Modification of the existing MRLs for pyraclostrobin in various crops 1

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1 EFSA Journal 2011;9(3):2120 REASONED OPINION Modification of the existing MRLs for pyraclostrobin in various crops 1 European Food Safety Authority 2 European Food Safety Authority (EFSA), Parma, Italy SUMMARY According to Article 6 of the Regulation (EC) No 396/2005, Germany received an application from the company BASF SE to set an import tolerance for pyraclostrobin in oilseeds. In order to accommodate the authorized uses in the USA, the existing EU MRLs for pyraclostrobin in certain oilseeds would have to be raised. The Evaluating Member State (EMS) Germany drafted an evaluation report according to Article 8 of Regulation (EC) No 396/2005 which was submitted to the European Commission and forwarded to EFSA on 13 September According to Article 6 of the Regulation (EC) No 396/2005, France received an application from the company BASF AGRO SAS to modify the existing MRLs for pyraclostrobin in citrus fruits. In order to accommodate for the intended use of pyraclostrobin in France, it is proposed to raise the existing MRL in citrus fruits to 2 mg/kg. The Evaluating Member State (EMS) France drafted an evaluation report according to Article 8 of Regulation (EC) No 396/2005 which was submitted to the European Commission and forwarded to EFSA on 1 December Considering that both applications refer to the modification of the existing MRLs for pyraclostrobin, for reasons of efficiency EFSA addressed both MRL applications in one reasoned opinion. EFSA derives the following conclusions based on the submitted evaluation reports prepared by Germany and France, the Draft Assessment Report (DAR) prepared by the rapporteur Member State (RMS) Germany under Directive 91/414/EEC as well as the data submitted on pyraclostrobin by the RMS Germany in the framework of Article 12 of Regulation (EC) No 396/2005. 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 residue 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 residue definition are available. EFSA concludes that the metabolism of pyraclostrobin in primary crops under consideration is sufficiently elucidated and that the derived residue definitions are appropriate. However, EFSA notes that some residue trials on soya, cotton, rape and sunflowers might have been performed with a genetically modified crop. The applicant should therefore provide evidence that the genetically modification does not alter the metabolism in the modified crop. If in the 1 On request from the European Commission, Question No EFSA-Q and EFSA-Q issued on 23 2 March Correspondence: praper.mrl@efsa.europa.eu Suggested citation: European Food Safety Authority; Modification of the existing MRLs for pyraclostrobin in various crops. EFSA Journal 2011;9(3):2120. [41 pp.] doi: /j.efsa Available online: European Food Safety Authority, 2011

2 genetically modified crop a gene is inserted that alternates pesticide metabolism, additional studies are required elucidating the metabolism in genetically modified crops. EFSA considers that the residue data are sufficient to derive the MRL proposals for oranges and certain oilseeds (see table below). In sunflower seeds and soya bean the residue trials data did not give evidence that the existing EU MRLs need to be changed. The proposed residue data extrapolation from oranges and mandarins to the whole group of citrus fruit is not fully supported by data and therefore only a MRL for oranges could be derived. The effects of processing on the nature of pyraclostrobin residues have been investigated in the peer review. Under core processing conditions no degradation of pyraclostrobin occurs and therefore in processed commodities the same residue definition as in raw agricultural commodities is applicable. In the framework of the current application, the applicant submitted studies investigating the effect of processing on the magnitude of pyraclostrobin residues in the processed rape seed, cotton seed and oranges. For processed oilseeds the submitted number of studies is not sufficient to propose the processing factors for enforcement. The following processing factors are proposed to be included in Annex VI of Regulation (EC) No 396/2005: Oranges, peeled; 0.09 Oranges, pasteurized juice: 0.15 Oranges, wet pomace: 2.25 The investigation of the possible occurrence of pyraclostrobin residues in rotational/succeeding crops is of no relevance for the import tolerance request on oilseeds and well as for citrus fruits. Since the crops under consideration and/or their by-products can be fed to livestock, a livestock exposure to pyraclostrobin residues was investigated. The livestock dietary burdens were calculated for the existing and the intended uses of pyraclostrobin on feed crops and exceeded the trigger value of 0.1 mg/kg (dry matter) for all relevant livestock species. Therefore the possible carry-over of pyraclostrobin residues to commodities of animal origin was assessed. The nature of pyraclostrobin residues in livestock has been sufficiently investigated and the peer review proposed the enforcement residue definition as pyraclostrobin. The risk assessment residue definition was proposed for liver (except poultry liver) and milk fat only as pyraclostrobin and its metabolites containing the 1-(4- chlorophenyl)-1h-pyrazole- or the 1-(4-chloro-2-hydroxyphenyl)-1H-pyrazole moiety, sum expressed as pyraclostrobin. In other tissues the risk assessment residue definition comprises parent pyraclostrobin only. A conversion factor of 4 on ruminant liver and 1 on all other commodities is proposed from enforcement to risk assessment. The calculated dietary burdens and the livestock feeding studies were used to assess the possible carry-over of residues to animal commodities. It is concluded that no residues above the LOQ will occur in commodities of animal origin and there is no need to modify the existing EU MRLs. The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). For the calculation of the chronic exposure, EFSA used the median residue values as derived from the residue trials on certain oilseeds and oranges. For the remaining commodities of plant and animal origin, the existing MRLs as established in Annexes III of Regulation (EC) No 396/2005 were used as input values. For several crops the risk assessment values were available from the previously issued EFSA reasoned opinions to refine the intake calculations. The acute exposure assessment was performed only with regard to the commodities under consideration assuming the consumption of a large portion of the food items as reported in the national food surveys containing residues at the highest level (for oranges) and the median level (for oilseeds) as observed in supervised field trials. For oranges the peeling factor of 0.09 was applied in EFSA Journal 2011;9(3):2120 2

