Reasoned Opinion on the modification of the existing MRLs for cyflufenamid in strawberries and peppers 1

Transcription

1 ESA Journal 2014;12(1):3542 ABSTRACT REASONED OPINION Reasoned Opinion on the modification the existing MRLs for id in strawberries and peppers 1 European ood Safety Authority 2 European ood Safety Authority (ESA), Parma, Italy In accordance with Article 6 Regulation (EC) No 396/2005, Greece, hereafter referred to as the evaluating Member State (EMS), received an application from Syngenta Hellas to modify the existing MRLs for id in peppers and strawberries. In order to accommodate for the intended indoor and outdoor European uses id, the EMS proposed to raise the existing MRLs to 0.04 mg/kg for both crops. EMS drafted an evaluation report in accordance with Article 8 Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to ESA. According to ESA the data are sufficient to derive a MRL proposal 0.04 mg/kg for id in strawberries and peppers. Based on the risk assessment results, ESA concludes that the intended use id on strawberries and peppers will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern. European ood Safety Authority, 2014 KEY WORDS id, strawberries and peppers, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, phenylacetamide fungicide 1 On request from the European Commission, Question No ESA-Q , approved on 15 January Correspondence: pesticides.mrl@efsa.europa.eu Suggested citation: European ood Safety Authority, Reasoned Opinion on the modification the existing MRLs for id in strawberries and peppers. ESA Journal 2014;12(1):3542, 25 pp. doi: /j.efsa Available online: European ood Safety Authority, 2014

2 SUMMARY In accordance with Article 6 Regulation (EC) No 396/2005, Greece, hereafter referred to as the evaluating Member State (EMS), received an application from Syngenta Hellas Aebe to modify the existing MRLs for id in peppers and strawberries. In order to accommodate for the intended indoor and outdoor European uses id, the EMS proposed to raise the existing MRL from 0.02 mg/kg to 0.04 mg/kg in both crops. EMS drafted an evaluation report in accordance with Article 8 Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to ESA on 30 August ESA bases its assessment on the evaluation report submitted by the EMS, the Draft Assessment Report (DAR) prepared by the rapporteur Member State United Kingdom under Council Directive 91/414/EEC, the conclusion on the peer review the pesticide risk assessment id as well as the conclusions from previous ESA reasoned opinions on id. The toxicological prile id was assessed in the framework the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI value 0.04 mg/kg bw per day and an ARfD value 0.05 mg/kg bw. The metabolism id in primary crops was investigated in wheat (cereals), apples and cucumbers (fruits and fruiting vegetable). or these crop groups the residue definition for enforcement and risk assessment has been established as the sum id (Z-). or the crops under consideration, ESA concludes that the metabolism id is sufficiently addressed and derived residue definitions are applicable. ESA concludes that the submitted supervised residue trials are sufficient to derive a MRL proposal 0.04 mg/kg for id in strawberries and peppers. Adequate analytical enforcement methods are available to control the residues id in the crops under consideration. The effect processing on the nature id has not been investigated. Specific studies to assess the magnitude id residues during the processing strawberries and peppers have not been submitted and are not necessary given low residues in the raw commodity. Strawberries and peppers can be grown in rotation with other plants and therefore the possible occurrence residues in succeeding crops has to be investigated. The metabolism id in rotational crops was assessed in the framework the peer review, where it was concluded that quantifiable residues id and its soil metabolites are not expected in parts rotational crops intended for human consumption and that field studies on rotational crops are not necessary. Since the intended total seasonal application rate on strawberries and peppers is lower than the application rate investigated in the framework the peer review, the same conclusions are applicable in the framework the current application. Since strawberries and peppers are normally not fed to livestock, the nature and magnitude id residues in livestock was not assessed in the framework this application. The consumer risk assessment was performed with revision 2 the ESA Pesticide Residues Intake Model (PRIMo). or the calculation chronic exposure, ESA used the median residue value as derived from the residue trials on strawberries and peppers. or several other commodities the risk assessment values were available from previously issued ESA reasoned opinions to refine the calculations. or the remaining commodities plant and animal origin, the existing MRLs as established in Annexes IIIA Regulation (EC) No 396/2005 were used as input values. The acute exposure assessment was performed only with regard to the commodities under consideration. The estimated exposure was then compared with the toxicological reference values derived for id. ESA Journal 2014;12(1):3542 2

3 No long-term consumer intake concerns were identified for any the European diets incorporated in the ESA PRIMo. The total calculated intake accounted for up to 4.6% the ADI (R toddler diet). The contribution residues in the crops under consideration to the total consumer exposure was low % the ADI both for strawberries (R toddler diet) and peppers (WHO Cluster diet B). No acute consumer risk was identified in relation to residues from the intended uses on strawberries (0.9% ARfD) and peppers (3.8% ARfD). ESA concludes that the intended use id on strawberries and peppers will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern. Thus ESA proposes to amend the existing MRLs as reported in the summary table. SUMMARY TABLE Code Commodity Existing number (a) EU MRL Proposed EU MRL Justification for the proposal Enforcement residue definition: the sum id (Z-) Strawberries 0.02* 0.04 The MRL proposals are sufficiently Peppers 0.02* 0.04 supported by data and no consumer health risk was identified for the intended uses. (a): According to Annex I Regulation (EC) No 396/2005. (*): Indicates that the MRL is set at the limit analytical quantification. ESA Journal 2014;12(1):3542 3

