Review of the existing maximum residue levels (MRLs) for pyraclostrobin according to Article 12 of Regulation (EC) No 396/2005 1

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1 EFSA Journal 2011;9(8):2344 REASONED OPINION Review of the existing maximum levels (MRLs) for pyraclostrobin according to Article 12 of Regulation (EC) No 396/ European Food Safety Authority 2, 3 European Food Safety Authority (EFSA), Parma, Italy SUMMARY Pyraclostrobin was included in Annex I to Directive 91/414/EEC on 01 June 2004, which is before the entry into force of Regulation (EC) No 396/2005 on 02 September EFSA is therefore required to provide a reasoned opinion on the review of the existing MRLs for that active substance in compliance with Article 12(2) of afore mentioned regulation. In order to collect the relevant pesticide s data, EFSA asked Germany, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile). The requested information was submitted to EFSA on 03 April 2009 and, after having considered several comments made by EFSA, the RMS provided on 19 January 2010 a revised PROFile. Based on the conclusions derived in the framework of Directive 91/414/EEC under the supervision of the European Commission, the MRLs established by the Codex Alimentarius Commission and the additional information provided by the RMS, EFSA issued on 23 February 2011 a draft reasoned opinion that was circulated to Member State experts for consultation. Comments received by 29 April 2011 were considered for finalisation of this reasoned opinion. The following conclusions are derived. The toxicological profile of pyraclostrobin was evaluated in the framework of Directive 91/414/EEC. The ADI and the ARfD were established at 0.03 mg/kg bw/d and 0.03 mg/kg bw respectively. Primary crop metabolism of pyraclostrobin was investigated in three different crop groups following foliar applications. Metabolic patterns in the different studies were shown to be similar and the relevant for enforcement and risk assessment in all plant commodities treated by foliar application could be defined as pyraclostrobin. Validated analytical methods for enforcement of this definition are available with a LOQ of at least 0.02 mg/kg in hops, high oil content, high water content, acidic and dry commodities. These methods were however not validated for coffee beans. Further validation in this commodity is therefore still required. Regarding the magnitude of s in all crops reported by the RMS, at least one GAP or import tolerance was supported by a sufficient number of supervised trials, which allowed EFSA to 1 On request from EFSA, Question No EFSA-Q , issued on 22 August Correspondence: pesticides.mrl@efsa.europa.eu 3 Acknowledgement: EFSA wishes to thank the rapporteur Member State Germany for the preparatory work on this scientific output. Suggested citation: European Food Safety Authority; Review of the existing maximum levels (MRLs) for pyraclostrobin according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2011;9(8):2344. [92 pp.] doi: /j.efsa Available online: European Food Safety Authority, 2011

2 estimate the expected concentrations in the relevant plant commodities and to derive appropriate MRLs, except for peppers, cotton seed and celery. In these three crops, the number of trials was not compliant with the minimum data requirements defined by EU guidance documents. EFSA was therefore not able to derive reliable MRL proposals and further s trials are required. Moreover, the MRL derived for coffee beans is considered tentative only because there is no analytical method available for enforcement of this commodity. In processed commodities, pyraclostrobin s were shown to be stable during pasteurisation, cooking, brewing and sterilisation. The relevant for enforcement and risk assessment in processed commodities is therefore expected to be the same as for primary crops. Magnitude of s in processed commodities was also investigated and reliable processing factors were derived for beer, peeled melons, several commodities derived from cherries (canned, juice), plums (prunes, jam) and wine grapes (juice, wet pomace, must, white wine). With regard to the risk assessment, further processing studies are not required because they are not expected to affect the outcome of the risk assessment. However, if there would be the intention from risk managers to derive more processing factors for enforcement purposes, additional processing studies might be required. The potential incorporation of soil s into succeeding and rotational crops was investigated in radish, lettuce and wheat. These studies showed a comparable metabolism as the one in primary crops and significant s in rotational crops are not expected, provided that pyraclostrobin is applied according to the GAPs supported in the framework of this review. Based on the uses reported by the RMS, significant exposures to pyraclostrobin are expected for dairy ruminant, meat ruminants and pigs. Metabolism in lactating ruminants and poultry was sufficiently investigated and findings can be extrapolated to pigs as well. The relevant definition for enforcement was defined as pyraclostrobin. For risk assessment the relevant definition was therefore defined as the sum of pyraclostrobin and its metabolites containing the 1-(4-chlorophenyl)- 1H-pyrazole moiety or the 1-(4-chloro-2-hydroxyphenyl)-1H-pyrazole moiety, expressed as pyraclostrobin, with a conversion factor of 4 on ruminant liver and 1 on all other commodities. A validated analytical method for enforcement of this definition in foods of animal origin is also available with a LOQ of 0.01 mg/kg in milk and 0.05 mg/kg in animal tissues and eggs. Available studies also demonstrated that s of pyraclostrobin are not expected in significant amounts and that MRLs in poultry, pigs and ruminants can be set at these LOQs. Both chronic and acute consumer exposure resulting from the MRLs proposed in the framework of this review were calculated. For those crops where appropriate MRLs and risk assessment values could not be derived, the existing EU MRL was considered instead. Based on these calculations, an exceedance of the ARfD was identified for scarole, table grapes and peppers, representing %, % and % of the ARfD respectively. Considering the fall-back MRLs resulting from the northern outdoor GAP for scarole, the southern outdoor GAP for table grapes, and a less critical indoor use for peppers, the highest chronic exposure represented 12.6 % of the ADI (German child) and the highest acute exposure amounted to 96.4 % of the ARfD (globe artichokes). Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs have also been established for pyraclostrobin. Additional calculations of the consumer exposure, including these CXLs (except those for products of animal origin as they were established on the basis of the metabolism study), were therefore performed and exceedances of the ARfD were identified for the existing CXLs in grapes (180.7 %), kale (137.5 %) and peaches (124.6 %). Excluding CXLs for these commodities from the calculation, the highest chronic exposure represented 13.3 % of the ADI (German child) and the highest acute exposure amounted to 96.4 % of the ARfD (globe artichokes). Based on the above assessment, EFSA does not recommend inclusion of this active substance in Annex IV to Regulation (EC) No 396/2005. MRL recommendations were derived in compliance with EFSA Journal 2011;9(8):2344 2

