Reasoned opinion on the modification of the existing MRLs for lambdacyhalothrin in azarole and persimmon 1

Transcription

1 EFSA Journal 2013;11(2):3117 REASONED OPINION Reasoned opinion on the modification of the existing MRLs for lambdacyhalothrin in azarole and persimmon 1 ABSTRACT European Food Safety Authority 2, European Food Safety Authority (EFSA), Parma, Italy In accordance with Article 6 of Regulation (EC) No 396/2005, Spain, herewith referred to as the evaluating Member State Spain, received an application from Syngenta Agro S.A. to raise the existing MRL for lambdacyhalothrin in persimmon from the LOQ (0.02 mg/kg) to 0.1 mg/kg in support of a new intended SEU use. Belgium (hereafter the EMS Belgium) compiled an application to raise the existing MRL for lambda-cyhalothrin in azarole from the LOQ to 0.2 mg/kg based on a new intended NEU use on kiwi berries (Actinidia arguta). The EMS Spain and the EMS Belgium drafted evaluation reports according to Article 8 of Regulation (EC) No 396/2005, which were submitted to the European Commission and forwarded to EFSA. According to EFSA, the submitted supervised residue trials are sufficient to derive a MRL proposal of 0.09 mg/kg for persimmon. The MRL proposal of 0.2 mg/kg for azarole (including kiwi berries) is derived as an extrapolation from the available residue data on black currant. According to the EMS Belgium, the intended spray concentration of lambdacyhalothrin on kiwi berries is identical to that in the black currant residue trials and thus these trials were considered appropriate to estimate residue levels in azarole (including kiwi berries). Based on the risk assessment results, EFSA concludes that the intended use of lambda-cyhalothrin on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern. European Food Safety Authority, 2013 KEY WORDS Lambda-cyhalothrin, azarole and kiwi berries, persimmon, MRL application, Regulation (EC) No 396/2005, pyrethroid insecticide 1 On request from European Commission, Question No EFSA-Q and EFSA-Q , approved on 20 February Correspondence: pesticides.mrl@efsa.europa.eu Suggested citation: European Food Safety Authority; Reasoned opinion on the modification of the existing MRLs for lambda-cyhalothrin in azarole and persimmon. EFSA Journal 2013;11(2):3117. [27 pp.] doi: /j.efsa Available online: European Food Safety Authority, 2013

2 SUMMARY In accordance with Article 6 of Regulation (EC) No 396/2005 3, Spain, herewith referred to as the evaluating Member State Spain, received an application from Syngenta Agro S.A. to raise the existing MRL for lambda-cyhalothrin in persimmon from the LOQ (0.02 mg/kg) to 0.1 mg/kg in support of a new intended SEU use. Belgium (hereafter the EMS Belgium) compiled an application to raise the existing MRL for lambda-cyhalothrin in azarole from the LOQ to 0.2 mg/kg based on a new intended NEU use on kiwi berries (Actinidia arguta). The EMS Spain and the EMS Belgium drafted evaluation reports according to Article 8 of Regulation (EC) No 396/2005, which were submitted to the European Commission and forwarded to EFSA on 24 May and 4 December 2012, respectively. Since both applications refer to the same active substance, for reasons of efficiency EFSA combined both MRL applications in one reasoned opinion. EFSA bases its assessment on the evaluation report submitted by the EMS Spain and the EMS Belgium, the Draft Assessment Report (DAR) prepared by the Rapporteur Member State (RMS) Sweden under Council Directive 91/414/EEC 4, the Commission Review Report on lambdacyhalothrin, the JMPR Evaluation report as well as the conclusions from previous EFSA opinions on lambda-cyhalothrin. The toxicological profile of lambda-cyhalothrin was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of mg/kg bw per day and an ARfD of mg/kg bw. The metabolism in primary crops was investigated for lambda-cyhalothrin in pulses and oilseeds (soya and cotton) and in cereals (wheat) and for cyhalothrin (sum of isomers) in fruits (apples) and leafy vegetables (cabbage). The peer review experts agreed that the parent compound lambda-cyhalothrin is the major part of the residues in treated plants and that the metabolic pathway is similar in all crops investigated. The peer review defined the residue in plants for the risk assessment and enforcement as lambda-cyhalothrin. The metabolism study in apples, which is representative for the fruits and fruiting vegetables category, has been performed with cyhalothrin labelled only in one position and provides limited information regarding the application rate and metabolic pathway. Although studies with other crops indicate that following foliar treatment, lambda-cyhalothrin is the main residue in the crop, adequate metabolism studies with lambda-cyhalothrin on fruits and fruiting vegetables would be desirable and the need for them is to be considered in the framework of the MRL review according to Article 12 of Regulation (EC) No 396/2005. EFSA considers that the submitted supervised residue trials are sufficient to derive a MRL proposal of 0.09 mg/kg for persimmon. The MRL proposal of 0.2 mg/kg for azarole (including kiwi berries) is derived as an extrapolation from the available residue data on black currant. According to the EMS Belgium, the intended spray concentration of lambda-cyhalothrin on kiwi berries is identical to that in the black currant residue trials and thus these trials were considered appropriate to estimate residue levels in azarole (including kiwi berries). Adequate analytical enforcement methods are available to control the residues of lambda-cyhalothrin in the crops under consideration at the validated LOQ of 0.01 mg/kg. The JMPR has evaluated the effects of processing on the nature of lambda-cyhalothrin in a hydrolysis study simulating baking/brewing/boiling, pasteurisation and sterilisation conditions. The majority of the residue under baking/brewing/boiling and pasteurisation conditions consists of the sum of lambdacyhalothrin and cyhalothrin enantiomeric pair A. Under sterilisation conditions lambda-cyhalothrin significantly degrades to several metabolites, toxicity of which has not been investigated. The possible inclusion of these metabolites in the residue definition for processed commodities is to be further considered in the framework of Article 12 of Regulation (EC) No 396/2005. Provisionally, the residue in processed commodities is to be defined as lambda-cyhalothrin. 3 Regulation (EC) No 396/2005 of the Parliament and of the Council of 23 February OJ L 70, , p Council Directive 91/414/EEC of 15 July OJ L 230, , p EFSA Journal 2013;11(2):3117 2

