Review of the existing maximum residue levels for fluxapyroxad according to Article 12 of Regulation (EC) No 396/2005
2020; Wiley; Volume: 18; Issue: 1 Linguagem: Inglês
10.2903/j.efsa.2020.5984
ISSN1831-4732
AutoresMaria Anastassiadou, Giovanni Bernasconi, Alba Brancato, Luis Carrasco Cabrera, Luna Greco, Samira Jarrah, Aija Kazocina, Renata Leuschner, José Oriol Magrans, Ileana Miron, Stéfanie Nave, Ragnor Pedersen, Hermine Reich, Alejandro Rojas, Angela Sacchi, Miguel Santos, Alois Stanek, Anne Theobald, Bénédicte Vagenende, Alessia Verani,
Tópico(s)Pesticide Exposure and Toxicity
ResumoEFSA JournalVolume 18, Issue 1 e05984 Reasoned OpinionOpen Access Review of the existing maximum residue levels for fluxapyroxad according to Article 12 of Regulation (EC) No 396/2005 European Food Safety Authority (EFSA), Corresponding Author European Food Safety Authority (EFSA) pesticides.mrl@efsa.europa.eu Correspondence:pesticides.mrl@efsa.europa.euSearch for more papers by this authorMaria Anastassiadou, Maria AnastassiadouSearch for more papers by this authorGiovanni Bernasconi, Giovanni BernasconiSearch for more papers by this authorAlba Brancato, Alba BrancatoSearch for more papers by this authorLuis Carrasco Cabrera, Luis Carrasco CabreraSearch for more papers by this authorLuna Greco, Luna GrecoSearch for more papers by this authorSamira Jarrah, Samira JarrahSearch for more papers by this authorAija Kazocina, Aija KazocinaSearch for more papers by this authorRenata Leuschner, Renata LeuschnerSearch for more papers by this authorJose Oriol Magrans, Jose Oriol MagransSearch for more papers by this authorIleana Miron, Ileana MironSearch for more papers by this authorStefanie Nave, Stefanie NaveSearch for more papers by this authorRagnor Pedersen, Ragnor PedersenSearch for more papers by this authorHermine Reich, Hermine ReichSearch for more papers by this authorAlejandro Rojas, Alejandro RojasSearch 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 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 author European Food Safety Authority (EFSA), Corresponding Author European Food Safety Authority (EFSA) pesticides.mrl@efsa.europa.eu Correspondence:pesticides.mrl@efsa.europa.euSearch for more papers by this authorMaria Anastassiadou, Maria AnastassiadouSearch for more papers by this authorGiovanni Bernasconi, Giovanni BernasconiSearch for more papers by this authorAlba Brancato, Alba BrancatoSearch for more papers by this authorLuis Carrasco Cabrera, Luis Carrasco CabreraSearch for more papers by this authorLuna Greco, Luna GrecoSearch for more papers by this authorSamira Jarrah, Samira JarrahSearch for more papers by this authorAija Kazocina, Aija KazocinaSearch for more papers by this authorRenata Leuschner, Renata LeuschnerSearch for more papers by this authorJose Oriol Magrans, Jose Oriol MagransSearch for more papers by this authorIleana Miron, Ileana MironSearch for more papers by this authorStefanie Nave, Stefanie NaveSearch for more papers by this authorRagnor Pedersen, Ragnor PedersenSearch for more papers by this authorHermine Reich, Hermine ReichSearch for more papers by this authorAlejandro Rojas, Alejandro RojasSearch 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 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 author First published: 16 January 2020 https://doi.org/10.2903/j.efsa.2020.5984Citations: 1 Requestor: European Commission Question number: EFSA-Q-2012-00690 Amendment: The Reasoned Opinion has been amended to take into account the omitted CXL for apricots, tomatoes, sweet peppers, aubergines (eggplants) okra/lady's fingers and poultry muscle derived by JMPR (FAO, 2012, 2015). In addition, MRL proposals for mangoes and globe artichokes were amended, in accordance with the OECD calculator. The original Reasoned Opinion is available on request as is a version showing all the changes made. Acknowledgement: EFSA wishes to thank the rapporteur Member State, France, for the preparatory work on this scientific output. EFSA wishes to thank the following for the support provided to this scientific output: Silvia Ruocco, Laszlo Bura, Georgios Chatzisotiriou and Viktor Toth. Adopted: 16 December 2019 Amended: 4 Dec 2020 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 fluxapyroxad. To assess the occurrence of fluxapyroxad residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Commission Regulation (EU) No 188/2011, the MRLs established by the Codex Alimentarius Commission as well as the import tolerances and 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 Fluxapyroxad was approved on 1 January 2013 by means of Commission Implementing Regulation (EU) No 589/2012 in the framework of Regulation (EC) No 1107/2009 as amended by Commission Implementing Regulations (EU) No 540/2011 and 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. As the basis for the MRL review, on 15 June 2018, EFSA initiated the collection of data for this active substance. In a first step, Member States were invited to submit by 16 July 2018 their national Good Agricultural Practices (GAPs) in a standardised way, in