Modification of the existing maximum residue levels (MRLs) for dimethomorph in various crops

Transcription

1 REASONED OPINION APPROVED: 08 January 2016 PUBLISHED: 27 January 2016 doi: /j.efsa Modification of the existing maximum residue levels (MRLs) for dimethomorph in various crops Abstract European Food Safety Authority (EFSA) In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Germany received an application from BASF SE to modify the existing MRLs for dimethomorph in flowering brassica (except broccoli), spinaches and similar leaves and globe artichokes. Germany drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005 which was submitted to the European Commission and forwarded to EFSA. According to EFSA the data are sufficient to derive MRL proposals of 0.6 mg/kg for cauliflowers and others (code ) and 4 mg/kg for purslanes, chards/beet leaves and others (code ). An amendment of the MRL is not necessary for spinaches and globe artichokes. Adequate analytical enforcement methods are available to control the residues of dimethomorph in the commodities under consideration. Based on the risk assessment results, EFSA concludes that the intended uses of dimethomorph on the crops under consideration are not expected to result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a health risk to consumers. European Food Safety Authority, 2016 Keywords: dimethomorph, vegetables, MRL application, consumer risk assessment Requestor: European Commission Question number: EFSA-Q Correspondence: pesticides.mrl@efsa.europa.eu EFSA Journal 2016;14(1):4381

2 Suggested citation: EFSA (European Food Safety Authority), Reasoned opinion on the modification of the existing maximum residues levels (MRLs) for dimethomorph in various crops. EFSA Journal 2016;14(1):4381, 19 pp. doi: /j.efsa ISSN: European Food Safety Authority, 2016 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 2016;14(1): 4381

3 Summary In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Germany received an application from BASF SE to raise the existing MRLs for dimethomorph in various crops. In order to accommodate for the intended uses of dimethomorph, Germany proposed the MRLs of 0.6 mg/kg for flowering brassica (except broccoli), 3 mg/kg for spinaches and similar leaves and to maintain the existing MRL level of 2 mg/kg for globe artichokes. Germany drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005 which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 6 October EFSA bases its assessment on the evaluation report, the draft assessment report (DAR) and its addendum prepared under Directive 91/414/EEC, the Commission review report on dimethomorph, the conclusion on the peer review of the pesticide risk assessment of the active substance dimethomorph, the JMPR evaluation report as well as the conclusions from previous EFSA opinions on dimethomorph, including the reasoned opinion on the review of the existing MRLs according to Article 12 of Regulation (EC) No 396/2005 (Article 12 MRL review). The toxicological profile of dimethomorph was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.05 mg/kg bw per day and an acute reference dose (ARfD) of 0.6 mg/kg bw. The metabolism of dimethomorph in primary crops was investigated in the fruit, root and leafy crop groups following foliar applications and through hydroponic systems (tomatoes). The residue definitions set during the peer review for enforcement and risk assessment were confirmed under the Article 12 MRL review as dimethomorph (sum of isomers) for all plant commodities, including the crops under consideration in this MRL application. EFSA concludes that the submitted supervised residue trials are sufficient to derive MRL proposals of 0.6 mg/kg for cauliflowers and others (code ) and 4 mg/kg for purslanes, chards/beet leaves and others (code ). An amendment of the MRL for spinaches and globe artichokes is not necessary. Adequate analytical enforcement methods are available to monitor the residues of dimethomorph on the commodities under consideration at the validated LOQ of 0.01 mg/kg. Studies investigating the nature of dimethomorph residues under standard hydrolysis conditions showed the active substance to be hydrolytically stable. Therefore, for processed commodities the same residue definition as for raw commodities (RAC) is applicable. Studies investigating the effect of processing on the magnitude of dimethomorph residues were not provided and are not requested due to the low contribution of the crops under consideration to the total consumer exposure. The occurrence of dimethomorph residues in rotational crops was investigated in the framework of the peer review and the Article 12 MRL review. It was concluded that the nature of residues in rotational and primary crops is expected to be similar and thus the same residue definitions are applicable. Considering the available data, EFSA recommends introducing at national level plant-back restrictions when granting an authorisation for the intended uses of a dimethomorph-based product. Residues of dimethomorph in commodities of animal origin were not assessed, since the crops under consideration in this MRL application are normally not fed to livestock. The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). EFSA updated the long-term risk assessment performed in the latest issued reasoned opinion with the supervised trials median residue (STMR) related to certain Codex limits assessed in the framework of the 47th session of the Codex Committee on Pesticide Residues and the STMRs derived for the crops under consideration. The acute risk assessment was performed only with regard to the crops under consideration. The highest calculated long-term intake accounted for 16% of the ADI (French toddler). The contribution of residues in the crops under consideration to the total consumer exposure was below 0.1% of the ADI. An acute consumer risk was not identified in relation to the MRL proposals (maximum 7% for chards/beet leaves). EFSA concludes that the intended uses of dimethomorph on flowering brassica different than broccoli, purslanes, chards/beet leaves and others (code ) are not expected to result in a consumer 3 EFSA Journal 2016;14(1): 4381

