aphis, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	7	0.12	0.21	kg a.i./ha	1	Max 0.410 Kg a.s./ha
Sweet peppers/bell peppers	USA, CA	F	Aphids, leafhopper, whitefly	SL	200.0	Soil treatment – general (see also comment field)		1		0.31	0.41	kg a.i./ha	45	Max 0.410 Kg a.s./ha
Aubergines/egg plants	USA, CA	F	Aphis, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	7	0.12	0.21	kg a.i./ha	1	Max 0.410 Kg a.s./ha
Aubergines/egg plants	USA, CA	F	Aphids, leafhopper, whitefly	SL	200.0	Soil treatment – general (see also comment field)		1		0.31	0.41	kg a.i./ha	45	Max 0.410 Kg a.s./ha
Cucumbers, gherkins, courgettes	USA, CA	F	Aphis, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	7	0.12	0.21	kg a.i./ha	1	Max 0.410 Kg a.s./ha EMS confirmed that no MRL modification was requested
Cucumbers, gherkins, courgettes	USA, CA	F	Aphids, leafhopper, whitefly	SL	200.0	Soil treatment – general (see also comment field)		1		0.31	0.41	kg a.i./ha	21	Max 0.410 Kg a.s./ha EMS confirmed that no MRL modification was requested
Melons	USA, CA	F	Aphis, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	7	0.12	0.21	kg a.i./ha	1	Max 0.410 Kg a.s./ha
Melons	USA, CA	F	Aphids, leafhopper, whitefly	SL	200.0	Soil treatment – general (see also comment field)		1		0.31	0.41	kg a.i./ha	21	Max 0.410 Kg a.s./ha
Sweet corn	USA	F	Aphids, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	7	0.12	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Broccoli	NEU	F	Aphids	SL	25.0	Foliar treatment – broadcast spraying	12–49	2	10	Water (500–1,000 L/ha)	125.00	g a.i./ha	3
Broccoli	SEU	F	Aphids	SL	25.0	Foliar treatment – broadcast spraying	12–49	2	10	Water (500–1,000 L/ha)	125.00	g a.i./ha	3
Cauliflowers	NEU	F	Aphids	SL	25.0	Foliar treatment – broadcast spraying	12–49	2	10	Water (500–1,000 L/ha)	125.00	g a.i./ha	3
Cauliflowers	SEU	F	Aphids	SL	25.0	Foliar treatment – broadcast spraying	12–49	2	10	Water (500–1,000 L/ha)	125.00	g a.i./ha	3
Other flowering brassica	NEU	F	Aphids	SL	25.0	Foliar treatment – broadcast spraying	12–49	2	10	Water (500–1,000 L/ha)	125.00	g a.i./ha	3
Other flowering brassica	SEU	F	Aphids	SL	25.0	Foliar treatment – broadcast spraying	12–49	2	10	Water (500–1,000 L/ha)	125.00	g a.i./ha	3
Head cabbages	NEU	F	Aphids	SL	25.0	Foliar treatment – broadcast spraying	12–49	2	10	Water (500–1,000 L/ha)	125.00	g a.i./ha	3
Head cabbages	SEU	F	Aphids	SL	25.0	Foliar treatment – broadcast spraying	12–49	2	10	Water (500–1,000 L/ha)	125.00	g a.i./ha	3
Brussels sprouts	NEU	F	Aphids	SL	25.0	Foliar treatment – broadcast spraying	12–49	2	10	Water (500–1,000 L/ha)	125.00	g a.i./ha	3
Kales	NEU	F	Aphids	SL	25.0	Foliar treatment – broadcast spraying	12–49	2	10	Water (500–1,000 L/ha)	125.00	g a.i./ha	3
Kales	SEU	F	Aphids	SL	25.0	Foliar treatment – broadcast spraying	12	1		Water (500–1,000 L/ha)	125.00	g a.i./ha	3
Kohlrabies	NEU	F	Aphids	SL	25.0	Foliar treatment – broadcast spraying	12	2	10		125.00	g a.i./ha	3
Lamb's lettuce/corn salads	NEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Lamb's lettuce/corn salads	SEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Lettuces	NEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Lettuces	SEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Escaroles/broadleaved endives	NEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Escaroles/broadleaved endives	SEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Cress and other sprouts and shoots	NEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Cress and other sprouts and shoots	SEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Land cress	NEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Land cress	SEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Roman rocket/rucola	NEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Roman rocket/rucola	SEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Red mustards	NEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Red mustards	SEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Baby leaf crops (including brassica species)	NEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Baby leaf crops (including brassica species)	SEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Spinaches	NEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Spinaches	SEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Purslanes	NEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Purslanes	SEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha (EU GAP)
Chards/beet leaves	NEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha (EU GAP)
Chards/beet leaves	SEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Chervil	NEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Chervil	SEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Chives	NEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Chives	SEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Celery leaves	NEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha (EU GAP)
Celery leaves	SEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Parsley	NEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Parsley	SEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Sage	NEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Sage	SEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Rosemary	NEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Rosemary	SEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Thyme	NEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Thyme	SEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Basil and edible flowers	NEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Basil and edible flowers	SEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Laurel/bay leaves	NEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Laurel/bay leaves	SEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Tarragon	NEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Tarragon	SEU	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	10		0.13	kg a.i./ha	3	Max 0.250 Kg a.s./ha
Beans (with pods)	NEU	F	aphids	SL	25.0	Foliar treatment – broadcast spraying	30–87	1		900 L/ha (water)	75.00	g a.i./ha	7
Beans (with pods)	NEU	F	aphids	SL	200.0	Foliar treatment – broadcast spraying	51–87	1		200–750 L/ha (water)	75.00	g a.i./ha	7
Beans (with pods)	SEU	F	aphids	SL	25.0	Foliar treatment – broadcast spraying	30–87	1		900 L/ha (water)	75.00	g a.i./ha	7
Beans (with pods)	USA, CA	F	Aphis, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha EMS confirmed that no modification is requested for this GAP
Beans (without pods)	NEU	F	aphids	SL	25.0	Foliar treatment – broadcast spraying	30–87	1		900 L/ha (water)	75.00	g a.i./ha	3
Beans (without pods)	NEU	F	aphids	SL	200.0	Foliar treatment – broadcast spraying	51–87	1		200–750 L/ha (water)	75.00	g a.i./ha	3
Beans (without pods)	SEU	F	aphids	SL	25.0	Foliar treatment – broadcast spraying	30–87	1		900 L/ha (water)	75.00	g a.i./ha	3
Beans (without pods)	USA, CA	F	Aphis, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha, EMS confirmed that no modification is requested for this GAP
Peas (with pods)	NEU	F	aphids	SL	25.0	Foliar treatment – broadcast spraying	30–87	1		900 l/ha (water)	75.00	g a.i./ha	7
Peas (with pods)	NEU	F	aphids	SL	200.0	Foliar treatment – broadcast spraying	30–87	1		750 L/ha (water)	75.00	g a.i./ha	7
Peas (with pods)	SEU	F	aphids	SL	25.0	Foliar treatment – broadcast spraying	30–87	1		900 l/ha (water)	75.00	g a.i./ha	7
Peas (with pods)	SEU	F	aphids	SL	200.0	Foliar treatment – broadcast spraying	30–87	1		400 l/ha (water)	75.00	g a.i./ha	7
Peas (with pods)	USA, CA	F	Aphis, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./h EMS confirmed that no modification is requested for this GAP
Peas (without pods)	NEU	F	aphids	SL	200.0	Foliar treatment – broadcast spraying	30–87	1		80–750 g/L (water)	75.00	g a.i./ha	3
Peas (without pods)	SEU	F	aphids	SL	200.0	Foliar treatment – broadcast spraying	30–87	1		80–400 g/L (water)	75.00	g a.i./ha	3
Peas (without pods)	USA, CA	F	Aphis, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha, EMS confirmed that no modification is requested for this GAP
Lentils	NEU	F	aphids	SL	200.0	Foliar treatment – broadcast spraying	30–87	1		80–750 L/Ha (water)	75.00	g a.i./ha	7
Lentils (fresh)	USA, CA	F	Aphis, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Celeries	USA, CA	F	Whiteflies, aphids, leafhoppers	SL	200.0	Foliar treatment – broadcast spraying		1–2	7	0.12	0.21	kg a.i./ha	1	Max 0.410 Kg a.s./ha/crop season
Beans	NEU	F	aphids	SL	200.0	Foliar treatment – broadcast spraying	51–87	1		150–750 L/ha (water)	75.00	g a.i./ha	7
Beans	SEU	F	aphids	SL	200.0	Foliar treatment – broadcast spraying	51–87	1		150–750 L/ha (water)	75.00	g a.i./ha	7
Beans	USA, CA	F	Aphis, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Lentils	NEU	F	aphids	SL	200.0	Foliar treatment – broadcast spraying	30–87	1		80–750 L/ha	75.00	g a.i./ha	7
Lentils	USA, CA	F	Aphis, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Peas	NEU	F	aphids	SL	200.0	Foliar treatment – broadcast spraying	30–87	1		80–750 L/ha (water)	75.00	g a.i./ha	7
Peas	SEU	F	aphids	SL	200.0	Foliar treatment – broadcast spraying	30–87	1		80–750 L/ha (water)	75.00	g a.i./ha	7
Peas	USA, CA	F	Aphis, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Lupins/lupini beans	NEU	F	aphids	SL	200.0	Foliar treatment – broadcast spraying	51–87	1			75.00	g a.i./ha	7
Lupins/lupini beans	USA, CA	F	Aphis, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Peanuts/groundnuts	USA, CA	F	Aphids, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Soyabeans	USA, CA	F	Aphis, whitefly, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	50.21	kg a.i./ha	21	Max 0.410 Kg a.s./ha
Cotton seeds	SEU	F	aphids	SL	200.0	Foliar treatment – broadcast spraying	12–90	1		200–600 L/ha (water)	125.00	g a.i./ha	21
Cotton seeds	USA	F	Aphids, leafhopper, whitefly	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	14	Max 0.410 Kg a.s./ha
Olives for oil production	SEU		Olive fruit fly, meadow froghopper	SL	200.0	Foliar treatment – broadcast spraying	55–85	1		500–1,200 L/ha (water)	150.00	g a.i./ha	14
Barley	USA	F	Aphids, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	7	0.12	0.21	kg a.i./ha	21	Max 0.410 Kg a.s./ha Forage, stover and straw are used as ingredients of animal feed
Maize/corn	USA	F	Aphids, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	7	0.12	0.21	kg a.i./ha	21	Max 0.410 Kg a.s./ha Forage, stover and straw are used as ingredients of animal feed
Sorghum	USA	F	Aphids, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	7	0.12	0.21	kg a.i./ha	21	Max 0.410 Kg a.s./ha Forage, stover and straw are used as ingredients of animal feed
Wheat	USA	F	Aphids, leafhopper	SL	200.0	Foliar treatment – broadcast spraying		1–2	7	0.12	0.21	kg a.i./ha	21	Max 0.410 Kg a.s./ha Forage, stover and straw are used as ingredients of animal feed
Coffee beans	Brazil	F	Leaf miner	SL	200.0	Local treatment – drenching		1	14	0.30	0.60	kg a.i./ha	21	Max 0.600 Kg a.s./ha per crop cycle
Coffee beans	Brazil	F	Leaf miner	SL	200.0	Foliar treatment – broadcast spraying		1–3	14	0.10	0.20	kg a.i./ha	21	Max 0.600 Kg a.s./ha per crop cycle
Cocoa beans	Ghana	F	miridae, distantiella theobroma, sahlbergella singularis	EC	75.0	Foliar treatment – broadcast spraying	August, September, October, December	1–4	30	40 L/ha (water)	15.00	g a.i./ha	7	Approved use in Ghana
Cocoa beans	Ivory Coast	F	miridae	EC	75.0	Foliar treatment – broadcast spraying	December/January, July/August	2		40 L/ha (water)	18.75	g a.i./ha	n.a.	Approved use in Ivory Coast
Hops (dried)	USA, CA	F	Aphids	SL	200.0	Foliar treatment – broadcast spraying		1		0.12	154.00	g a.i./ha	21	Max 0.154 Kg a.s./ha
Alfalfa	USA	F	Aphids, leafhopper, alfalfa hopper, whitefly	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	7	Max 0.410 Kg a.s./ha
Clover	USA	F	Aphids, leafhopper, alfalfa hopper, whitefly	SL	200.0	Foliar treatment – broadcast spraying		1–2	10	0.12	0.21	kg a.i./ha	14	Max 0.410 Kg a.s./ha

NEU: northern European Union; SEU: southern European Union; MS: Member State; SL: soluble concentrate; EC: emulsifiable concentrate; a.s.: active substance; MRL: maximum residue level.

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

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

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

^dPHI – minimum preharvest interval.

Appendix B – List of end points

B.1. Residues in plants

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

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

Primary crops (available studies)	Crop groups	Crop(s)	Application(s)	Sampling (DAT)	Comment/Source
	Fruit crops	Apple	Foliar a) 1 × 86 g/ha metre canopy height (CH); BBCH 69 b) 2 × 86 g/ha/m CH; BBCH 69	a) 89 DAT b) 14 DALA	Radiolabelled active substance: [furanone‐4‐14C] and [pyridinylmethyl‐14C] flupyradifurone (Netherlands, 2014; EFSA, 2015)
		Tomato	Soil drench, 2 × 300 g/ha, BBCH 14‐15, interval 14 days	56–73 DALA	Radiolabelled active substance: [furanone‐4‐14C], [pyridinylmethyl‐14C] and [ethyl‐1‐14C] flupyradifurone (Netherlands, 2014; EFSA, 2015)
	Root crops	Potato	In furrow, 1 × 626 g/ha, BBCH 03	97 DAT	Radiolabelled active substance: [furanone‐4‐14C] and [pyridinylmethyl‐14C] flupyradifurone (Netherlands, 2014; EFSA, 2015)
			Seed treatment, 1 × 254 g/ha, BBCH 03	97 DAT
	Cereals/grass	Rice	Foliar, 175 g/ha, BBCH 13/15 + 240 g/ha, BBCH 87–89	29 DALA	Radiolabelled active substance: [furanone‐4‐14C] and [pyridinylmethyl‐14C] flupyradifurone (Netherlands, 2014; EFSA, 2015)
			Soil granule at planting, 1 × 409‐434 g/ha, BBCH 13/15	127 DAT	Radiolabelled active substance: [furanone‐4‐14C] and [pyridinylmethyl‐14C] flupyradifurone (Netherlands, 2014; EFSA, 2015)
	Pulses/oilseeds	Cotton	Foliar a) 1 × 210 g/ha, BBCH 15‐18 b) 210 +175 g/ha, BBCH 15–18	a) 169 DAT b) 14–15 DALA	Radiolabelled active substance: [furanone‐4‐14C] and [pyridinylmethyl‐14C] flupyradifurone (Netherlands, 2014; EFSA, 2015)

Rotational crops (available studies)	Crop groups	Crop(s)	Application(s)	PBI (DAT)	Comment/Source
	Root/tuber crops	Turnips	Soil, 436 g/ha	29, 135 and 296	Radiolabelled active substance: [furanone‐4‐14C] and [pyridinylmethyl‐14C] flupyradifurone (Netherlands, 2014, EFSA, 2015)
	Leafy crops	Swiss chard
	Cereal (small grain)	Wheat

Processed commodities (hydrolysis study)	Conditions	Stable?	Comment/Source
	Pasteurisation (20 min, 90°C, pH 4)	Flupyradifurone: yes DFA: not investigated	EFSA (2015)
	Baking, brewing and boiling (60 min, 100°C, pH 5)	Flupyradifurone: yes DFA: not investigated	EFSA (2015)
	Sterilisation (20 min, 120°C, pH 6)	Flupyradifurone: yes DFA: not investigated	EFSA (2015)
	Other processing conditions	–	–

B.1.1.2. Stability of residues in plants

Plant products (available studies)	Category	Commodity	T (°C)	Stability period		Compounds covered	Comment/Source
				Value	Unit
	High water content	Spinach, sugar cane, tomato	−18	52	Months	Flupyradifurone, DFA	EFSA (2015), Netherlands (2017)
	High oil content	Soyabean seed	−18	52	Months	Flupyradifurone, DFA
	High protein content	Bean seed	−18	52	Months	Flupyradifurone, DFA
	Dry/High starch	Wheat grain	−18	52	Months	Flupyradifurone, DFA
	High acid content	Oranges	−18	52	Months	Flupyradifurone, DFA
	Other	Coffee bean	−18	52	Months	Flupyradifurone, DFA

