Review of the existing maximum residue levels for chloridazon according to Article 12 of Regulation (EC) No 396/2005

Transcription

1 REASONED OPINION APPROVED: 28 August 2015 PUBLISHED: 03 September 2015 doi: /j.efsa Review of the existing maximum residue levels for chloridazon 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 substance chloridazon. In order to assess the occurrence of chloridazon 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 found to be missing. Hence, the consumer risk assessment is considered indicative only and almost all MRL proposals derived by EFSA still require further consideration by risk managers. European Food Safety Authority, 2015 Keywords: chloridazon, MRL review, Regulation (EC) No 396/2005, consumer risk assessment, pyridazinone, herbicide, 5-amino-4-chloro-3(2H)-pyridazinone Requestor: European Commission Question number: EFSA-Q Correspondence: pesticides.mrl@efsa.europa.eu EFSA Journal 2015;13(9):4226

2 Acknowledgement: EFSA wishes to thank the rapporteur Member State, Germany, 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 chloridazon according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2015;13(9):4226, 52 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(9):4226

3 Summary Chloridazon was included in Annex I to Directive 91/414/EEC on 1 January 2009 by Commission Directive 2008/41/EC, and has been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011. As the active substance was approved after the entry into force of Regulation (EC) No 396/2005 on 2 September 2008, EFSA is required to provide a reasoned opinion on the review of the existing MRLs for that active substance in compliance with Article 12(1) of the aforementioned regulation. In order to collect the relevant pesticide residues data, EFSA asked Germany, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile) and to prepare a supporting evaluation report. The PROFile and evaluation report provided by the RMS were made available to the Member States. A request for additional information was addressed to the Member States in the framework of a completeness check period which was initiated by EFSA on 22 December 2014 and finalised on 23 February After having considered all the information provided, EFSA prepared a completeness check report which was made available to Member States on 26 March 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 June 2015 a draft reasoned opinion, which was circulated to Member States for consultation via a written procedure. Comments received by 30 June 2015 were considered during the finalisation of this reasoned opinion. The following conclusions are derived. The metabolism of chloridazon has been investigated in primary crops (sugar beet) and rotational crops (leafy, roots and cereals). Similar metabolic patterns were observed in these studies. Moreover, hydrolysis studies demonstrated that chloridazon and its main metabolite chloridazon-desphenyl (also called metabolite B) were stable under processing by pasteurisation, baking/brewing/boiling and sterilisation. Consequently, the residue definition for monitoring is proposed as the sum of chloridazon and chloridazon-desphenyl, expressed as chloridazon. A validated analytical method for enforcement of the proposed residue definition in plant commodities is available. The risk assessment residue definition was proposed as the sum of chloridazon, chloridazon-desphenyl, and their conjugates, expressed as chloridazon. These residue definitions cover all the authorised GAPs reported in this review (root and leafy crops) but would not be applicable to other crop groups. The available residue trials allowed EFSA assessing the magnitude of residues resulting from the authorised GAPs reported in this review. However, results of field rotational crops studies indicated that a significant uptake of residues in leafy crops and in wheat straw cannot be avoided. For these crops, EFSA therefore assessed the impact of proposing 3 different plant-back intervals. For all leafy crops that can be grown in rotation (even when GAPs are not authorised), different MRL proposals were derived depending on the plant-back interval, while for roots crops the MRLs derived from the primary crop use always cover the negligible uptake from rotational crops. However, all the MRL proposals other than sugar beet roots were derived on a tentative basis due to uncertainties regarding residues levels in primary crops and rotational crops. Based on available data on sugar beet and red beet (roots and tops), tentative conversion factors were derived for root and leafy crops. Furthermore, residue transfer from sugar beet to white sugar has also been investigated, indicating that transfer from raw sugar beet to white sugar does not occur. Chloridazon is authorised for use on sugar and fodder beets that might be fed to livestock. The metabolism of chloridazon and chloridazon-desphenyl was investigated separately, both in goats and laying hens. As metabolic pathways are expected to be similar in ruminants and pigs, the results of the goat metabolism study could be extrapolated to swine. From these studies, it was agreed that chloridazon-desphenyl was the only relevant compound in livestock commodities. The presence of chloridazon is not expected in livestock commodities. Therefore, EFSA proposed to proceed with a common residue definition for monitoring and risk assessment being chloridazon-desphenyl, expressed as chloridazon. A validated analytical method for enforcement of the proposed residue definition is available. In the absence of a reliable feeding study for ruminants, EFSA considered the results of the metabolism studies to derive MRLs and risk assessment values in livestock commodities. Different calculations were performed according to the respective dietary burdens resulting from the 3 different risk mitigation options. 3 EFSA Journal 2015;13(9):4226

