Prioritised review of the existing maximum residue levels for dimethoate and omethoate according to Article 43 of Regulation (EC) No 396/2005

Transcription

1 REASONED OPINION APPROVED: 14 November 2016 doi: /j.efsa Prioritised review of the existing maximum residue levels for dimethoate and omethoate according to Article 43 of Regulation (EC) No 396/2005 European Food Safety Authority (EFSA) Abstract In compliance with Article 43 of Regulation (EC) No 396/2005, EFSA received from the European Commission a mandate to conduct a prioritised review of the existing maximum residue levels (MRL) for dimethoate and omethoate, as a follow up of its statement on the assessment of the risk to human health through the pesticide active substance dimethoate and its metabolites in food. Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, all MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure will also need to be considered European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on belf of European Food Safety Authority. Keywords: dimethoate, omethoate, MRL review, Regulation (EC) No 396/2005, consumer risk assessment, insecticide Requestor: European Commission Question number: EFSA-Q Correspondence: pesticides.mrl@efsa.europa.eu EFSA Journal 2016;14(11):4647

2 Suggested citation: EFSA (European Food Safety Authority), Reasoned opinion on the prioritised review of the existing maximum residue levels for dimethoate and omethoate according to Article 43 of Regulation (EC) No 396/2005. EFSA Journal 2016;14(11):4647, 50 pp. doi: /j.efsa ISSN: European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on belf of European Food Safety Authority. This is an open access article under the terms of the Creative Commons Attribution-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited and no modifications or adaptations are made. The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. 2 EFSA Journal 2016;14(11):4647

3 Summary Dimethoate is an active substance tt was included in Annex I to Directive 91/414/EEC on 1 October 2007 by Commission Directive 2007/25/EC and s been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011. On 29 March 2016, the French authorities informed the European Commission of a request to take emergency measures as regards the use of plant protection products (PPPs) containing dimethoate on vegetables and orcrds/fruits ( sur les cultures legumieres et en arboriculture ) and the placing on the market of cherries from the Member States (MSs) or third countries where the use of such plant protection products is authorised. The European Food Safety Authority (EFSA) was requested by the European Commission under Article 69 of Regulation (EC) No 1107/2009 and Article 53 of Regulation (EC) No 178/2002 in conjunction with Article 29 of tt Regulation, to assess the available information on dimethoate and its residues and metabolites, and to conclude on whether it is clear tt the use of PPPs containing dimethoate on vegetables and orcrds/fruits is likely to constitute a serious risk to human health and whether it is evident tt cherries from the MSs or third countries where the use of PPPs containing dimethoate is authorised are likely to constitute a serious risk to human health. EFSA finalised its statement on the assessment of the risk to human health through the pesticide active substance dimethoate and its metabolites in food on 8 April On 7 June 2016, EFSA received a further mandate from the European Commission to conduct a maximum residue level (MRL) review under Art.43 of Regulation (EC) No 396/2005 taking into account the following: All Good Agricultural Practices (GAPs) in line with the current MRLs for dimethoate and omethoate (both MRLs above and at the limit of quantification (LOQ)) tt will be submitted by the MSs in response to a call for data made by EFSA. This would also include information on GAPs for existing import tolerances submitted by the MSs. Residue trial data for the critical GAPs (cgaps): The MSs should only submit data sets in which residues for omethoate and dimethoate are measured separately in order to allow proposing MRLs for omethoate and dimethoate separately. All relevant metabolism studies for the crop groups for which GAPs are reported, tt were submitted under the renewal dossier or by the MSs in response to EFSA call for data and tt satisfy the quality criteria. This will allow assessing for which crops the metabolites, for which toxicological data are missing, are not of relevance. For crops in which these metabolites can occur, a description/estimate of their contribution to the total residue amount should be made in qualitative terms. An assessment of Codex MRLs (CXLs) is not part of the current mandate and should be carried out during the Art. 12 review at a later stage. For this assessment, EFSA mainly relied on the conclusion of the peer review of the pesticide risk assessment of the active substance dimethoate, on the EFSA conclusion on the peer review of the pesticide risk assessment of confirmatory data submitted for the active substance dimethoate and previously finalised reasoned opinions in response to MRL applications for dimethoate. Furthermore, the additional information on the authorised uses provided by the rapporteur Member State (RMS) and the MSs were also considered in the assessment. The following conclusions were derived. According to the results from the metabolism studies, dimethoate is rapidly degraded to yield a wide range of metabolites; no dimethoate or omethoate was detected in mature potato tubers and wheat grain at rvest while they were recovered but at a very low proportion in wheat straw and olive fruits (10% total radioactive residue (TRR)) either in potato tuber or in the different wheat plant parts. The predominant residue in all plant matrices was metabolite XXIII accounting for 43% TRR in potato tuber, 26% TRR in wheat whole plant, up to 40% TRR in wheat straw and grain and up to 60% TRR in olive fruit. The metabolites XX, XII and XI were also identified in significant proportions in potato tuber and wheat plant parts (> 10% TRR). Although not detected in potatoes and cereal plant parts, the metabolite III (dimethoate carboxylic acid) was identified in amounts higher tn dimethoate and omethoate in the olive fruits but its toxicological properties are covered by the toxicity studies of the parent dimethoate. According to the results from the additional residues trials analysing for dimethoate and its metabolites, in wheat treated according to the most cgap authorised in southern European Union (SEU; considered as the worst case), metabolites are not expected to be present in grain, while in straw metabolites III, XX, X and XI can account for a maximum of 9%, 4%, 16% and 8% of the total residue. 3 EFSA Journal 2016;14(11):4647