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)
Enforcement residue definition: 1) flupyradifurone (F); 2) DFA, expressed as DFA (DFA) Risk assessment residue definition: Sum of flupyradifurone and DFA, expressed as flupyradifurone
Citrus fruits	USA (foliar)	Oranges Mo: 1) 0.067; 0.12; 0.194; 0.207; 0.251; 0.286; 0.339(PHI=8 days); 0.634; 0.697; 0.8843; 1.213; 2.0810 2) 8 × < 0.0067; 0.0088; 0.01921; 0.0221; 0.03210 RA: 0.087; 0.14; 0.21; 0.23; 0.27; 0.31; 0.368; 0.65; 0.72; 0.913; 1.33; 2.2	Residue trials on oranges compliant with the GAP.	1) 3.0 2) 0.05	RA: 2.20 F: 2.08 DFA: 0.03	RA: 0.34 F: 0.31 DFA: 0.01
	USA (foliar)	Grapefruit Mo: 1) 0.158; 2 × 0.185; 0.19; 0.273; 0.317; 2) 6 × < 0.0067 RA: 0.18; 3 × 0.21; 0.293; 0.34	Insufficient number of residue trials on grapefruit submitted (2 additional trials are required)	No proposal	–	–
	USA (foliar)	Lemons Mo: 1) 0.123; 0.183; 0.23; 0.29610; 0.35; 0.443; 0.669; 0.713 2) 7 × < 0.0067; 0.033 RA: 0.14; 0.20; 0.25; 0.3210; 0.37; 0.543; 0.69; 0.73	Residue trials on lemons compliant with the GAP Extrapolation to limes possible.	1) 1.5 2) 0.05	RA: 0.73 F: 0.71 DFA: 0.03	RA:0.35 F: 0.32 DFA: 0.01
	USA (foliar)	Mandarins Mo: 1) 0.16; 0.2121; 0.35; 0.3921; 0.513; 0.553; 0.613; 0.9010 2) 4 × < 0.017; 0.01821; 0.022; 0.02320; 0.03110 RA: 0.21; 0.2621; 0.40; 0.4421; 0.563; 0.603; 0.663; 0.9910	Residue trials on mandarins compliant with the GAP.	1) 1.5 2) 0.05	RA: 0.99 F: 0.90 DFA: 0.03	RA: 0.50 F: 0.45 DFA: 0.02
	USA (soil)	Oranges Mo: 1) 6 × < 0.01; 0.011; 0.012; 0.013; 0.021; 0.023; 0.031 2) 6 < 0.0067; < 0.02; 0.024 RA: 6 × < 0.03; 0.032; 0.033; 0.035; 0.041; 0.043; 0.051	Residue trials on oranges compliant with the GAP	1) 0.05 2) 0.03	RA: 0.05	RA: 0.03
	USA (soil)	Grapefruit Mo: 1) 0.01; 0.011; 0.013; 0.014; 0.038; 0.049 2) 6 × < 0.067 RA: 0.03; 0.031; 0.033; 0.034; 0.058; 0.069	Insufficient number of residue trials on grapefruit submitted (2 additional required)	1) 0.09 2) 0.01a	RA: 0.07	RA: 0.03
	USA (soil)	Lemons Mo: 1) 8 × < 0.01 2) 8 × < 0.067 RA: 8 × < 0.03	Residue trials on lemons compliant with the GAP Extrapolation to limes possible.	1) 0.01a 2) 0.01a	RA: < 0.03	RA: < 0.03
	USA (soil)	Mandarins Mo: 1) 8 × < 0.015 2) 8 × < 0.017 RA: 8 × < 0.065	Residue trials on mandarins compliant with the GAP	1) 0.02a 2) 0.02	RA: < 0.007	RA: < 0.007
Tree nuts	USA (foliar)	Mo: 1) Almonds: 4 × < 0.01; 0.0145 Pecan nuts: 4 × < 0.01; 0.0115 2) Almonds: 4 × < 0.017; 0.033 Pecan nuts: 5 × < 0.017 RA: Almonds: 3 × < 0.06; 0.0645; 0.105 Pecan nuts: 4 × < 0.06; 0.0615	Residue trials on almonds (5) and pecan nuts (5) compliant with GAP Extrapolation to the whole group of tree nuts possible	1) 0.02 2) 0.04	RA: 0.11 F: 0.01 DFA: 0.03	RA: 0.06 F: 0.01 DFA: 0.02
Pome fruit	USA (foliar)	Mo: 1) 0.06; 0.084; 0.094; 0.097; 0.118; 0.12721; 0.14; 0.1528; 0.175; 0.205; 0.219; 0.224; 0.25; 0.296 2) 8 × < 0.017; 0.017; 0.021; 0.02335; 0.026; 0.03335; 0.1228 RA: 0.30; 0.1821; 0.13; 0.11; 0.14; 0.15; 0.17; 0.19; 0.23; 0.2528; 0.27; 2 × 0.28; 0.63	Residue trials on apples compliant with GAP Extrapolation to quinces, medlars and loquats possible	1) 0.5 2) 0.15	RA: 0.63 F: 0.3 DFA: 0.12	RA: 0.21 F: 0.15 DFA: 0.02
	USA (foliar)	Mo: 1) 0.18; 0.19221; 0.197; 0.20; 0.21; 0.225; 0.319; 0.393; 0.467 2) 0.03135; 0.032; 0.04635; 0.07; 0.075; 0.087; 0.096; 0.099; 0.1135 RA: 0.23; 0.2821; 0.29; 2 × 0.44; 0.49; 0.58; 0.63; 0.69	Residue trials on pears compliant with the GAP.	1) 0.8 2) 0.3	RA: 0.69 F: 0.47 DFA: 0.11	RA:0.44 F: 0.21 DFA: 0.08
	USA (foliar)	Apples Mo: 1) 0.06; 0.084; 0.094; 0.097; 0.118; 0.12721; 0.14; 0.1528; 0.175; 0.205; 0.219; 0.224; 0.25; 0.296 2) 8 × < 0.017; 0.017; 0.021; 0.02335; 0.026; 0.03335; 0.1228 RA: 0.30; 0.1821; 0.13; 0.11; 0.14; 0.15; 0.17; 0.19; 0.23; 0.2528; 0.27; 2 × 0.28; 0.63 Pears Mo: 1) 0.18; 0.19221; 0.197; 0.20; 0.21; 0.225; 0.319; 0.393; 0.467 2) 0.03135; 0.032; 0.04635; 0.07; 0.075; 0.087; 0.096; 0.099; 0.1135 RA: 0.23; 0.2821; 0.29; 2 × 0.44; 0.49; 0.58; 0.63; 0.69	Combined reside data on apples and pears. Combination of two statistically different residue data sets and possible extrapolation of combined residue data to the whole group of pome fruit requires risk management decision	1) 0.6 2) 0.2	RA: 0.69 F: 0.47 DFA: 0.12	RA: 0.28 F: 0.20 DFA: 0.03
Table and wine grapes	USA (foliar)	Mo: 1) 0.31; 0.317; 0.39; 0.4353; 0.455; 0.52; 0.56; 0.583; 0.693; 0.80; 1.017; 1.13; 1.90 2) 8 × < 0.017; 0.0220; 0.0297; 0.0317; 0.0447; 0.06321 RA: 0.36; 0.365; 0.435; 0.4853; 0.505; 0.575; 0.615; 0.633; 0.743; 0.855; 1.2; 1.1457; 1.95	Residue trials on grapes compliant with the GAP. Foliar use results in a more critical residue situation in grapes	1) 3.0 2) 0.08	RA: 1.95 F: 1.9 DFA: 0.06	RA: 0.62 F: 0.57 DFA: 0.02
	US/CA (soil)	Mo: 1) 11 × < 0.01; 0.024; 0.04 2) 9 × < 0.017; 0.0195; 0.021; 0.024; 0.027 RA: 8 × < 0.06; 0.07; 0.074; 0.08; 0.09; 0.10		1) 0.05 2) 0.04	RA: 0.10	RA: 0.06
Blueberries	US/CA (foliar)	Mo: 1) 0.13; 0.207; 0.23; 0.27; 0.35; 0.39; 0.42; 0.45; 0.56; 0.57; 0.67; 0.77; 0.78; 0.83; 0.90; 0.95; 0.98; 1.02; 1.15; 1.25; 1.537; 1.58; 1.7214; 1.73; 2.33; 2.48 2) 20 × < 0.017; 0.01914; 0.02; 0.02514; 0.02914; 0.036; 0.04114 RA: 0.18; 0.277; 0.28; 0.32; 0.40; 0.44; 0.47; 0.50; 0.61; 0.62; 0.72; 0.82; 0.83; 0.88; 0.95; 1.00; 1.03; 1.07; 1.20; 1.30; 1.597; 1.63; 1.78; 1.7914; 2.39; 2.59	Residue trails on blueberries compliant with the GAP	1) 4.0 2) 0.05	RA: 2.59 F: 2.48 DFA: 0.04	RA: 0.86 F:0.81 DFA: 0.02
Prickly pear/cactus	USA (foliar)	Mo: 1) 0.10; 0.12 2) 2 × < 0.017 RA: 0.15; 0.17	Residue trials on prickly pear cactus fruit compliant with the GAP. Insufficient number of trials provided	No proposal	–	–
Potatoes; Tropical root and tuber vegetables	US/CA (foliar)	Mo: 1) 18 × < 0.01; 0.0114; 0.012; 0.01221; 0.0214; 0.02; 0.022; 2 × 0.037 2) 23 x< 0.017; 0.024; 0.02621; 0.0285 RA: 16 × < 0.06; 0.062; 0.06221; 0.0714; 0.07; 0.072; 0.079; 0.088; 0.089; 0.095; 0.09814	Residue trials on potatoes compliant with the GAP Extrapolation to the whole group of tropical root and tuber vegetables possible	1) 0.05 2) 0.03	RA: 0.10 F: 0.04 DFA: 0.03	RA: 0.06 F: 0.01 DFA: 0.02
Root and tuber vegetables (except sugar beet)	USA (foliar)	Mo: 1) Carrots: 2 × < 0.01; 0.016; 0.0165; 0.017; 0.021; 0.026; 0.0365; 0.056; 0.6012 Radishes: 0.024; 0.029; 0.031; 0.037; 0.04; 0.043; 0.046 2) Carrots: 2 × < 0.017; 0.02514; 0.02614; 0.026; 0.055; 0.059; 0.071; 0.145; 0.19528 Radishes: < 0.017; 2 × 0.021; 0.02433; 0.041; 0.062; 0.07 RA: Carrots: 0.066; 0.09314; 0.09514; 0.107; 0.18; 0.20; 0.22; 0.44; 0.6028; 0.67512 Radishes: 0.079; 0.085; 0.09220; 0.10; 0.15; 0.23; 0.25	Residue trials on carrots (10) and radish (7) compliant with the GAP Residue data on carrots extrapolated to the whole group of root and tuber vegetables (except sugar beet) in order to account for the import tolerance, that is established at 0.9 mg/kg for the whole group of root and tuber vegetables	1) 0.9 2) 0.3	RA: 0.68 F: 0.6 DFA: 0.195	RA: 0.15 F: 0.02 DFA: 0.04
Tomatoes and aubergines	US/CA (foliar)	Mo: 1) 0.055; 0.057; 0.059; 0.0687; 0.086; 0.088; 0.106; 0.134; 0.135; 0.1387; 0.14; 0.15; 0.226; 0.27; 0.28; 0.3067; 0.45; 0.57; 0.737 2)11 × < 0.017; 0.03714; 0.0387; 0.04221; 0.0528; 0.05928; 0.09428; 0.1128; 0.18528 RA: 2 × 0.105; 0.11; 0.14; 0.14521; 0.15514; 2 × 0.185; 0.19; 0.207; 0.27521; 0.28; 0.32; 0.335; 0.3921; 0.4228; 0.5114; 0.62; 0.86514	Residue trials on tomatoes compliant with the GAP Residue data extrapolation to aubergines possible	1) 1.0 2) 0.3	RA: 0.87 F: 0.73 DFA: 0.19	RA: 0.20 F: 0.14 DFA: 0.02
	US/CA (soil)	Mo: 1) 7 × < 0.01; 0.010; 0.011; 0.012; 0.01350; 0.135; 0.015; 0.01560; 0.029; 0.03; 0.03449; 0.069; 0.236 2) 3 × < 0.017; 0.0185; 0.023; 0.02960; 0.03970; 0.046; 0.048; 0.053; 0.058; 0.069; 0.104; 0.2069; 0.26; 0.2670; 0.2650; 0.3670; 0.5460 RA: 2 × < 0.06; 0.065; 0.07; 0.08; 0.1060; 0.12570; 2 × 0.15; 2 × 0.185; 0.22; 0.32; 0.6269; 0.78570; 0.8170; 0.82; 1.0550; 1.8060		1) 0.3 2) 0.7	RA: 1.8 F: 0.24 DFA: 0.54	RA: 0.19 F: 0.01 DFA: 0.05
Peppers	US/CA (foliar)	Mo: 1) 0.03; 0.05; 2 × 0.07; 0.08; 0.087; 0.12; 0.1214; 0.12; 0.37; 0.297; 0.37; 0.47; 0.53 2) 4 × < 0.017; 0.02914; 0.03928; 0.0421; 0.0527; 0.06428; 0.0828; 0.09828; 0.10528; 0.1128; 0.17521 RA: 0.10514; 0.12; 0.14; 0.16521; 0.165; 0.2027; 0.21528; 0.26528; 0.3557; 0.3928; 0.42; 0.44528; 0.525; 0.67521	Residue trials on bell peppers (10) and chili peppers (4) compliant with the GAP	1) 0.9 2) 0.3	RA:0.68 F: 0.53 DFA: 0.18	RA: 0.24 F: 0.12 DFA: 0.05
	US/CA (soil)	Mo: 1) 4 × < 0.01; 0.01148; 2 × 0.011; 0.013; 0.02; 0.02470; 0.0265; 0.035; 0.047; 0.18 2) 0.0270; 2 × 0.03; 3 × 0.04; 0.0460; 0.05; 0.0568; 0.11; 0.1750; 0.24; 0.3070; 0.48 RA: 0.07; 0.09; 0.9070; 0.10; 3 × 0.14; 0.1460; 0.1668; 0.17; 0.36; 0.5259; 0.7360; 1.65		1) 0.3 2) 0.7	RA: 1.65 F: 0.18 DFA: 0.48	RA:0.15 F:0.01 DFA: 0.05
Melons	USA (foliar)	Mo: 1) 0.058; 0.10; 0.12; 0.153; 0.207 Pulp: 4 × < 0.01; 0.012 2) 0.02121; 0.04314; 0.06321; 0.15528; 0.19521 Pulp: 4 × < 0.017; 0.028 RA: 0.17; 0.2221; 0.37628; 0.5028; 0.6621 Pulp: 3 × < 0.06; 0.062; 0.095 Mo: 1) Cucumbers: 0.039; 0.08; 0.083; 0.092; 0.10; 0.112; 0.133; 0.187; 0.225 Courgettes: 0.032; 0.0337; 0.048; 0.053; 0.054; 0.068; 0.0817; 0.10 2) Cucumbers: 0.031; 0.0435; 0.04728; 0.08214; 0.08421; 0.1357; 0.2028; 0.2621; 0.3228 Courgettes:< 0.017; 0.027; 0.038; 0.047; 0.06721; 0.1928; 0.31514; 0.37528 RA: Cucumbers: 0.155; 0.185; 0.275; 0.2814; 0.3414; 0.437; 0.60528; 0.8321; 0.97528 Courgettes: 0.104; 0.132; 0.16; 0.208; 0.2121; 0.60528; 0.95514; 1.13528	Residue trials on melon compliant with the GAP. Insufficient number of trials available to support the use and to derive an MRL proposal To complement the residue data set, the applicant provided residue trials on cucumbers and courgettes (cucurbits with edible peel); these trials were compliant with the authorized GAP on melons The EMS and the applicant propose to combine available residue trials on melons with the residue data on cucurbits (edible peel) (see above) as these data are of the same population and a combined data set is basis of a tolerance established in the USA and Canada. This proposal requires risk management decision	Combined: 1) 0.4 2) 0.6	Combined: RA: 1.14 F: 0.23 DFA: 0.38	Combined: RA: 0.31 F: 0.09 DFA: 0.07