3 the decision tree reported in Appendix D (see table below for a summary). All MRL values listed as Recommended in the table are sufficiently supported by data and therefore proposed for inclusion in Annex II to the Regulation. The remaining MRL values listed in the table are not recommended for inclusion in Annex II because they require further consideration by risk managers (see table footnotes for details). In particular, certain existing EU MRLs still needs to be confirmed by submission of the following data: 8 s trials complying with the import tolerance GAP on cotton seed; 8 trials supporting the southern FR GAP on grapes (data gap resulting from a fall back GAP); 4 s trials complying with the import tolerance GAP on celery; a validated method for enforcement of pyraclostrobin in coffee beans. It is highlighted that some of the Recommended MRLs resulted from a CXL or from a GAP in one climatic zone only, while other GAPs reported by the RMS were not fully supported by data. EFSA therefore identified the following data gaps which are not expected to impact on the recommended MRLs but which might have an impact on national authorisations: 8 s trials supporting the northern outdoor GAP and 8 s trials supporting the indoor GAPs on strawberries; 2 s trials on blueberries, gooseberries or currants supporting the northern outdoor GAP on blueberries, gooseberries and currants; 8 s trials supporting each import tolerance GAP on pome fruits, carrots, tomatoes, aubergines, peppers and lettuce; 8 s trials supporting the northern outdoor GAP on potatoes; 4 s trials supporting the northern outdoor GAP on lamb s lettuce; 4 s trials supporting the northern outdoor GAP and 4 s trials supporting the southern outdoor GAP on cress, land cress, rocket, rucola, red mustard and leaves and sprouts of Brassica spp; 4 s trials supporting the southern outdoor GAP on leek. If the above reported data gaps are not addressed in the future, Member States are recommended to withdraw or modify the relevant authorisations at national level or to further monitor the import of products treated with pyraclostrobin from third countries. Minor deficiencies were also identified in the assessment but these deficiencies are not expected to impact either on the validity of the Recommended MRLs or on the national authorisations. The following actions and/or data are therefore considered desirable but not essential: 4 trials on apricots compliant with the outdoor GAPs on peaches and apricots (data gap resulting from a new extrapolation rule); reporting of the separate northern and southern s trials datasets on apricots, peaches, cherries and plums; confirmation that trials samples and livestock feeding samples were stored in compliance with demonstrated storage stability; EFSA Journal 2011;9(8):2344 3

4 trials supporting the GAPs on mangoes and papaya carried out with analytical methods achieving a LOQ of 0.02 mg/kg. Code number Commodity Existing EU MRL Enforcement definition: pyraclostrobin Existing CXL MRL Result of the review Comment Citrus fruit Recommended (a) Almonds 0.02* 0.02* 0.02* Recommended (b) Brazil nuts 0.02* * Recommended (c) Cashew nuts 0.02* * Recommended (c) Chestnuts 0.02* - 0,02* Recommended (c) Hazelnuts 0.02* * Recommended (c) Macadamia 0.02* * Recommended (c) Pecans 0.02* 0.02* 0.02* Recommended (b) Pistachios Recommended (b) Walnuts 0.02* * Recommended (c) Pome fruit Recommended (b) Apricots Recommended (a) Cherries Recommended (b) Peaches Recommended (d) Plums Recommended (a) Table grapes Further consideration needed (e) Wine grapes Recommended (b) Strawberries Recommended (b) Blackberries 1-2 Recommended (c) Dewberries 0.02* - 2 Recommended (c) Raspberries Recommended (b) Blueberries Recommended (b) Cranberries Recommended (c) Currants (red, black and white) 2-3 Recommended (c) Gooseberries Recommended (c) Rose hips Recommended (c) Mulberries Recommended (c) Azarole (mediteranean medlar) Recommended (c) Elderberries Recommended (c) Bananas 0.02* 0.02* 0.02* Recommended (b) EFSA Journal 2011;9(8):2344 4

5 Code number Commodity Existing EU MRL Existing CXL MRL Result of the review Comment Mangoes * 0.05 Recommended (b) Papaya * 0.05 Recommended (b) Potatoes 0.02* 0.02* 0.02* Recommended (b) Beetroot 0.02* Recommended (c) Carrots Recommended (a) Celeriac 0.02* Recommended (c) Horseradish Recommended (c) Parsnips Recommended (c) Parsley root Recommended (c) Radishes Recommended (a) Salsify Recommended (c) Garlic * 0.3 Recommended (b) Onions Recommended (b) Shallots Recommended (c) Spring onions 0.02* - 1 Recommended (c) Tomatoes Recommended (b) Peppers Recommended (a) Aubergines (egg plants) Recommended (b) Cucumbers 0.02* Recommended (a) Gherkins 0.02* Recommended (c) Courgettes 0.02* Recommended (b) Melons 0.02* Recommended (b) Pumpkins 0.02* Recommended (c) Watermelons 0.02* Recommended (c) Flowering brassica Recommended (b) Brussels sprouts Recommended (a) Head cabbage Recommended (a) Kale 0.02* 1 - Further considerations needed (f) Kohlrabi 0.02* * Recommended (c) Lamb's lettuce Recommended (c) Lettuce Recommended (b) Scarole (broad-leaf endive) Recommended (c) Cress 2-10 Recommended (c) Land cress 2-10 Recommended (c) Rocket, Rucola 2-10 Recommended (c) Red mustard 2-10 Recommended (c) EFSA Journal 2011;9(8):2344 5