4 exposure exceeding the toxicological reference values and therefore are unlikely to pose a health risk to consumers. EFSA proposes to amend the existing MRLs as reported in the summary table below. Code (a) Commodity Existing EU MRL Proposed EU MRL Comment/Justification Enforcement residue definition: Dimethomorph (sum of isomers) Cauliflowers SEU (outdoor). Extrapolation from trials on Others 0.01* 0.6 broccoli and cauliflowers Spinaches 1 (30) CXL of 30 mg/kg not yet implemented in the EU legislation. See previous assessment (EFSA, 2015) Purslanes 0.01* 4 SEU (outdoor). Extrapolation from trials on Chards/beet leaves 1 4 lettuces and lamb s lettuces Others 0.01* Globe artichokes 2 No change GAP and data already assessed in previous reasoned opinions (EFSA 2010, 2011a). * Indicates that the MRL is set at the limit of analytical quantification (LOQ). (a): Commodity code number according to Annex I of Regulation (EC) No 396/ EFSA Journal 2016;14(1): 4381

5 Table of contents Abstract... 1 Summary... 3 Background... 6 The active substance and its use pattern... 6 Assessment Method of analysis Methods for enforcement of residues in food of plant origin Methods for enforcement of residues in food of animal origin Mammalian toxicology Residues Nature and magnitude of residues in plant Primary crops Rotational crops Nature and magnitude of residues in livestock Consumer risk assessment Conclusions and recommendations References Abbreviations Appendix A Good Agricultural Practice (GAPs) Appendix B Pesticide Residue Intake Model (PRIMo) Appendix C Used compound code EFSA Journal 2016;14(1): 4381

6 Background Regulation (EC) No 396/ establishes the rules governing the setting of pesticide maximum residue levels (MRLs) at European Union (EU) level. Article 6 of the Regulation lays down that any party having a legitimate interest or requesting an authorisation for the use of a plant protection product in accordance Directive 91/414/EEC, 2 repealed by Regulation (EC) No 1107/2009, 3 shall submit to a Member State, when appropriate, an application to modify a MRL in accordance with the provisions of Article 7 of the Regulation. Germany, hereafter referred to as the evaluating Member State (EMS), received an application from the company BASF SE 4 to modify the existing MRLs for the active substance dimethomorph in flowering brassica (except broccoli), spinaches and similar leaves and globe artichokes. This application was notified to the European Commission and the European Food Safety Authority (EFSA) and was subsequently evaluated by the EMS in accordance with Article 8 of the Regulation. After completion, the evaluation report was submitted to the European Commission and to EFSA on 6 October The application was included in the EFSA Register of Questions with the reference number EFSA-Q and the following subject: Dimethomorph Modification of existing MRLs in various crops. Germany proposed to raise the value of the existing MRLs from 0.05 mg/kg and from the limit of quantification (LOQ) of 0.01 mg/kg to 0.6 mg/kg for flowering brassica (except broccoli), from 1 to 3 mg/kg for spinaches and chards/beet leaves, from the LOQ to 3 mg/kg for purslanes and others spinaches and similar leaves (code ) and to maintain the existing MRL of 2 mg/kg for globe artichokes. EFSA proceeded with the assessment of the application and the evaluation report as required by Article 10 of Regulation (EC) No 396/2005. EFSA identified a data gap regarding the use patterns the applicant was applying for, which needed further clarifications. On 10 November 2015 the applicant provided a revised application form, which was taken into consideration for the finalisation of this reasoned opinion. In accordance with Article 10 of Regulation (EC) No 396/2005, EFSA shall, based on the evaluation report provided by the EMS, provide a reasoned opinion on the risks to the consumer associated with the application. In accordance with Article 11 of the Regulation, the reasoned opinion shall be provided as soon as possible and at the latest within three months (which may be extended to six months if more detailed evaluations need to be carried out) from the date of receipt of the application. If EFSA requests supplementary information, the time limit laid down shall be suspended until that information has been provided. The active substance and its use pattern Dimethomorph is the ISO common name for (E,Z)-4-[3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl) acryloyl]morpholine (IUPAC). The chemical structures of the two isomers of the active substance are reported in Appendix C. Dimethomorph was evaluated in the framework of Directive 91/414/EEC with Germany designated as rapporteur Member State (RMS). It was included in Annex I of this directive by Commission Directive 2007/25/EC 5 which entered into force on 1 October 2007 for use as fungicide only. In accordance with 1 Regulation (EC) No 396/2005 of the 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 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 BASF SE, Speyerer Straße 2, Limburgerhof, Germany. 5 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 EFSA Journal 2016;14(1): 4381