3 Specific studies to assess the magnitude of lambda-cyhalothrin residues during the processing of the crops under consideration have not been submitted. However, since the two crops under consideration are very minor crops and are consumed fresh (persimmon), such studies are not required. Since the proposed use of lambda-cyhalothrin is on permanent/semi-permanent crops investigations of residues in rotational/succeeding crops are not required. Residues of lambda-cyhalothrin in commodities of animal origin were not assessed in the framework of this application, since the crops under consideration are not fed to livestock. The consumer risk assessment was performed with revision 2 of the EFSA Pesticides Residues Intake Model (PRIMo). For the calculation of the chronic exposure, EFSA used the median residue value as derived from the residue trials on persimmon and black currant; the latter was used as an input value for azarole (including kiwi berries). To refine the exposure calculation, for several commodities the risk assessment values were available from the JMPR evaluation and from the previously issued EFSA reasoned opinions. For the remaining commodities of plant and animal origin, the existing MRLs as established in Annexes II and IIIB of Regulation (EC) No 396/2005 were used as input values. The acute exposure assessment was performed only with regard to the commodities under consideration assuming the consumption of a large portion of the food items as reported in the national food surveys containing residues at the highest level as observed in supervised field trials. The estimated exposure was then compared with the toxicological reference values derived for lambda-cyhalothrin. No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake values accounted for up to 88.4% of the ADI (NL child diet). The individual contribution of residues in azarole and persimmon to the total consumer exposure (in % of the ADI) accounted for 0.017% (DE child diet) and 0.011% (WHO Cluster diet B), respectively. No individual consumption data are available for kiwi berries. No acute consumer risk was identified in relation to the MRL proposals for the crops under consideration. The calculated maximum exposure in percentage of the ARfD was 21.3% for persimmon and 1.3% for azarole. No consumption data are available for kiwi berries. EFSA concludes that the intended use of lambda-cyhalothrin on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern. Thus EFSA proposes to amend the existing MRLs as reported in the summary table. Summary table Code Commodity Existing number (a) EU MRL Proposed EU MRL Enforcement residue definition: Lambda-cyhalothrin (F) Azarole (mediterranean medlar) Justification for the proposal 0.02* 0.2 The MRL proposal is sufficiently supported by data and no risk for consumers was identified for the intended NEU use of lambda-cyhalothrin on azarole, including kiwi berries Persimmon 0.02* 0.09 The MRL proposal is sufficiently supported by data and no risk for consumers was identified for the intended SEU use. (a): According to Annex I of Regulation (EC) No 396/2005. (*): Indicates that the MRL is set at the limit of analytical quantification. (F): Fat-soluble pesticide. MRL is expressed as mg/kg of fat contained in the whole product. EFSA Journal 2013;11(2):3117 3

4 TABLE OF CONTENTS Abstract... 1 Summary... 2 Table of contents... 4 Background... 5 Terms of reference... 5 The active substance and its use pattern... 6 Assessment Method of analysis Methods for enforcement of residues in food of plant origin Methods for enforcement of residues in food of animal origin Mammalian toxicology Residues Nature and magnitude of residues in plant Primary crops Rotational crops Nature and magnitude of residues in livestock Consumer risk assessment Conclusions and recommendations References Appendices A. Good Agricultural Practice (GAPs) B. Pesticide Residues Intake Model (PRIMo ) C. Existing EU maximum residue levels (MRLs) Abbreviations EFSA Journal 2013;11(2):3117 4

5 BACKGROUND Regulation (EC) No 396/2005 establishes the rules governing the setting of pesticide MRLs at European Union level. Article 6 of that Regulation lays down that any party having a legitimate interest or requesting an authorisation for the use of a plant protection product in accordance with Council Directive 91/414/EEC, repealed by Regulation (EC) No 1107/2009, shall submit to a Member State, when appropriate, an application to set or modify an MRL in accordance with the provisions of Article 7 of that Regulation. Spain, hereafter referred to as the evaluating Member State Spain (EMS Spain), received an application from the company Syngenta Agro S.A. 5 to modify the existing MRL for the active substance lambda-cyhalothrin in persimmon. This application was notified to the European Commission and EFSA and subsequently evaluated by the EMS in accordance with Article 8 of the Regulation. After completion, the evaluation report was submitted to the European Commission who forwarded the application, the evaluation report and the supporting dossier to EFSA on 24 May The application was included in the EFSA Register of Questions with the reference number EFSA-Q and the following subject: Lambda-cyhalothrin - Application to modify the existing MRL in persimmon. Belgium 6, hereafter referred to as the evaluating Member State Belgium (EMS Belgium), compiled an application to modify the existing MRLs for the lambda-cyhalothrin in azarole, based on the intended use on kiwi berry (Actinidia arguta). This application was notified to the European Commission and EFSA and subsequently evaluated in accordance with Article 8 of the Regulation. After completion, the evaluation report was submitted to the European Commission who forwarded the application, the evaluation report and the supporting dossier to EFSA on 4 December The application was included in the EFSA Register of Questions with the reference number EFSA-Q and the following subject: Lambda-cyhalothrin -Application to modify the existing MRLs in kiwi berries (azarole). The EMS Spain proposed to raise the existing MRL for lambda-cyhalothrin in persimmon from the LOQ of 0.02 mg/kg to 0.1 mg/kg. The EMS Belgium proposed to raise the existing MRL for lambdacyhalothrin in azarole (including kiwi berries) from the LOQ of 0.02 mg/kg to 0.2 mg/kg. EFSA proceeded with the assessment of the application and the evaluation report as required by Article 10 of the Regulation. TERMS OF REFERENCE In accordance with Article 10 of Regulation (EC) No 396/2005, EFSA shall, based on the evaluation report provided by the evaluating Member State, provide a reasoned opinion on the risks to the consumer associated with the application. In accordance with Article 11 of that Regulation, the reasoned opinion shall be provided as soon as possible and at the latest within three months (which may be extended to six months where more detailed evaluations need to be carried out) from the date of receipt of the application. Where EFSA requests supplementary information, the time limit laid down shall be suspended until that information has been provided. In this particular case the calculated deadline for providing the reasoned opinion is 24 August 2012 for the MRL application on persimmon and 4 March 2013 for the MRL application on kiwi berries (azarole). 5 Syngenta Agro, S.A., Ribera del Loira 8-10, 3a planta, 28042, Madrid, Spain 6 Belgium. FPS Health, Food chain safety and Environment, DG4, Place Victor Horta, 40 box 10, Eurostation II, lacal 7D115, 1060, Brussels, Belgium EFSA Journal 2013;11(2):3117 5