	USA (soil)	Mo: 1) < 0.01; 0.01227; 0.01241; 0.01728; 0.02834 Pulp: 4 × < 0.01; 0.026 2) 0.02442; 0.02634; 0.06941; 0.1442; 0.2241 Pulp: 2 × < 0.017; 0.035; 0.07; 0.11 RA: 0.08234; 0.08834; 0.2341; 0.4342; 0.8734 Pulp: 2 × < 0.06; 0.13; 0.22; 0.355 Mo: 1) Cucumbers: 4 × < 0.01; 0.011; 0.013; 0.0145; 0.0215; 0.026528 Courgettes: 4 × < 0.01; 0.0195; 0.02434; 0.03128; 0.057 2) Cucumbers: 2 × < 0.017; 0.01940; 0.0442; 0.05642; 0.07641; 0.13541; 0.14; 0.3342 Courgettes: 4 × < 0.017; 0.04228; 0.3534; 0.3728; 0.4642 RA: Cucumbers: 2 × < 0.06; 0.066; 0.12542; 0.17542; 0.23541; 0.4241; 0.45; 1.0342 Courgettes: 4 × < 0.06; 0.15528; 1.134; 1.1128; 1.4542	Combined: 1) 0.07 2) 0.7	Combined: RA: 1.45 F: 0.01 DFA: 0.05	Combined: RA: 0.17 F: 0.06 DFA: 0.46
Sweet corn	US/CA(foliar)	Mo: 1) 9 × < 0.01; 0.018; 0.027; 0.038; 0.016 2) 3 × < 0.017; 0.019; 0.03; 3 × 0.037; 0.039; 0.056; 0.0621; 0.075; 0.0814 RA: 3 × < 0.06; 0.068; 0.10; 0.12; 2 × 0.13; 0.15; 0.18; 0.2021; 0.2514; 0.25	Residue trials on sweet corn compliant with the GAP	1) 0.05 2) 0.15	RA: 0.25 F: 0.04 DFA: 0.08	RA:0.13 F: 0.01 DFA: 0.04
Broccoli, cauliflower	NEU (foliar)	Mo: 1) Cauliflower: 0.0447; 0.071; 0.15; 0.19 Broccoli: 0.11; 0.13; 0.18; 0.22 2) Cauliflower: 0.01513; 0.02114; 0.029; 0.0367 Broccoli: 0.044; 0.05714; 0.115; 0.2710 RA: Cauliflower: 0.10; 0.12; 0.17; 0.28 Broccoli: 0.26; 0.30; 0.475; 0.8210	Residue trials on cauliflower and broccoli compliant with the intended GAP.	1) 0.4 2) 0.5	RA: 0.82 F: 0.22 DFA: 0.27	RA: 0.27 F: 0.14 DFA: 0.04
	SEU (foliar)	Mo: 1) Cauliflower: 0.015; 0.018; 0.019; 0.052 Broccoli: 0.23; 0.19; 0.26; 0.27 2) Cauliflower: 0.01814; 2 × 0.02414; 0.03214 Broccoli: 0.0914; 2 × 0.09314; 0.03114 RA: Cauliflower: 0.06314; 0.0837; 0.09; 0.1114 Broccoli: 0.23; 0.36; 0.385; 0.477		1) 0.6 2) 0.2	RA: 0.47 F: 0.27 DFA: 0.09	RA: 0.17 F: 0.12 DFA: 0.03
Brussels sprouts	NEU (foliar)	Mo: 1) 0.01; 0.015; 0.02; 0.022; 0.032; 2 × 0.04; 0.055 2) 0.0217; 0.02710; 0.028; 0.0367; 0.0597; 0.0814; 0.08514; 0.1014 RA: 0.09; 0.097; 0.09110; 0.137; 0.197; 0.2514; 0.2814; 0.3114	Residue trials on Brussels sprouts compliant with the intended GAP.	1) 0.09 2) 0.2	RA: 0.31 F: 0.06 DFA: 0.10	RA: 0.16 F: 0.03 DFA: 0.05
Head cabbage	NEU (foliar)	Mo: 1) < 0.01; 0.0115; 0.012; 3 × 0.02; 0.0545; 0.07 2) < 0.0067; 0.0197; 0.0214; 0.02714; 0.0297; 0.0514; 0.08614; 0.0925 RA: 0.0714; 0.075; 0.09; 0.105; 0.115; 0.1614; 0.2714; 0.295	Residue trials on head cabbage compliant with the intended GAP.	1) 0.15 2) 0.20	RA: 0.29 F: 0.07 DFA: 0.09	RA: 0.11 F: 0.02 DFA: 0.03
	SEU (foliar)	Mo: 1) 0.035; 0.049; 0.059; 0.13 2) 0.03214; 0.03810; 0.0545; 0.08714 RA: 0.1114; 0.1410; 0.275; 0.2714	Residue trials on head cabbage compliant with the intended GAP.	1) 0.3 2) 0.2	RA: 0.27 F: 0.13 DFA: 0.09	RA: 0.21 F: 0.05 DFA: 0.05
Kale	NEU (foliar)	Mo: 1) 0.09; 0.22; 1.10; 1.90 2) 0.0587; 0.115; 0.1414; 0.2010 RA: 0.207; 0.54; 1.40; 2.20	Residue trials on kale compliant with the intended GAP.	1) 5.0 2) 0.4	RA: 2.2 F: 1.9 DFA: 0.2	RA: 0.97 F: 0.66 DFA: 0.13
	SEU (foliar)	–	Residue data not provided.
Kohlrabi	NEU (foliar)	Mo: 1) 0.02; 0.026; 0.03; 0.041 2) 0.0437; 0.057; 0.07114; 0.0814 RA: 0.157; 0.167; 0.2214; 0.2514	Residue trials on kohlrabi compliant with the intended GAP.	1) 0.09 2) 0.2	RA: 0.25 F: 0.04 DFA: 0.08	RA: 0.19 F:0.03 DFA:0.06
Lettuces	NEU (foliar)	Mo: 1)Head forming lettuce: 0.37; 0.58; 0.68 Open leaf lettuce: 0.11; 0.43; 0.83; 1.0; 1.5; 2.9 2)Head forming lettuce: 2 × < 0.0067; 0.00977 Open leaf lettuce: 2 × < 0.0067; 0.00910; 0.00927; 0.017; 0.06714; RA: Head forming lettuce: 0.39; 0.6; 0.70 Open leaf lettuce: 0.13; 0.46; 0.85; 1.0; 1.5; 3.0	Residue trials on lettuce compliant with the intended GAP. Residue data on open leaf and head forming lettuce varieties combined to derive an MRL proposal and risk assessment values for lettuce.	1) 5.0 2) 0.1	RA: 3.0 F: 2.90 DFA: 0.07	RA: 0.7 F: 0.68 DFA: 0.01
	SEU (foliar)	Mo: 1)Head forming lettuce: 0.4; 2.7; 0.48 Open leaf lettuce: 0.35; 0.72; 1.1; 1.5; 2.1; 3.1 2)Head forming lettuce: 0.0087; 0.0117; 0.017 Open leaf lettuce: 0.00677; 0.01314; 0.01610; 0.0185; 0.0427; 0.0514 RA: Head forming lettuce: 0.42; 0.53; 2.7 Open leaf lettuce: 0.38; 0.76; 1.12; 1.6; 2.2; 3.2		1) 6.0 2) 0.07	RA: 3.2 F: 3.10 DFA: 0.04	RA: 1.12 F: 1.10 DFA: 0.02
Lettuces and salad plants (except lettuce) Spinach and similar (leaves) Herbs and edible flowers	NEU (foliar)	Mo: 1) Open leaf lettuce: 0.11; 0.43; 0.83; 1.0; 1.5; 2.9 2)Open leaf lettuce: 2 × < 0.0067; 0.00910; 0.00927; 0.017; 0.06714; RA: Open leaf lettuce: 0.13; 0.46; 0.85; 1.0; 1.5; 3.0	Residue trials on lettuce compliant with the intended GAP. Residue data on trials with open leaf lettuce used to derive an MRL proposal and risk assessment values for the group of lettuce and other salad plants (except lettuce), spinach and similar (leaves) and herbs and edible flowers	1) 5.0 2) 0.15	RA: 3.0 F: 2.9 DFA: 0.07	RA: 0.93 F: 0.92 DFA: 0.01
	SEU (foliar)	Mo: 1) Open leaf lettuce: 0.35; 0.72; 1.1; 1.5; 2.1; 3.1 2) Open leaf lettuce: 0.00677; 0.01314; 0.01610; 0.0185; 0.0427; 0.0514 RA: Open leaf lettuce: 0.38; 0.76; 1.12; 1.6; 2.2; 3.2		1) 6.0 2) 0.1	RA: 3.20 F: 3.10 DFA: 0.05	RA: 1.36 F: 1.30 DFA: 0.02
Legume vegetables: bean and peas (with pods)	NEU (foliar)	Mo: 1) 0.06; 0.096; 0.12; 0.13; 0.14; 0.15; 0.17; 0.24 2) < 0.006714; 0.008714; 0.01114; 0.01914; 0.0214; 0.02514; 0.03314; 0.04514 RA: 0.08; 0.12; 0.14; 0.15; 0.16; 0.19; 0.21; 0.30	Residue trials on peas compliant with the intended GAP. Extrapolation to beans (with pods) acceptable	1) 0.5 2) 0.08	RA: 0.30 F: 0.24 DFA: 0.05	RA: 0.16 F: 0.14 DFA: 0.02
	SEU (foliar)	Mo: 1) 0.06; 0.094; 0.12; 0.14; 0.15; 0.2; 0.28; 0.29 2) 2 × 0.0114; 0.016; 0.02114; 0.02614; 0.02714; 0.027; 0.03114 RA: 0.1014; 0.12; 0.15; 0.17; 0.20; 0.25; 0.30; 0.37		1) 0.5 2) 0.07	RA: 0.37 F: 0.29 DFA: 0.03	RA: 0.19 F: 0.15 DFA: 0.02
Legume vegetables: beans and peas (without pods), lentils	NEU (foliar)	Mo: 1) 0.0517; 0.05310; 0.0617; 0.06310; 0.06510; 0.0887; 0.0927; 0.127 2) 0.01214; 0.01821; 0.02417; 2 × 0.02621; 0.02921; 2 × × 0.05121 RA: 0.0717; 0.08921; 0.1017; 0.1110; 0.117; 0.1214; 0.1721; 0.2114	Residue trials on peas (without pods) compliant with the intended GAP. Extrapolation to beans (without pods) and lentils is acceptable	1) 0.3 2) 0.09	RA: 0.21 F: 0.12 DFA: 0.05	RA: 0.11 F: 0.06 DFA: 0.03
	SEU (foliar)	Mo: 1) 0.0411; 0.04410; 0.0466; 0.05114; 0.0597; 0.097; 0.1310; 0.217 2) 0.01514; 0.01814; 0.0214; 0.0314; 0.04221; 0.0520; 0.05614; 0.07515 RA: 0.09414; 0.1010; 0.157; 0.1521; 0.1620; 0.1710; 0.2214; 0.367		1) 0.4 2) 0.15	RA: 0.36 F: 0.21 DFA: 0.08	RA: 0.16 F:0.06 DFA: 0.04
Celery	US/CA (foliar)	Mo: 1) 0.22; 0.55; 1.09; 1.95; 2.12; 2.17; 2.37; 3.16; 3.51; 5.99 2) 8 × < 0.017; 0.02; 0.04728 RA: 0.27; 0.61; 1.15; 2.00; 2.15; 2.20; 2.45; 3.20; 3.55; 6.0	Residue trials on celery (untrimmed stems) compliant with the GAP	1) 9.0 2) 0.06	RA: 6 F: 5.99 DFA: 0.05	RA: 2.18 F: 2.14 DFA: 0.02
Pulses	US/CA (foliar)	Peas: Mo: 1) 0.02; 0.13; 0.3812; 0.45; 0.47; 0.67; 0.8133; 1.0428; 1.17; 1.33 2) < 0.017; 2 × 0.038; 0.0412; 0.057; 0.09; 0.1533; 0.17521; 0.187; 1.3514 RA: 0.07; 0.25; 0.5012; 0.58; 0.62; 0.95; 1.2633; 1.5021; 1.73; 5.3014	Residue trials on peas and beans compliant with the GAP. Residue situation in peas more critical and therefore used to derive an MRL proposal and risk assessment values, extrapolated to beans, lentils and lupins	1) 3.0 2) 2.0	RA: 5.3 F: 1.33 DFA: 1.35	RA: 0.79 F: 0.57 DFA: 0.08
		Beans: Mo: 1) < 0.01; 0.011; 0.02; 0.0435; 2 × 0.04; 0.07; 0.12; 0.2428 2) 8 × < 0.017; 0.02535; 0.1135 RA: < 0.06; 0.06; 0.07; 2 × 0.09; 0.12; 0.17; 0.2928; 0.3635		1) 0.4 2) 0.15	RA: 0.36 F: 0.24 DFA: 0.11	RA: 0.09 F: 0.04 DFA: 0.02
	NEU (foliar)	Mo: 1) 0.0643; 0.07135; 0.08823; 0.09139; 0.09414; 0.1235; 0.1221; 0.1821 2) 0.01921; 0.05528; 0.05943; 0.05936; 0.06442; 0.0742; 0.07645; 0.09742 RA: 0.2443; 0.2436; 0.2445; 0.2421; 0.2539; 0.2628; 0.3242; 0.3442	Residue trials on peas compliant with the GAP. Extrapolation to beans, lentils and lupins acceptable	1) 0.3 2) 0.2	RA: 0.34 F: 0.18 DFA: 0.10	RA: 0.25 F: 0.09 DFA: 0.06
	SEU (foliar)	Mo: 1) 0.06921; 0.07435; 0.07435; 0.07728; 0.09228; 0.1328; 0.1414; 0.2528 2) 0.06428; 0.06135; 0.07442; 0.07542; 0.1235; 0.1235; 0.1335; 0.1528 RA: 0.2442; 0.2735; 0.2828; 0.2935; 0.3935; 0.4235; 0.5728; 0.6128		1) 0.4 2) 0.3	RA: 0.61 F: 0.25 DFA: 0.15	RA: 0.34 F: 0.08 DFA: 0.10
Peanuts	USA (foliar)	Mo: 1) 7 × < 0.01; 0.01114; 0.014; 0.01721; 0.027 2) 9 × < 0.017; 0.01921; 0.02414 RA: 6 × < 0.06; 0.064; 0.06521; 0.06821; 0.077; 0.08214	Residue trials on peanuts compliant with the authorised GAP	1) 0.04 2) 0.03	RA: 0.08 F: 0.03 DFA: 0.02	RA: 0.06 F: 0.01 DFA: 0.02
Soyabean	US/CA (foliar)	Mo: 1) 4 × < 0.01; 0.01; 3 × 0.02; 0.04; 0.06; 2 × 0.07; 0.09; 0.16; 0.22; 0.26; 0.28; 0.3628; 0.61; 1.02 2) 8 × < 0.017; 0.02; 2 × 0.03; 2 × 0.04; 0.06; 0.09; 0.12; 0.13; 0.17; 0.2028; 0.54 RA: 4 × < 0.06; 0.06; 03 × 0.07; 0.14; 0.15; 0.16; 0.27; 0.32; 0.33; 0.44; 0.54; 0.66; 0.9428; 0.96; 2.65	Residue trials on soya compliant with the authorised GAP	1) 1.5 2) 0.6	RA: 2.65 F: 1.02 DFA: 0.54	RA: 0.15 F: 0.06 DFA: 0.03
Cotton	USA (foliar)	Mo: 1) 0.01; 0.02; 0.04; 0.07; 0.08; 0.1221; 0.13; 0.18; 0.20; 0.40; 0.4919 2) 9 × < 0.017; 0.0228; 0.024 RA: 0.06; 0.07; 0.11; 0.13; 0.13; 0.1721; 0.18; 0.23; 0.26; 0.45; 0.5419	Residue trials on cotton compliant with the authorised GAP	1) 0.8 2) 0.03	RA: 0.54 F: 0.49 DFA: 0.12	RA: 0.17 F: 0.02 DFA: 0.02
	SEU (foliar)	Mo: 1) 4 × < 0.01; 0.0128; 0.01628; 0.04728; 0.135 2) 9 × × < 0.0067; 0.01334 RA: 3 × < 0.03; 0.0328; 0.03628; 0.04934; 0.06728; 0.1235	Residue trials on cotton compliant with the intended GAP	1) 0.2 2) 0.02	RA: 0.12 F: 0.10 DFA: 0.01	RA: 0.03 F: 0.01 DFA: 0.01
Olives for oil production/Table olives	SEU (foliar)	Mo: 1) 0.18; 0.25; 0.2821; 0.40; 0.49; 0.5720; 0.89; 3.2021 2) 0.01628; 0.01935; 0.01934; 0.02528; 0.02534; 0.03435; 0.05535; 0.08434 RA: 0.20; 0.2828; 0.3428; 0.43; 0.5621; 0.6320; 0.91; 3.3021	Residues on olives compliant with the intended GAP. Residue data extrapolation between table olives and olives fir oil production acceptable	1) 5.0 2) 0.15	RA: 3.3 F: 3.20 DFA: 0.08	RA: 0.5 F: 0.45 DFA: 0.03
Barley (grain)	USA (foliar)	Mo: 1) 0.04; 0.07; 0.10; 0.21; 0.24; 0.25; 0.27; 0.30; 0.3127; 0.44; 0.4629; 0.48; 0.68; 0.68; 0.71; 0.81; 0.84; 1.18; 1.68; 2.26 2) 2 × < 0.017; 0.026; 0.027; 0.029; 0.033; 0.059; 0.08; 0.085; 0.10; 0.105; 0.1129; 0.12; 0.13; 0.155; 0.175; 0.18; 0.2734; 0.365; 0.385 RA: 0.49; 0.51; 0.56; 0.64; 0.65; 0.70; 0.74; 0.76; 0.77; 0.7829; 0.84; 0.89; 1.01; 1.1334; 1.19; 1.19; 1.21; 1.27; 1.76; 2.34	Residue trials on barley compliant with the GAP	1) 3.0 2) 0.6	RA: 2.34 F: 2.26 DFA: 0.385	RA: 0.81 F: 0.45 DFA: 0.10