7 Commission Implementing Regulation (EU) No 540/2011, 6 dimethomorph is approved under Regulation (EC) No 1107/2009, repealing Directive 91/414/EEC. The representative use evaluated in the peer review was on potatoes in northern and southern Europe. The Draft Assessment Report (DAR) of dimethomorph has been peer reviewed by EFSA (EFSA, 2006). The EU MRLs for dimethomorph are established in Annexes II of Regulation (EC) No 396/2005. EFSA has issued several opinions on the modification of MRLs for dimethomorph, including the reasoned opinion on the review of the existing MRLs according to Article 12 of the abovementioned regulation (Article 12 MRL review). The MRL recommended by EFSA have been implemented in the EU legislation. The MRL changes that were reported in the EU legislation from Article 12 MRL review onwards are summarised in Table 1. Table 1: Overview of the MRL changes as from MRL review in Regulation (EC) No 396/2005 Procedure (a) Considered by Regulation Remarks Art. 12 (EFSA, 2011a) (EU) No 668/2013 Review of existing MRLs. Art. 10 (EFSA, 2013) (EU) No 51/2014 Seed of spices, caraway. Art. 43 (EFSA, 2015) SANTE/12014/2015 Adoption of CXLs. Not yet legally implemented. (a): Art. 10: Assessment of MRL application according to Article 6 to 10 of Regulation (EC) No 396/2005. Art. 12: Review of the existing MRLs according to Article 12 of Regulation (EC) No 396/2005. Art. 43: EFSA scientific opinion according to Article 43 of Regulation (EC) No 396/2005. Codex Alimentarius has established maximum residue limits (CXLs) for a wide range of commodities, including spinaches and globe artichokes for which the CXLs are set at 30 and 2 mg/kg, respectively. The details of the intended Good Agricultural Practice (GAPs) for dimethomorph are given in Appendix A. Assessment EFSA bases its assessment on the evaluation report submitted by the EMS (Germany, 2015), the DAR and its addendum prepared under Directive 91/414/EEC (Germany, 2004, 2006), the Commission review report on dimethomorph (European Commission, 2006), the conclusion on the peer review of the pesticide risk assessment of the active substance dimethomorph (EFSA, 2006), the JMPR evaluation report (FAO, 2014) as well as the conclusions from previous EFSA opinions on dimethomorph (EFSA, 2010, 2011a, 2011b, 2012, 2013, 2015). The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation of Plant Protection Products adopted by Commission Regulation (EU) No 546/ and the currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues (European Commission, 1996, 1997a g, 2000, 2010a, b, 2011; OECD, 2011). 1. Method of analysis 1.1. Methods for enforcement of residues in food of plant origin Under the Article 12 MRL review it was concluded that the multi-residue QuEChERS method using HPLC-MS/MS quantification (CEN, 2008) is applicable to enforce dimethomorph (sum of isomers) in high water content commodities, to which the crops under consideration belong, with the LOQ of 0.01 mg/kg (EFSA, 2011a). 6 Commission Implementing Regulation (EU) No 540/2011 of 23 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 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(1): 4381

8 1.2. Methods for enforcement of residues in food of animal origin Analytical methods for the determination of residues in food of animal origin are not assessed in the current MRL application, since none of the crop under consideration is fed to livestock. 2. Mammalian toxicology The toxicological profile of the active substance dimethomorph was assessed in the framework of the peer review under Directive 91/414/EEC (Germany, 2004; EFSA, 2006; European Commission, 2006). The data were sufficient to derive the toxicological reference values compiled in Table 2. Table 2: Overview of the toxicological reference values Source Year Value Study Safety factor Dimethomorph ADI European mg/kg bw per day Dog, 1 year study 100 ARfD Commission mg/kg bw Rat, developmental toxicity Residues 3.1. Nature and magnitude of residues in plant Primary crops Nature of residues The metabolism of dimethomorph in primary crops was evaluated in the framework of the peer review under Directive 91/414/EEC (Germany, 2004; EFSA, 2006) in the fruit, root and leafy crop groups. An overview of the available metabolism studies is presented in Table 3. Table 3: Summary of available metabolism studies in plants Crop group Crops Application Sampling Comments Fruit Grapes Foliar (4 900 g/ha) 35 DALA Tomatoes hydroponic media (8 mg/l) 7, 14, 28 DAT Plant uptake study Foliar (4 600 g/ha) 7 DALA Root Potato Foliar (3 300 g/ha) 28 DALA Plant uptake study Leafy Lettuce Foliar ( g/ha,10 days interval) 7 DALA DALA: days after last application; DAT: days after treatment. The residue definitions set during the peer review for enforcement and risk assessment were confirmed under the Article 12 MRL review (EFSA, 2011a) as dimethomorph (sum of isomers). The residue definition for enforcement reported in Regulation (EC) No 396/2005 for plants is identical to the residue definition set during the peer review. For the uses on the crops under consideration, EFSA concludes that the metabolism of dimethomorph is sufficiently addressed and the residue definitions for enforcement and risk assessment agreed during the peer review are applicable Magnitude of residues a. Cauliflowers and others (flowering brassica) (SEU GAP: g/ha, PHI 7 days) Eight GAP compliant residue trials on cauliflowers and broccoli (four each) were submitted and are sufficient to derive a MRL proposal of 0.6 mg/kg. Based on the guidance document 7525/VI/95 rev.9 (European Commission, 2011), this value is extrapolated to cauliflowers and others (flowering brassica). 8 EFSA Journal 2016;14(1): 4381

