European Food Safety Authority (EFSA)

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1 REASOED OPIIO APPROVED: 5 July 2016 doi: /j.efsa Modification of the existing maximum residue level for cyantraniliprole in table grapes Abstract European Food Safety Authority (EFSA) In accordance with Article 6 of Regulation (EC) o 396/2005, the evaluating Member State (EMS), France, received an application from DuPont de emours to modify the existing maximum residue level (MRL) for the active substance cyantraniliprole in table grapes. To accommodate for the intended use of cyantraniliprole, France proposed to raise the existing MRL from the limit of quantification (LOQ) of 0.01* to 1.5 mg/kg. According to EFSA, the data are sufficient to derive a MRL proposal of 1.5 mg/kg for the proposed use. Adequate analytical enforcement methods are available to control the residues of cyantraniliprole in table grapes. Based on the risk assessment results, EFSA concludes that the proposed use of cyantraniliprole on table grapes will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. Keywords: cyantraniliprole, table grapes, MRL application, consumer risk assessment Requestor: European Commission Question number: EFSA-Q Correspondence: pesticides.mrl@efsa.europa.eu EFSA Journal 2016;14(7):4553

2 Suggested citation: EFSA (European Food Safety Authority), Reasoned opinion on the modification of the existing maximum residue level for cyantraniliprole in table grapes. EFSA Journal 2016;14(7):4553, 14 pp. doi: /j.efsa ISS: European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. This is an open access article under the terms of the Creative Commons Attribution-oDerivs 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(7):4553

3 Summary In accordance with Article 6 of Regulation (EC) o 396/2005, the evaluating Member State (EMS) France, received an application from DuPont de emours to modify the existing maximum residue level (MRL) for the active substance cyantraniliprole in table grapes. To accommodate for the intended use of cyantraniliprole, France proposed to raise the existing MRL from the limit of quantification (LOQ) of 0.01 mg/kg to the proposed MRL of 1.5 mg/kg. France drafted an evaluation report in accordance with Article 8 of Regulation (EC) o 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 26 February EFSA bases its assessment on the evaluation report submitted by the EMS, the draft assessment report (DAR) prepared under Regulation (EC) 1107/2009, the conclusion on the peer review of the pesticide risk assessment of the active substance cyantraniliprole, the Joint Meeting on Pesticide Residues (JMPR) Evaluation report as well as the conclusions from previous EFSA opinions on cyantraniliprole. The toxicological profile of cyantraniliprole was assessed in the framework of the peer review under Regulation (EC) o 1107/2009 and the data were sufficient to derive an acceptable daily intake (ADI) of 0.01 mg/kg body weight (bw) per day. o acute reference dose (ARfD) was deemed necessary. The metabolism of cyantraniliprole in primary crops was investigated in the fruit, leafy, cereal/grass, pulses/oilseeds crop groups following foliar and soil applications. The peer review established the residue definition for enforcement and for risk assessment as cyantraniliprole. For the use on table grapes, EFSA concludes that the metabolism of cyantraniliprole in primary crops has been sufficiently addressed and that the residue definitions derived are applicable. The intended use on table grapes is adequately supported by the submitted supervised residue trials to derive a MRL proposal of 1.5 mg/kg. Adequate analytical enforcement methods are available to monitor the residues of cyantraniliprole in plant matrices/on the commodities under consideration at the validated limit of quantification (LOQ) of 0.01 mg/kg. Standard hydrolysis studies simulating the effect on the nature of cyantraniliprole residues under processing conditions representative of pasteurisation, boiling and sterilisation