the format of specific GAP forms, allowing the designated rapporteur Member State (RMS), France, to identify the critical GAPs in the format of a specific GAP overview file. Subsequently, Member States were requested to provide residue data supporting the critical GAPs, within a period of 1 month, by 19 October 2018. On the basis of all the data submitted by Member States and by the EU Reference Laboratories for Pesticides Residues (EURLs), EFSA asked the RMS to complete the Pesticide Residues Overview File (PROFile) and to prepare a supporting evaluation report. The PROFile and evaluation report, together with Pesticide Residues Intake Model (PRIMo) calculations and an updated GAP overview file were provided by the RMS to EFSA on 19 December 2018. Subsequently, EFSA performed the completeness check of these documents with the RMS. The outcome of this exercise including the clarifications provided by the RMS, if any, was compiled in the completeness check report. Based on the information provided by the RMS, Member States and the EURLs, and taking into account the conclusions derived by EFSA in the framework of Commission Regulation (EU) No 188/2011 and the MRLs established by the Codex Alimentarius Commission, EFSA prepared in October 2019 a draft reasoned opinion, which was circulated to Member States for consultation via a written procedure. Comments received by 20 November 2019 were considered during the finalisation of this reasoned opinion. The following conclusions are derived. The metabolism of fluxapyroxad in plant was investigated in primary and rotational crops. According to the results of the metabolism studies, the residue definition for enforcement and risk assessment can be proposed as fluxapyroxad. These residue definitions are also applicable to processed commodities. Fully validated analytical methods are available for the enforcement of the proposed residue definition in all four main plant matrices at the limit of quantification (LOQ) of 0.01 mg/kg. According to the EURLs, the LOQ of 0.01 mg/kg is achievable by using the QuEChERS method in routine analyses. The available data on primary crops are considered sufficient to derive (tentative) MRL proposals as well as risk assessment values for all commodities under evaluation, except for garlic, onions and shallots where data were insufficient to derive MRLs. MRLs and risk assessment values considering a worst-case scenario reflecting crop failure (PBI of 30 days) were also derived for rotational crops on a tentative basis. For garlic, onions and shallots, the (tentative) MRL and risk assessment values derived are based on the results of the rotational field trials on roots, since no residue trials on primary uses were available. For fruiting vegetables and pulses and oilseeds, the tentative MRLs are based on the primary uses only, since representative of these crop groups was not assessed in the rotational crop field studies. Since the rotational crop field studies were underdosed compared to the total predicted environmental concentration in soil (PECsoil total) for the authorised uses in annual crops, the possible occurrence of residues of fluxapyroxad at levels higher than the derived (tentative) MRLs, following multiannual applications, cannot be excluded. Therefore, Member States granting an authorisation should request additional rotational crop field studies conducted with application rates that cover the plateau background concentrations for these crops. Pending the submission of these studies, Member States are recommended to implement appropriate mitigation measures in order to avoid exceedances of the derived MRLs. Fluxapyroxad is authorised for use on crops that might be fed to livestock. Livestock dietary burden calculations were therefore performed for different groups of livestock according to OECD guidance. The dietary burdens calculated for all groups of livestock were found to exceed the trigger value of 0.1 mg/kg dry matter (DM). Behaviour of residues was therefore assessed in all commodities of animal origin. The metabolism of fluxapyroxad residues in livestock was investigated in lactating goats and laying hens at dose rate covering the maximum dietary burdens calculated in this review. According to the results of these studies, the residue definitions were proposed for enforcement as fluxapyroxad only, and for risk assessment as sum of fluxapyroxad and metabolite M700F008, expressed as parent equivalent. An analytical method for the enforcement of the proposed residue definition at the LOQ of 0.01 mg/kg in all animal tissues and 0.001 mg/kg in milk and eggs is available. According to the EURLs screening data for commodities of animal origin show that fluxapyroxad can be monitored in meat with a screening detection limit (SDL) of 0.0025 mg/kg and in milk with an SDL of 0.005 mg/kg. Livestock feeding studies on animal were used to derive (tentative) MRL and risk assessment values in milk, eggs and tissues of ruminants and poultry. Since extrapolation from ruminants to pigs is acceptable, results of the livestock feeding study on