4 Chronic consumer exposure resulting from this assessment was calculated using revision 2 of the EFSA PRIMo. These calculations included residues from the authorised GAP reported in this review and the potential uptake of chloridazon residues in crops that may be grown in rotation. EFSA evaluated the 3 different scenarios corresponding to the 3 proposed risk mitigation options. The highest chronic exposure was calculated for British toddler, representing 7.2 % of the ADI in scenario 1 (PBI 30 days), 6.1 % of the ADI in scenario 2 (PBI 120 days) and 6.4 % of the ADI in scenario 3 (PBI 365 days). Acute exposure calculations were not carried out because an ARfD was not deemed necessary for this active substance. 4 EFSA Journal 2015;13(9):4226

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 Nature of residues in livestock and methods of analysis in livestock Magnitude of 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) Appendix F Comparison of residue levels from primary and rotational crop data EFSA Journal 2015;13(9):4226

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 chloridazon was included in Annex I to Council Directive 91/414/EEC on 1 January 2009 by means of Commission Directive 2008/41/EC, 3 and has 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 that active substance. According to the legal provisions, EFSA shall base its reasoned opinion in particular on the relevant assessment report prepared under Directive 91/414/EEC. It should be noted, however, that in the framework of Directive 91/414/EEC only a few representative uses are evaluated, 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. Germany, the designated rapporteur Member State (RMS) in the framework of Directive 91/414/EEC, was asked to complete the PROFile for chloridazon and to prepare a supporting evaluation report (Germany, 2014). The PROFile and the supporting evaluation report were submitted to EFSA on 21 July 2014 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 22 December 2014 and finalised on 23 February Additional evaluation reports were submitted by Belgium, Germany, France and United Kingdom (Belgium, 2015; Germany, 2015; France, 2015; United Kingdom, 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 26 March Further clarifications were sought from Member States via a written procedure in March-April 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 June 2015 a draft reasoned 1 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/ Commission Directive 2008/41/EC of 31 March 2008 amending Council Directive 91/414/EEC to include chloridazon as active substance. OJ L 89, , 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(9):4226

7 opinion, which was submitted to Member States for commenting via a written procedure. All comments received by 30 June 2015 were considered by EFSA during the finalisation of the reasoned opinion. The evaluation report submitted by the RMS (Germany, 2014), and the evaluation reports submitted by Member States Belgium, Germany, France, United Kingdom (Belgium, 2015; Germany, 2015; France, 2015; United Kingdom, 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. Also the chronic 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. 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. 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 Chloridazon is the ISO common name for 5-amino-4-chloro-2-phenylpyridazin-3(2H)-one (IUPAC). Chloridazon belongs to the group of pyridazinone compounds. It acts as systemic soil and leaf herbicide by inhibiting the photosynthesis. The chemical structure of the active substance and its main metabolites are reported in Appendix E. Chloridazon was evaluated in the framework of Directive 91/414/EEC with Germany designated as rapporteur Member State (RMS). The representative uses supported for the peer review process were pre- and early post- emergence applications on beta beet (sugar and fodder beets, red beets and chard), onion, shallot, garlic and flowers, both in northern and southern Europe. Following the peer review, which was carried out by EFSA, a decision on inclusion of the active substance in Annex I to Directive 91/414/EEC was published by means of Commission Directive 2008/41/EC, which entered into force on 1 January According to Regulation (EU) No 540/2011, chloridazon is deemed to have been approved under Regulation (EC) No 1107/2009. This approval is restricted to uses as herbicide only. Furthermore, a restriction limiting the maximal application rate at 2.6 kg a.s./ha in a 3 year period, was set in order to prevent the leaching of chloridazon metabolites to groundwater. The EU MRLs for chloridazon are established in Annexes IIIA of Regulation (EC) No 396/2005 and CXLs for chloridazon are not available. For the purpose of this MRL review, the critical uses of chloridazon 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 chloridazon 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. 7 EFSA Journal 2015;13(9):4226