3 the chronic and acute exposure calculations. The calculated chronic and acute exposure was then compared with the toxicological reference values as derived for pyraclostrobin. No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake values ranged from 5-33 % of the ADI (FR all population). The contribution of residues in individual crops under consideration to the total consumer exposure accounted for a maximum of 0.56% of the ADI for peeled oranges (DE child diet) and was below 0.13% of the ADI for various oilseeds. No acute consumer risk was identified for the MRL proposals for the crops under consideration. The calculated maximum exposure in percentage of the ARfD was 52% for peeled oranges, 0.5% for safflower and sunflower seed and <0.5 % for other oilseeds. EFSA concludes that the intended use of pyraclostrobin on oranges and the authorized use on various oilseeds will not result in a consumer exposure exceeding the toxicological reference values and therefore will not pose a public health concern. The recommendations of EFSA are compiled in the table below: Code Commodity Existing EC number a MRL Proposed EC MRL Justification for the proposal Enforcement residue definition: Pyraclostrobin Grapefruit Lemons Limes Mandarins 1 No proposal The submitted residue data set is not sufficient to derive the MRL proposal Oranges 1 2 The MRL proposals are sufficiently Peanuts 0.02* 0.04 supported by data and no consumer intake concerns were identified Cotton seed 0.02* 0.3 The MRL proposal is sufficiently supported by data, but are acceptable if the applicant provides the evidence that the genetical modification of cotton does not alter the metabolism in the crop Linseed 0.02* 0.2 The MRL proposals are sufficiently Poppy seed 0.02* supported by data, but are acceptable if the applicant provides the evidence that Sesame seed 0.02* the genetical modification of rape and Rape seed 0.02* sunflower does not alter the metabolism in the crop Mustard seed 0.02* Safflower 0.02* Borage 0.02* Gold of pleasure 0.02* Castor bean 0.02* Sunflower seed The residue data confirm the existing EU Soya bean 0.02* 0.02* MRL. (*): Indicates that the MRL is set at the limit of analytical quantification. a - according to Annex I of Regulation (EC) No 396/2005 EFSA Journal 2011;9(3):2120 3

4 KEY WORDS Pyraclostrobin, oilseeds, oranges, citrus fruits, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, strobilurin fungicide EFSA Journal 2011;9(3):2120 4

5 TABLE OF CONTENTS Summary... 1 Table of contents... 5 Background... 6 Terms of reference... 6 The active substance and its use pattern... 8 Assessment Methods of analysis Methods for enforcement of residues in food of plant origin Methods for enforcement of residues in food of animal origin Mammalian toxicology Residues Nature and magnitude of residues in plant Primary crops Rotational crops Nature and magnitude of residues in livestock Dietary burden of livestock Nature of residues Magnitude of residues Consumer risk assessment Conclusions and recommendations References Appendix A. Good Agricultural Practices (GAPs) Appendix B. Pesticide Residues Intake Model (PRIMo) Appendix C. Existing EU maximum residue limits (MRLs) Abbreviations EFSA Journal 2011;9(3):2120 5

6 BACKGROUND Commission Regulation (EC) No 396/ establishes the rules governing the setting of pesticide MRLs at Community level. Article 6 (1) of that regulation lays down that a party requesting an authorisation for the use of a plant protection product in accordance with Council Directive 91/414/EEC 4, shall submit to a Member State, when appropriate, an application to set or modify an MRL in accordance with the provisions of Article 7 of that regulation. Article 6 (4) of Regulation (EC) no 396/2005 lays down that any party having a legitimate commercial interest may submit to the rapporteur Member State designated pursuant to Council Directive 91/414/EEC an application to set an import tolerance in accordance with the provisions of Article 7 of that regulation. Germany, hereafter referred to as the evaluating Member State Germany (EMS Germany), received from the company BASF SE 5 an import tolerance application to modify the existing MRL for the active substance pyraclostrobin in oilseeds. This application was notified to the European Commission and EFSA and subsequently evaluated by the EMS in accordance with Article 8 of the Regulation. France, hereafter referred to as the evaluating Member State France (EMS France), received an application from the company BASF AGRO SAS 6 to modify the existing MRLs for the active substance pyraclostrobin in citrus fruits. This application was notified to the European Commission and EFSA and subsequently evaluated by the EMS in accordance with Article 8 of the Regulation. After completion, the evaluation reports of the EMS Germany and the EMS France were submitted to the European Commission who forwarded the applications, the evaluation reports and the supporting dossiers to EFSA on 13 September 2010 and 1 December 2010, respectively. These applications were included in the EFSA Register of Questions with the reference number EFSA-Q and EFSA-Q and the following subjects: Pyraclostrobin - Application to modify the existing MRLs in oilseeds. Pyraclostrobin - Application to modify the existing MRLs in citrus fruits. The EMS Germany proposes the following MRLs: 0.02* mg/kg in soya bean, 0.05 mg/kg in peanuts, 0.2 mg/kg in cotton seed and 0.3 mg/kg in linseed, poppy seed, sesame seed, sunflower seed, rape seed, mustard seed, pumpkin seed, safflower seed, borage, gold of pleasure, hempseed, castor bean. The EMS France proposes the MRL of 2 mg/kg in citrus fruits. EFSA then proceeded with the assessment of the application as required by Article 10 of the Regulation. TERMS OF REFERENCE In accordance with Article 10 of Regulation (EC) No 396/2005, EFSA 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. 3 Regulation of European Parliament and Council 396/2005/EC of 23 February OJ L 70, , p Council Directive 91/414/EEC of 15 July 1991, OJ L 230, , p BASF SE, P.O. Box 120, 67114, Limburgerhof, Germany 6 BASF AGRO SAS, 21 chemin de la Sauvegarde, 69134, Ecully cedex, France EFSA Journal 2011;9(3):2120 6