ruminants were relied upon to derive the (tentative) MRL and risk assessment values in pigs. Chronic and acute consumer exposure resulting from the authorised uses reported in the framework of this review was calculated using revision 3 of the EFSA PRIMo. For those commodities where data were insufficient to derive an MRL, EFSA considered the existing EU MRL for an indicative calculation. The highest chronic exposure was calculated for Dutch toddler, representing 44% of the acceptable daily intake (ADI), and the highest acute exposure was calculated for celeries, representing 77% of the acute reference dose (ARfD). Apart from the MRLs evaluated in the framework of this review, internationally recommended Codex MRLs (CXLs) have also been established for fluxapyroxad. Additional calculations of the consumer exposure, considering these CXLs were performed, the highest chronic exposure was calculated for Dutch toddler representing 55% of the ADI and the highest acute exposure was calculated for celeries, representing 77% of the ARfD. Although uncertainties remain due to the data gaps identified, these indicative exposure calculations did not indicate a risk to consumer's health. 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 fluxapyroxad was approved on 1 January 2013 by means of Commission Implementing Regulation (EU) No 589/20123 in the framework of Regulation (EC) No 1107/20094 as amended by Commission Implementing Regulations (EU) No 540/20115 and 541/20116, EFSA initiated the review of all existing MRLs for that active substance. By way of background information, in the framework of Commission Regulation (EU) No 188/20117, Fluxapyroxad was evaluated by France, designated as rapporteur Member State (RMS). Subsequently, a peer review on the initial evaluation of the RMS was conducted by EFSA, leading to the conclusions as set out in the EFSA scientific output (EFSA, 2012). According to the legal provisions, EFSA shall base its reasoned opinion in particular on the relevant assessment report prepared under Directive 91/414/EEC repealed by Regulation (EC) No 1107/2009. It should be noted, however, that, in the framework of Regulation (EC) No 1107/2009, 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 Regulation (EC) No 1107/2009 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. As the basis for the MRL review, on 15 June 2018, EFSA initiated the collection of data for this active substance. In a first step, Member States were invited to submit by 16 July 2018 their Good Agricultural Practices (GAPs) that are authorised nationally, in a standardised way, in the format of specific GAP forms. In the framework of this consultation, 18 Member States provided feedback on their national authorisations of fluxapyroxad. Based on the GAP data submitted, the designated RMS France was asked to identify the critical GAPs to be further considered in the assessment, in the format of specific GAP overview file. Subsequently, in a second step, Member States were requested to provide residue data supporting the critical GAPs by 19 October 2018. On the basis of all the data submitted by Member States and the EU Reference Laboratories for Pesticides Residues (EURLs), EFSA asked France to complete the PROFile and to prepare a supporting evaluation report. The PROFile and the supporting evaluation report, together with the Pesticide Residues Intake Model (PRIMo) calculations and an updated GAP overview file, were submitted to EFSA on 19 December 2018. Subsequently, EFSA performed the completeness check of these documents with the RMS. The outcome of this exercise including the clarifications provided by the RMS, if any, was compiled in the completeness check report. During this completeness check, an additional PROFile was compiled to perform the calculation of MRLs in rotational crops. Considering all the available information and taking into account the MRLs established by the Codex Alimentarius Commission (CAC) (i.e. codex maximum residue limit; CXLs), EFSA prepared in October 2019 a draft reasoned opinion, which was circulated to Member States for commenting via a written procedure. All comments received by 20 November 2019 were considered by EFSA during the finalisation of the reasoned opinion. The evaluation report submitted by the RMS (France, 2018), taking into account also the information provided by Member States during the collection of data, and the EURLs report on analytical methods (EURLs, 2018) are considered as main supporting documents to this reasoned opinion and, thus, made publicly available. In addition, further supporting documents to this reasoned opinion are the completeness check report (EFSA, 2019a) and the Member States consultation report (EFSA, 2019b). These reports are developed to address all issues raised in the course of the review, from the initial completeness check to the reasoned opinion. Furthermore, the exposure calculations for all crops reported in the framework of this review performed using the EFSA Pesticide Residues Intake Model (PRIMo) and the PROFiles as well as the GAP overview file