Review of the existing maximum residue levels for lufenuron according to Article 12 of Regulation (EC) No 396/2005

European Food Safety Authority (EFSA)

doi:10.2903/j.efsa.2016.4652

. 2017 Jan 5;15(1):e04652. doi: 10.2903/j.efsa.2016.4652

Review of the existing maximum residue levels for lufenuron according to Article 12 of Regulation (EC) No 396/2005

European Food Safety Authority (EFSA)

PMCID: PMC7010094 PMID: 32625251

Abstract

According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at the European level for the pesticide active substance lufenuron. To assess the occurrence of lufenuron residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission as well as the authorisations reported by the Member States (including the supporting residues data) and import tolerances. Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Although no apparent risk to consumers was identified, some information required by the regulatory framework was missing. Hence, the consumer risk assessment is considered indicative only and some MRL proposals derived by EFSA still require further consideration by risk managers.

Keywords: lufenuron, MRL review, Regulation (EC) No 396/2005, consumer risk assessment, benzoylurea, insecticide

Summary

Lufenuron was included in Annex I to Directive 91/414/EEC on 1 January 2010 by Commission Directive 2009/77/EC, and has been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011. As the active substance was approved after the entry into force of Regulation (EC) No 396/2005 on 2 September 2008, the European Food Safety Authority (EFSA) is required to provide a reasoned opinion on the review of the existing maximum residue levels (MRLs) for that active substance in compliance with Article 12(1) of the aforementioned regulation. To collect the relevant pesticide residues data, EFSA asked Portugal, designated as the rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile) and to prepare a supporting evaluation report. The PROFile and evaluation report provided by the RMS were made available to the Member States. A request for additional information was addressed to the Member States in the framework of a completeness check period, which was initiated by EFSA on 29 March 2016 and finalised on 29 May 2016. After having considered all the information provided, EFSA prepared a completeness check report which was made available to Member States on 21 June 2016.

Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission and the additional information provided by the RMS and the Member States, EFSA prepared a draft reasoned opinion in August 2016, which was circulated to the Member States for consultation via a written procedure. Comments received by 16 September 2016 were considered during the finalisation of this reasoned opinion. The following conclusions are derived.

The primary crop metabolism of lufenuron was investigated in three different crop categories. Lufenuron was the major compound in all studies and is therefore the only significant residue expected in plant commodities. The metabolic profile observed in the confined rotational crops studies was similar and hydrolysis studies demonstrated that processing by pasteurisation, baking/brewing/boiling and sterilisation is not expected to have a significant impact on the composition of residues. Therefore, the following general residue definition for monitoring and risk assessment is proposed: lufenuron (any ratio of constituent isomers). A validated analytical method for enforcement of the proposed residue definition in the four main analytical matrices is available.

The available residue trials were sufficient to derive (tentative) MRL proposals as well as risk assessment values for all commodities under evaluation, except for strawberries, gherkins, lettuces and other salad plants including Brassicaceae where the available data were insufficient.

In the confined rotational crop studies, the low residues which were observed in lettuce and carrots were deemed to be due to soil contamination. Due to the very high log K _ow, it was concluded that lufenuron can easily be adsorbed into the soil and not taken up by plants. It was therefore concluded that significant residues are not expected in the succeeding crops and rotational crop field trials were therefore not required.

Studies investigating the magnitude of residues in several processed commodities of grapes, tomatoes, apples and melons (peeled) are available. Robust processing factors were derived for apples (juice, dry pomace and sauce), wine grapes (juice and must), raisins and tomatoes (peeled and canned, sauce and juice) as well as for peeled melon. The other processing factors derived in this review are only indicative because the available data sets are limited.

Only the dietary burden calculated for cattle (all) was found to exceed the trigger value of 0.1 mg/kg dry matter (DM).

The metabolism of lufenuron was investigated in goats and laying hens and lufenuron was the only significant residue. Therefore, as for primary crops, lufenuron (any ratio of constituent isomers) is an appropriate residue definition for monitoring and risk assessment in commodities of animal origin. This residue definition is fat soluble. A validated analytical method for the determination of lufenuron and its isomers in muscle, fat, milk and eggs is available but a validation of this method on liver and kidney is still missing.

The feeding study performed on dairy cow was fully reliable to derive MRL and risk assessment values bovine products. According to the OECD guidance, these values also apply to equine products. In the absence of validated analytical method for liver and kidney, MRLs and risk assessment values derived for these tissues remain tentative. MRLs for sheep, swine and poultry products as well as for milk were not derived because the related groups of livestock are not expected to be exposed to significant levels of lufenuron residues.

Chronic consumer exposure resulting from the authorised uses reported in the framework of this review was calculated using revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). For cucurbits with inedible peel, the peeling factor derived on melons was taken into account. For those commodities where data were insufficient to derive an MRL, EFSA considered the existing European Union (EU) MRL for an indicative calculation. The highest chronic exposure represented 9.0% of the acceptable daily intake (ADI) (DE child). Acute exposure calculations were not carried out because an acute reference dose (ARfD) was not deemed necessary for this active substance.

Apart from the MRLs evaluated in the framework of this review, internationally recommended codex maximum residue limits (CXLs) have also been established for lufenuron. Additional calculations of the consumer exposure, considering these CXLs, were therefore carried out and the highest chronic exposure represented 24.5% of the ADI (FR toddler).

The above risk assessments were performed disregarding the possible impact of the isomer ratios due to plant or livestock metabolism. Considering, however, that the isomer ratio of the lufenuron is an equimolar mixture of R‐ and S‐enantiomer and that toxicological studies have been carried out according to these specifications, a change in isomer ratios in the residue might, in the worst‐case situation, lead to a duplication of the toxicological burden of the residue. Since the exposure calculations represent less than 50% of the ADI, EFSA concludes that the potential change in isomer ratios in the final residue will not be of concern for the authorised uses reported in the framework of this review. In case future uses of lufenuron would lead to a higher consumer exposure, further information regarding the impact of plant and livestock metabolism on the isomer ratio might be required.

Background

Regulation (EC) No 396/20051 (hereinafter referred to as ‘the Regulation’) establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at the European level. Article 12(1) of that Regulation stipulates that the European Food Safety Authority (EFSA) shall provide within 12 months from the date of the inclusion or non‐inclusion of an active substance in Annex I to Directive 91/414/EEC2 a reasoned opinion on the review of the existing MRLs for lufenuron. As lufenuron was included in Annex I to Council Directive 91/414/EEC on 1 January 2010 by means of Commission Directive 2009/07/EC,3 and has been deemed to be approved under Regulation (EC) No 1107/20094, in accordance with Commission Implementing Regulation (EU) No 540/20115, as amended by Commission Implementing Regulation (EU) No 541/20116, EFSA initiated the review of all existing MRLs for that active substance.

According to the legal provisions, EFSA shall base its reasoned opinion in particular on the relevant assessment report prepared under Directive 91/414/EEC. It should be noted, however, that, in the framework of Directive 91/414/EEC, only a few representative uses are evaluated, whereas MRLs set out in Regulation (EC) No 396/2005 should accommodate all uses authorised within the European Union (EU), and uses authorised in third countries that have a significant impact on international trade. The information included in the assessment report prepared under Directive 91/414/EEC is therefore insufficient for the assessment of all existing MRLs for a given active substance.

To gain an overview of the pesticide residues data that have been considered for the setting of the existing MRLs, EFSA developed the Pesticide Residues Overview File (PROFile). The PROFile is an inventory of all pesticide residues data relevant to the risk assessment and MRL setting for a given active substance. This includes data on:

the nature and magnitude of residues in primary crops;
the nature and magnitude of residues in processed commodities;
the nature and magnitude of residues in rotational crops;
the nature and magnitude of residues in livestock commodities;
the analytical methods for enforcement of the proposed MRLs.

Portugal, the designated rapporteur Member State (RMS) in the framework of Directive 91/414/EEC, was asked to complete the PROFile for lufenuron and to prepare a supporting evaluation report (Portugal, 2010). The PROFile and the supporting evaluation report were submitted to EFSA on 15 December 2010 and made available to the Member States. A request for additional information was addressed to the Member States in the framework of a completeness check period which was initiated by EFSA on 29 March 2016 and finalised on 29 May 2016. Additional evaluation reports were submitted by the EU Reference Laboratories (EURLs), Portugal and Greece (EURLs, 2016; Greece, 2016; Portugal, 2016) and, after having considered all the information provided by the RMS and the Member States, EFSA prepared a completeness check report which was made available to all the Member States on 21 June 2016. Further clarifications were sought from the Member States via a written procedure in June–July 2016.

Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission (codex maximum residue limit; CXLs) and the additional information provided by the Member States, EFSA prepared a draft reasoned opinion in August 2016, which was submitted to the Member States for commenting via a written procedure. All comments received by 16 September 2016 were considered by EFSA during the finalisation of the reasoned opinion.

The evaluation reports submitted by the RMS (Portugal 2010, 2016) and the evaluation reports submitted by the EURLs and Greece (EURLs, 2016; Greece, 2016) are considered as supporting documents to this reasoned opinion and, thus, are made publicly available.

In addition, key supporting documents to this reasoned opinion are the completeness check report (EFSA, 2016a) and the Member States consultation report (EFSA, 2016b). These reports are developed to address all issues raised in the course of the review, from the initial completeness check to the reasoned opinion. Also, the chronic exposure calculations for all crops reported in the framework of this review performed using the EFSA Pesticide Residues Intake Model (PRIMo) and the PROFile are key supporting documents and made publicly available.

Considering the importance of the completeness check and consultation report, all documents are considered as background documents to this reasoned opinion and, thus, are made publicly available.

Terms of Reference

According to Article 12 of Regulation (EC) No 396/2005, EFSA shall provide a reasoned opinion on:

the inclusion of the active substance in Annex IV to the Regulation, when appropriate;
the necessity of setting new MRLs for the active substance or deleting/modifying existing MRLs set out in Annex II or III of the Regulation;
the inclusion of the recommended MRLs in Annex II or III to the Regulation;
the setting of specific processing factors as referred to in Article 20(2) of the Regulation.

The active substance and its use pattern

Lufenuron is the ISO common name for (RS)‐1‐[2,5‐dichloro‐4‐(1,1,2,3,3,3‐hexafluoro‐propoxy)‐ phenyl]‐3‐(2,6‐difluorobenzoyl)‐urea (IUPAC).

Lufenuron belongs to the group of benzoylurea compounds which are used as insecticides, to the class of chitin synthesis inhibitors. It acts mostly by ingestion; larvae are unable to moult, and also cease feeding. Lufenuron is used as a foliar application and bait stations for the control of fruit fly in a range of crops.

The chemical structure of the active substance and its main metabolite are reported in Appendix E.

Lufenuron was evaluated in the framework of Directive 91/414/EEC with Portugal designated as the rapporteur Member State (RMS). The representative uses supported for the peer review process were as an insecticide on grapes and tomatoes. Following the peer review, which was carried out by EFSA (EFSA, 2009), a decision on inclusion of the active substance in Annex I to Directive 91/414/EEC was published by means of Commission Directive 2009/77/EC, which entered into force on 1 January 2010. According to Regulation (EU) No 540/2011, lufenuron is deemed to have been approved under Regulation (EC) No 1107/2009. This approval is restricted to indoor uses or use in outdoor bait stations as an insecticide only. After the Annex I inclusion, confirmatory data in the area of ecotoxicology addressing the gaps identified during the peer review were submitted in the framework of Directive 91/414/EEC. On 21 November 2011, the Standing Committee on the Food Chain and Animal Health agreed that the conclusions of the original risk assessment were not substantially modified by the submitted confirmatory data (European Commission, 2011). No further review by EFSA was considered necessary.

The EU MRLs for lufenuron are established in Annex IIIA of Regulation (EC) No 396/2005 and CXLs for active substance are also established by the Codex Alimentarius Commission (CAC). It is also noted that an MRL on fin fish resulting from the use of lufenuron as a veterinary medicine is laid down in Regulation (EU) No 967/20147. For the purpose of this MRL review, the critical uses of lufenuron currently authorised within the EU, as well as uses authorised in third countries that might have a significant impact on international trade, have been collected by the RMS and reported in the PROFile. The additional good agricultural practices (GAPs) reported by the Member States during the completeness check were also considered. The details of the authorised GAPs for lufenuron are given in Appendix A.

Assessment

EFSA has based its assessment on the PROFile submitted by the RMS, the evaluation report accompanying the PROFile (Portugal, 2010), the draft assessment report (DAR) prepared under Council Directive 91/414/EEC (Portugal, 2006), the conclusion on the peer review of the pesticide risk assessment of the active substance lufenuron (EFSA, 2009), the Joint Meeting on Pesticide residues (JMPR) Evaluation report (FAO, 2015), as well as the evaluation reports submitted during the completeness check (EURLs, 2016; Greece, 2016; Portugal, 2016). The assessment is performed in accordance with the legal provisions of the uniform principles for evaluation and authorisation of plant protection products as set out in Commission Regulation (EU) No 546/20118 and the currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues (European Commission, 1997a, b, c, d, e, f, g, 2000, 2010a,b, 2011 and OECD, 2011, 2013).

More detailed information on the available data and on the conclusions derived by EFSA can be retrieved from the list of end points reported in Appendix B.

1. Residues in plants

1.1. Nature of residues and methods of analysis in plants

1.1.1. Nature of residues in primary crops

The metabolism of lufenuron was investigated in representatives of three different crop categories: fruit crops, leafy crops, and pulses and oilseeds (Portugal, 2006). Lufenuron was the major compound in all studies, which indicate that significant degradation does not occur in plant. Only one minor metabolite CGA 2382779 was identified in head cabbage (0.6% total radioactive residue (TRR) – 0.012 mg eq/kg), cabbage wrapper leaves (3.3% TRR – 0.023 mg eq/kg) and tomatoes (0.2–2% TRR; ≤ 0.002 mg/kg). It was noted that the foliar metabolism study performed on tomatoes was underdosed compared to some of the critical GAPs (cGAPs) reported for indoor conditions (only 30% of the critical authorised application rate). However, in spite of this low dosing, the metabolic picture was clearly elucidated. Lufenuron is a stable and persistent compound and it is the only significant residue found in plant commodities.

1.1.2. Nature of residues in rotational crops

According to the soil degradation studies evaluated in the framework of the peer review, period required for 90% dissipation (DT₉₀) values of lufenuron range between 503 and 1,444 days, which is higher than the trigger value of 100 days (EFSA, 2009). Therefore, further investigation of residues in rotational crops was required.

Two confined rotational crops studies were reported during the peer review of lufenuron (Portugal, 2006). In the first study performed with the application rate of 150 g a.s./ha, the only significant residue identified was lufenuron. This is consistent with the fact that lufenuron is known as an environmentally persistent compound. In the second study performed with the application rate of 130 g a.s./ha, TRR was too low for identification (< 0.005 mg eq/kg) in all investigated crops, at any investigated plant back intervals (PBI) (76, 126, 306 and 331 days after treatment (DAT)).

1.1.3. Nature of residues in processed commodities

The effect of processing on the nature of residues was investigated in the framework of the peer review (Portugal, 2006). Studies were conducted with lufenuron, simulating representative hydrolytic conditions for pasteurisation (20 min at 90°C, pH 4), boiling/brewing/baking (60 min at 100°C, pH 5) and sterilisation (20 min at 120°C, pH 6). From these studies, it was concluded that processing by pasteurisation, baking/brewing/boiling and sterilisation is not expected to have a significant impact on the composition of residues in matrices of plant origin.

1.1.4. Methods of analysis in plants

During the peer review, a multiresidue analytical method using high‐performance liquid chromatography with tandem mass spectrometry (HPLC–MS/MS) and its independent laboratory validation (ILV) were validated for the determination of lufenuron and its isomers in high water, high acid content and dry commodities, with an limit of quantification (LOQ) of 0.02 mg/kg (EFSA, 2009). Furthermore, the EURLs also reported validation data for Quick, Easy, Cheap, Effective, Rugged, and Safe (QuEChERS) and QuOil methods using HPLC–MS/MS. These methods are applicable for the determination of lufenuron in the four main plant matrices, with an LOQ of 0.01 mg/kg (EURLs, 2016).

Hence, it is concluded that lufenuron and its isomers can be enforced with an LOQ of 0.01 mg/kg in high water content, high acid content, high oil content and dry commodities.