6 Code number Commodity Leaves and sprouts of Brassica spp Existing EU MRL Existing CXL MRL Result of the review Comment 2-10 Recommended (c) Spinach Recommended (c) Beet leaves (chard) Recommended (c) Fresh herbs 2-2 Recommended (c) Peas (fresh, with pods) 0.02* 0.02* 0.02* Recommended (g) Peas (fresh, without pods) 0.02* * Recommended (c) Asparagus 0.02* * Recommended (c) Celery 0.02* * Further consideration needed (h) Globe artichokes 0.02* - 2 Recommended (c) Leek Recommended (a) Beans (dry) Recommended (b) Lentils (dry) Recommended (a) Peas (dry) Recommended (b) Lupins (dry) Recommended (c) Peanuts 0.02* 0.02* 0.02* Recommended (b) Sunflower seed 0.02* Recommended (b) Soya bean 0.02* Recommended (a) Cotton seed 0.02* * Further consideration needed (h) Barley grain Recommended (a) Maize grain 0.02* 0.02* 0.02* Recommended (b) Oats grain Recommended (a) Rye grain Recommended (c) Wheat grain Recommended (a) Coffee beans 0.05* Further consideration needed (i) Hops (dried) Recommended (b) Sugar beet (root) 0.02* Recommended (b) Swine meat 0.05* * (F) Recommended (j) Swine fat (free of lean meat) 0.05* * Recommended (j) Swine liver 0.05* 0.05* 0.05* Recommended (j) Swine kidney 0.05* 0.05* 0.05* Recommended (j) Bovine meat 0.05* * (F) Recommended (j) Bovine fat 0.05* * Recommended (j) Bovine liver 0.05* 0.05* 0.05* Recommended (j) Bovine kidney 0.05* 0.05* 0.05* Recommended (j) EFSA Journal 2011;9(8):2344 6

7 Code number Commodity Existing EU MRL Existing CXL MRL Result of the review Comment Sheep meat 0.05* * (F) Recommended (j) Sheep fat 0.05* * Recommended (j) Sheep liver 0.05* 0.05* 0.05* Recommended (j) Sheep kidney 0.05* 0.05* 0.05* Recommended (j) Goat meat 0.05* * (F) Recommended (j) Goat fat 0.05* * Recommended (j) Goat liver 0.05* 0.05* 0.05* Recommended (j) Goat kidney 0.05* 0.05* 0.05* Recommended (j) Poultry meat 0.05* 0.05* 0.05* Recommended (j) Poultry fat 0.05* 0.05* 0.05* Recommended (j) Poultry liver 0.05* 0.05* 0.05* Recommended (j) Poultry kidney 0.05* 0.05* 0.05* Recommended (j) Cattle milk 0.01* * Recommended (j) Sheep milk 0.01* * Recommended (j) Goat milk 0.01* * Recommended (j) Birds' eggs 0.05* 0.05* 0.05* Recommended (j) - Other products of plant and animal origin See App C Further consideration needed (k) (*): Indicates that the MRL is set at the limit of analytical quantification. (F): MRL is expressed as mg/kg of fat contained in the whole product. (a): MRL is derived from the existing CXL, which is supported by data and for which no risk to consumers is identified; GAP evaluated at EU level, which is fully supported by data, leads to a lower MRL (combination G-VII in Appendix D). (b): MRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to consumers is identified; existing CXL is covered by the recommended MRL (combination G-III in Appendix D). (c): MRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to consumers is identified; no CXL is available (combination G-I in Appendix D). (d): MRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to consumers is identified; CXL is higher, supported by data but a risk to consumers cannot be excluded (combination G-VI in Appendix D). (e): Tentative MRL is derived from a GAP evaluated at EU level, which is not fully supported by data but for which no risk to consumers could be identified; CXL is higher, supported by data but a risk to consumers cannot be excluded (combination E-VI in Appendix D). (f): There are no relevant authorisations or import tolerances reported at EU level; CXL is supported by data but a risk to consumers cannot be excluded. Either the specific LOQ or the default MRL of 0.01 mg/kg may be considered. (combination A-VI in Appendix D). (g): MRL is derived from the existing CXL, which is supported by data and for which no risk to consumers is identified; there are no relevant authorisations or import tolerances reported at EU level (combination A-VII in Appendix D). (h): GAP evaluated at EU level is not supported by data but no risk to consumers could be identified for the existing EU MRL; no CXL is available (combination C-I in Appendix D). (i): MRL is derived from the existing CXL, which is not sufficiently supported by data but for which no risk to consumers is identified; GAP evaluated at EU level, which is also not fully supported by data, would lead to a lower tentative MRL (combination E-V in Appendix D). (j): MRL is derived from a GAP evaluated at EU level, which is fully supported by data and for which no risk to consumers is identified; CXL is not compatible with EU definitions (combination G-II in Appendix D). (k): There are no relevant authorisations or import tolerances reported at EU level; no CXL is available. Either the specific LOQ or the default MRL of 0.01 mg/kg may be considered (combination A-I in Appendix D). EFSA Journal 2011;9(8):2344 7

8 KEY WORDS Pyraclostrobin, MRL review, Regulation (EC) No 396/2005, consumer risk assessment, strobilurins, fungicide, plant growth regulator, desmethoxymetabolite 500M07. EFSA Journal 2011;9(8):2344 8

9 TABLE OF CONTENTS Summary... 1 Table of contents... 9 Background Terms of reference The active substance and its use pattern Assessment Methods of analysis Methods for enforcement of s in food of plant origin Methods for enforcement of s in food of animal origin Mammalian toxicology Residues Nature and magnitude of s in plant Primary crops Rotational crops Nature and magnitude of s in livestock Dietary burden of livestock Nature of s Magnitude of s Consumer risk assessment Consumer risk assessment without consideration of the existing CXLs Consumer risk assessment with consideration of the existing CXLs Conclusions and recommendations Documentation provided to EFSA References Appendix A Good Agricultural Practices (GAPs) Appendix B Pesticide Residues Intake Model (PRIMo) Appendix C Existing EU maximum limits (MRLs) and Codex Limits (CXLs) Appendix D Decision tree for deriving MRL recommendations Appendix E List of metabolites and related structural formula Abbreviations EFSA Journal 2011;9(8):2344 9