6 THE ACTIVE SUBSTANCE AND ITS USE PATTERN Lambda-cyhalothrin is the ISO common name for 1:1 mixture of (R)-α-cyano-3-phenoxybenzyl (1S)- cis-3-[(z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethylcyclopropanecarboxylate and (S)-α-cyano-3- phenoxybenzyl (1R)-cis-3-[(Z)-2-chloro-3,3,3-trifluoropropenyl]-2,2-dimethyl- cyclopropanecarboxylate (IUPAC). The chemical structure is the following: Molecular weight: Lambda-cyhalothrin is a synthetic pyrethroid. It is an enriched isomeric form of the two biologically active diastereoisomeric pairs of isomers of cyhalothrin (FAO, 2009). One of the two enantiomers of lamda-cyhalothrin is the insecticidally active gamma-cyhalothrin. Cyhalothrin comprises about 50% of lambda-cyhalothrin (FAO, 2007). Lambda-cyhalothrin is mainly used for plant protection purposes as a non-systemic broad spectrum insecticide in a wide range of crops. It is highly active against a wide range of species of Lepidoptera, Hemiptera, Diptera, and Coleoptera. Lambda-cyhalothrin was peer reviewed under Directive 91/414/EEC with Sweden being the designated rapporteur Member State (RMS). The active substance was included in Annex I by Directive 2000/80/EC 7 which entered into force on 29 December The Annex I inclusion is restricted to use as an insecticide. Lambda-cyhalothrin was not peer reviewed by EFSA and thus an EFSA conclusion is not available. The representative uses evaluated in the peer review referred to a foliar application on a wide range of fruits and vegetables. The MRL review of lambda-cyhalothrin according to Article 12 of Regulation (EC) No 396/2005 is at an early stage. The EU MRLs for lambda-cyhalothrin are established in Annexes II and IIIB of Regulation (EC) No 396/2005 (Appendix C). After the adoption of this Regulation, EFSA issued two reasoned opinions on the modification of the existing MRLs for lambda-cyhalothrin in currants (EFSA, 2009a) and globe artichokes (EFSA, 2009b), and the recommended MRLs have been implemented in the EU legislation. Codex Alimentarius has established CXLs for a wide range of commodities, but no CXLs are set for the commodities under consideration. A CXL of 0.2 mg/kg is set for berries and other small fruits (FAO, 2009). Many of the CXLs for lambda-cyhalothrin have been taken over in the EU legislation by Regulation (EC) No 459/ The details of the intended GAPs for lambda-cyhalothrin are given in Appendix A. 7 Commission Directive 2000/80/ECof 4 December 2000, OJ L 309, , p Commission Regulation (EU) No 459/2010 of 27 May 2010, OJ L 129, , p EFSA Journal 2013;11(2):3117 6

7 ASSESSMENT EFSA bases its assessment on the evaluation report submitted by the EMS Spain (Spain, 2012) and the EMS Belgium (Belgium, 2012), the Draft Assessment Report (DAR) prepared under Council Directive 91/414/EEC (Sweden, 1996), the Commission Review Report on lambda-cyhalothrin (EC, 2001), the JMPR Evaluation report (FAO, 2009) as well as the conclusions from previous EFSA opinions on lambda-cyhalothrin (EFSA, 2009a, 2009b). 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/ and the currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues (EC, 1996, 1997a, 1997b, 1997c, 1997d, 1997e, 1997f, 1997g, 2000, 2010a, 2010b, 2011; OECD, 2011). 1. Method of analysis 1.1. Methods for enforcement of residues in food of plant origin Analytical methods for the determination of lambda-cyhalothrin residues in plant commodities were assessed during the peer review under Directive 91/414/EEC (Sweden, 1996). A single residue method based on GC-ECD and the DFG multi-residue method S 19 were sufficiently validated for the determination of lambda-cyhalothrin residues in all plant matrices at the validated LOQ of 0.01 mg/kg (in hops at 0.1 mg/kg). EFSA concludes that sufficiently validated analytical methods are available to control lambdacyhalothrin residues in the crops under consideration Methods for enforcement of residues in food of animal origin Analytical methods for the determination of residues in food of animal origin are not assessed in the current application, since the crops under consideration are normally not fed to livestock. 2. Mammalian toxicology The toxicological profile of the active substance lambda-cyhalothrin was assessed in the framework of the peer review under Directive 91/414/EEC in studies both with lambda-cyhalothrin and cyhalothrin (EC, 2001, Sweden, 1996). Lambda-cyhalothrin has higher biological activity compared to cyhalothrin. The acute oral and dermal toxicity of lambda-cyhalothrin was approximately 2 times higher than of cyhalothrin. For both compounds, liver is the main target organ in 90-day feeding studies in rats. The long-term toxicity and reproductive toxicity was only tested for cyhalothrin (Sweden, 1996). No toxicological reference values were derived for cyhalothrin. The derived toxicological reference values for lambda-cyhalothrin are compiled in Table 2-1. Table 2-1: Overview of the toxicological reference values Lambda-cyhalothrin Source Year Value Study relied upon Safety factor ADI EC mg/kg bw per day 1 yr dog 100 ARfD EC mg/kg bw 42 d dog Commission Regulation (EU) No 546/2011 of 10 June OJ L 155, , p EFSA Journal 2013;11(2):3117 7