4 In olives treated according to the most cgap authorised in SEU, metabolites III, XII and XXIII are not expected to be present at significant levels in the whole fruit while metabolites X, XI and XX may account for a maximum of 15%, 10% and 17% of the total residue, respectively. Nevertheless, it is noted tt residue data for metabolites X, XI and XXII are not covered by storage stability studies and can be underestimated. It is also noted tt, although indicative information on the metabolism in leafy vegetables can be derived from potato leafs where dimethoate, omethoate and metabolite XXIII represented the main contributors to the total TRR at 7 and 14 days prervest interval (PHI), available data are not sufficient to conclude on the levels of metabolites potentially expected in leafy vegetables according to the existing uses. From the available metabolism studies and residue trials, it is concluded tt the metabolites for which the toxicological properties still need to be clarified may be of relevance in fruit crops (metabolites X, XI and XX, according to the results of the residue trials on olives; metabolites XII and XXIII, according to the metabolism study), in leafy vegetables (metabolite XXIII), and in root and tuber vegetables (metabolites XI, XX and XXIII). Although in wheat treated according to the GAPs, metabolites XII and XXIII were not observed in grain, they occurred in significant amounts in the metabolism study. Thus, these two metabolites may be also of relevance for cereals. Regarding the magnitude of omethoate and dimethoate, the available data are considered sufficient to derive MRL proposals as well as risk assessment values for all commodities under evaluation, except for witloof where the available data were insufficient to derive MRL and risk assessment values. Nevertheless, considering the data gaps identified for the possible occurrence of the metabolites in primary crops and the toxicological properties of the identified metabolites, all derived MRLs should be considered tentative only. Dimethoate is authorised for use on several crops tt might be fed to livestock. Nevertheless, considering tt no MRLs are currently set for animal commodities and no additional livestock feeding studies were received by MSs, MRLs for animal commodities were not derived in this assessment. EFSA proposes to derive and assess the MRLs in animal commodities during the Article 12 review once the data gaps identified in the previous assessments will be addressed. 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). Since the proposed and the existing residue definitions are not comparable, for witloof where residue data were insufficient to derive an MRL proposal and risk assessment values, EFSA was not able to perform an indicative risk assessment considering the existing MRL. The risk assessment input values were recalculated according to the provisional residue definitions for chronic (sum of the median residue of dimethoate and three times the median residue of omethoate, expressed as dimethoate) and acute risk assessment (sum of the highest residue of dimethoate and six times the highest residue of omethoate, expressed as dimethoate). The median processing factors for crude oil and canned table olives derived from processing studies and residue trials evaluated during the peer review and in the framework of this review, were applied. The exposures calculated were compared with the toxicological reference values for dimethoate, derived by EFSA (2006) under Directive 91/414/EEC. The highest chronic exposure was calculated for the UK toddlers, representing 102% of the acceptable daily intake (ADI), with sugar beet roots identified as major contributor of the chronic exposure accounting for 91% of the ADI. Lacking specific processing studies in particular for the main contributors in the chronic exposure assessment, such as sugar beet, a more refined intake calculation could not be performed. With regard to the acute exposure, an exceedance of the acute reference dose (ARfD) was identified for Chinese cabbages and melons, representing 1,032% and 106% of the ARfD, respectively. A second exposure calculation was therefore performed, considering a fall-back GAP for sugar beet. For melons and Chinese cabbage, no fall-back GAP could be identified by EFSA. These crops were therefore excluded from the calculation. According to the results of this second calculation, the highest chronic exposure accounted for 49% of the ADI for the WHO, cluster diet B; the highest acute exposure is then calculated for oranges, representing 93% of the ARfD. EFSA empsises tt the above assessment does not yet take into consideration the possible contribution to the overall toxicological burden of metabolites III, X, XXIII, XX, XII and XI. Therefore, the risk assessment in the framework of this opinion should be considered as provisional and may underestimate the actual consumer risk. 4 EFSA Journal 2016;14(11):4647

5 Table of contents Abstract... 1 Summary... 3 Background... 6 Terms of Reference... 6 Regulatory history of dimethoate... 6 Assessment Metabolism in primary crops and occurrence of metabolites Root and tuber vegetables Cereals Fruits and fruiting vegetables Overall conclusions Magnitude of dimethoate and omethoate residues in plants resulting from the currently authorised uses 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 Used compound codes EFSA Journal 2016;14(11):4647