1.1.5. Stability of residues in plants

In the framework of the peer review, storage stability of lufenuron was demonstrated for a period of 24 months at −18°C in commodities with high water, high acid and high oil content (EFSA, 2009).

1.1.6. Proposed residue definitions

Lufenuron is a stable and persistent compound and it is the only significant residue that was observed in the metabolism studies. Therefore, a general residue definition for monitoring and risk assessment including any constituent isomers of lufenuron only was agreed during the peer review (EFSA, 2009). In line with the other actives substances which contain isomers, EFSA proposes to slightly modify the wording of the residue definition for lufenuron (any ratio of constituent isomers).

Lufenuron is not degraded through the plant metabolism. However, during the peer review, it was already emphasised that the above studies do not investigate the possible impact of plant metabolism on the isomer ratio of lufenuron. In addition, it was highlighted that light energy can cause photolytic conversion of one isomer to another. Therefore, further investigation on this matter would in principle be required. Since guidance on the consideration of isomer ratios in the consumer risk assessment is not yet available, EFSA recommends that this issue is reconsidered when such guidance is available.

1.2. Magnitude of residues in plants

1.2.1. Magnitude of residues in primary crops

To assess the magnitude of lufenuron residues resulting from the reported GAPs, EFSA considered all residue trials reported by the RMS in its evaluation report (Portugal, 2010), including residue trials evaluated in the framework of the peer review (EFSA, 2009). During the completeness check, the RMS confirmed that almost all residue trial samples considered in this framework were stored in compliance with the demonstrated storage conditions (EFSA, 2016a). Storage conditions for the residue performed on peaches were not reported but, considering that storage stability in high water content and high acid content commodities was demonstrated for 24 months, decline of residues during storage of the trial samples is not expected.

The number of residue trials and extrapolations were evaluated in accordance with the European guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs (European Commission, 2016).

In line with the European restrictions for lufenuron, outdoor uses of lufenuron are exclusively limited to targeted application as bait stations. The outdoor GAPs reported in this review are compliant with this restriction. Significant residues in plants resulting from this kind of use are not expected. Therefore, for all crops where only the use in bait stations is authorised, MRL and risk assessment values can be set at the enforcement LOQ (0.01* mg/kg) and further residue trials are not required. For the other crops, the following considerations were made by EFSA.

For strawberries, gherkins as well as for lettuces and other salad plants, MRL or risk assessment values could not be derived and the following data gaps were identified:

Strawberries: only two trials compliant with the indoor GAP are available. Since strawberry is a major crop in Europe, six additional trials compliant with the indoor GAP are required.
Gherkins: trials compliant with GAP are not available. The extrapolation from the trials performed on cucumbers is not possible because GAPs are different. Trials on cucumbers were performed with two applications while the cGAP on gherkins is authorised for three applications. Considering that lufenuron is very persistent and that preharvest interval (PHI) for these GAPs is very short and equivalent to the minimum interval between applications (7 days), it is not considered acceptable to use trials performed with two applications to support a GAP with three applications. Therefore, four trials on cucumbers, gherkins or courgettes, and compliant with the indoor GAP for gherkins are required.
Lettuces: trials compliant with GAP are not available. Therefore, eight trials on lettuces (open leaf varieties), and compliant with the indoor GAP for lettuces, are required.
Other salads plants including Brassicaceae (lamb's lettuce, escaroles, cresses, land cresses, roman rocket, red mustards and baby leaf crops): trials compliant with GAP are not available. Therefore, eight trials on lettuces (open leaf varieties), and compliant with the indoor GAP for other salad plants including Brassicaceae, are required.

For peaches, apricots, potatoes, tomatoes and cucumbers, available residue trials are sufficient to derive (tentative) MRL and risk assessment values, taking note of the following data gap and considerations:

Peaches and apricots: Nine trials performed on peaches and compliant with GAP are available but data on apricots are not available. According to the current guidance document for extrapolations, a minimum of four trials performed on apricots are required to derive a common MRL on peaches and apricots. In the absence of these data, MRLs and risk assessment values for peaches and apricots are tentative.
Potatoes: only three trials compliant with GAP are available. However, these trials show residue levels below the LOQ of 0.02 mg/kg. In addition, four overdosed trials (performed with two applications instead of one) also show results below LOQ (0.01 mg/kg). Therefore, a no residues situation is expected in potatoes and further residue trials are not required.
Tomatoes: the number of residue trials supporting the import tolerance on tomatoes is not compliant with the data requirements (four trials instead of eight). However, the available data clearly confirm that this GAP (3 × 30 g a.s./ha; PHI 7 days) is less critical than the indoor GAP reported in Europe (3 × 100 g a.s./ha; PHI 7 days). Therefore, the available limited data set is considered acceptable in this case. Further residue trials are therefore not required.
Cucumbers: although appropriate MRL and risk assessment values can be derived from the indoor GAP reported by Hungary and Portugal (2 × 113 g a.s./ha; PHI 7 days), a more cGAP reported by Greece (with three applications) is not supported by data. Therefore, eight trials compliant with the indoor GAP reported by Greece are still required. It is noted that these trials would also allow to derive MRL and risk assessment values for gherkins, for which the same GAP is authorised.

1.2.2. Magnitude of residues in rotational crops

In the confined rotational crop studies evaluated during the peer review (see also Section 1.1.2), the total radioactivity was generally < 0.01 mg eq/kg with the exception of lettuce (0.047 mg eq/kg) and carrots (0.023 mg eq/kg) in the study performed with 150 g a.s./ha. However, lufenuron was quantified in very low amounts in lettuce (0.025 mg/kg) and was not found in carrots.

It is highlighted that lufenuron is a very persistent compound that can accumulate in soil for up to 6 years and that the confined metabolism studies were performed with lower application rate (1 × 130 or 1 × 150 g a.s./ha) compared to the most cGAPs reported for indoor uses (3 × 100 g a.s./ha). This was already discussed during the peer review and the meeting of expert also considered that, due to the very high log K _ow, lufenuron is most probably adsorbed into the soil rather than taken up by plants. It was therefore concluded that the positive residues observed in lettuce and carrots may be due to soil contamination and that significant residues are not expected in the succeeding crops (EFSA, 2009). Rotational crop field trials are therefore not required.

1.2.3. Magnitude of residues in processed commodities

Studies investigating the magnitude of residues in raisins, wine and several processed commodities of tomatoes were reported in the framework of the peer review (Portugal, 2006). In addition, further processing studies performed on wine grape (juice and must), apples, as well as peeling factors for melons were reported in the framework of this MRL review (Portugal, 2010). An overview of all available processing studies is available in Appendix B.1.2.3. Robust processing factors were derived for apples (juice, dry pomace and sauce), wine grapes (juice and must), raisins and tomatoes (peeled and canned, sauce and juice) as well as for peeled melon. The other processing factors derived in this review are only indicative because the available datasets are limited.

Further processing studies are not required as they are not expected to affect the outcome of the risk assessment. However, if more robust processing factors were to be required by risk managers, in particular for enforcement purposes, additional processing studies would be needed.

1.2.4. Proposed MRLs

Consequently, the available data are considered sufficient to derive (tentative) MRL proposals as well as risk assessment values for all commodities under evaluation, except for strawberries, gherkins, lettuces and other salad plants including Brassicaceae where the available data were insufficient.

2. Residues in livestock

Lufenuron is authorised for use on citrus fruits, apples and potatoes that might be fed to livestock. Livestock dietary burdens were therefore calculated for different groups of livestock according to the OECD guidance (OECD, 2013), which has now also been agreed upon at the European level. The input values for all relevant commodities are summarised in Appendix C. Only the dietary burden calculated for cattle (all) was found to exceed the trigger value of 0.1 mg/kg dry matter (DM). Behaviour of residues was therefore assessed in this group of livestock.

2.1. Nature of residues and methods of analysis in livestock

The metabolism of lufenuron was investigated in goats and laying hens (Portugal, 2006). As expected for such a stable compound, lufenuron was the only significant residue that was observed in the metabolism studies. Therefore, lufenuron is the appropriate residue definition for monitoring and risk assessment in commodities of animal origin. This is in line with the conclusion of the peer review where a residue definition for monitoring and risk assessment including any constituent isomers of lufenuron only was already proposed (EFSA, 2009). As for plant commodities, EFSA proposes to slightly modify the wording of the residue definition for lufenuron (any ratio of constituent isomers). This residue definition is fat soluble.