8 3. Residues 3.1. Nature and magnitude of residues in plant Primary crops Nature of residues The metabolism of lambda-cyhalothrin in primary crops was evaluated by the RMS Sweden in the framework of the peer review under Directive 91/414/EEC (Sweden, 1996). In these studies the substance (lambda-cyhalothrin and cyhalothrin) was radio labelled in one of three different positions, cyclopropyl-, benzyl- or phenyl-labelling. The overview of the metabolism study designs is presented in the table below. Table 3-1: Summary of available metabolism studies in plants Group Crop Label position Fruits and fruiting vegetable Leafy vegetables Pulses and oilseeds Apples Cabbage Soya [Cyclopropyl- 14C]- cyhalothrin [Cyclopropyl- 14C]- cyhalothrin [Cyclopropyl- 14C]- and [benzyl- 14 C] lambdacyhalothrin Method, F or G (a) Spotting on 10 apples Leaf spotting Foliar spray Rate (kg a.s./ha ca. 33 g per apple ca. 26 g per leaf Application details No/ Interval ) 4 times 2) 8 times Sampling 1 2 apples- 0,7, 14, 28 and 56 DAT 1 Leaves harvested 2, 4, 5, 6, 7 wk after treatment Remarks 7 DALA Two plants treated Foliar /G /18 days 39 DALA (leaves) and 51 DALA (beans) Cotton [Cyclopropyl- 14C]- and [benzyl- 14 C] lambdacyhalothrin Foliar/F /n.r. Leaves-78 d after 1st appl. and 30 DALA; seeds- 101 d after 1st appl. and 50 DALA. Freshly ripened bolls were treated separately with a.s. at a rate of 1 g/seed and kept for 14 d on plant. EFSA Journal 2013;11(2):3117 8

9 Group Crop Label position Cereals Wheat [Cyclopropyl- 14C]- and [phenyl- 14 C] lambdacyhalothrin Method, F or G (a) Rate (kg a.s./ha Application details No/ Interval Foliar/F 0.22 Three treatment patterns: 1) 2/At crop emergence and prior ear emergence Sampling 1) 14 DALA (grain and foliage) Remarks (a): Outdoor/field use (F) or glasshouse/protected crops/indoor application (G) n.r. not reported in the DAR 2) 2/At crop emergence and prior ear emergence 3)3/3rd appl. 30 d before maturity 2) 85 d DALA (grain) 3) 30 DALA (grain and foliage) In wheat grain the TRR was low (up to mg eq./kg (phenyl label) and mg eq./kg (cyclopropyl label) for treatment patterns 1) and 2)). In study with treatment pattern 3), the TRR in wheat grain ranged from 0.11 mg eq./kg for phenyl study and 0.13 mg eq./kg for cyclopropyl study and the majority of radioactivity 83.4% (0.093 mg/kg) and 76.4% (0.1 mg/kg), respectively - consisted of parent lambda-cyhalothrin. In wheat foliage the TRR accounted for 0.45 to 1.8 mg eq./kg for treatment 1) and 8-10 mg eq./kg for treatment 3). The main component of the TRR was parent lambda-cyhalothrin. In soya beans very low radioactivity was found for both labels ( mg eq./kg) and thus further characterisation was not undertaken. In the leaves of soya bean the TRR ranged from mg eq./kg and for both labels the parent accounted for 43-52% of the TRR ( mg/kg). Metabolite Ia 10 was identified as a major metabolite in cyclopropyl labelled study and accounted for 25% TRR (0.37 mg/kg). Several other metabolites were identified but did not individually exceed 10% TRR. In cotton foliage the TRR accounted for mg eq./kg (in benzyl study) and mg eq./kg (in cyclopropyl study) and parent lambda-cyhalothrin was the main component (up to 52% TRR (up to 1.7 mg/kg). Metabolite Ia was again identified in cyclopropyl labelled study and amounted for 17.6% TRR (0.71 mg/kg). In cotton seed the TRR was found at levels between 0.01 mg eq./kg (benzyl study) and mg eq./kg (cyclopropyl study). Characterisation was performed only for cyclopropyl study and indicated that the majority of the radioactivity was hexane-soluble (32% TRR) and aqueous acid soluble (27% TRR). No further characterisation was undertaken. In directly treated cotton seed all radioactivity consisted of unchanged parent compound. In cabbage leaves (leaf spotting study), the radioactivity consisted of cyhalothrin (both isomers) and accounted for 83.6% in leaves 14 DAT and decreased down to 54% TRR 6 weeks after the treatment. 10 Metabolite Ia; cyclopropane acid: (Z)-3-(2-chloro-3,3,3-trifluoropropenyl)- 2,2-dimethylcyclopropane carboxylic acid EFSA Journal 2013;11(2):3117 9