6 Background Dimethoate is an active substance tt was included in Annex I to Directive 91/414/EEC 1 on 1 October 2007 by Commission Directive 2007/25/EC 2 and s been deemed to be approved under Regulation (EC) No 1107/2009 3, in accordance with Commission Implementing Regulation (EU) No 540/ On 29 March 2016, the French authorities informed the European Commission of a request to take emergency measures as regards the use of plant protection products (PPPs) containing dimethoate on vegetables and orcrds/fruits ( sur les cultures legumieres et en arboriculture ) and the placing on the market of cherries from the Member States (MSs) or third countries where the use of such PPPs is authorised. The European Food Safety Authority (EFSA) was requested by the European Commission under Article 69 of Regulation (EC) No 1107/2009 and Article 53 of Regulation (EC) No 178/2002 in conjunction with Article 29 of tt Regulation, to assess the available information on dimethoate and its residues and metabolites, and to conclude on whether it is clear tt the use of PPPs containing dimethoate on vegetables and orcrds/fruits is likely to constitute a serious risk to human health and whether it is evident tt cherries from the MSs or third countries where the use of PPPs containing dimethoate is authorised are likely to constitute a serious risk to human health. EFSA finalised its statement on the assessment of the risk to human health through the pesticide active substance dimethoate and its metabolites in food on 8 April On 7 June 2016, EFSA received a further mandate from the European Commission, while awaiting the outcome of the renewal procedure and subsequent Art. 12 maximum residue level (MRL) review, to conduct a MRL review under Art. 43 of Regulation (EC) No 396/ (EFSA, 2016a). Terms of Reference EFSA sll review the existing MRLs for dimethoate, taking into account the following: All Good Agricultural Practices (GAPs) in line with the current MRLs for dimethoate and omethoate (both MRLs above and at the limit of quantification (LOQ)) tt will be submitted by the MSs in response to a call for data made by EFSA. This would also include information on GAPs for existing import tolerances submitted by the MSs. Residue trial data for the critical GAPs (cgaps): The MSs should only submit data sets in which residues for omethoate and dimethoate are measured separately in order to allow proposing MRLs for omethoate and dimethoate separately. All relevant metabolism studies for the crop groups for which GAPs are reported, tt were submitted under the renewal dossier or by the MSs in response to EFSA call for data and tt satisfy the quality criteria. This will allow assessing for which crops the metabolites, for which toxicological data are missing, are not of relevance. For crops in which these metabolites can occur, a description/estimate of their contribution to the total residue amount should be made in qualitative terms. An assessment of Codex MRLs (CXLs) is not part of the current mandate and should be carried out during the Art. 12 review at a later stage. Regulatory history of dimethoate Dimethoate is the ISO common for O,O-dimethyl S-methylcarbamoylmethyl phosphorodithioate or 2-dimethoxyphosphinothioylthio-N-methylacetamide (IUPAC). The chemical structures of the active substance and its main metabolites are reported in Appendix D. 1 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 2007/25/EC of 23 April 2007 amending Council Directive 91/414/EEC to include dimethoate, dimethomorph, glufosinate, metribuzin, phosmet and propamocarb as active substances. OJ L 106, , 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 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 EFSA Journal 2016;14(11):4647

7 Dimethoate is an organophosphorous insecticide and acaricide for the control of a wide range of pests. It acts by contact and systemic action by inhibiting the enzyme acetylcholinesterase. Dimethoate s been assessed in the framework of Directive 91/414/EEC in the second stage with the United Kingdom being the designated rapporteur Member State (RMS). The representative uses submitted for the peer review were foliar application of dimethoate on wheat, olives, sugar beet, tomatoes and lettuce. In the EFSA conclusion, several critical areas of concern were identified; as regards consumer safety, it was not possible to perform a robust risk assessment due to the lack of information on the relative toxicity to parent compound and actual levels of metabolites XX, XII and III in plant commodities (EFSA, 2006). The active substance was included in Annex I to Directive 91/414/EEC by Commission Directive 2007/25/EC. The Annex I inclusion was restricted to the use as an insecticide only. It was a specific provision of the approval tt the notifier was required to submit to the European Commission by 1 October 2009 for further studies to confirm the risk assessment for birds, mammals and non-target arthropods, as well as to confirm the toxicological assessment on metabolites potentially present in crops. The Commission requested EFSA to provide scientific and technical assistance on the assessment of the confirmatory data; the EFSA conclusion on the peer review of the pesticide risk assessment of confirmatory data submitted for the active substance dimethoate was published in July 2013 (EFSA, 2013). During the assessment of the confirmatory data, metabolite III was considered covered by the toxicity studies on the parent, while for metabolites XII, XX, XXIII, XI and X, a data gap concerning their toxicological information s been identified. A general residue definition for monitoring was set as dimethoate and omethoate, to be determined separately (EFSA, 2013). The multiresidue Quick, Easy, Cheap, Effective, Rugged, and Safe (QuEChERS) method