During the peer review, it was already emphasised that the above studies do not investigate the possible impact of the livestock metabolism on the isomer ratio of lufenuron. Further investigation on this matter would in principle be required. Since guidance on the consideration of isomer ratios in the consumer risk assessment is not yet available, EFSA recommends that this issue is reconsidered when such guidance is available.

A multiresidue analytical method using HPLC–MS/MS was validated for the determination of lufenuron and its isomers with an LOQ of 0.02 mg/kg in muscle, fat, milk and eggs. This method is supported by an ILV and a confirmatory method was evaluated and found acceptable (EFSA, 2009). However, a validation of this method on liver and kidney was not performed and is missing.

Storage stability of lufenuron and its isomers was demonstrated for a period of 9 months at −18°C in muscle, fat, liver, kidney and milk (EFSA, 2009).

2.2. Magnitude of residues in livestock

Two feeding studies performed on ruminants (dairy cow and beef cattle) were evaluated by the RMS in the DAR (Portugal, 2006). In the study performed on dairy cow, three dose levels were tested (0.039, 0.23 and 0.42 mg lufenuron/kg body weight (bw) per day). The tested levels all cover the calculated dietary burdens for cattle. On the opposite, the feeding levels used in the beef cattle study are too low (0.0006 and 0.031 mg/kg bw per day). Therefore, the results of the dairy cow study were considered more reliable to derive MRL and risk assessment values. During the completeness check, the RMS confirmed that most of the samples were stored in compliance with the demonstrated storage conditions of 9 months (EFSA, 2016a). A few samples were stored for a maximum of 12 months but it is deemed acceptable in this case considering the small deviation and the fact that lufenuron is a very stable compound. A decline of residues during storage of the samples is therefore not expected. MRLs and risk assessment values for bovine products were derived according to the OECD guidance on this matter which was agreed upon at the European level (OECD, 2013). The overview of the study results used to derive the risk assessment values and the MRL proposals are summarised in Appendix B.2.2. According to the OECD guidance, MRLs and risk assessment values derived for bovine also apply to equine products. It is noted that in the absence of validated analytical method for liver and kidney, MRLs and risk assessment values derived for these tissues should only remain tentative.

MRLs for sheep, swine and poultry products as well as for milk are not required because the related groups of livestock are not expected to be exposed to significant levels of lufenuron residues.

3. Consumer risk assessment

In the framework of this review, only the uses of lufenuron reported in Appendix A were considered; however, the use of lufenuron was previously also assessed by the JMPR (FAO, 2015). The CXLs, resulting from this assessment by JMPR and adopted by the CAC, are now international recommendations that need to be considered by European risk managers when establishing MRLs. To facilitate consideration of these CXLs by risk managers, the consumer exposure was calculated both with and without consideration of the existing CXLs.

3.1. Consumer risk assessment without consideration of the existing CXLs

Chronic exposure calculations for all crops reported in the framework of this review were performed using revision 2 of the EFSA PRIMo (EFSA, 2007). Input values for the exposure calculations were derived in compliance with the decision tree reported in Appendix D. Hence, for those commodities where an MRL could be derived by EFSA in the framework of this review, input values were derived according to the internationally agreed methodologies (FAO, 2009). For all commodities of plant origin, input values refer to the raw agricultural commodities, except for cucurbits with inedible peel, where the peeling factor is taken into account. For those commodities where data were insufficient to derive an MRL, EFSA considered the existing EU MRL for an indicative calculation. All input values included in the exposure calculations are summarised in Appendix C. Acute exposure calculations were not carried out because an acute reference dose (ArfD) was not deemed necessary for this active substance.

The exposures calculated were compared with the toxicological reference value for lufenuron, derived by EFSA (2009) under Directive 91/414/EEC. The highest chronic exposure was calculated for German children, representing 9.0% of the acceptable daily intake (ADI). Although uncertainties remain due to the data gaps identified in the previous sections, this indicative exposure calculation did not indicate a risk to consumers.

3.2. Consumer risk assessment with consideration of the existing CXLs

To include the CXLs in the calculations of the consumer exposure, CXLs were compared with the EU MRL proposals in compliance with Appendix D and all data relevant to the consumer exposure assessment have been collected from JMPR evaluations. It is noted that the data gap identified for a validated analytical method for enforcement in liver and kidney also applies to the existing CXLs on these tissues. In addition, since the LOQ for enforcement in livestock commodities is 0.02 mg/kg, the CXL of 0.01 mg/kg on poultry tissues needs to be reconsidered up to the current LOQ of 0.02* mg/kg. This value was also used for risk assessment for those commodities where CXLs was set at the LOQ (poultry meat, liver and eggs). An overview of the input values used for this exposure calculation is also provided in Appendix C.

Chronic exposure calculations were also performed using revision 2 of the EFSA PRIMo and the exposures calculated were compared with the toxicological reference value derived for lufenuron. The highest chronic exposure was calculated for French toddlers, representing 24.5% of the ADI. Based on these calculations, EFSA concludes that the CXLs are not expected to be of concern for European consumers.

3.3. Additional considerations on the consumer risk assessment

It is noted that the above risk assessments are only relevant for lufenuron residues related to the pesticide use. However, lufenuron may also be used as a veterinary medicine on fin fish. To accommodate this use, an MRL of 1.35 mg/kg for fin fish was implemented for lufenuron (RS‐isomers) in Regulation (EU) 967/2014. Rational for this MRL setting was reported in the European public MRL assessment report of EMA (2015). In this report, the chronic exposure calculation was performed considering a daily portion of 5 g fish/kg bw per day (300 g fish/person per day). However, the highest daily consumption considered in the EFSA PRIMo is 1.2 g/kg bw per day (WHO Cluster diet B). This value is also consistent with the consumption data considered in a recent opinion prepared by EFSA as regards recommendations on the fish consumption with view to exposure to mercury (EFSA Scientific Committee, 2015). Based on this consumption data, and considering the veterinary MRL of 1.35 mg/kg (conservative approach with regard to chronic intake calculations), the contribution of the veterinary use of lufenuron to the chronic exposure would be of 10% of the ADI. Therefore, EFSA estimates that the chronic exposure to lufenuron resulting from both pesticide (24.5% ADI) and veterinary uses (10% ADI) is likely to be lower than 35% of the ADI.

It is highlighted that the possible impact of the isomer ratios due to plant or livestock metabolism was not assessed by EFSA. Similarly, EMA assessed lufenuron (RS‐isomers) and did also assume that the isomers ratio remained unchanged in fish. Considering, however, that the isomer ratio of the lufenuron is an equimolar mixture of R‐ and S‐enantiomer and that toxicological studies have been carried out according to these specifications (EFSA, 2009), a change in isomer ratios in the residue might, in the worst‐case situation, lead to a duplication of the toxicological burden of the residue. Since the above exposure calculations represent in any case less than 50% of the ADI, EFSA concludes that the potential change in isomer ratios in the final residue will not be of concern for the authorised uses reported in the framework of this review. In case future uses of lufenuron would lead to a higher consumer exposure, further information regarding the impact of plant and livestock metabolism on the isomer ratio might be required.

Conclusions

Only the dietary burden calculated for cattle (all) was found to exceed the trigger value of 0.1 mg/kg DM.

Chronic consumer exposure resulting from the authorised uses reported in the framework of this review was calculated using revision 2 of the EFSA PRIMo. For cucurbits with inedible peel, the peeling factor derived on melons was taken into account. For those commoditieswhere data were insufficient to derive an MRL, EFSA considered the existing EU MRL for an indicative calculation. The highest chronic exposure represented 9.0% of the ADI (DE child). Acute exposure calculations were not carried out because an ARfD was not deemed necessary for this active substance.

Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs have also been established for lufenuron. Additional calculations of the consumer exposure, considering these CXLs, were therefore carried out and the highest chronic exposure represented 24.5% of the ADI (FR toddler). The chronic exposure also taking into account the veterinary use of lufenuron was also estimated. It was concluded that the chronic exposure to lufenuron resulting from both pesticide (24.5% ADI) and veterinary uses (10% ADI) was lower than 35 % of the ADI.