10 Cabbage from foliar treatment contained 0.44 mg eq./kg of the TRR and the majority of the radioactivity concentrated on outer leaves (1.13 mg eq./kg) with lower amounts in inner leaves (0.003 mg eq./kg). Cyhalothrin (isomers) was the main component of the TRR in outer leaves (80% TRR; 0.91 mg/kg). No other metabolites accounted for significant amounts in leave samples analysed 6 weeks after the treatment. Little translocation of residues was observed. In apples, a slow degradation of the applied active substance was observed within 28 DAT (>95% TRR was attributed to cyhalothrin). In sample taken 56 DAT, 89.5% TRR consisted of parent compound. Peel and pulp analyses showed that only small part of radioactivity had been translocated from peel into flesh (0.2% and 0.4% TRR 28 and 56 DAT). The results of the available studies indicate that lambda-cyhalothrin (as applied on wheat, cotton, soya) or cyhalothrin (as applied on cabbage and apple) are the main components in all plant groups investigated. Only in cotton and soya foliage another metabolite - metabolite Ia was identified at levels exceeding 10% TRR. The peer review noted that the metabolites formed in plants are a result of ester cleavage. The peer review experts agreed that the parent compound lambda-cyhalothrin is the major part of the residues in treated plants and that the metabolic pathway is similar in all crops investigated. The peer review defined the residue in plants for the risk assessment and enforcement as lambda-cyhalothrin. The metabolism study in apples, which is representative for the fruits and fruiting vegetables category, has been performed with cyhalothrin (sum of isomers) labelled only in one position and provides limited information regarding the application rate and metabolic pathway. Although studies with other crops indicate that following foliar treatment, lambda-cyhalothrin is the main residue in the crop, adequate metabolism studies with lambda-cyhalothrin on fruits and fruiting vegetables would be desirable and the need for them is to be considered in the framework of the MRL review according to Article 12 of Regulation (EC) No 396/ Magnitude of residues a. Persimmon The applicant submitted 4 GAP compliant residue trials on persimmon which were performed in Spain in 2007 and All residue trials were designed as decline trials. Residue data indicate that a MRL of 0.09 mg/kg would be required to support the intended use in Spain. b. Azarole, including kiwi berries (Actinidia arguta) GAP: 1-2 x g a.s./ha soil 11 ; spray concentration kg a.s./hl; PHI 14 days Conditions of black currant residue trials: 2 x ca.22g a.s./ha; spray concentration kg a.s./hl; PHI of 14 days The applicant did not submit residue trials on kiwi berries or azarole. Instead, the applicant refers to four residue trials on black currant which were assessed in the framework of the previously issued EFSA reasoned opinion (EFSA, 2009a). Although the residue trials on blackcurrant were overdosed in terms of application rate (a.s./ha), they were compliant with the GAP in terms of a spray concentration and thus were accepted to derive a MRL proposal of 0.2 mg/kg in black currant (EFSA, 2009a). As confirmed by the EMS Belgium, intended spray concentration of lambda-cyhalothrin for the use on kiwi berries is the same as the spray concentration in the residue trials on black currants. On a basis of this information the residue trials on black currant were considered representative for the use of lambda-cyhalothrin on kiwi berries. It is noted that kiwi berries according to Regulation (EU) No 600/ fall under the subgroup of azarole and thus the MRL will firstly refer to azarole. 11 According to the EMS the application rate on soil is 1.5 the application rate on hedge. 12 Commission Regulation (EU) No 600/2010 of 8 July 2010, OJ L 174, , pp EFSA Journal 2013;11(2):

11 According to EU guidance document (EC, 2011), an extrapolation of residue data from currants to azarole, which is considered as a very minor crop, is acceptable. A sufficient number of residue trials is submitted to support a MRL proposal of 0.2 mg/kg in azarole (including kiwi berries). The results of the residue trials, the related risk assessment input values (highest residue, median residue) and the MRL proposals are summarised in Table 3-2. The storage stability of lambda-cyhalothrin in primary crops was investigated in the DAR under Directive 91/414/EEC (Sweden, 1996). Residues of lambda-cyhalothrin were found to be stable at -18 C for up to 26 months in matrices with high water-, high oil content as well as in dry matrices. The applicant has not submitted storage stability studies for the high acid content commodities which berries belong to (EFSA, 2009a), but taking into account the wide range of commodities in which storage stability is demonstrated, the analytical results in currant can be considered reliable. Nevertheless, the need for a freezer storage stability study for acidic matrices will be considered in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005. According to the EMS Spain, the analytical methods used to analyse the supervised residue trial samples have been sufficiently validated and were proven to be fit for purpose (Spain, 2012). EFSA Journal 2013;11(2):