7 In accordance with Article 11 of 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 of receipt of the application. Where EFSA requests supplementary information, the time limit laid down shall be suspended until that information has been provided. The calculated deadline for providing the reasoned opinion is 13 December 2010 (for the application on oilseeds) and 1 March 2011 (for the application on citrus fruits). EFSA Journal 2011;9(3):2120 7

8 THE ACTIVE SUBSTANCE AND ITS USE PATTERN Pyraclostrobin is the ISO common name for methyl 2-[1-(4-chlorophenyl)pyrazole-3-yloxymethyl]-Nmethoxycarbanilate (IUPAC). The chemical structure is as follows: Cl N N O O N O O 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 relationship in the plant, increases greening effect and improves tolerance against stresses. Pyraclostrobin is used on a wide range of dicotyledonous and monocotyledonous crop species. The active substance is considered as fatsoluble. Pyraclostrobin was peer reviewed under Directive 91/414/EEC with Germany being the designated rapporteur Member State. The active substance was included in Annex I to this Directive by the Commission Directive 2004/30/EC 7 for the use as a fungicide. Representative use evaluated under the peer review was foliar application of the active substance on grapes. From 4 August 2009, according to Directive 2009/25/EC 8 which amends Directive 91/414/EEC, pyraclostrobin can also be used as a plant growth regulator. Pyraclostrobin has not been peer reviewed by EFSA and therefore no EFSA conclusion is available. The existing EU MRLs for pyraclostrobin are established in Annexes II and IIIB of Regulation (EC) No 396/2005 and are summarized in Appendix C to this document. The MRL proposals for various crops have also been assessed by EFSA in 2009 and 2010 (EFSA, 2009a, 2009b, 2010). The MRL proposals derived by EFSA for pyraclostrobin in celeriac, tomatoes, aubergines and globe artichokes (EFSA, 2010) were voted in the SCoFCAH in its meeting on 9-10 December 2010, but are not yet enforced. The existing EU MRLs for oilseeds are set at the LOQ of 0.02 mg/kg, except for sunflower seed (0.3 mg/kg); the EU MRL for citrus fruits is set at 1 mg/kg. The Codex Alimentarius Commission has established CXLs for a wide range of crops, including citrus fruits (1 mg/kg), peanuts (0.02 mg/kg), soya bean (0.05 mg/kg) and sunflower seeds (0.3 mg/kg). The intended GAPs on citrus in France and the authorized GAPs on various oilseeds in the USA for the use of pyraclostrobin are summarized in Appendix A. 7 Commission Directive 2004/30/EC of 10 March 2004, OJ L 77, , p Commission Directive 2009/25/EC of 2 April 2009, PJ L 91, , p EFSA Journal 2011;9(3):2120 8

9 ASSESSMENT EFSA bases its assessment on the evaluation reports submitted by the EMS Germany (Germany, 2010) and the EMS France (France, 2010), the Draft Assessment Report (DAR) prepared under Directive 91/414/EEC (Germany, 2001), the EU Review Report (EC, 2004), the EFSA reasoned opinions on the modification of the existing MRLs for pyraclostrobin (EFSA, 2009a, 2009b, 2010) and the data submitted by the RMS Germany in the framework of Article 12 of Regulation (EC) No 396/2005 (Germany, 2009). The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation of the Authorization of Plant Protection Products set out in Annex VI to Council Directive 91/414/EEC and the currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues (EC, 1996, 1997a, 1997b, 1997c, 1997d, 1997e, 1997f, 1997g, 2000, 2004, 2008, 2010). 1. Methods of analysis 1.1. Methods for enforcement of residues in food of plant origin The analytical methods for the determination of pyraclostrobin residues in foodstuffs of plant origin were evaluated in the framework of the peer review of Directive 91/414/EEC (Germany, 2001). Pyraclostrobin residues in plant matrices with high acid-, high oil content and in dry matrices can be determined by reverse phase HPLC-MS-MS or HPLC-UV methods with an LOQ of 0.02 mg/kg. In addition, the multi-residue QuEChERS method (determination using GC-MS and/or LC-MS(/MS) described in the European Standard EN 15662:2008 is sufficiently validated at the LOQ of 0.01 mg/kg for the determination of pyraclostrobin in plant matrices with high acid-, high water content matrices and in dry matrices (CEN, 2008). Hence it is concluded that pyraclostrobin residues can be enforced in food of plant origin with a LOQ of 0.02 mg/kg in high oil content commodities and 0.01 mg/kg in high water content, acidic, and dry commodities. EFSA concludes that sufficiently validated analytical methods are available to monitor all compounds given in the enforcement residue definition in the crops under consideration Methods for enforcement of residues in food of animal origin The analytical methods for the determination of pyraclostrobin in foodstuffs of animal origin were evaluated in the framework of the peer review of Directive 91/414/EEC (Germany, 2001). Pyraclostrobin residues in commodities of animal origin can be determined by HPLC-UV method with a validated LOQ of 0.01 mg/kg in milk and 0.05 mg/kg in muscle, liver, kidney, fat and eggs. EFSA concludes that sufficiently validated analytical methods are available to monitor all compounds given in the enforcement residue definition in animal matrices. EFSA Journal 2011;9(3):2120 9