Recommendations

MRL recommendations were derived in compliance with the decision tree reported in Appendix D of the reasoned opinion (see summary table). All MRL values listed as ‘Recommended’ in the table are sufficiently supported by data and are therefore proposed for inclusion in Annex II to the Regulation. The remaining MRL values listed in the table are not recommended for inclusion in Annex II because they require further consideration by risk managers (see summary table footnotes for details). In particular, some tentative MRLs and existing EU MRLs need to be confirmed by the following data:

a validated analytical method for enforcement of lufenuron in liver and kidney tissues;
additional residue trials supporting the indoor GAPs on apricots, peaches, strawberries, gherkins, lettuces, other salads plants including Brassicaceae (lamb's lettuce, escaroles, cresses, land cresses, roman rocket, red mustards, baby leaf crops).

It is highlighted that the MRL derived for cucumbers results from an indoor GAP supported by data, whereas more critical indoor GAP reported by Greece was not supported by data. EFSA therefore identified the following data gap which is not expected to impact on the validity of the MRL derived but which might have an impact on national authorisations:

eight residue trials supporting the indoor GAP on cucumbers reported by Greece (3 × 100 g a.s./ha; PHI 7 days);

If the above reported data gaps are not addressed in the future, the Member States are recommended to withdraw or modify the relevant authorisations at national level (Table 1).

Table 1.

Summary table

Code number1	Commodity	Existing EU MRL (mg/kg)	Existing CXL (mg/kg)	Outcome of the review
Code number1	Commodity	Existing EU MRL (mg/kg)	Existing CXL (mg/kg)	MRL (mg/kg)	Comment
Enforcement residue definition (existing): lufenuronF Enforcement residue definition (proposed): lufenuron (any ratio of constituent isomers)F
110020	Oranges	1	–	0.01*	Recommendeda
110030	Lemons	1	–	0.01*	Recommendeda
110040	Limes	1	–	0.01*	Recommendeda
110050	Mandarins	1	–	0.01*	Recommendeda
130010	Apples	0.5	–	0.15	Recommendeda
130020	Pears	0.5	–	0.15	Recommendeda
130030	Quinces	0.2	–	0.15	Recommendeda
130040	Medlar	0.2	–	0.15	Recommendeda
130050	Loquats/Japanese medlars	0.2	–	0.15	Recommendeda
140010	Apricots	1	–	0.2	Further consideration neededb
140020	Cherries (sweet)	1	–	0.01*	Recommendeda
140030	Peaches	1	–	0.2	Further consideration neededb
140040	Plums	1	–	0.01*	Recommendeda
151010	Table grapes	1	–	0.01*	Recommendeda
151020	Wine grapes	1	–	0.01*	Recommendeda
152000	Strawberries	1	–	1	Further consideration neededc
161020	Figs	0.02*	–	0.01*	Recommendeda
161060	Kaki/Japanese persimmons	0.02*	–	0.01*	Recommendeda
162010	Kiwi fruits	0.02*	–	0.01*	Recommendeda
211000	Potatoes	0.05	0.01*	0.01*	Recommendede
231010	Tomatoes	0.5	0.4	0.4	Recommendedh
231020	Sweet peppers/bell peppers	1	0.8	0.8	Recommendedh
231030	Aubergines/eggplants	0.2	–	0.3	Recommendeda
232010	Cucumbers	0.2	0.09	0.15	Recommendede
232020	Gherkins	0.2	–	0.2	Further consideration neededc
232030	Courgettes	0.2	–	0.15	Recommendeda
233010	Melons	0.3	0.4	0.4	Recommendede
233020	Pumpkins	0.2	–	0.4	Recommendeda
233030	Watermelons	0.3	–	0.4	Recommendeda
251010	Lamb's lettuces/corn salads	0.02*	–	0.02	Further consideration neededc
251020	Lettuces	0.5	–	0.5	Further consideration neededc
251030	Escaroles/broad‐leaved endives	0.02*	–	0.02	Further consideration neededc
251040	Cresses and other sprouts and shoots	0.02*	–	0.02	Further consideration neededc
251050	Land cresses	0.02*	–	0.02	Further consideration neededc
251060	Roman rocket/rucola	0.02*	–	0.02	Further consideration neededc
251070	Red mustards	0.02*	–	0.02	Further consideration neededc
251080	Baby leaf crops (including Brassica species)	0.02*	–	0.02	Further consideration neededc
401070	Soya bean	0.02*	0.01*	0.01*	Recommendedi
1011010	Swine muscle	0.02*	0.03	0.03	Recommendedi
1011020	Swine fat tissue	0.02*	0.7	0.7	Recommendedi
1011030	Swine liver	0.02*	0.04	0.04	Further consideration neededg
1011040	Swine kidney	0.02*	0.04	0.04	Further consideration neededg
1012010	Bovine muscle	0.02*	0.03	0.03	Recommendedh
1012020	Bovine fat tissue	0.02*	0.7	0.7	Recommendedh
1012030	Bovine liver	0.02*	0.04	0.04	Further consideration neededf
1012040	Bovine kidney	0.02*	0.04	0.04	Further consideration neededf
1013010	Sheep muscle	0.02*	0.03	0.03	Recommendedi
1013020	Sheep fat tissue	0.02*	0.7	0.7	Recommendedi
1013030	Sheep liver	0.02*	0.04	0.04	Further consideration neededg
1013040	Sheep kidney	0.02*	0.04	0.04	Further consideration neededg
1014010	Goat muscle	0.02*	0.03	0.03	Recommendedi
1014020	Goat fat tissue	0.02*	0.7	0.7	Recommendedi
1014030	Goat liver	0.02*	0.04	0.04	Further consideration neededg
1014040	Goat kidney	0.02*	0.04	0.04	Further consideration neededg
1015010	Equine muscle	0.02*	0.03	0.03	Recommendedh
1015020	Equine fat tissue	0.02*	0.7	0.7	Recommendedh
1015030	Equine liver	0.02*	0.04	0.04	Further consideration neededf
1015040	Equine kidney	0.02*	0.04	0.04	Further consideration neededf
1016010	Poultry muscle	0.02*	0.01*	0.02*	Recommendedi
1016020	Poultry fat tissue	0.02*	0.04	0.04	Recommendedi
1016030	Poultry liver	0.02*	0.02	0.02*	Further consideration neededg
1020010	Cattle milk	0.02*	0.1	0.1	Recommendedi
1020020	Sheep milk	0.02*	0.1	0.1	Recommendedi
1020030	Goat milk	0.02*	0.1	0.1	Recommendedi
1020040	Horse milk	0.02*	0.1	0.1	Recommendedi
1030000	Birds eggs	0.02*	0.02	0.02*	Recommendedi
–	Other commodities of plant and/or animal origin	See Reg. (EC) No 839/2008	–	–	Further consideration neededd