12 Table 3-2: Overview of the available residues trials data Commodity Residue region (a) Outdoor /Indoor Individual trial results Enforcement (Lambda-cyhalothrin) Risk assessment (Lambda-cyhalothrin) Median residue (b) Highest residue (c) MRL proposal Median CF (d) Comments (e) Persimmon SEU Outdoor <0.01; <0.02; 0.02; 0.04 <0.01; <0.02; 0.02; R ber = 0.07 R max = 0.09 MRL OECD = 0.08/0.09 Black currant azarole (incl. kiwi berries) NEU Outdoor <0.01; 2 x 0.07; 0.08 <0.01; 2 x 0.07; EFSA, 2009a. R ber =0.16 R max =0.22 MRL OECD = 0.186/0.2 (a): NEU (Northern and Central Europe), SEU (Southern Europe and Mediterranean), EU (i.e. outdoor use) or Import (country code) (EC, 2011). (b): Median value of the individual trial results according to the enforcement residue definition. (c): Highest value of the individual trial results according to the enforcement residue definition. (d): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors for each residue trial. (e): Statistical estimation of MRLs according to the EU methodology (R ber, R max ; EC, 1997g) and unrounded/rounded values according to the OECD methodology (OECD, 2011). EFSA Journal 2013;11(2):

13 Effect of industrial processing and/or household preparation The effect of processing on the nature of lambda-cyhalothrin has not been investigated under the peer review and in the current application. The JMPR has evaluated a hydrolysis study where the stability of [cyclopropyl-14c]- and [phenyl-14c] lambda-cyhalothrin was tested under conditions simulating baking/brewing/boiling, pasteurisation and sterilisation (FAO, 2009). The majority of the residue under baking/brewing/boiling and pasteurisation conditions for both radiolabels consisted of the sum of lambda-cyhalothrin and cyhalothrin enantiomeric pair A. Under sterilisation conditions phenyl labelled lambda-cyhalothrin degraded to a component IV 13 (63.7%), the rest being the sum of lambdacyhalothrin and cyhalothrin enantiomeric pair A (18.5%). Cyclopropyl labelled lambda-cyhalothrin under sterilisation conditions degraded to compound Ia (59.2%) and metabolite CSCD (14.6%). No other compounds exceeded 10% of the applied radioactivity (AR). The relevant metabolites have not been tested for their toxicity. Thus, the possible inclusion of these metabolites in the residue definition for processed commodities is to be further considered in the framework of Article 12 of Regulation (EC) No 396/2005. Provisionally, the residue in processed commodities is to be defined as lambda-cyhalothrin. Specific studies to assess the magnitude of lambda-cyhalothrin residues during the processing of the crops under consideration have not been submitted. However, since the two crops under consideration are very minor crops and are consumed fresh (persimmon), such studies are not required Rotational crops Kiwi berry (Actinidia arguta), azarole and persimmon are not grown in annual crop rotation and thus the nature and magnitude of lambda-cyhalothrin residues in rotational/succeeding crops was not assessed in the framework of the current application Nature and magnitude of residues in livestock Kiwi berry (Actinidia arguta), azarole and persimmon and/or their by-products are not fed to livestock and therefore the nature and magnitude of lambda-cyhalothrin residues in livestock was not assessed in the framework of this application. 4. Consumer risk assessment The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). This exposure assessment model contains the relevant European food consumption data for different sub-groups of the EU population 15 (EFSA, 2007). For the calculation of the chronic exposure, EFSA used the median residue value as derived from the residue trials on persimmon and black currant (see Table 3-2); the median residue value in black currant was used as an input value for azarole (including kiwi berries). For several commodities for which the Codex Residue Limits (CXLs) have been taken over in the EU legislation, the median residue values were available from the JMPR evaluation to refine the exposure calculation (FAO, 2009). For currants and globe artichokes the median residue values were available from the previously issued EFSA reasoned opinions (EFSA, 2009a, 2009b). For the remaining commodities of plant and animal origin, the existing MRLs as established in Annexes II and IIIB of Regulation (EC) No 396/2005 were used as input values. The model assumptions for the long-term exposure assessment are considered to be sufficiently conservative for a first tier exposure assessment, assuming that all food items consumed have been 13 Compound IV: 3-phenoxybenzaldehyde 14 CSCD113175: γ-lactone,4-(1-chloro-2,2,2-trifluoro-ethyl)-6,6-dimethyl-3-oxa-bicyclo[3.1.0]hexane-2-one 15 The calculation of the long-term exposure (chronic exposure) is based on the mean consumption data representative for 22 national diets collected from MS surveys plus 1 regional and 4 cluster diets from the WHO GEMS Food database; for the acute exposure assessment the most critical large portion consumption data from 19 national diets collected from MS surveys is used. The complete list of diets incorporated in EFSA PRIMo is given in its reference section (EFSA, 2007). EFSA Journal 2013;11(2):

14 treated with the active substance under consideration. In reality, it is not likely that all food consumed will contain residues at the MRL or at levels of the median residue values identified in supervised field trials. However, if this first tier exposure assessment does not exceed the toxicological reference value for long-term exposure (i.e. the ADI), a consumer health risk can be excluded with a high probability. The acute exposure assessment was performed only with regard to the commodities under consideration assuming the consumption of a large portion of the food items as reported in the national food surveys containing residues at the highest level as observed in supervised field trials. A variability factor accounting for the inhomogeneous distribution on the individual items consumed was included in the calculation, when required (EFSA, 2007). The input values used for the dietary exposure calculation are summarised in Table 4-1. Table 4-1: Input values for the consumer dietary exposure assessment Commodity Chronic exposure assessment Acute exposure assessment Input value Comment Risk assessment residue definition: Lambda-cyhalothrin Input value Comment Persimmon 0.02 Median residue 0.04 Highest residue Azarole 0.07 Median residue (black currant) (Table 3-2) 0.08 Highest residue (black currant) (Table 3-2) Citrus fruits 0.01 Median residue (FAO, 2009) Acute risk assessment was undertaken Cherries Median residue (FAO, 2009) only with regard to the crops under consideration. Plums 0.02 Median residue (FAO, 2009) Berries and small fruit (except currants and azarole) Currants (red, black and white) Table olives and olives for oil production 0.02 Median residue (FAO, 2009) 0.07 Median residue (EFSA, 2009a) Median residue (FAO, 2009) Bulb vegetables 0.05 Median residue (FAO, 2009) Globe artichokes 0.04 Median residue (EFSA, 2009b) Dry pulses 0.01 Median residue (FAO, 2009) Linseed, peanuts, poppy seed, sesame seed, sunflower seed, rape seed, mustard seed, cotton seed, safflower 0.01 Median residue (FAO, 2009) Barley 0.02 Median residue (FAO, 2009) Rice 0.3 Median residue (FAO, 2009) EFSA Journal 2013;11(2):