4 TABLE O CONTENTS Abstract... 1 Summary... 2 Table contents... 4 Background... 5 Terms reference... 5 The active substance and its use pattern... 6 Assessment Method analysis Methods for enforcement residues in food plant origin Methods for enforcement residues in food animal origin Mammalian toxicology Residues Nature and magnitude residues in plant Primary crops Rotational crops Nature and magnitude residues in livestock Consumer risk assessment Conclusions and recommendations References Appendices Appendix A. Good Agricultural Practice (GAPs) Appendix B. Pesticide Residue Intake Model (PRIMo) Appendix C. Existing EU maximum residue levels (MRLs) Appendix D. List metabolites and related structural formula Abbreviations ESA Journal 2014;12(1):3542 4

5 BACKGROUND Regulation (EC) No 396/ establishes the rules governing the setting pesticide MRLs at European Union level. Article 6 that Regulation lays down that any party having a legitimate interest or requesting an authorisation for the use a plant protection product in accordance with Council Directive 91/414/EEC 4, repealed by Regulation (EC) No 1107/2009 5, shall submit to a Member State, when appropriate, an application to set or to modify a MRL in accordance with the provisions Article 7 that Regulation. Greece, hereafter referred to as the evaluating Member State (EMS), received an application from the company Syngenta Hellas Aebe 6 to modify the existing MRLs for the active substance id in strawberries and peppers. This application was notified to the European Commission and ESA and was subsequently evaluated by the EMS in accordance with Article 8 the Regulation. After completion the evaluation report was submitted to the European Commission who forwarded the application, the evaluation report and the supporting dossier to ESA on 30 August The application was included in the ESA Register Questions with the reference number ESA-Q and the following subject: Cyflufenamid - Application to modify the existing MRLs in strawberries and pepper. EMS proposed to raise the existing MRL id from the limit quantification (LOQ) 0.02 mg/kg to 0.04 mg/kg both in strawberries and peppers. ESA proceeded with the assessment the application and the evaluation report as required by Article 10 the Regulation. TERMS O REERENCE In accordance with Article 10 Regulation (EC) No 396/2005, ESA shall, based on the evaluation report provided by the evaluating Member State, provide a reasoned opinion on the risks to the consumer associated with the application. In accordance with Article 11 that 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 where more detailed evaluations need to be carried out) from the date receipt the application. Where ESA requests supplementary information, the time limit laid down shall be suspended until that information has been provided. In this particular case the deadline for providing the reasoned opinion is 30 November Regulation (EC) No 396/2005 the Parliament and the Council 23 ebruary 2005 on maximum residue levels pesticides in or on food and feed plant and animal origin and amending Council Directive 91/414/EEC. OJ L 70, , p Council Directive 91/414/EEC 15 July 1991 concerning the placing plant protection products on the market. OJ L 230, , p Regulation (EC) No 1107/2009 the European Parliament and the Council 21 October 2009 concerning the placing plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. OJ L 309, , p Syngenta Hellas Aebe, Anthoussas Avenue, Anthoussa Attikis, GR-15349, Athens, Greece ESA Journal 2014;12(1):3542 5

6 THE ACTIVE SUBSTANCE AND ITS USE PATTERN Cyflufenamid is the ISO common name for (Z)-N-[α-(cyclopropylmethoxyimino)-2,3-difluoro-6- (trifluoromethyl)benzyl]-2-phenylacetamide (IUPAC). The chemical structure the compound is reported below. N O O C 3 N H Molecular weight: Cyflufenamid is a fungicide belonging to the phenylacetamide chemical class. Although its mode action is still unknown, the compound has shown to be effective against powdery/downy mildew in plants. Cyflufenamid has good translaminar movement and vapour action, but is poorly translocated within the plant. Cyflufenamid was evaluated in the framework Council Directive 91/414/EEC with the United Kingdom designated as a rapporteur Member State (RMS). It was included in Annex I this Directive by Commission Directive 2009/154/EC 7 which entered into force on 1 April 2010 for use as fungicide. In accordance with Commission Implementing Regulation (EU) No 540/ id is approved under Regulation (EC) No 1107/2009. The representative uses evaluated in the peer review were foliar applications on wheat, rye and barley. The Draft Assessment Report (DAR) id has been peer reviewed by ESA and therefore an ESA conclusion is available (ESA, 2009a). The EU MRLs for id are established in Annex IIIA Regulation (EC) No 396/2005 (Appendix C). Since the entry into force the above mentioned Regulation, MRL proposals for oats, animal products, apples, pears, grapes, cucumbers, courgettes and melons have been evaluated by ESA (ESA, 2009b, 2011). Recently an ESA reasoned opinion was issued on the modification the existing MRLs for id in pome fruits, cucurbits (inedible peel) and gherkins (ESA, 2013). These MRL proposals were voted by the SCoCAH on September 2013, but the Regulation is not yet published. The existing EU MRLs for id on strawberries and peppers are set at the LOQ 0.02 kg/kg. There are no CXLs established for id. The review id MRLs according to Article 12 Regulation (EC) No 396/2005 is currently at an early stage and is not expected to be finalized imminently. The details the intended indoor and outdoor SEU and NEU GAPs for the use id on strawberries and peppers are given in Appendix A. 7 Commision Directive 2009/154/EC 30 November 2009 amending Council Directive 91/414/EEC to include id as active substance. OJ L 314, , p Commission Implementing Regulation (EU) No 540/ May 2011 implementing Regulation (EC) No 1107/2009 the European Parliament and the Council as regards the list approved active substances. OJ L 153, , p ESA Journal 2014;12(1):3542 6