Critical outdoor GAPs for Southern Europe
Crop		Region	Outdoor/indoor	Member state or country	Pest controlled	Formulation			Application										PHI or waiting period (days)	Comments (max. 250 characters)
Common name	Scientific name					Type	Content		Method	Growth stage		Number		Interval (days)		Rate
Common name	Scientific name					Type	Conc.	Unit	Method	From BBCH	Until BBCH	Min.	Max.	Min.	Max.	Min.	Max.	Unit
Oranges	Citrus sinensis	SEU	Outdoor	ES, IT	Ceratitis capitata	RB	3.0	% (w/w)	Local treatment – general (see also comment field)	n.a.	n.a.		1	n.a.	n.a.	14.4	28.8	g a.i./ha	n.a.	Authorised in bait stations only. 12 or 24 baits/ha (1.2 g a.i./bait)
Lemons	Citrus limon	SEU	Outdoor	ES, IT	Ceratitis capitata	RB	3.0	% (w/w)	Local treatment – general (see also comment field)	n.a.	n.a.		1	n.a.	n.a.	14.4	28.8	g a.i./ha	n.a.	See oranges
Limes	Citrus aurantiifolia	SEU	Outdoor	ES	Ceratitis capitata	RB	3.0	% (w/w)	Local treatment – general (see also comment field)	n.a.	n.a.		1	n.a.	n.a.	14.4	28.8	g a.i./ha	n.a.	See oranges
Mandarins	Citrus reticulata, syn: Citrus deliciosa	SEU	Outdoor	ES, IT	Ceratitis capitata	RB	3.0	% (w/w)	Local treatment – general (see also comment field)	n.a.	n.a.		1	n.a.	n.a.	14.4	28.8	g a.i./ha	n.a.	See oranges
Apples	Malus domestica	SEU	Outdoor	ES, IT	Ceratitis capitata	RB	3.0	% (w/w)	Local treatment – general (see also comment field)	n.a.	n.a.		1	n.a.	n.a.	14.4	28.8	g a.i./ha	n.a.	See oranges
Pears	Pyrus communis	SEU	Outdoor	ES, IT	Ceratitis capitata	RB	3.0	% (w/w)	Local treatment – general (see also comment field)	n.a.	n.a.		1	n.a.	n.a.	14.4	28.8	g a.i./ha	n.a.	See oranges
Apricots	Armeniaca vulgaris, syn: Prunus armeniaca	SEU	Outdoor	ES, IT	Ceratitis capitata	RB	3.0	% (w/w)	Local treatment – general (see also comment field)	n.a.	n.a.		1	n.a.	n.a.	14.4	28.8	g a.i./ha	n.a.	See oranges
Cherries	Cerasus avium, syn: Prunus avium	SEU	Outdoor	ES	Ceratitis capitata	RB	3.0	% (w/w)	Local treatment – general (see also comment field)	n.a.	n.a.		1	n.a.	n.a.	14.4	28.8	g a.i./ha	n.a.	See oranges
Peaches	Persica vulgaris, syn: Prunus persica	SEU	Outdoor	ES, IT	Ceratitis capitata	RB	3.0	% (w/w)	Local treatment – general (see also comment field)	n.a.	n.a.		1	n.a.	n.a.	14.4	28.8	g a.i./ha	n.a.	See oranges
Plums	Prunus domestica	SEU	Outdoor	ES, IT	Ceratitis capitata	RB	3.0	% (w/w)	Local treatment – general (see also comment field)	n.a.	n.a.		1	n.a.	n.a.	14.4	28.8	g a.i./ha	n.a.	See oranges
Table grapes	Vitis vinifera	SEU	Outdoor	ES, IT	Ceratitis capitata	RB	3.0	% (w/w)	Local treatment – general (see also comment field)	n.a.	n.a.		1	n.a.	n.a.	14.4	28.8	g a.i./ha	n.a.	See oranges
Wine grapes	Vitis vinifera	SEU	Outdoor	ES, IT	Ceratitis capitata	RB	3.0	% (w/w)	Local treatment – general (see also comment field)	n.a.	n.a.		1	n.a.	n.a.	14.4	28.8	g a.i./ha	n.a.	See oranges
Figs	Ficus carica	SEU	Outdoor	ES, IT	Ceratitis capitata	RB	3.0	% (w/w)	Local treatment – general (see also comment field)	n.a.	n.a.		1	n.a.	n.a.	14.4	28.8	g a.i./ha	n.a.	See oranges
Kaki	Diospyros kaki	SEU	Outdoor	ES, IT	Ceratitis capitata	RB	3.0	% (w/w)	Local treatment – general (see also comment field)	n.a.	n.a.		1	n.a.	n.a.	14.4	28.8	g a.i./ha	n.a.	See oranges
Kiwi fruits	Actinidia deliciosa; Actinidia chinensis	SEU	Outdoor	ES	Ceratitis capitata	RB	3.0	% (w/w)	Local treatment – general (see also comment field)	n.a.	n.a.		1	n.a.	n.a.	14.4	28.8	g a.i./ha	n.a.	See oranges

Primary crops (available studies)	Crop groups	Crop(s)	Application(s)	Sampling (DAT)
	Fruit crops	Tomatoes	Foliar: 3 x 30 g a.s./ha	0, 12, 28
	Leafy crops	Head cabbage	Foliar: 3 x 20 g a.s./ha	0, 28
	Pulses/oilseeds	Cotton seed	Foliar: 3 x 30 g a.s./ha	0, 14, 28, 52, 84
	Source: Portugal, 2006
Rotational crops (available studies)	Crop groups	Crop(s)	Application(s)	PBI (DAT)
	Root/tuber crops	Carrots	Bare soil, 150 g a.s./ha	63
	Root/tuber crops	Sugar beet	Bare soil, 130 g a.s./ha	306
	Leafy crops	Lettuce	Bare soil, 150 g a.s./ha	63
	Leafy crops		Bare soil, 130 g a.s./ha	76
	Cereal (small grain)	Wheat and maize	Bare soil, 150 g a.s./ha	63
	Cereal (small grain)		Bare soil, 130 g a.s./ha	126, 331
	Source: Portugal, 2006
Processed commodities (hydrolysis study)	Conditions			Investigated?
	Pasteurisation (20 min, 90°C, pH 4)			Yes
	Baking, brewing and boiling (60 min, 100°C, pH 5)			Yes
	Sterilisation (20 min, 120°C, pH 6)			Yes
	Source: Portugal, 2006

Can a general residue definition be proposed for primary crops?	Yes
Rotational crop and primary crop metabolism similar?	Yes
Residue pattern in processed commodities similar to residue pattern in raw commodities?	Yes
Plant residue definition for monitoring (RD‐Mo)	Lufenuron (any ratio of constituent isomers)
Plant residue definition for risk assessment (RD‐RA)	Lufenuron (any ratio of constituent isomers)
Conversion factor (monitoring to risk assessment)	Not relevant
Methods of analysis for monitoring of residues (analytical technique, crop groups, LOQs)	HPLC–MS/MS (EURLs, 2016 ): QuEChERS method (EURL‐FV – 2014‐M15) validated in high water and high acid content commodities QuOil method (BVL L 13.04‐5:2013‐08) validated on high oil content commodities QuEChERS method (EN 15662:2008) validated in dry commodities LOQ: 0.01 mg/kg

Plant products (available studies)	Category	Commodity	T (°C)	Stability (Months/years)
	High water content	Cabbage	−18	24 months
	High oil content	Cotton seed	−18	24 months
	High acid content	Orange	−18	24 months
	Source: EFSA, 2009