10 BACKGROUND Regulation (EC) No 396/ establishes the rules governing the setting as well as the review of pesticide MRLs at Community level. Article 12(2) of that regulation lays down that EFSA shall provide by 01 September 2009 a reasoned opinion on the review of the existing MRLs for all active substances included in Annex I to Directive 91/414/EEC 5 before 2 September As pyraclostrobin was included in Annex I to the above mentioned directive on 01 June 2004, EFSA initiated the review of all existing MRLs for that active substance and a task with the reference number EFSA-Q was included in the EFSA Register of Questions. According to the legal provisions, EFSA shall base its reasoned opinion in particular on the relevant assessment report prepared under Directive 91/414/EEC. It should be noted, however, that in the framework of Directive 91/414/EEC only a few representative uses are evaluated while MRLs set out in Regulation (EC) No 396/2005 should accommodate for all uses authorised within the EC as well as uses authorised in third countries having a significant impact on international trade. The information included in the assessment report prepared under Directive 91/414/EEC is therefore insufficient for the assessment of all existing MRLs for a given active substance. In order to have an overview on the pesticide s data that have been considered for the setting of the existing MRLs, EFSA developed the Pesticide Residue Overview File (PROFile). The PROFile is an electronic inventory of all pesticide s data relevant to the risk assessment as well as the MRL setting for a given active substance. This includes data on: the nature and magnitude of s in primary crops; the nature and magnitude of s in processed commodities; the nature and magnitude of s in rotational crops; the nature and magnitude of s in livestock commodities and; the analytical methods for enforcement of the proposed MRLs. Germany, the designated rapporteur Member State (RMS) in the framework of Directive 91/414/EEC, was asked to complete the PROFile for pyraclostrobin. The requested information was submitted to EFSA on 03 April 2009 and subsequently checked for completeness. On 19 January 2010, after having clarified some issues with EFSA, the RMS provided a revised PROFile. A draft reasoned opinion was issued by EFSA on 23 February 2011 and submitted to Member States (MS) for commenting. All MS comments received by 29 April 2011 were considered by EFSA for finalization of the reasoned opinion. 4 Commission Regulation (EC) No 396/2005 of 23 February OJ L 70, , p Council Directive 91/414/EEC of 15 July 1991, OJ L 230, , p EFSA Journal 2011;9(8):

11 TERMS OF REFERENCE According to Article 12 of Regulation (EC) No 396/2005, EFSA shall provide a reasoned opinion on: the inclusion of the active substance in Annex IV to the Regulation, when appropriate; the necessity of setting new MRLs for the active substance or deleting/modifying existing MRLs set out in Annex II or III of the Regulation; the inclusion of the recommended MRLs in Annex II or III to the Regulation; the setting of specific processing factors as referred to in Article 20(2) of the Regulation. THE ACTIVE SUBSTANCE AND ITS USE PATTERN Pyraclostrobin is the ISO common name for methyl N-(2-{[1-(4-chlorophenyl)-1H-pyrazol-3- yl]oxymethyl}phenyl) N-methoxy carbamate (IUPAC). Cl N N O N CH 3 O CO 2 CH 3 Pyraclostrobin is a fungicide belonging to the group of strobilurins. The biochemical mode of action of strobilurins is the inhibition of mitochondrial respiration. Pyraclostrobin is active against fungi both on the plant surface and within the tissues. It has a protective as well as an eradicative/curative action. Pyraclostrobin also affects the plant metabolism and physiology exhibiting properties of a plant growth regulator. It changes the phytohormone relationships in the plant, increases greening effects and improves tolerance against stresses. Pyraclostrobin is used on a wide range of dicotyledonous and monocotyledonous crop species. Pyraclostrobin was evaluated in the framework of Directive 91/414/EEC with Germany being the designated rapporteur Member State (RMS). The representative use supported for the peer review process was the outdoor application in grapes both in northern and southern Europe. Following the peer review, which was not carried out by EFSA, a decision on inclusion of the active substance in Annex I to Directive/91/414/EEC was published by means of Commission Directive 2004/30/EC 6, entering into force on 01 June The Annex I inclusion of pyraclostrobin was initially restricted to uses as a fungicide only but, according to Commission Directive 2009/25/EC 7 amending Directive 91/414/EEC, pyraclostrobin can also be used as a plant growth regulator since 04 August According to Regulation (EU) No 540/2011 8, pyraclostrobin is also deemed to have been approved under Regulation (EC) No 1107/ EU MRLs for pyraclostrobin in products of plant and animal origin have been set for the first time in 2005 by means of Directive 2005/70/EC 10. These MRLs were modified on several occasions and subsequently transferred to Annex II of Regulation (EC) No 396/2005 when the Regulation entered into force. Additional MRLs for commodities that were not covered by the former European MRL legislation are established in Annex III B of the Regulation. These temporary MRLs were derived from the MRLs that have been set at national level before the Regulation entered into force. EFSA 6 Commission Directive 2004/30/EC of 10 March 2004, OJ L 77, , p Commission Directive 2009/25/EC of 2 April 2009, OJ L 91, , p Regulation (EU) No 540/2011 of 25 May 2011, OJ L 153, , p Regulation (EC) No 1107/2009 of 21 October 2009, OJ L 309, , p Commission Directive 2005/70/EC of 20 October 2005, OJ L 276, , p EFSA Journal 2011;9(8):