described in the European Standard EN 15662:2008 is validated for the determination of dimethoate and omethoate at the LOQ of 0.01 mg/kg for each compound in high water content, high acid content and oil content and in dry commodities (EFSA, 2012). The agreed provisional residue definitions for risk assessment were the sum of dimethoate and six times omethoate expressed as dimethoate for acute risk assessment and the sum of dimethoate and three times omethoate expressed as dimethoate for chronic risk assessment. EFSA also concluded tt based on its significant occurrence in all the edible parts of the crops, metabolite XXIII should definitively be included in the residue definition either combined with the parent compound or considered separately based on the requested toxicological assessment of this metabolite. Furthermore, pending on their toxicological properties, metabolites XII, XX and XI may also be included in the residue definition for risk assessment (EFSA, 2013). The same residue definitions were also tentatively proposed for animal commodities, pending the submission of a ruminant feeding study carried out with simultaneous administration of dimethoate and omethoate at a ratio representative of the practical conditions and investigating also the potential transfer through the feed items of the metabolites XXIII, XI and XX in animal matrices (EFSA, 2013). All the identified data gaps are expected to be addressed during the assessment for the renewal of the approval of dimethoate. Therefore, it was decided to postpone the MRL review under Article 12(2) of Regulation (EC) No 396/2005 awaiting the outcome of the renewal. The dossier for renewal of the approval of dimethoate s been submitted to the RMS Italy. Italy is currently performing the assessment of the supplementary dossier and is preparing its renewal assessment report. The existing European Union (EU) MRLs for dimethoate/omethoate, which are set for the sum of dimethoate and omethoate, expressed as dimethoate, are included in Annexes II and IIIB of Regulation (EC) No 396/2005. Regulation (EC) No 396/2005 does not contain MRLs for products of animal origin. In 2009 following an EFSA opinion (EFSA, 2009) assessing the safety of existing MRLs of dimethoate, a risk management decision was taken to lower some of the existing MRLs as proposed by EFSA or to set the MRLs at a lower level reflecting less cgaps. Between 2010 and 2012, EFSA issued several reasoned opinions in response to MRL applications for dimethoate (EFSA, 2010a,b, 2011, 2012). However, the MRL applications did not result in an amendment of the existing EU MRLs since the data gaps regarding the metabolites of dimethoate identified in the framework of the peer review did not allow to finalise the consumer risk assessment. Assessment In order to address the questions to be assessed according to the Terms of Reference, EFSA asked MSs on 10 June 2016 to provide the following information: 7 EFSA Journal 2016;14(11):4647

8 All GAPs and fall-back GAPs (when relevant) in line with the current MRLs for dimethoate and omethoate (both MRLs above and at the LOQ) and information on GAPs for existing import tolerances. The MSs were also encouraged to submit information on possible GAPs for which applications for authorisations are currently under evaluation at the MS level (for information purposes only). Residue trial data for the critical GAPs: The MSs should only submit data sets in which residues for omethoate and dimethoate are measured separately in order to allow proposing MRLs for omethoate and dimethoate separately. It is noted tt for a large number of GAPs, no residue trials were available. In these cases, since the existing MRLs are set for the sum of dimethoate and omethoate, it was not possible to perform the risk assessment. The MSs were strongly encouraged to submit residue trials supporting these GAPs. All relevant metabolism studies for the crop groups for which GAPs are reported. Livestock feeding studies carried out with simultaneous administration of dimethoate and omethoate at a ratio representative of the practical conditions allowing to estimate the residues of dimethoate and omethoate expected in animal commodities. All comments received were evaluated and considered by EFSA during the finalisation of the reasoned opinion. For the purpose of this assessment, the critical uses of dimethoate currently authorised within the EU, collected by the former RMS at the time of the first peer review (the United Kingdom) and reported in the EFSA Pesticide Residues Overview File (PROFile) ve been taken into consideration. The additional GAPs reported by the MSs during the call for data were also considered. The details of the authorised GAPs for dimethoate are given in Appendix A (A.1). According to the information received by the MSs during the call for data, several GAPs are currently under evaluation in Spain. The details of the GAP currently under evaluation are also given in Appendix A (A.2). The MSs did not report any use authorised in third countries tt might ve a significant impact on international trade. EFSA s based its assessment on the PROFile for dimethoate and the PROFile for omethoate based on the PROFile for dimethoate submitted to EFSA in December 2010 by the former RMS at the time of the first peer review (the United Kingdom), the draft assessment report (DAR) and its final addendum prepared under Council Directive 91/414/EEC (United Kingdom, 2004, 2006), the conclusion on the peer review of the pesticide risk assessment of the active substance dimethoate (EFSA, 2006), the previous reasoned opinions on dimethoate (EFSA, 2009, 2010a,b, 2011, 2012), the conclusion on the peer review of the pesticide risk assessment of confirmatory data (EFSA, 2013), as well as the evaluation reports submitted during consultation of the MSs (Belgium, 2016; Czech Republic, 2016; Finland, 2016a,b, Germany, 2016; Greece, 2016; Italy, 2016; Portugal, 2016; Spain, 2016; United Kingdom, 2016). The assessment is