Modification of the existing maximum residue levels for fosetyl/phosphonic acid in various crops
2020; Wiley; Volume: 18; Issue: 1 Linguagem: Inglês
10.2903/j.efsa.2020.5964
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 Residue Analysis and Safety
ResumoEFSA JournalVolume 18, Issue 1 e05964 Reasoned OpinionOpen Access Modification of the existing maximum residue levels for fosetyl/phosphonic acid in various crops 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: 22 January 2020 https://doi.org/10.2903/j.efsa.2020.5964Citations: 4 Requestor: European Commission Question numbers: EFSA-Q-2019-00399; EFSA-Q-2019-00538; EFSA-Q-2019-00670 Acknowledgments: EFSA wishes to acknowledge the contribution of Silvia Ruocco, Laszlo Bura, Georgios Chatzisotiriou, and Viktor Toth to this opinion. Adopted: 11 December 2019 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 In accordance with Article 6 of Regulation (EC) No 396/2005, the applicants BASF SE, Landwirtschaftliches Technologiezentrum Augustenberg and Tilco Biochemie GmbH submitted a request to the competent national authorities in Greece and Germany to modify the existing maximum residue levels (MRLs) for fosetyl/phosphonic acid in various crops related to the use of potassium phosphonates. The data submitted in support of the request were found to be sufficient to derive MRL proposals for several tree nuts, pomegranates, fresh herbs and edible flowers, currants, gooseberries and blueberries. Adequate analytical methods for enforcement are available to control the residues of phosphonic acid in the plant matrices under consideration at the validated limit of quantification (LOQ) of 0.1 mg/kg in high acid content matrices and at 0.01 mg/kg in high water and high oil content matrices. Based on the risk assessment results, EFSA concluded that the intake of residues resulting from the use of potassium phosphonates is unlikely to present a risk to consumer health. Summary In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted an application to the competent national authority in Greece (evaluating Member State, EMS) to modify the existing maximum residue levels (MRLs) for fosetyl and phosphonic acid related to the use of potassium phosphonates in kaki/Japanese persimmon, granate apples/pomegranates and tree nuts. The EMS drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 20 June 2019. To accommodate for the intended uses of potassium phosphonates, the EMS proposed to raise the existing MRL for fosetyl in tree nuts from 500 mg/kg to 1,500 mg/kg or to set an MRL of 1,000 mg/kg for phosphonic acid. For granate apples/pomegranates, the EMS proposed to raise the existing MRL for fosetyl from the limit of quantification (LOQ) of 2.0 mg/kg to 90 mg/kg or to set an MRL of 70 mg/kg for phosphonic acid. For kaki/persimmon the application was withdrawn by the applicant during the assessment. Two further applications were submitted by the applicants Tilco Biochemie GmbH and Landwirtschaftliches Technologiezentrum Augustenberg to the competent national authority in Germany (EMS) to modify the existing MRLs for fosetyl and phosphonic acid related to the use of potassium phosphonates in herbs and edible flowers, currants, blueberries, gooseberries, raspberries and blackberries. The EMS Germany drafted two evaluation reports, which were submitted to the European Commission and forwarded to EFSA on 20 August 2019 and 24 October 2019. The EMS proposed to raise the existing MRLs for fosetyl in herbs and edible flowers from 75 mg/kg to 400 mg/kg or to set an MRL of 300 mg/kg for phosphonic acid. To support the intended use on small fruits and berries, Germany proposed to raise the MRLs for fosetyl in blueberries, gooseberries and currants from 80 mg/kg to 200 mg/kg or to set an MRL of 150 mg/kg for phosphonic acid. For raspberries/blackberries, the EMS identified no need to modify the existing EU MRL for fosetyl. EFSA assessed the applications and the evaluation reports as required by Article 10 of the MRL regulation. EFSA identified points which needed further clarification concerning the application on pomegranates and fresh herbs and edible flowers, which were requested from the EMSs. On 22 November 2019 and 2 December 2019, respectively, the EMSs submitted the requested information in the form of revised evaluation reports. Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC and the data evaluated under previous MRL assessments and the additional data provided by the EMS in the framework of these applications, the following conclusions are derived. No experimental studies on the metabolism of potassium phosphonates in primary crops are available. However, the EU peer review concluded that, given the elementary nature of potassium phosphonates and according to available data from public literature, the main metabolite of potassium phosphonates in plants is phosphonic acid. Studies investigating the effect of processing on the nature of phosphonates (hydrolysis studies) demonstrated that phosphonic acid is stable. In rotational crops, the major residue identified was phosphonic acid. Based on the metabolic pattern identified