Review of the existing maximum residue levels for emamectin according to Article 12 of Regulation (EC) No 396/2005
2019; Wiley; Volume: 17; Issue: 8 Linguagem: Inglês
10.2903/j.efsa.2019.5803
ISSN1831-4732
AutoresMaria Anastassiadou, Alba Brancato, Luis Carrasco Cabrera, Lucien Ferreira, Luna Greco, Samira Jarrah, Aija Kazocina, Renata Leuschner, José Oriol Magrans, Ileana Miron, Stéfanie Nave, Ragnor Pedersen, Marianna Raczyk, Hermine Reich, Alejandro Rojas, Silvia Ruocco, Angela Sacchi, Miguel Santos, Alois Stanek, Anne Theobald, Bénédicte Vagenende, Alessia Verani,
Tópico(s)Effects and risks of endocrine disrupting chemicals
ResumoEFSA JournalVolume 17, Issue 8 e05803 Reasoned OpinionOpen Access Review of the existing maximum residue levels for emamectin 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 authorMaria Anastassiadou, Maria AnastassiadouSearch 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 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 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 authorMarianna Raczyk, Marianna RaczykSearch for more papers by this authorHermine Reich, Hermine ReichSearch for more papers by this authorAlejandro Rojas, Alejandro RojasSearch for more papers by this authorSilvia Ruocco, Silvia RuoccoSearch 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), European Food Safety Authority (EFSA)Search for more papers by this authorMaria Anastassiadou, Maria AnastassiadouSearch 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 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 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 authorMarianna Raczyk, Marianna RaczykSearch for more papers by this authorHermine Reich, Hermine ReichSearch for more papers by this authorAlejandro Rojas, Alejandro RojasSearch for more papers by this authorSilvia Ruocco, Silvia RuoccoSearch 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: 29 August 2019 https://doi.org/10.2903/j.efsa.2019.5803Citations: 1 Correspondence: pesticides.mrl@efsa.europa.eu Requestor: European Commission Question number: EFSA-Q-2013-00777 Acknowledgement: EFSA wishes to thank the rapporteur Member State the Netherlands for the preparatory work on this scientific output. Approved: 18 July 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 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 emamectin. To assess the occurrence of emamectin residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Regulation (EC) No 1107/2009, 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. Some information required by the regulatory framework was missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, some MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered. Summary Emamectin was approved on 1 May 2014 by means of Commission Implementing Regulation (EU) No 828/2013 in accordance with Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market, and amending the Annex to Commission Implementing Regulation (EU) No 540/2011. 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 December 2017 EFSA initiated the collection of data for this active substance. In a first step, Member States were invited to submit by 15 January 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) the Netherlands 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 8 March 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 were provided by the RMS to EFSA on 15 June 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 EURL, 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 February 2019 a draft reasoned opinion, which was circulated to Member States for consultation via a written procedure. Comments received by 22 March 2019 were considered during the finalisation of this reasoned opinion. The following conclusions are derived. The metabolism of emamectin in plant was investigated in primary and rotational crops. According to the results of the metabolism studies, the residue definition for enforcement can be proposed as emamectin B1a and its salts, expressed as emamectin B1a (free base). This residue definition is applicable to all plant and processed commodities. For the risk assessment purpose, the residue definition is proposed as sum of emamectin B1a, emamectin B1b, 8,9-Z-MAB1a, plus 3 times AB1a, plus 3 times MFB1a and 3 times FAB1a, expressed as emamectin B1a (free base). This residue definition applies to all plant commodities (raw and processed). Although not sufficiently validated for all matrices, analytical methods are available for the enforcement of the proposed residue definition in the four main plant matrices. According to the EURLs, the limit of quantification (LOQ) of 0.002 mg/kg in high water and high acid content commodities and 0.005 mg/kg in high oil content and dry commodities are achievable in routine analyses. Available residue trials data were considered sufficient to derive (tentative) MRL proposals as well as risk assessment values for all commodities under evaluation, except for kohlrabi and cotton seeds, for which no data were available. Robust and tentative peeling factors could be