9 This extrapolation is not proposed to broccoli since, based on a more critical GAP (3 225 g/ha, PHI 0 day) an import tolerance of 5 mg/kg has been derived for broccoli (EFSA, 2012) and implemented in the EU legislation by Regulation (EU) No 35/ b. Spinaches and similar leaves (SEU GAP: g/ha, PHI 7 days) Germany derived the MRL proposal by extrapolation form a combined dataset of residue trials on lettuces (twelve, reported as all on closed lettuce varieties) and lamb s lettuces (four), conducted according to the intended GAP (Germany, 2015). According to the guidance 7525/VI/95 rev.9 in force at time of application (European Commission, 2011), eight trials on lettuces of which, at least four on open leaf varieties, are required for the extrapolation to the whole group spinaches and similar leaves. Instead of open leaf variety of lettuces, the EMS proposed to consider four trials conducted on lamb s lettuce leaves. Taking into account that residues in lamb s lettuce are expected to be higher than in lettuces because of the small size of the leaves, EFSA proposes to accept this proposal. Based on a combined dataset of eleven trials on head lettuces and four on lamb s lettuces with residues in the range of <0.01 to 2.5 mg/kg a MRL of 4 mg/kg 9 is derived for the group spinaches and similar leaves. However, for spinaches, a more critical Codex use has been recently evaluated by EFSA and an increase of the MRL to 30 mg/kg recommended (FAO, 2014; EFSA, 2015). This proposal has been voted by the Standing Committee on Plants, Animals, Food and Feed held on 30 November and 1 December 205 (European Commission, 2015), but not yet implemented in the EU legislation. c. Globe artichokes (SEU GAP: g/ha, PHI 3 days) The EMS refers to four residue trials and a GAP already assessed by EFSA in a previous MRL application (EFSA, 2010) and confirmed during the Article 12 MRL review (EFSA, 2011a). Therefore, no change to the existing MRL of 2 mg/kg is proposed. The results of the residue trials, the related risk assessment input values (HR, STMR) and the MRL proposals are summarised in Table 4. The storage stability of dimethomorph residues was demonstrated in matrices with high water (tomatoes, broccoli, spinaches), high water/starch (potatoes), high acid (grapes), high oil (rape seed, hops) content for up to 24 months at 18 C (EFSA, 2006, 2011a). As the trial samples were stored for a maximum period of 16 months under conditions for which integrity of the samples was demonstrated, it is concluded that the residue data are valid with regard to storage stability. According to the EMS, the analytical methods used to analyse the residue trial samples have been sufficiently validated and were proven to be fit for the purpose (Germany, 2005). EFSA concludes that the data are sufficient to derive the following MRL proposals: 0.6 mg/kg Cauliflowers and others (flowering brassica) (SEU use), 4 mg/kg Purslanes, chards/beet leaves and others (SEU use). No change is proposed to the current MRL of 2 mg/kg on globe artichokes and to the MRL proposal of 30 mg/kg recently recommended for spinaches by EFSA in a previous scientific report (EFSA, 2015). 8 Commission Regulation (EU) No 35/2013 of 18 January 2013 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for dimethomorph, indoxacarb, pyraclostrobin and trifloxystrobin in or on certain products. OJ L 25, , p The difference in the MRL derived by the EMS (3 mg/kg) is due to the fact that EFSA has disregarded one value (0.46 mg/kg) from the MRL calculation, since related to immature lettuces collected in a trial conducted with an application at early growth stage (BBCH 17). 9 EFSA Journal 2016;14(1): 4381

10 Table 4: Overview of the available residues trials data Crop (trial GAP) Cauliflowers, Broccoli (3 180 g/ha, PHI 7 days) Lettuces, Lamb s lettuce (3 180 g/ha, PHI 7 days) Globe artichokes (3 180 g/ha, PHI 3 days) Region/ Indoor (a) Residue levels observed in the supervised residue trials (b) Recommendations/comments (c) SEU ; 0.02; 0.04; 0.05; 0.15; 0.22; 0.30 Data on broccoli underlined. MRL OECD :0.54/0.60 Extrapolation to cauliflowers and others (flowering brassica). SEU < 0.01; 0.02; 0.04; 0.08; 0.10; ; 0.26; 0.31; 0.45; 0.46; 0.50; 1.20; 1.20; 2.50 Data on lamb s lettuces are underlined. MRL OECD : 3.19/4.00 Extrapolation to the group spinaches and similar leaves, except spinaches. SEU 0.06; 0.09; 0.14; 0.32; 1.14 Data already assessed by EFSA (EFSA, 2010, 2011a). Higher value at a longer PHI (8 days) underlined. MRL OECD : 2.08/2.00 (a): NEU: Outdoor trials conducted in northern Europe, SEU: Outdoor trials conducted in southern Europe, Indoor: indoor EU trials or Country code: if non-eu trials. (b): Individual residue levels considered for MRL calculation are reported in ascending order. Mo: residue level according to the monitoring residue definition. RA: residue level according to the residue definition for risk assessment. (c): Any information/comment supporting the decision and OECD MRL calculation (unrounded/rounded values). (d): HR: Highest residue level according to the residue definition for risk assessment. (e): STMR: Median residue level according to residue definition for risk assessment. MRL proposal HR (d) STMR (e) EFSA Journal 2016;14(1): 4381