in metabolism studies, hydrolysis studies, the toxicological significance of metabolites and degradation products, the residue definitions for plant products were proposed as 'sum of phosphonic acid and its salts expressed as phosphonic acid' for enforcement and risk assessment. These residue definitions are applicable to primary crops, rotational crops and processed products. EFSA concluded that for the crops assessed in these applications, the metabolism of potassium phosphonates in primary and in rotational crops, and the possible degradation in processed products has been sufficiently addressed and that the previously proposed residue definitions are applicable. Sufficiently validated analytical methods based on high-performance liquid chromatography with tandem mass spectrometry (HPLC–MS/MS) are available to quantify residues of fosetyl and phosphonic acid at or above an LOQ of 0.01 mg/kg in high water and high oil content matrices and at 0.1 mg/kg in high acid content matrices. The available residue trials are sufficient to derive MRL proposals for fosetyl and phosphonic acid for all crops under consideration. For raspberries and blackberries, the existing EU MRL is higher than the one that would be required to support the new intended use. For tree nuts, the MRL proposals were derived for almonds, chestnuts, pistachios, hazelnuts and walnuts since the intended use of potassium phosphonates in the southern Europe (SEU) is limited to these nuts only. In the framework of the current assessment, the applicant provided a study where the magnitude of phosphonic acid was investigated in processed commodities from apples: canned apples, juice, dried apples, apple sauce and fruit syrup. A concentration of phosphonic acid residues was observed in dried apples and dried pomace only. In the remaining processed commodities, a reduction of residues was observed. The occurrence of residues of potassium phosphonates in rotational crops was investigated in the framework of the EU pesticides peer review. Based on the available information EFSA could not exclude that the use of potassium phosphonates according to the proposed Good Agricultural Practice (GAP) will result in significant residues of phosphonic acid in rotational crops. Therefore, Member States should consider the need of setting specific risk mitigation measures to avoid the presence of potassium phosphonates residues in rotational crops. Residues of potassium phosphonates in commodities of animal origin were not assessed since the crops under consideration in these MRL applications are normally not fed to livestock. The toxicological profile of potassium phosphonates was assessed in the framework of the EU pesticides peer review and the data were sufficient to derive an acceptable daily intake (ADI) of 2.25 mg/kg body weight (bw) per day for phosphonic acid, which is the toxicologically relevant metabolite of potassium phosphonates in plants. An acute reference dose (ARfD) was deemed unnecessary. The consumer risk assessment was performed with revision 3.1 of the EFSA Pesticide Residues Intake Model (PRIMo). Using the implemented toxicological reference value, no long-term consumer intake concerns were identified; the calculated long-term exposure accounted for a maximum of 47% ADI (NL toddler diet). EFSA also performed an indicative risk assessment, using the proposed revised ADI of 1 mg/kg bw per day, according to the recent EFSA conclusion on fosetyl, noting that the value is not yet formally adopted. The long-term dietary exposure accounted for a maximum of 105% of the ADI (NL toddler), with apples being the main contributors (25% of the ADI). The contribution of residues in the crops under consideration is minor (all individually below 3% of the ADI). When excluding the crops for which the existing EU MRL is set at the LOQ, assuming that no uses are authorised for these crops, the overall chronic exposure to phosphonic acid residues is below the ADI (93% of the ADI). The calculations are affected by uncertainties since the comprehensive review of the existing MRLs resulting from the use of phosphonic acid has not yet been performed. Hence for a number of crops, the exposure calculations were performed with the MRL instead of the supervised trials median residue (STMR) which is likely to overestimate the exposure. EFSA concluded that the proposed use of potassium phosphonates on the crops under evaluation will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a risk to consumers' health. EFSA proposes to amend the existing MRLs as reported in the summary table below. Full details of all endpoints and the consumer risk assessment can be found in Appendices B, B–D. Codea Commodity Existing EU MRL (mg/kg) Proposed EU MRL (mg/kg) Comment/justification Enforcement residue definition: 1) Existing enforcement residue definition: fosetyl-Al (sum of fosetyl, phosphonic acid and their salts, expressed as fosetyl) (Reg. (EC) No 396/2005) 2) Proposed enforcement residue definition: phosphonic acid and their salts expressed as phosphonic acid (EFSA, 2012b) 0120010 0120040 0120060 0120100 0120110 Almonds Chestnuts