Sorghum (grain)	USA (foliar)	Mo: 1) 0.34; 2 × 0.46; 0.50; 0.51; 0.80; 0.86; 1.36; 1.5326 2) 4 × < 0.017; 0.0226; 0.018; 0.019; 0.04; 0.044 RA: 0.40; 0.51; 0.55; 0.59; 0.64; 0.86; 0.90; 1.40; 1.6023	Residue trials on sorghum compliant with the GAP	1) 3.0 2) 0.07	RA: 1.6 F: 1.53 DFA: 0.04	RA: 0.64 F: 0.51 DFA: 0.02
Wheat (grain)	US/CA(foliar)	Mo: 1) 3 × 0.02; 3 × 0.03; 0.04; 0.05; 0.06; 0.07; 2 × 0.09; 2 × 0.10; 0.15; 0.1527;0.16; 0.1635; 0.17; 0.18; 0.2134; 0.22; 0.23; 0.26; 0.34; 0.37; 0.58; 0.61; 0.73 2) 4 × < 0.017; 2 × 0.02; 2 × 0.04; 0.06; 3 × 0.09; 0.11; 0.14; 2 × 0.16; 0.1727; 2 × 0.1834; 0.20; 0.22; 0.24; 0.28; 2 × 0.33; 0.47; 0.5535; 0.65; 0.72 RA: 0.07; 0.08; 0.09; 0.10; 0.21; 0.24; 0.26; 0.29; 0.30; 0.37; 0.56; 0.59; 3 x 0.6527; 0.67; 0.74; 0.7534; 0.76; 0.77; 0.81; 0.87; 0.90; 1.08; 1.20; 1.46; 1.8335; 2.54; 2.69	Residue trials on wheat compliant with the GAP	1) 1.0 2) 1.0	RA: 2.69 F: 0.73 DFA: 0.72	RA: 0.65 F: 0.15 DFA: 0.16
Maize	US/CA (foliar)	Mo: 1) 19 × < 0.01; 0.011 2) 19 × < 0.017; 0.04 RA: 18 × < 0.06; 0.061; 0.14	Residue trials on maize compliant with the GAP	1) 0.02 2) 0.05	RA: 0.14 F: 0.01 DFA: 0.04	RA: 0.06 F: 0.01 DFA: 0.02
Coffee (beans)	BR (drench+foliar)	Mo: 1) 2 × < 0.01; 0.0233; 0.05; 0.07; 0.0828; 0.14; 0.1428; 0.2028; 0.2235; 0.35; 0.5526; 0.6135 2) 3 × 0.017; 2 × 0.02735; 0.03228; 0.033; 0.03528; 0.04; 0.044; 0.0535; 0.09826; 0.14 RA: 2 × < 0.06; 0.10; 0.1033; 0.1728; 0.20; 0.2428; 0.2928; 0.3035; 0.47; 0.56; 0.7535; 0.8526	Residue trials on coffee compliant with the GAP	1) 1.0 2) 0.2	RA: 0.85 F: 0.61 DFA: 0.14	RA: 0.24 F: 0.14 DFA: 0.03
Cocoa beans	Ghana (foliar)	Mo: 1) 9 × < 0.01 2) 0.01110; 0.01322; 0.01428; 0.01658; 0.0258; 0.0260; 0.02661; 0.0358; 0.03258 RA: 0.04410; 0.0522; 0.05128; 0.05958; 0.0758; 0.07160; 0.08761; 0.09958; 0.1158	Residue trials on cocoa compliant with the GAP in Ghana	1) 0.01 a 2) 0.06	RA: 0.11 F: 0.01 DFA: 0.03	RA: 0.07 F:0.01 DFA: 0.02
Hops	USA (foliar)	Mo: 1) 2.41; 2.7; 4.72 2) 0.27; 0.32; 1.1 RA: 3.31; 3.34; 7.95	Insufficient number of residue trials submitted	No proposal	–	–
Alfalfa forage	USA (foliar 2 × 210 g/ha)	F: 0.44; 1.07; 1.13; 2.64; 2.75; 3.04; 3.08; 3.37; 3.64; 3.69; 4.04; 4.15; 7.87 DFA: 0.16; 0.22; 0.31; 0.32; 0.33; 0.39; 0.41; 0.44; 0.56; 0.60; 0.65; 0.66; 1.06 SUM: 1.4; 1.6; 3.0; 3.8; 4.0; 4.4; 4.5; 2 × 5.0; 5.3; 5.6; 6.9; 8.8	Samples of forage and hay collected from GAP compliant trials at 5‐ to 7‐day PHI	n/a	F: 7.87 DFA: 1.06	F: 3.08 DFA: 0.41
Alfalfa hay		F: 2.55; 3.95; 4.24; 4.78; 5.50; 5.89; 6.14; 6.22; 7.42; 8.45; 9.30; 9.43; 9.48 DFA: 0.61; 0.63; 0.69; 0.77; 1.04; 1.06; 1.52; 1.55; 1.62; 1.91; 2.05; 2.74; 5.24 SUM:7.1; 2 × 7.4; 7.7; 8.3; 2 × 10; 11; 12.2; 13; 14; 15; 25		n/a	F: 9.48 DFA: 5.24	F: 6.14 DFA: 1.52
Clover forage	USA (foliar 2 × 210 g/ha)	F: 4.60; 4.79; 5.77; 6.01 DFA: 0.04; 0.04; 0.05; 0.05 SUM:4.71; 4.91; 5.92; 6.16	Samples of forage and hay collected from GAP compliant trials at 6‐ to 7‐day PHI	n/a	F: 6.01 DFA: 0.05	F: 5.28 DFA: 0.05
Clover hay		F: 8.29; 9.50; 10.06; 11.15 DFA: 2 × 0.27; 0.3; 0.63 SUM:9.11; 10.86; 11.4; 12.06		n/a	F: 11.15 DFA: 0.63	F: 9.78 DFA: 0.29
Maize stover	USA	F: 0.01; 0.9; 1.2; 1.21; 1.24; 1.35; 1.36; 1.4235; 1.47; 1.6; 1.71; 1.7228; 1.89; 2.14; 2.58; 2.98; 3.10; 3.22; 4.59; 5.90 DFA: 7 × < 0.017; 0.017; 0.018; 2 × 0.019; 0.03; 0.032; 0.034; 2 × 0.038; 0.042; 0.046; 0.063; 0.113 SUM:0.06; 0.95; 2 × 1.30; 1.35; 1.45; 2 × 1.5; 1.535; 1.65; 1.75; 1.828; 2 × 2.20; 2.70; 3.05; 3.25; 3.30; 4.70; 6.0	Samples of stover collected from GAP compliant trials at the PHI of 19–21 days.	n/a	F: 5.9 DFA: 0.11	F: 1.66 DFA: 0.02
Maize forage	USA	F: 0.8222; 1.49; 1.55; 1.68; 1.71; 1.77; 1.82; 1.8514; 1.92; 2.10; 2.16; 2.3; 2.39; 2.47; 2.56; 2.67; 2.79; 3.04; 3.23; 3.80 DFA: 2 × < 0.017; 3 × 0.02; 0.021; 0.02120; 2 × 0.023; 0.027; 0.033; 0.034; 0.035; 0.036; 0.037; 0.038; 0.04; 0.05219; 0.059; 0.08321 SUM: 0.8722; 1.60; 1.65; 2 × 1.85; 3 × 1.914; 2; 2.20; 2.30; 2.40; 2.50; 2.55; 2.62; 2.80; 2.85; 3.10; 3.30; 3.90	Samples of forage collected from GAP compliant trials at the PHI of 5–7 days.	n/a	F: 3.8 DFA: 0.08	F: 2.13 DFA: 0.03
Pea forage (green material)	USA	F: 1.52; 3.4; 3.48; 3.4928; 3.65; 4.33; 2 × 4.63; 5.01; 5.7435 DFA: 0.092; 0.096; 0.12; 0.21; 2 × 0.24; 0.32; 0.4435; 0.45; 1.528 SUM: 2.19; 3.85; 3.86; 4.37; 4.97; 5.3; 5.33; 5.5; 7.0435; 8.0528	Samples of pea vines (green material) and hay were collected form GAP compliant residue trials at 5‐ to 7‐day PHI	n/a	F: 5.74 DFA: 1.50	F: 3.99 DFA: 0.24
Pea hay	USA	F: 4.69; 5.03; 6.41; 6.81; 8; 8.26; 9.12; 9.88; 10; 15.1 DFA: 0.39; 0.42; 0.65; 0.71; 0.72; 0.81; 0.99; 1.09; 1.16; 1.6 SUM: 5.86; 7.07; 8.81; 9.82; 11; 11.1; 11.5; 12; 13; 18.5		n/a	F: 15.1 DFA: 1.6	F: 8.13 DFA: 0.77
Bean forage (green material)	USA	F: 0.055; 0.27; 0.39; 0.705; 0.8; 0.81; 1.13; 1.34; 2.2; 2.34 DFA: 0.021; 0.059; 0.072; 0.14; 0.175; 0.19; 0.335; 0.4134; 0.52; 0.8821 SUM: 0.27; 1.03; 1.17; 1.44; 1.68; 1.75; 1.83; 2.821; 3.2; 4.10	Samples of pea vines (green material) and hay were collected from GAP compliant residue trials at 5‐ to 7‐day PHI	n/a	F: 2.34 DFA: 0.88	F: 0.81 DFA: 0.16
Bean hay	USA	F: < 0.04; 0.71; 2.17; 2.72; 3.014.72; 7.6; 7.86; 9.814 DFA: < 0.067; 0.089; 0.3421; 0.34; 0.37; 0.38; 0.4428;0.65535; 0.93 SUM: < 0.24; 1.628; 2.43; 3.74; 4.14; 5.92; 8.6; 10.214; 10.7		n/a	F: 9.8 DFA: 0.93	F: 3.01 DFA: 0.37
Peanut hay	USA	F: 1.714; 2.0; 2.7; 3.7; 4.5; 5; 5.7; 9.1; 1014; 2 × 11 DFA: 0.35; 0.5; 0.51; 0.54; 2 × 0.58; 0.714; 0.84; 0.92; 1.2; 1.314 SUM: 3.8; 5.4; 5.414; 5.5; 6; 6.1; 8.2; 12; 3 × 13	Hay samples were collected from GAP compliant trials at the 6‐ to 7‐d PHI	n/a	F: 11 DFA: 1.3	F: 5 DFA: 0.58
Soyabean forage	USA	F: 0.94; 1.01; 1.11; 1.95; 2.22; 2.52; 2.78; 2.84; 2.89; 3.02; 3.56; 3.75; 3.9; 4.07; 4.08; 4.26; 4.48; 4.98; 5.3; 6.77 DFA: 0.085; 0.18; 0.27; 0.2921; 0.3; 0.31; 0.35; 0.38; 0.42; 0.46; 0.49; 3 × 0.5; 2 × 0.52; 0.53; 0.55; 0.57; 0.8 SUM: 1.7; 2.15; 2.5; 3.25; 3.7; 3.85; 4.1; 4.3; 2 × 4.4; 5; 5.05; 5.1; 5.3; 5.35; 5.4; 2 × 5.6; 5.85; 8.3	Samples of forage and hay were collected from GAP compliant residue trials at 5‐ to 7‐day PHI	n/a	F: 6.77 DFA: 0.8	F: 3.29 DFA: 0.48
Soyabean hay	USA	F: 1.47; 2.57; 3.91; 4.19; 6.22; 6.44; 6.56; 6.75; 6.9; 6.95; 8.05; 8.31; 8.45; 8.5; 9.35; 11.2; 11.65; 12.6; 15.84; 17.36 DFA: 0.35; 0.42; 0.49; 0.5414; 0.56; 0.64; 0.93; 1; 1.2; 1.3; 3 × 1.4; 2 × 1.5; 1.7; 1.8521; 2.1; 2.25; 2.7 SUM: 3.4; 6.7; 8.4; 9.35; 9.6; 9.8; 10.1; 10.4; 10.5; 10.6; 10.9; 11.4; 11.5; 12.8; 12.9; 13.9; 15.6; 17.9; 19.9; 21.5		n/a	F: 17.36 DFA: 2.7	F: 7.5 DFA: 1.35
Cotton gin by‐products	USA	F: 6.1; 7.5; 12.5; 18.1; 19.7 DFA: 5 × < 0.33 SUM: 2.10; 7.10; 8.5; 14; 19.50	Samples were collected from GAP compliant residue trials at 13 to 14‐day PHI	n/a	F: 19.7 DFA: < 0.33	F: 12.50 DFA: < 0.33
Wheat straw		F: 0.24; 0.44; 0.58; 0.66; 0.93; 1.03; 1.14; 1.16; 1.97; 2.01; 2.06; 2.52; 3.3827; 3.52; 3.75; 3.81; 3.98; 4.63; 4.6; 5.68; 6.09; 6.98; 6.87; 6.95; 7.72; 8.08;10.99; 12.70; 19.25 DFA: 4 × <  0.02; 0.02; 3 × 0.04; 0.05; 0.06; 0.07; 0.0727; 0.08; 0.09; 2 × 0.10; 0.13; 0.16; 0.17; 0.18; 0.20; 3 × 0.22; 0.27; 0.29; 0.31; 0.35; 0.55 SUM: 0.6; 0.94; 1.30; 1.40; 2 × 1.5; 1.55; 2; 2.25; 2.70; 3.00; 3.60; 3.627; 3.8; 3.9; 4.10; 4.65; 4.70; 5.25; 6.15; 6.75; 6.95; 7; 7.05; 7.90; 8.10; 11; 13; 19.50	Straw samples collected from GAP compliant trials at PHI interval of 21 days	n/a	F: 19.25 DFA: 0.55	F: 3.75 DFA: 0.10
Wheat hay	USA	F: 2.2; 2.5; 2.6; 3.5; 3.6; 4.3; 5.5; 5.7; 5.7; 5.9; 6.4; 6.6; 6.7; 7.2; 7.5; 7.8; 8; 8.1; 8.4; 8.4; 9.213; 9.9; 2 × 11; 12; 13; 2 × 16; 18 DFA: 2 × < 0.017; 0.02; 0.046; 0.05; 2 × 0.055; 0.063; 0.064; 0.066; 0.076; 0.11; 0.13; 3 × 0.16; 0.17; 0.2; 0.22; 0.2513; 0.32; 0.35; 0.38; 2 × 0.44; 0.52; 0.53; 0.56; 0.71 SUM: 2.3; 2 × 3.6; 3.9; 4.1; 5.7; 2 × 5.9; 6.2; 6.4; 7.1; 7.3; 7.4; 7.7; 7.8; 8.2; 8.5; 8.9; 9.5; 9.713; 9.9; 10; 11; 3 × 13; 17; 2 × 18	Samples of hay and forage collected from GAP compliant residue trials at the PHI of 7 days	n/a/	F: 18 DFA: 0.71	F: 7.5 DFA: 0.16
Wheat forage	USA	F: 2 × 0.05; 0.07; 0.07; 0.10; 0.10; 0.12; 0.15; 0.16; 0.19; 0.2; 0.33; 0.46; 0.49; 0.50; 0.50; 0.57; 0.9; 1.80; 2.10; 2.20; 2.4; 2.6; 5.4; 5.6; 5.9; 9.3; 13; 15 DFA: 6 × 0.017; 0.017; 0.018; 0.01814; 2 × 0.022; 0.025; 0.026; 0.032; 0.044; 0.07; 3 × 0.075; 2 × 0.09; 0.09120; 0.096; 0.09620; 2 × 0.11; 0.15; 2 × 0.18 SUM: 0.10; 3 × 0.12; 2 × 0.15; 0.17; 2 × 0.22; 0.27; 0.29; 0.41; 0.54; 0.56; 0.59; 0.62; 0.73; 1.1; 2.2; 2.4; 2.5; 2.6; 2.8; 5.7; 5.9; 6.4; 9.3; 14; 15		n/a	F: 15 DFA: 0.18	F: 0.5 DFA: 0.04
Barley straw	USA	F: 0.312; 0.41; 0.42; 0.52; 0.61; 0.7729; 0.77; 0.92; 1.02; 2 × 1.32; 1.37; 2.21; 2.47; 3.14; 3.78; 3.8; 3.98; 5.06; 5.58 DFA: 0.02; 2 × 0.03; 4 × 0.04; 0.05; 0.06; 0.07; 2 × 0.08; 0.0929; 0.10; 0.1034; 2 × 0.13; 0.20; 0.24; 0.25 SUM: 0.40; 0.58; 0.82; 0.83; 1.01; 1.05; 1.15; 1.17; 1.25; 1.44; 1.45; 1.48; 2.46; 2.55; 3.53; 3.93; 4.07; 4.23; 5.25; 5.64	Straw samples collected from GAP compliant trials at PHI interval of 21 days	n/a	F: 5.59 DFA: 0.25	F:1.32 DFA: 0.08
Barley hay	USA	F: 0.33; 0.5913; 0.8414; 1.37; 1.53; 1.60; 1.80; 2.04; 2.89; 3.33; 3.77; 4.67; 5.18; 5.42; 7.15; 7.28; 8.82; 12; 17.5; 24.1 DFA: 0.10; 0.12; 0.12; 0.13; 0.13; 0.14; 0.15; 0.1713; 0.1914; 0.19; 0.22; 0.22; 0.24; 0.26; 0.27; 0.28; 0.31; 0.33; 0.53; 0.67 SUM: 0.66; 1.0213; 1.4114; 1.68; 2.04; 2.18; 2.26; 2.4; 3.55; 3.75; 4.44; 5.03; 5.47; 6.06; 7.53; 8.08; 9.62; 13.6; 18.3; 25	Hay samples collected from GAP compliant residue trials at PHI interval of 7 days	n/a	F: 24.1 DFA: 0.67	F: 3.55 DFA: 0.21
Sorghum stover	USA	F: 0.97; 1.22; 1.3; 1.73; 2.28; 2.38; 2.42; 2.69; 5.01 DFA: 0.018; 0.02; 2 × 0.033; 0.036; 0.056; 0.082; 0.085; 0.12 SUM: 1.08; 1.35; 1.35; 1.75; 2.4; 2.6; 2.75; 2.9; 5.3	Stover samples collected from GAP compliant residue trials at PHI interval of 21 days	n/a	F: 5.01 DFA: 0.12	F: 0.12 DFA: 0.04
Sorghum forage	USA	F: 2.20; 2.23; 2.49; 2.73; 2.78; 3.1; 3.25; 4.06; 4.23 DFA: < 0.017; 0.018; 2 × 0.025; 0.035; 0.039; 0.042; 0.04619; 0.05 SUM: 2.3; 2.4; 2.55; 2.8; 2.8; 3.2; 3.35; 4.2; 4.3	Forage samples collected from GAP compliant residue trials at PHI interval of 7 days	n/a	F: 4.23 DFA: 0.05	F: 2.78 DFA: 0.04