7 ASSESSMENT ESA bases its assessment on the evaluation report submitted by the EMS (Greece, 2013), the Draft Assessment Report (DAR) prepared under Council Directive 91/414/EEC (United Kingdom, 2006), the conclusion on the peer review the pesticide risk assessment the active substance id (ESA, 2009a) as well as the conclusions from previous ESA reasoned opinions on id (ESA, 2009b, 2011, 2013). The assessment is performed in accordance with the legal provisions the Uniform Principles for the Evaluation and the Authorisation Plant Protection Products adopted by Commission Regulation (EU) No 546/ and the currently applicable guidance documents relevant for the consumer risk assessment pesticide residues (EC, 1996, 1997a-g, 2000, 2010a,b; OECD, 2011). 1. Method analysis 1.1. Methods for enforcement residues in food plant origin The availability the analytical enforcement methods for the determination id residues in plant commodities was investigated in the framework the peer review (ESA, 2009a) and in the previously issued ESA reasoned opinions (ESA, 2011; 2013). An analytical enforcement method using GC-MSD has been sufficiently validated for the determination id in dry commodities and in commodities with high water and high acid content. The method is compliant with the enforcement residue definition in plants, which includes the Z- (id) and the E-, and is validated at the LOQ 0.01 mg/kg for the sum s (ESA, 2009a, 2011). The multi-residue QuEChERS method (HPLC-MS/MS) described in the European Standard EN 15662:2008 is also validated to analyse id residues in matrices with high water-, high acid-, high oil content and in dry commodities at the LOQ 0.01 mg/kg for the sum s (CEN, 2008). ESA concludes that sufficiently validated analytical methods are available to control id residues in the crops under consideration Methods for enforcement residues in food animal origin Analytical methods for the determination residues in food animal origin were not assessed in the current application, since the crops under consideration are not fed to livestock. 2. Mammalian toxicology The toxicological prile the active substance id was assessed in the framework the peer review under Council Directive 91/414/EEC (ESA, 2009a). The data were sufficient to derive toxicological reference values for id which are compiled in Table 2-1. Table 2-1: Overview the toxicological reference values Cyflufenamid Source Year Value Study relied upon Safety factor ADI ESA mg/kg bw per day 2-yr rat and 1-yr dog studies 100 ARfD ESA mg/kg bw Rabbit, developmental toxicity study (maternal toxicity) Commission Regulation (EU) No 546/ June 2011 implementing Regulation (EC) No 1107/2009 the European Parliament and the Council as regards uniform principles for evaluation and authorisation plant protection products. OJ L 155, , p ESA Journal 2014;12(1):3542 7

8 3. Residues 3.1. Nature and magnitude residues in plant Primary crops Nature residues The metabolism id in primary crops was investigated after foliar applications in wheat (cereals) during the peer review (United Kingdom, 2006; ESA, 2009a) and in apples and cucumbers (fruits and fruiting vegetables) in the framework a previous MRL application (ESA, 2011). The studies were performed with the compound radiolabelled in the phenyl ring or the cyclopropyl ring (wheat only). The details the metabolism studies are reported in the previous ESA reasoned opinion (ESA, 2011). The peer review established the residue definition for both enforcement and risk assessment as the sum id (Z-) for cereals. The E- was included in the residue definition for enforcement because the analytical method does not allow a separate determination the two s (ESA, 2013). Although in the apple and cucumber metabolism studies no significant ic conversion from the Z- to the E- occurred, ESA proposed to apply the residue definitions derived by the peer review for cereals also to fruits and fruiting vegetables (ESA, 2011). The current enforcement residue definition in plants set in Regulation (EC) No 396/2005 is identical to the residue definition for enforcement derived in the peer review for cereals and for fruits and fruiting vegetables. or the use on the crops under consideration, ESA concludes that the metabolism id is sufficiently addressed Magnitude residues a. Strawberries The applicant submitted in total twenty four GAP compliant residue trials on strawberries in support the SEU use (8 trials), NEU use (8 trials) and indoor use (8 trials). All trials were performed in various European countries over growing seasons 2011 and Residue data are sufficient to derive a MRL proposal 0.04 mg/kg for id in strawberries. b. Peppers The applicant submitted in total twenty four GAP compliant residue trials on peppers in support the SEU use (8 trials), NEU use (8 trials) and indoor use (8 trials). All trials were performed in various European countries over growing seasons 2009, 2011 and The intended uses are sufficiently supported by residue trials data. Based on slightly more critical NEU and indoor uses, a MRL proposal 0.04 mg/kg is derived for id in peppers. The results the residue trials, the related risk assessment input values (highest residue, median residue) and the MRL proposals are summarised in Table 3-1. reezer storage stability data were reported in the DAR under Directive 91/414/EEC (United Kingdom, 2006) and were evaluated during the peer review (ESA, 2009a). The data showed that residues id are stable at -18 C in barley straw and shoots for at least 25 months and in barley grain for at least 22 months. Storage stability data on high water content commodities (apples, cucumbers) and high acid content commodities (grapes) were submitted and assessed in the previous ESA reasoned opinion (ESA, 2011). The residues the parent compound were stable in matrices with high water content for up to 283 days (ca. 9 months) and in matrices with high acid content for 126 days (ca. 4 months) when samples are stored at -18 C. ESA Journal 2014;12(1):3542 8

9 In the framework the current application, the applicant submitted a new study where the storage stability id was investigated for 2 years in grapes, wheat grain, rape seeds and dry beans (Greece, 2013). The samples were fortified separately with id and E-. In samples (fresh or frozen) fortified with id, a slight isation to E- was observed (4%). In frozen and freshly fortified samples with E- the isation to id ranged from 4-23% and 2-24% respectively, indicating that isation primarily occurred during sample preparation. Results demonstrated that residues id are stable in grapes, dry beans and wheat grain for 24 months under deep frozen conditions. Cyflufenamid was stable in oilseed rape for at least 18 months, whereas for E- recoveries below 70% were observed at the sampling points 3 and 18 months. It is not fully clear whether these were related to isation to id (Z-). The supervised residue trial samples strawberries prior to analysis were stored frozen for a maximum 6 months and residue trials samples peppers for 8 months. As the supervised residue trial samples were stored under conditions for which integrity 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 supervised residue trial samples have been sufficiently validated and were proven to be fit for the purpose (Greece, 2013). ESA Journal 2014;12(1):3542 9