Hazelnuts/cobnuts Pistachios Walnuts 500 1) 1,500 2) 1,000 The submitted data are sufficient to derive a MRL proposal for the intended SEU use. Risk for consumers unlikely 0163050 Granate apples/pomegranates 2.0* 1) 90 2) 70 The submitted data are sufficient to derive a MRL proposal for the intended SEU use. Risk for consumers unlikely 0256000 Herbs and edible flowers 75 1) 400 2) 300 The submitted data are sufficient to derive an MRL proposal for the indoor EU use. The intended NEU use is not supported by residue data. Risk for consumers unlikely 0153030 0153010 Raspberries Blackberries 300 1) No change 2)150 The submitted data indicate no need to modify the existing EU MRL. The MRL proposal for phosphonic acid is lower than the proposal of 200 mg/kg derived in the previous EFSA assessment 0154010, 0154040 0154030 Blueberries Gooseberries Currants 80 1) 200 2) 150 The submitted data are sufficient to derive a MRL proposal for the indoor EU use. Risk for consumers unlikely MRL: maximum residue level; NEU: northern Europe. * Indicates that the MRL is set at the limit of analytical quantification (LOQ). a Commodity code number according to Annex I of Regulation (EC) No 396/2005. Assessment The European Food Safety Authority (EFSA) received three applications to modify the existing maximum residue levels (MRLs) for fosetyl in various crops on the basis of the intended use of potassium phosphonates. The detailed description of these uses, which are the basis for the current MRL application, is reported in Appendix A. Potassium phosphonates is the name commonly used for the mixture of potassium hydrogen phosphonate and dipotassium phosphonate (EFSA, 2012b). The chemical structures of the active substance and its main metabolites are reported in Appendix E. The active substance potassium phosphonates was evaluated in the framework of Directive 91/414/EEC with France designated as rapporteur Member State (RMS) for the representative use of foliar spraying on grapes. The draft assessment report (DAR) prepared by the RMS (France, 2005, 2012) has been peer reviewed by EFSA (2012b). Potassium phosphonates were approved1 for the use as a fungicide on 1 October 2013. The EU MRLs for potassium phosphonates are established in Annex III of Regulation (EC) No 396/20052. The current residue definition for enforcement is set as the 'sum of fosetyl, phosphonic acid and their salts, expressed as fosetyl'. Thus, the existing MRLs reflect the uses of fosetyl, disodium phosphonate and the uses of potassium phosphonates. The review of existing MRLs according to Article 12 of Regulation (EU) 396/2005 (MRL review) for potassium phosphonates has not yet been initiated. For fosetyl, the MRL review is completed (EFSA, 2012a). However, the proposed modifications of the existing MRLs have not yet been legally implemented since it is appropriate to await the MRL review for the related active substances, i.e. potassium phosphonates and disodium phosphonate, as these active substances share the common metabolite phosphonic acid. EFSA has issued several reasoned opinions on the modification of MRLs for potassium phosphonates. The proposals from these reasoned opinions have been considered in recent MRL regulation3. In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant BASF SE submitted an application to the competent national authority in Greece (evaluating Member State, EMS Greece) to modify the existing MRLs for fosetyl and phosphonic acid related to the use of potassium phosphonates in kaki/Japanese persimmon, granate apples/pomegranates and tree nuts. The EMS drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to EFSA on 20 June 2019. To accommodate for the intended uses of potassium phosphonates, the EMS proposed to raise the existing MRL for fosetyl in tree nuts from 500 mg/kg to 1,500 mg/kg (or 1,000 mg/kg if expressed as phosphonic acid). For granate apples/pomegranates the EMS proposed to raise the existing MRL for fosetyl from the limit of quantification (LOQ) 2.0 mg/kg to 90 mg/kg (or 70 mg/kg if expressed as phosphonic acid). For kaki/persimmon the application was withdrawn by the applicant during the assessment. Two further applications were submitted by the applicants Tilco Biochemie GmbH and Landwirtschaftliches Technologiezentrum Augustenberg to the competent national authority in Germany (EMS) to modify the existing MRLs for fosetyl and phosphonic acid related to the use of potassium phosphonates in herbs and edible flowers, currants, blueberries, gooseberries, blackberries and raspberries. The EMS Germany drafted two evaluation reports, which were submitted to the European Commission and forwarded to EFSA on 20 August 2019 and 24 October 2019. The EMS proposed to raise the existing MRLs for fosetyl in herbs and edible flowers from 75 mg/kg to 400 mg/kg or to set an MRL of 300 mg/kg for phosphonic acid. To support the intended use on small fruits and berries, Germany proposed to raise the MRLs for fosetyl in blueberries, gooseberries and currants from 80 mg/kg to 200 mg/kg or to set an MRL of 150 mg/kg for phosphonic acid. For raspberries/blackberries the EMS identified no need to modify