were assessed in the peer review process. In processed commodities, the residue definition was proposed as cyantraniliprole for enforcement and as the sum of cyantraniliprole and I-J9Z38 expressed as cyantraniliprole for risk assessment. Studies investigating the effect of processing on the magnitude of cyantraniliprole residues in processed products were assessed during the peer review and several processing factors (PF) were proposed. ew studies on the processing of table grapes have not been submitted and are not necessary as the total theoretical maximum daily intake (TMDI) is less than 10% of the ADI. As the proposed use of cyantraniliprole is on permanent crops and table grapes and their by-products are not intended to be used to feed livestock, investigations of residues in rotational crops and residues in livestock are not required. The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). 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 68% of the ADI (German, child). The contribution of table grapes to the overall long-term exposure accounted for 3%. o short-term consumer risk assessment was necessary as the toxicological studies for cyantraniliprole demonstrated that no ARfD was necessary. EFSA concludes that the proposed use of cyantraniliprole on table grapes will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a health risk to consumers. EFSA proposes to amend the existing MRL as reported in the summary table below: Code (a) Commodity Existing EU MRL (b) Proposed EU MRL Comment/justification Enforcement residue definition: Cyantraniliprole Table grapes 0.01* 1.5 The proposed MRL is sufficiently supported by data (residue trials in EU and SEU zones) o consumer health risk was identified MRL: maximum residue level; EU: northern Europe; SEU: southern Europe. (*): Indicates that the MRL is set at the limit of analytical quantification (LOQ). (a): Commodity code number according to Annex I of Regulation (EC) o 396/2005. (b): Default MRL value of 0.01 mg/kg (LOQ) according to Article 18(1)(b) of Regulation (EC) o 396/ EFSA Journal 2016;14(7):4553

4 Table of contents Abstract... 1 Summary... 3 Background... 5 The active substance and its use pattern... 5 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 ature and magnitude of residues in plant Primary crops ature of residues Magnitude of residues Effect of industrial processing and/or household preparation Rotational crops ature and magnitude of residues in livestock Consumer risk assessment... 9 Conclusions and recommendations References Abbreviations Appendix A Good agricultural practice Appendix B Used compound codes EFSA Journal 2016;14(7):4553

5 Background Regulation (EC) o 396/ (hereinafter referred to as the Regulation ) establishes the rules governing the setting of pesticide maximum residue levels (MRLs) at the 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 with Council Directive 91/414/EEC, 2 repealed by Regulation (EC) o 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. France, hereafter referred to as the evaluating Member State (EMS), received an application from the company DuPont de emours 4 to modify the existing MRL for the active substance cyantraniliprole in table grapes. 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 26 February The application was included in the EFSA Register of Questions with the reference number EFSA-Q and the following subject: Cyantraniliprole Modification of existing MRLs in table grapes France proposed to raise the existing MRL of cyantraniliprole in table grapes from the limit of quantification (LOQ) of 0.01* to 1.5 mg/kg. EFSA proceeded with the assessment of the application and the evaluation report as required by Article 10 of the Regulation. In accordance with Article 10 of Regulation (EC) o 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. The evaluation report submitted by the EMS (France, 2016) and the exposure calculations using the EFSA Pesticide Residues Intake Model (PRIMo) are considered as supporting documents to this reasoned