10 Table 3-1: Overview the available residues trials data Commodity Residue region (a) Outdoor/ Indoor Individual trial results Enforcement (sum id (Z-) ) Risk assessment (sum id (Z-) ) Median residue (b) Highest residue (c) MRL proposal Median C (d) Comments (e) Strawberries NEU Outdoor 5 x <0.02; 2 x 0.02; x <0.02; 2 x 0.02; 0.03 R ber =0.04 R max =0.033 MRL OECD = 0.037/0.04 SEU Outdoor 6 x <0.02; 0.02; x <0.02; 0.02; 0.03 R ber = R max =0.033 MRL OECD = 0.035/0.04 EU Indoor 7 x <0.02; x <0.02; 0.03 R ber =0.04 R max =0.033 MRL OECD = 0.035/0.04 Peppers NEU Outdoor 6 x <0.02; 0.02; x <0.02; 0.02; R ber =0.04 R max =0.033 MRL OECD = 0.035/0.04 SEU Outdoor 8 x < x <0.02 <0.02 < * 1 - EU Indoor 5 x <0.02; 2 x 0.02; x <0.02; 2 x 0.02; R ber =0.04 R max =0.033 MRL OECD = 0.037/0.04 (a): NEU (Northern and Central Europe), SEU (Southern Europe and Mediterranean), EU (i.e. indoor use) or Import (country code) (EC, 2011). (b): Median value the individual trial results according to the enforcement residue definition. (c): Highest value the individual trial results according to the enforcement residue definition. (d): The median conversion factor for enforcement to risk assessment is obtained by calculating the median the individual conversion factors for each residue trial. (e): Statistical estimation MRLs according to the EU methodology (R ber, R max ; EC, 1997g) and unrounded/rounded values according to the OECD methodology (OECD, 2011). (*): Indicates that the MRL is set at the limit analytical quantification. ESA Journal 2014;12(1):

11 Effect industrial processing and/or household preparation The effect processing on the nature id has not been investigated as the need for studies was not triggered in the framework the peer review (ESA, 2009a). Specific studies to assess the magnitude id residues during the processing strawberries and peppers have not been submitted and are not necessary given low residues in the raw commodity Rotational crops Preliminary considerations Strawberries and peppers can be grown in rotation with other plants and therefore the possible occurrence residues in succeeding crops resulting from the use on primary crops has to be assessed. According to the soil degradation studies performed in the framework the peer review, the DT90 values were derived for id and its relevant soil metabolites. Under aerobic soil conditions id exhibits low to high persistence (DT 90f 301 day) and forms its relevant soil metabolites: , , and (United Kingdom, 2006). The DT 90 values for id and its metabolites (DT 90lab 1093 days) and (DT 90lab 2138 days), exceed 100 days and therefore rotational crop studies are necessary Nature residues The metabolism id in rotational crops was assessed in the framework the peer review (United Kingdom, 2006; ESA, 2009a). The studies have been discussed in more detail in the previous ESA reasoned opinions on the modification the existing MRLs for id (ESA, 2011, 2013). Based on a confined rotational crop study where soil was treated with 50 g a.s./ha and rotational crops (wheat, carrots, lettuce) were sown or planted at various plant back intervals (30, 120 and 270 days), the peer review concluded that quantifiable residue (above the LOQ) id and its soil metabolites are not expected in parts rotational crops intended for human consumption and that field studies on rotational crops are not necessary (ESA, 2009a). Since the intended total seasonal application rate on strawberries and pepper is lower (0.6N) than the application rate investigated in the framework the peer review, ESA concludes that significant residue levels id in rotational/succeeding crops are not expected, provided that id is used according to the intended GAP Magnitude residues Rotational crop field studies are not available (see section ) Nature and magnitude residues in livestock Since strawberries and peppers are not normally fed to livestock, the nature and magnitude id residues in livestock was not assessed in the framework this application : N'-(cyclopropylmethoxy)-2,3-difluoro-6-(trifluoromethyl)benzenecarboximidamide: see Appendix D : (Z)-N-[α-(cyclopropylmethoxyimino)-2,3-difluoro-6-(trifluoromethyl)benzyl]malonamic acid: see Appendix D : 2,3-difluoro-6-(trifluoromethyl)benzamidine: see Appendix D : 2,3-difluoro-6-(trifluoromethyl)benazamide: see Appendix D ESA Journal 2014;12(1):

