APPROVED: 4 December 2015 PUBLISHED: 9 December 2015

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1 REASONED OPINION APPROVED: 4 December 2015 PUBLISHED: 9 December 2015 doi: /j.efsa Review of the existing maximum residue levels for sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate according to Article 12 of Regulation (EC) No 396/2005 European Food Safety Authority (EFSA) Abstract According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substances sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p--nitrophenolate. In order to assess the occurrence of resulting residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC as well as the European authorisations reported by Member States (incl. 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 all MRL proposals derived by EFSA still require further consideration by risk managers. European Food Safety Authority, 2015 Keywords: Sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate, MRL review, Regulation (EC) No 396/2005, consumer risk assessment, plant growth regulator Requestor: European Commission Question number: EFSA-Q , EFSA-Q , EFSA-Q Correspondence: pesticides.mrl@efsa.europa.eu EFSA Journal 2015;13(12):4356

2 Acknowledgement: EFSA wishes to thank the rapporteur Member State Greece for the preparatory work on this scientific output. Suggested citation: EFSA (European Food Safety Authority), Reasoned opinion on the review of the existing maximum residue levels for sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2015;13(12):4356, 39 pp. doi: /j.efsa ISSN: European Food Safety Authority, 2015 Reproduction is authorised provided the source is acknowledged. The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. 2 EFSA Journal 2015;13(12):4356

3 Summary Sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate were included in Annex I to Directive 91/414/EEC on 1 November 2009 by Commission Directive 2009/11/EC, and have 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 substances were approved after the entry into force of Regulation (EC) No 396/2005 on 2 September 2008, EFSA is required to provide a reasoned opinion on the review of the existing MRLs for those active substances in compliance with Article 12(1) of the aforementioned regulation. In order to collect the relevant pesticide residues data, EFSA asked Greece, 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 28 April 2015 and finalised on 29 June After having considered all the information provided, EFSA prepared a completeness check report which was made available to Member States on 17 August Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC and the additional information provided by the RMS and Member States, EFSA prepared in September-October 2015 a draft reasoned opinion, which was circulated to Member States for consultation via a written procedure. Comments received by 3 November 2015 were considered during the finalisation of this reasoned opinion. The following conclusions are derived. The metabolism of sodium nitrocompounds (sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate) has been investigated for foliar treatment in fruit crops, root crops and pulses/oilseeds. These compounds are always used in co-formulation and they do not degrade into significant metabolites in edible part of the investigated crops. As DT 90 values of sodium nitrocompounds are all expected to be well below the trigger value of 100 days, investigation of residues in rotational crops was not required. Furthermore, as quantifiable residues of sodium nitrocompounds are not expected in the treated food crops, there is also no need to investigate the effect of industrial and/or household processing on the nature of residues. Considering that these three compounds share the same toxicological reference values, EFSA proposed a common residue definition for monitoring and risk assessment being the sum of sodium 5-nitroguaiacolate, sodium o--nitrophenolate and sodium p-nitrophenolate, expressed as sodium 5-nitroguaicolate. A validated analytical method for the monitoring of the proposed residue definition is available for high water content and high oil content commodities but is missing for commodities with high acid content commodities, dry commodities and hops (dried). Due to uncertainties observed in sugar beet leaves where two significant metabolites remain unidentified, the proposed residue definition is tentative for sugar beet leaves. Southern outdoor and indoor trials were adequately evaluated by the RMS but it was not the case for the northern residue trials which were therefore considered on a tentative basis only. The number of residue trials was considered sufficient to derive maximum residue level (MRL) proposals as well as risk assessment values for all commodities under evaluation, except for olives (table and oil) and sugar beet leaves where specific concerns were identified. However, due to the fact that northern residue trials were not evaluated and since analytical methods for monitoring in high acid content commodities, dry commodities and hops (dried) are still required, all MRL proposals other than for tomatoes, aubergines, melons and watermelons are made on tentative basis. The dietary burdens calculated for dairy ruminants, meat ruminants and pigs were found to exceed the trigger value of 0.1 mg/kg DM. However, the calculated dietary burdens were close to the trigger value of 0.1 mg/kg DM and may have been overestimated because of the use of the combined limit of quantification (LOQ) of 0.03 mg/kg as an input value for crops where a no-residue situation was demonstrated. Consequently, EFSA concluded that MRLs for nitrocompounds in animal commodities were not required. However, it is highlighted that this conclusion does not take into consideration the possible intake of sugar beet leaves for which uncertainties on the nature and magnitude of residues were identified. Therefore, Member States will need to pay attention to this issue when authorising a good agricultural practice (GAP) on sugar beet. 3 EFSA Journal 2015;13(12):4356

