Review of the existing maximum residue levels for tebufenozide according to Article 12 of Regulation (EC) No 396/2005
2018; Wiley; Volume: 16; Issue: 2 Linguagem: Inglês
10.2903/j.efsa.2018.5190
ISSN1831-4732
AutoresAlba Brancato, Daniela Brocca, Chloé De Lentdecker, Lucien Ferreira, Luna Greco, Samira Jarrah, Dimitra Kardassi, Renata Leuschner, Christopher Lythgo, Paula Medina, Ileana Miron, Tünde Molnar, Alexandre Nougadère, Ragnor Pedersen, Hermine Reich, Angela Sacchi, Miguel Santos, Alois Stanek, Juergen Sturma, José Tarazona, Anne Theobald, Bénédicte Vagenende, Alessia Verani, Laura Villamar‐Bouza,
Tópico(s)Vitamin K Research Studies
ResumoEFSA JournalVolume 16, Issue 2 e05190 Reasoned OpinionOpen Access Review of the existing maximum residue levels for tebufenozide according to Article 12 of Regulation (EC) No 396/2005 European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this authorAlba Brancato, Alba BrancatoSearch for more papers by this authorDaniela Brocca, Daniela BroccaSearch for more papers by this authorChloe De Lentdecker, Chloe De LentdeckerSearch for more papers by this authorLucien Ferreira, Lucien FerreiraSearch for more papers by this authorLuna Greco, Luna GrecoSearch for more papers by this authorSamira Jarrah, Samira JarrahSearch for more papers by this authorDimitra Kardassi, Dimitra KardassiSearch for more papers by this authorRenata Leuschner, Renata LeuschnerSearch for more papers by this authorChristopher Lythgo, Christopher LythgoSearch for more papers by this authorPaula Medina, Paula MedinaSearch for more papers by this authorIleana Miron, Ileana MironSearch for more papers by this authorTunde Molnar, Tunde MolnarSearch for more papers by this authorAlexandre Nougadere, Alexandre NougadereSearch for more papers by this authorRagnor Pedersen, Ragnor PedersenSearch for more papers by this authorHermine Reich, Hermine ReichSearch for more papers by this authorAngela Sacchi, Angela SacchiSearch for more papers by this authorMiguel Santos, Miguel SantosSearch for more papers by this authorAlois Stanek, Alois StanekSearch for more papers by this authorJuergen Sturma, Juergen SturmaSearch for more papers by this authorJose Tarazona, Jose TarazonaSearch for more papers by this authorAnne Theobald, Anne TheobaldSearch for more papers by this authorBenedicte Vagenende, Benedicte VagenendeSearch for more papers by this authorAlessia Verani, Alessia VeraniSearch for more papers by this authorLaura Villamar-Bouza, Laura Villamar-BouzaSearch for more papers by this author European Food Safety Authority (EFSA), European Food Safety Authority (EFSA)Search for more papers by this authorAlba Brancato, Alba BrancatoSearch for more papers by this authorDaniela Brocca, Daniela BroccaSearch for more papers by this authorChloe De Lentdecker, Chloe De LentdeckerSearch for more papers by this authorLucien Ferreira, Lucien FerreiraSearch for more papers by this authorLuna Greco, Luna GrecoSearch for more papers by this authorSamira Jarrah, Samira JarrahSearch for more papers by this authorDimitra Kardassi, Dimitra KardassiSearch for more papers by this authorRenata Leuschner, Renata LeuschnerSearch for more papers by this authorChristopher Lythgo, Christopher LythgoSearch for more papers by this authorPaula Medina, Paula MedinaSearch for more papers by this authorIleana Miron, Ileana MironSearch for more papers by this authorTunde Molnar, Tunde MolnarSearch for more papers by this authorAlexandre Nougadere, Alexandre NougadereSearch for more papers by this authorRagnor Pedersen, Ragnor PedersenSearch for more papers by this authorHermine Reich, Hermine ReichSearch for more papers by this authorAngela Sacchi, Angela SacchiSearch for more papers by this authorMiguel Santos, Miguel SantosSearch for more papers by this authorAlois Stanek, Alois StanekSearch for more papers by this authorJuergen Sturma, Juergen SturmaSearch for more papers by this authorJose Tarazona, Jose TarazonaSearch for more papers by this authorAnne Theobald, Anne TheobaldSearch for more papers by this authorBenedicte Vagenende, Benedicte VagenendeSearch for more papers by this authorAlessia Verani, Alessia VeraniSearch for more papers by this authorLaura Villamar-Bouza, Laura Villamar-BouzaSearch for more papers by this author First published: 26 February 2018 https://doi.org/10.2903/j.efsa.2018.5190Citations: 1 Correspondence: pesticides.mrl@efsa.europa.eu Requestor: European Commission Question number: EFSA-Q-2009-00075 Acknowledgement: EFSA wishes to thank the rapporteur Member State, Germany, for the preparatory work on this scientific output. Approved: 5 February 2018 AboutSectionsPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract According to Article 12 of Regulation (EC) No 396/2005, EFSA has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance tebufenozide. To assess the occurrence of tebufenozide 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 European authorisations reported by Member States (including the supporting residues data). 