11 Effect of industrial processing and/or household preparation Standard hydrolysis studies simulating the effect on the nature of dimethomorph residues under processing conditions representative of pasteurisation, boiling and sterilisation were assessed during the peer review (EFSA, 2006). The active substance was confirmed to be hydrolytically stable under the representative conditions (EFSA, 2011a) and thus, for processed commodities, the same residue definitions as for RAC apply. Studies investigating the effect of processing on the magnitude of dimethomorph residues in cooked cauliflowers, purslanes or beet leaves/chards have not been submitted and are not necessary considering the low contribution of their residues to the total consumer exposure Rotational crops The metabolism in rotational crops was shown to be similar to that observed in primary crops and dimethomorph residues in the tested crops (carrots, spinaches and beans planted within 30 days after the last application of the active substance on potatoes treated three times at an application rate of 180 g/ha) were generally below the LOQ (0.01 mg/kg), except in dry beans or in the case of the early harvest of carrots or spinach. In the framework of the Article 12 MRL review, EFSA recommended plant-back restrictions (EFSA, 2011a). Flowering brassica and spinaches and similar leaves can be grown in crop rotation. As the proposed GAPs are comparable to the maximum rate assessed in the Article 12 MRL review, the same conclusions apply. EFSA recommends introducing at national level, plant-back restrictions when granting an authorisation for the intended uses of a dimethomorph-based plant protection product Nature and magnitude of residues in livestock As the crops under consideration are not normally fed to livestock, the nature and magnitude of dimethomorph residues in livestock is not assessed in the framework of this application (European Commission, 1996). 4. Consumer risk assessment The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). This exposure assessment model contains the relevant European food consumption data for different sub-groups of the EU population 10 (EFSA, 2007). In the framework of the Article 12 MRL review for dimethomorph, a comprehensive long-term exposure assessment was performed taking into account the existing uses at the EU level and the acceptable CXLs (EFSA, 2011a). Afterwards, this consumer exposure assessment has been updated by EFSA (EFSA, 2011b, 2012, 2013). EFSA now updated the long-term risk assessment performed in the latest issued reasoned opinion with the STMRs related to the CXLs assessed in the framework of the 47th session of the Codex Committee on Pesticide Residues (EFSA, 2015) and the STMRs for the crops under consideration derived from the residue trials reported in Table 4. The consumer safety of the use on globe artichokes reported in this MRL application was already assessed during the Article 12 MRL review and the conclusion remains valid (EFSA, 2011a). The acute exposure assessment was performed only with regard to the commodities for which a change of the existing MRL is proposed assuming the consumption of a large portion of the food items as reported in the national food surveys and that these items contained residues at the HR as observed in supervised field trials (see Table 4). A variability factor accounting for the inhomogeneous distribution on the individual items consumed was included in the calculation (EFSA, 2007). The input values used for the dietary exposure calculation are summarised in Table The calculation of the long-term exposure (chronic exposure) is based on the mean consumption data representative for 22 national diets collected from MS surveys plus 1 regional and 4 cluster diets from the WHO GEMS Food database; for the acute exposure assessment the most critical large portion consumption data from 19 national diets collected from MS surveys is used. The complete list of diets incorporated in EFSA PRIMo is given in its reference section (EFSA, 2007) EFSA Journal 2016;14(1): 4381

12 Table 5: Input values for the consumer dietary exposure assessment Commodity Chronic exposure assessment Input Comment Acute exposure assessment Input Comment Risk assessment residue definition: dimethomorph (sum of isomers) Cauliflowers 0.05 STMR 0.3 HR Others (flowering brassica) 0.05 STMR 0.3 HR Purslanes 0.3 STMR 2.5 HR Chards/beet leaves 0.3 STMR 2.5 HR Others (spinaches, similar leaves) 0.3 STMR 2.5 HR Spring onions 2.1 STMR (CXL) (EFSA, 2015) Acute risk assessment Spinaches 8.3 STMR (CXL) (EFSA, 2015) undertaken only with regard to the crops for which a Peas (without pods) 0.01 STMR (CXL) (EFSA, 2015) modification of MRL is proposed. Other commodities of plant and animal origin See Table 4-1 in Reasoned opinion on Article 10 (EFSA, 2013). The estimated exposure was then compared with the toxicological reference values derived for dimethomorph (see Table 2). The results of the intake calculation are presented in Appendix B. A long-term consumer intake concern was not identified for any of the European diets incorporated in the EFSA PRIMo. The total chronic intake calculated accounted for up to 16% of the ADI (French toddler). The contribution of residues in chards/beets leaves and cauliflowers to the total consumer exposure accounted for a maximum of 0.05% of the ADI (Spanish adult and Dutch child, respectively), whereas in purslanes was less than 0.01% of the ADI. An acute consumer risk was not identified in relation to the MRL proposals for the crops under consideration. The highest acute consumer exposure was calculated to be 7% of the ARfD for chards/beet leaves. EFSA concludes that the intended uses of dimethomorph on flowering brassica different than broccoli, purslanes, chards/beet leaves and others (code ) are not expected to result in a consumer exposure exceeding the toxicological reference values and therefore are unlikely to pose a health risk to consumers. Conclusions and recommendations The information submitted was sufficient to propose the MRLs summarised in the table below: Code (a) Commodity Existing EU MRL Proposed EU MRL Comment/Justification Enforcement residue definition: Dimethomorph (sum of isomers) Cauliflowers SEU (outdoor). Extrapolation from trials on Others 0.01* 0.6 broccoli and cauliflowers Spinaches 1 (30) CXL of 30 mg/kg not yet implemented in the EU legislation. See previous assessment (EFSA, 2015) Purslanes 0.01* 4 SEU (outdoor). Extrapolation from trials on Chards/beet leaves 1 4 lettuces and lamb s lettuces Others 0.01* Globe artichokes 2 No change GAP and data already assessed in previous reasoned opinions (EFSA 2010, 2011a). * Indicates that the MRL is set at the limit of analytical quantification (LOQ). (a): Commodity code number according to Annex I of Regulation (EC) No 396/ EFSA Journal 2016;14(1): 4381