Crop	Region/indoorb	Residue levels observed in the supervised residue trials relevant to the supported GAPs (mg/kg)	Recommendations/comments (OECD calculations)	MRL proposals (mg/kg)	HR (mg/kg)c	STMR (mg/kg)d
Oranges Lemons Limes Mandarins	SEU	–	Use in bait stations only. No residues are expected	0.01a	0.01	0.01
Pome fruits	SEU	–	Use in bait stations only. Use in bait stations only. No residues are expected. No authorised use on quinces, medlars and loquats in SEU	0.01	0.01	0.01
Pome fruits	Import (DZ, MA, TN)	NEU: 0.02; 0.03; 0.03; 0.04; 0.05; 0.05; 0.07; 0.08 SEU: 0.03; 0.03; 0.04; 0.04; 0.05; 0.05; 0.07; 0.08	Combined data set of eight SEU trials and eight NEU trials, all performed on apples and compliant with GAP (Portugal, 2010). Extrapolation to other pome fruits is applicable MRL_OECD = 0.14	0.15	0.08	0.05
Peaches Apricots	SEU	–	Use in bait stations only. No residues are expected	0.01a	0.01	0.01
Peaches Apricots	Import (DZ)	Peaches: 0.02; 0.14; 0.03; 0.03; 0.02; 0.01; 0.04; 0.03; 0.07; 0.05 Apricots: no data available	Trials performed in SEU compliant with GAP for peaches and apricots (25% deviation on application rate) (Portugal, 2010). Since data on apricots are missing, the MRL proposal should remain tentative MRL_OECD = 0.2	0.2 (tentative)	0.14	0.03
Cherries (sweet)	SEU	–	Use in bait stations only. No residues are expected	0.01a	0.01	0.01
Plums	SEU	–	Use in bait stations only. No residues are expected	0.01a	0.01	0.01
Table and wine grapes	SEU	–	Use in bait stations only. No residues are expected	0.01a	0.01	0.01
Strawberries	Indoor	0.18; 0.42	Trials compliant with GAP (Portugal, 2010) but not sufficient to derive an MRL	–	–	–
Figs	SEU	–	Use in bait stations only. No residues are expected	0.01a	0.01	0.01
Kaki/Japanese persimmons	SEU	–	Use in bait stations only. No residues are expected	0.01a	0.01	0.01
Kiwi fruits	SEU	–	Use in bait stations only. No residues are expected	0.01a	0.01	0.01
Potatoes	Import (DZ)	Two applications (overdosed): 4 × < 0.01 One application (GAP‐compliant): 3 × < 0.02	Trials performed in SEU: Four trials performed with two applications instead of one (acceptable since residues < 0.01 mg/kg) and three trials compliant with GAP (Portugal, 2010)	0.01a	0.01	0.01
Tomatoes Aubergines	Indoor	0.02; 0.04; 0.04; 0.05; 0.06e; 0.08e; 0.08; 0.08; 0.09e; 0.09; 0.10; 0.11; 0.25	Trials performed on tomatoes and compliant with GAP (EFSA, 2009; Portugal, 2010). Extrapolation to aubergines is applicable MRL_OECD = 0.31	0.3	0.25	0.07
Tomatoes Aubergines	Import (MA)	< 0.02; < 0.02; 0.05; 0.06	Trials performed on tomatoes in SEU and compliant with GAP (Portugal, 2010). The available limited data set is acceptable since the import tolerance GAP is less critical than the EU indoor GAP. No authorised import tolerance for aubergines MRL_OECD = 0.12	0.15	0.06	0.04
Sweet peppers/bell peppers	Indoor	0.06; 0.07; 0.08; 0.13; 0.13; 0.17; 0.19; 0.47	Trials on sweet peppers compliant with GAP (Portugal, 2010) MRL_OECD = 0.69	0.7	0.47	0.13
Cucumbers Courgettes	Indoor	0.01; 0.02; 0.02; 0.02; 0.02; 0.03; 0.03; 0.03; 0.06; 0.06; 0.06	Trials on cucumbers compliant with GAP (25% deviation on the application rate) (Portugal, 2010). Extrapolation to courgettes is applicable. For cucumbers, the most critical GAP reported by Greece is not supported by data MRL_OECD = 0.11	0.15	0.06	0.03
Gherkins	Indoor	–	Trials compliant with GAP are not available. Extrapolation from cucumbers not possible because the trials were performed with only two applications instead of three	–	–	–
Melons Pumpkins Watermelons	Indoor	0.03; 0.03; 0.06; 0.07; 0.09; 0.14; 0.19; 0.19	Trials on melons compliant with GAP for all cucurbits with inedible peel (Portugal, 2010) MRL_OECD = 0.36	0.4	0.19	0.08
Lettuces	Indoor	–	No data available	–	–	–
Other salad plants including Brassicaceae	Indoor	–	No data available	–	–	–

Confined rotational crop study (quantitative aspect)	Residues were generally < 0.01 mg/kg after treatment with 130 and 150 g a.s./ha. The low radioactivity observed in carrot and lettuce (0.023–0.047 mg eq/kg) was considered to be due to soil contamination; significant residues are not expected in the succeeding crops (EFSA, 2009)
Field rotational crop study	Not available and not required

Processed commodity	Number of studiesa	Processing factor (PF)
Processed commodity	Number of studiesa	Individual values	Median PF
Robust processing factors (sufficiently supported by data)
Apples, juice (extrapolated to pears)	4	0.2; 0.2; 0.2; 0.2	0.2b
Apples, dry pomace (extrapolated to pears)	4	16; 18; 18; 19	18
Apples, sauce	4	0.2; 0.2; 0.2; 0.2	0.2b
Table grapes, raisins	4	5.7; 5.7; 5.9; 7.3	5.8
Wine grapes, juice	4	0.08; 0.13; 0.14; 0.22	0.14b
Wine grapes, must	5	0.44; 0.61; 0.86; 2.4; 2.9	0.86
Tomatoes, peeled and canned	4	0.17; 0.17; 0.17; 0.17	0.17b
Tomatoes, sauce	4	0.79; 0.83; 0.86; 0.90	0.85
Tomatoes, juice	4	0.17; 0.17; 0.17; 0.17	0.17b
Melons, peeled (extrapolated to other cucurbits with inedible peel)	4	0.14; 0.33; 0.67; 0.67	0.5b
Indicative processing factors (limited data set)
Apples, wet pomace (extrapolated to pears)	2	3.6; 5.8	4.7
Wine grapes, wet pomace	1	4.4	4.4
Wine grapes, red wine (unheated)	2	0.08; 0.13	0.11b
Wine grapes, white wine	2	0.14; 0.22	0.18b

Relevant groups	Dietary burden expressed in				Most critical dieta	Most critical commoditya	Trigger exceeded (Y/N)
	mg/kg bw per day		mg/kg DM
	Med.	Max.	Med.	Max.
Cattle (all diets)	0.0029	0.0029	0.12	0.12	Cattle (beef)	Apple, wet pomace	Y
Cattle (dairy only)	0.0026	0.0026	0.07	0.07	Cattle (dairy)	Apple, wet pomace	N
Sheep (all diets)	0.0027	0.0027	0.07	0.07	Sheep (lamb)	Potato, process waste	N
Sheep (ewe only)	0.0023	0.0023	0.07	0.07	Sheep (ram/ewe)	Apple, wet pomace	N
Swine (all diets)	0.0010	0.0010	0.04	0.04	Swine (breading)	Potato, process waste	N
Poultry (all diets)	0.0007	0.0007	0.01	0.01	Poultry (turkey)	Potato, culls	N
Poultry (layer only)	0.0005	0.0005	0.01	0.01	Poultry (layer)	Potato, culls	N

Livestock (available studies)	Animal	Dose (mg/kg bw per day)	Duration (days)	N rate/comment
	Laying hen	0.21–0.33^(a)	14	21N rate
	Lactating goat	0.15–0.17^(b)	10	1.3N/compared to beef cattle 2N/compared to dairy cattle
	Source: Portugal, 2006 (a): Nominal doses of 3.4–5.2 mg/kg DM; theoretical administrated dose converted in mg/kg bw per day assuming a feed intake of 0.12 kg DM/day and a standard body weight of 1.9 kg (b): Nominal doses of 5.4–6 mg/kg DM; theoretical administrated dose converted in mg/kg bw per day assuming a feed intake of 2 kg DM/day and a standard body weight of 70 kg

Time needed to reach a plateau concentration in milk and eggs (days)	Milk: 8–10 days Eggs: 10–11 days
Metabolism in rat and ruminant similar (Yes/No)	Yes
Animal residue definition for monitoring (RD‐Mo)	Lufenuron (any ratio of constituent isomers)
Animal residue definition for risk assessment (RD‐RA)	Lufenuron (any ratio of constituent isomers)
Conversion factor (monitoring to risk assessment)	Not relevant
Fat soluble residues (Yes/No)	Yes
Methods of analysis for monitoring of residues (analytical technique, crop groups, LOQs)	HPLC–MS/MS (Portugal, 2006): Method validated in muscle, fat, milk and eggs ILV available Missing validation for liver/kidney LOQ: 0.02 mg/kg