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. Summary Tebufenozide was included in Annex I to Directive 91/414/EEC on 1 June 2011 by Commission Directive 2011/60/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 Germany, as the designated 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 2 March 2017 and finalised on 2 May 2017. After having considered all the information provided, EFSA prepared a completeness check report which was made available to Member States on 9 June 2017. 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 Member States, EFSA prepared in November 2017 a draft reasoned opinion, which was circulated to Member States for consultation via a written procedure. Comments received by 11 December 2017 were considered during the finalisation of this reasoned opinion. The following conclusions are derived. The metabolism of tebufenozide was assessed in fruits, cereals, root crops and leafy vegetables (tentative). A general residue definition is proposed for risk assessment: sum of tebufenozide and all metabolites including ethylphenyl and dimethylphenyl structures, expressed as tebufenozide. For enforcement, the residue definition should be limited to tebufenozide only. A validated analytical method for enforcement of the proposed residue definition in the four main analytical matrices is available. The metabolism of rotational crops was found to be similar as the metabolism in primary crops; therefore, the same residue definitions apply. Tebufenozide was stable to hydrolysis under standard conditions of pasteurisation, baking and sterilisation. Studies investigating the magnitude of residues in several processed commodities of citrus (oranges and mandarins), apples, tomatoes and rice are available. Robust-processing factors could be derived for citrus (peel, peeled), apples (washed, juice (unpasteurised), puree, wet pomace), grape (must (with and without skins), pomace, wine), rice (husked grain, polished grain), tomato (juice (sterilised), wet pomace, fruit (preserved), paste) and limited processing factors (not fully supported by data) were derived for citrus (washed fruits, juice, dried pulp, cold pressed oil), apple (juice (pasteurised), peel and core) and tomato (puree). The available data are considered sufficient to derive MRL proposals as well as risk assessment values for all crops under review with the exception of chestnuts/walnuts, hazelnuts/cobnuts, pine nut kernels, cherries (sweet), plums, table/wine grapes, strawberries, tomatoes, aubergines and courgette. For lettuces/escaroles and rice grain, only tentative MRLs were derived. Due to the lack of confirmatory analytical methods for animal matrices and the fact that conversion factors were derived from metabolism studies, the MRLs in commodities of animal origin should be considered as tentative only. All dietary burdens were found to exceed the trigger value of 0.1 mg/kg dry matter (DM). The metabolism of tebufenozide was investigated in ruminants (lactating goats) and poultry (laying hens). A feeding study performed on ruminants (dairy cow) was also available for this MRL review. The residue definition in livestock for both enforcement and risk assessment is limited to parent compound only. A validated analytical method for enforcement for residues in milk, meat, fat and liver is available. For eggs, a similar method was reported, but the method was not validated. No confirmatory methods are available for analytical methods in animal matrices. 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 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 29.6% of the acceptable daily intake (ADI) (DE children). 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 tebufenozide. Additional calculations of the consumer exposure, considering these CXLs, were therefore carried out. The highest chronic exposure represented 39.6% of the ADI (DE children). 