13 References CEN (European Committee for Standardisation), Foods of plant origin Determination of pesticide residues using GC-MS and/or LC-MS/MS following acetonitrile extraction/partitioning and clean-up by dispersive SPE. QuEChERS-method. EN November EFSA (European Food Safety Authority), Conclusion on the peer review of the pesticide risk assessment of the active substance dimethomorph. EFSA Journal 2006;4(7):82r, 69 pp. doi:102903/j.efsa r EFSA (European Food Safety Authority), Reasoned opinion on the potential chronic and acute risk to consumers health arising from proposed temporary EU MRLs. EFSA Journal 2007;5(3):32r, 1141 pp. doi: /j.efsa r EFSA (European Food Safety Authority), Reasoned opinion on the modification on the modification of the existing MRLs for dimethomorph in various crops. EFSA Journal 2010;8(5):1622, 25 pp. doi: /j.efsa EFSA (European Food Safety Authority), 2011a. Review of the existing maximum residue levels (MRLs) for dimethomorph according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2011;9(8):2348, 64 pp. doi: /j.efsa EFSA (European Food Safety Authority), 2011b. Modification of the existing MRLs for dimethomorph in spinach and beet leaves (chard). EFSA Journal 2011;9(11):2437, 24 pp. doi: /j.efsa EFSA (European Food Safety Authority), Reasoned opinion on the modification of the existing MRLs for dimethomorph in several vegetable crops. EFSA Journal 2012;10(7):2845, 35 pp. doi: /j.efsa EFSA (European Food Safety Authority), Reasoned opinion on the modification of the existing MRLs for dimethomorph in seeds of spices and caraway. EFSA Journal 2013;11(2):3126, 27 pp. doi: /j.efsa EFSA (European Food Safety Authority), Scientific support for preparing an EU position in the 47th Session of the Codex Committee on Pesticide Residues (CCPR). EFSA Journal 2015;13(7):4208, 178 pp. doi: /j.efsa European Commission, Appendix G. Livestock Feeding Studies. 7031/VI/95-rev.4. European Commission, 1997a. Appendix A. Metabolism and distribution in plants. 7028/IV/95-rev.3. European Commission, 1997b. Appendix B. General recommendations for the design, preparation and realisation of residue trials. Annex 2. Classification of (minor) crops not listed in the Appendix of Council Directive 90/642/EEC. 7029/VI/95-rev.6. European Commission, 1997c. Appendix C. Testing of plant protection products in rotational crops. 7524/VI/95-rev.2. European Commission, 1997d. Appendix E. Processing studies. 7035/VI/95-rev.5. European Commission, 1997e. Appendix F. Metabolism and distribution in domestic animals. 7030/VI/95-rev.3. European Commission, 1997f. Appendix H. Storage stability of residue samples. 7032/VI/95-rev.5. European Commission, 1997g. Appendix I. Calculation of maximum residue level and safety intervals. 7039/VI/95. European Commission, Residue analytical methods. For pre-registration data requirement for Annex II (part A, section 4) and Annex III (part A, section 5 of Directive 91/414). SANCO/3029/99- rev.4. European Commission, Review report for the active substance dimethomorph. Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 24 November 2006 in 13 EFSA Journal 2016;14(1): 4381

14 view of the inclusion of dimethomorph in Annex I of Council Directive 91/414/EEC. SANCO/10040/2006-Rev.3, 24 November 2006, 8 pp. European Commission, 2010a. Classes to be used for the setting of EU pesticide Maximum Residue Levels (MRLs). SANCO 10634/2010 Rev. 0, finalised in the Standing Committee on the Food Chain and Animal Health at its meeting of March European Commission, 2010b. Residue analytical methods. For post-registration control. SANCO/825/00-rev.8.1. European Commission, Appendix D. Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs. 7525/VI/95-rev.9. European Commission, Summary report of the Standing Committee on Plants, Animals, Food and Feed (Section Phytopharmaceuticals Pesticide residues) held in Brussels on 30 November December sante.ddg2.g.001(2015) FAO (Food and Agriculture Organization of the United Nations), Submission and evaluation of pesticide residues data for the estimation of Maximum Residue Levels in food and feed. Pesticide Residues. 2nd Ed. FAO Plant Production and Protection Paper 197, 264 pp. FAO (Food and Agriculture Organization of the United Nations), 2014 Dimethomorph. In: Pesticide residues in food Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Core Assessment Group on Pesticide Residues. FAO Plant Production and Protection Paper 221, Germany, Draft assessment report on the active substance dimethomorph prepared by the rapporteur Member State Germany in the framework of Council Directive 91/414/EEC, December Available online: Germany, Addendum to the draft assessment report on the active substance dimethomorph prepared by the rapporteur Member State Germany in the framework of Council Directive 91/414/EEC, April Available online: Germany, Evaluation report on the modification of MRLs for dimethomorph in spinaches, cauliflowers, artichokes prepared by the evaluating Member State Germany under Article 8 of Regulation (EC) No 396/2005, 28 August 2015, 37 pp. OECD (Organisation for Economic Co-operation and Development), OECD MRL calculator: spreadsheet for single data set and spreadsheet for multiple data set, 2 March EFSA Journal 2016;14(1): 4381