12 recently recommended the modification of the existing MRLs for various crops (EFSA, 2009a, 2009b, 2010) which were legally implemented in Regulation (EC) No 459/2010/EC 11, Regulation (EC) No 750/2010/EC 12 and Regulation (EC) No 508/2011/EC 13. MRLs were also recommended by EFSA for oilseeds and oranges (EFSA, 2011) which were already approved by the meeting of the Standing Committee on the Food Chain and Animal Health held on 9-10 June 2011 but which were not yet legally implemented. All existing EU MRLs for pyraclostrobin are summarized in Appendix C.1 to this document. CXLs were also established by the Codex Alimentarius Commission and are reported in Appendix C.2 to this reasoned opinion. Both the EU MRLs and the CXLs were established for parent pyraclostrobin. For the purpose of this MRL review, the critical uses of pyraclostrobin currently authorized within the EU as well as uses authorised in third countries that might have a significant impact on international trade, have been collected by the RMS and reported in the PROFile. Uses of pyraclostrobin previously evaluated by EFSA were also considered (EFSA, 2009a, 2009b, 2010) and an overview of all authorised GAPs is reported in Appendix A. According to the reported GAPs, pyraclostrobin is applied on a wide range of crops by foliar spraying, both indoor and outdoor. Within the EU, PHIs may vary between 3 and 42 days but applications on the day of harvest are also authorised in third countries (PHI of 0 days). ASSESSMENT EFSA mainly based its assessment on the PROFile submitted by Germany, the Draft Assessment Report (DAR) and its addenda prepared under Council Directive 91/414/EEC (Germany, 2001, 2003), the Review Report on pyraclostrobin (EC, 2004a), the JMPR Evaluation report (FAO, 2004, 2006), the evaluation reports submitted during the Member States consultation (Belgium, France, The Netherlands, 2011) as well as the previous reasoned opinions on pyraclostrobin (EFSA, 2009a, 2009b, 2010, 2011). The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation of the Authorization 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 s (EC, 1996, 1997a, 1997b, 1997c, 1997d, 1997e, 1997f, 1997g, 2000, 2004b, 2010, 2011). 1. Methods of analysis 1.1. Methods for enforcement of s in food of plant origin During the peer review under Directive 91/414/EEC, a single- method using HPLC-MS/MS and its ILV were evaluated and validated for the determination of parent pyraclostrobin in plant matrices with an LOQ of 0.02 mg/kg in high oil content (peanut), acidic (grapes, orange) and dry (wheat) commodities (Germany, 2001). An additional method using HPLC-UV and its ILV were also validated for the determination of parent pyraclostrobin in plant matrices with an LOQ of 0.02 mg/kg in high fat content (peanut), acidic (grapes, orange) and dry (wheat) commodities (Germany, 2001). Furthermore, an analytical method using HPLC-MS/MS and its ILV were evaluated after inclusion in Annex I and validated for the determination of parent pyraclostrobin in high water content (carrots, tomatoes, broccoli), high oil content (oilseed rape), dry (wheat) and acidic commodities (strawberries, grapes) as well as in hops with an LOQ of 0.02 mg/kg. 11 Commission Regulation (EU) No 459/2010 of 27 May 2010, OJ L 129 of , p Commission Regulation (EU) No750/2010 of 7 July OJ L 220, , p Commission Regulation (EC) 508/2011 of 24 May 2011, OJ L 137, , p Regulation (EU) No 546/2011 of 10 June OJ L 155, , p EFSA Journal 2011;9(8):

13 The multi- QuEChERS method using HPLC-MS/MS described in the European Standard EN 15662:2008 for the determination of s in high water content, acidic and dry commodities is also applicable. This method is also reported in the PROFile. Table 1-1: Recovery data for the analysis of pyraclostrobin in different crop groups using the QuEChERS method in combination with LC-MS/MS (CEN, 2008) Commodity group Spiking levels Recoveries Mean (%) RSD (%) n No of labs Acidic Dry (cereals) Watery Hence it is concluded that pyraclostrobin s can be enforced in food of plant origin with a LOQ of at least 0.02 mg/kg in high oil content, high water content, acidic and dry commodities as well as in hops. No analytical method is available for coffee beans, and should therefore be provided Methods for enforcement of s in food of animal origin During the peer review under Directive 91/414/EEC, an analytical method using HPLC-UV confirmed by RPLC-UV and its ILV were evaluated and validated for the determination of parent pyraclostrobin in food of animal origin with a LOQ of 0.01 mg/kg in milk and a LOQ of 0.05 mg/kg in muscle, liver, kidney, fat and eggs (Germany, 2001). An additional method using HPLC-MS/MS was evaluated and validated for the determination of parent pyraclostrobin in food of animal origin with a LOQ of 0.01 mg/kg in milk and a LOQ of 0.05 mg/kg in muscle, liver, kidney, fat and eggs. A GC-MS version of this method including hydrolysis and methylation was also developed and validated for milk with a LOQ of 0.01 mg/kg (Germany, 2001). Hence it is concluded that parent pyraclostrobin can be enforced in food of animal origin with a LOQ of 0.01 mg/kg in milk and a LOQ of 0.05 mg/kg in muscle, liver, kidney, fat and eggs. 2. Mammalian toxicology The toxicological assessment of pyraclostrobin was peer reviewed under Directive 91/414/EEC and toxicological reference values were established by the European Commission (2004a). These toxicological reference values are summarized in Table 2-1. EFSA Journal 2011;9(8):

14 Table 2-1: Overview of the toxicological reference values pyraclostrobin Source Year Value Study relied upon Safety factor ADI EC mg/kg bw/d Chronic rat 100 ARfD EC mg/kg bw Rabit developmental toxicity Residues 3.1. Nature and magnitude of s in plant Primary crops Nature of s Metabolism of pyraclostrobin was investigated for foliar applications on cereals (wheat), on fruits and fruiting vegetables (grapes) and on root and tuber vegetables (potatoes) using [tolyl-u- 14 C]- pyraclostrobin and [chlorophenyl-u- 14 C]- pyraclostrobin (Germany, 2001). The studies are summarized in table 3-1. Table 3-1: Summary of available metabolism studies in plants Group Crop Label position Fruits and fruiting vegetable Root and tuber vegetables Grapes [tolyl-u- 14 C]- pyraclostrobin and [chlorophenyl- U- 14 C]- pyraclostrobin Method, F or G (a) Application and sampling details Rate (kg a.s./ha) Foliar, F 0.48, 0.24, 0.18, 0.13, 0.24, 0.24 Potatoes Foliar, F 0.30, 0.30; 0.30; 0.40; 0.30; 0.30 No Sampling (DAT) Remarks 6 40 Applications: BBCH (1 st appli.); BBCH 81 (last application) 6 7 days after the 3 rd application and 7 days after last application (maturity) Applications: BBCH 31 (1 st appli.) then application every 9 days Cereals Wheat Foliar, F , 31, 41 Applications: BBCH 32 (1 st (a): Outdoor/field application (F) or glasshouse/protected/indoor application (G) appli.); BBCH 61 (2 nd appli.) EFSA Journal 2011;9(8):