8 Assessment EFSA has based its assessment on the PROFile submitted by the RMS, the evaluation report accompanying the PROFile (Germany, 2014), the draft assessment report (DAR) and its addenda prepared under Council Directive 91/414/EEC (Germany, 2005, 2007), the conclusion on the peer review of the pesticide risk assessment of the active substance chloridazon (EFSA, 2007b), as well as the evaluation reports submitted during the completeness check (Belgium, 2015; Germany, 2015; France, 2015; United Kingdom, 2015). 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, 1997 a-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 chloridazon has been investigated on sugar beet with pre- or post-emergence application (EFSA, 2007b). The parent compound, the soil metabolite chloridazon-desphenyl resulting from the loss of the phenyl-ring (also called metabolite B - see Appendix E), and conjugates of both substances (including metabolite A see Appendix E) were identified as main constituents of the TRR in roots and leaves. The ratio of these compounds varies according to the stage of application of the product and the crop part (root or leaves). After post-emergence application at the relevant growth stage, metabolism data in roots indicate a high contribution of conjugates of chloridazon-desphenyl to the total residue (about 40 % of the TRR). Minor parts of the TRR were incorporated in starch, cellulose, lignin and protein. A primary crop metabolism study for leafy crops is not available but, as agreed during the peer review, the results of the confined rotational crops study performed with beet leaves (chard; see below) are applicable to cover the soil treatments on leafy crops. All GAPs on leafy crops that were reported in the present review correspond to soil treatment and are therefore deemed covered by these studies. However, if a GAP for foliar treatment in leafy crops would be evaluated in the future, the need for a metabolism study covering this kind of treatment might be required Nature of residues in rotational crops A confined rotational crop study using sorghum, wheat, oats, radish, sugar beets and chard planted in soil treated with chloridazon was assessed during the peer review (EFSA, 2007b). It indicated a clear potential for residues in succeeding crops, resulting from soil uptake of the active substance and its degradation products (chloridazon-desphenyl in particular). As in primary crops, the major constituents of the residue were the parent compound and the soil metabolite chloridazon-desphenyl. In most cases chloridazon-desphenyl was present at clearly higher level than chloridazon and analysis indicated that it was mainly present as its free form. Nevertheless, the absence of conjugates in this analysis should be balanced by the fact that the conditions of extraction applied in this study (using subsequent Soxhlet extractions) may have been severe enough to release the free forms of the conjugates. It is also noted that the conditions of extractions used in the primary crop metabolism studies were significantly softer (simply using methanol), which is not expected to hydrolyse the conjugates. Therefore, the occurrence of conjugates in primary and rotational crops is expected to be similar. Another major metabolite was tentatively identified as an analogue of chloridazon-desphenyl, and two other metabolites (p-oh-chloridazon - see Appendix E; and one unidentified metabolite) were 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(9):4226