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 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 that active substance. As tebufenozide was included in Annex I to Council Directive 91/414/EEC on 1 June 2011 by means of Commission Directive 2011/60/EC3 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. Germany, the designated rapporteur Member State (RMS) in the framework of Directive 91/414/EEC, was asked to complete the PROFile for tebufenozide and to prepare a supporting evaluation report (Germany, 2013). The PROFile and the supporting evaluation report were submitted to EFSA on 10 September 2013 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 2 March 2017 and finalised on 2 May 2017. Additional evaluation reports were submitted by Member States France, Germany, Greece, Italy, Spain and the European Union Reference Laboratories for Pesticide Residues (EURL, 2017; France, 2017; Germany, 2017; Greece, 2017; Italy, 2017; Spain, 2017) and, after having considered all the information provided by RMS and Member States, EFSA prepared a completeness check report which was made available to all Member States on 9 June 2017. Further clarifications were sought from Member States via a written procedure in June 2017. Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission (CAC) (codex maximum residue limit; CXLs) and the additional information provided by the Member States, EFSA prepared in November 2017 a draft reasoned opinion, which was submitted to Member States for commenting via a written procedure. All comments received by 11 December 2017 were considered by EFSA during the finalisation of the reasoned opinion. The evaluation report submitted by the RMS (Germany, 2013) and the evaluation reports submitted by Member States France, Germany, Greece, Italy, Spain and the EURL (EURL, 2017; France, 2017; Germany, 2017, Greece, 2017; Italy, 2017; Spain, 2017) 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, 2017) and the Member States consultation report (EFSA, 2018). 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) (excel file) and the PROFile are key supporting documents and made publicly available as background documents to this reasoned opinion. Furthermore, a screenshot of the Report sheet of the PRIMo(EU) and PRIMo(CXL) is presented in Appendix C. 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 Tebufenozide is the ISO common name for N-tert-butyl-N′-(4-ethylbenzoyl)-3,5-dimethylbenzohydrazide (IUPAC). Tebufenozide belongs to the group of diacylhydrazine compounds which are used as insecticide. The compound is effective against many species of Lepidoptera pests in fruits, vegetables and other crops. It interferes with the production of the natural insect-moulting hormone, ecdysone. The larvae, upon ingesting tebufenozide from treated crops, stop feeding and within 24 hours after exposure die from premature moult. The chemical structure of the active substance and its main metabolites is reported in Appendix F. Tebufenozide was evaluated in the framework of Directive 91/414/EEC with Germany designated as RMS. The representative uses supported for the peer review process comprise outdoor foliar spraying against insect pests on grapes and pome fruit. Since the notifier voluntarily withdrew its support to the application, a non-inclusion decision was published by Commission Decision 2008/934/EC7. Following the first decision on non-inclusion of the active substance in Annex I to Directive 91/414/EEC, the applicant submitted a new application within the framework of Commission Regulation (EC) No 33/20088, for the inclusion of the active substance in Annex I of Directive 91/414/EEC. Following the peer review, which was carried out by EFSA, a decision on inclusion of the active substance in Annex I to Directive 91/414/EEC was published by means of Commission Directive 2011/60/EU, which entered into force on 1 June 2011. According to Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011, tebufenozide is deemed to have been approved under Regulation (EC) No 1107/2009. This approval is restricted to uses as insecticide only. The EU MRLs for tebufenozide are established in Annexes IIIA of Regulation (EC) No 396/2005 and CXLs for active substance were also established by the CAC. An overview of the MRL changes that occurred since the entry into force of the Regulation mentioned above is provided below (Table 1). Table 1. Overview of the MRL changes since the entry into force of Regulation (EC) No 396/2005 Procedure Legal implementation Remarks MRL application Commission Regulation (EC) No 893/2010a Modification of MRL in rice MRL: maximum residue level. a Commission Regulation (EU) No 893/2010 of 8 October 2010 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for acequinocyl, bentazone, carbendazim, cyfluthrin, fenamidone, fenazaquin, flonicamid, flutriafol, imidacloprid, ioxynil, metconazole, prothioconazole, tebufenozide and thiophanate-methyl in or on certain products. OJ L 266, 9.10.2010, p. 10–38. For the purpose of this MRL review, the critical uses of tebufenozide currently authorised within the EU have been collected by the RMS and reported in the PROFile. The additional good agricultural practices (GAPs) reported by Member States during the completeness check were also considered. The details of the authorised GAPs for active substance are given