15 Abbreviations a.s. ADI ARfD BBCH bw CEN CXL DALA DAR DAT EC EMS FAO GAP GCPF HPLC HR ISO IUPAC JMPR LOQ MRL MS/MS OECD PHI PRIMo QuEChERS RAC RMS SANTE SEU STMR TMDI WHO active substance acceptable daily intake acute reference dose growth stages of mono- and dicotyledonous plants body weight European Committee for Standardisation (Comité Européen de Normalisation) Codex maximum residue limit (Codex MRL) days after last application draft assessment report days after treatment emulsifiable concentrate evaluating Member State Food and Agriculture Organization of the United Nations good agricultural practice Global Crop Protection Federation (formerly International Group of National Associations of Manufacturers of Agrochemical Products (GIFAP)) high performance liquid chromatography highest residue International Organisation for Standardisation International Union of Pure and Applied Chemistry Joint FAO/WHO Meeting on Pesticide Residues limit of quantification maximum residue level tandem mass spectrometry detector Organisation for Economic Co-operation and Development pre-harvest interval (EFSA) Pesticide Residues Intake Model Quick, Easy, Cheap, Effective, Rugged, and Safe (analytical method) raw agricultural commodity rapporteur Member State European Commission s Directorate-General for Health and Food Safety, former SANCO southern Europe supervised trials median residue theoretical maximum daily intake World Health Organization 15 EFSA Journal 2016;14(1): 4381

16 Appendix A Good Agricultural Practice (GAPs) Crop and/or situation (a) NEU/ SEU F G or I (b) Pest or group of pests controlled (c) Formulation Application Application rate per treatment type (d f) conc. a.s. (i) Method kind (f h) Growth stage & season (j) Number min-max (k) Interval g/hl min-max Water L/ha min-max g/ha min-max PHI (days) (l) Remarks (m) Flowering brassica Spinaches & similar leaves Globe artichokes SEU F Peronospora, Alternaria brassicae EC 72 g/l SEU F Peronospora spp. EC 72 g/l SEU F Bremia lactucae EC 72 g/l Foliar spraying Foliar spraying Foliar spraying BBCH BBCH BBCH Remarks: (a) For crops, EU or other classifications, e.g. Codex, should be used; where relevant, the usage situation should be described (e.g. fumigation of a structure) (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (c) e.g. biting and sucking insects, soil-born insects, foliar fungi, weeds (d) e.g. wettable powder (WP), water soluble granule (WG) (e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 (f) all abbreviations must be explained (g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (h) Kind, eg. overall, broadcast, aerial spraying, row, individual plant, between the plants. type of equipment used must be indicated (i) g/kg or µg/l (j) Growth stage at last treatment (Meier U, Growth Stages of mono- and dicotyledonous plants. BBCH Monograph, 2nd Ed., Federal Biological Research Centre of Agriculture and Forestry, Braunschweig, Germany, 2001), including where relevant, information on season at time of application (k) The minimum and maximum number of application possible under practical conditions of use must be provided (l) PHI minimum pre-harvest interval (m) Remarks may include: Extent of use/economic importance/restrictions 16 EFSA Journal 2016;14(1): 4381