15 The relevant in grapes consisted of parent pyraclostrobin ( % TRR) and its desmethoxy metabolite 500M07 15 ( % TRR). In potatoes the highest TRR was identified in green matter ( mg/kg) in both studies. Parent pyraclostrobin was the main component of the TRR in green matter and potato tubers in studies with [chlorophenyl-u- 14 C]-pyraclostrobin, amounting for 55 % and 29.4 % of the TRR, respectively. In the green matter desmethoxy metabolite 500M07 was identified in levels > 20 % of the TRR in both studies. In the tolyl study the major component of the TRR in potato tubers was identified as natural amino acid L-tryptophan (29.2 % TRR). In cereals, the lowest TRR was found in grains, varying between mg/kg in the chlorophenyl labelled and mg/kg in the tolyl labelled matrix. The highest TRR was identified in wheat straw, amounting for up to mg/kg (chlorophenyl study) and mg/kg (tolyl study). The major component of the TRR in straw and grain in the chlorophenyl study was parent pyraclostrobin and its desmethoxy metabolite (500M07). In the tolyl study the major component of the TRR in grain was L-tryptophan (23 % TRR), any other components being below 10 % of the TRR. L-tryptophan is an essential natural amino acid therefore it is of no toxicological relevance (EFSA, 2010). Generally it was concluded in the peer review (EC, 2002) that the metabolic pathway is similar in all crop groups investigated. Results from the supervised trials indicated that desmethoxy metabolite 500M07 occurs in crops in small amounts compared to parent pyraclostrobin; therefore in the peer review it was concluded that a general definition for risk assessment and enforcement should be set as parent pyraclostrobin only. Validated analytical methods for enforcement of the proposed definition are available (see also section 1.1) Magnitude of s The use of pyraclostrobin is reported on a large number of crops by the RMS (Appendix A). To assess the magnitude of pyraclostrobin s resulting from these GAPs, EFSA considered all s trials reported in the PROFile, including s trials evaluated in the framework of the peer review (Germany, 2001) or in the framework of an MRL application (EFSA, 2009a, 2009b, 2010, 2011) and additional data submitted during the Member State consultation (Belgium, France, The Netherlands, 2011). All available s trials that, according to the RMS, comply with the authorised GAPs, are summarized in Table 3-2. The number of s trials and extrapolations were evaluated in view of the European guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs (EC, 2011). A sufficient number of s trials compliant with the GAPs was reported by the RMS for all crops under consideration, except in the following cases: No trials are available to support the use of pyraclostrobin on pome fruits, carrots, tomatoes, aubergines, peppers and lettuce in the US but trials complying with the European GAP are sufficient to derive MRL and risk assessment values in these crops. If the proposed MRL does not accommodate for the use of pyraclostrobin in the US, 8 representative trials would have to be submitted for each crop. For strawberries, no s trials compliant with the northern and the indoor GAP are available (PHI 1d). EFSA therefore used values from a 0d PHI to derive tentative MRLs. Although an adequate MRL can be derived from the import tolerance, additional trials representing the situation at the PHI of 1 day are normally still required for each area: 8 for the northern use, 8 for the indoor use. Regarding the use of pyraclostrobin on strawberries in southern Europe, the data requirement of 8 s trials normally applies M07. methyl-n-(2{[1-(4-chlorophenyl)-1h-pyrazol-3-yl]oxymethyl}phenyl). See Appendix E. EFSA Journal 2011;9(8):

16 while only 7 trials are available. Considering the overall availability of s trials, further trials are not required in this case. Regarding the use of pyraclostrobin on blueberries and gooseberries in northern Europe, the number of trials reported is not compliant with the data requirements. Although appropriate MRL and risk assessment values can be derived from the import tolerance data, 2 additional trials on currants, blueberries or gooseberries complying with the northern GAP are still required. Regarding the use of pyraclostrobin on grapes in southern Europe, only trials carried out at a more critical GAP are available. Although appropriate MRL and risk assessment values are derived from the northern GAP only for wine grapes, 8 trials complying with the FR southern GAP are normally still required. Regarding the use of pyraclostrobin on potatoes in northern Europe, no trials are available. Although appropriate MRL and risk assessment values can be derived from the import tolerance data, 8 trials complying with the northern outdoor GAPs are still required. Regarding the indoor use of pyraclostrobin on peppers, no s trials compliant with the Dutch GAP are available (PHI 1 d). EFSA therefore used values from 0 or 4 d PHI to derive tentative MRLs. Considering however that interpolations between different PHIs are not supported by EFSA, 8 additional trials representing the situation at the PHI of 1 day are still required for the Dutch indoor use on peppers and only a tentative MRL is derived for this critical GAP. Regarding the use of pyraclostrobin on lamb s lettuce in northern Europe, no trials are available. Although appropriate MRL and risk assessment values can be derived from the indoor data, 4 trials complying with the northern outdoor GAPs are still required. Regarding the use of pyraclostrobin on the whole group of lettuces and similar (except lettuce, lamb s lettuce and scarole) in northern and southern Europe, no trials are available. Although appropriate MRL and risk assessment values can be derived from the indoor data, 4 trials complying with the northern outdoor GAPs are still required. Regarding the use of pyraclostrobin on asparagus, considering that the application is made on the field after harvest and that no s are expected according to the rotational crop studies, s exceeding the enforcement LOQ of 0.02 mg/kg are not expected. Consequently, a waiver for trials can be accepted. For the use of pyraclostrobin on leek in southern Europe, no trials are available and 4 trials complying with the FR GAP are therefore required. In the meantime, appropriate MRL and risk assessment values are derived from the northern GAP. No sufficient trials are available to support the use of pyraclostrobin on cotton seed in the US and 8 representative trials are missing. Therefore no MRL or risk assessment values are derived. No sufficient trials are available to support the use of pyraclostrobin on celery in Norway and at least 4 representative trials are missing. Therefore no MRL or risk assessment values are derived. For industrial beetroot, a data requirement of 8 s trials normally applies while only 4 trials are available in southern Europe. Considering however that all results are below the LOQ, indicating a no s situation, further s trials are not required. EFSA Journal 2011;9(8):