9 present in lower amounts. Consequently, the metabolic patterns observed in primary crops and rotational crops were found to be similar Nature of residues in processed commodities The effect of processing on the nature of residues was investigated in the framework of the peer review (EFSA, 2007b). Studies were conducted, for chloridazon and chloridazon-desphenyl separately, 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). From these studies, it was concluded that processing by pasteurisation, baking/brewing/boiling and sterilisation is not expected to have a significant impact on the composition of residues in matrices of plant origin Methods of analysis in plants During the peer review, analytical methods using LC-MS/MS were validated for the determination of chloridazon and chloridazon-desphenyl in the four main crop groups with an LOQ of 0.05 mg/kg for each compound. These methods, supported by ILV and confirmatory methods, were evaluated for both compounds and found acceptable (EFSA, 2007b). These methods use simple extractions with methanol and are therefore not expected to hydrolyse the conjugates of the above mentioned compounds. Hence, it is concluded that chloridazon and chloridazon-desphenyl can be enforced separately with an LOQ of 0.05 mg/kg, resulting in a combined LOQ of 0.1 mg/kg. This conclusion is valid for the four main crop groups Stability of residues in plants In the framework of the peer review, storage stability of the sum of chloridazon (including its conjugates) and chloridazon-desphenyl (without its conjugates) was demonstrated for a period of 24 months at -18 C in commodities with high water content (sugar beet roots and tops) (EFSA, 2007b). This study does not cover the stability of the conjugates of chloridazon-desphenyl which are major constituent of the residues. However, it is assumed that any conjugates of chloridazondesphenyl are expected to be hydrolysed into chloridazon-desphenyl. A residue definition including chloridazon-desphenyl together with its conjugates would cover this potential degradation but is not possible for monitoring purpose. As the degradation of the conjugates of chloridazon-desphenyl into their free form during storage may result in an overestimation when analysing chloridazon-desphenyl levels, further data on the stability of conjugates of chloridazon-desphenyl are still deemed desirable (minor deficiency) Proposed residue definitions During the peer review, chloridazon-desphenyl was considered to be of comparable toxicity to the parent compound and the same is concluded for its conjugates (EFSA, 2007b). Therefore, based on the available data, it was agreed to propose a residue definition for monitoring as the sum of chloridazon and chloridazon-desphenyl, expressed as chloridazon. A validated analytical method for enforcement of the proposed residue definition in plant commodities is available. For risk assessment, the residue definition should also include the conjugates of these compounds. Therefore, the risk assessment residue definition was proposed as the sum of chloridazon, chloridazon-desphenyl, and their conjugates, expressed as chloridazon. It is noted that this residue definition would cover the potential degradation of the conjugates of chloridazon-desphenyl into their free form during storage. Therefore, the minor deficiency identified for the stability of conjugates of chloridazon-desphenyl (see section 1.1.5) is not expected to have an impact on the overall residue levels analysed for risk assessment. Considering that only two different crop groups (roots and tubers and leafy crops) are covered by metabolism studies (only for soil treatment in leafy crops), it is not possible to set a global residue definition covering all plant commodities. The proposed residue definitions should apply only to root crops (pre- or post-emergence application) and leafy crops (soil treatment only). 9 EFSA Journal 2015;13(9):4226

10 1.2. Magnitude of residues in plants Magnitude of residues in primary crops To assess the magnitude of chloridazon residues resulting from the reported GAPs, EFSA considered all residue trials reported by the RMS in its evaluation report (Germany, 2014), including residue trials evaluated in the framework of the peer review (Germany, 2005, 2007) and additional data submitted during the completeness check (Belgium, 2015; Germany, 2015; France, 2015; United Kingdom, 2015). All residue trial samples considered in this framework were stored in compliance with the demonstrated storage conditions. Decline of residues during storage of the trial samples is therefore not expected. 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). The southern residue trials available on sugar beet allowed EFSA to derive appropriate MRLs and risk assessment values for sugar and fodder beet (roots and tops). Moreover, together with southern trials performed on red beet (which are not reported in Appendix B1.2.1 because southern GAP on red beet is not authorised), these data allowed EFSA to derive conversion factors for roots (CF=1.7) and tops (CF=1.7). These CF are deemed applicable for both southern and northern GAPs on sugar and fodder beet as well as for the northern GAP on beetroot. For sugar and fodder beet roots, the lack of data for the risk assessment residue definition in the northern zone is therefore considered as a minor deficiency and the following minor data gap is identified: Sugar and fodder beets (roots and tops): 8 trials compliant with the northern GAP and analysing simultaneously for monitoring and risk assessment residue definitions are desirable. For beetroots, the lack of data for the risk assessment residue definition should also be considered as a minor deficiency. However, it is also noted that the number of trials supporting the northern GAP is not compliant with the data requirement for this crop (6 trials instead of 8). Therefore, a major data gap is identified for this crop: Beetroots: 2 trials compliant with the northern GAP and analysing simultaneously for monitoring and risk assessment residue definitions are required. This data gap is assumed to cover the minor deficiency discussed above. For all other GAPs reported in this review, residue trials analysing simultaneously the residues definitions for monitoring and risk assessment are not available. Therefore, EFSA is not able to derive conversion factors for most of the crops under evaluation. Consequently, complete data sets of residue trials analysing simultaneously for monitoring and risk assessment residue definitions are still required for all crops other than sugar beet, fodder beet and beetroots; the overall list of the data requirements is reported here: Horseradish: 4 trials compliant with the northern GAP are required. Onions: 8 trials compliant with the northern GAP are required. Garlic and shallot: two different GAPs were reported by United Kingdom (1x0.91 kg as/ha; at BBCH 12) and Belgium (3x0.26 kg as/ha; at BBCH 12-19) but the available trials are not compliant with any of these GAPs. For the first GAP, United Kingdom (2015) proposed to scale the available trial results (performed at 2.6 kg a.s./ha) to the application rate that is currently authorised, using the proportionality approach. This proposal was considered acceptable by EFSA. It is however not possible to apply this principle for the Belgian GAP. In any case, considering that simultaneous analysis for monitoring and risk assessment residue definitions are missing, 4 residue trials compliant with the British GAP and 4 residue trials compliant with the Belgian GAP are still required EFSA Journal 2015;13(9):4226