4 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 3 times the default MRL (which is currently defined by the legislation for each nitrocompound) as an input value for individual risk assessment. The highest chronic exposure represented 35% of the acceptable daily intake (ADI) (UK toddler) and the highest acute exposure amounted to 10.3% of the acute reference dose (ARfD) (potatoes). 4 EFSA Journal 2015;13(12):4356

5 Table of contents Abstract... 1 Summary... 3 Background... 6 Terms of reference... 7 The active substance and its use pattern... 7 Assessment Residues in plants Nature of residues and methods of analysis in plants Nature of residues in primary crops Nature of residues in rotational crops Nature of residues in processed commodities Methods of analysis in plants Stability of residues in plants Proposed residue definitions Magnitude of residues in plants Magnitude of residues in primary crops Magnitude of residues in rotational crops Magnitude of residues in processed commodities Proposed MRLs Residues in livestock Consumer risk assessment Conclusions Recommendations References Abbreviations Appendix A Summary of authorised uses considered for the review of MRLs Appendix B List of end points Appendix C Input values for the exposure calculations Appendix D Decision tree for deriving MRL recommendations Appendix E Used compound code(s) EFSA Journal 2015;13(12):4356

6 Background Regulation (EC) No 396/ 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 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/EEC 2 a reasoned opinion on the review of the existing MRLs for that active substance. As sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate were included in Annex I to Council Directive 91/414/EEC on 1 November 2015 by means of Commission Directive 2009/11/EC, 3 and have been deemed to be approved under Regulation (EC) No 1107/2009, 4 in accordance with Commission Implementing Regulation (EU) No 540/2011, 5 as amended by Commission Implementing Regulation (EU) No 541/2011, 6 EFSA initiated the review of all existing MRLs for those active substances. 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, while MRLs set out in Regulation (EC) No 396/2005 should accommodate all uses authorised within the 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. In order 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 and; the analytical methods for enforcement of the proposed MRLs. Greece, the designated rapporteur Member State (RMS) in the framework of Directive 91/414/EEC, was asked to complete the PROFile for sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate and to prepare a supporting evaluation report (Greece, 2011). The PROFile and the supporting evaluation report were submitted to EFSA on 11 November 2011 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 28 April 2015 and finalised on 29 June Additional evaluation reports were submitted by Czech Republic, Greece, Hungary and Spain (Czech Republic, 2015; Greece, 2015a; Hungary, 2015; Spain, 2015) 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 17 August Further clarifications were sought from Member States via a written procedure in August-September Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC. OJ L 70, , p Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. OJ L 230, , p Repealed by Regulation (EC) No 1107/2009. Commission Directive 2009/11/EC of 18 February 2009 amending Council Directive 91/414/EEC to include bensulfuron, sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate and tebufenpyrad as active substances. OJ L 48, , p Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. OJ L 309, , p Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances. OJ L 153, , p Commission Implementing Regulation (EU) No 541/2011 of 1 June 2011 amending Implementing Regulation (EU) No 540/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances. OJ L 153, , p EFSA Journal 2015;13(12):4356