listing all authorised uses and import tolerances are key supporting documents and made publicly available as background documents to this reasoned opinion. A screenshot of the report sheet of the PRIMo 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 Fluxapyroxad is the ISO common name for 3-(difluoromethyl)-1-methyl-N-(3′,4′,5′-trifluorobiphenyl-2-yl)pyrazole-4-carboxamide (IUPAC). The chemical structure of the active substance and its main metabolites are reported in Appendix F. The EU MRLs for fluxapyroxad are established in Annexes IIIA of Regulation (EC) No 396/2005. Codex maximum residue limits (CXLs) for fluxapyroxad were also established by the Codex Alimentarius Commission (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 Regulation (EC) No 2018/685 In various crops (EFSA, 2017) Regulation (EC) No 2016/1902 In various crops (EFSA, 2016a) Regulation (EC) No 2016/486 Grapes and potatoes (EFSA, 2015b) Regulation (EC) No 978/2011 In various commodities (EFSA, 2011) Implementation of CAC Regulation (EC) No 2017/626 47th CCPR (EFSA, 2015a) 48th CCPR (EFSA, 2016b) Regulation (EC) No 491/2014 45th CCPR (EFSA, 2013) For the purpose of this MRL review, all the uses of fluxapyroxad currently authorised within the EU and in third countries as submitted by the Member States during the GAP collection, have been reported by the RMS in the GAP overview file. The critical GAPs identified in the GAP overview file were then summarised in the PROFile and considered in the assessment. The details of the authorised critical GAPs for fluxapyroxad are given in Appendix A. Assessment EFSA has based its assessment on the following documents: the PROFile submitted by the RMS; the additional PROFile prepared by EFSA for the calculation of MRLs in rotational crops; the evaluation report accompanying the submitted PROFile (France, 2018); the draft assessment report (DAR) and its addenda prepared under Council Directive 91/414/EEC (United Kingdom, 2011a,b); the conclusion on the peer review of the pesticide risk assessment of the active substance fluxapyroxad (EFSA, 2012); the Joint Meeting on Pesticide residues (JMPR) Evaluation report (FAO, 2012, 2015); the previous reasoned opinions on fluxapyroxad (EFSA, 2011, 2015b, 2016a, 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 546/20118 and the currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues (European Commission, 1997a–g, 2000, 2010a,b, 2017; 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 fluxapyroxad was investigated following foliar applications in fruits, pulses and oilseeds and cereals (United Kingdom, 2011b) and assessed in the framework of the peer review (EFSA, 2012). An additional metabolism study on wheat following seed treatment was submitted in support of a previous MRL application (EFSA, 2015b). In all studies fluxapyroxad was radiolabelled in both the aniline and pyrazole rings of the molecule. After foliar applications on tomatoes and wheat, fluxapyroxad was the major component of the radioactive residues, accounting for 54% total radioactive residue (TRR) up to more than 90% TRR and residue concentrations of 0.03 mg/kg in wheat grains and up to 0.16 mg/kg in tomato fruits (EFSA, 2012). Fluxapyroxad was more extensively metabolised in soyabean seeds, accounting for only 7% TRR up to 21% TRR, and two major metabolites were identified as M700F002 (33.5% TRR, pyrazole labelling) and M700F048 (20% TRR, aniline labelling). Minor metabolites were identified at very low levels, accounting for less than 2% of the TRR (EFSA, 2012). After a seed treatment on wheat, fluxapyroxad was identified as the major component of the total residue, accounting for 58–79% of the TRR in forage, hay, straw and chaff and 17% of the TRR in grains (EFSA, 2015b). The metabolic pattern found in wheat after seed application was found comparable to the pathway observed in wheat after foliar application and comparable to the metabolism following foliar application in soyabean and tomato. The metabolic pathway of fluxapyroxad was similar in fruits, pulses and oilseeds and cereals following foliar application, and in cereals after seed treatment. The application of fluxapyroxad on witloofs is authorised for post-harvest treatment (dipping, drenching of roots, before forcing), for which no metabolism study was submitted. However, considering that the behaviour of fluxapyroxad is the same in three crop groups following foliar application and soil treatments (in rotational crops), it can be assumed that the metabolism following post-harvest treatment would also follow the same pathway. Therefore, no metabolism study following post-harvest treatment is required. The application of fluxapyroxad on several root crops (e.g. potatoes) is in the form of soil treatment, for which no metabolism study was submitted. However, since the metabolism observed in rotational crops, following bare soil application, was similar to the primary crop metabolism (see Section 1.1.2), further metabolism studies in primary roots following soil treatment are not required and deemed covered by the metabolism studies in rotational crops. 