17 For cherries and plums, the RMS pooled the northern and southern dataset, considering the homogeneity of the levels. Nevertheless, EFSA normally does not support that the pooling of data among climatic regions without further analysis. Reporting the northern and southern datasets separately is therefore desirable. For apricots and peaches, appropriate MRL and risk assessment values are derived. Nevertheless, EFSA points out that only s trials performed on peaches are available while, according to the new extrapolation rules (to be legally implemented on 01 April 2013), at least 4 trials on apricots will be required to support the use on apricot both in northern and southern Europe (EC, 2011). Moreover, the RMS pooled the northern and southern datasets, considering the homogeneity of the levels, while EFSA normally does not support that the pooling of data among climatic regions without further analysis. Therefore it would still be desirable to report the northern and southern datasets separately and to provide 4 trials on apricots compliant with the GAPs. UK reported uses on edible flowers. According to the legislation, edible flowers are considered to fall within the category of other fresh herbs. As a unique MRL is proposed for all fresh herbs, EFSA concludes that the UK GAP is covered by the MRL proposal for fresh herbs. For mangoes and papaya, a MRL of 0.05 mg/kg is proposed because all levels were found to be below the LOQ values. Considering however that a LOQ of 0.02 mg/kg can be achieved for enforcement purposes (see also section 1.1), the elaboration of s trials with a LOQ of 0.02 mg/kg is desirable. The demonstrated storage stability of pyraclostrobin in treated crops was evaluated under the peer review of Directive 91/414/EEC (Germany, 2001). Studies demonstrated storage stability of pyraclostrobin in high oil content, high water content, acidic and dry commodities for up to 18 months when stored deep frozen. The storage conditions for most of the s trials were not reported but considering that storage stability of pyraclostrobin was demonstrated for a long period of time, degradation of s during the storage of the s trials samples is not expected. Nevertheless, it would be desirable to confirm that all s trial samples were stored according to the above reported conditions. Consequently, the available s data are considered acceptable to derive MRL proposals and risk assessment values for all commodities under evaluation, except for celery and cotton seed where the available data were not sufficient to derive tentative MRLs (see also Table 3-2). The MRL derived for for peppers is however considered tentative as trials were not compliant with GAP and the MRL for coffee beans is considered tentative as well because there is no analytical method available for enforcement of this commodity (see also section 1.1). For sugar beet tops and cereals straws, tentative MRLs are derived in view of the future need to set MRLs in feed items. In case several uses are supported for one commodity, the final MRL proposal was derived from the most critical use and indicated in bold in Table 3-2. EFSA Journal 2011;9(8):

18 Table 3-2: Overview of the available s trials data Commodity Region (a) Outdoor /Indoor Individual trial results Enforcement (pyraclostrobin) Risk assessment (pyraclostrobin) (b) Highest (c) MRL proposal CF (d) Comments Citrus fruit Import (US) Outdoor Orange: 0.12; 0.13; 0.17; 2x0.18; 0.23; 0.24; 2x0.25; 0.34; 0.36; 0.37; 0.51 Grapefruit: 0.07; 0.08; 2x0.12; 0.19; 0.25 Orange: 0.12; 0.13; 0.17; 2x0.18; 0.23; 0.24; 2x0.25; 0.34; 0.36; 0.37; 0.51 Grapefruit: 0.07; 0.08; 2x0.12; 0.19; Combined dataset on oranges (13), grapefruit (6) and lemons (5) compliant with GAP for citrus fruits. Rmax = 0.46 Rber = 0.55 Lemon: 0.19; 0.16; 0.20; 0.28; 0.32 Lemon: 0.19; 0.16; 0.20; 0.28; 0.32 Almonds Brazil nuts Cashew nuts Chestnuts Hazelnuts Macadamia Pecans Walnuts Import (US) Outdoor Almond: 5x<0.02 Pecan nut : 5x<0.02 Almond: 5x<0.02 Pecan nut : 5x<0.02 <0.02 < * 1.00 Combined dataset on almonds (5) and pecan nuts (5) compliant with GAP on tree nuts (except pistachios). Rmax = 0.02 Rber = 0.04 Pistachios Import (US) Outdoor 2x <0.02; 0.16; 0.27; 0.44; x <0.02; 0.16; 0.27; 0.44; Trials compliant with GAP. Rmax = 0.94 Rber = 0.89 EFSA Journal 2011;9(8):