7 Based on the conclusions derived by EFSA in the framework of Directive 91/414/EEC, and the additional information provided by the Member States, EFSA prepared in September-October 2015 a draft reasoned opinion, which was submitted to Member States for commenting via a written procedure. All comments received by 3 November 2015 were considered by EFSA during the finalisation of the reasoned opinion. During this Member States consultation, a new evaluation report was also provided by the RMS (Greece, 2015b). Since this evaluation report included detailed summaries of studies that were already taken into account in the draft reasoned opinion, it was taken into account in the finalisation of the reasoned opinion. The evaluation reports submitted by the RMS (Greece, 2011, 2015a, 2015b), and the additional evaluation reports submitted by Member States Czech Republic, Hungary and Spain (Czech Republic, 2015; Hungary, 2015; Spain, 2015) 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, 2015a) and the Member States consultation report (EFSA, 2015b). These reports are developed to address all issues raised in the course of the review, from the initial completeness check to the reasoned opinion. Considering the importance of the completeness check and consultation report, all documents are considered as background documents to this reasoned opinion and, thus, are made publicly available. Also the chronic and acute exposure calculations for all crops reported in the framework of this review performed using the EFSA Pesticide Residues Intake Model (PRIMo) are key supporting documents and made publicly available. 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 There are no ISO common names for the sodium nitrocompounds but, within the European legislation on pesticides, sodium 5-nitroguaiacolate is the used name for sodium 2-methoxy-5-nitrophenolate while sodium 2-nitrophenolate (or sodium o-nitrophenolate) and sodium 4-nitrophenolate (or sodium p-nitrophenolate) were named in accordance with the IUPAC nomenclature. The chemical structures of the active substances are reported in Appendix E. Sodium 5-nitroguaiacolate (Na 5-NG), sodium o-nitrophenolate (Na o-np) and sodium p- nitrophenolate (Na p-np) belong to the class of nitrophenolate plant growth regulators. They act as plant growth s which increase nutrient uptake by the acceleration of cytoplasmic streaming and increase of assimilates uptake, by prolongation of auxin activity by inhibiting the IAA (indolylacetic acid) oxydases and inhibition of ABA (abscissic acid) effects and by increase of the nitrate reductase activity. They are translocated in plants systemically. Na 5-NG, Na o-np and Na p-np are used in agriculture for qualitative and quantitative yield improvement. Sodium 5-nitroguaiacolate, sodium o- nitrophenolate and sodium p-nitrophenolate were evaluated in the framework of Directive 91/414/EEC with Greece designated as rapporteur Member State (RMS). The representative uses supported for the peer review process comprised foliar on sugar beet, oilseed rape and tomato at the maximum rate of 1 g Na 5-NG/ha, 2 g Na o-np/ha and 3 g Na p- NP/ha. Following the peer review, which was carried out by EFSA, a decision on inclusion of the active substances in Annex I to Directive 91/414/EEC was published by means of Commission Directive 2009/11/EC, which entered into force on 11 November According to Regulation (EU) No 540/2011, sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate are deemed to have been approved under Regulation (EC) No 1107/2009. This approval is restricted to uses as plant growth regulators only. 7 EFSA Journal 2015;13(12):4356

8 EU MRLs were not established for sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p- nitrophenolate. Hence, according to Art 18(1)(b) of Regulation (EC) No 396/2005, the default MRL of 0.01 mg/kg applies for each compound. CXL for sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate are not available. For the purpose of this MRL review, the critical uses of sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate currently authorised within the EU, have been collected by the RMS and reported in the PROFile. The additional GAPs reported by Member States during the completeness check were also considered. The details of the authorised GAPs for these compounds are given in Appendix A. It is noted that the three compounds are always used in co-formulations. The composition of the formulated product is as follow: 1 g/l of sodium 5-nitroguaiacolate, 2 g/l of sodium o-nitrophenolate and 3 g/l of sodium-nitrophenolate. 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 (Greece, 2011), the draft assessment report (DAR) and its addenda prepared under Council Directive 91/414/EEC (Greece, 2007, 2008), the conclusion on the peer review of the pesticide risk assessment of sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate (EFSA, 2008), as well as the evaluation reports submitted during the completeness check (Czech Republic, 2015; Greece, 2015a; Hungary, 2015; Spain, 2015) or during the Member States consultation (Greece, 2015b). 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/ and the currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues (European Commission, 1996, 1997a-g, 2000, 2010a, b, 2011 and OECD, 2011). 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 Nature of residues in primary crops The metabolism of the three sodium nitrocompounds considered in this review (sodium 5- nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate) was investigated in fruit crops, root crops and pulses and oilseeds. Metabolism studies have been performed using foliar application of a mixture of the three active substances (in concentrations representative of the authorised formulations). The tested application rates were exaggerated by a factor of 10 compared to the authorised GAPs but the total radioactivity was very low in sugar beet roots, tomatoes and rape seeds ( mg eq/kg, expressed as the sum of the three sodium nitrocompounds). Further characterisation demonstrated that the radioactivity was made of several constituents, none of them exceeding mg eq/kg. Among these constituents, only 5-nitroguaiacol and p-nitrophenol were identified. Other significant metabolites were not identified. Therefore, at the authorised application rates, significant residues are not expected in edible parts of the investigated crops. In sugar beet leaves however, the total radioactive residue (TRR) was significantly higher, accounting for 0.40 mg eq/kg. The two main important fractions, named metabolite 6 and 7 during the peer review (EFSA, 2008) and respectively accounting for 0.11 and 0.06 mg eq/kg, were not identified. Even considering the overdosing factor of the application rate, these compounds may still exceed 0.01 mg/kg in sugar beet leaves when active substances are applied in accordance with GAP. During the peer review, the experts already concluded that further information on the structure of these two unknown fractions should be requested. As a GAP on sugar beet (roots and tops) is authorised within 7 Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products. OJ L 155, , p EFSA Journal 2015;13(12):4356