derived for melons and citrus fruits, respectively. Emamectin 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. Since the calculated dietary burdens for all groups of livestock were found to be below the trigger value of 0.1 mg/kg dry matter (DM), further investigation of residues as well as the setting of MRLs in commodities of animal origin was in principle unnecessary. However, in this particular case, given the high chronic toxicity of emamectin and its fat solubility, EFSA assessed the nature and magnitude of residues in ruminants and swine. The metabolism of emamectin residues in livestock was investigated in lactating goats at dose rate covering the maximum dietary burdens calculated in this review (700–940N). According to the results of these studies, the residue definition for enforcement and risk assessment in ruminants and swine was proposed as emamectin B1a and its salts, expressed as emamectin B1a (free base). A sufficiently validated analytical method for the enforcement of the proposed residue definition in livestock matrices is not available and it is required (data gap). According to the EURLs, the LOQ of 0.01 mg/kg is achievable by using a single residue method in routine analyses. A livestock feeding study on dairy cows was used to derive MRL and risk assessment values in milk and tissues of ruminants. Since extrapolation from ruminants to pigs is acceptable, results of the livestock feeding study on ruminants were relied upon to derive the MRL and risk assessment values in pigs. In view of the data gaps identified for the analytical methods and storage stability of residues in livestock, all MRLs are tentative. Chronic and acute 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 EU MRL, multiplied by the corresponding conversion factor, as an indicative calculation. The highest chronic exposure was calculated for the Spanish adult, representing 28% of the acceptable daily intake (ADI). However, an exceedance of the acute reference dose (ARfD) was identified for lettuces and escaroles (broad-leaved endives) representing 218% and 102% of the ARfD, respectively. Considering fall-back GAPs for these crops, the highest chronic exposure represented 17% of the ADI (DE child) and the highest acute exposure amounted to 40% of the ARfD (lettuce). Apart from the MRLs evaluated in the framework of this review, internationally recommended codex maximum residue limits (CXLs) have also been established for emamectin. Additional calculations of the consumer exposure, considering these CXLs, were therefore carried out and an exceedance of the ARfD was identified for the existing CXL in lettuce (117%). Excluding this CXL from the calculation, the highest chronic exposure represented 19% of the ADI (DE child) and the highest acute exposure amounted to 54% of the ARfD (Chinese cabbage). 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 emamectin was approved on 1 May 2014 by means of Commission Implementing Regulation (EU) No 828/20133 in accordance with Regulation (EC) No 1107/20094 and amending the Annex to Commission Implementing Regulation (EU) No 540/20115, 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 188/20116 emamectin was evaluated by the Netherlands, 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 conclusion (EFSA, 2012). The representative uses evaluated in the peer review were field and glasshouse foliar spray applications on grapes, tomatoes, peppers, cucumbers, melons and lettuce. Emamectin has been approved for use as an insecticide. Furthermore, according to the provisions of the approval regulation, confirmatory information was requested, as regards the risk of enantioselective metabolisation or degradation. The applicant shall submit to the Commission, Member States and the Authority the relevant information 2 years after adoption of the pertinent guidance document on evaluation of isomer mixtures, however, since the guidance document has not been adopted this information is pending. 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 December 2017 EFSA initiated the collection of data for this active substance. In a first step, Member States were invited to submit by 15 January 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, 15 Member States provided feedback on their national authorisations of emamectin. Based on the GAP data submitted, the designated RMS the Netherlands was asked to identify the critical GAPs (cGAPs) to be further considered in the assessment, in the format of a specific GAP overview file. Subsequently, in a second step, Member States were requested to provide residue data supporting the cGAPs by 8 March 2018. On the basis of all the data submitted by Member States and the EU Reference Laboratories for Pesticides Residues (EURL), EFSA asked the Netherlands 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, were submitted to EFSA on 15 June 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. Considering all the available information, and taking into account the MRLs established by the Codex Alimentarius Commission (CAC) (i.e. codex maximum residue limits (CXLs)), EFSA prepared in February 2019 a draft reasoned opinion, which was circulated to Member States for commenting via a written procedure. All comments received by 22 March 2019 were considered by EFSA during the finalisation of the reasoned opinion. The evaluation report submitted by the RMS (Netherlands, 2018), taking into account also the information provided by Member States during the collection of data (Austria, 2018; France, 2018; Greece, 2018; Hungary, 2018; Italy, 2018) and the EURL report on analytical methods (EURL, 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, 2019c). 