performed in accordance with the legal provisions of the uniform principles for evaluation and authorisation of PPPs 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, 1997a g, 2000, 2010a,b, 2011; OECD, 2011, 2013). The evaluation reports submitted by MSs Belgium, the Czech republic, Germany, Greece, Finland, Italy, Portugal, Spain and the United Kingdom (Belgium, 2016; Czech republic, 2016; Finland, 2016a,b; Germany, 2016, Greece, 2016; Italy, 2016; Portugal, 2016; Spain, 2016; United Kingdom, 2016) are considered as supporting documents to this reasoned opinion. In addition, key supporting documents to this reasoned opinion are the MSs consultation report (EFSA, 2016b) and the chronic and acute exposure calculations for all crops reported in the framework of this assessment using the EFSA Pesticide Residues Intake Model (PRIMo) and the PROFile. Hence, these documents are also made publicly available. 1. Metabolism in primary crops and occurrence of metabolites The metabolism of dimethoate in potatoes, wheat and olives following foliar application was assessed during the peer review under Directive 91/414/EEC and during the assessment of a previous MRL application (United Kingdom, 2004, EFSA, 2011, 2013). The key parameters of the available metabolism studies are reported in Appendix B. No additional metabolism studies were received from MSs. However, residue trials on olives (eight compliant with the southern European union (SEU) GAP) 6 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 2016;14(11):4647

9 and wheat (eight compliant with the northern European Union (NEU) GAP and eight compliant with the SEU GAP) analysed for dimethoate, omethoate and metabolites III, X, XI, XII, XX, XXIII were used as an additional source of information for the metabolism in primary crops. These residue trials were provided by MSs during the call for data and considered in this review (Greece, 2016; Italy, 2016; Spain, 2016) Root and tuber vegetables In the metabolism study on potatoes performed at 0.9N compared to the most cgap authorised on carrots in NEU, at the plant rvest interval (PHI) of 14 and 28 days, the radioactive residues were mainly found in potato foliage (1.32 and 3.46 mg eq./kg) with approximately 10-fold lower values in tubers (0.19 and 0.24 mg eq./kg). In potato tubers, dimethoate and omethoate were not found in significant concentrations (> 0.1% total radioactive residue (TRR)). In all tuber samples taken 14, 21 and 28 days after treatment (DAT), three metabolites exceeded 10% of the TRR: O-desmethyl omethoate carboxylic acid (XX) (18.4%, 11.1% and 12.1% TRR), O-desmethyl-N-desmethyl omethoate (XXIII) (45.5%, 40.3% and 43.6% TRR) and O-desmethyl omethoate (XI) (12.5%, 17.7% and 14.8% TRR). The cracterisation of the TRR in foliage indicated tt parent dimethoate was the main component accounting for a maximum of 40.7% TRR (1.89 mg/kg) in PHI of 7 days and 15% TRR (0.2 mg/kg) in the PHI of 14 days. In foliage samples taken 7 DAT and 14 DAT, omethoate accounted for 15.6% TRR (0.72 mg/kg) and 9.3% TRR (0.12 mg/kg), respectively. O-desmethyl-N-desmethyl omethoate (XXIII) accounted for 8.75% TRR (0.11 mg/kg) in foliage samples taken 14 DAT and 5.2% TRR (0.24 mg/kg) in foliage samples taken 7 DAT Cereals After treatment at 4N compared to the most cgap for wheat authorised in NEU, TRR in mature wheat grain, hull and straw accounted for 4.28, and 7.83 mg/kg, respectively. The cracterisation of the TRR in mature wheat grain, hull and straw indicated tt the main compound in all crop parts was O-desmethyl-N-desmethyl omethoate (XXIII) which accounted up to 45.2% TRR (15.23 mg/kg) in hull, 40.5% TRR (3.17 mg/kg) in straw and 35% TRR (1.5 mg/kg) in grain. Metabolite des-o-methyl isodimethoate (XII) accounted for up to 31%, 20% and 11% TRR in hull, straw and grain, respectively. Parent dimethoate and omethoate were not identified in mature wheat grain. Omethoate accounted for 10.2% TRR (2.37 mg/kg) in wheat hull sample taken 21 DAT. In the wheat plant 41 DAT, parent dimethoate was the main component of the TRR (83.2%; 13.4 mg/kg) with all other compounds being below 4.4%. In northern European trials, dimethoate and all metabolite residues in grain were < 0.01 mg/kg at rvest. In straw, dimethoate ranged from < 0.01 to 0.02 mg/kg while omethoate was < 0.01 mg/kg. No other metabolites were observed in straw above the LOQ (0.01 mg/kg). In southern European trials, dimethoate and all metabolite residues in grain were 0.01 mg/kg at rvest. In straw, dimethoate ranged from < 0.01 to 0.88 mg/kg while omethoate ranged from < 0.01 to 0.07 mg/kg. No other metabolites were observed in straw above the LOQ (0.01 mg/kg) except for two trials where residues ranged from 0.04 to 0.21 mg/kg for metabolite X (corresponding to 4 16% of total residue) and 0.02 to 0.08 mg/kg for metabolite XI (corresponding to 2 8% of total residue). In one trial, residues were 0.05 mg/kg for metabolite XX (corresponding to 4% of total residue) and 0.12 mg/kg for metabolite III (corresponding to 9% of total residue). It is noted tt, according to the information reported by MSs, for four out of the eight northern trials, due to the length of storage prior to analysis, the levels of metabolite XI on straw and metabolite XXIII on grain and straw are uncertain. Nevertheless, considering tt the SEU use is the more critical, this can be considered not relevant Fruits and fruiting vegetables In mature olives treated at 3N compared to the most cgap for olives, the total radioactivity accounted for 3.93 mg eq./kg in green olives and 3.69 mg eq./kg in black olives. The increasing radioactivity in olive stones ( mg eq./kg) indicates a residue transfer from flesh to stone. Good extraction of residues was achieved for olive flesh. In olives at rvest, the main component of the residues was O-desmethyl N-desmethyl omethoate (XXIII) accounting for 57% (2.23 mg/kg) and 59.9% (2.22 mg/kg) in green and black olives, respectively. Metabolite des-o-methyl isodimethoate 9 EFSA Journal 2016;14(11):4647