opinion and, thus, are made publicly available. In accordance with Article 11 of the Regulation, the reasoned opinion shall be provided as soon as possible and at the latest within 3 months (which may be extended to 6 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 Cyantraniliprole is the ISO common name for 3-bromo-1-(3-chloro-2-pyridyl)-4 0 -cyano-2 0 -methyl (methylcarbamoyl) pyrazole-5-carboxanilide (IUPAC). The chemical structures of the active substance and its main metabolites are reported in Appendix B. Cyantraniliprole is used as insecticide. Cyantraniliprole is a new active substance currently not yet approved under Regulation (EC) o 1107/2009, for which the European Commission has established the completeness of the application dossier and the date of admissibility of the application was recognised as being 10 August The representative uses evaluated in the peer review process were foliar applications on various crops. The draft assessment report (DAR) (United Kingdom, 2013) has been peer reviewed by EFSA (2014). The peer review has been finalised, but a final decision concerning the approval of cyantraniliprole under Regulation (EC) o 1107/2009 is pending. The current EU MRLs for cyantraniliprole are established in Annex IIIA of Regulation (EC) o 396/2005. In accordance with Article 11(2) of Regulation (EC) o 1107/2009, the applicant requested to set MRLs for several commodities (orange/mandarin, apples/pears, peaches/apricots, plums, wine grapes, 1 Regulation (EC) o 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) o 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 DuPont de emours (Deutschland) GmbH, Hugenottenallee 175, eu-isenburg, Germany. 5 EFSA Journal 2016;14(7):4553

6 potatoes, tomatoes, peppers, cucumber/courgette, melon, lettuce, beans and olives) (EFSA, 2014). Following a complete consumer risk assessment, EFSA proposed MRLs for the crops mentioned. However, the MRLs have not yet been implemented in Regulation (EC) o 396/2005. Table 1 summarises the expected changes in the EU MRL legislation following recent assessments by EFSA. Table 1: Overview of MRL evolution since the entry into force of Regulation (EC) o 396/2005 Procedure (a) Considered by Regulation Implementation of CXL (EU) o 2015/845 Peer review conclusion ot yet implemented (EFSA, 2014) The Codex Alimentarius Commission (CAC) has established maximum residue limits (codex maximum residue limits; CXLs) for a wide range of commodities already implemented at the EU level; but no CXLs have been set for cyantraniliprole in table grapes. The details of the intended GAP for cyantraniliprole are given in Appendix A. Assessment EFSA has based its assessment on the evaluation report submitted by the EMS (France, 2016), the DAR prepared under Regulation (EC) o 1107/2009 (United Kingdom, 2013), the conclusion on the peer review of the pesticide risk assessment of the active substance cyantraniliprole (EFSA, 2014), the JMPR Evaluation report (FAO, 2013) as well as the conclusions from previous EFSA reasoned opinions on cyantraniliprole (EFSA, 2015, 2016). 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) o 546/ and the currently applicable guidance documents relevant to the consumer risk assessment of pesticide residues (European Commission, 1996, 1997a g, 2000, 2010a,b, 2015; OECD, 2011). 1. Method of analysis Remarks FAO (2014a,b) MRL proposals in accordance with Article 11(2) of Regulation (EC) o 1107/2009 Art. 10 (EFSA, 2015) ot yet implemented Cherries, strawberries, carrots, other root and tuber vegetables, Brussels sprouts, beans/peas (without pods), globe artichokes, herbal infusions, cucumbers (import tolerance) Art. 10 (EFSA, 2016) ot yet implemented Rice and coffee beans (import tolerance) FAO: Food and Agriculture Organization of the United ations; EFSA: European Food Safety Authority; CXL: Codex maximum residue limit; MRL: maximum residue level. (a): Art. 10: Assessment of MRL application according to Article 6 to 10 of Regulation (EC) o 396/ Methods for enforcement of residues