10 2. Mammalian toxicology The toxicological reference values for pyraclostrobin were derived in the peer review under Directive 91/414/EEC and are compiled in Table 2-1 (EC, 2004). Table 2-1: Overview of the toxicological reference values Pyraclostrobin Source Year Value Study relied upon Safety factor ADI COM mg/kg bw/d Chronic rat 100 ARfD COM mg/kg bw Rabbit developmental toxicity Residues 3.1. Nature and magnitude of residues in plant Primary crops Nature of residues The metabolism of pyraclostrobin in primary crops was evaluated by the RMS in the framework of the peer review under Directive 91/414/EEC (Germany, 2001). The overview of the metabolism study designs is presented in the table below. Table 3-1: Summary of available metabolism studies in plants Group Crop Label position Fruits and fruiting vegetable Grapes [chlorophenyl- U- 14 C]- pyraclostrobin Method, F, G or P (a) Rate (kg a.s./ha) F (total 1.5) Application details No/ Interval Samplin g (DAT) 6 40 (harvest) Root and tuber Potato F d after vegetables the 3 rd and appl.; at Cereals Wheat [tolyl-u- 14 C]- pyraclostrobin G harvest 0, 31 and 41 (a): Outdoor/field use (F) or glasshouse/ /indoor application (G) or protected (P) Remarks Foliar spray Foliar spray Foliar spray EFSA Journal 2011;9(3):

11 The relevant residue in grapes consisted of parent pyraclostrobin ( % TRR) and its desmethoxy metabolite 500M07 9 ( % TRR). In potatoes the highest TRR was identified in the green matter ( mg eq./kg) from both studies. Parent pyraclostrobin was the main component of the TRR in mature potato tubers in studies with chlorophenyl labelling, accounting for 29.4 % of the TRR (0.012 mg/kg). 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 ( mg eq./kg). The highest TRR was identified in wheat straw accounting for mg eq./kg. The major component of the TRR in grain in the chlorophenyl study was parent pyraclostrobin (36.1% TRR) and its desmethoxy metabolite 500M07 (10.5% TRR). Also in the straw pyraclostrobin (57.5% TRR) and its metabolite 500M07 (15.2% TRR) were the main components. 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. It was concluded in the peer review that the metabolic pathway is similar in all crop groups investigated. The peer review concluded that a general residue definition for risk assessment and monitoring should be set as parent pyraclostrobin only. Identical residue definition is established in Regulation (EC) No 396/2005 and by Codex Alimentarius Commission. Regarding crops under consideration, EFSA concludes that the metabolic pathway is sufficiently addressed and no additional metabolism studies are necessary Magnitude of residues a. Soya beans In total 16 GAP compliant residue trials on soybean were submitted having been performed in 2003 in various regions of the US. In all soybean samples the residues of pyraclostrobin were below the LOQ of 0.02 mg/kg. The samples were also analysed for the metabolite 500M07 which in all samples was below the LOQ. b. Sunflower In total 9 residue trials on sunflower were submitted. 1 trial was disregarded as it was performed with an exaggerated application rate (2N). All trials have been performed in 2002 and 2005 in the US and CAN. The samples were also analysed for the metabolite 500M07 which in all samples was below the LOQ. c. Rapeseed In total 20 supervised residue field trials on rapeseed were submitted, out of which 16 were considered as GAP compliant. Four trials were disregarded because they were performed with a lower application rate (0.5N). All trials have been carried out in the US and CAN in The samples Cl N N O H N O 9 500M07: Methyl N-(2{[1-(4-chlorophenyl)-1H-pyrazol-3-yl]oxymethyl}phenyl) carbamate O EFSA Journal 2011;9(3):

12 were also analysed for the metabolite 500M07 which in all samples were within a range of < mg/kg. d. Peanuts The authorised GAP envisages 2 applications of the active substance at an application rate up to 0.28 kg a.s./ha, with a total maximum critical application rate of 1.37 kg a.s./ha per season in case of a high risk of a fungal disease. The applicant submitted 12 residue trials in which the active substance was applied 5 times to the crop; the trials were compliant with the GAP regarding the total intended application rate per season. Residue trials have been performed in 1999 in various regions of the US. In all trials, except one (0.023 mg/kg), the residues in the crop were below the LOQ of 0.02 mg/kg. Metabolite 500M07 in all samples was below the LOQ. e. Cotton seed The authorised GAP envisages 2 applications of the active substance at an application rate 0.22 kg a.s./ha, with a total maximum application rate of 0.65 kg a.s./ha per season. The applicant submitted 12 residue trials with 4 applications of the active substance. 1 application was done in a furrow and can be considered as a soil application having insignificant impact on the final residue levels in the crop, whereas other 3 applications were foliar sprays. The seasonal foliar application rate was compliant with the maximum total application rate of 0.65 kg a.s./ha. All trials have been performed in various regions of the US in The samples of undelinted seed were analysed for residues. Metabolite 500M07 was above the LOQ only in one sample (0.028 mg/kg). The residue data on rape seed and sunflower seed were combined and were sufficient to support the proposed extrapolation to other oilseeds on which identical GAP is authorized (linseed, poppy seed, sesame seed, mustard seed, safflower, borage, gold of pleasure and castor bean). f. Citrus fruits In support of the intended GAP in France, the applicant submitted 8 residue trials on oranges and 6 residue trials on mandarins. The residue trials have all been performed in the SEU over 2004 and The applicant proposes to combine the residue data on oranges and mandarins and to extrapolate the residue data to the whole group of citrus fruits. Residue data on mandarins and oranges were within the same range, but, according to the EU guidance documents, additional 2 residue trials on mandarins would be required to support the group tolerance. To cover up for the data gap, the applicant submitted residue trials which have been performed in the USA. EFSA did not use these residue data as the samples from the residue trials from the US have all been analysed at a PHI interval of 0 days. The proposed residue data extrapolation from oranges and mandarins to the whole group of citrus fruit is not fully supported by data and therefore only a MRL proposal in oranges can be supported. The results of the residue trials, the related risk assessment input values (highest residue, median residue) and the MRL proposals are summarized in Table 3-2. 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 commodities with high oil-, water- and acid content as well as in dry commodities for up to 18 months when stored deep frozen. The supervised residue trial samples of oilseeds were stored frozen at -10ºC for a maximum of 15 months. The supervised residue trial samples of oranges and mandarins were stored for a maximum of 66 days deep frozen. As the supervised residue trial samples were stored under conditions for which integrity of the samples was demonstrated, it is concluded that the residue data are valid with regard to storage stability. EFSA Journal 2011;9(3):