10 (XII) accounted for % of the TRR ( mg/kg). Levels of dimethoate ( % TRR) were lower tn those of omethoate ( %). In southern European trials, dimethoate residues on whole olives following overall foliar spray application according to the most cgap authorised in SEU, ranged from 0.06 to 1.5 mg/kg. Dimethoate metabolites ranged from 0.07 to 0.88 mg/kg for omethoate, 0.03 to 0.19 mg/kg for metabolite X (corresponding to 2 15% of total residue), 0.01 to 0.13 mg/kg for metabolite XI (corresponding to 3 10% of total residue) and 0.01 to 0.35 mg/kg for metabolite XX (corresponding to 3 17% of total residue). Metabolite III was only present in one residue trial at levels above the LOQ (0.01 mg/kg, corresponding to 0.3% of total residue). Metabolites XII and XXIII were always below the LOQ of 0.01 mg/kg. It is noted tt there is uncertainty on the residue levels of metabolites X, XI and XXIII measured in the residue trials, as they were not shown to be stable for the maximum period of storage prior to analysis (more tn 30% degradation s been observed on the longest storage period) Overall conclusions According to the results from the metabolism studies, dimethoate is rapidly degraded to yield a wide range of metabolites; no dimethoate or omethoate was detected in mature potato tubers and wheat grain at rvest while they were recovered but at a very low proportion in wheat straw and olive fruits (10% TRR) either in potato tuber or in the different wheat plant parts. The predominant residue in all plant matrices was metabolite XXIII accounting for 43% TRR in potato tuber, 26% TRR in wheat whole plant, up to 40% TRR in wheat straw and grain and up to 60% TRR in olive fruit. The metabolites XX, XII and XI were also identified in significant proportions in potato tuber and wheat plant parts (> 10% TRR). Although not detected in potatoes and cereal plant parts, the metabolite III (dimethoate carboxylic acid) was identified in amounts higher tn dimethoate and omethoate in the olive fruits but its toxicological properties are covered by the toxicity studies of the parent dimethoate. According to the results from the additional residue trials analysing for dimethoate and its metabolites, in wheat treated according to the most cgap authorised in SEU (considered as the worst case), metabolites are not expected to be present in grain, while in straw metabolites III, XX, X and XI can account for a maximum of 9%, 4%, 16% and 8% of the total residue. In olives treated according to the most cgap authorised in SEU, metabolites III, XII and XXIII are not expected to be present at significant levels in the whole fruit while metabolites X, XI and XX may account for a maximum of 15%, 10% and 17% of the total residue, respectively. Nevertheless, it is noted tt residue data for metabolites X, XI and XXIII are not covered by storage stability studies and can be underestimated. It is also noted tt, although indicative information on the metabolism in leafy vegetables can be derived from potato leafs where dimethoate, omethoate and metabolite XXIII represented the main contributors to the total TRR at 7 and 14 days PHI, available data are not sufficient to conclude on the levels of metabolites potentially expected in leafy vegetables according to the existing uses. The GAPs to be assessed in the framework of this evaluation (see Appendix A) refer to crops belonging to the following crop groups: fruit crops, roots and tuber vegetables, leafy vegetables and cereals. A qualitative estimation of the occurrence of dimethoate and its metabolites in the different crop groups is summarised in Appendix B (B.1.2). From the available metabolism studies and residue trials, it is concluded tt the metabolites for which the toxicological properties still need to be clarified may be of relevance in fruit crops (metabolites X, XI and XX, according to the results of the residue trials on olives; metabolites XII and XXIII, according to the metabolism study), in leafy vegetables (metabolite XXIII) and in root and tuber vegetables (metabolites XI, XX and XXIII). Although in wheat treated according to the GAPs, metabolites XII and XXIII were not observed in grain, they occurred in significant amounts in the metabolism study. Thus, these two metabolites may be also of relevance for cereals. 2. Magnitude of dimethoate and omethoate residues in plants resulting from the currently authorised uses To assess the magnitude of dimethoate and omethoate residues resulting from the reported GAPs, EFSA considered residue trials evaluated in the framework of the peer review (United Kingdom, 2004, 2006) or in the framework of previous MRL assessments (EFSA, 2009, 2010a,b, 2011, 2012) and 10 EFSA Journal 2016;14(11):4647

11 additional data submitted during the call for data (Belgium, 2016; Czech Republic, 2016; Finland, 2016a,b, Germany, 2016; Greece, 2016; Italy, 2016; Portugal, 2016; Spain, 2016; United Kingdom, 2016). According to the storage stability studies evaluated during the peer review, dimethoate and omethoate showed to be stable in a range of commodities (potatoes, oranges, sorghum grain and forage, cotton seed) covering the four matrices for up to 27 months (6 months in the case of cherries) when stored at temperatures between 10 and 20 C (EFSA, 2006). 