in food of plant origin Analytical methods for the determination of cyantraniliprole residues in plant commodities were assessed during the peer review under Regulation (EC) o 1107/2009 (EFSA, 2014). The multiresidue DFG S19 method using LC-MS/MS quantification and its ILV were concluded to be fully validated for the determination of residues of cyantraniliprole and its metabolite I-J9Z38 in high water (apple, peach, tomato, lettuce, cucumber), high acid (orange, lemon, lime), high oil (almond, rape seed) content commodities, dry/starch (wheat grain, potato) matrices and in processed commodities (tomato paste and sun-dried tomato) at the LOQ of 0.01 mg/kg for each analyte (EFSA, 2015). Table grapes belong to the high acid content commodity group; therefore, EFSA concludes that sufficiently validated analytical methods are available for the control of cyantraniliprole in table grapes 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 application as grapes and their by-products are normally not fed to livestock. 5 Commission Regulation (EU) o 546/2011 of 10 June 2011 implementing Regulation (EC) o 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(7):4553

7 2. Mammalian toxicology The toxicological profile of the active substance cyantraniliprole was assessed in the framework of the peer review under Regulation (EC) o 1107/2009 (EFSA, 2014). The data were sufficient to derive toxicological reference values compiled in Table 2. Table 2: Overview of the toxicological reference values Source Year Value Study Safety factor Cyantraniliprole ADI EFSA mg/kg bw per day 1 year dog 100 ARfD EFSA 2014 ot necessary ADI: acceptable daily intake; ARfD: acute reference dose; bw: body weight; EFSA: European Food Safety Authority. 3. Residues 3.1. ature and magnitude of residues in plant Primary crops ature of residues The metabolism of cyantraniliprole in primary crops was evaluated in the framework of the peer review under Regulation (EC) o 1107/2009 in the fruit, leafy, cereals/grass, pulses/oilseeds crop groups (EFSA, 2014). An overview of the available metabolism studies is presented in Table 3. Table 3: Crop group Summary of available metabolism studies in plants Crops Applications Sampling (DAT) (a) Comments Fruit Tomato Foliar ( g/ha, BBCH 14-61) 125 DAT 3 (leaves, fruits) Foliar applications: Leafy Lettuce Soil drench ( g/ha, BBCH 19-61) 14 C-Cyano and C-pyrazole Foliar ( g/ha, BBCH 50) 0, 7, 14, 32 DAT 3 cyantraniliprole in Soil drench ( g/ha, BBCH 18-19) 7, 14, 32 DAT 3 a 1:1 mixture Cereals/ Rice Foliar ( g/ha, BBCH 13/14) 140 DAT 3 (straw, grain) formulation grass Soil granule ( g/ha, BBCH 13) 175 DAT (straw, grain) Soil applications: Pulses/ Cotton Foliar ( g/ha, BBCH 16-19) 124 DAT 3 (leaves, bolls) Separate studies with oilseeds each label Soil drench ( g/ha, BBCH 19) 125 DAT 3 (leaves, bolls) BBCH: growth stages of mono- and dicotyledonous plants. (a): DATx, days after treatment x. Based on these metabolism studies, the residue definition was proposed as cyantraniliprole for monitoring and for risk assessment in the conclusion of the peer review (EFSA, 2014). The current residue definition set in Regulation (EC) o 396/2005 is identical to the residue definition for enforcement derived in the peer review process. As table grapes belong to the fruit crop group, EFSA concludes that the metabolism of cyantraniliprole is sufficiently addressed and the residue definition as cyantraniliprole for enforcement and risk assessment is applicable Magnitude of residues In support of the MRL application, residues conducted on wine grapes according to the proposed GAP (EU, SEU GAP: g/ha, PHI 10 days) were provided. Ten residue trials were conducted in the EU zone, one of them was disregarded for being considered a replicate and four out of nine were slightly overdosed. Also, five of the nine supervised residue trials conducted in the SEU zone were conducted overdosed. Both EU and SEU data sets were merged for deriving the MRL as the p-value of the Mann Whitney U-test showed no significant difference among the two zones (FAO, 2009). Samples were analysed for cyantraniliprole at several PHIs (before and after the application at time 0, PHI 10, 21, 28, 56). The residues of cyantraniliprole were detected in the range of mg/kg 7 EFSA Journal 2016;14(7):4553