in Appendix A. The RMS did not report any use authorised in third countries that might have a significant impact on international trade. Assessment EFSA has based its assessment on the PROFile submitted by the RMS, the evaluation report accompanying the PROFile (Germany, 2013), the draft assessment report (DAR) and its addenda prepared under Council Directive 91/414/EEC (Germany, 2005, 2009, 2010), the conclusion on the peer review of the pesticide risk assessment of the active substance tebufenozide (EFSA, 2010b), the Joint Meeting on Pesticide residues (JMPR) Evaluation report (FAO, 2001), the previous reasoned opinions on tebufenozide (EFSA, 2010a, 2014) as well as the evaluation reports submitted during the completeness check (EURL, 2017; France, 2017; Germany, 2017; Greece, 2017; Italy, 2017; Spain, 2017). 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 546/20119 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, 2016; 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 tebufenozide was investigated in fruits, cereals (Germany, 2009) and root/tuber crops (Germany, 2013). In all metabolism studies, tebufenozide was radiolabelled at three different positions: A-ring [14C-ethylphenyl]-tebufenozide; B-ring [14C-dimethylphenyl]-tebufenozide and t-butyl [14C-t-butyl]-tebufenozide), with the exception of the study on apples where tebufenozide was labelled on the A-ring only. After two foliar applications of 1.1 kg a.s./ha on apples, the major component identified in any part of the crop was tebufenozide, representing 71.2–77.3% total radioactive residue (TRR) in fruit and 93.4% TRR in apple foliage. Tebufenozide levels varied between 0.3–5.3 mg eq/kg in immature fruit and 0.2 mg eq/kg in mature fruit (68 days after treatment (DAT)). Four minor metabolites were identified in fruit (RH-111788, RH-89886, RH-120282, RH-122778) and RH-120282 (an intermediate to the formation of RH-122778) was identified in foliage. After one foliar application of 1.2 kg a.s./ha on grapes, the major component of the residue was tebufenozide (89.2–92.4% TRR; 0.78–1.99 mg/kg). The parent compound was found in the fruit at 1.0–2.45 mg eq/kg and no individual metabolites were identified. After one foliar application of 1.2 kg a.s./ha on rice, tebufenozide was the main compound detected, representing 76% TRR and 51% TRR in straw and grain, respectively. Tebufenozide was found at 68.3 mg eq/kg in straw (64 DAT, B-ring) and at 0.4 mg eq/kg in grain (64 DAT, B-ring). Minor metabolites RH-120970, RH-96595, RH-111788 and RH-89886 were detected at levels below 10% TRR. The metabolism of tebufenozide was investigated in sugarbeet roots and tops by the RMS (Germany, 2013), EFSA (EFSA, 2014) and by JMPR (FAO, 2001), but it was not peer reviewed. The study provided results of the total radioactivity at each sampling point and the metabolic profile of residues at harvest in roots and tops treated with the B-ring-labelled active substance (Germany, 2013). After one foliar application of 2.24 kg a.s./ha on sugar beets, tebufenozide was the major component of the residues in both tops and roots at harvest (120 DAT), representing about 66 % and 41 % of the TRR, respectively. In sugar beet roots, parent was the dominant residue as no individual metabolite exceeded 3.5% TRR (0.008 mg/kg). In sugar beet tops, tebufenozide accounted for 41.4% TRR (equal to 71% of identified residue compounds containing the ethylphenyl and dimethylphenyl structures). The conclusions made in sugar beet tops and apples foliage were used to depict, on a tentative basis, the metabolism of tebufenozide in leafy vegetables. 1.1.2 Nature of residues in rotational crops Tebufenozide is authorised on crops that may be grown in rotation. The field DT90 reported in the field soil dissipation studies evaluated in the framework of the peer review were 47–512 days (EFSA, 2010b). According to the peer review, the three major transformation products of tebufenozide (RH-6595, RH-2703 and RH-2651) may be considered moderately persistent in soil. Another transformation product (M2) was observed in the soil but remained unidentified (EFSA, 2010b). One confined rotational crop study with radiolabelled tebufenozide at three different positions (A-ring, B-ring and side chain) was assessed by the RMS (Germany, 2013), EFSA (EFSA, 2014) and by JMPR (FAO, 2001). After four applications of 280 g a.s/ha on bare soil, turnip, kale (collard) and wheat were planted at different plant back intervals (30, 90, 250, 365 or 384 for kale) DAT. Tebufenozide was recorded 30 DAT in wheat forage and straw at the highest levels (2.6 and 7.3 mg eq/kg, respectively) and at 0.4 mg eq/kg in wheat grain. Residues at 365 DAT were 0.3 mg eq/kg and 0.1 mg eq/kg in wheat straw and forage, respectively, and 