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. According to the information provided by MSs, the analytical method used to analyse supervised residue trial samples s been sufficiently validated and was proven to be fit for purpose. The residue trials were evaluated in accordance with the European guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs (European Commission, 2011). All submitted residue trials were analysed separately for dimethoate and omethoate and individual residue trial data are given in Appendix B (B.1.3). Residue trials were not available to support the authorisation on witloof. Therefore, MRL or risk assessment values for this crop could not be derived by EFSA and the following data gap was identified: four trials on witloof compliant with the northern outdoor GAP. For some crops, only tentative MRL and risk assessment values could be derived by EFSA and the following data gaps were identified: Parsnips, parsley roots, celeriacs, horseradishes, salsify, radishes, turnips, swedes: Trials in carrots supporting the northern GAP are all performed according to a more cgap and no residue trials are available to support the indoor GAPs for radishes and turnips. Although tentative MRLs can be derived from northern overdosed trials, eight residue trials compliant with the northern GAP and eight residue trials compliant with the indoor GAP (for radishes and turnips only) are still required. It is also noted tt the northern residue trials in carrots are also expected to cover the different outdoor GAP authorised for parsnips and parsley roots in the Czech Republic ( kg/; PHI: 28 days). Spring onions: Although tentative MRLs can be derived from available trials performed according to a more cgap, eight residue trials compliant with the northern GAP are still required. Chinese cabbages: Although tentative MRLs can be derived from available trials performed according to a more cgap, eight residue trials compliant with the northern GAP are still required. Lettuces: The number of residue trials supporting the northern outdoor GAP is not compliant with the data requirements for this crop. Although in the available trials residues were always below the LOQ, no information on the tested varieties was reported. Therefore, it is not possible to conclude tt a no residue situation is expected at the most critical conditions and four additional trials on open leaf varieties or the confirmation tt available trials were performed on open leaf varieties are still required. Asparagus: No residue trials supporting the northern outdoor GAP are available. Nevertheless, considering tt the application is done on young stands or after rvest, no residues are expected in this crop. Two residue trials confirming a no residue condition are still required. Barley and oats: Although tentative MRLs can be derived from available trials performed according to a more cgap, eight residue trials compliant with the northern GAP are still required. It is noted tt a different GAP ( kg/; PHI: 28 days) not supported by data is authorised in Finland. Therefore, eight residue trials supporting the FI GAP for barley and oats are still required. For all other crops, available residue trials are sufficient to derive MRL and risk assessment values, taking note of the following considerations: Citrus fruits: The number of residue trials supporting the southern outdoor GAP is not compliant with the data requirements for this crop. Moreover available trials were compliant with a more critical GAP (performed at kg/; PHI: 100 days). However, the available 11 EFSA Journal 2016;14(11):4647

12 data is considered acceptable in this case because all results were below the LOQ and a no residues situation is expected. Further residue trials are therefore not required. It is noted tt the data set considered, also cover the different outdoor GAP authorised in Portugal ( kg/; PHI: 106 days). Table olives and olive for oil production: The derived MRL is based on the GAP authorised in Greece and Italy which is fully supported by data. Nevertheless, it is noted tt a different GAP, which is not supported by data is authorised in ES ( kg/; PHI: 12 days). Therefore, eight residue trials supporting the ES GAP for table olives and olives for oil production are still required. Beetroots: Three out of the four residue trials supporting the northern outdoor GAP were compliant with a more cgap (performed at kg/; PHI: 15 days). However, the available data is considered acceptable in this case because all results were below the LOQ and a no residues situation is expected. Further residue trials are therefore not required. Carrots: The number of residue trials supporting the southern outdoor GAP is not compliant with the data requirements for this crop. However, the reduced number of residue trials is considered acceptable in this case because all results were below the LOQ and a no residues situation is expected. Further residue trials are therefore not required. Onions, garlic and sllots: The number of residue trials supporting the southern and the northern outdoor GAPs is not compliant with the data requirements for this crop. However, the reduced number of residue trials is considered acceptable in this case because all results were below the LOQ and a no residues situation is expected. Further residue trials are therefore not required. Tomatoes, aubergines: Available residue trials supporting the southern GAP were overdosed (performed with a dose rate 2.6N compared to the GAP). Nevertheless, applying the proportionality approach to the residues above the LOQ (omethoate: mg/kg), a no residues situation is expected at the authorised GAPs. Further residue trials are therefore not required. Cucurbits with inedible peel: Available residue trials were performed according to a more cgap (dose rate 2.6N compared to the GAP and residue analysed at a shorter PHI of 28 days). Nevertheless, applying the proportionality approach to the residues above the LOQ (dimethoate: 0.01 and 0.02 mg/kg), a no residues situation is expected. Further residue trials are therefore not required. Head cabbages: The number of residue trials supporting the southern and the northern outdoor GAPs is not compliant with the data requirements for this crop. However, the reduced number of residue trials is considered acceptable in this case because all results were below the LOQ and a no residues situation is expected. Further residue trials are therefore not required. Peas (dry): The number of residue trials supporting the southern outdoor GAP is not compliant with the data requirements for this crop. Moreover, available trials were performed on fresh peas without pods according to a more cgap ( kg/; PHI: 14 days). However, the available data is considered