15 Commodity Chronic exposure assessment Acute exposure assessment Input value Comment Oats, rye, wheat 0.01 Median residue (FAO, 2009) Milk 0.01 Median residue (Sweden, 2009) Other commodities of plant and animal origin MRL See Appendix C Input value Comment The estimated exposure was then compared with the toxicological reference values derived for lambda-cyhalothrin (see Table 2-1). The results of the intake calculation are presented in Appendix B to this reasoned opinion. No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake values accounted for up to 88.4% of the ADI (NL child diet). The contribution of residues to the total consumer exposure (in % of the ADI) accounted for 0.017% for azarole (DE child diet) and 0.011% for persimmon (WHO Cluster diet B). No acute consumer risk was identified in relation to the MRL proposals for the crops under consideration. The calculated maximum exposure in percentage of the ARfD was 21.3% for persimmon and 1.3% for azarole. No consumption data are available for kiwi berries. EFSA concludes that the intended use of lambda-cyhalothrin on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern. EFSA Journal 2013;11(2):

16 CONCLUSIONS AND RECOMMENDATIONS CONCLUSIONS The toxicological profile of lambda-cyhalothrin was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of mg/kg bw per day and an ARfD of mg/kg bw. The metabolism in primary crops was investigated for lambda-cyhalothrin in pulses and oilseeds (soya and cotton) and in cereals (wheat) and for cyhalothrin (sum of isomers) in fruits (apples) and leafy vegetables (cabbage). The peer review experts agreed that the parent compound lambda-cyhalothrin is the major part of the residues in treated plants and that the metabolic pathway is similar in all crops investigated. The peer review defined the residue in plants for the risk assessment and enforcement as lambda-cyhalothrin. The metabolism study in apples, which is representative for the fruits and fruiting vegetables category, has been performed with cyhalothrin labelled only in one position and provides limited information regarding the application rate and metabolic pathway. Although studies with other crops indicate that following foliar treatment, lambda-cyhalothrin is the main residue in the crop, adequate metabolism studies with lambda-cyhalothrin on fruits and fruiting vegetables would be desirable and the need for them is to be considered in the framework of the MRL review according to Article 12 of Regulation (EC) No 396/2005. EFSA considers that the submitted supervised residue trials are sufficient to derive a MRL proposal of 0.09 mg/kg for persimmon. The MRL proposal of 0.2 mg/kg for azarole (including kiwi berries) is derived as an extrapolation from the available residue data on black currant. According to the EMS Belgium, the intended spray concentration of lambda-cyhalothrin on kiwi berries is identical to that in the black currant residue trials and thus these trials were considered appropriate to estimate residue levels in azarole (including kiwi berries). Adequate analytical enforcement methods are available to control the residues of lambda-cyhalothrin in the crops under consideration at the validated LOQ of 0.01 mg/kg. The JMPR has evaluated the effects of processing on the nature of lambda-cyhalothrin in a hydrolysis study simulating baking/brewing/boiling, pasteurisation and sterilisation conditions. The majority of the residue under baking/brewing/boiling and pasteurisation conditions consists of the sum of lambdacyhalothrin and cyhalothrin enantiomeric pair A. Under sterilisation conditions lambda-cyhalothrin significantly degrades to several metabolites, toxicity of which has not been investigated. The possible inclusion of these metabolites in the residue definition for processed commodities is to be further considered in the framework of Article 12 of Regulation (EC) No 396/2005. Provisionally, the residue in processed commodities is to be defined as lambda-cyhalothrin. Specific studies to assess the magnitude of lambda-cyhalothrin residues during the processing of the crops under consideration have not been submitted. However, since the two crops under consideration are very minor crops and are consumed fresh (persimmon), such studies are not required. Since the proposed use of lambda-cyhalothrin is on permanent/semi-permanent crops investigations of residues in rotational/succeeding crops are not required. Residues of lambda-cyhalothrin in commodities of animal origin were not assessed in the framework of this application, since the crops under consideration are not fed to livestock. The consumer risk assessment was performed with revision 2 of the EFSA Pesticides Residues Intake Model (PRIMo). For the calculation of the chronic exposure, EFSA used the median residue value as derived from the residue trials on persimmon and black currant; the latter was used as an input value for azarole (including kiwi berries). To refine the exposure calculation, for several commodities the risk assessment values were available from the JMPR evaluation and from the previously issued EFSA reasoned opinions. For the remaining commodities of plant and animal origin, the existing MRLs as EFSA Journal 2013;11(2):