13 According to the EMS Germany, the analytical method used to analyse supervised residue trial samples of oilseeds has been sufficiently validated and was proven to be fit for purpose (Germany, 2010). Also the analytical methods used to analyse the supervised residue trial samples of oranges and mandarins were sufficiently validated and fit for purpose (France, 2010). EFSA notes that some residue trials on oilseeds (soybean, sunflowers, rape seed and cotton) might have been performed with a genetically modified crop. Residue data and the MRL proposals are therefore only acceptable if the applicant provides evidence that the genetical modification of these crops does not alter the metabolism in the crop. If a gene is inserted that conveys active substance resistance due to pesticide metabolism, additional metabolism studies are required for the crop group to which the genetically modified crops belong (OECD/OCDE, 2007). EFSA concludes that the residue data are sufficient to derive the following MRL proposals: 2 mg/kg in oranges, 0.02* mg/kg in soybean, 0.04 mg/kg in peanuts, 0.2 mg/kg in rapeseed, 0.3 mg/kg in cotton seed and sunflower seed, 0.2 mg/kg in other oilseeds (except hempseed and pumpkin seeds). The MRL proposals for soya bean and sunflower seeds, however, confirm the existing EU MRLs for these crops. EFSA Journal 2011;9(3):

14 Table 3-2: Overview of the available residues trials data Commodity Region (a) Outdoor /Indoor Individual trial results Enforcement (Pyraclostrobin) Risk assessment (Pyraclostrobin) Median residue (b) Highest residue (c) MRL proposal Median CF (d) Comments Soya bean Import Outdoor 16 x < x <0.02 <0.02 < * 1.0 R ber =0.04 R max =0.02 The proposed MRL is identical with the existing EU MRL. Peanuts Import Outdoor 11 x <0.02; x <0.02; R ber =0.04 R max =0.023 Sunflower seed Import Outdoor <0.02; 0.02; 0.041; 0.045; 0.06; 0.061; 0.099; 0.22 Rape seed Import Outdoor 6 x <0.02; 2 x 0.03; 2 x 0.04; 2 x 0.06; 0.08; 0.1; 0.16; 0.2 Cotton seed Import Outdoor 3 x <0.02; 0.023; 0.024; 0.028; 0.032; 0.064; 0.083; 0.12; 0.13; 0.15 <0.02; 0.02; 0.041; 0.045; 0.06; 0.061; 0.099; x <0.02; 2 x 0.03; 2 x 0.04; 2 x 0.06; 0.08; 0.1; 0.16; x <0.02; 0.023; 0.024; 0.028; 0.032; 0.064; 0.083; 0.12; 0.13; R ber =0.18 R max =0.28 The proposed MRL is identical with the existing EU MRL R ber =0.15 R max = R ber =0.22 R max =0.19 EFSA Journal 2011;9(3):

15 Commodity Rape seed, sunflower seed poppy seeds, sesame seeds, mustard seeds, safflower, borage, gold of pleasure, castor bean, linseed Oranges Mandarins Region (a) Outdoor /Indoor Individual trial results Enforcement (Pyraclostrobin) Import Outdoor 7 x <0.02; 0.02; 2 x 0.03; 2 x 0.04; 0.041; 0.045; 3 x 0.06; 0.061; 0.08; 0.099; 0.1; 0.16; 0.2; 0.22 France (SEU) France (SEU) Outdoor 0.24; 0.29 e ; 0.34 e ; 0.39; 0.58; 0.6; 1.10 e ; 1.31 Risk assessment (Pyraclostrobin) 7 x <0.02; 0.02; 2 x 0.03; 2 x 0.04; 0.041; 0.045; 3 x 0.06; 0.061; 0.08; 0.099; 0.1; 0.16; 0.2; ; 0.29 e ; 0.34 e ; 0.39; 0.58; 0.6; 1.10 e ; 1.31 Median residue (b) Highest residue (c) MRL proposal Median CF (d) Comments Combined data set: Rber=0.15 Rmax= R ber =1.95 R max =1.87 Outdoor 0.25; 0.52; 0.54 e ; 0.76 e ; 0.87; 1.15 e 0.25; 0.52; 0.54 e ; 0.76 e ; 0.87; 1.15 e Insufficient residue data set. (a): NEU, SEU, EU or Import (country code). In the case of indoor uses there is no necessity to differentiate between NEU and SEU. (b): Median value of the individual trial results according to the enforcement residue definition. (c): Highest value of 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 of the individual conversion factors for each residues trial. (e): Higher residue value within a trial measured at a longer PHI interval of 14 days (*): Indicates that the MRL is set at the limit of analytical quantification. EFSA Journal 2011;9(3):