9 Europe, this data requirement is still applicable. Meanwhile, the nature of residue in sugar beet leaves remains not elucidated Nature of residues in rotational crops Several crops under consideration may be grown in rotation. According to the soil degradation studies which were evaluated in the framework of the peer review for the three sodium nitrocompounds, the maximum DT 90 value is 7.5 days (sodium p-nitrophenolate), which is far below the trigger value of 100 days (EFSA, 2008). According to the European guidelines on rotational crops (European Commission, 1997b), further investigation of residues in rotational crops is not required and relevant residues in rotational crops are not expected Nature of residues in processed commodities As quantifiable residues of sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate are not expected in the treated food crops (see section 1.2.1), there is currently no need to investigate the effect of industrial and/or household processing on the nature of residues Methods of analysis in plants An analytical method using HPLC-MS/MS was validated for the monitoring of sodium 5-nitroguaiacolate, sodium o-phenolate and sodium p-nitrophenolate with, for each compound, a limit of quantification (LOQ) of 0.01 mg/kg in high water content and high oil content commodities (EFSA, 2008). This method is supported by an independent laboratory validation (ILV) and a confirmatory method was not deemed necessary. During the Member States consultation, EURLs indicated to EFSA that a single residue method was validated for enforcement of sodium 5-nitroguaiacolate, sodium o-phenolate and sodium p-nitrophenolate in dry commodities. However, as this statement is not supported by data, it cannot be evaluated in the present assessment. Hence analytical methods for monitoring of sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate in high acid content commodities, dry commodities and hops (dried) are still required Stability of residues in plants Stability of sodium nitrocompounds was not investigated in the framework of Directive 91/414/EEC. In the framework of the MRL review, the RMS has reported four storage stability studies respectively performed on cucumbers, oilseed rape, maize grain and strawberries hereby covering the four main plant matrices (Greece, 2015b). According to these studies, the three sodium nitrocompounds are stable for a period of 9 months in high oil content and dry commodities. In high water content and high acid content commodities, sodium 5-nitroguaiacolate and sodium p-nitrophenolate were also demonstrated stable for a period of 9 months but a significant degradation of sodium o-nitrophenolate was observed after 3 months of storage. Hence, it is concluded that the sodium nitrocompounds are stable for a period of 9 months in high oil content and dry commodities and for a period of 3 months in high water content and high acid content commodities Proposed residue definitions Based on the available information, sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate are always applied together and they do not degrade into significant metabolites in edible part of the investigated crops. Considering that these three compounds share the same toxicological reference values, EFSA proposed a common residue for monitoring and risk assessment being the sum of the three compounds (EFSA, 2008). As the toxicological reference values were expressed as sodium 5-nitroguaiacolate in the peer review, the proposed wording is: sum of sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, expressed as sodium 5-nitroguaicolate. A validated analytical method for the monitoring of the proposed residue definition with a combined LOQ of 0.03* mg/kg (sum of LOQs validated for each compound) is available for 9 EFSA Journal 2015;13(12):4356