MRL: maximum residue level; GAP: Good Agricultural Practice; n/a: not applicable; Mo: residue levels expressed according to the monitoring residue definition; RA: residue levels expressed according to risk assessment residue definition; F: flupyradifurone.

^*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.

^bValues in the upper case refer to a PHI at which higher residues were observed from trials compliant with the GAP.

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

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

B.1.2.2. Residues in rotational crops

B.1.2.3. Processing factors

Processed commodity	No of valid studiesa	Processing Factor (PF)	Median PFb			Comment/Source
		Individual values	F	DFA	Sum
Risk assessment residue definition: Sum of flupyradifurone and DFA, expressed as flupyradifurone Enforcement residue definition: 1) flupyradifurone; 2) DFA, expressed as DFA
Oranges, grapefruit, lemon peeled	2	F: < 0.08; 0.10 DFA: < 0.34; 0.3 Sum: 0.21; 0.21	0.09	0.3	0.2	Data from SEU trials (PHI 29 days)
	6	F: < 0.04; < 0.5; < 0.19; < 0.03; 0.88; 1.17 DFA: 5 × < 1; 1 Sum: < 0.12; < 0.75; < 0.41; < 0.08; 1.16; 0.9	0.3	< 1	0.6	Residue data from US residue trials (4) and US processing studies (2) (PHI 1 day). Residues of DFA < LOQ in all RAC samples
Oranges, juice	2	F: < 0.05; < 0.08; DFA: < 0.7; < 1 Sum: < 0.13; < 0.2	< 0.07	< 0.8	< 0.17	SEU trials
	2	F: 0.03; 0.03 DFA: < LOQ	0.03	–	–	USA trials. Residues of DFA < LOQ in the RAC and processed commodity
Oranges, marmalade	2	F: 0.57; 0.08 DFA: 1; < 1 Sum: 0.63; 0.20	0.33c	1	0.42	SEU trials. PFs for flupyradifurone differ of more than 50%, therefore third processing study recommended (OECD, 2008a,b)
	2	F: < 0.03; < 0.02 DFA: < LOQ	< 0.02	–	–	USA trials. Residues of DFA < LOQ in the RAC and processed commodity
Oranges, oil	2	F: < 0.05; < 0.08 DFA: < 0.7; < 1 Sum: < 0.13; < 0.2	< 0.07	< 0.8	< 0.17	SEU trials
	2	F: 0.03; 0.02 DFA: < LOQ	0.025	–	–	USA trials. Residues of DFA < LOQ in the RAC
Oranges, dry pomace	2	F: 5.3; 3.9 DFA: < 1; 2 Sum: 4.77; 3.7	4.6	1.5	4.2	The data from two SEU trials were not considered as information on the method validation in dry pomace was not provided
Oranges, wet pomace	2	F: 1.3; 1.05 DFA: < LOQ Sum: 1.3; 1.05	1.2	–	1.2	USA trials. Residues of DFA < LOQ in the RAC and processed commodity
	2	F: 1.38; 1.25 DFA: 1.3; 1.5 Sum: 1.4; 1.3	1.3	1.4	1.3	SEU trials
Soyabean, aspirated grain fraction	2	F: 15.8; 11.7 DFA: 8.4; 4.8 Sum: 15.3; 8.8	14	7	12
Soyabean, meal	2	F: 0.85; 1.3 DFA: 1.2; 1.4 Sum: 0.9; 1.3	1.1	1.3	1.1
Soyabean, refined oil	2	F: < 0.01; < 0.02 DFA: < 1; < 0.2 Sum:< 0.1; < 0.08	< 0.02	< 0.6	< 0.1
Soyabean, milk	2	F: 0.04; 0.09 DFA: < 1; < 0.17 Sum: 0.1; 0.12	0.07	< 0.6	0.1
Soyabean, defatted flour	2	F: 1.05; 1.2 DFA: 1.5; 1.3 Sum: 1.1; 1.2	1.1	1.4	1.1
Soyabean, hulls	2	F: < 0.07; 1.17 DFA: 1.06; 0.8 Sum: 0.8; 1	0.6	0.9	0.9	Tentativec. PFs differ of more than 50%. Third processing study recommended (OECD, 2008a,b)
Potato, peeled	3	F: < LOQ DFA: 1.1, 1.02; 1.04 Sum: 1.12; 1.18; 1.03	–	1.07	1.12	Residues of flupyradifurone below the LOQ in the RAC and processed commodity
Potato, flakes	4	F: 1.1 DFA: < 0.77; 1.9; 1.6 Sum: < 0.83; 1.5; 1.8;	1.1c	1.7	1.5	Residues of flupyradifurone below the LOQ in the RAC in all trials. Concentration of flupyradifurone residues on the basis of one trial cannot be confirmed
Potato, chips	4	F: – DFA: 3.3, 1.75; 1.5 Sum: 1.4; 2.5; 1.5	–	1.75	1.5	Residues of flupyradifurone below the LOQ in the RAC
Potato, dried waste	2	F: – DFA: < 0.77; < 0.8 Sum: < 0.8; < 0.86	–	< 0.8	< 0.85
Potato, dry pulp Potato, starch	2	F: – DFA: 2 × < 0.8 Sum: < 0.84; < 0.87	–	< 0.8	< 0.86
Barley, brewer`s grain (dried)	2	F: 0.08; 0.03 DFA: < 0.5; < 0.7 Sum: 0.1; 0.04	0.05c	< 0.6	0.07	PFs for flupyradifurone differ of more than 50%, therefore third processing study recommended (OECD, 2008a,b)
Barley, malt sprouts	2	F: 0.38; 0.4 DFA: 12.3; 12.6 Sum: 0.92; 0.63	0.4	12.5	0.8
Barley, brewer`s yeast	2	F: 0.07; 0.11 DFA: < 0.5; < 0.7 Sum: 0.09; 0.12	0.09	< 0.6	0.1
Barley, beer	2	F: 0.07; 0.05 DFA: < 0.5; < 0.7 Sum: 0.09; 0.06	0.06	< 0.6	0.08
Barley, pearl barley	2	F: 0.14; 0.06 DFA: 0.7; < 0.7 Sum: 0.17; 0.08	0.1	0.7	0.1
Barley, pear barley rub‐off	2	F: 3.3; 2.5 DFA: 2.0; 1.7 Sum: 3.3; 2.6	2.9	1.8	2.9
Wheat, semolina	2	F: 1.4; 0.4 DFA: 1.5 Sum: 1.4; 0.5	0.9c	1.5c	0.95	PFs for flupyradifurone differ of more than 50%, therefore third processing study recommended (OECD, 2008a,b). Residues of DFA < LOQ in RAC. Concentration of residues on the basis of one trial cannot be confirmed
Wheat, white flour	4	F: 0.3; 0.14; 0.2; 0.33 DFA: 1.19; 0.73; 0.85 Sum: 0.4; 0.25; 0.5; 0.69	0.2	0.8	0.5	NEU and USA trials combined
Wheat, white flour bran	2	F: 6.5; 5.8 DFA: 23.3; 1.3 Sum: 8; 5.25	6	12c	7	PFs for DFA differ of more than 50%, therefore third processing study recommended (OECD, 2008a,b)
Wheat, bran	2	F: 2.38; 2.33 DFA: 1.13; 1 Sum: 1.5; 1.6	2.4	1.07	1.5
Wheat, white bread	4	F: 0.22; 0.14; 0.14; 0.22 DFA: 0.92; 0.52; 0.67 Sum: 0.28; 0.25; 0.37; 0.52	0.2	0.7	0.3	NEU and USA trials combined
Wheat, whole meal flour	4	F: 1.6; 1.5; 1.27; 1.12 DFA: 1.3; 0.9; 1.13 Sum: 1.5; 1.4; 1.08; 1.12	1.4	1.1	1.3	NEU and USA trials combined
Wheat, whole meal bread	4	F: 0.96; 0.86; 0.75; 0.65 DFA: 0.92; 0.66; 0.68 Sum: 0.96; 0.87; 0.7; 0.67	0.8	0.7	0.8	NEU and USA trials combined
Wheat, germ	4	F: 1.3; 0.8; 1.6; 1.6 DFA: 1.37; 0.99; 0.98 Sum: 1.3; 0.8; 1.3; 1.2	1.45	0.99	1.25	NEU and USA trials combine
Wheat, aspirated grain fraction	2	F: 13.8; 21.5 DFA: 8.8; 5.05 Sum: 11.05; 10	18	7	11
Wheat, gluten	2	F: 0.22; 0.5 DFA: 0.18; 0.67 Sum: 0.2; 0.6	0.4	0.4	0.4
Wheat, starch	2	F: 0.01; < 0.01 DFA: 0.05; 0.02 Sum: 0.03; 0.02	0.01	0.04	0.03
Wheat, fresh pasta	2	F: 0.18; 0.23 DFA: 0.66; 0.76 Sum: 0.45; 0.6	0.2	0.7	0.5
Wheat, dry pasta	2	F: 0.24; 0.33 DFA: 0.84; 0.92 Sum: 0.58; 0.7	0.3	0.89	0.7
Wheat, shorts	2	F: 1.2; 0.6 DFA: 0.95; 0.9 Sum: 1.1; 0.8	0.9	0.9	0.94
Wheat, middlings	2	F: 0.8; 0.6 DFA: 0.88; 0.9 Sum: 0.84; 0.83	0.7	0.9	0.84
Maize, aspirated grain fraction	2	F: 19.2; 26 DFA: < LOQ	23	–	–	Residues of DFA < LOQ in the RAC and in processed commodity. Trials performed at 1.5–2.5N the authorized GAP and for the risk assessment it can be concluded that concentration of DFA residues in processed commodities is not expected when maize is treated at the critical use pattern
Maize, bran	2	F: 1.9; 3.5 DFA: < LOQ	2.7	–	–
Maize, germ (dry milling)	2	F: 0.86; 1.1 DFA: < LOQ	1	–	–
Maize, germ (wet milling)	2	F: 0.86; 0.5 DAF:< LOQ	0.7	–	–
Maize, refined oil/starch/grits/flour	2	F: < 0.86; 0.38 DAF: < LOQ	< 0.6	–	–
Cotton, refined oil/refined oil	2	F: < 0.01; < 0.04 DFA: < LOQ	< 0.02	–	–	Residues of DFA < LOQ in the RAC and in processed commodity. Trials performed at 1.5–2.5N the authorised GAP and for the risk assessment, it can be concluded that concentration of DFA residues in processed commodities is not expected when cotton is treated at the critical use pattern
Cotton, hull	2	F: 0.1; 0.9 DFA: < LOQ	0.5c	–	–	PFs for flupyradifurone differ of more than 50%, therefore third processing study recommended (OECD, 2008a,b) Residues of DFA < LOQ in the RAC and in processed commodity. Trials performed at 1.5–2.5N the authorised GAP and for the risk assessment it can be concluded that concentration of DFA residues in processed commodities is not expected when cotton is treated at the critical use pattern
Cotton, meal	2	F: 0.04; 0.25 DFA: 1.3	0.14 c	1.3 c	–	PFs for flupyradifurone differ of more than 50%, therefore third processing study recommended (OECD, 2008a,b) Residues of DFA were < LOQ in the RAC, and, since a concentration of residues is observed in one trial, additional trial would be required for confirmation
Peanut, meal	2	F: 1.47; 2 DFA: 1.3	1.7	1.3 c	–	Variation of DFA residues in the RAC samples too wide (< LOQ – 0.1 mg/kg). Third study would be required to confirm the processing factor. Trials 1.5–2N the authorised GAP
Peanut, refined oil	1	F: < 0.08 DFA: < 0.17	< 0.08	< 0.17	–	Tentativec
Peanut, butter/roasted peanut	1	F: 0.2 DFA: 0.6	0.2	0.6	–	Tentativec
Coffee, roasted	2	F: 0.55; 0.62 DFA: 0.78; 1.12 Sum: 0.6; 0.8	0.6	0.9	0.7
Coffee, instant	2	F: 1.74; 2 DFA: 4.3; 5.5 Sum: 2.4; 3.1	1.9	4.9	2.7
Melon, peeled	5	F: 0.1; < 0.17; < 0.06; < 0.1; < 0.05 DFA: 4 × < LOQ; 1.64	< 0.1	1.64c	–	Residues of DFA in four trials below the LOQ both in processed and in the RAC. Since a concentration of DFA residues is observed in one trial, additional trial would be required for confirmation
Mustard greens, cooked	1	F: 0.18 DFA: 0.9 Sum: 0.19	0.18	0.9	0.19	Tentativec
Broccoli, cooked	1	F: 0.52 DFA: 0.54 Sum: 0.52	0.52	0.54	0.52	Tentativec
Carrot, cooked	3	F: 0.88; 0.7; 0.74 DFA: < 0.8	0.78	< 0.8c	–	Data from residue trials. In two trials, residues of DFA were < LOQ in the RAC
Courgettes, cooked	3	F: 0.58; 0.2; 0.5 DFA: 0.7; 0.63 Sum: 0.66; 0.46; 0.75	0.5	0.67	0.56	Data from residue trials. In one trial, residues of DFA were < LOQ in the RAC
Pea, green cooked	1	F: 0.4 DFA: 0.27 Sum: 0.3	0.4	0.27	0.3	Tentativec
Pea, green, canned	1	F: 0.38 DFA: 0.4 Sum: 0.4	0.38	0.4	0.4	Tentativec
Olives, crude oil	1	F: 0.13 DFA: – Sum: 0.22	0.13	–	0.22	Tentativec
Olives, refined oil	2	F: < 0.025; < 0.056 DFA: < 0.56 Sum: < 0.07; < 0.15	< 0.04	< 0.56c	< 0.11	In one trial residues of DFA < LOQ in the RAC. Trials performed at 1N GAP rate
Olives, refined solvent extracted oil	2	F: < 0.025; < 0.056 DFA: < 0.56 Sum: < 0.07; < 0.15	< 0.04	< 0.56c	< 0.11
Cocoa beans, roasted	2	F: < 1 DFA: 0.53; 0.94 Sum: 0.58; 0.96	< 1	0.74	0.77	Residues of flupyradifurone in RAC (< 0.01–0.01 mg/kg) from overdosed trials (6N cGAP). For the risk assessment, a reduction of flupyradifurone residues in processed commodity can be confirmed
Cocoa beans, cacao powder	2	F: 1.4; 1.3 DFA: 0.98; 1.89 Sum: 1.05; 1.78	1.35	1.4c	1.4	PFs for DFA differ of more than 50% and therefore the third processing study recommended (OECD, 2008a,b) Residues of flupyradifurone < LOQ in RAC from one trial
Cocoa beans, chocolate	2	F: 1.3 DFA: 0.45; 0.83 Sum: 0.53; 0.87	1.3c	0.64	0.7	Residues of flupyradifurone < LOQ in RAC from one trial. Since a concentration of residues is observed, additional trial would be required for confirmation

PF: Processing factor (=Residue level in processed commodity expressed according to RD‐Mo/Residue level in raw commodity expressed according to RD‐Mo); GAP: Good Agricultural Practice; RAC: raw agricultural commodity; LOQ: limit of quantification; NEU: northern European Union; SEU: southern European Union; F: flupyradifurone.

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

PF highlighted in bold is valid for enforcement purposes.

A tentative PF is derived based on a limited dataset.

Processing factors highlighted in bold are proposed for enforcement purposes.

B.2. Residues in livestock

a) Dietary burden EU scenario

Dietary burden for EU livestock considering primary and rotational crops grown in the EU as well as imported feed items and their by‐products from the US/CA.

Flupyradifurone:

Dietary burden calculated for the intake of flupyradifurone residues

Relevant groups (subgroups)	Dietary burden expressed in				Most critical subgroupa	Most critical commodityb	Trigger exceeded (Y/N)
	mg/kg bw per day		mg/kg DM
	Median	Maximum	Median	Maximum
Cattle (all)	0.063	0.170	1.78	5.60	Dairy cattle	Kale leaves	Y
Cattle (dairy only)	0.063	0.170	1.64	4.41	Dairy cattle	Kale leaves	Y
Sheep (all)	0.047	0.155	1.36	3.86	Lamb	Kale leaves	Y
Sheep (ewe only)	0.045	0.129	1.36	3.86	Ram/Ewe	Kale leaves	Y
Swine (all)	0.028	0.097	1.21	4.22	Swine (breeding)	Kale leaves	Y
Poultry (all)	0.037	0.078	0.52	1.10	Poultry broiler	Swede roots	Y
Poultry (layer only)	0.035	0.074	0.51	1.08	Poultry layer	Swede roots	Y
Fish	n/a	–	–	–	–	–	–

bw: body weight; DM: dry matter; n/a: not applicable.

^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’.

Difluoroacetic acid (DFA), expressed as DFA

Dietary burden calculated for the intake of DFA residues expected in primary and in rotational crops

Relevant groups (subgroups)	Dietary burden expressed in				Most critical subgroupa	Most critical commodityb	Trigger exceeded (Y/N)
	mg/kg bw per day		mg/kg DM
	Median	Maximum	Median	Maximum
Cattle (all)	0.038	0.057	1.14	1.99	Dairy cattle	Swede roots	Y
Cattle (dairy only)	0.038	0.057	1.00	1.49	Dairy cattle	Swede roots	Y
Sheep (all)	0.039	0.065	0.99	1.60	Lamb	Swede roots	Y
Sheep (ewe only)	0.033	0.053	0.99	1.60	Ram/ewe	Swede roots	Y
Swine (all)	0.022	0.044	0.87	1.66	Swine (finishing)	Swede roots	Y
Poultry (all)	0.036	0.050	0.53	0.73	Poultry layer	Swede roots	Y
Poultry (layer only)	0.036	0.050	0.53	0.73	Poultry layer	Swede roots	Y
Fish	n/a	–	–	–	–	–	–

bw: body weight; DM: dry matter; n/a: not applicable.

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

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

b) Dietary burden US scenario

Feeding of animals in North America, exported to EU

Flupyradifurone

The dietary burden for US/Canadian livestock has not been calculated.16

Difluoroacetic acid (DFA)

The dietary burden for DFA in US/CA as calculated by the EMS, the Netherlands, in the Evaluation Report (2019) is summarised in the table below:

Relevant groups (subgroups)	Dietary burden expressed in
	mg/kg bw per day	mg/kg DM
	Maximum	Maximum
Cattle (meat)	0.030	1.65
Cattle (dairy)	0.126	3.15
Sheep (all)	n/a	n/a
Sheep (ewe only)	n/a	n/a
Swine (all)	0.021	0.68
Poultry (broiler)	0.056	0.69
Poultry (layer only)	0.056	0.88
Poultry (turkey)	0.042	0.68
Fish	n/a	n/a

bw: body weight; DM: dry matter; n/a: not applicable.

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 d)	Duration (days)	Comment/Source
	Laying hen	F: 1.02–1.05	14	14C‐ 4 furanone, 14C‐pyridiniylethyl flupyradifurone (EFSA, 2015)
	Lactating ruminants	F: 0.92–1	5	Goat. 14C‐pyridiniylethyl flupyradifurone (EFSA, 2015)

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
	Bovine	Muscle	−20	43	days	DFA	EFSA (2015)
	Bovine	Liver
	Bovine	Kidney
	Bovine	Fat

B.2.2. Magnitude of residues in livestock

B.2.2.1. EU scenario

Feeding of animals in the EU considering primary and rotational crops grown in the EU as well as imported feed items from the USA and their by‐products.

Flupyradifurone, expressed as flupyradifurone: Risk assessment values and MRL proposals for EU scenario; comparison with US tolerance.

Animal commodity	Residues at the closest feeding level (mg/kg)		Estimated value at 1N		MRL proposal (EU scenario) (mg/kg)	US tolerance (mg/kg)g
	Mean	Highest	STMRa (mg/kg)	HRb (mg/kg)
Cattle (all) – Closest feeding level (0.18 mg/kg bw; 1.1 N rate)c
Muscle	0.04	0.04	0.02	0.04	0.05	0.3 h
Fat	0.02	0.02	0.007	0.020	0.02	0.2
Liver	0.15	0.15	0.05	0.28	0.3	1.0
Kidney	0.16	0.16	0.06	0.15	0.15	1.0
Cattle (dairy only) – Closest feeding level (0.18 mg/kg bw; 1.1 N rate)c
Milkd	0.02	0.02	0.01	0.02	0.03	0.15
Sheep (all) f – Closest feeding level (0.18 mg/kg bw; 1.2 N rate (lamb))c
Muscle	0.04	0.04	0.01	0.04	0.04	0.3 h
Fat	0.02	0.02	0.005	0.02	0.02	0.2
Liver	0.15	0.15	0.04	0.27	0.3	1.0
Kidney	0.16	0.16	0.04	0.14	0.15	1.0
Sheep (ewe only) f – Closest feeding level (0.18 mg/kg bw; 1.4 N rate (ewe))c
Milkd	0.02	0.02	0.01	0.02	0.02	0.15
Swine (all) f – Closest feeding level (0.18 mg/kg bw; 1.9 N rate (breeding))c
Muscle	0.04	0.04	0.01	0.02	0.03	0.01
Fat	0.02	0.02	0.003	0.01	0.015	0.01
Liver	0.15	0.15	0.02	0.08	0.08	0.04
Kidney	0.16	0.16	0.02	0.09	0.09	0.04
Poultry (all) – Closest feeding level (0.1 mg/kg bw; 1.3 N rate (broiler))c
Muscle	0.01	0.01	0.01	0.01	0.01 *	–
Fat	0.01	0.01	0.01	0.01	0.01 *	–
Liver	0.01	0.01	0.01	0.01	0.01 *	–
Poultry (layer only) – Closest feeding level (0.1 mg/kg bw; 1.4 N rate (layer))c
Eggse	0.01	0.01	0.01	0.01	0.01 *	–

STMR: supervised trials median residue; HR: highest residue; MRL: maximum residue level.

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

^aThe mean residue level for milk and the mean residue levels for eggs and tissues were recalculated at the 1N rate for the median dietary burden.

^bThe mean residue level in milk and the highest residue levels in eggs and tissues, were recalculated at the 1N rate for the maximum dietary burden.

^cClosest feeding level and N dose rate related to the maximum dietary burden.

^dHighest residue level from day 1 to day 28 (daily mean of 3 cows).

^eHighest residue level from day 1 to day 28 (daily mean of 12 laying hens).

^fSince extrapolation from cattle to other ruminants and swine is acceptable, results of the livestock feeding study on ruminants were relied upon to derive the MRL and risk assessment values in sheep and swine.

^gEnvironmental Protection Agency, 40 CFR Part 180, Federal Register/Vol.80, No 15/Friday, January 23, 2015.

^hUS tolerance refers to meat.

Difluoroacetic acid (DFA), expressed as DFA

1) Risk assessment values reflecting intake of primary and rotational crops containing DFA residues

Animal commodity	Residues at the closet feeding level (mg/kg)		Estimated value at 1N level
	Mean	Highest	STMRa (mg/kg)	HRb (mg/kg)
Cattle (all) – Closest feeding levelc: 0.032 mg/kg bw 0.6 N Dairy cattle (highest diet)
Muscle	0.07	0.09	0.08	0.16
Fat	0.05	0.07	0.05	0.13
Liver	0.05	0.06	0.06	0.12
Kidney	0.11	0.12	0.13	0.21
Cattle (dairy only) – Closest feeding levelc: 0.032 mg/kg bw 0.6 N Dairy cattle
Milkd	0.01	0.02	0.02	0.03
Sheep (all) f – Closest feeding levela: 0.032 mg/kg bw 0.5N Lamb (highest diet)
Muscle	0.07	0.09	0.08	0.18
Fat	0.05	0.07	0.06	0.15
Liver	0.05	0.06	0.07	0.13
Kidney	0.11	0.12	0.13	0.24
Sheep (ewe only) f – Closest feeding levelc: 0.032 mg/kg bw 0.6 N Ewe
Milkd	0.01	0.02	0.01	0.02
Swine (all) f – Closest feeding levelc: 0.032 mg/kg bw 0.7 N Finishing (highest diet)
Muscle	0.07	0.09	0.05	0.12
Fat	0.05	0.07	0.03	0.10
Liver	0.05	0.06	0.04	0.09
Kidney	0.11	0.12	0.07	0.16
Poultry (all) – Closest feeding levelc: 0.054 mg/kg bw 1.1 N Turkey (highest diet)
Muscle	0.09	0.10	0.06	0.10
Fat	0.02	0.02	0.01	0.02
Liver	0.17	0.19	0.21	0.19
Poultry (layer only) – Closest feeding levelc: 0.054 mg/kg bw 1.1 N Layer
Eggse	0.06	0.08	0.04	0.08

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

^aThe mean residue level for milk and the mean residue levels for eggs and tissues were recalculated at the 1N rate for the median dietary burden.

^bThe mean residue level in milk and the highest residue levels in eggs and tissues were recalculated at the 1N rate for the maximum dietary burden.

^cClosest feeding level and N dose rate related to the maximum dietary burden.

^dHighest residue level from day 1 to day 28 (daily mean of 3 cows).

^eHighest residue level from day 1 to day 28 (daily mean of 12 laying hens).

^fSince extrapolation from cattle to other ruminants and swine is acceptable, results of the livestock feeding study on ruminants were relied upon to derive the MRL and risk assessment values in sheep and swine.