12 4. Consumer risk assessment Modification the existing MRLs for id in strawberries and peppers The consumer risk assessment was performed with revision 2 the ESA Pesticide Residues Intake Model (PRIMo). This exposure assessment model contains the relevant European food consumption data for different sub-groups the EU population 14 (ESA, 2007). or the calculation chronic exposure, ESA used the median residue value as derived from the residue trials on strawberries and peppers (see Table 3-1). or several other commodities the risk assessment values were available from the previously issued ESA reasoned opinions to refine the calculations (ESA, 2009b; 2011, 2013). or the remaining commodities plant and animal origin, the existing MRLs as established in Annexes IIIA Regulation (EC) No 396/2005 were used as input values. The model assumptions for the long-term exposure assessment are considered to be sufficiently conservative for a first tier exposure assessment, assuming that all food items consumed have been treated with the active substance under consideration. In reality, it is not likely that all food consumed will contain residues at the MRL or at levels the median residue values identified in supervised field trials. However, if this first tier exposure assessment does not exceed the toxicological reference value for long-term exposure (i.e. the ADI), a consumer health risk can be excluded with a high probability. The acute exposure assessment was performed only with regard to the commodities under consideration assuming the consumption a large portion the food items as reported in the national food surveys containing residues at the highest level as observed in supervised field trials. A variability factor accounting for the inhomogeneous distribution on the individual items consumed was included in the calculation, when required (ESA, 2007). The input values used for the dietary exposure calculation are summarised in Table 4-1. Table 4-1: Input values for the consumer dietary exposure assessment Commodity Chronic exposure assessment Acute exposure assessment Input value Comment Input value Risk assessment residue definition: Sum id (Z-) Strawberries 0.02 Median residue (Table 3-1) Peppers 0.02 Median residue (Table 3-1) Pome fruit Median residue (ESA, 2011, 2013) Table and wine grapes Cucurbits (inedible peel) Gherkins, courgettes Median residue (ESA, 2011) Median residue (ESA, 2011, 2013) 0.02 Median residue (ESA, 2011, 2013) Cucumbers 0.01 Median residue (ESA, 2011) Comment 0.03 Highest residue (Table 3-1) 0.03 Highest residue (Table 3-1) Acute risk assessment was undertaken only with regard to the crops under consideration. 14 The calculation 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 ood 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 diets incorporated in ESA PRIMo is given in its reference section (ESA, 2007). ESA Journal 2014;12(1):

13 Commodity Chronic exposure assessment Acute exposure assessment Input value Comment Oats 0.02 Median residue (ESA, 2009b) Other commodities plant and animal origin MRL See Appendix C Input value Comment The estimated exposure was then compared with the toxicological reference values derived for id (see Table 2-1). The results the intake calculation are presented in Appendix B to this reasoned opinion. No long-term consumer intake concerns were identified for any the European diets incorporated in the ESA PRIMo. The total calculated intake accounted for up to 4.6% the ADI (R toddler diet). The contribution residues in the crops under consideration to the total consumer exposure accounted for a maximum 0.03% the ADI both for strawberries (R toddler diet) and peppers (WHO Cluster diet B). No acute consumer risk was identified in relation to the intended uses on strawberries (0.9% ARfD) and peppers (3.8% ARfD). ESA concludes that the intended use id on strawberries and peppers will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern. CONCLUSIONS AND RECOMMENDATIONS CONCLUSIONS The toxicological prile id was assessed in the framework the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI value 0.04 mg/kg bw per day and an ARfD value 0.05 mg/kg bw. The metabolism id in primary crops was investigated in wheat (cereals), apples and cucumbers (fruits and fruiting vegetable). or these crop groups the residue definition for enforcement and risk assessment has been established as the sum id (Z-). or the crops under consideration, ESA concludes that the metabolism id is sufficiently addressed and derived residue definitions are applicable. ESA concludes that the submitted supervised residue trials are sufficient to derive a MRL proposal 0.04 mg/kg for id in strawberries and peppers. Adequate analytical enforcement methods are available to control the residues id in the crops under consideration. The effect processing on the nature id has not been investigated. Specific studies to assess the magnitude id residues during the processing strawberries and peppers have not been submitted and are not necessary given low residues in the raw commodity. Strawberries and peppers can be grown in rotation with other plants and therefore the possible occurrence residues in succeeding crops has to be investigated. The metabolism id in rotational crops was assessed in the framework the peer review, where it was concluded that quantifiable residues id and its soil metabolites are not expected in parts rotational crops intended for human consumption and that field studies on rotational crops are not necessary. Since the intended total seasonal application rate on strawberries and peppers is lower than the ESA Journal 2014;12(1):

14 application rate investigated in the framework the peer review, the same conclusions are applicable in the framework the current application. Since strawberries and peppers are normally not fed to livestock, the nature and magnitude id residues in livestock was not assessed in the framework this application. The consumer risk assessment was performed with revision 2 the ESA Pesticide Residues Intake Model (PRIMo). or the calculation chronic exposure, ESA used the median residue value as derived from the residue trials on strawberries and peppers. or several other commodities the risk assessment values were available from previously issued ESA reasoned opinions to refine the calculations. or the remaining commodities plant and animal origin, the existing MRLs as established in Annexes IIIA Regulation (EC) No 396/2005 were used as input values. The acute exposure assessment was performed only with regard to the commodities under consideration. The estimated exposure was then compared with the toxicological reference values derived for id. No long-term consumer intake concerns were identified for any the European diets incorporated in the ESA PRIMo. The total calculated intake accounted for up to 4.6% the ADI (R toddler diet). The contribution residues in the crops under consideration to the total consumer exposure was low % the ADI both for strawberries (R toddler diet) and peppers (WHO Cluster diet B). No acute consumer risk was identified in relation to residues from the intended uses on strawberries (0.9% ARfD) and peppers (3.8% ARfD). ESA concludes that the intended use id on strawberries and peppers will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a public health concern. RECOMMENDATIONS Code Commodity Existing number (a) EU MRL Proposed EU MRL Justification for the proposal Enforcement residue definition: the sum id (Z-) Strawberries 0.02* 0.04 The MRL proposals are sufficiently Peppers 0.02* 0.04 supported by data and no consumer health risk was identified for the intended uses. (a): According to Annex I Regulation (EC) No 396/2005. (*): Indicates that the MRL is set at the limit analytical quantification REERENCES CEN (European Committee for Standardisation), oods plant origin - Determination pesticide residues using GC-MS and/or LC-MS/MS following acetonitrile extraction/partitioning and clean-up by dispersive SPE. QuEChERS-method. EN November EC (European Commission), Appendix G. Livestock eeding Studies. 7031/VI/95-rev.4. EC (European Commission), 1997a. Appendix A. Metabolism and distribution in plants. 7028/IV/95- rev.3. EC (European Commission), 1997b. Appendix B. General recommendations for the design, preparation and realisation residue trials. Annex 2. Classification (minor) crops not listed in the Appendix Council Directive 90/642/EEC. 7029/VI/95-rev.6. EC (European Commission), 1997c. Appendix C. Testing plant protection products in rotational crops. 7524/VI/95-rev.2. ESA Journal 2014;12(1):