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 PRIMo and the PROFile, as well as the GAP overview file listing all authorised uses 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 Emamectin is the ISO common name for a mixture of emamectin B1a (≥ 90%) and emamectin B1b (≤ 10%): (10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-6′-[(S)-sec-butyl]-21,24-dihydroxy-5′,11,13,22-tetramethyl-2-oxo-(3,7,19-trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22 tetraene)-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl2,6-dideoxy-3-O-methyl-4-O-(2,4,6-trideoxy-3-O-methyl-4-methylamino-α-l-lyxo-hexapyranosyl)-α-l-arabino-hexapyranoside; and (10E,14E,16E,22Z)-(1R,4S,5′S,6S,6′R,8R,12S,13S,20R,21R,24S)-21,24-dihydroxy-6′-isopropyl-5′,11,13,22-tetramethyl-2-oxo-(3,7,19trioxatetracyclo[15.6.1.14,8.020,24]pentacosa-10,14,16,22-tetraene)-6-spiro-2′-(5′,6′-dihydro-2′H-pyran)-12-yl2,6-dideoxy-3-O-methyl-4-O-(2,4,6-trideoxy-3-O-methyl-4-methylamino-α-l-lyxo-hexapyranosyl)-α-l-arabino-hexapyranoside(E,Z)-3-(2-chloro-thiazol-5-ylmethyl)-5-methyl-[1,3,5]oxadiazinan-4-ylidene-N-nitroamine; respectively (IUPAC). The chemical structure of the active substance and its main metabolites are reported in Appendix F. The EU MRLs for emamectin are established in Annex IIIA of Regulation (EC) No 396/2005. CXLs for emamectin 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 1050/2009a Various crops (EFSA, 2009). MRL application Commission Regulation (EU) No 813/2011b Plums, apricots and citrus fruit (EFSA, 2011) Implementation of CAC 2012 Regulation (EU) No 293/2013c Implementation of CXL (EFSA, 2015). MRL application Commission Regulation (EU 2018/1514d Leafy brassica and beans and peas with pods (EFSA, 2018) MRL application Not yet legally implemented Kiwi (EFSA, 2019b) MRL: maximum residue level; CAC: codex maximum residue limit; CXL: codex maximum residue limit. a Commission Regulation (EC) No 1050/2009 of 28 October 2009 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 azoxystrobin, acetamiprid, clomazone, cyflufenamid, emamectin benzoate, famoxadone, fenbutatin oxide, flufenoxuron, fluopicolide, indoxacarb, ioxynil, mepanipyrim, prothioconazole, pyridalyl, thiacloprid and trifloxystrobin in or on certain products. OJ L 290, 6.11.2009, p. 7–55. b Commission Regulation (EC) No 813/2011 of 11 August 2011 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, emamectin benzoate, ethametsulfuron-methyl, flubendiamide, fludioxonil, kresoxim-methyl, methoxyfenozide, novaluron, thiacloprid and trifloxystrobin in or on certain products. OJ L 208, 13.8.2011, p. 23–79. c Commission Regulation (EU) No 293/2013 of 20 March 2013 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 emamectin benzoate, etofenprox, etoxazole, flutriafol, glyphosate, phosmet, pyraclostrobin, spinosad and spirotetramat in or on certain products. OJ L 96, 5.4.2013, p. 1–30. d Commission Regulation (EU) 2018/1514 of 10 October 2018 amending Annexes II, III and IV to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for abamectin, acibenzolar-S-methyl, clopyralid, emamectin, fenhexamid, fenpyrazamine, fluazifop-P, isofetamid, Pasteuria nishizawae Pn1, talc E553B and tebuconazole in or on certain products. OJ L 256, 12.10.2018, p. 8–32. For the purpose of this MRL review, all the uses of emamectin currently authorised within the European Union (EU) as submitted by the Member States during the GAP collection, have been reported by the RMS in the GAP overview file. The cGAPs identified in the GAP overview file were then summarised in the PROFile and considered in the assessment. The details of the authorised cGAP for emamectin 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 following documents: the PROFile submitted by the RMS; the evaluation report accompanying the PROFile (Netherlands, 2018); the draft assessment report (DAR) and the final addendum to draft assessment report on emamectin benzoate prepared under Council Directive 91/414/EEC (Netherlands, 2008, 2012); the conclusion on the peer review of the pesticide risk assessment of the active substance emamectin (EFSA, 2012); the Joint Meeting on Pesticide residues (JMPR) Evaluation report (FAO, 2009, 2011, 2014), the previous reasoned opinions on emamectin (EFSA, 2009, 2011, 2015, 2018). 