19 Commodity Region (a) Outdoor /Indoor Individual trial results Enforcement (pyraclostrobin) Risk assessment (pyraclostrobin) (b) Highest (c) MRL proposal CF (d) Comments Pome fruits NEU Outdoor 2x0.03; 0.04; 0.05; 3x0.06; 3x0.07; 0.08; 3x0.1; 2x0.12; 0.13; 3x0.14; 0.16; 0.17; 0.18; 0.26; 0.28; 0.29 Peaches Apricots SEU Outdoor 0.03; 0.04; 0.06; 0.07; 0.07; 0.12; 2x 0.14; 0.17; 0.18; 0.28; 2x 0.29 Import (US) NEU/ SEU 2x0.03; 0.04; 0.05; 3x0.06; 3x0.07; 0.08; 3x0.1; 2x0.12; 0.13; 3x0.14; 0.16; 0.17; 0.18; 0.26; 0.28; ; 0.04; 0.06; 0.07; 0.07; 0.12; 2x 0.14; 0.17; 0.18; 0.28; 2x Trials on apples in compliance with German GAP on pome fruits. These trials also support the Belgian GAP on apples and pears that is slightly more critical (0.12 instead of 0.1 kg/ha; Belgium, 2011). Rmax = 0.28 Rber = Trials on apples in compliance with southern GAP for all pome fruits (France, 2011). Rmax = 0.39 Rber = 0.46 Outdoor The reported 32 trials on apples were performed with 6 applications at 0.17 kg as/ha (6 x kg as/hl) and are not compliant with GAP. Outdoor 3x<0.02; 0.02; 5x0.03; 6x0.04; 0.05; 3x0.06; 2x0.07; 2x0.08; 0.09; 0.11; 0.12; x<0.02; 0.02; 5x0.03; 6x0.04; 0.05; 3x0.06; 2x0.07; 2x0.08; 0.09; 0.11; 0.12; Combined dataset of northern and southern s trials on peaches compliant with GAP on peaches and apricots. However, 4 trials on apricots compliant with the outdoor GAP will be required in view of application of the new extrapolation rule (EC, 2011). Rmax = 0.12 Rber = 0.14 EFSA Journal 2011;9(8):

20 Commodity Region (a) Outdoor /Indoor Individual trial results Enforcement (pyraclostrobin) Risk assessment (pyraclostrobin) (b) Highest (c) MRL proposal CF (d) Comments Cherries NEU/ SEU Outdoor 0.04; 2x0.05; 0.06; 2x 0.07; 2x0.09; 0.12; 0.13; 2x0.16; 0.18; 0.2; 0.21; ; 2x0.05; 0.06; 2x 0.07; 2x0.09; 0.12; 0.13; 2x0.16; 0.18; 0.2; 0.21; Combined dataset of northern and southern s trials on cherries compliant with GAP. Rmax = 0.30 Rber = 0.35 Import (US) Outdoor 0.025; 2x0.25; 0.27; 0.34; 0.38; 0.42; 0.43; 0.47; 0.48; 2x0.5; 0.51; 0.56; 0.63; 0.67; 0.82; 2x1.1; ; 2x0.25; 0.27; 0.34; 0.38; 0.42; 0.43; 0.47; 0.48; 2x0.5; 0.51; 0.56; 0.63; 0.67; 0.82; 2x1.1; Trials on cherries compliant with GAP. Rmax = 1.43 Rber = 1.32 Plums NEU/ SEU Outdoor 4x0.02; 0.03; 2x0.04; 2x0.05; 0.06; 0.07; 2x0.13 4x0.02; 0.03; 2x0.04; 2x0.05; 0.06; 0.07; 2x Combined dataset of northern and southern s trials on plums compliant with GAP. Rmax = 0.15 Rber = 0.13 Import (US) Outdoor 0.01; 0.02; 0.023; 0.024; 0.026; 0.035; 0.039; 0.051; 0.059; 0.063; 0.064; 0.065; 0.085; 0.12; 0.13; 0.19; 0.22; 0.34; 0.38; 0.4; ; 0.02; 0.023; 0.024; 0.026; 0.035; 0.039; 0.051; 0.059; 0.063; 0.064; 0.065; 0.085; 0.12; 0.13; 0.19; 0.22; 0.34; 0.38; 0.4; Trials on plums compliant with GAP. Rmax = 0.46 Rber = 0.41 EFSA Journal 2011;9(8):

21 Commodity Region (a) Outdoor /Indoor Individual trial results Enforcement (pyraclostrobin) Risk assessment (pyraclostrobin) (b) Highest (c) MRL proposal CF (d) Comments Table grapes Wine grapes NEU Outdoor 0.19; 2x0.25; 2x0.26; 0.36; 2x0.44; 0.46; 0.47; 2x0.48; 0.57; 2x0.78; 0.82; 0.84; 0.89; 1.15; 1.27 SEU Outdoor 0.13; 2x0.14; 0.16; 0.18; 0.2; 0.21; 2x0.23; 0.27; 0.28; 0.34; 0.37; 0.38; 0.39; 0.4; 0.45; 0.47; 0.48; 0.56; 2x0.59; 2x0.72 Strawberries NEU Outdoor 0.04; 0.05; 0.09; 0.09; 0.10; 0.10; 0.10; 0.15; 0.15; 0.19 SEU Outdoor 0.11; 2x0.12; 0.18; 0.19; 0.22; ; 2x0.25; 2x0.26; 0.36; 2x0.44; 0.46; 0.47; 2x0.48; 0.57; 2x0.78; 0.82; 0.84; 0.89; 1.15; ; 2x0.14; 0.16; 0.18; 0.2; 0.21; 2x0.23; 0.27; 0.28; 0.34; 0.37; 0.38; 0.39; 0.4; 0.45; 0.47; 0.48; 0.56; 2x0.59; 2x ; 0.05; 0.09; 0.09; 0.10; 0.10; 0.10; 0.15; 0.15; ; 2x0.12; 0.18; 0.19; 0.22; Trials on grapes compliant with GAP. Trials with a higher number of applications were also considered because first applications are not expected to impact on the s levels. Rmax = 1.31 Rber = Trials on grapes compliant with a more critical GAP (4 x 160 g/ha instead of 3 x 100 g/ha; PHI compliant with GAP). Trials indicate that southern GAP is less critical than northern GAP on grapes. Also used as tentative fallback position in section 4.1 for table grapes. Rmax = 0.78 Rber = Trials on strawberries carried out with a PHI of 0d instead of 1d (The Netherlands, 2011). Rmax = 0.24 Rber = Trials on strawberries compliant with GAP. Rmax = 0.45 Rber = 0.44 EFSA Journal 2011;9(8):