2) Risk assessment values reflecting intake of flupyradifurone

Animal commodity	Residues at the closest feeding level (mg/kg)		Estimated value at 1N
	Mean	Highest	STMRa (mg/kg)	HRb (mg/kg)
Cattle (all) – Closest feeding level (0.18 mg/kg bw; 1.1 N rate)c
Muscle	0.007	0.007	0.007	0.007
Fat	0.007	0.007	0.007	0.007
Liver	0.007	0.007	0.01	0.007
Kidney	0.006	0.006	0.002	0.005
Cattle (dairy only) – Closest feeding level (0.18 mg/kg bw; 1.1 N rate)c
Milkd	0.007	0.007	0.007	0.007
Sheep (all) f – Closest feeding level (0.18 mg/kg bw; 1.2 N rate (lamb))c
Muscle	0.007	0.007	0.007	0.007
Fat	0.007	0.007	0.007	0.007
Liver	0.007	0.007	0.007	0.007
Kidney	0.006	0.006	0.001	0.005
Sheep (ewe only) f – Closest feeding level (0.18 mg/kg bw; 1.4 N rate (ewe))c
Milkd	0.007	0.007	0.007	0.007
Swine (all) f – Closest feeding level (0.18 mg/kg bw; 1.9 N rate(breeding))c
Muscle	0.007	0.007	0.007	0.007
Fat	0.007	0.007	0.007	0.007
Liver	0.007	0.007	0.007	0.007
Kidney	0.006	0.006	0.001	0.003
Poultry (all) – Closest feeding level (0.1 mg/kg bw; 1.3 N rate (broiler))c
Muscle	0.028	0.028	0.01	0.022
Fat	0.01	0.01	0.004	0.008
Liver	0.035	0.035	0.013	0.036
Poultry (layer only) – Closest feeding level (0.1 mg/kg bw; 1.4 N rate (layer))c
Eggse	0.016	0.017	0.006	0.019

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

^aThe mean residue level for milk and the mean residue levels for eggs and tissues were recalculated at the 1N rate for the median dietary burden.

^bThe mean residue level in milk and the highest residue levels in eggs and tissues were recalculated at the 1N rate for the maximum dietary burden.

^cClosest feeding level and N dose rate related to the maximum dietary burden.

^dHighest residue level from day 1 to day 28 (daily mean of 4 cows).

^eHighest residue level from day 1 to day 28 (daily mean of 12 laying hens).

^fSince extrapolation from cattle to other ruminants and swine is acceptable, results of the livestock feeding study on ruminants were relied upon to derive the MRL and risk assessment values in sheep and swine.

3) Risk assessment values for EU scenario reflecting total intake of DFA residues, expressed as DFA

Animal commodity	Estimated value at 1N		MRL proposal EU scenario (mg/kg)
	STMR (mg/kg)	HR (mg/kg)
Cattle muscle	0.08	0.16	0.2
Cattle fat	0.05	0.13	0.15
Cattle liver	0.07	0.12	0.15
Cattle kidney	0.13	0.21	0.3
Cattle milk	0.02	0.03	0.03
Sheep muscle	0.08	0.18	0.2
Sheep fat	0.06	0.15	0.15
Sheep liver	0.07	0.13	0.15
Sheep kidney	0.13	0.24	0.30
Sheep milk	0.01	0.02	0.03
Swine muscle	0.05	0.12	0.15
Swine fat	0.03	0.10	0.1
Swine liver	0.04	0.09	0.1
Swine kidney	0.07	0.16	0.2
Poultry muscle	0.07	0.12	0.15
Poultry fat	0.01	0.03	0.03
Poultry liver	0.22	0.23	0.3
Eggs	0.05	0.10	0.1

STMR: supervised trials median residue; HR: highest residue; MRL: maximum residue level.

B.2.1.2. US scenario

Feeding of animals in the US to estimate residues in commodities of animal origin, exported to EU

Flupyradifurone

An assessment of MRLs required for the US/Canadian situation was not performed, since this falls under the responsibility of US/Canadian authorities.

Difluoroacetic acid (DFA), expressed as DFA

The MRL proposals were as calculated by the EMS, the Netherlands, in the Evaluation report (2019) since no MRLs are set in the USA and Canada for DFA; the proposals derived by the EMS are summarised below:

1) Risk assessment values for DFA reflecting intake of flupyradifurone* (Netherlands, 2019)

Animal commodity	DFA residues at the closet feeding level (mg DFA/kg)		Estimated value at 1N level
	Mean	Highest	STMR (mg/kg)	HR (mg/kg)
Cattle (all diets) – Closest feeding levela: 0.9 mg/kg bw day, corresponding to 1.16 N Dairy cattle (highest diet)
Meat	–	–	–	–
Muscle	0.018	0.022	0.018	0.022
Fat	0.013	0.017	0.013	0.015
Liver	0.019	0.024	0.018	0.023
Kidney	0.027	0.033	0.026	0.029
Cattle (dairy only) – Closest feeding levela: 0.9 mg/kg bw day, corresponding to 1.16 N Dairy cattle (highest diet)
Milkb	0.007	0.008	0.0082	0.0082
Swine – Closest feeding levela: 0.18 mg/kg bw, corresponding to 10.2 N Finishing (highest diet)
Meat	–	–	–	–
Muscle	< 0.007	< 0.007	< 0.007	< 0.007
Fat	< 0.007	< 0.007	< 0.007	< 0.007
Liver	< 0.007	< 0.007	< 0.007	< 0.007
Kidney	0.007	0.007	< 0.007	< 0.007
Poultry (all diets) – Closest feeding levela: 0.10 mg/kg bw day, corresponding to 1.89 N Broiler (highest diet)
Meat	–	–	–	–
Muscle	0.028	0.032	0.015	0.017
Fat	0.010	0.012	0.007	0.007
Liver	0.035	0.037	0.018	0.020
Poultry (layer only) – Closest feeding levela: 0.10 mg/kg bw day, corresponding to 2.8 N Layer
Eggsc	0.016	0.017	0.007	0.007

bw: body weight; STMR: supervised trials median residue; HR: highest residue.

^*It is noted that the dietary burdens calculated for flupyradifurone by the EMS do not fully reflect the dietary burdens for which the MRLs are established for flupyradifurone by EPA.

^aClosest feeding level and N dose rate related to the maximum dietary burden.

^bHighest residue level from day D1 to day D28 (daily mean of 3 cows).

^cHighest residue level from day D1 to day D28 (daily mean of 12 laying hens).

Residues for meat were calculated considering a certain fat proportion in the consumed fat. For mammal meat, a ratio muscle/fat of 80/20 is assumed, whereas for poultry meat, a ratio muscle/fat of 90/10 is assumed (FAO, 2009).

STMR values were calculated on the basis of the estimated dietary burden (OECD calculator) and the mean residue level calculated for a certain matrix.

2) Risk assessment values reflecting from the intake DFA in primary and rotational crops used for feed purpose (Netherlands, 2019)

Animal commodity	Residues at the closet feeding level (mg/kg)		Estimated value at 1N level
	STMRa (mg/kg)	HRb (mg/kg)
			Mean	Highest
Cattle (all) – Closest feeding levelc: 0.17 mg/kg bw 1.35 N Dairy cattle (highest diet)
Muscle	0.329	0.351	0.253	0.291
Fat	0.336	0.552	0.268	0.418
Liver	0.296	0.328	0.235	0.285
Kidney	0.508	0.527	0.394	0.440
Cattle (dairy only) – Closest feeding levelc: 0.17 mg/kg bw 1.3 N Dairy cattle
Milkd	0.054	0.072	0.056	0.056
Swine f – Closest feeding levelc: 0.032 mg/kg bw 1.78 N Finishing (highest diet)
Muscle	0.070	0.090	0.039	0.050
Fat	0.074	0.131	0.042	0.074
Liver	0.053	0.065	0.030	0.036
Kidney	0.106	0.119	0.060	0.067
Poultry (all) – Closest feeding levelc: 0.054 mg/kg bw 0.96 N Layer (highest diet)
Muscle	0.094	0.103	0.107	0.112
Fat	0.021	0.022	0.022	0.025
Liver	0.175	0.188	0.209	0.221
Poultry (layer only) – Closest feeding levelc: 0.054 mg/kg bw 0.96 N Layer
Eggse	0.083	0.093	0.086	0.097

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

^aThe mean residue level for milk and the mean residue levels for eggs and tissues were recalculated at the 1N rate for the median dietary burden.

^bThe mean residue level in milk and the highest residue levels in eggs and tissues, were recalculated at the 1N rate for the maximum dietary burden.

^cClosest feeding level and N dose rate related to the maximum dietary burden.

^dHighest residue level from day 1 to day 28 (daily mean of 3 cows).

^eHighest residue level from day 1 to day 28 (daily mean of 12 laying hens).

^fSince extrapolation from cattle to other ruminants and swine is acceptable, results of the livestock feeding study on ruminants were relied upon to derive the MRL and risk assessment values in sheep and swine.

3) Risk assessment values and MRL proposals reflecting total intake of DFA residues, expressed as DFA (Netherlands, 2019)

Animal commodity	Estimated value at 1N		MRL proposal US scenario (mg/kg)
	STMR (mg/kg)	HR (mg/kg)
Cattle muscle	0.268	0.308	0.4
Cattle fat	0.277	0.426	0.5
Cattle liver	0.248	0.303	0.4
Cattle kidney	0.414	0.462	0.5
Cattle milk	0.063	0.063	0.07
Sheep muscle	n.c.	n.c.	n.c.
Sheep fat	n.c.	n.c.	n.c.
Sheep liver	n.c.	n.c.	n.c.
Sheep kidney	n.c.	n.c.	n.c.
Sheep milk	n.c.	n.c.	n.c.
Swine muscle	0.042	0.052	0.06
Swine fat	0.044	0.073	0.08
Swine liver	0.034	0.039	0.04
Swine kidney	0.06	0.067	0.07
Poultry muscle	0.102	0.109	0.15
Poultry fat	0.025	0.028	0.03
Poultry liver	0.185	0.198	0.2
Eggs	0.08	0.09	0.09

STMR: supervised trials median residue; HR: highest residue; MRL: maximum residue level; n.c.: not calculated.