Critical indoor GAPs for Northern and Southern Europe (including post‐harvest treatments)
Crop		Region	Outdoor/indoor	Member state or country	Pest controlled	Formulation			Application										PHI or waiting period (days)	Comments (max. 250 characters)
Common name	Scientific name					Type	Content		Method	Growth stage		Number		Interval (days)		Rate
Common name	Scientific name					Type	Conc.	Unit	Method	From BBCH	Until BBCH	Min.	Max.	Min.	Max.	Min.	Max.	Unit
Strawberries	Fragaria x ananassa	NEU/SEU	Indoor	IT, PT	Frankliniella sp.	EC	50.0	g/L	Foliar treatment – spraying			1	2	7	14	0.05	100	g a.i./ha	7
Tomatoes	Lycopersicon esculentum	NEU/SEU	Indoor	ES, HU, EL, PT	Frankliniella sp.	EC	50.0	g/L	Foliar treatment – spraying			1	3	7			100	g a.i./ha	7
Sweet peppers	Capsicum annuum	NEU/SEU	Indoor	ES, HU, EL, PT	Frankliniella sp.	EC	50.0	g/L	Foliar treatment – spraying			1	3	7			100	g a.i./ha	7
Aubergines	Solanum melongena	NEU/SEU	Indoor	EL	Helicoverpa armigera; Spodoptera sp.; Frankliniella occidentalis; Thrips tabaci	EC	50.0	g/L	Foliar treatment – spraying			1	3	7		50	100	g a.i./ha	7
Cucumbers	Cucumis sativus	NEU/SEU	Indoor	HU, PT	Frankliniella sp.	EC	50.0	g/L	Foliar treatment – spraying			1	2	7			113	g a.i./ha	7	Also authorised in EL: 3 × 100 g a.i./ha; PHI 7 days (no data)
Gherkins	Cucumis sativus	NEU/SEU	Indoor	EL	Helicoverpa armigera; Spodoptera sp.; Frankliniella occidentalis; Thrips tabaci	EC	50.0	g/L	Foliar treatment – spraying			1	3	7			100	g a.i./ha	7
Courgettes	Cucurbita pepo Zucchini group	NEU/SEU	Indoor	PT		EC	50.0	g/L	Foliar treatment – spraying			1	2	7			100	g a.i./ha	7
Melons	Cucumis melo	NEU/SEU	Indoor	EL	Helicoverpa armigera; Spodoptera sp.; Frankliniella occidentalis; Thrips tabaci	EC	50.0	g/L	Foliar treatment – spraying			1	3	7		50	100	g a.i./ha	3
Pumpkins	Cucurbita maxima	NEU/SEU	Indoor	EL	Helicoverpa armigera; Spodoptera sp.; Frankliniella occidentalis; Thrips tabaci	EC	50.0	g/L	Foliar treatment – spraying			1	3	7		50	100	g a.i./ha	3
Watermelons	Citrullus vulgaris, syn: Citrullus lanatus	NEU/SEU	Indoor	EL	Helicoverpa armigera; Spodoptera sp.; Frankliniella occidentalis; Thrips tabaci	EC	50.0	g/L	Foliar treatment – spraying			1	3	7		50	100	g a.i./ha	3
Lamb's lettuces	Valerianella locusta	NEU/SEU	Indoor	ES	Frankliniella occidentalis; Heliothis armigera; Laphygma exigua	EC	50.0	g/L	Foliar treatment – spraying			1	3	7	10		30	g a.i./ha	7
Lettuces	Lactuca sativa	NEU/SEU	Indoor	ES	Frankliniella occidentalis; Heliothis armigera	EC	50.0	g/L	Foliar treatment – spraying			1	3	7	10		100	g a.i./ha	7
Escaroles	Cichorium endivia var. latifolia	NEU/SEU	Indoor	ES	Frankliniella occidentalis; Heliothis armigera; Laphygma exigua	EC	50.0	g/L	Foliar treatment – spraying			1	3	7	10		30	g a.i./ha	7
Cresses	Lepidium sativum subsp. sativum	NEU/SEU	Indoor	ES	Frankliniella occidentalis; Heliothis armigera; Laphygma exigua	EC	50.0	g/L	Foliar treatment – spraying			1	3	7	10		30	g a.i./ha	7
Land cresses	Barbarea verna	NEU/SEU	Indoor	ES	Frankliniella occidentalis; Heliothis armigera; Laphygma exigua	EC	50.0	g/L	Foliar treatment – spraying			1	3	7	10		30	g a.i./ha	7
Roman rocket	Eruca sativa	NEU/SEU	Indoor	ES	Frankliniella occidentalis; Heliothis armigera; Laphygma exigua	EC	50.0	g/L	Foliar treatment – spraying			1	3	7	10		30	g a.i./ha	7
Red mustards	Brassica juncea var. rugosa	NEU/SEU	Indoor	ES	Frankliniella occidentalis; Heliothis armigera; Laphygma exigua	EC	50.0	g/L	Foliar treatment – spraying			1	3	7	10		30	g a.i./ha	7
Baby leaf crops	Not specified	NEU/SEU	Indoor	ES	Frankliniella occidentalis; Heliothis armigera; Laphygma exigua	EC	50.0	g/L	Foliar treatment – spraying			1	3	7	10		30	g a.i./ha	7

Animal products (available studies)	Animal	Commodity	T (°C)	Stability (Months)
	Beef	Muscle	−18	9
	Beef	Fat	−18	9
	Beef	Liver	−18	9
	Beef	Kidney	−18	9
	Cow	Milk	−18	9
	Source: EFSA, 2009

Animal commodity	Residues at the closest feeding level (mg/kg)		Estimated value at 1N		MRL proposal (mg/kg)
Animal commodity	Mean	Highest	STMRb (mg/kg)	HRc (mg/kg)	MRL proposal (mg/kg)
Cattle (all diets) – Closest feeding level (0.039 mg/kg bw; 13.5N rate)d
Muscle	0.03	0.05	< 0.02	< 0.02	0.02a
Fat	0.75	1.2	0.06	0.09	0.09
Liver	0.06	0.07	< 0.02	< 0.02	0.02a ^, d (tentative)
Kidney	0.04	0.04	< 0.02	< 0.02	0.02a ^, d (tentative)
Cattle (dairy only) – MRLs are not required since the trigger value is not exceeded
Sheep (all diets) – MRLs are not required since the trigger value is not exceeded
Sheep (dairy only) – MRLs are not required since the trigger value is not exceeded
Swine – MRLs are not required since the trigger value is not exceeded
Poultry (all diets) – MRLs are not required since the trigger value is not exceeded
Poultry (layer only) – MRLs are not required since the trigger value is not exceeded

ARfD	Not deemed necessary (EFSA, 2009)
Highest IESTI, according to EFSA PRIMo	Not relevant
Assumptions made for the calculations	Not relevant

Feed commodity	Median dietary burden		Maximum dietary burden
Feed commodity	Input value (mg/kg)	Comment	Input value (mg/kg)	Comment
Citrus, dried pulp	0.01a	STMRb	0.01a	STMRb
Apples, wet pomace	0.21	STMR × PF	0.21	STMR × PF
Potatoes, culls	0.01a	STMR	0.01a	HR
Potatoes, dried pulp	0.01a	STMRc	0.01a	STMRc
Potatoes, process waste	0.01a	STMRc	0.01a	STMRc

PERMALINK

Review of the existing maximum residue levels for lufenuron according to Article 12 of Regulation (EC) No 396/2005

Abstract

Summary

Background

Terms of Reference

The active substance and its use pattern

Assessment

1. Residues in plants

1.1. Nature of residues and methods of analysis in plants

1.1.1. Nature of residues in primary crops

1.1.2. Nature of residues in rotational crops

1.1.3. Nature of residues in processed commodities

1.1.4. Methods of analysis in plants

1.1.5. Stability of residues in plants

1.1.6. Proposed residue definitions

1.2. Magnitude of residues in plants

1.2.1. Magnitude of residues in primary crops

1.2.2. Magnitude of residues in rotational crops

1.2.3. Magnitude of residues in processed commodities

1.2.4. Proposed MRLs

2. Residues in livestock

2.1. Nature of residues and methods of analysis in livestock

2.2. Magnitude of residues in livestock

3. Consumer risk assessment

3.1. Consumer risk assessment without consideration of the existing CXLs

3.2. Consumer risk assessment with consideration of the existing CXLs

3.3. Additional considerations on the consumer risk assessment

Conclusions

Recommendations

Table 1.

Abbreviations

Appendix A – Summary of authorised uses considered for the review of MRLs

1.

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

B.1.1.2. Stability of residues in plants

B.1.2. Magnitude of residues in plants

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

B.1.2.2. Residues in succeeding crops

B.1.2.3. Processing factors

B.2. Residues in livestock

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

B.2.1.2. Stability of residues in livestock

B.2.2. Magnitude of residues in livestock

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

B.3. Consumer risk assessment

B.3.1. Consumer risk assessment without consideration of the existing CXLs

B.3.2. Consumer risk assessment with consideration of the existing CXLs

B.4. Proposed MRLs

Appendix C – Input values for the exposure calculations

C.1. Livestock dietary burden calculations

C.2. Consumer risk assessment without consideration of the existing CXLs

C.3. Consumer risk assessment with consideration of the existing CXLs

Appendix D – Decision tree for deriving MRL recommendations

1.

Appendix E – Used compound codes

1.

Notes

References

ACTIONS

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RESOURCES

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