11 Spinach, leaves and sprouts of Brassica spp, fresh herbs: 4 trials compliant with the northern GAP (all crops) and 4 trials compliant with the southern GAP (only spinach) are required. For spinach, a more critical northern GAP was also reported by Sweden (1x1.95 kg as/ha; at BBCH 00) but the available data cannot support this GAP. Therefore, 4 residue trials compliant with the Swedish GAP are also required. Beet leaves (chard): 4 residue trials compliant with the northern GAP are required. In the absence of such data, the CF derived from sugar beet and beetroots (roots and tops) was tentatively extrapolated to the groups of root and leafy crops. It is also noted that the available data for the monitoring residue definition were also deemed insufficient for horseradish (tentative extrapolation from sugar beet root not foreseen by the current guidance) and beet leaves (chard) (tentative extrapolation from trials not compliant with GAP). However, these deficiencies should be covered by the overall data requirements reported above Magnitude of residues in rotational crops From the results of the confined rotational crop study, the peer review already concluded that residues above LOQ in the succeeding crops may occur. The potential uptake of residues was also confirmed by the results of a field rotational crop study performed in the US, with a tested rate of 8.5 kg a.s./ha and a pre-planting intervals of 360 days (EFSA, 2007b). However, due to the overdosing factor of 3 compared to the critical authorised GAPs reported in this review, the results of this study are not further considered to assess the magnitude of residues in rotational crops. Two European field studies on the magnitude of residues in rotational crop were also evaluated by the RMS, the first one in the addendum to the DAR (Germany, 2007), and the second one in the framework of the present MRL review (Germany, 2014). These studies reflect the current critical dose rate of 2.6 kg a.s./ha, applied on bare soil. The application to bare soil is not considered overly conservative because the authorised GAPs are soil, or early post-emergence applications. Interception of residues by the primary crop is therefore negligible. The first study focuses on the plant back interval (PBI) of 30 days while the second one covers the plant back intervals of 120 and 365 days. Representative crops for leafy vegetables (spinach, lettuce, and cauliflower), roots vegetables (carrots) and cereals (wheat) were planted/sown on aged soils. At harvest, crop samples were analysed for chloridazon and chloridazon-desphenyl in the first study, or for total residues corresponding to the risk assessment residue definition (sum of chloridazon, chloridazon-desphenyl and their conjugates, expressed as chloridazon) in the second study. These studies show no significant residues uptake in cereal grain, roots crops and cauliflower. However, significant residue levels were observed in spinach leaves and lettuce (at all PBI). Residues levels in spinach leaves decrease with longer plant-back intervals, from 2.47 mg eq/kg (max at 30 DAT), to 0.95 mg eq/kg (max at 120 DAT), to 0.63 mg eq/kg (max at 365 DAT). However, these results also demonstrate that a plant-back interval of 365 DAT would in any case not prevent from significant uptake of residues in leafy crops grown in rotation. In wheat straw, significant uptake was also observed when planted 30 DAT (1.03 mg/kg) but data for longer PBI are not available. An overview of these results is reported in Table 1. These results give a clear indication of a potential residue uptake in leafy crops and cereals straw, which is significant even with a PBI of 365 DAT. Therefore, it is not possible to propose a risk mitigation measure sufficiently protective to avoid residues uptake in these crops and the available data should be considered when proposing MRLs (see section 1.2.4). However, these data are subject to several limitations which were highlighted by EFSA: In the available rotational crop field studies, analysis were performed either for the enforcement residue definition (PBI of 30 DAT) or for the risk assessment residue definition (PBI of 120 and 365 DAT), but never for both simultaneously. As there are indications that conjugates of chloridazon-desphenyl might be significant constituents of the residues in rotational crops (see section 1.1.2), it is assumed that residue data for plant-back interval of 120 and 365 DAT may overestimate the STMR Mo, HR Mo and calculated MRLs in succeeding crops. Moreover, EFSA is not able to derive robust conversion factor from enforcement to risk assessment in rotational crops. Therefore, additional data including simultaneous analysis for 11 EFSA Journal 2015;13(9):4226