10 high water content and high oil content commodities. Since there are authorised GAPs on commodities with high acid content commodities, dry commodities and hops (dried), additional analytical methods for monitoring in these matrices are also required. As similar results were observed in three different crop groups (fruits, roots and pulses/oilseeds), a general residue definition can be proposed for food commodities of plant origin. However, it is highlighted that two significant compounds remain unidentified in sugar beet leaves and further information on their possible structure was required by EFSA. Meanwhile, in the absence of this information, the residue definition in sugar beet leaves is deemed tentative. During the Member States consultation, EURLs also informed EFSA that sodium p-nitrophenolate, which is the main component in the current authorised sodium nitrocompounds formulations, is also the most sensitive component in analysis; the sensitivity of the available method to sodium o-nitrophenolate is limited. Therefore, assuming that the proportions of the three compounds are always the same in the authorised formulations, EURL proposed to restrict the monitoring residue definition to sodium p-nitrophenolate only. EFSA acknowledges that this proposal might have an interest in order to simplify the monitoring of sodium nitrocompounds residues. Moreover, as all MRLs are derived at the LOQ levels (see section 1.2.1), using a conversion factor of 3 for enforcement to risk assessment would result in the same outcome regarding the risk assessment. However, it is highlighted that this monitoring residue definition would not be sufficient if new formulations with different proportions of the three compounds would be authorised in the future, especially if sodium 5-nitroguaiacolate and sodium o-nitrophenolate would be used without sodium p-nitrophenolate. Therefore, taking all these elements into account, EFSA favours the initial residue definition proposed but the proposal from EURLs may still be considered as a second option for risk managers Magnitude of residues in plants Magnitude of residues in primary crops To assess the magnitude of sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate residues resulting from the reported GAPs, EFSA considered all residue trials reported by the RMS in its evaluation report (Greece, 2011). However, in this first evaluation report, the reported residue data were not adequately evaluated and summaries of the studies were not submitted. This was noted by EFSA during the completeness check (EFSA, 2015a) and following this request, an additional evaluation report, containing the residue trials summaries, was submitted by the RMS (Greece, 2015a). Nevertheless, only the southern outdoor and indoor residue trials were evaluated and summarised in this report. Additional reports were also provided by other Member States during the completeness check (Czech Republic, 2015; France, 2015; Hungary, 2015 and Spain, 2015), but none of them contains summaries of the northern outdoor residue data. Therefore, the northern outdoor residue trials reported in this review can only be considered on a tentative basis and an adequate evaluation report for these data is still required. Based on the evaluation report of the RMS (Greece, 2015a), the southern outdoor and indoor residue trials were considered and evaluated by EFSA. For high oil content and dry commodities, the residue trial samples were all stored in compliance with the storage conditions reported in section For high water and high acid content commodities however, 5 out of 15 trials were stored for a period of 5 or 6 months while degradation of sodium o-nitrophenolate was observed after such a period (see section 1.1.5). Nevertheless, as all other trials where the storage period was less than 3 months showed residues levels below LOQ, EFSA is on the opinion all trials can be taken into account. The number of residue trials and extrapolations were evaluated in accordance with the European guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs (European Commission, 2011). As a general issue, it is noted that most of the authorised GAPs are supported by only two (±1) residue trials, which is never compliant with the data requirements. However, in most of the cases, a reduced number of residue trials could be considered acceptable considering that results are below the LOQ and that a no-residues situation is expected in fruit crops, root crops and pulses/oilseeds (see also section 1.1.1). Hence, for most of these crops, provided that the available residue trials will be adequately reported (northern data) in the future, further residue trials should not be required. For 10 EFSA Journal 2015;13(12):4356

11 olives, fruiting vegetables and sugar beet leaves however, additional concerns were identified by EFSA: Table olives and olives for oil production: two residue trials compliant with the southern outdoor GAP are available but, due to the presence of sodium p-nitrophenolate in the control samples, these trials (2 x <0.12 mg/kg) are not deemed sufficient to derive MRL and risk assessment values. In the absence of validated data, 8 residue trials compliant with the southern outdoor GAP are required. Fruiting vegetables (indoor uses): one trial performed on indoor melons shows residues above LOQ for sodium p-nitrophenolate (0.012 mg/kg), resulting in a total residue level of mg/kg. A justification for this discrepancy could not be retrieved. Also considering that the authorised pre-harvest interval (PHI) for fruit crops is only 3 days (while it was 6 days in the metabolism study), it is not possible to conclude on a no-residue situation for the indoor GAPs on fruit crops. Therefore, although the other trials performed on indoor tomatoes (1), peppers (2), cucumbers (2) and melons (1) show residues below LOQ, the available data are not deemed sufficient to derive MRL and risk assessment values from the indoor GAPs. Although MRL and risk assessment values can be derived from the northern and/or southern outdoor GAPs, additional residue trials compliant with the indoor GAPs are required for tomatoes/aubergines (7 trials), peppers (6 trials), cucumbers/courgettes (6 trials) and melons/watermelons (6 trials). Sugar beet leaves: two major unidentified compounds were found in the metabolism study performed on sugar beet tops (see section 1.1.6). Therefore, although the 2 available data show residue below LOQ for parent compounds, it is not possible to conclude on a no-residue situation and to derive MRL and risk assessment values in this crop. Further information on the structure of the unidentified compounds is still required; depending on the outcome of the requested information, further residue trials might be required in the future, in accordance with the nature of residue in sugar beet leaves Magnitude of residues in rotational crops Residues are not expected in rotational crops (see section 1.1.2) Magnitude of residues in processed commodities As quantifiable residues of sodium 5-nitroguaiacolate, sodium o-nitrophenolate, sodium p-nitrophenolate are not expected in the treated food crops, there is no need to investigate the effect of industrial and/or household processing on the magnitude of residues Proposed MRLs Consequently, the number of residue trials is considered sufficient to derive MRL proposals as well as risk assessment values for all commodities under evaluation, except for olives (table and oil) and sugar beet leaves where specific concerns were identified. However, due to the fact that northern residue trials were not evaluated and since analytical methods for monitoring in high acid content commodities, dry commodities and hops (dried) are still required, all MRL proposals other than for tomatoes, aubergines, melons and watermelons are made on tentative basis. 2. Residues in livestock The sodium nitrocompounds are authorised for use on crops that might be fed to livestock. Livestock dietary burdens were therefore calculated for different groups of livestock using the agreed European methodology (European Commission, 1996). In accordance with the proposed residue definition for risk assessment in plant commodities, the dietary burdens were calculated for the sum of sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, expressed as sodium 5-nitroguaiacolate. The input values for all relevant commodities have been selected according to the recommendations of JMPR (FAO, 2009) and are summarised in Appendix C. The dietary burdens calculated for dairy ruminants, meat ruminants and pigs were found to exceed the trigger value of 0.1 mg/kg DM. Therefore, behaviour of residues should normally be assessed in these groups of livestock. However, the following considerations are made by EFSA: 11 EFSA Journal 2015;13(12):4356