the existing EU MRL for fosetyl. EFSA based its assessment on the evaluation reports submitted by the EMSs (Germany, 2019a,b; Greece, 2019), the DAR (and its addendum) on potassium phosphonates (France, 2005, 2012) prepared under Council Directive 91/414/EEC and the renewal assessment report (RAR) on fosetyl (France, 2017, 2019) prepared under Regulation (EU) No 1107/20094, the Commission review report on potassium phosphonates (European Commission, 2013), the conclusion on the peer review of the pesticide risk assessment of the active substance potassium phosphonates (EFSA, 2012b) and fosetyl (EFSA, 2018c), as well as the conclusions from previous EFSA opinions on potassium phosphonates and fosetyl (EFSA, 2012c, 2015, 2018b,d, 2019b) and the MRL review of fosetyl (EFSA, 2012a). For these applications, the data requirements established in Regulation (EU) No 544/20115 and the guidance documents applicable at the date of submission of the application to the EMS are applicable (European Commission, 1997a, b, c, d, e, f-g, 2000, 2010a, b, 2017; OECD, 2011). 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 546/20116. A selected list of end points of the studies assessed by EFSA in the framework of these MRL applications including the end points of relevant studies assessed previously, are presented in Appendix B. The evaluation report submitted by the EMSs (Germany, 2019a,b; Greece, 2019) and the exposure calculations using the EFSA Pesticide Residues Intake Model (PRIMo) are considered as supporting documents to this reasoned opinion and, thus, are made publicly available as background documents to this reasoned opinion. 1 Residues in plants 1.1 Nature of residues and methods of analysis in plants 1.1.1 Nature of residues in primary crops The metabolism of potassium phosphonates was assessed during the EU pesticides peer review (EFSA, 2012b). It was concluded that data from the public literature are sufficient to address the metabolism in plants which mainly involves the transformation of potassium phosphonate salts into phosphonic acid. No further studies on the metabolism of potassium phosphonates in primary crops were submitted in the present MRL applications. For the intended uses, the metabolic behaviour in primary crops is sufficiently addressed. 1.1.2 Nature of residues in rotational crops Among all crops under consideration, only herbs and edible flowers could be grown in rotation. According to the soil degradation studies evaluated in the framework of the fosetyl peer review (EFSA, 2018c), moderate to high soil persistence is reported for phosphonic acid (DT90 91 to > 1,000 days), which is a common metabolite of fosetyl and potassium phosphonates Therefore, transfer of soil residues from treatments of antecedent crops need to be considered. EFSA noted that no confined residue study is known for phosphonates or fosetyl. However, due to the chemical nature of potassium phosphonates, no other breakdown products than phosphonic acid is expected and therefore new studies addressing the nature of residues in rotational crops are not deemed necessary. 1.1.3 Nature of residues in processed commodities The effect of processing on the nature of phosphonic acid was investigated in the framework of the EU pesticides peer reviews for potassium phosphonates and fosetyl (EFSA, 2012b, EFSA, 2018c). These studies showed that phosphonic acid is hydrolytically stable under standard processing conditions representative of pasteurisation, baking/brewing/boiling and sterilisation. 1.1.4 Methods of analysis in plants Different analytical methods, using high-performance liquid chromatography with tandem mass spectrometry (HPLC–MS/ MS), were previously assessed with view on their use for enforcement of the MRLs for phosphonic acid (EFSA, 2018c). Sufficiently validated method is available for the determination of both phosphonic acid and fosetyl in matrices with high water-, dry/high starch- and high oil content at the LOQ of 0.01 mg/kg while for both compounds a LOQ of 0.1 mg/kg was achieved in high acid matrices (EFSA, 2018c). In the framework of the current assessment the applicant provided a new analytical method (method L0275/01) based on liquid chromatography with tandem mass spectrometry (LC–MS/MS) which was validated for the determination of phosphonic acid in grape and pome fruits matrices at the LOQs of 0.1 and 0.5 mg/kg, respectively. For this method no independent laboratory validation (ILV) was provided, therefore EFSA does not propose to use this method for enforcement purposes. EFSA concludes that for all crops under assessment, sufficiently validated analytical methods are available to enforce the MRLs for potassium phosphonates according to the existing residue definition (sum of fosetyl, phosphonic acid and their salts, expressed as fosetyl) as well as the residue definition proposed in the EU pesticides peer review (sum of phosphonic acid and their salts, expressed as phosphonic acid) (EFSA, 2012b). 