8 in the samples at PHI 10 days. Only in four of a total of 18 combined residue trials, the residue of cyantraniliprole was found highest after PHI 10, at a maximum residue level of 0.68 mg/kg at PHI 28. The results of the residue trials, the related risk assessment input values (highest residue, median residue) and the MRL proposal are summarised in Table 4. The stability of cyantraniliprole residues in plant matrices under storage conditions prior to analysis was assessed during the peer review under Regulation (EC) o 1107/2009 (EFSA, 2014). Residues of cyantraniliprole were found to be stable at 20 C at least 24 months in high water-, high acid- and dry/starch and dry/protein content matrices and for 18 months in high oil content matrices. As the trial samples were stored for a maximum period of 12 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 method used to analyse the residue trial samples has been sufficiently validated and was proved to be fit for purpose and guarantee the detection of cyantraniliprole residues and its metabolites at the LOQ of 0.01 mg/kg (France, 2016). EFSA concludes that the combined data are sufficient to derive a MRL proposal of 1.5 mg/kg in table grapes in EU and SEU zones resulting from the extrapolation from supervised residue trials in wine grapes. Table 4: Overview of the available residue trials data Crop (GAPs) Region/ indoor (a) Wine grapes GAP ( g/ha, PHI 10 days) Residue levels observed in the supervised residue trials (b) EU 0.07, 0.10, 0.14, 0.16, 0.24, 0.30, 0.33, 0.49, 0.68 SEU 0.07, 0.14, 0.19, 0.21, 0.28, 0.41, 0.48, 0.67, 0.80 Recommendations/ comments (c) Extrapolation from wine grapes to table grapes according to extrapolation rules (European Commission, 2015) Underlined values: overdosed residue values from residue trials conducted with an application rate of g/ha EU and SEU data sets show no significant difference (Mann- Whitney U-Test, 5%). Data sets combined to derive the MRL proposal MRL OECD : 1.21/1.50 MRL proposal HR (d) STMR (e) MRL: maximum residue level; OECD: Organisation for Economic Co-operation and Development; GAP: good agricultural practice; PHI: pre-harvest interval. (a): EU: 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. (c): Any information/comment supporting the decision and OECD MRL calculation (unrounded/rounded values). (d): HR: highest residue level according to the residue definition (cyantraniliprole parent compound). (e): STMR: median residue level according to residue definition (cyantraniliprole parent compound) Effect of industrial processing and/or household preparation Standard hydrolysis studies simulating the effect on the nature of cyantraniliprole residues under processing conditions representative for pasteurisation, boiling and sterilisation were assessed during the peer review process (EFSA, 2014). It was concluded that the active substance is hydrolytically stable under the representative conditions of pasteurisation and sterilisation, but slightly degraded under boiling conditions to I-J9Z38 and in a minor proportion, to metabolites I-5M09 and I-F6L99 resulting from the cleavage of the parent compound. Therefore, the residue definitions in processed commodities were proposed as cyantraniliprole for enforcement and as the sum of cyantraniliprole and I-J9Z38 expressed as cyantraniliprole for risk assessment (EFSA, 2014). Studies investigating the effect of processing on the magnitude of cyantraniliprole residues in processed products were assessed during the peer review process and processing factors (PF) were 8 EFSA Journal 2016;14(7):4553