17 established in Annexes II and IIIB of Regulation (EC) No 396/2005 were used as input values. The acute exposure assessment was performed only with regard to the commodities under consideration assuming the consumption of a large portion of the food items as reported in the national food surveys containing residues at the highest level as observed in supervised field trials. The estimated exposure was then compared with the toxicological reference values derived for lambda-cyhalothrin. No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake values accounted for up to 88.4% of the ADI (NL child diet). The individual contribution of residues in azarole and persimmon to the total consumer exposure (in % of the ADI) accounted for 0.017% (DE child diet) and 0.011% (WHO Cluster diet B), respectively. No individual consumption data are available for kiwi berries. No acute consumer risk was identified in relation to the MRL proposals for the crops under consideration. The calculated maximum exposure in percentage of the ARfD was 21.3% for persimmon and 1.3% for azarole. No consumption data are available for kiwi berries. EFSA concludes that the intended use of lambda-cyhalothrin on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern. RECOMMENDATIONS Code Commodity Existing number (a) EU MRL Proposed EU MRL Enforcement residue definition: Lambda-cyhalothrin (F) Azarole (mediterranean medlar) Justification for the proposal 0.02* 0.2 The MRL proposal is sufficiently supported by data and no risk for consumers was identified for the intended NEU use of lambda-cyhalothrin on azarole, including kiwi berries Persimmon 0.02* 0.09 The MRL proposal is sufficiently supported by data and no risk for consumers was identified for the intended SEU use. (a): According to Annex I of Regulation (EC) No 396/2005. (*): Indicates that the MRL is set at the limit of analytical quantification. (F): Fat-soluble pesticide. MRL is expressed as mg/kg of fat contained in the whole product. EFSA Journal 2013;11(2):

18 REFERENCES Belgium, Evaluation report on the modification of MRLs for lambda-cyhalothrin in kiwiberries prepared by the evaluating Member State (EMS) Belgium under Article 8 of Regulation (EC) No 396/2005, 5 November 2012, 10 pp. EC (European Commission), Appendix G. Livestock Feeding Studies. 7031/VI/95 rev.4. Available from: EC (European Commission), 1997a. Appendix A. Metabolism and distribution in plants. 7028/IV/95- rev.3. Available from: EC (European Commission), 1997b. Appendix B. General recommendations for the design, preparation and realisation of residue trials. Annex 2. Classification of (minor) crops not listed in the Appendix of Council Directive 90/642/EEC. 7029/VI/95-rev.6. Available from: EC (European Commission), 1997c. Appendix C. Testing of plant protection products in rotational crops. 7524/VI/95-rev.2. Available from: EC (European Commission), 1997d. Appendix E. Processing studies. 7035/VI/95-rev.5. Available from: EC (European Commission), 1997e. Appendix F. Metabolism and distribution in domestic animals. 7030/VI/95-rev.3. Available from: EC (European Commission), 1997f. Appendix H. Storage stability of residue samples. 7032/VI/95- rev.5. Available from: EC (European Commission), 1997g. Appendix I. Calculation of maximum residue level and safety intervals. 7039/VI/95. Available from: EC (European Commission), Residue analytical methods. For pre-registration data requirement for Annex II (part A, section 4) and Annex III (part A, section 5 of Directive 91/414). SANCO/3029/99-rev.4. Available from: EC (European Commission), Review report for the active substance lambda-cyhalothrin. Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 19 October 2000 in view of the inclusion of lambda-cyhalothrin in Annex I of Council Directive 91/414/EEC. SANCO/7572/VI/97-final, 25 January pp. EC (European Commission), 2010a. Classes to be used for the setting of EU pesticide Maximum Residue Levels (MRLs). SANCO 10634/2010 Rev. 0, finalised in the Standing Committee on the Food Chain and Animal Health at its meeting of March EC (European Commission), 2010b. Residue analytical methods. For post-registration control. SANCO/825/00-rev.8.1. Available from: EC (European Commission), Appendix D. Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs. 7525/VI/95-rev.9. Available from: EFSA (European Food Safety Authority), Reasoned opinion on the potential chronic and acute risk to consumers health arising from proposed temporary EU MRLs. Available online: EFSA (European Food Safety Authority), 2009a. Reasoned opinion on the modification of the existing MRL for lambda-cyhalothrinin in currants prepared by EFSA Pesticide Risk Assessment Peer Review (PRAPeR) Unit. EFSA Scientific Report (2009) 226, EFSA (European Food Safety Authority), 2009b. Reasoned opinion on the modification of the existing MRL(s) for lambda-cyhalothrinin in globe artichokes prepared by EFSA Pesticide Risk Assessment Peer Review (PRAPeR) Unit. EFSA Scientific Report (2009) 330, EFSA Journal 2013;11(2):

19 FAO (Food and Agriculture Organisation of the United Nations), Lambda-cyhalothrin In: Pesticide residues in food Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Expert Group on Pesticide Residues. FAO Plant Production and Protection Paper 191, pp FAO (Food and Agriculture Organisation of the United Nations), Lambda-cyhalothrin In: Pesticide residues in food Evaluations. Part I. Residues. FAO Plant Production and Protection Paper 194, pp. Meier U, Growth Stages of mono- and dicotyledonous plants. BBCH Monograph, 2 nd Ed., Federal Biological Research Centre of Agriculture and Forest. Braunschweig, Germany. Available from: OECD (Organisation for Economic Co-operation and Development), OECD MRL Calculator: spreadsheet for single data set and spreadsheet for multiple data set, 2 March In: Pesticide Publications/Publications on Pesticide Residues. Available from: Spain, Evaluation report on the modification of MRLs for lambda-cyhalothrin in persimmon prepared by the evaluating Member State (EMS) Spain under Article 8 of Regulation (EC) No 396/2005, April 2012, 37 pp. Sweden, Draft Assessment Report on lambda-cyhalothrin prepared by National Chemicals Inspectorate (KEMI) in the framework of Directive 91/414. June Sweden, PROFile (Pesticides Residue Overview File) prepared by the RMS Sweden in the framework of Article 12 of Regulation (EC) No 396/2005. Submitted to EFSA on 10 June 2009 (not reviewed by EFSA). EFSA Journal 2013;11(2):