15 EC (European Commission), 1997d. Appendix E. Processing studies. 7035/VI/95-rev.5. EC (European Commission), 1997e. Appendix. Metabolism and distribution in domestic animals. 7030/VI/95-rev.3. EC (European Commission), 1997f. Appendix H. Storage stability residue samples. 7032/VI/95- rev.5. EC (European Commission), 1997g. Appendix I. Calculation maximum residue level and safety intervals. 7039/VI/95. EC (European Commission), Residue analytical methods. or pre-registration data requirement for Annex II (part A, section 4) and Annex III (part A, section 5 Directive 91/414). SANCO/3029/99-rev.4. EC (European Commission), Review report for the active substance id. inalised in the Standing Committee on the ood Chain and Animal Health at its meeting on 2 October 2009 in view the inclusion id in Annex I Council Directive 91/414/EEC. SANCO/6612/09 - final, 2 October 2009, 8 pp. EC (European Commission), 2010a. Classes to be used for the setting EU pesticide Maximum Residue Levels (MRLs). SANCO 10634/2010 Rev. 0, finalised in the Standing Committee on the ood Chain and Animal Health at its meeting March EC (European Commission), 2010b. Residue analytical methods. or post-registration control. SANCO/825/00-rev.8.1. EC (European Commission), Appendix D. Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs. 7525/VI/95-rev.9. ESA (European ood Safety Authority), Reasoned opinion on the potential chronic and acute risk to consumers health arising from proposed temporary EU MRLs. Available online ESA (European ood Safety Authority), 2009a. Conclusion on the peer review the pesticide risk assessment the active substance id. The ESA Journal 2009, 258r, 1-99, doi: /j.efsa r ESA (European ood Safety Authority), 2009b. Reasoned opinion on the modification the existing MRL for id in oats. The ESA Journal 2009, 291r, 1-25, doi: /j.efsa r ESA (European ood Safety Authority), Reasoned opinion on the modification the existing MRLs for id in various crops. ESA Journal 2011;9(5):2161, 35 pp. doi: /j.efsa ESA (European ood Safety Authority), Reasoned opinion on the modification the existing MRLs for id in pome fruits, cucurbits (inedible peel) and gherkins prepared by ESA Pesticide Residues (PRAS) Unit. ESA Journal 2013;11(7):3336, 28 pp. doi: /j.efsa Greece, Evaluation report on the modification MRLs for id in strawberries and peppers prepared by the evaluating Member State EMS under Article 8 Regulation (EC) No 396/2005, August 2013, 66 pp. Meier U, Growth Stages mono- and dicotyledonous plants. BBCH Monograph, 2 nd Ed., ederal Biological Research Centre Agriculture and orest. Braunschweig, Germany. 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. United Kingdom, Draft assessment report on the active substance id prepared by the rapporteur Member State the United Kingdom in the framework Council Directive 91/414/EEC, January ESA Journal 2014;12(1):

16 APPENDICES Appendix A. Good Agricultural Practice (GAPS) Crop and/or situation (a) Member State or Country G or I (b) Strawberries NEU/SEU /G Peppers Remarks: (a) (b) (c) (d) (e) (f) (g) Pest or group pests controlled (c) (d - f) (i) (f - h) Podosphaera macularis, Mycosphaerella oliar fragarie, DC 15 g/l spray Colletotrichum acuatum, Alternaria sp. Leveillula taurica, Erysiphe lycopersici, oliar NEU/SEU /G DC 15 g/l Alternaria solani, spray ulvia fulva or crops, EU or other classifications, e.g. Codex, should be used; where relevant, the use situation should be described (e.g. fumigation a structure) Outdoor or field use (), glasshouse application (G) or indoor application (I) e.g. biting and sucking insects, soil born insects, foliar fungi, weeds e.g. wettable powder (WP), emulsifiable concentrate (EC), granule (GR) GCP Technical Monograph No 2, 4 th Ed., 1999 or other codes, e.g. OECD/CIPAC, should be used All abbreviations used must be explained Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench ormulation Application Application rate per treatment PHI type conc. method number interval kg as/hl kg a.s./ha (days) a.s. kind min max min max min max min max growth stage & season (j) BBCH BBCH (h) (i) (j) (k) (l) (m) (k) water L/ha min max (l) Remarks Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants - type equipment used must be indicated g/kg or g/l Growth stage at last treatment (Growth stages mono-and dicotyledonous plants. BBCH Monograph, 2 nd Ed., 2001), including where relevant, information on season at time application The minimum and maximum number application possible under practical conditions use must be provided PHI - minimum pre-harvest interval Remarks may include: Extent use/economic importance/restrictions (i.e. feeding, grazing) (m) ESA Journal 2014;12(1):