9 proposed for several processed commodities (EFSA, 2014). ew studies on the processing of table grapes have not been submitted in the framework of the current application and are not necessary as the total theoretical maximum daily intake (TMDI) for table grapes is less than 10% of the ADI (European Commission, 1997d) Rotational crops As the proposed use of cyantraniliprole is on permanent crops, the investigation of residues in rotational crops is not required and is therefore not considered in this reasoned opinion ature and magnitude of residues in livestock As table grapes and/or their by-products are normally not fed to livestock, the nature and magnitude of cyantraniliprole 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 PRIMo. This exposure assessment model contains the relevant European food consumption data for different subgroups of the EU population 6 (EFSA, 2007). A large number of CXLs adopted by the CAC (FAO, 2014a,b) have been recently transposed in EU legislation by Regulation (EU) o 2015/845. The STMR values derived by JMPR for the crops concerned were taken into account in the long-term consumer intake calculation (FAO, 2014a,b); In addition, residues on crops assessed in the framework the peer review (EFSA, 2014) and in previous EFSA assessments (EFSA, 2015, 2016) were considered for the overall long-term exposure calculation. The input values used for the dietary exposure calculation are summarised in Table 5. It is highlighted that for plant and animal commodities, the same residue definitions for enforcement and risk assessment were proposed at Codex and EU level. For animal commodities, the residue definition for enforcement and risk assessment differs; therefore, conversion factors should be used for risk assessment purposes. The conversion factor for risk assessment of 2 (except for meat and honey, that is 1) proposed by EFSA in the conclusion of the peer review (EFSA, 2014) was also adopted by the JMPR for the purpose of the dietary intake calculations. Table 5: Input values for the consumer dietary exposure assessment Chronic exposure assessment Commodity Input Comment Risk assessment residue definition: Cyantraniliprole Table grapes 0.26 STMR (Table 4) Citrus fruit 0.16 STMR (EFSA, 2014) Pome fruit 0.16 STMR (FAO, 2013) Cherries 0.93 STMR (FAO, 2013) Peaches 0.34 STMR (FAO, 2013) Plums 0.12 STMR (EFSA, 2014) Wine grapes 0.32 STMR 9 PF 9 YF (a) (EFSA, 2014) Strawberries 0.16 STMR (EFSA, 2015) Blueberries (bush berries) 0.75 STMR (FAO, 2013) Currants (black, red and white) 0.75 STMR (FAO, 2013) Gooseberries (green, red and yellow) 0.75 STMR (FAO, 2013) Rose hips 0.75 STMR (FAO, 2013) Azarole/Mediterranean medlars 0.16 STMR (FAO, 2013) 6 The calculation of the long-term exposure (chronic exposure) is based on the mean consumption data representative of 22 national diets collected from MS surveys plus one regional and four 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 Member States surveys are used. The complete list of diets incorporated in EFSA PRIMo is given in its reference section (EFSA, 2007). 9 EFSA Journal 2016;14(7):4553

10 Chronic exposure assessment Commodity Input Comment Table olives 0.27 STMR (EFSA, 2014) Kaki/Japanese persimmons 0.16 STMR (FAO, 2013) Root and tuber vegetables 0.01 STMR (FAO, 2013) Garlic, onions, shallots 0.02 STMR (FAO, 2013) Spring onions, Welsh onions 1.3 STMR (FAO, 2013) Tomatoes 0.17 STMR (EFSA, 2014) Peppers 0.14 STMR (EFSA, 2014) Aubergines 0.14 STMR (EFSA, 2014) Okra, lady s fingers 0.14 STMR (EFSA, 2014) Cucurbits edible peel (excl. cucumbers) 0.08 STMR (EFSA, 2014) Cucumbers STMR (FAO, 2013) Cucurbits with inedible peel (excl. melon) 0.01 STMR (FAO, 2013) Melon 0.06 STMR (EFSA, 2014) Flowering brassica 0.56 STMR (FAO, 2013) Head brassica 0.56 STMR (FAO, 2013) Kohlrabies 0.56 STMR (FAO, 2013) Head lettuce 0.79 STMR (FAO, 2013) Beans without pods 0.01 STMR (EFSA, 2015) Peas without pods 0.01 STMR (EFSA, 2015) Celeries 2 STMR (FAO, 2013) Globe artichokes 0.03 STMR (EFSA, 2015) Rice 0.01 STMR (EFSA, 2016) Coffee beans 0.01 STMR (EFSA, 2016) Herbal infusions from roots 0.08 STMR (EFSA, 2015) Root and rhizome spices 0.08 STMR (EFSA, 2015) Sugar beet root 0.01 STMR (FAO, 2013) Chicory