12 The dietary burdens are close to the trigger value and are mainly driven by potatoes for which the input value was the combined LOQ of 0.03 mg/kg. According to the metabolism study performed on sugar beet roots, the total residue levels should not exceed mg eq/kg in root crops (when scaling results to the authorised application rate). A no-residue situation has been demonstrated in root crops. This input value is therefore expected to be overly conservative. The other contributors to the livestock dietary burden are apple pomace, cereals and oilseeds for which a no-residue situation was also demonstrated in section 1. For each nitrocompound, residue levels are expected to remain below the LOQ of 0.01* mg/kg. Therefore, the use of the combined LOQ of 0.03 mg/kg for these commodities (and of 0.06 mg/kg for wheat straw) is also expected to overestimate the calculations. Consequently, EFSA is of the opinion that MRLs for nitrocompounds in animal commodities are currently not required. Nevertheless, it is highlighted that this conclusion does not take into consideration the possible intake of sugar beet leaves for which uncertainties on the nature and magnitude of residues were identified in section 1. Therefore, when authorising a GAP on sugar beet, Member States are recommended to recalculate the dietary burden following submission of the missing data for sugar beet leaves and re-assess the need to establish MRLs in livestock commodities. 3. Consumer risk assessment Chronic and acute exposure calculations for all crops reported in the framework of this review were performed using revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo) (EFSA, 2007). Input values for the exposure calculations were derived in compliance with the decision tree reported in Appendix D. Hence, for those commodities where a MRL could be derived by EFSA in the framework of this review, input values were derived according to the internationally agreed methodologies (FAO, 2009). For olives (table and oil), the available data were insufficient to derive MRLs and risk assessment values. For these commodities, the existing EU MRLs should normally be considered for an indicative calculation. It is noted that currently the default MRL of 0.01 mg/kg applies for each nitrocompound individually. EFSA therefore considered 3 times the default MRL as an input value for indicative risk assessment. All input values included in the exposure calculations are summarised in Appendix C. The exposures calculated were compared with the toxicological reference values for sodium nitrocompounds, derived by EFSA (2008) under Directive 91/414/EEC. The highest chronic exposure was calculated for British toddler, representing 35% of the ADI, and the highest acute exposure was calculated for potatoes, representing 10.3% of the ARfD. Although major uncertainties remain due to the data gaps identified in the previous sections, this indicative exposure calculation did not indicate a risk to consumers. Conclusions The metabolism of sodium nitrocompounds (sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate) has been investigated for foliar treatment in fruit crops, root crops and pulses/oilseeds. These compounds are always used in co-formulation and they do not degrade into significant metabolites in edible part of the investigated crops. As DT 90 values of sodium nitrocompounds are all expected to be well below the trigger value of 100 days, investigation of residues in rotational crops was not required. Furthermore, as quantifiable residues of sodium nitrocompounds are not expected in the treated food crops, there is also no need to investigate the effect of industrial and/or household processing on the nature of residues. Considering that these three compounds share the same toxicological reference values, EFSA proposed a common residue definition for monitoring and risk assessment being the sum of sodium 5-nitroguaiacolate, sodium o- nitrophenolate and sodium p-nitrophenolate, expressed as sodium 5-nitroguaicolate. A validated analytical method for the monitoring of the proposed residue definition is available for high water content and high oil content commodities but is missing for commodities with high acid content commodities, dry commodities and hops (dried). Due to uncertainties observed in sugar beet leaves where two significant metabolites remain unidentified, the proposed residue definition is tentative for sugar beet leaves EFSA Journal 2015;13(12):4356