12 monitoring and risk assessment residue definitions are required in order to have an accurate view on the residue levels in succeeding crops. Meanwhile, EFSA considered the available results for PBI 30, 120 and 365 days to derive STMR Mo, HR Mo and MRLs in rotational crops, acknowledging that they might be overestimated for PBI 120 and 365 days. The conversion factor from enforcement to risk assessment derived from primary crops studies (see section 1.2.1) can be applied on a tentative basis, although overly protective for PBI 120 and 365 days. Leafy crops (other than brassica vegetables): residue data on spinach leaves show higher residues levels than in lettuce. Therefore, the assessment for leafy crops should be based on the spinach data. Nevertheless, EFSA is of the opinion that the number of rotational crop field trials (4 trials available for each PBI) is not sufficient to derive robust MRL and risk assessment values for the whole group of leafy vegetables (which includes a large number of crops). Also considering the uncertainty regarding the occurrence of conjugates in rotational crops (see bullet point above), it is the opinion of EFSA that at least 4 additional rotational field trials on spinach leaves should be required. However, as a specific guidance on this matter is not yet available, it is highlighted that this data gap, reflecting the view of EFSA, still needs further consideration by risk managers. During the Member States consultation, the United Kingdom has reported a different view, meaning that the available data was set sufficient to assess the residue in leafy crops. Cereals straw: residue data are only available for the plant-back interval of 30 DAT. The residues uptake observed at this PBI is significant and is expected to impact on the livestock dietary burden (see also section 2). Although MRLs are not currently set for feed commodities, EFSA is of the opinion that additional data are still necessary to properly assess the residues uptake in cereals straw at longer PBI. This would allow a better assessment of the impact of different plant-back intervals on the residue levels in livestock commodities. Pulses/oilseeds and fruit crops: there are also crops that might be grown in rotation in these groups. However, in the absence of specific data on succeeding crops for these items, EFSA is not able to assess the potential uptake in succeeding crops at the different PBI. Based on the results observed in cereals grains, significant residues uptake is not expected in pulses and oilseeds grains and only few fruit crops might be grown in rotation (strawberries, tomatoes, peppers, aubergines and okras). Therefore, significant impact on the final outcome of the risk assessment is not expected. Nevertheless, the necessity to properly assess the residue levels in these crops remain an important issue which should be addressed by means of additional rotational crops data for pulses/oilseeds and fruits. EFSA is on the opinion that the deficiencies identified above should in principle result as data requirement but, in the absence of guidance on the setting of MRLs in succeeding crops, EFSA is not in position to require this data. Nevertheless, when deciding on a risk mitigation option, risk managers should consider the need for further investigation on this matter (see also section 1.2.4) EFSA Journal 2015;13(9):4226

13 Table 1: Overview of the residues data from the rotational crops field trials Data on DAT (days) Residue levels observed in rotational crops field trials Recommendations /comments (OECD calculations) MRL (a) HR Mo (b) STMR Mo (c) Leafy crops Spinach leaves ; 0.81; 0.92; 2.47 MRL OECD = (t) ; 0.33; 0.37; 0.95 MRL OECD = (t) ; 0.13; 0.20; 0.63 MRL OECD = (t) Lettuce 30 - No data available ; 0.14; 0.18; 0.20 MRL OECD = (t) ; 0.05; 0.14; 0.25 MRL OECD = (t) Cauliflower 30 4 <0.1 Residue levels remain <0.1 <0.1 < ; 0.03; 0.04; 0.04 below the LOQ for monitoring. <0.1 <0.1 < <0.025; 0.03; 0.03 <0.1 <0.1 <0.1 Roots crops Carrots roots 30 4 <0.1 Residue levels remain <0.1 <0.1 < ; 0.03; 0.03; 0.05 below the LOQ for monitoring. <0.1 <0.1 < ; 0.03; 0.04; 0.04 <0.1 <0.1 <0.1 Cereals Wheat grain 30 4 <0.1 Residue levels remain below the LOQ for monitoring. <0.1 <0.1 < No data available No data available Wheat straw ; 0.17; 0.45; 1.03 MRL OECD = (t) No data available No data available * Indicates that the MRL is proposed at the limit of quantification. (a): MRL proposal resulting from rotational crops data (based on the OECD calculator). In trials performed with PBI 120 and 365 DAT, analysis also includes the conjugates, which may overestimate the residues for monitoring. (b): Highest residue observed in the rotational crops field trials for a given PBI. In trials performed with PBI 120 and 365 DAT, analysis also includes the conjugates, which may overestimate the residues for monitoring. (c): Supervised trials median residue observed in the rotational crops field trials for a given PBI. In trials performed with PBI 120 and 365 DAT, analysis also includes the conjugates, which may overestimate the residues for monitoring. (t): Only tentative MRL and risk assessment values could be derived because the data set is deemed insufficient Magnitude of residues in processed commodities Residue transfer from sugar beet to white sugar has been investigated in the framework of the peer review. In this study, neither chloridazon nor chloridazon-desphenyl was quantified at or above the LOQ in white sugar. Although processing factors cannot be derived from this study, it clearly indicates that transfer from raw sugar beet to white sugar does not occur. Further processing studies are not required as they are not expected to affect the outcome of the risk assessment. However, if processing factors were to be required by risk managers, in particular for enforcement purposes, additional processing studies would be needed EFSA Journal 2015;13(9):4226