0.07 mg eq/kg in grain. In kale, highest residues levels were observed 30 DAT (0.1 mg eq/kg), decreasing to levels below 0.01 mg eq/kg at 365 DAT. In turnip tops, residues were higher than 0.01 mg eq/kg in all sampling dates; however, in turnip roots, residues were 0.08 mg/kg at 30 DAT, decreasing to levels below 0.01 mg eq/kg in subsequent sampling dates. Only in turnip roots, a significant percentage of residues was identified as unchanged tebufenozide (20% of the TRR or 0.02 mg/kg at 30 DAT). Tebufenozide was extensively degraded in the rotational crops. Many soil metabolites are taken up and transformed in the rotational crops in a large amount of sugar conjugates. The main component of residues was the plant metabolite RH-1788, free or conjugated. All other quantifiable components were individually present in low concentrations (< 10% of the TRR). The data on metabolism and distribution of tebufenozide in rotational crops indicated that the metabolism of tebufenozide in rotational crops is similar to the pathway observed in primary crops, but more extensive as tebufenozide was a minor component of the residues or even undetectable. 1.1.3 Nature of residues in processed commodities Studies investigating the nature of residues in processed commodities were assessed in the framework of the peer review (EFSA, 2010b). Studies were conducted with radiolabelled tebufenozide 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). Tebufenozide was stable to hydrolysis under standard conditions of pasteurisation, baking and sterilisation. 1.1.4 Methods of analysis in plants During the peer review, a multiresidue analytical method using high-performance liquid chromatography with mass spectrometry (HPLC-MS) was validated for the determination of tebufenozide in high water and high acid-content commodities with an limit of quantification (LOQ) of 0.02 mg/kg (EFSA, 2010b). A multiresidue analytical method using LC-MS/MS, validated for the determination of tebufenozide in all four plant matrices with an LOQ of 0.01 mg/kg was reported by France (2017). However, extraction efficiency of the method reported by France was not demonstrated. Furthermore, the EURL reported a multiresidue analytical method using LC-MS/MS for the four main plant matrices with an LOQ of 0.01 mg/kg (EURL, 2017). Hence, it is concluded that tebufenozide can be enforced with a 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 tebufenozide was demonstrated for a period of 30 months at −10°C in high water- and high acid-content matrices (EFSA, 2010b). Furthermore, the storage stability of tebufenozide was demonstrated for a period of 36 months at −18°C in high water-content, for a period of 32 months at −18°C in high acid-content, for a period of 42 months in high oil-content matrices and for a period of for 54 months at −18°C in dry commodities (Germany, 2013). 1.1.6 Proposed residue definitions The metabolism of tebufenozide is similar in fruits, cereals and root crops as there were no qualitative differences observed in the metabolism studies. However, it is noted that are quantitative differences in the compartmentalisation of tebufenozide in different plant parts. In addition, the metabolism in rotational crops is similar to the metabolism observed in primary crops. An analytical method for the enforcement of the proposed residue definition at the LOQ of 0.01 mg/kg in all matrices is available. In the framework of the peer review, it was concluded on a risk assessment residue definition on fruit crops and cereals as 'tebufenozide and all metabolites including ethylphenyl and dimethylphenyl structures, calculated as tebufenozide' and a residue definition for enforcement as tebufenozide, only (EFSA, 2010b). Therefore, a general residue definition for risk assessment can be proposed: sum of tebufenozide and all metabolites including ethylphenyl and dimethylphenyl structures, expressed as tebufenozide. For enforcement, the general residue definition is proposed as tebufenozide, only. 1.2 Magnitude of residues in plants 1.2.1 Magnitude of residues in primary crops To assess the magnitude of tebufenozide residues resulting from the reported GAPs, EFSA considered all residue trials reported by the RMS in its evaluation report (Germany, 2013), including residue trials evaluated in the framework of the peer review (EFSA, 2010b) or in the framework of a previous MRL application (EFSA, 2010a, 2014) and additional data submitted during the completeness check (France, 2017; Germany, 2017; Greece, 2017; Italy, 2017; Spain, 2017). All residue trial samples considered in this framework were stored in compliance with the demonstrated storage conditions. Decline of residues du
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