1.1.5 Storage stability of residues in plants The storage stability of phosphonic acid under frozen conditions was investigated in the framework of the peer review of fosetyl (EFSA, 2018c), peer review of potassium phosphonates (EFSA, 2012b) and in previous MRL applications (EFSA, 2019b). Phosphonic acid is stable under frozen conditions for up to 25 months in commodities with high water, high oil, high protein, high starch and high acid contents. 1.1.6 Proposed residue definitions The following residue definitions have been derived in previous assessments of potassium phosphonates: Residue definition for enforcement: – Sum of fosetyl, phosphonic acid and their salts expressed as fosetyl (current residue definition set in Regulation (EC) No 396/2005); – Phosphonic acid and its salts, expressed as phosphonic acid (peer review of potassium phosphonates, EFSA, 2012b). Residue definition for risk assessment: – Phosphonic acid and its salts, expressed as phosphonic acid (peer review of potassium phosphonates, EFSA, 2012b). It is noted that in previous assessments of fosetyl, different residue definitions have been derived which have not been legally implemented (e.g. sum of fosetyl, phosphonic acid and their salts, expressed as phosphonic acid (EFSA, 2018c) or separate residue definitions for phosphonic acid and fosetyl (EFSA, 2012a)). For the current application, MRL proposals were derived for the following residue definitions: Phosphonic acid and its salts, expressed as phosphonic acid; Sum of fosetyl, phosphonic acid and their salts, expressed as fosetyl.7 Considering that the final decision on the residue definition for risk assessment has not yet been taken, in line with the previously issued reasoned opinion of EFSA (2019b), the consumer risk assessment was performed for the following residue definition: Phosphonic acid and its salts, expressed as phosphonic acid. The residue definitions apply to primary crops, rotational crops and processed products. The potassium phosphonates residue definition for enforcement currently set in Regulation (EC) No 396/2005 is the one set for fosetyl (covering also phosphonates), i.e. 'sum of fosetyl, phosphonic acid and their salts expressed as fosetyl'. However, the residue definition for risk assessment and enforcement proposed in the peer review of potassium phosphonates (EFSA, 2012b) is the 'sum of phosphonic acid and its salts expressed as phosphonic acid'. 1.2 Magnitude of residues in plants 1.2.1 Magnitude of residues in primary crops In support of the intended Good Agricultural Practices (GAPs), three different applications were submitted and are merged into this reasoned opinion. These three different applications refer to: tree nuts, kaki/Japanese persimmons and granate apple/pomegranates, fresh herbs and edible flowers and other small fruits and berries. To support the first application, an applicant submitted residue trials performed in almonds and pistachios, and pomegranates while the application for kaki/Japanese persimmon was later withdrawn during the assessment. Therefore, the EMS updated the corresponding evaluation report including and addressing only the uses in tree nuts and pomegranates. Regarding the application on fresh herbs and edible flowers, an applicant submitted residue trials performed in basil, parsley and sage. Finally, in relation to the last application on other small fruits and berries, the applicant submitted residue trials performed in raspberries, black currants and blueberries. In all trials, samples were analysed for phosphonic acid residues. The results were expressed also as fosetyl, by applying the molecular weight conversion factor of 1.34 in order to derive data for the existing enforcement residue definition. According to the EMS Greece and EMS Germany, the methods of analysis used to analyse the residue trial samples were sufficiently validated and were fit for purpose (Germany 2019a,b, Greece 2019). All samples of these residue trials prior to analysis were stored under conditions for which integrity of the samples has been demonstrated. The results of the individual residue trials, the related risk assessment input values (highest residue, median residue) and the MRL proposals are summarised in Appendix B.1.2.1. 1.2.1.1 Tree nuts In support of the proposed southern Europe (SEU) GAP, the applicant provided six GAP-compliant residue trials on tree nuts (three trials in almonds and three trials in pistachios), performed in Spain, Italy and southern France in the growing season of 2017. The residues in tree nuts were in a range of 138 mg/kg to 450 mg/kg measured as phosphonic acid and of 185 mg/kg to 603 mg/kg calculated as fosetyl. The applicant proposes to combine the available residue data on almonds and pistachios and to extrapolate to the whole group of tree nuts. Such an extrapolation is acceptable according to EU guidance document (European Commission, 2017). However, since the intended use of potassium phosphonates is reported in southern Europe on almonds, chestnuts, pistachios, hazelnuts and walnuts, the extrapolation is limited to these crops only. An MRL proposal for almonds, chestnuts, pistachios, hazelnuts and walnuts is thus calculated at 1000 mg/kg for phosphonic acid and at 1,500 mg/
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