16 Effect of industrial processing and/or household preparation The effect of processing on the nature of pyraclostrobin residues was investigated in the framework of the peer review. A study was conducted simulating representative hydrolytic conditions for pasteurisation (20 minutes at 90 C, ph 4), boiling/brewing/baking (60 minutes at 100 C, ph 5), and sterilisation (20 minutes at 120 C, ph 6). This study demonstrates that food processes such as brewing, cooking, sterilisation or pasteurisation, will not impact the nature of pyraclostrobin residues. The relevant residue for enforcement and risk assessment in processed commodities is therefore expected to be the same as in primary crops (Germany, 2001). Specific studies to assess the magnitude of pyraclostrobin residues during the processing were submitted on rape seed, cotton seed and oranges. Rapeseed and cotton seed were processed into the meal and the crude oil (cotton seed only) and refined oil. The residues in raw rape seed ranged from mg/kg and in raw cotton seed from mg/kg. The study details are not available. The results from the studies with rapeseed indicate a concentration of residues in refined rape seed oil, while residues in the meal remain at the same level as in the raw crop. The processing of cotton seed results in residue levels below the LOQ of 0.02 mg/kg in seed meal, crude oil and refined oil. Oranges were treated 4 times at an exaggerated application rate of kg a.s./ha and harvested 7 d after the last treatment. Unwashed oranges were processed into fresh and pasteurized juice, wet and dry pomace, marmalade and canned fruit. Part of oranges was also washed to obtain the wash water specimens. Results of the studies indicate a concentration of residues in dry and wet pomace only. In all other fractions a reduction of pyraclostrobin residues is observed. Residues are reduced significantly by peeling and washing of the fruit. It is noted that from the residue trials submitted on citrus fruits for the JMPR evaluation in 2003, a median peeling factor of 0.13 could be derived, reflecting the residue distribution in fruit at a longer PHI of 14 days (WHO/FAO, 2004). The overview of the study results is given in the table below. Table 3-3: Overview of the available processing studies Processed commodity Number of studies Median PF (a) Median CF (b) Comments Enforcement residue definition: Pyraclostrobin Rape seed, meal Rape seed, oil Cotton seed, meal Residues in the processed Cotton seed, crude oil commodity in both samples were <0.02 mg/kg. Cotton seed, refined oil Oranges, washed Oranges, peeled Peeling factor. Oranges, fresh juice Oranges, pasteurized juice Oranges, wet pomace EFSA Journal 2011;9(3):

17 Processed commodity Number of studies Median PF (a) Median CF (b) Comments Oranges, dry pomace Oranges, marmalade Oranges, canned (a): The median processing factor is obtained by calculating the median of the individual processing factors of each processing study. (b): The median conversion factor for enforcement to risk assessment is obtained by calculating the median of the individual conversion factors of each processing study. EFSA proposes to include the derived processing factors for pasteurized orange juice, wet pomace and peeled oranges in Annex VI of Regulation (EC) No 396/2005. For oilseeds the number of processing studies is not sufficient to propose the derived processing factors for enforcement. The processing factors for orange marmalade and canned oranges are not proposed for enforcement as well, because no details on the sugar/water content have been provided for the final product Rotational crops Preliminary considerations The investigation of the possible occurrence of pyraclostrobin residues in rotational/succeeding crops is of no relevance for the import tolerance request on oilseeds and well as for citrus fruits which are permanent crops Nature and magnitude of residues in livestock Since oilseeds and citrus fruits and/or their by-products are normally fed to livestock, the nature and magnitude of pyraclostrobin residues in livestock has to be assessed in the framework of this application (EC, 1996) Dietary burden of livestock The median and maximum dietary burden for livestock was calculated using the agreed European methodology (EC, 1996). The input values for the dietary burden calculation were selected according to the latest FAO recommendations (FAO, 2009) considering the livestock intake from: 1) feed products under consideration: orange pomace, peanuts, sunflower seed, soybean, rape seed, cotton seed and linseed and their by-products; 2) feed products for which the MRLs are set above the LOQ of 0.02 mg/kg in Regulation (EC) No 396/2005: citrus fruits (except orange), pome fruits, cabbage, pulses, barley, oats, wheat, rye 3) feed products on which additional authorized uses have been reported by the RMS in the framework of the MRL review for pyraclostrobin according to Article 12 of Regulation (EC) No 396/2005: sugar beet, potatoes, maize (Germany, 2009). For the refined calculations of the dietary burden the risk assessment values (STMR and HR) as reported by the RMS Germany in the framework of Article 12 of Regulation (EC) No 396/2005 were used as input values (Germany, 2009). For apple pomace, cereal bran and oilseed meals, default EFSA Journal 2011;9(3):

18 processing factors have been included in the calculation in order to consider the potential concentration of residues in these commodities. For orange pomace the processing factor of 2.25 as derived in the studies submitted under the current application was applied (Table 3-3). The input values are summarized in the Table 3-4. Table 3-4: Input values for the livestock dietary burden calculation Commodity Median dietary burden Maximum dietary burden Input value Enforcement residue definition: Pyraclostrobin Comment 1) Residues resulting from the intended/authorized uses Input value Comment Orange pomace 1.10 Median residue x PF (2.25) 1.10 Median residue x PF (2.25) Peanuts 0.02 Median residue 0.02 Median residue Peanuts meal 0.04 Median residue x PF (2) 0.04 Median residue x PF (2) Sunflower seed Median residue Median residue Sunflower seed meal Median residue x PF (2) Median residue x PF (2) Soya bean 0.02 Median residue 0.02 Median residue Soya bean meal 0.03 Median residue x PF (1.3) 0.03 Median residue x PF (1.3) Rape seed Median residue Median residue Rape seed meal 0.07 Median residue x PF (2) 0.07 Median residue x PF (2) Cotton seed 0.03 Median residue 0.03 Median residue Cotton seed meal 0.04 Median residue x PF (1.3) 0.04 Median residue x PF (1.3) Linseed 0.04 Median residue (combined rape seed and sunflower seed) Linseed meal 0.07 Median residue (combined rape seed and sunflower seed) x PF (1.3) 0.04 Median residue (combined rape seed and sunflower seed) 0.07 Median residue (combined rape seed and sunflower seed) x PF (1.3) 2) Residues resulting from the feed crops for which the MRLs are set above the LOQ in Regulation (EC) No 396/2005 3) Residues arising from the additional authorized uses reported in the framework of Article 12 of Regulation (EC) No 396/2005 Cabbage 0.02 STMR 0.09 HR Sugar beet tops 0.04 STMR 0.12 HR Citrus pomace (except orange pomace) 0.45 STMR x PF(2.25) 0.45 STMR x PF(2.25) Apples pomace 0.25 STMR x PF(2.5) 0.25 STMR x PF(2.5) Barley and oat grain 0.07 STMR 0.07 STMR Wheat and rye grain 0.02 STMR 0.02 STMR Wheat and rye bran 0.16 STMR x PF (8) 0.16 STMR x PF (8) EFSA Journal 2011;9(3):