13 Southern outdoor and indoor trials were adequately evaluated by the RMS but it was not the case for the northern residue trials which were therefore considered on a tentative basis only. The number of residue trials was considered sufficient to derive MRL proposals as well as risk assessment values for all commodities under evaluation, except for olives (table and oil) and sugar beet leaves where specific concerns were identified. However, due to the fact that northern residue trials were not evaluated and since analytical methods for monitoring in high acid content commodities, dry commodities and hops (dried) are still required, all MRL proposals other than for tomatoes, aubergines, melons and watermelons are made on tentative basis. The dietary burdens calculated for dairy ruminants, meat ruminants and pigs were found to exceed the trigger value of 0.1 mg/kg DM. However, the calculated dietary burdens were close to the trigger value of 0.1 mg/kg DM and may have been overestimated because of the use of the combined LOQ of 0.03* mg/kg as an input value for crops where a no-residue situation was demonstrated. Consequently, EFSA concluded that MRLs for nitrocompounds in animal commodities were not required. However, it is highlighted that this conclusion does not take into consideration the possible intake of sugar beet leaves for which uncertainties on the nature and magnitude of residues were identified. Therefore, Member States will need to pay attention to this issue when authorising a GAP on sugar beet. 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 3 times the default MRL (which is currently defined by the legislation for each nitrocompound) as an input value for individual risk assessment. The highest chronic exposure represented 35% of the ADI (UK toddler) and the highest acute exposure amounted to 10.3% of the ARfD (potatoes). Recommendations MRL recommendations were derived in compliance with the decision tree reported in Appendix D of the reasoned opinion (see summary table). All MRL values listed as Recommended in the table are sufficiently supported by data and are therefore proposed for inclusion in Annex II to the Regulation. The remaining MRL values listed in the table are not recommended for inclusion in Annex II because they require further consideration by risk managers (see summary table footnotes for details). In particular, tentative MRLs and existing EU MRLs need to be confirmed by the following data: a validated analytical method for monitoring in high acid content commodities, dry commodities and hops (dried); a detailed evaluation of all northern residue trials reported by the RMS in this review; additional residue trials supporting authorisations on olives (table and oil). Furthermore, it is highlighted that MRLs derived for fruiting vegetable results from the outdoor GAPs while the indoor GAPs were not sufficiently supported by data. Furthermore, although MRLs are currently not derived for feed items, concerns were identified regarding the nature and magnitude of residues in sugar beet leaves. EFSA therefore identified the following data gaps which are not expected to impact on the validity of the MRLs derived but which might have an impact on national authorisations: additional residue trials supporting indoor authorisations on tomatoes, peppers, aubergines, cucumbers, courgettes, melons and watermelons; identification of the significant metabolites observed in sugar beet leaves; additional residue trials supporting authorisations on sugar beet leaves (in accordance with the nature of residues which should be elucidated in sugar beet leaves). If the above reported data gaps are not addressed in the future, Member States are recommended to withdraw or modify the relevant authorisations at national level. When authorising a GAP on sugar beet, Member States are in any case recommended to recalculate the dietary burden following the submission of the missing data on sugar beet leaves and re-assess the need to establish MRLs in livestock commodities EFSA Journal 2015;13(12):4356

14 It is also highlighted that the MRL values listed in the table below are derived for the sum of sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, expressed as sodium 5- nitroguaiacolate, according to the monitoring residue definition proposed by EFSA. Nevertheless, EURLs proposed to establish MRLs for sodium p-nitrophenolate only; this option would facilitate the burden of enforcement laboratories as the sensitivity of the analytical methods for this compound is better. As all MRLs are now derived at the combined LOQ of 0.03 mg/kg (sum of three LOQs), the MRL proposals under this second option would be at the LOQ of 0.01 mg/kg and, using a conversion factor of 3 for enforcement to risk assessment, the outcome regarding the risk assessment would not be affected. However, it is highlighted by EFSA that this second option may not be appropriate if new formulations with different proportions of the three compounds would be authorised in the future, especially if sodium 5-nitroguaiacolate and sodium o-nitrophenolate would be used without sodium p- nitrophenolate. Table 1: Summary table Code number Commodity Existing EU MRL MRL Outcome of the review Comment Enforcement residue definition (existing): None Enforcement residue definition (proposed): sum of sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, expressed as sodium 5-nitroguaiacolate Apples * Further consideration needed (a) Cherries * Further consideration needed (a) Table grapes * Further consideration needed (a) Wine grapes * Further consideration needed (a) Strawberries * Further consideration needed (a) Raspberries * Further consideration needed (a) Currants (red, black and * Further consideration needed (a) white) Table olives * Further consideration needed (b) Potatoes * Further consideration needed (a) Carrots * Further consideration needed (a) Onions * Further consideration needed (a) Tomatoes * Recommended (c) Peppers * Further consideration needed (a) Aubergines (egg plants) * Recommended (c) Cucumbers * Further consideration needed (a) Courgettes * Further consideration needed (a) Melons * Recommended (c) Watermelons * Recommended (c) Poppy seed * Further consideration needed (a) Sunflower seed * Further consideration needed (a) Rape seed * Further consideration needed (a) Olives for oil production * Further consideration needed (b) Maize grain * Further consideration needed (a) Rice grain * Further consideration needed (a) Wheat grain * Further consideration needed (a) Hops (dried) * Further consideration needed (a) Sugar beet (root) * Further consideration needed (a) - Other commodities of plant or animal origin - - Further consideration needed (d) (*): Indicates that the MRL is set at the limit of quantification. (a): Tentative MRL is derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk to consumers was identified; no CXL is available (combination E-I in Appendix D). (b): GAP evaluated at EU level is not supported by data but no risk to consumers was identified for the existing EU MRL (as the default MRL currently applies for each nitrocompound individually, EFSA considered 3 times the default MRL); no CXL (c): is available (combination C-I in Appendix D). MRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to consumers is identified; no CXL is available (combination G-I in Appendix D). (d): There are no relevant authorisations or import tolerances reported at EU level; no CXL is available. Either a specific LOQ or the default MRL of 0.01 mg/kg may be considered (combination A-I in Appendix D) EFSA Journal 2015;13(12):4356