B.3. Consumer risk assessment

B.4. Recommended MRLs

Codea	Commodity	Existing EU MRLb (mg/kg)	Proposed EU MRL (mg/kg)	Comment/justification
Enforcement residue definition 1: Flupyradifurone
110010	Grapefruit	0.01a	No proposal or 3 Further risk management discussion	Insufficient residue trials in grapefruit data to support the import tolerance request (US GAP). Extrapolation from oranges to grapefruit could be considered by risk managers. US tolerance: 3 mg/kg Risk for consumers unlikely
110020	Oranges		3	The submitted data are sufficient to derive an import tolerance (US GAP). Risk for consumers unlikely
110030	Lemons		1.5
110040	Limes
110050	Mandarins
120000	Tree nuts	0.01a	0.02	The submitted data are sufficient to derive an import tolerance (US/Canadian GAP). Risk for consumers unlikely
130010	Apples	0.4	0.5 or 0.6	The submitted data are sufficient to derive an import tolerance (US/Canadian GAP). The MRL proposal derived from the merged data set of trials in apples and pears is 0.6 mg/kg. Considering that a statistical testing demonstrated that the two data sets belong to different populations, the setting of separate MRLs for pears (0.8 mg/kg) and apples (0.5 mg/kg), with extrapolation to quinces, medlars and loquat should be discussed by risk managers. The US/Canadian MRL is 0.7 mg/kg. Risk for consumers unlikely
130020	Pears		0.8 or 0.6
130030	Quinces		0.5 or 0.6 Further risk management discussion
130040	Medlars
130050	Loquats
151000	Grapes (wine and table grapes)	0.8	3	The submitted data are sufficient to derive an import tolerance (US/Canadian GAP). Risk for consumers unlikely
154010	Blueberries	0.01a	4	The submitted data are sufficient to derive an import tolerance (US/Canadian GAP). Risk for consumers unlikely
161030	Table olives	0.01a	5	The submitted data are sufficient to support the intended SEU uses. Risk for consumers unlikely
162040	Prickly pear (cactus fruit)	0.01a	No proposal	Insufficient residue data to support the import tolerance request
211000	Potatoes	0.01a	0.05	The submitted data are sufficient to derive an import tolerance (US/Canadian GAP). Risk for consumers unlikely
212000	Tropical root and tuber vegetables
213000	Other root and tuber vegetables except sugar beet	0.01a	0.9	The submitted data are sufficient to derive an import tolerance (US/Canadian GAP). Risk for consumers unlikely
231010	Tomato	0.7	No proposal	The submitted data suggest an import tolerance of 1 mg/kg (US/Canadian GAP). However, an acute consumer intake concern could not be excluded, considering the residues from primary crop treatment and residues taken up via roots (rotational crop). The US/Canadian MRL is set at a level of 1.5 mg/kg. The existing MRL is reflecting an existing EU use, for which no consumer intake concern was identified. A modification of the existing MRL is not proposed
231020	Pepper (including chili pepper)	0.9	No change	The data submitted in support of the import tolerance (US/Canadian GAP) are sufficient to derive an MRL proposal which is at the same level as the existing EU MRL reflecting an EU use. Risk for consumers unlikely
231040	Aubergine (eggplant)	0.7	1.0	The submitted data are sufficient to derive an import tolerance (US/Canadian GAP) by extrapolation from tomatoes. Risk for consumers unlikely
233010	Melon	0.01a	No proposal	Insufficient residue trials in melons data to support the import tolerance request (US/Canadian GAP). For the MRL proposal of 0.4 mg/kg derived from a combined residue data set of melons and cucurbits with edible peel, an acute intake consumer risk could not be excluded
234000	Sweet corn	0.01a	0.05	The submitted data are sufficient to derive an import tolerance (US GAP). Risk for consumers unlikely
241000	Flowering brassica	0.01a	0.6	The submitted data are sufficient to support the intended EU outdoor uses. Risk for consumers unlikely
242010	Brussels sprouts	0.01a	0.09	The submitted data are sufficient to support the intended NEU outdoor uses. Risk for consumers unlikely
242020	Head cabbage	0.01a	0.3	The submitted data are sufficient to support the intended EU outdoor uses. Risk for consumers unlikely.
243020	Kales	0.01a	5.0	The submitted data are sufficient to support the intended NEU outdoor use. For the intended SEU use no residue trials were submitted. Risk for consumers unlikely
244000	Kohlrabies	0.01a	0.09	The submitted data are sufficient to support the intended NEU outdoor use. Risk for consumers unlikely
251020	Lettuces	5.0	6.0	The submitted data are sufficient to support the intended EU outdoor uses Risk for consumers unlikely
251030	Escaroles	0.03 (ft.1)	0.07	For the intended NEU and SEU outdoor uses, an MRL of 6 mg/kg and 5 mg/kg, respectively, would be required, but for these proposals an acute consumer intake concerns cannot be excluded MRL required for escaroles grown as rotational crop is 0.07 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
251000 (except 251020 and 251030)	Lettuces and salad plants (except lettuces and escaroles)	0.03 (ft.1)	6.0	The submitted data are sufficient to support the intended EU outdoor uses. The data gap identified in the peer review (ft.1) was sufficiently addressed. Risk for consumers unlikely
252000	Spinach and similar (leaves)	0.03 (ft.1)	6.0	The submitted data are sufficient to support the intended EU outdoor uses. The data gap identified in the peer review (ft.1) was sufficiently addressed Risk for consumers unlikely
254000	Watercresses	0.03 (ft.1)	0.07	MRL proposal reflecting residues taken up via roots for EU soil plateau concentration. The data gap identified in the peer review (ft.1) was sufficiently addressed Risk for consumers unlikely
256000	Herbs and edible flowers	0.03 (ft.1)	6.0	The submitted data are sufficient to support the intended EU outdoor uses The data gap identified in the peer review (ft.1) was sufficiently addressed Risk for consumers unlikely
253000	Grape leaves and similar species	0.03 (ft.1)	Further risk management considerations required	The data gap identified in the peer review (ft.1) was sufficiently addressed. It is however noted that these crops are unlikely to be affected by residue uptake via crop rotation (vine grape is a permanent crop, witloof is not grown in soil). Hence, risk managers could consider the lowering of the existing MRLs
255000	Witloof/ Belgian endives
260010 260030	Beans (with pods) Peas (with pods)	0.01a	0.5	The submitted data are sufficient to support the intended EU outdoor uses Risk for consumers unlikely
260020 260040 260050	Beans (without pods) Peas (without pods) Lupins	0.01a	0.4
270030	Celeries	0.01a	No proposal	The submitted data are sufficient to derive a proposal for an import tolerance of 9 mg/kg (US/Canadian GAP). However, an acute consumer intake concerns could not be excluded
300000	Pulses	0.01a	3.0	The submitted data are sufficient to derive an import tolerance (US/Canadian GAP) which covers the less critical intended EU use Risk for consumers unlikely
401020	Peanuts	0.01a	0.04	The submitted data are sufficient to derive an import tolerance (US/Canadian GAP). Risk for consumers unlikely
401070	Soyabeans	0.01a	1.5
401090	Cotton	0.01a	0.8	The submitted data are sufficient to derive an import tolerance (US GAP) which covers the less critical intended EU use Risk for consumers unlikely
402010	Olives for oil production	0.01a	5	The submitted data are sufficient to support the intended SEU uses Risk for consumers unlikely
500010	Barley	0.01a	3.0	The submitted data are sufficient to derive an import tolerance (US GAP). Risk for consumers unlikely
500080	Sorghum	0.01a	3.0
500090	Wheat	0.01a	1.0
500030	Maize/corn	0.01a	0.02
620000	Coffee	0.05a	1.0	The submitted data are sufficient to derive an import tolerance (Brazilian GAP). Risk for consumers unlikely
640000	Cocoa beans	0.05a	No change	The data submitted in support of import tolerance (Ghana GAP) do not provide evidence that the existing MRL has to be modified
700000	Hops	4.0	No proposal	Insufficient data to support the US import tolerance request
1011010	Swine muscle	0.01a	0.03	MRL proposal based on the calculated EU livestock exposure. Risk for consumers unlikely
1011020	Swine fat	0.01a	0.015
1011030	Swine liver	0.01a	0.08
1011040	Swine kidney	0.01a	0.09
1011050	Swine edible offal	0.01a	0.09
1012010/1015010	Bovine/equine muscle	0.01a	0.3	MRL proposal derived on basis of tolerance established in the USA. The calculated EU livestock exposure results in lower MRL proposals (0.05 mg/kg in muscle, 0.02 mg/kg in fat, 0.3 mg/kg in liver, 0.15 mg/kg in kidney). Risk for consumers unlikely
1012020/1015020	Bovine/equine fat	0.01a	0.2
1012030/1015030	Bovine/equine liver	0.01a	1.0
1012040/1015040	Bovine/equine kidney	0.01a	1.0
1012050/1015050	Bovine/equine edible offal	0.01a	1.0
1013010/1014010	Sheep/goat muscle	0.01a	0.3	MRL proposal derived on basis of tolerance established in the USA. The calculated EU livestock exposure results in lower MRL proposals (0.04 mg/kg in muscle, 0.02 mg/kg in fat, 0.3 mg/kg in liver, 0.15 mg/kg in kidney). Risk for consumers unlikely
1013020/1014020	Sheep/goat fat	0.01a	0.2
1013030/1014030	Sheep/goat liver	0.01a	1.0
1013040/1014040	Sheep/goat kidney	0.01a	1.0
1013050/1014050	Sheep/goat edible offal	0.01a	1.0
1016000	Poultry muscle	0.01a	No change	The calculated livestock dietary burdens do not provide evidence that the existing MRL has to be modified. Risk for consumers unlikely
1016020	Poultry fat	0.01a
1016030	Poultry liver	0.01a
1020010	Milk (cattle)	0.01a	0.15	MRL proposal derived on basis of US tolerance. The calculated EU livestock exposure results in lower MRL proposals (0.03 mg/kg in cattle milk and 0.02 mg/kg in sheep/goat milk). Risk for consumers unlikely
1020020/1020030	Milk (sheep/goat)	0.01a	0.15
1030000	Eggs	0.01a	No change	The calculated livestock dietary burdens do not provide evidence that the existing MRL has to be modified
Enforcement residue definition 2: DFA
110010	Grapefruit	0.02a	No modification or 0.05 Further risk management discussion required	Insufficient residue trials in grapefruit data to support the import tolerance request (US GAP). Extrapolation from oranges to grapefruit could be considered by risk managers Risk for consumers unlikely
110020	Oranges		0.05	The submitted data are sufficient to derive an import tolerance (US GAP). Risk for consumers unlikely
110030	Lemons		0.05
110040	Limes
110050	Mandarins
120000	Tree nuts	0.02a	0.04
130010	Apples	0.03	0.15 or 0.2	The submitted data are sufficient to derive an import tolerance (US/Canadian GAP) The MRL proposal derived from the merged data set of trials in apples and pears is 0.2 mg/kg. Considering that a statistical testing demonstrated that the two data belong to different populations, the separate MRLs for pears (0.3 mg/kg) and apples (0.15 mg/kg), with extrapolation to quinces, medlars and loquat should be discussed by risk managers Risk for consumers unlikely
130020	Pears		0.3 or 0.2
130030	Quinces		0.15 or 0.2 Further risk management discussion required
130040	Medlars
130050	Loquats
151000	Grapes (wine and table grapes)	0.15	No change	The MRL derived for the reported US/Canadian use is lower (0.08 mg/kg) than the existing EU MRL. Hence, no modification of the existing MRL is required
152000	Strawberries	0.03	0.3	MRL proposal for existing EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.03 mg/kg Risk for consumers unlikely
154010	Blueberries	0.02a	0.05	The submitted data are sufficient to derive an import tolerance for US/Canadian use. Risk for consumers unlikely
161030	Table olives	0.02a	0.15	The submitted data are sufficient to support the intended SEU use Risk for consumers unlikely
162040	Prickly pear (cactus fruit)	0.02a	No proposal	Insufficient residue data to support the import tolerance request
211000	Potatoes	0.09 (ft.1)	0.2c	MRL proposal for US/Canadian use reflecting direct treatment and residues taken up via roots Risk for consumers unlikely Direct treatment of the crop with flupyradifurone (primary crop treatment) would require an MRL of 0.03 mg/kg The data gap identified in the peer review (ft.1) was sufficiently addressed
212000	Tropical root and tuber vegetables
213000	Other root and tuber vegetables except sugar beet	0.09 (ft.1)	0.4c	MRL proposal for US/Canadian use reflecting direct treatment and residues taken up via roots. Risk for consumers unlikely Direct treatment of the crop with flupyradifurone (primary crop treatment) would require an MRL of 0.3 mg/kg The data gap identified in the peer review (ft.1) was sufficiently addressed
220000	Bulb vegetables	0.06 (ft.1)	0.15	MRL proposal reflecting residues taken up via roots for EU soil plateau concentration. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
231010	Tomato	0.15 (ft.1)	0.4	For the authorized US/CAN GAP acute consumer intake concern for primary crop use could not be excluded. Therefore an MRL proposal was derived for existing EU use reflecting direct treatment (foliar application) and residues taken up via roots. Direct treatment of tomatoes with flupyradifurone according to EU GAP would require an MRL of 0.06 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
231020	Pepper (including chili pepper)	0.15 (ft.1)	0.9c	MRL proposal for US/Canadian use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.7 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
231040	Aubergine (eggplant)	0.15 (ft.1)	0.9	MRL proposal for EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.7 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
232000	Cucurbits with edible peel	0.4	0.7	MRL proposal for EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone alone would require an MRL of 0.4 mg/kg Risk for consumers unlikely
233010	Melon	0.15 (ft.1)	0.3	For the authorized US/CAN GAP reflecting direct treatment and residues taken up via roots (MRL proposal of 0.9 mg/kg) an acute consumer intake concern could not be excluded. Therefore, an MRL proposal was derived reflecting the residues taken up via roots in the EU (no primary crop treatment) Direct treatment of the crop with flupyradifurone would require an MRL of 0.15 mg/kg. The data gap identified in the peer review (ft.1) was sufficiently addressed. Risk for consumers unlikely
233020	Pumpkin	0.15 (ft.1)	0.3	MRL proposal reflecting residues taken up via roots in the EU. The data gap identified in the peer review (ft.1) was sufficiently addressed. Risk for consumers unlikely
234000	Sweet corn	0.15 (ft.1)	0.2c	MRL proposal for US/Canadian use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.15 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
241000	Flowering brassica	0.02a	0.7	MRL proposal for EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.5 mg/kg. The submitted data are sufficient to support the MRL proposal. Risk for consumers unlikely
242010	Brussels sprouts	0.02a	0.4	MRL proposal for EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.2 mg/kg. Risk for consumers unlikely
242020	Head cabbage
243020	Kales	0.02a	0.6	MRL proposal for EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.4 mg/kg. Risk for consumers unlikely
244000	Kohlrabies	0.02a	0.4	MRL proposal for EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.2 mg/kg. Risk for consumers unlikely
251020	Lettuces	0.09	0.2	MRL proposal for EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.1 mg/kg. Risk for consumers unlikely
201030	Escaroles	0.04 (ft.1)	0.08	For the use of flupyradifurone (primary crop treatment) an acute consumer intake concerns was identified for cooked escaroles from the primary crop treatment and residue soil uptake. Therefore no MRL proposal was derived for primary crop treatment of escaroles. The MRL proposal is reflecting residues taken up via roots. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
251000 (except 251020 and 251030)	Lettuces and salad plants (except lettuces and escaroles)	0.04 (ft.1)	0.3	MRL proposal for EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.15 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
252000	Spinach and similar (leaves)	0.04 (ft.1)	0.3	MRL proposal for EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.15 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
254000	Watercresses	0.04 (ft.1)	0.08	MRL proposal for EU use reflecting residues taken up via roots. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
256000	Herbs and edible flowers	0.04 (ft.1)	0.3	MRL proposal for EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.15 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
253000	Grape leaves and similar species	0.04 (ft.1)	Further risk management considerations required.	The data gap identified in the peer review (ft.1) was sufficiently addressed, noting that these crops are unlikely to be affected by residue uptake via soil (vine grapes are a permanent crop, witloof are not grown in soil). Hence, a modification of the existing MRL is considered not necessary
255000	Witloof/Belgian endives
260010 260030	Beans (with pods) Peas (with pods)	0.4 (ft.1)	0.9	MRL proposal for EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.08 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
260020 260040 260050	Beans (without pods) Peas (without pods) Lupins	0.4 (ft.1)	1.0	MRL proposal for EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.15 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
270000	Stem vegetables, except celery	0.08 (ft.1)	0.2	MRL proposal for EU use reflecting residues taken up via roots. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
270030	Celeries	0.08 (ft.1)	0.2	For the US/Canadian import tolerance request (primary crop treatment), an acute consumer intake concerns was identified. Therefore, an MRL proposal was derived reflecting residues taken up via roots (rotational crop). Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
300000	Pulses	0.8 (ft.1)	3.0	MRL proposal for intended EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop in EU with flupyradifurone would require an MRL of 0.3 mg/kg. The direct treatment of the crop according to US/CAN GAP would require an MRL of 2 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
401020	Peanuts	0.05 (ft.1)	0.06c	MRL proposal for US/CA use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.03 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
401070	Soyabeans	0.05 (ft.1)	0.7c	MRL proposal for US/CA use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.6 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
401090	Cotton	0.05 (ft.1)	0.08	MRL proposal for intended EU use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone in EU would require an MRL of 0.02 mg/kg. The direct treatment of the crop according to US/CAN GAP would require an MRL of 0.03 mg/kg. The data gap identified in the peer review (ft.1) was sufficiently addressed
401000	Oilseeds, except peanuts, cotton, soyabeans	0.05 (ft.1)	0.05	MRL proposal for EU use reflecting residues taken up via roots. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
402010	Olives for oil production	0.02a	0.15	The submitted data are sufficient to support the MRL proposal Risk for consumers unlikely
500010	Barley	0.3 (ft.1)	0.8c	MRL proposal for US/CA use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.6 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
500080	Sorghum		No change	MRL proposal for US/CA use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.07 mg/kg. Risk for consumers unlikely. The data gap identified in the peer review (ft.1) was sufficiently addressed
500090	Wheat		1.5c	MRL proposal for US/CA use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 1 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
500030	Maize/corn		0.1c	MRL proposal for US/CA use reflecting direct treatment and residues taken up via roots. Direct treatment of the crop with flupyradifurone would require an MRL of 0.05 mg/kg. Risk for consumers unlikely The data gap identified in the peer review (ft.1) was sufficiently addressed
620000	Coffee	0.1a	0.2	The submitted data are sufficient to derive an import tolerance. Risk for consumers unlikely
640000	Cocoa beans	0.1a	0.06	The submitted data are sufficient to derive an import tolerance. Risk for consumers unlikely
700000	Hops	0.3	No proposal	Insufficient data to support the import tolerance request
1011010	Swine muscle	0.1 (ft.1)	0.15	MRL proposal based on the calculated EU livestock exposure. Risk for consumers unlikely
1011020	Swine fat	0.1 (ft.1)	0.1
1011030	Swine liver	0.1 (ft.1)	0.09
1011040	Swine kidney	0.15 (ft.1)	0.2
1011050	Swine edible offal	0.15 (ft.1)	0.2
1012010/1015010	Bovine/equine muscle	0.1 (ft.1)	0.4	MRL proposal based on the calculated US/Canadian livestock exposure The calculated EU livestock exposure results in lower MRL proposals. Risk for consumers unlikely
1012020/1015020	Bovine/equine fat	0.1 (ft.1)	0.5
1012030/1015030	Bovine/equine liver	0.1 (ft.1)	0.4
1012040/1015040	Bovine/equine kidney	0.15 (ft.1)	0.5
1012050/1015050	Bovine/equine edible offal	0.15 (ft.1)	0.5
1013010/1014010	Sheep/goat muscle	0.1 (ft.1)	0.2	MRL proposal reflects EU livestock dietary burden. Risk for consumers unlikely
1013020/1014020	Sheep/goat fat	0.1 (ft.1)	0.15
1013030/1014030	Sheep/goat liver	0.1(ft.1)	0.15
1013040/1014040	Sheep/goat kidney	0.15 (ft.1)	0.3
1013050/1014050	Sheep/goat edible offal	0.15 (ft.1)	0.3
1016000	Poultry muscle	0.05 (ft.1)	0.15	MRL proposal based on the calculated EU livestock exposure. Risk for consumers unlikely
1016020	Poultry fat	0.03 (ft.1)	0.03
1016030	Poultry liver	0.1 (ft.1)	0.3
1020010	Milk (cattle)	0.03 (ft.1)	0.07	MRL proposal based on the calculated US/Canadian livestock exposure. Risk for consumers unlikely
1020020	Milk (sheep)	0.03 (ft.1)	0.03	MRL proposal based on the calculated EU livestock exposure. Risk for consumers unlikely
1030000	Eggs	0.03 (ft.1)	0.1

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

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

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

^bMRL according to Commission Regulation (EU) 2016/1902 of 27 October 2016.

^cMRL proposals do not take into account the theoretical worst‐case scenario for uptake of DFA residues via soil in crops growth in rotation after three seasonal soil treatments according to the critical US GAP reported in the framework of this application.

^ft.1The European Food Safety Authority identified some information on rotational crops 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 6 April 2018, or, if that information is not submitted by that date, the lack of it. ((Footnote related to data gap No 1).

Appendix C – Pesticide Residue Intake Model (PRIMo)

1.

Scenario 1:

Scenario 2:

Fall‐back MRL:

Appendix D – Input values for the exposure calculations

D.1. Livestock dietary burden calculations

a) Feeding of animals in EU considering primary and rotational crops grown in the EU as well as imported feed items from the USA and their by‐products

Flupyradifurone

Feed commodity	Median dietary burden		Maximum dietary burden
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Apple, wet pomace	0.18	STMR × PF (1.6) (EFSA, 2015)	0.18	STMR × PF (1.6) (EFSA, 2015)
Citrus, dried pulp	2.07	STMR (mandarins) × PF (4.6)	2.07	STMR (mandarins) × PF (4.6)
Head cabbage	0.05	STMR (SEU)	0.13	HR (SEU)
Kale leaves	0.66	STMR	1.9	HR
Potato culls, cassava/tapioca roots	0.01	STMR	0.04	HR
Potato process waste	0.2	STMR × PF (20)a	0.2	STMR × PF (20)a
Potato dried pulp	0.38	STMR × PF (38)a	0.38	STMR × PF (38)a
Carrot culls, swede, roots, turnip roots	0.02	STMR	0.6	HR
Dry beans, lupins, cowpeas, peas	0.57	STMR (US)	0.57	STMR (US)
Lupin seed meal	0.63	STMR × PF (1.1)a	0.63	STMR × PF (1.1)a
Peanut meal	0.02	STMR × PF (2)a	0.02	STMR × PF (2)a
Soyabean seed	0.06	STMR	0.06	STMR
Soyabean meal	0.07	STMR × PF (1.1)	0.07	STMR × PF (1.1)
Soyabean hulls	0.04	STMR × PF (0.6)	0.04	STMR × PF (0.6)
Cotton seed	0.02	STMR (US)	0.02	STMR (US)
Cotton seed meal	0.02	STMR × PF (1b	0.02	STMR × PF (1)b
Barley grain	0.45	STMR	0.45	STMR
Barley, brewer's grain	0.45	STMR × PF (1)b	0.45	STMR × PF (1)b
Maize grain	0.01	STMR	0.01	STMR
Maize, milled by‐products, hominy meal, gluten feed, gluten meal	0.01	STMR × PF (1)b	0.01	STMR × PF (1)b
Sorghum grain	0.51	STMR	0.51	STMR
Wheat grain	0.15	STMR	0.15	STMR
Distiller's grain dried (from wheat)	0.50	STMR × PF (3.3)a	0.50	STMR × PF (3.3)a
Wheat gluten meal	0.15	STMR × PF (1)b	0.15	STMR × PF (1)b
Wheat, milled by‐products	0.36	STMR × PF (bran, 2.4)	0.36	STMR × PF (bran, 2.4)

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

^aFor potato process waste, potato dried pulp, lupin seed meal, peanut meal, and distiller's grain in the absence of processing factors supported by data, default processing factors of 20, 38, 1.1, 2 and 3.3 were respectively included in the calculation to consider the potential concentration of residues in these commodities.

^bNo concentration of residues expected according to processing studies provided (Netherlands, 2019).

Difluoroacetic acid (DFA)

Feed commodity	Median dietary burden		Maximum dietary burden
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Apple, wet pomace	0.08	STMR × PFb (EFSA, 2015)	0.08	STMR × PFb (EFSA, 2015)
Citrus, dried pulp	0.03	STMR (mandarins) × PF (1.5)	0.03	STMR (mandarins) × PF (1.5)
Head cabbage	0.15	STMR + STMR (brassica rotational crop (RC) at EU plateau)	0.22	HR + HR (brassica rotational crop (RC) at EU plateau)
Kale leaves	0.23	STMR + STMR (brassica RC at EU plateau)	0.33	HR + HR (brassica RC at EU plateau)
Potato culls, cassava/tapioca roots	0.08	STMR (potato RC at EU plateau)	0.18	HR (potato RC at EU plateau)
Potato process waste, dried pulp	0.08	STMR (potato RC at EU plateau) × PF (1)b	0.18	HR (potato RC at EU plateau) × PF (1)b
Carrot culls, swede, roots, turnip roots	0.07	STMR + STMR (carrot/turnip RC at US plateau	0.25	HR+ HR (carrot/turnip RC at US plateau
Dry lupins, cowpeas, peas, beans	1.14	STMR + STMR (pea RC at EU plateau)	1.14	STMR + STMR (pea RC at EU plateau)
Lupin seed meal	1.25	STMR pea + STMR (pea RC at EU plateau) × PF (1.1)a	1.25	STMR pea + STMR (pea RC at EU plateau) × PF (1.1)a
Peanut meal	0.08	STMR (peanut) + STMR (rape seed RC at US plateau × PF (2)a	0.08	STMR (peanut) + STMR (rape seed RC at US plateau × PF (2)a
Linseed, rapeseed, safflower, sunflower meal	0.06	STMR (rape seed RC at EU plateau) × PF (2) a	0.06	STMR (rape seed RC at EU plateau) × PF (2)a
Soyabean seed	0.05	STMR + STMR (RC rape seed at NA plateau)	0.05	STMR + STMR (RC rape seed at NA plateau)
Soyabean meal	0.07	STMR (soyabean seed) + STMR (rape seed RC at NA plateau) × PF (1.3)	0.07	STMR (soyabean seed) + STMR (rape seed RC at NA plateau) × PF (1.3)
Soyabean hulls	0.05	STMR (soyabean seed) + STMR (rape seed RC at NA plateau) × PF (0.9)	0.05	STMR (soyabean seed) + STMR (rape seed RC at NA plateau) × PF (0.9)
Cotton seed	0.05	STMR+ STMR (rape seed RC at EU plateau)	0.05	STMR+ STMR (rape seed RC at EU plateau)
Cotton seed meal	0.07	STMR (rape seed RC at EU plateau) × PF (1.3)	0.07	STMR (rape seed RC at EU plateau) × PF (1.3)
Barley, oat grain	0.19	STMR (barley grain) + STMR (barley grain RC at NA plateau)	0.19	STMR (barley grain) + STMR (barley grain RC at NA plateau)
Barley, brewer`s grain	0.19	STMR barley grain + STMR (barley grain RC at NA plateau) × PF (1)b	0.19	STMR barley grain + STMR (barley grain RC at NA plateau) × PF (1)b
Maize grain, milled by‐products, hominy meal, gluten feed, gluten meal	0.06	STMR + STMR (maize grain RC at NA plateau) × PF (1)b	0.06	STMR + STMR (maize grain RC at NA plateau) × PF (1)b
Sorghum grain	0.11	STMR + STMR (barley grain RC at NA plateau)	0.11	STMR + STMR (barley grain RC at NA plateau)
Wheat,	0.25	STMR (wheat grain) + STMR (barley grain RC at NA plateau)	0.25	STMR (wheat grain) + STMR (barley grain RC at NA plateau)
Triticale, millet grain	0.09	STMR (barley grain RC at NA plateau)	0.09	STMR (barley grain RC at NA plateau)
Distiller's grain dried (from wheat)	0.83	STMR (wheat grain, see above) × PF (3.3)a	0.83	STMR (wheat grain, see above) × PF (3.3)a
Wheat gluten meal	0.10	STMR (wheat grain, see above) × PF (0.4)	0.10	STMR (wheat grain, see above) × PF (0.4)
Wheat, milled by‐products	0.27	STMR × PF (bran, 1.07)	0.27	STMR × PF (bran, 1.07)
Forages of alfalfa, clover, trefoil, grass, cereals (except maize), oilseeds (except rape) and legumes, clover silage	0.04	STMR (barley forage RC at EU plateau)	0.09	HR (barley forage RC at EU plateau)
Alfalfa hay, meal	0.10	STMR (barley forage RC at EU plateau) × PF (2.5)a	0.23	HR (barley forage RC at EU plateau) × PF (2.5)a
Alfalfa silage	0.04	STMR (barley forage RC at EU plateau) × PF (1.1)a	0.1	HR (barley forage RC at EU plateau) × PF (1.1)a
Rape forage	0.07	STMR (rape forage RC at EU plateau)	0.18	HR (rape forage RC at EU plateau)
Maize forage	0.03	STMR (maize forage RC at EU plateau)	0.04	HR (maize forage RC at EU plateau)
Straw of cereals	0.06	STMR (barley straw RC at EU plateau)	0.07	HR (barley straw RC at EU plateau)
Silage of cereals	0.05	STMR (barley forage RC at EU plateau) × PF (1.3)a	0.12	HR (barley forage RC at EU plateau) × PF (1.3)a
Grass, pea silage	0.06	STMR (barley forage RC at EU plateau) × PF (1.6)a	0.14	HR (barley forage RC at EU plateau) × PF (1.6)a
Soyabean, sorghum silage	0.02	STMR (barley forage RC at EU plateau) × PF (0.5)a	0.05	HR (barley forage RC at EU plateau) × PF (0.5)a
Clover, oat hay	0.12	STMR (barley forage RC at EU plateau) × PF (3)a	0.27	HR (barley forage RC at EU plateau) × PF (3)a
Cowpea, triticale hay	0.12	STMR (barley forage RC at EU plateau) × PF (2.9)a	0.26	HR (barley forage RC at EU plateau) × PF (2.9)a
Grass, pea, wheat hay	0.14	STMR (barley forage RC at EU plateau) × PF (3.5)a	0.32	HR (barley forage RC at EU plateau) × PF (3.5)a
Soyabean hay	0.06	STMR (barley forage RC at EU plateau) × PF (1.5)a	0.14	HR (barley forage RC at EU plateau) × PF (1.5)a
Trefoil hay	0.11	STMR (barley forage RC at EU plateau) × PF (2.8)a	0.25	HR (barley forage RC at EU plateau) × PF (2.8)a
Maize stover	0.02	STMR (maize stover RC at EU plateau)	0.05	HR (maize stover RC at EU plateau)
Tops of beets and turnips	0.02	STMR (lettuce RC at EU plateau)	0.08	HR (lettuce RC at EU plateau)

STMR: supervised trials median residue; HR: highest residue; PF: processing factor; RC: rotational crop; NA: North America; EU: European Union.