14 Proposed MRLs Based on the available data, EFSA derived MRLs and risk assessment values, also considering the fact that chloridazon residues uptake in succeeding crops cannot be avoided. It is noted that, due to the restriction set during the peer review, the minimum interval between two consecutive treatments is 3 years. Therefore, the cumulative contamination from residues arising from uptake in succeeding crops and from a new primary treatment is not expected. Taking into account these considerations, EFSA assessed the impact of proposing a minimum plant-back interval of 30 DAT (option 1), 120 DAT (option 2) or 365 DAT (option 3). For all commodities where an authorised GAP was reported by Member States (see section 1.2.1), EFSA performed a rough estimate whether or not the possible uptake of chloridazon residues would exceed the MRL derived from primary crop treatment (comparison made on the highest residue values). If the uptake of residues from rotational crops exceeds the MRL derived from primary treatment, EFSA proposes to raise the MRL based on the rotational crops data. On the opposite, if the uptake of residues is inferior to the MRL derived from primary crop treatment, EFSA keeps the MRL proposal derived from the primary treatment. For all crops that may be grown in rotation but for which GAPs are not authorised, the need for an MRL proposal was estimated on the basis of the results of the rotational crops data. It is noted that, when deriving an MRL proposal from rotational crops data, EFSA uses the OECD calculation as it is done for primary crops. For leafy crops other than brassica vegetables, the most critical case with regard to residues uptake in succeeding crops is spinach leaves. Therefore, results of spinach rotational crops studies were considered for the assessment. For brassica vegetables, root crops and cereals (grain and straw), results in cauliflower, carrots and wheat (grain and straw) were respectively considered for the assessment. This methodology was applied to all leafy crops, roots crops and cereals (grain and straw), for all PBI where data are available (30 DAT, 120 DAT and 365 DAT). Therefore, three different options for risk managers were evaluated. The outcome of this assessment is reported in Appendix F. For all root crops considered in this review (beetroots, horseradish, onions, garlic, shallots, sugar and fodder beet), MRLs derived from the primary crop use are expected to cover the negligible uptake from rotational crops at all plant-back intervals (min 30 DAT). The final MRL proposals were therefore derived from the primary crop use, noting that the data gaps for beetroots, horseradish, onions, garlic and shallots identified in section are still applicable. MRL proposals for these crops therefore remain tentative. This conclusion is valid for the three risk management options evaluated by EFSA. For the leafy crops considered in this review (spinach, leaves and sprouts of brassica spp, fresh herbs, beet leaves, sugar and fodder beet tops), the MRL proposals depend on the risk management option. In any case, additional trials data for the assessment of residues levels in primary crops as well as additional data for rotational crops are needed. Meanwhile, tentative MRL and risk assessment values could be derived for spinach, leaves and sprouts of brassica spp, fresh herbs and beet leaves (chard), sugar and fodder beet tops. For the other annual crops that might be grown in rotation for which data are available, leafy crops and cereals straw are the only commodities where MRL proposals were deemed necessary. However, in the absence of full data sets, only tentative MRL proposals could be derived. In the groups of pulses/oilseeds and fruit crops, there are also annual crops that might be grown in rotation. However, in the absence of specific data on succeeding crops for these items, EFSA was not able to propose MRLs and risk assessment values. Therefore, additional rotational crops data for pulses/oilseeds and fruits should still be required if risk managers intend to set MRLs in these crops. Based on the southern residue trials available on sugar and red beet, conversion factors were derived for roots (CF=1.7) and tops (CF=1.7). These CF are directly applicable to sugar beet, fodder beet and beetroot and are tentatively applied to all other crops considered in this review (root crops and leafy crops) and to cereals straw EFSA Journal 2015;13(9):4226