15 References Czech Republic, Evaluation report prepared under Article 12 of Regulation (EC) No 396/2005. Authorised uses to be considered for the review of the existing EU MRLs for sodium 5- nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate, August Available online: EFSA (European Food Safety Authority), Reasoned opinion on the potential chronic and acute risk to consumers health arising from proposed temporary EU MRLs. The EFSA Journal 2007, 32r, doi: /j.efsa r EFSA (European Food Safety Authority), Conclusion on the peer review of the pesticide risk assessment of the active substance sodium 5-nitroguaiacolate, sodium o-nitrophenolate and sodium p-nitrophenolate. EFSA Scientific Report (2008) 191, EFSA (European Food Safety Authority), 2015a. Completeness check report on the review of the existing MRLs of active substance prepared by EFSA in the framework of Article 12 of Regulation (EC) No 396/2005, 12 October Available online: EFSA (European Food Safety Authority), 2015b. Member States consultation report on the review of the existing MRLs of active substance prepared by EFSA in the framework of Article 12 of Regulation (EC) No 396/2005, 24 November Available online: European Commission, Appendix G. Livestock Feeding Studies. 7031/VI/95 rev.4, 22 July European Commission, 1997a. Appendix A. Metabolism and distribution in plants. 7028/IV/95-rev., 22 July European Commission, 1997b. Appendix B. General recommendations for the design, preparation and realization of residue trials. Annex 2. Classification of (minor) crops not listed in the Appendix of Council Directive 90/642/EEC. 7029/VI/95-rev.6, 22 July European Commission, 1997c. Appendix C. Testing of plant protection products in rotational crops. 7524/VI/95-rev.2, 22 July European Commission, 1997d. Appendix E. Processing studies. 7035/VI/95-rev.5, 22 July European Commission, 1997e. Appendix F. Metabolism and distribution in domestic animals. 7030/VI/95-rev.3, 22 July European Commission, 1997f. Appendix H. Storage stability of residue samples. 7032/VI/95-rev.5, 22 July European Commission, 1997g. Appendix I. Calculation of maximum residue level and safety intervals.7039/vi/95 22 July As amended by the document: classes to be used for the setting of EU pesticide maximum residue levels (MRLs). SANCO 10634/2010, finalised in the Standing Committee on the Food Chain and Animal Health at its meeting of March European Commission, Residue analytical methods. For pre-registration data requirement for Annex II (part A, section 4) and Annex III (part A, section 5 of Directive 91/414. SANCO/3029/99- rev.4. European Commission, 2010a. Classes to be used for the setting of EU pesticide Maximum Residue Levels (MRLs). SANCO 10634/2010 Rev. 0, Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting of March European Commission, 2010b. Residue analytical methods. For post-registration control. SANCO/825/00-rev.8.1, 16 November European Commission, Appendix D. Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs. 7525/VI/95-rev.9, March Greece, Draft assessment report on the active substance sodium 5-nitroguaiacolate, sodium o- nitrophenolate and sodium p-nitrophenolate, prepared by the rapporteur Member State Greece in the framework of Council Directive 91/414/EEC, September Available online: EFSA Journal 2015;13(12):4356

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