17 Appendix B Pesticide Residue Intake Model (PRIMo) Dimethomorph Status of the active substance: approved Code no. LOQ (mg/kg bw): proposed LOQ: Toxicological end points ADI (mg/kg bw/day): 0.05 ARfD (mg/kg bw): 0.6 Source of ADI: EC Source of ARfD: EC Year of evaluation: 2006 Year of evaluation: 2006 Chronic risk assessment - refined calculations TMDI (range) in % of ADI minimum - maximum 2 16 No of diets exceeding ADI: Highest calculated TMDI values in % of ADI MS Diet Highest contributor to MS diet (in % of ADI) Commodity / group of commodities 2nd contributor to MS diet (in % of ADI) Commodity / group of commodities 3rd contributor to MS diet (in % of ADI) Commodity / group of commodities ptmrls at LOQ (in % of ADI) 15.8 FR toddler 11.7 Spinach 1.0 Broccoli 0.8 Oranges NL child 6.2 Spinach 1.2 Oranges 0.9 Table grapes WHO Cluster diet B 2.6 Lettuce 2.1 Wine grapes 1.7 Tomatoes FR infant 7.4 Spinach 0.8 Broccoli 0.5 Milk and milk products: Cattle DE child 3.4 Spinach 1.5 Table grapes 1.4 Oranges IE adult 2.1 Spinach 1.5 Wine grapes 0.6 Celery ES adult 3.9 Lettuce 1.2 Spinach 0.5 Wine grapes WHO regional European diet 2.7 Lettuce 0.9 Head cabbage 0.6 Tomatoes NL general 2.4 Spinach 0.9 Lettuce 0.7 Wine grapes FR all population 4.7 Wine grapes 0.7 Lettuce 0.2 Tomatoes ES child 3.0 Lettuce 1.3 Spinach 0.8 Oranges WHO cluster diet E 1.9 Wine grapes 0.7 Spinach 0.7 Lettuce IT adult 2.7 Lettuce 1.6 Spinach 0.6 Tomatoes WHO Cluster diet F 2.2 Lettuce 0.7 Wine grapes 0.7 Head cabbage SE general population 90th percentile 1.5 Head cabbage 1.1 Spinach 0.4 Potatoes IT kids/toddler 2.1 Lettuce 1.0 Spinach 0.8 Tomatoes PT General population 2.9 Wine grapes 0.5 Potatoes 0.5 Tomatoes UK vegetarian 1.0 Lettuce 1.0 Wine grapes 0.6 Spinach UK Adult 1.3 Wine grapes 0.8 Lettuce 0.3 HOPS (dried), WHO cluster diet D 0.5 Tomatoes 0.4 Head cabbage 0.4 Wine grapes UK Toddler 0.8 Oranges 0.5 Spinach 0.3 Potatoes DK child 1.0 Lettuce 0.7 Cucumbers 0.3 Tomatoes DK adult 1.6 Wine grapes 0.2 Tomatoes 0.1 Head cabbage PL general population 0.9 Head cabbage 0.5 Tomatoes 0.4 Table grapes LT adult 1.0 Head cabbage 0.5 Lettuce 0.3 Tomatoes FI adult 0.6 Lettuce 0.4 Oranges 0.4 Wine grapes UK Infant 0.5 Oranges 0.3 Potatoes 0.2 Head cabbage 0.0 Conclusion: The estimated Theoretical Maximum Daily Intakes (TMDI), based on ptmrls were below the ADI. A long-term intake of residues of Dimethomorph is unlikely to present a public health concern EFSA Journal 2016;14(1): 4381

18 Processed commodities Unprocessed commodities Modification of the existing MRLs for dimethomorph in various crops Acute risk assessment /children - refined calculations Acute risk assessment / adults / general population - refined calculations The acute risk assessment is based on the ARfD. For each commodity the calculation is based on the highest reported MS consumption per kg bw and the corresponding unit weight from the MS with the critical consumption. If no data on the unit weight was available from that MS an average European unit weight was used for the IESTI calculation. In the IESTI 1 calculation, the variability factors were 10, 7 or 5 (according to JMPR manual 2002), for lettuce a variability factor of 5 was used. In the IESTI 2 calculations, the variability factors of 10 and 7 were replaced by 5. For lettuce the calculation was performed with a variabilty factor of 3. Threshold MRL is the calculated residue level which would leads to an exposure equivalent to 100 % of the ARfD. No of commodities for which ARfD/ADI is exceeded (IESTI 1): No of commodities for which No of commodities for which No of commodities for which ARfD/ADI is --- ARfD/ADI is exceeded (IESTI 2): --- ARfD/ADI is exceeded (IESTI 1): --- exceeded (IESTI 2): --- IESTI 1 *) **) IESTI 2 *) **) IESTI 1 *) **) IESTI 2 *) **) Highest % of ARfD/ADI ptmrl/ threshold MRL ptmrl/ threshold MRL ptmrl/ threshold MRL ptmrl/ threshold MRL Highest % of Highest % of Highest % of Commodities ARfD/ADI Commodities ARfD/ADI Commodities ARfD/ADI Commodities 7.3 Beet leaves (chard) 2.5 / Beet leaves 2.5 / Purslane 2.5 / Purslane 2.5 / Purslane 2.5 / Purslane 2.5 / Beet leaves (chard) 2.5 / Beet leaves (chard) 2.5 / Cauliflower 0.3 / Cauliflower 0.3 / Cauliflower 0.3 / Cauliflower 0.3 / No of critical MRLs (IESTI 1) No of critical MRLs (IESTI 2) No of commodities for which ARfD/ADI is exceeded: Highest % of ARfD/ADI No of commodities for which --- ARfD/ADI is exceeded: --- ***) ***) ptmrl/ ptmrl/ threshold MRL Highest % of Processed threshold MRL ARfD/ADI commodities Processed commodities *) The results of the IESTI calculations are reported for at least 5 commodities. If the ARfD is exceeded for more than 5 commodities, all IESTI values > 90% of ARfD are reported. **) ptmrl: provisional temporary MRL ***) ptmrl: provisional temporary MRL for unprocessed commodity Conclusion: For Dimethomorph IESTI 1 and IESTI 2 were calculated for food commodities for which ptmrls were submitted and for which consumption data are available. No exceedance of the ARfD/ADI was identified for any unprocessed commodity EFSA Journal 2016;14(1): 4381

19 Appendix C Used compound code Code/Trivial name Chemical name Structural formula dimethomorph (E,Z)-4-[3-(4-chlorophenyl)-3-(3,4- dimethoxyphenyl)acryloyl]morpholine 19 EFSA Journal 2016;14(1): 4381