1.1.2 Nature of residues in rotational crops Fluxapyroxad is authorised on crops that may be grown in rotation. The field DT90 reported in the soil degradation studies evaluated in the framework of the peer review was higher than 1000 days (EFSA, 2012). One confined rotational crop study with fluxapyroxad radiolabelled on the aniline and pyrazole rings of the molecule was available for this review (United Kingdom, 2011a; EFSA, 2012). Fluxapyroxad was applied once at a rate of 250 g a.s./ha onto bare soil. Spinach, white radish and spring wheat were planted at nominal plant back intervals (PBI) of 30, 120/149 and 365 days after treatment (DAT). Residues in wheat straw were up to 2.2 mg/kg (pyrazole label) and 2.65 mg/kg (aniline label), in spinach up to 0.18 mg/kg and 0.1 mg/kg for the pyrazole and aniline labels, respectively, and in roots up to 0.015 mg/kg for both labels (United Kingdom, 2011a). Residues in wheat grain accounted for 0.043 mg/kg and 0.02 mg/kg for the pyrazole and aniline labels, respectively (United Kingdom, 2011a). Fluxapyroxad was the major component in all matrices, while metabolite M700F002 was also present at relevant levels in all matrices. No specific compound for rotational crops was identified. The metabolism and distribution of fluxapyroxad in rotational crops are similar to the metabolic pathway observed in primary crops (EFSA, 2012). 1.1.3 Nature of residues in processed commodities Studies investigating the nature of residues in processed commodities were assessed in the peer review (United Kingdom, 2011b; EFSA, 2012). Studies were conducted with radiolabelled fluxapyroxad on the ring 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). Fluxapyroxad is stable to hydrolysis under standard conditions of pasteurisation, baking/brewing/boiling and sterilisation (EFSA, 2012). 1.1.4 Methods of analysis in plants Adequately validated analytical methods, involving high-performance liquid chromatography with tandem mass spectrometry (HPLC–MS/MS) measurement, were submitted by the applicant, assessed during the peer review, and found being suitable for the control of fluxapyroxad residues in all major category crop groups (high water, high acid, high oil content and dry matrices) with a limit of quantification (LOQ) of 0.01 mg/kg (EFSA, 2012). The EURLs informed EFSA that fluxapyroxad can be monitored in high water and high acid content commodities with an LOQ of 0.002 mg/kg and in dry and high oil content commodities with an LOQ of 0.005 mg/kg, and in honey with an LOQ of 0.005 mg/kg (EURLs, 2018). Herbal infusions are classified as difficult matrices to analyse for which separate validation data would be required to demonstrate the applicability of the analytical methods. Since no analytical methods were provided for theses matrices a data gap is set for these crops. 1.1.5 Stability of residues in plants The storage stability of fluxapyroxad was investigated in the framework of the peer review (United Kingdom, 2011a,b, EFSA, 2012). Fluxapyroxad was found to be stable in all plant matrices for a period of 737 days when stored at –20°C (EFSA, 2012). Moreover, when stored at –20°C, metabolite M700F002 was stable for 824 days in all plant matrices, metabolite M700F048 for 733 days in high starch, high acid, high oil and high water content matrices and in wheat straw and metabolite M700F008 was stable 725 days in high starch matrices and in wheat straw, and up to 133 days in high oil and high water content matrices (EFSA, 2012). Fluxapyroxad was also found to be stable for 24 months at –20°C in processed products: apple juice, soybean refined oil, potato crisps, grape raisins and barley beer (United Kingdom, 2011b). No specific study is available for the storage stability in herbal infusions and spices. However, as storage stability was investigated and demonstrated in the four main plant matrices, the most limiting storage stability conditions demonstrated for general matrices can be considered applicable to these specific matrices. 1.1.6 Proposed residue definitions The metabolism of fluxapyroxad was similar in all crops following foliar application and seed treatment. Fluxapyroxad is the only toxicologically relevant compound to be considered in the consumer exposure. In the framework of the peer review, the residue definition for risk assessment was proposed as fluxapyroxad (EFSA, 2012). The same residue definition is proposed in the current review. The metabolism in rotational crops is similar to the metabolism observed in primary crops and the processing of fluxapyroxad is not expected to modify the nature of residues. For soil treatments, the metabolism in primary and rotational crops is depicted by the metabolism studies performed in the confined rotational crops on spinach, white radish and spring wheat. As the parent compound was found to be a sufficient marker in fruits, pulses and oilseeds and cereals, the residue definition for enforcement is proposed as fluxapyroxad only. An analytical method for the en
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