root 0.01 STMR (FAO, 2013) Ruminant meat STMR muscle STMR fat (FAO, 2013) Ruminant fat STMR 9 CF (b) (FAO, 2013) Ruminant liver, kidney STMR 9 CF (b) (FAO, 2013) Ruminant edible offal STMR 9 CF (b) (FAO, 2013) Milk STMR 9 CF (b) (FAO, 2013) Eggs 0.02 STMR 9 CF (b) (FAO, 2013) Other plant and animal Commodities MRL (c) MRLs in Regulation (EU) 2015/845 STMR: supervised trials median residue; FAO: Food and Agriculture Organization of the United ations; EFSA: European Food Safety Authority; PF: processing factors; MRL: maximum residue level. (a): Consumption figure in the PRIMo model is expressed for the raw commodity (grape). A yield factor (YF) of 0.7 is therefore considered to estimate the consumption figure for wine. (b): CF: Conversion factor for risk assessment of 2 has been proposed for animal commodities (except meat and honey) in the conclusion of the peer review (EFSA, 2014). (c): Chronic exposure performed taking into account the MRLs in the EU regulation, except, those set by default according to the Article 18(1)(b) of Regulation (EC) o 396/2005. The estimated exposure was then compared with the toxicological reference values derived for cyantraniliprole (Table 2). The results of the intake calculation using the EFSA PRIMo is a key supporting document and is made publicly available as a background document to this reasoned opinion. 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 68% of the ADI (German, child). The contribution of table grapes to the overall long-term exposure accounted for 3%. An acute 10 EFSA Journal 2016;14(7):4553

11 consumer exposure assessment was not performed, as the setting of an ARfD was concluded to be unnecessary for cyantraniliprole (EFSA, 2014). EFSA concludes that the intended use of cyantraniliprole on table grapes will not result in a consumer exposure scenario exceeding the toxicological reference value and therefore is unlikely to pose a concern for public health once the last EFSA MRL proposals would be implemented. Conclusions and recommendations The information submitted was sufficient to propose the MRL summarised in the table below: Code (a) Commodity Existing EU MRL (b) Proposed EU MRL Comment/justification Enforcement residue definition: Cyantraniliprole Table grapes 0.01* 1.5 The proposed MRL is sufficiently supported by data (residue trials in EU and SEU zones) o consumer health risk was identified MRL: maximum residue level; EU: northern Europe; SEU: southern Europe. (*): Indicates that the MRL is set at the limit of analytical quantification (LOQ). (a): Commodity code number according to Annex I of Regulation (EC) o 396/2005. (b): Default MRL value of 0.01 mg/kg (LOQ) according to Article 18(1)(b) of Regulation (EC) o 396/2005. References 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), Conclusion on the peer review of the pesticide risk assessment of the active substance cyantraniliprole. EFSA Journal 2014;12(9):3814, 249 pp. doi: /j.efsa EFSA (European Food Safety Authority), Modification of existing MRLs for cyantraniliprole in various crops. EFSA Journal 2015;13(10):4263, 25 pp. doi: /j.efsa EFSA (European Food Safety Authority), Setting of import tolerances for cyantraniliprole in rice and coffee beans. EFSA Journal 2016;14(4):4447, 14 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). SACO/3029/99-rev.4. European Commission, 2010a. Classes to be used for the setting of EU pesticide Maximum Residue Levels (MRLs). SACO 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. SACO/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. FAO (Food and Agriculture Organization of the United ations), Submission and evaluation of pesticide residues data for the estimation of Maximum Residue Levels in food and feed. Pesticide Residues. 2nd Edition. FAO Plant Production and Protection Paper 197, 264 pp. FAO (Food and Agriculture Organization of the United ations), Cyantraniliprole. 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 Expert Group on Pesticide Residues. FAO Plant Production and Protection Paper 219 FAO (Food and Agriculture Organization of the United ations), 2014a. Report of the 46th session of the Codex Committee on Pesticide Residues. anjing, China, 5 10 May FAO (Food and Agriculture Organization of the United ations), 2014b. Joint FAO/WHO food standards programme. Codex Alimentarius Commission. Appendices II and III. 37th session. Geneva, Switzerland, July EFSA Journal 2016;14(7):4553