^aFor lupin seed meal, peanut/linseed/rapeseed/safflower/sunflower meal, distiller`s grain, alfalfa hay/meal, alfalfa silage, silage of cereals, grass/pea silage, soyabean/sorghum silage, clover/oat hay, cowpea/triticale hay, grass/pea/wheat hay, soyabean hay and trefoil hay in the absence of processing factors supported by data, default processing factors of 1.1, 2, 3.3, 2.5, 1.1, 1.3, 1.6, 0.5, 3.0, 2.9, 3.5, 1.5 and 2.8 were respectively included in the calculation to consider the potential concentration of residues in these commodities.

^bNo accumulation of residues expected according to processing studies (EFSA, 2015; Netherlands, 2017).

b) Feeding of animals in the USA (to estimate residue levels of DFA in imported food commodities of animal origin) (Netherlands, 2019 )

Difluoroacetic acid (DFA), expressed as DFA

Feed Commodity	Input value (mg/kg)	Comment
Alfalfa forage	1.1	HR (primary crop)
Alfalfa hay	5.2	HR (primary crop)
Alfalfa silage	1.3	HR (forage, corrected for DM)
Barley hay	0.67	HR (primary crop)
Barley	0.25	HR (primary crop)
Clover, forage	0.21	HR (rotational crop barley green material)
Clover hay	0.22	HR (rotational crop barley straw)
Clover silage	0.21	HR (rotational crop barley green material)
Corn, field, forage/silage	0.21	HR (rotational crop barley green material)
Corn, field, stover	0.11	HR (primary crop)
Corn, sweet, forage	0.21	HR (rotational crop barley green material)
Corn, sweet, stover	0.11	HR (primary crop)
Grass (fresh)	0.21	HR (rotational crop barley green material)
Pea vines	1.5	HR (primary crop)
Pea hay	1.6	HR (primary crop)
Pea silage	2.4	HR (primary crop, pea vines, corrected for DM)
Peanut hay	0.024	HR (primary crop)
Sorghum forage	0.21	HR (rotational crop barley green material)
Sorghum stover	0.22	HR (rotational crop barley straw)
Sorghum silage	0.13	HR (rotational crop barley green material corrected for DM)
Soyabean forage	0.8	HR (primary crop)
Soyabean hay	2.7	HR (primary crop)
Soyabean silage	0.43	HR (forage, corrected for DM)
Wheat forage	0.21	HR (rotational crop barley green material)
Wheat hay	0.71	HR (primary crop)
Wheat straw	0.55	HR (primary crop)
Carrot culls	0.20	HR (primary crop)
Potato culls	0.24	HR (rotational crop potato)
Barley grain	0.31	STMR (rotational crop barley grain)
Maize grain	< 0.017	STMR (primary crop)
Cotton, undelinted seed	< 0.017	STMR (primary crop)
Pea seed	1.7	STMR (rotational crop pea)
Sorghum grain	0.31	STMR (rotational crop barley grain)
Soyabean seed	1.7	STMR (rotational crop pea)
Wheat grain	0.31	STMR (rotational crop barley grain)
Almond hulls	0.018	STMR (primary crop)
Apple, wet pomace	0.014	STMR × PF (0.8)
Barley bran fraction	0.56	STMR (rotational crop barley grain) × PF (1.8 for pearl barley rub off)
Citrus, dried pulp	0.027	STMR × PF (4.1)
Corn, field, aspirated grain fraction	0.13	STMR (rotational crop) × PF (1)a
Cotton meal	0.022	STMR (primary crop) × PF (1.3)
Cotton hulls	0.017	STMR (primary crop) × PF (1)a
Cotton, gin by‐products	0.33	STMR (primary crop)
Peanut meal	0.022	STMR (primary crop) × PF (1.3)
Soyabean aspirated grain fraction	0.20	STMR (primary crop) × PF (6.5)
Soyabean meal	2.2	STMR (rotational crop pea) × PF (1.3)
Wheat, aspirated grain fraction	2.1	STMR (rotational crop barley grain) × PF (6.9)
Wheat, milled by‐products	0.34	STMR (rotational crop barley grain) × PF (1.1)

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

^aNo accumulation of residues expected according to processing studies (EFSA, 2015; Netherlands, 2017).

D.2. Consumer risk assessment

a) Scenario 1: Exposure to residues from the intake of primary crops and commodities of animal origin

	Chronic risk assessment		Acute risk assessment
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Risk assessment residue definition: flupyradifurone and the DFA, expressed as flupyradifurone
Oranges, grapefruit	0.14	STMR × PFa (0.4)	0.88	HR × PFa (0.4)
Lemons, limes	0.14	STMR × PFa (0.4)	0.29	HR × PFa (0.4)
Mandarins	0.2	STMR × PFa (0.4)	0.396	HR × PFa (0.4)
Tree nuts	0.06	STMR	0.11	HR
Pome fruit	0.28	STMR	0.69	HR
Table and wine grapes	0.62	STMR	1.95	HR
Strawberries	0.15	STMR (EFSA, 2016)	0.22	HR (EFSA, 2016)
Blackberries, raspberries	0.39	STMR (EFSA, 2016)	0.66	HR (EFSA, 2016)
Blueberries	0.86	STMR	2.59	HR
Table olives	0.5	STMR	3.3	HR
Potatoes, tropical root and tuber vegetables	0.06	STMR	0.10	HR
Root and tuber vegetables (except sugar beets)	0.15	STMR	0.68	HR
Tomatoes, aubergines	0.20	STMR	1.8	HR
Tomatoes (fall‐back MRL)	–	–	0.46	HR primary crop (EFSA, 2015)
Peppers	0.24	STMR	1.65	HR
Cucurbits (edible peel)	0.13	STMR (EFSA, 2015)	0.66	HR (EFSA, 2015)
Watermelon	0.065	STMR pulp (EFSA, 2015)	0.199	HR pulp (EFSA, 2015)
Melons	0.17	STMR	1.45	HR
Melons (fall‐back MRL)	–	–	0	No primary crop treatment
Sweet corn	0.13	STMR	0.25	HR
Broccoli, cauliflower	0.27	STMR	0.82	HR
Brussels sprouts	0.16	STMR	0.31	HR
Head cabbage	0.21	STMR	0.29	HR
Kale	0.97	STMR	2.2	HR
Kohlrabi	0.19	STMR	0.25	HR
Lettuce	1.12	STMR	3.2	HR
Lettuce and other salad plants (except lettuce and escarole); Herbs and edible flowers; Spinach and similar	1.36	STMR	3.2	HR
Escaroles (fall‐back MRL)	–	–	0	No primary crop treatment
Legume vegetables (with pods)	0.19	STMR	0.37	STMR
Legume vegetables (without pods)	0.16		0.36
Celeries	2.19	STMR	6.0	HR
Celeries (fall‐back MRL)	–	–	0	No primary crop treatment
Pulses	0.79	STMR	0.79	STMR
Peanuts	0.06	STMR	0.06	STMR
Soyabean	0.15	STMR	0.15	STMR
Cotton seed	0.17	STMR	0.17	STMR
Olives for oil production	0.5	STMR	3.3	HR
Barley grain	0.81	STMR	0.81	STMR
Sorghum grain	0.64	STMR	0.64	STMR
Wheat grain	0.65	STMR	0.65	STMR
Maize grain	0.06	STMR	0.06	STMR
Coffee beans	0.24	STMR	0.24	STMR
Cocoa beans	0.07	STMR	0.11	HR
Hops	1.08	STMR (EFSA, 2015)	2.3	HR (EFSA, 2015)
Cattle, equine muscle	1.10	Tolerance US flupyradifurone + STMR DFAb (US intake) (Netherlands, 2019)	1.22	Tolerance US flupyradifurone + HR DFAb (US intake) (Netherlands, 2019)
Cattle, equine fat	1.03	Tolerance US flupyradifurone + STMR DFAb (US intake) (Netherlands, 2019)	1.48	Tolerance US flupyradifurone + HR DFAb (US intake) (Netherlands, 2019)
Cattle, equine liver	1.74	Tolerance US flupyradifurone + STMR DFAb (US intake) (Netherlands, 2019)	1.91	Tolerance US flupyradifurone + HR DFAb (US intake) (Netherlands, 2019)
Cattle, equine kidney, edible offal	2.24	Tolerance US flupyradifurone + STMR DFAb (US intake) (Netherlands, 2019)	2.39	Tolerance US flupyradifurone + HR DFAb (US intake) (Netherlands, 2019)
Cattle, equine milk	0.34	Tolerance US flupyradifurone + STMR DFAb (US intake) (Netherlands, 2019)	0.34	Tolerance US flupyradifurone + STMR DFAb (US intake) (Netherlands, 2019)
Sheep, goat muscle	0.54	Tolerance US flupyradifurone + STMR DFAb (EU intake)	0.84	Tolerance US flupyradifurone + HR DFAb (EU intake)
Sheep, goat fat	0.38	Tolerance US flupyradifurone + STMR DFAb (EU intake)	0.65	Tolerance US flupyradifurone + HR DFAb (EU intake)
Sheep, goat liver	1.21	Tolerance USA flupyradifurone + STMR DFAb (EU intake)	1.39	Tolerance US flupyradifurone + HR DFAb (EU intake)
Sheep, goat kidney, edible offal	1.39	Tolerance US flupyradifurone + STMR DFAb (EU intake)	1.72	Tolerance US flupyradifurone + HR DFAb (EU intake)
Sheep, goat milk	0.18	Tolerance US flupyradifurone + STMR DFAb (EU intake)	0.18	Tolerance US flupyradifurone + STMR DFAb (EU intake)
Swine muscle	0.16	STMR DFAb (EU intake) + STMR FL (EU intake)	0.38	HR DFAb (EU intake) + HR FL (EU intake)
Swine fat	0.14	Tolerance US flupyradifurone + STMR DFAb (US intake) (Netherlands, 2019)	0.31	HR DFAb (EU intake) + HR FL (EU intake)
Swine liver	0.14	STMR DFAb (EU intake) + STMR FL (EU intake)	0.35	HR DFAb (EU intake) + HR FL (EU intake)
Swine kidney, edible offal	0.23	STMR DFAb (EU intake) +STMR FL (EU intake)	0.57	HR DFAb (EU intake) + HR FL (EU intake)
Poultry muscle	0.32	Tolerance US flupyradifurone + STMR DFAb (US intake) (Netherlands, 2019)	0.38	HR DFAb (EU intake) + HR FL (EU intake)
Poultry fat	0.09	Tolerance US flupyradifurone + STMR DFAb (US intake) (Netherlands, 2019)	0.09	HR DFAb (EU intake) + HR FL (EU intake)
Poultry liver, kidney, edible offal	0.68	STMR DFAb (EU intake) +STMR FL (EU intake)	0.69	HR DFAb (EU intake) + HR FL (EU intake)
Eggs	0.25	Tolerance US flupyradifurone + STMR DFAb (US intake) (Netherlands, 2019)	0.31	HR DFAb (EU intake) + HR FL (EU intake)

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

^aAverage processing factor from two studies.

^bExpressed as flupyradifurone; recalculation using molecular weight conversion factor of 3.

b) Scenario 2: exposure to flupyradifurone and DFA residues (expressed as flupyradifurone) from rotational crops

	Chronic risk assessment		Acute risk assessment
	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Strawberries	0.33	STMR DFA RC strawberry at EU plateau	0.74	HR DFA RC strawberry at EU plateau
Potatoes, tropical root and tuber vegetables	0.23	STMR DFA in RC potatoes at EU plateau	0.54	HR DFA in RC potatoes at EU plateau
Root and tuber vegetables (except sugar beets)	0.11	STMR DFA in RC carrot/turnip at EU plateau	0.21	HR DFA in RC carrot/turnip at EU plateau
Bulb vegetables	0.13	STMR DFA in RC onions at EU plateau	0.33	HR DFA in RC onions at EU plateau
Tomatoes, aubergines, peppers	0.62	STMR DFA in RC cucumber at EU plateau	0.85	HR DFA in RC cucumber at EU plateau
Tomatoes (fall back MRL)	–	–	0.85	HR DFA in RC cucumber at EU plateau
Cucurbits (edible peel)	0.62	STMR DFA in RC cucumber at EU plateau	0.85	HR DFA in RC cucumber at EU plateau
Cucurbits (inedible peel)	0.62	STMR DFA in RC cucumbers at EU plateau	0.85	HR DFAa in RC cucumbers at EU plateau
Melon (fall back MRL)	–	–	0.85	HR DFAa in RC cucumbers at EU plateau
Sweet corn	0.17	STMR DFA in RC maize grain at EU plateau	0.23	HR DFA in RC maize grain at EU plateau
Brassica vegetables	0.3	STMR DFA in RC cauliflower/broccoli at EU plateau	0.4	HR DFA in RC cauliflower/broccoli at EU plateau
Lettuce and other salad plants Herbs and edible flowers Spinach and similar	0.08	STMR flupyradifurone (0.01 mg/kg) at EU plateau + STMR DFA in RC lettuce at EU plateau	0.29	HR flupyradifurone (0.06 mg/kg) lettuce at EU plateau + HR DFA in RC lettuce at EU plateau
Escaroles (fall‐back MRL)	–	–	0.29	HR flupyradifurone (0.06 mg/kg) lettuce at EU plateau + HR DFA in RC lettuce at EU plateau
Grape leaves, watercress, witloofs/Belgian endives	0.08	STMR flupyradifurone (0.01 mg/kg) at EU plateau + STMR DFA in RC lettuce at EU plateau	0.29	HR flupyradifurone (0.06 mg/kg) lettuce at EU plateau + HR DFA in RC lettuce at EU plateau
Legume vegetables	0.98	STMR DFA in RC beans with pods at EU plateau	2.27	HR DFA in RC beans with pods at EU plateau
Stem vegetables	0.14	STMR DFA in RC leek at EU plateau	0.47	HR DFA in RC leek at EU plateau
Celeries (fall‐back MRL)	–	–	0.47	HR DFA in RC leek at EU plateau
Pulses	3.19	STMR DFA in RC peas (dry) at EU plateau	3.19	STMR DFA in RC peas (dry) at EU plateau
Oilseeds	0.09	STMR DFA in RC rapeseed at EU plateau	0.09	STMR DFA in RC rapeseed at EU plateau
Cereals	0.43	STMR flupyradifurone (0.01 mg/kg) barley grain at EU plateau + STMR DFA (0.42 mg/kg) in RC barley grain at EU plateau	0.43	STMR flupyradifurone (0.01 mg/kg) barley grain at EU plateau + STMR DFA (0.42 mg/kg) in RC barley grain at EU plateau

STMR: supervised trials median residue; HR: highest residue; RC: rotational crop; EU: European Union.

^aAverage processing factor from two studies.

Appendix F – Used compound codes

1.

Code/trivial namea	IUPAC name/SMILES notation/InChiKeyb	Structural formulac
flupyradifurone	4‐{[(6‐chloro‐3‐pyridyl)methyl](2,2‐difluoroethyl)amino}furan‐2(5H)‐one FC(F)CN(Cc1ccc(Cl)nc1)C1=CC(=O)OC1 QOIYTRGFOFZNKF‐UHFFFAOYSA‐N
DFA	difluoroacetic acid FC(F)C(=O)O PBWZKZYHONABLN‐UHFFFAOYSA‐N
6‐CNA	6‐chloropyridine‐3‐carboxylic acid OC(=O)c1cnc(Cl)cc1 UAWMVMPAYRWUFX‐UHFFFAOYSA‐N
CHMP 6‐CPA (6‐chloro‐picolylalcohol)	(6‐chloropyridin‐3‐yl)methanol OCc1cnc(Cl)cc1 GOXYBEXWMJZLJB‐UHFFFAOYSA‐N
acetyl‐AMCP	N‐[(6‐chloropyridin‐3‐yl)methyl]acetamide Clc1ccc(CNC(C)=O)cn1 PKLYKZAYVXYVQX‐UHFFFAOYSA‐N
flupyradifurone‐hydroxy M8 metabolite	4‐{[(6‐chloropyridin‐3‐yl)methyl](2,2‐difluoroethyl)amino}‐5‐hydroxyfuran‐2(5H)‐one VCISBQOTABLQEA‐UHFFFAOYSA‐N OC1OC(=O)C=C1N(CC(F)F)Cc1ccc(Cl)nc1

^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 July 2019).

^cACD/ChemSketch 2019.1.1 ACD/Labs 2019 Release (File version C05H41, Build 110712, 24 July 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, modification of existing maximum residue levels and evaluation of confirmatory data following the Article 12 MRL review for flupyradifurone and DFA. EFSA Journal 2020;18(6):6113, 141 pp. 10.2903/j.efsa.2020.6133