19 Barley and oat straw 3.38 STMR 6.92 HR Wheat and oat straw 1.85 STMR 5.68 HR Maize grain 0.02 STMR 0.02 STMR Peas (dry, beans (dry) 0.04 STMR 0.04 STMR Potatoes 0.02 STMR 0.02 HR Sugar beet root 0.04 STMR 0.11 HR The results of the dietary burden calculation are summarized in the following table. Table 3-5: Results of the dietary burden calculation Maximum dietary burden (mg/kg bw/d) Median dietary burden (mg/kg bw/d) Risk assessment residue definition: Pyraclostrobin Highest contributing commodity Max dietary burden (mg/kg DM) (a) Trigger exceeded (Y/N) Dairy ruminants Barley straw 2.31 Y Meat ruminants Barley straw 5.57 Y Poultry Barley grain 0.21 Y Pigs Sugar beets 0.54 Y The calculated dietary burden indicates that the trigger value of 0.1 mg/kg dry matter (DM) is exceeded for all livestock species and is mainly driven by the existing uses of pyraclostrobin on barley and sugar beets. As the livestock dietary burden is exceeded for all livestock species, the possible carry-over of pyraclostrobin residues to food commodities of animal origin have to be further assessed Nature of residues The nature of pyraclostrobin residues in commodities of animal origin was investigated in the framework of Directive 91/414/EEC (Germany, 2001). Reported metabolism studies include 4 studies, two in lactating goats and two in laying hens using 14 C-chlorophenyl and 14 C-tolyl labeled pyraclostrobin. These studies were also considered by the 2004 JMPR (FAO, 2004). Lactating goats. After five consecutive daily oral administrations of 14 C-pyraclostrobin at a nominal dosage of 12 or 50 mg/kg DM feed, radioactivity was excreted mainly via the faeces (48-64% TRR). The radiolabel in milk accounted for only % of the total applied radioactivity. There was no indication of accumulation of 14 C-pyraclostrobin in tissues (Germany, 2001). From the low dose group the parent compound was found in goat fat ( % TRR), muscle ( % TRR) and, at lower amounts, in liver ( % TRR; parent and metabolite 500M07 together). In fat and muscle metabolite 500M07 accounted for 21.7% TRR and 14.2% TRR, respectively. Pyraclostrobin together with metabolite 500M07 in milk accounted for % TRR and in kidney for % TRR. In studies with chlorophenyl label, two other metabolites EFSA Journal 2011;9(3):

20 were identified in milk: metabolite 500M04 (BF 500-5) 10 (16.3% of the TRR in high dose group) and metabolite 500M05 11 ( % TRR) which seems to be a further metabolism product of metabolite 500M04. Pyraclostrobin was present in all tissues and in milk and was the main residue component in muscle and in fat (logpow = 3.9) (FAO, 2004). Laying hen. Tissues and eggs from hens that received an exaggerated dose of 0.70 or 0.88 mg/kg bw/d on seven consecutive days contained low residue levels consisting of three main metabolites. The TRR in a lower dose group accounted for mg eq./kg in eggs, mg eq./kg in muscle, mg eq./kg in fat and mg eq./kg in liver. The parent compound was found in fat ( % TRR; mg/kg) and eggs ( % TRR; mg/kg), but not in liver. Metabolite 500M07 was the main metabolite in fat ( % TRR; mg/kg) and eggs ( % TRR; mg/kg). The main metabolite in liver was the glucuronic acid conjugate (500M32 12 ) ( % TRR; mg/kg), which was bound to the tolyl ring of the demethoxylated parent structure. The metabolic patterns identified for goats and hens were consistent with the rat metabolism and a specific metabolism study in pigs is not considered necessary. Pyraclostrobin was identified as the major indicator compound in commodities of animal origin except in ruminant liver and milk fat. The peer review set the enforcement residue definition in animal matrices as pyraclostrobin. Residue is fat-soluble. Under the peer review the risk assessment residue definition was derived for liver (except poultry liver) and milk fat only as pyraclostrobin and its metabolites containing the 1-(4-chlorophenyl)-1Hpyrazole - or the 1-(4-chloro-2-hydroxyphenyl)-1H-pyrazole moiety, sum expressed as pyraclostrobin. In other tissues the risk assessment residue definition comprises parent pyraclostrobin only. From the available feeding study results, EFSA proposes to set different levels of conversion factors from enforcement to risk assessment. Conversion factors are proposed at 4 for ruminant liver and at 1 for all other commodities. Validated analytical methods for enforcement of the proposed residue definition are available (see also section 1.2.) Magnitude of residues During the peer review of Directive 91/414/EEC the magnitude of pyraclostrobin residues in livestock was investigated in a feeding study with lactating cows (Germany, 2001). Three groups of lactating cows, each consisting of three animals, were dosed for 28 days with pyraclostrobin at levels of 0.22, 0.37 and 2.4 mg pyraclostrobin/kg bw/day. Results of the livestock feeding study are summarized in Table 3-6. The samples were analyzed separately for parent pyraclostrobin and its metabolites containing the 1-(4-chlorophenyl)-1H-pyrazole moiety or the 1-(4-chloro-2-hydroxyphenyl)-1Hpyrazole moiety. No residues of pyraclostrobin and its metabolites could be detected in samples of whole milk from the 1x and 3x levels except for cream samples where residues in the range of 0.02 mg/kg to 0.04 mg/kg occurred. In the exaggerated 10 x dose group, residues up to 0.18 mg/kg were detected in milk, which mainly consisted of hydroxylated metabolites. As expected, the residue concentrations were higher in cream than in milk or skimmed milk, but the concentration was only moderate (Germany, 2001). Cl M04: 1-(4-chlorophenyl)-1H-pyrazol-3-ol N N OH O N SO3 H M05: 1-(4-chlorophenyl)-1H-pyrazol-3-yl hydrogensulfate N M32: Methyl N-(2{[1-4-chlorophenyl)-1H-pyrazol-3-yl]oxymethyl}-(glucopyranuronosyl oxy)phenyl) carbamate Cl EFSA Journal 2011;9(3):