12 France, Evaluation report on the setting of MRL for cyantraniliprole in table grapes prepared by the evaluating Member State France under Article 8 of Regulation (EC) o 396/2005, 23 February 2016, 16 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 In: Pesticide Publications/Publications on Pesticide Residues. Available online: United Kingdom, Draft assessment report on the active substance cyantraniliprole prepared by the rapporteur Member State the United Kingdom in the framework of Regulation (EC) o. 1107/2009, May Abbreviations a.s. ADI ARfD BBCH bw CAC CAS CF CXL DAR DAT EMS FAO GAP HR ILV ISO IUPAC JMPR LC LOQ MRL MS MS/MS MW EU OECD PF PHI PRIMo QuEChERS SACO SEU STMR TMDI WHO YF active substance acceptable daily intake acute reference dose growth stages of mono- and dicotyledonous plants body weight Codex Alimentarius Commission Chemical Abstracts Service conversion factor for enforcement to risk assessment residue definition Codex maximum residue limit draft assessment report days after treatment evaluating Member State Food and Agriculture Organization of the United ations good agricultural practice highest residue independent laboratory validation International Organisation for Standardisation International Union of Pure and Applied Chemistry Joint FAO/WHO Meeting on Pesticide Residues liquid chromatography limit of quantification maximum residue level Member States tandem mass spectrometry detector molecular weight northern Europe Organisation for Economic Co-operation and Development processing factor pre-harvest interval (EFSA) Pesticide Residues Intake Model Quick, Easy, Cheap, Effective, Rugged, and Safe (analytical method) Directorate-General for Health and Consumers southern Europe supervised trials median residue theoretical maximum daily intake World Health Organization yield factor 12 EFSA Journal 2016;14(7):4553

13 Appendix A Good agricultural practice Crop and/or situation EU, SEU, MS or country F G or I (a) Pests or group of pests controlled Preparation Application Application rate per treatment Type (b) Conc. a.s. Method kind Range of growth stages and season (c) umber min max Interval between application (min) g a.s./hl min max Water L/ha min max g a.s./ha min max PHI (days) (d) Remarks Table grapes EU SEU F Lobesia botrana, Eupoecilia ambiguella, Empoasca vitis SE 100 g/l Mist blowerfoliar spray BBCH days , Minimum recommended application rate 500 ml product/ha When applying low spray volume equipment, apply the equivalent amount of product to 1,000 L/ha EU: northern Europe; SEU: southern Europe; MS; Member State; BBCH: growth stages of mono- and dicotyledonous plants. (a): Outdoor or field use (F), greenhouse application (G) or indoor application (I). (b): CropLife International Technical Monograph no 2, 6th Edition. Revised May Catalogue of pesticide. (c): Growth stage range from first to last treatment (BBCH Monograph, Growth Stages of Plants, 1997, Blackwell, ISB ), including, where relevant, information on season at time of application. (d): PHI minimum pre-harvest interval EFSA Journal 2016;14(7):4553

14 : Appendix B Used compound codes Code/trivial Chemical name name Cyantraniliprole 3-bromo-1-(3-chloro-2-pyridyl)-4 0 -cyano-2 0 -methyl (methylcarbamoyl)pyrazole-5-carboxanilide MW: g/mol Structural formula O CH 3 H O H Br CH 3 Cl I-J9Z38 2-[3-bromo-1-(3-chloropyridin-2-yl)-1H-pyrazol-5-yl]-3, 8-dimethyl-4-oxo-3,4-dihydroquinazoline-6-carbonitrile Cl CH 3 Br O CH3 I-5M09 6-chloro-4-methyl-11-oxo-11H-pyrido[2,1-b]quinazoline- 2-carbonitrile Cl CH 3 O I-F6L99 3-bromo--methyl-1H-pyrazole-5-carboxamide O Br H CH 3 H 14 EFSA Journal 2016;14(7):4553