17 Appendix B. Pesticide Residue Intake Model (PRIMO) Cyflufenamid Status the active substance: Approved Code no. LOQ (mg/kg bw): proposed LOQ: Toxicological end points ADI (mg/kg bw/day): 0,04 ARfD (mg/kg bw): 0,05 Source ADI: ESA Source ARfD: ESA Year evaluation: 2009 Year evaluation: 2009 Prepare workbook for refined calculations Undo refined calculations Chronic risk assessment - refined calculations TMDI (range) in % ADI minimum - maximum 1 5 No diets exceeding ADI: --- Highest calculated TMDI values in % ADI MS Diet Highest contributor to MS diet (in % ADI) Commodity / group commodities 2nd contributor to MS diet (in % ADI) Commodity / group commodities 3rd contributor to MS diet (in % ADI) Commodity / group commodities 4,6 R toddler 3,0 Milk and cream, 0,3 Wheat 0,3 Potatoes 4,6 UK Infant 2,9 Milk and cream, 0,5 Sugar beet (root) 0,3 Wheat 4,5 NL child 2,2 Milk and cream, 0,6 Wheat 0,3 Potatoes 4,0 UK Toddler 1,5 Milk and cream, 1,1 Sugar beet (root) 0,5 Wheat 3,4 DE child 1,1 Milk and cream, 0,5 Wheat 0,5 Apples 3,2 WHO Cluster diet B 1,1 Wheat 0,2 Milk and cream, 0,2 Tomatoes 3,1 DK child 0,9 Milk and cream, 0,7 Wheat 0,6 Rye 2,9 R infant 1,9 Milk and cream, 0,2 Potatoes 0,1 Carrots 2,6 ES child 0,9 Milk and cream, 0,6 Wheat 0,1 Bovine 2,5 IE adult 0,3 Barley 0,3 Wheat 0,2 Milk and cream, 2,2 SE general population 90th percentile 0,9 Milk and cream, 0,4 Wheat 0,2 Potatoes 2,2 WHO cluster diet E 0,5 Wheat 0,2 Milk and cream, 0,2 Barley 2,1 WHO cluster diet D 0,8 Wheat 0,4 Milk and cream, 0,2 Potatoes 1,9 WHO Cluster diet 0,5 Wheat 0,3 Milk and cream, 0,2 Potatoes 1,9 WHO regional European diet 0,4 Wheat 0,4 Milk and cream, 0,2 Potatoes 1,6 NL general 0,5 Milk and cream, 0,3 Wheat 0,1 Potatoes 1,5 ES adult 0,4 Milk and cream, 0,3 Wheat 0,1 Barley 1,4 PT General population 0,5 Wheat 0,3 Potatoes 0,2 Wine grapes 1,3 R all population 0,4 Wheat 0,3 Wine grapes 0,2 Milk and cream, 1,3 IT kids/toddler 0,8 Wheat 0,1 Other cereal 0,1 Tomatoes 1,3 DK adult 0,4 Milk and cream, 0,3 Wheat 0,1 Wine grapes 1,1 UK vegetarian 0,3 Wheat 0,2 Milk and cream, 0,2 Sugar beet (root) 1,1 LT adult 0,3 Milk and cream, 0,2 Potatoes 0,1 Rye 1,1 UK Adult 0,2 Milk and cream, 0,2 Wheat 0,2 Sugar beet (root) 1,0 I adult 0,4 Milk and cream, 0,1 Wheat 0,1 Rye 0,9 IT adult 0,5 Wheat 0,1 Tomatoes 0,0 Other cereal 0,5 PL general population 0,2 Potatoes 0,1 Apples 0,0 Tomatoes ptmrls at LOQ (in % ADI) Conclusion: The estimated Theoretical Maximum Daily Intakes (TMDI), based on ptmrls were below the ADI. A long-term intake residues Cyflufenamid is unlikely to present a public health concern. ESA Journal 2014;12(1):

18 Processed commodities Unprocessed commodities Modification the existing MRLs for id in strawberries and peppers Acute risk assessment /children - refined calculations Acute risk assessment / adults / general population - refined calculations The acute risk assessment is based on the ARfD. or 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 5 was used. In the IESTI 2 calculations, the variability factors 10 and 7 were replaced by 5. or lettuce the calculation was performed with a variabilty factor 3. Threshold MRL is the calculated residue level which would leads to an exposure equivalent to 100 % the ARfD. No commodities for which ARfD/ADI is exceeded (IESTI 1): No commodities for which No commodities for which No 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 % ARfD/ADI ptmrl/ threshold MRL ptmrl/ threshold MRL ptmrl/ threshold MRL ptmrl/ threshold MRL Highest % Highest % Highest % Commodities ARfD/ADI Commodities ARfD/ADI Commodities ARfD/ADI Commodities 3,8 Peppers 0,03 / - 2,7 Peppers 0,03 / - 1,0 Peppers 0,03 / - 0,7 Peppers 0,03 / - 0,9 Strawberries 0,03 / - 0,9 Strawberries 0,03 / - 0,3 Strawberries 0,03 / - 0,3 Strawberries 0,03 / - No critical MRLs (IESTI 1) --- No critical MRLs (IESTI 2) --- No commodities for which ARfD/ADI is exceeded: Highest % ARfD/ADI Processed commodities No commodities for which --- ARfD/ADI is exceeded: --- ***) ***) ptmrl/ ptmrl/ threshold MRL Highest % Processed threshold MRL ARfD/ADI commodities *) The results the IESTI calculations are reported for at least 5 commodities. If the ARfD is exceeded for more than 5 commodities, all IESTI values > 90% ARfD are reported. **) ptmrl: provisional temporary MRL ***) ptmrl: provisional temporary MRL for unprocessed commodity Conclusion: or Cyflufenamid IESTI 1 and IESTI 2 were calculated for food commodities for which ptmrls were submitted and for which consumption data are available. No exceedance the ARfD/ADI was identified for any unprocessed commodity. or processed commodities, no exceedance the ARfD/ADI was identified. ESA Journal 2014;12(1):