21 In fat and muscle, no residues have been detected at any dose level. In kidneys, residues were only found in the 10x group. In liver, the highest residues were found mainly consisting of hydroxylated metabolites. The withdrawal cows (daily dose of 1400 mg/day and animal) showed a rapid decline of residues. After seven days of withdrawal, residues could only be detected in liver (0.5 mg/kg). Therefore, it can be concluded that pyraclostrobin and its metabolites were eliminated rapidly from the animal (Germany, 2001). This livestock feeding study was rejected by JMPR because no residues were found in fat (FAO, 2004). However, under the peer-review, it was concluded that this livestock feeding study was acceptable (EC, 2002). Based on the available livestock feeding study, MRLs and risk assessment values in ruminant and swine products were calculated in compliance with the latest international recommendations on this matter (FAO, 2009). It is therefore concluded that significant residues in edible matrices of ruminants and pigs are not expected and that MRLs for these commodities can be established at the LOQ. Consequently, there is no need to modify the existing EU MRLs in ruminant and swine commodities. The storage stability of pyraclostrobin in animal products was evaluated under the peer review of Directive 91/414/EEC (Germany, 2001). Studies demonstrated storage stability of pyraclostrobin in milk and animal tissues for up to 8 months when stored deep frozen. No storage stability study was performed on poultry eggs. The storage conditions of samples of the livestock feeding study were not reported. The RMS considered the available feeding study adequate but, according to EFSA, a confirmation that livestock feeding samples were stored in compliance with the above reported conditions is desirable. No livestock feeding study is available for poultry but the metabolism study in laying hens was performed at dose levels of approximately 0.7 and 0.88 mg/kg bw/d, which represents 100 times the calculated dietary intake. When extrapolating residue levels obtained in the metabolism study to the calculated intake, no residues above LOQ are expected in any poultry tissues or eggs. Consequently, no feeding study is necessary and the existing EU MRLs in eggs and poultry tissues which are currently established at the LOQ, do not need to be modified. EFSA Journal 2011;9(3):

22 Table 3-6: Overview of the values derived from the livestock feeding studies Commodity Dietary burden Results of the livestock feeding study Median residue No Result for enf. Result for RA Med. (mg/kg bw/d) Max. (mg/kg bw/d) Dose Level (mg/kg bw/d) Mean Max. Mean Max. Highest residue MRL proposal CF for RA Residue definition for enforcement: pyraclostrobin and risk assessment: 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 Pig meat <0.05 n.r. <0.05 n.r * <0.05 n.r. <0.05 n.r <0.05 n.r. <0.05 n.r. Pig fat <0.05 n.r. <0.05 n.r * <0.05 n.r. <0.05 n.r <0.05 n.r. <0.05 n.r. Pig kidney <0.05 n.r. <0.05 n.r * <0.05 n.r. <0.05 n.r <0.05 n.r. <0.05 n.r. Pig liver <0.05 n.r n.r * <0.05 n.r n.r <0.05 n.r n.r. Ruminant meat <0.05 n.r. <0.05 n.r * <0.05 n.r. <0.05 n.r <0.05 n.r. <0.05 n.r.. EFSA Journal 2011;9(3):

23 Commodity Dietary burden Results of the livestock feeding study Median residue No Result for enf. Result for RA Med. (mg/kg bw/d) Max. (mg/kg bw/d) Dose Level (mg/kg bw/d) Mean Max. Mean Max. Highest residue MRL proposal Ruminant fat <0.05 n.r. <0.05 n.r * <0.05 n.r. <0.05 n.r <0.05 n.r. <0.05 n.r. Ruminant kidney <0.05 n.r. <0.05 n.r * <0.05 n.r. <0.05 n.r <0.05 n.r. <0.05 n.r. Ruminant liver <0.05 n.r n.r * <0.05 n.r n.r <0.05 n.r n.r. CF for RA Milk <0.01 (a) n.a. <0.02 (a) n.a * 1.00 (c) <0.01 (a) n.a. <0.02 (a) n.a <0.01 (b) n.a (b) n.a. n.a.: not applicable only the mean values are considered for calculating MRLs in milk n.r.: not reported but not considered relevant in this case because residues according to the enforcement residue definition are always below the LOQ (*): indicates that the MRL is set at the limit of analytical quantification (a): mean residue level from day -1 until day 27 (3 cows, 4 sampling days) (b): mean residue level from day -1until end of dosing (3 cows, 2 depuration cows, 14 sampling days) (c): as residue levels were below the LOQ, no conversion factor is necessary. (F): MRL is expressed as mg/kg of fat contained in the whole product. EFSA Journal 2011;9(3):

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