acceptable to derive a MRL and risk assessment values for dry peas because all results were below the LOQ and a no residues situation is expected. Further residue trials are therefore not required. Wheat and rye: Residue trials supporting the northern use were all performed with dose rate within the 25% variation and last application done at a later growth stage of 69 (instead of 55). Nevertheless, considering tt the southern GAP is clearly the most critical, no additional trials supporting the northern GAP are required. It is noted tt a different GAP ( kg/; PHI: 28 days) not supported by data is authorised in Finland. Therefore, eight residue trials supporting the FI GAP for wheat and rye are still required. Sugar and fodder beets: Three out of the four residue trials supporting the northern outdoor GAP were compliant with a more cgap (performed at kg/; PHI: 15 days). However, the available data is considered acceptable in this case because all results were below the LOQ and a no residues situation is expected in roots. Further residue trials supporting the northern outdoor GAP are therefore not required. It is also noted tt a fall-back GAP fully supported by data is authorised in the Czech Republic EFSA Journal 2016;14(11):4647

13 Consequently, the available data are considered sufficient to derive MRL proposals as well as risk assessment values for all commodities under evaluation, except for witloof where the available data were insufficient to derive MRL and risk assessment values. Nevertheless, considering the data gaps identified for the possible occurrence of the metabolites in primary crops and the toxicological properties of the identified metabolites, all derived MRLs should be considered tentative only. 3. Residues in livestock Dimethoate is authorised for use on several crops tt might be fed to livestock. Nevertheless, considering tt no MRLs are currently set for animal commodities and no additional livestock feeding studies were received by MSs, MRLs for animal commodities were not derived in this assessment. EFSA proposed to derive and assess the MRLs in animal commodities during the Article 12 review once the data gaps identified in the previous assessments will be addressed. 4. 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 PRIMo (EFSA, 2007). For those commodities where a tentative MRL could be derived by EFSA in the framework of this review, input values were derived according to the internationally agreed methodologies (FAO, 2009). Since for witloof residue data were insufficient to derive an MRL proposal and risk assessment values in Section 2 for dimethoate and omethoate, EFSA was not able to perform an indicative risk assessment for the proposed new residue definitions. All input values included in the exposure calculations are summarised in Appendix C. The consumer risk assessment is based on the assumption tt metabolites III, X, XXIII, XX, XII and XI do not contribute to the overall toxicological burden taking into account the authorised uses of dimethoate as notified by the MSs. The risk assessment input values were recalculated according to the provisional residue definitions for chronic (sum of the median residue of dimethoate and three times the median residue of omethoate, expressed as dimethoate) and acute risk assessment (sum of the highest residue of dimethoate and six times the highest residue of omethoate, expressed as dimethoate). The median processing factors (PFs) for crude oil (dimethoate: 0.33; omethoate: 0.01) and canned table olives (dimethoate: 0.28; omethoate: 0.01), derived from processing studies and residue trials evaluated during the peer review and in the framework of this review (United Kingdom, 2004; Italy, 2016), were applied. The exposures calculated were compared with the toxicological reference values for dimethoate, derived by EFSA (2006) under Directive 91/414/EEC. The highest chronic exposure was calculated for the UK toddlers, representing 102% of the acceptable daily intake (ADI), with sugar beet roots identified as major contributor of the chronic exposure accounting for 91% of the ADI. Lacking specific processing studies in particular for the main contributors in the chronic exposure assessment, such as sugar beet, a more refined intake calculation could not be performed. With regard to the acute exposure, an exceedance of the acute reference dose (ARfD) was identified for Chinese cabbages and melons, representing 1,032% and 106% of the ARfD, respectively. A second exposure calculation was therefore performed, considering a fall-back GAP for sugar beet. For melons and Chinese cabbage, no fall-back GAP could be identified by EFSA. These crops were therefore excluded from the calculation. According to the results of this second calculation, the highest chronic exposure accounted for 49% of the ADI for the WHO, cluster diet B; the highest acute exposure is then calculated for oranges, representing 93% of the ARfD. Based on these calculations, a risk to consumers cannot be excluded for the most cgaps on melons, Chinese cabbages and sugar beet. While for sugar beet a fall-back GAP may be considered by risk managers in order to reduce the exposure of consumers to an acceptable level, no fall-back GAPs could be identified for melons and Chinese cabbages and based on the data available to EFSA no further refinements of the risk assessment were possible. For the remaining commodities, the indicative exposure calculation for dimethoate and omethoate did not indicate a risk to consumers. However, since this calculation did not take into account the contribution of other metabolites associated with the use of dimethoate, the risk assessment calculation is affected by additional uncertainties compared to the standard risk assessments approach used for pesticide residues. It is noted tt the intake concerns identified for melons and sugar beet showed tt the enforcement LOQ of 0.01 mg/kg which is currently validated, is not sufficiently protective for 13 EFSA Journal 2016;14(11):4647