19 Appendix C. Existing EU maximum residue levels (MRLS) (Pesticides - Web Version - EU MRLs (ile created on 03/12/ :26)) Code number Groups and examples individual products to which the Cyflufena mid: sum id (Z) RUIT RESH OR ROZEN NUTS (i) Citrus fruit 0,02* Grapefruit (Shaddocks, pomelos, 0,02* sweeties, tangelo (except mineola), ugli and other hybrids) Oranges (Bergamot, bitter orange, 0,02* chinotto and other hybrids) Lemons (Citron, lemon, Buddha s 0,02* hand (Citrus medica var. sarcodactylis)) Limes 0,02* Mandarins (Clementine, tangerine, 0,02* mineola and other hybrids tangor (Citrus reticulata x sinensis)) Others 0,02* (ii) Tree nuts 0,02* Almonds 0,02* Brazil nuts 0,02* Cashew nuts 0,02* Chestnuts 0,02* Coconuts 0,02* Hazelnuts (ilbert) 0,02* Macadamia 0,02* Pecans 0,02* Pine nuts 0,02* Pistachios 0,02* Walnuts 0,02* Others 0,02* (iii) Pome fruit 0,05 a Apples (Crab apple) 0, Pears (Oriental pear) 0, Quinces 0,05 a Medlar 0,05 a Loquat 0,05 a Others 0,05 a (iv) Stone fruit 0,02* Apricots 0,02* Cherries (Sweet cherries, sour cherries) 0,02* Code number Groups and examples individual products to which the Cyflufena mid: sum id (Z) 0,02* Peaches (Nectarines and similar hybrids) Plums (Damson, greengage, 0,02* mirabelle, sloe, red date/chinese date/chinese jujube (Ziziphus zizyphus)) Others 0,02* (v) Berries & small fruit (a) Table and wine grapes 0, Table grapes 0, Wine grapes 0, (b) Strawberries 0,02* (c) Cane fruit 0,02* Blackberries 0,02* Dewberries (Loganberries, 0,02* tayberries, boysenberries, cloudberries and other Rubus hybrids) Raspberries (Wineberries, arctic 0,02* bramble/raspberry, (Rubus arcticus), nectar raspberries (Rubus arcticus x Rubus idaeus)) Others 0,02* (d) Other small fruit & berries 0,02* Blueberries (Bilberries) 0,02* Cranberries (Cowberries/red 0,02* bilberries (V. vitis-idaea)) Currants (red, black and white) 0,02* Gooseberries (Including hybrids 0,02* with other Ribes species) Rose hips 0,02* Mulberries (Arbutus berry) 0,02* Azarole (mediteranean medlar) (Kiwiberry (Actinidia arguta)) 0,02* Elderberries (Black 0,02* chokeberry/appleberry, mountain ash, buckthorn/sea sallowthorn, hawthorn, serviceberries, and other treeberries) Others 0,02* Code Groups and examples Cyflufena number individual products to which the mid: sum id (Z) (vi) Miscellaneous fruit 0,02* (a) Edible peel 0,02* Dates 0,02* igs 0,02* Table olives 0,02* Kumquats (Marumi kumquats, 0,02* nagami kumquats, limequats (Citrus aurantifolia x ortunella spp.)) Carambola (Bilimbi) 0,02* Persimmon 0,02* Jambolan (java plum) (Java apple/water apple, pomerac, rose apple, Brazilean cherry, Surinam 0,02* cherry/grumichama (Eugenia uniflora)) Others 0,02* (b) Inedible peel, small 0,02* Kiwi 0,02* Lychee (Litchi) (Pulasan, 0,02* rambutan/hairy litchi, longan, mangosteen, langsat, salak) Passion fruit 0,02* Prickly pear (cactus fruit) 0,02* Star apple 0,02* American persimmon (Virginia kaki) (Black sapote, white sapote, 0,02* green sapote, canistel/yellow sapote, mammey sapote) Others 0,02* (c) Inedible peel, large 0,02* Avocados 0,02* Bananas (Dwarf banana, plantain, 0,02* apple banana) Mangoes 0,02* Papaya 0,02* Pomegranate 0,02* Cherimoya (Custard apple, sugar apple/sweetsop, ilama (Annona diversifolia) and other medium 0,02* Code number Groups and examples individual products to which the Cyflufena mid: sum id (Z) sized Annonaceae fruits) Guava (Red pitaya/dragon fruit 0,02* (Hylocereus undatus)) Pineapples 0,02* Bread fruit (Jackfruit) 0,02* Durian 0,02* Soursop (guanabana) 0,02* Others 0,02* VEGETABLES RESH OR ROZEN (i) Root and tuber vegetables 0,02* (a) Potatoes 0,02* (b) Tropical root and tuber vegetables 0,02* Cassava (Dasheen, 0,02* eddoe/japanese taro, tannia) Sweet potatoes 0,02* Yams (Potato bean/yam bean, 0,02* Mexican yam bean) Arrowroot 0,02* Others 0,02* (c) Other root and tuber vegetables 0,02* except sugar beet Beetroot 0,02* Carrots 0,02* Celeriac 0,02* Horseradish (Angelica roots, 0,02* lovage roots, gentiana roots) Jerusalem artichokes (Crosne) 0,02* Parsnips 0,02* Parsley root 0,02* Radishes (Black radish, Japanese radish, small radish and similar 0,02* varieties, tiger nut (Cyperus esculentus)) Salsify (Scorzonera, Spanish 0,02* salsify/spanish oysterplant, edible burdock) Swedes 0,02* Turnips 0,02* ESA Journal 2014;12(1):