15 2. Residues in livestock Chloridazon is authorised for use on sugar and fodder beets that might be fed to livestock. Furthermore, livestock may also be exposed to chloridazon residues arising from feed crops grown in rotation. Livestock dietary burdens were therefore calculated for different groups of livestock using the agreed European methodology (European Commission, 1996). As residue levels arising from rotational crops depend on the plant-back interval, EFSA assessed the impact of the 3 different risk mitigation options discussed above: PBI 30 days (option 1), PBI 120 days (option 2), PBI 365 days (option 3). The input values for all relevant commodities, corresponding to each option, have been selected according to the recommendations of JMPR (FAO, 2009) and are summarised in Appendix C1. The conversion factors from enforcement to risk assessment, derived in section 1.2.1, were also considered. Regardless of the plant-back interval, the calculated dietary burdens for all groups of livestock were found to exceed the trigger value of 0.1 mg/kg DM. Behaviour of residues was therefore assessed in all commodities of animal origin Nature of residues in livestock and methods of analysis in livestock The metabolism of chloridazon and chloridazon-desphenyl (also called metabolite B see Appendix E) was investigated separately, both in goats and laying hens (Germany, 2005, 2007). Two main metabolic pathways were observed for chloridazon and consisted in dechlorination of the parent compound and hydroxylation of the phenyl ring, followed by sulphate conjugation. The ratio between the parent compound and its main metabolites (4-OH-chloridazon, its sulphate conjugate and deschloro-chloridazon; see Appendix E) is varying in the different tissues. Chloridazon-desphenyl is not formed from chloridazon in livestock metabolism. The study performed with chloridazon-desphenyl indicates that this compound is not metabolised by livestock and is found unchanged in all tissue, representing more than 95 % of the respective TRR. No accumulation was observed in any species for any compound. During the peer review, it was agreed that the residue intake in livestock is mainly driven by chloridazon-desphenyl (and its conjugates), and to a lower extent by the parent compound (and its conjugates) because of the residue composition found in plant feed items. Therefore, the metabolites observed in the chloridazon study are not expected to be significant constituents of the residues in livestock commodities. Furthermore, these metabolites are not expected to be of higher toxicity than the parent compound. Consequently, it was agreed during the peer review that chloridazon-desphenyl was a sufficient marker for monitoring in livestock commodities. For risk assessment, the residue definition was initially set as the sum of chloridazon and chloridazon-desphenyl, expressed as chloridazon. However, considering that livestock is not significantly exposed to the parent compound and that chloridazondesphenyl remains unchanged when fed to livestock, the presence of chloridazon is not expected in livestock commodities. Therefore, EFSA proposes to proceed with a common residue definition for monitoring and risk assessment being chloridazon-desphenyl, expressed as chloridazon. This residue definition is not fat soluble. An analytical method using LC-MS/MS was validated for the determination of chloridazon-desphenyl with an LOQ of 0.05 mg/kg in muscle, fat, liver, kidney and eggs and 0.01 mg/kg in milk. This method is supported by an ILV and a confirmatory method was evaluated and found acceptable (EFSA, 2007b). This method uses simple extractions with methanol and is therefore not expected to hydrolyse the conjugates of chloridazon-dephenyl. Therefore, the proposed residue definition can be enforced properly in commodities of animal origin Magnitude of residues in livestock During the peer review, the magnitude of chloridazon residues in ruminants was investigated in two different feeding studies with lactating cows (Germany, 2005, 2007). In the first study, animals were fed with chloridazon only. Livestock exposure to chloridazon-desphenyl was addressed in the second study. As residue intake in livestock is mainly driven by chloridazon-desphenyl, this it should in principle be considered to calculate MRLs in ruminant commodities. However, the sensitiveness of the 15 EFSA Journal 2015;13(9):4226