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 546/20117 and the currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues (European Commission, a, b,c,d,e,f–g, a, a,b, a; 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 emamectin was investigated after foliar treatment in fruits (pears), leafy vegetables (lettuce and head cabbage) and cereals (sweet corn) using emamectin B1a benzoate only, labelled as [3, 7, 11, 13, 23-14C]-emamectin B1a or as [23-14C]-emamectin B1a in the pear study (Netherlands, 2008). All four studies were assessed in the framework of the peer-review (EFSA, 2012). After eight foliar applications of 16.8 or 84 g a.s./ha on lettuce and head cabbage, the major component identified was parent emamectin B1a, representing 7–34% TRR (0.01–0.1 mg eq/kg, low dose; 0.09–1.0 mg eq/kg, high dose) of the total radioactive residues (TRR) within 3 days after application, and typically less than 5% TRR, after 7 days. The remaining radioactivity was resolved into six degradation compounds structurally related to emamectin B1a, out of which four were photometabolites (8,9-Z-MAB1a, FAB1a, MFB1a, AB1a), each occurring mostly at less than 5% TRR. However, when considered altogether, the photometabolites represented up to 20% TRR (0.07 mg eq/kg low dose; 0.6 mg eq/kg high dose). A similar metabolic pathway was observed in sweet corn, for which parent and photometabolites were observed. Emamectin B1a was the major component identified in both leaves and husk, accounting for up to 14% (0.1 mg eq/kg) and 23% TRR (0.06 mg eq/kg), respectively. After three foliar applications of 16.8 or 168 g a.s./ha on pears, only the parent was identified, being the photometabolites totally absent. Initially, a different metabolic profile was suggested in fruit crops. However, such a specific metabolism was not confirmed by the supervised residue trials conducted on apple and peach (reported in a previous reasoned opinion, EFSA, 2009), melons (assessed in the peer-review, EFSA, 2012) and strawberries (submitted in the framework of this MRL review, Italy, 2018), where the photometabolites were quantified (see also Section 1.2.1). According to the EFSA conclusion, the differences observed in the pear metabolism study should thus be considered as a result from different experimental patterns (characterisation of the residues after 14 and 28 days in pear, while after 0–7 days in the other crops), rather than from a particular metabolism in fruit crops. The metabolic pathway of emamectin was similar in fruits, leafy vegetables and cereals, exhibiting an extensive photodegradation of emamectin B1a benzoate in the surface of the crops. 1.1.2 Nature of residues in rotational crops Emamectin 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 53 days (Netherlands, 2008), indicating that there is no potential for residues to be present in soil at the time rotational crops would be planted. Although not required, confined rotational crop studies with radiolabelled [3, 7, 11, 13, 23-14C] emamectin B1a benzoate were submitted and assessed in the framework of the peer review (EFSA, 2012). Emamectin B1a benzoate was applied at a rate of 100.8 g a.s./ha (covering the most cGAP evaluated in this review) onto bare soil. Crops were planted at nominal plant-back intervals (PBI) of 30, 120/141 and 365 days after treatment (DAT). Crops planted at each interval consisted of leafy vegetable (lettuce), roots (carrots) and cereals (barley). Total radioactive residues were below 0.01 mg eq./kg in all plant matrices, except in barley straw (0.03 mg eq/kg at 141 DAT). Further characterisation of the TRRs was not performed and it is not needed. 1.1.3 Nature of residues in processed commodities Studies investigating the nature of residues in processed commodities were assessed in the peer-review (Netherlands, 2008; EFSA, 2012). Studies were conducted with radiolabelled [23-14C]-emamectin B1a benzoate simulating representative hydrolytic conditions for pasteurisation (20 minutes at 90°C, pH 4), boiling/brewing/baking (60 minutes at 100°C, pH 5) and sterilisation (20 minutes at 120°C, pH 6). The studies demonstrated that emamectin undergoes limited hydrolysis (ca. 15–20%). The level of degradation increases with temperature/pH: 15% degradation under pasteurisation, 14% degradation under boiling/brewing/baking and 20% degradation under sterilisation. The monosaccharide MSB1a (4.8% of the total applied radioactivity (TAR) under boiling/brewing/baking; 7.2% TAR under sterilisation), AB1a (1.8% TAR under sterilisation) and aglycone milbemectin B (1.4% under boiling/brewing/baking) were the metabolites identified. Further minor unknown degradation products could not be identified. All the breakdown products were below 10% of TAR. The toxicological properties of the metabolite MSB1a were not discussed in the peer review. These studies are considered sufficient to assess the nature of parent emamectin B1a in processed commodities. Concerning the photometabolites, having regard to the low residue levels observed in the raw commodities (maximum residue observed 0.04 mg/kg), their similar chemical structure to the parent and the safety margin of the risk assessment (19% acceptable daily intake (ADI)), EFSA is of the
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