Modification of the existing MRLs for spinosad in various crops 1. European Food Safety Authority 2

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1 EFSA Journal 2011;9(9):2352 REASONED OPINION 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, the United Kingdom herewith referred to as the Evaluating Member State United Kingdom (EMS UK), received an application from the Horticultural Development Company to modify the existing MRLs for spinosad in blackberries and raspberries. In order to accommodate for the intended outdoor use of spinosad on these crops in the United Kingdom it is proposed to raise the existing MRL from 0.3 mg/kg to 0.5 mg/kg. The EMS UK 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 20 January On 25 May 2011 some data requirements were identified, which prevented EFSA to conclude on the consumer risk assessment. An updated evaluation report, addressing those data requirements, was submitted by the EMS UK on 15 August 2011 and taken into consideration by EFSA for finalization of this reasoned opinion. According to Article 6 of the Regulation (EC) No 396/2005, Germany, herewith referred to as the Evaluating Member State Germany (EMS DE), received an application from the LWK NRW Pflanzenschutzdienst to modify the existing MRL for spinosad in parsley. In order to accommodate for the intended indoor use of spinosad on parsley in Germany, it is proposed to raise the existing MRL from 10 mg/kg to 50 mg/kg. The EMS DE 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 23 June According to Article 6 of the Regulation (EC) No 396/2005, the Netherlands, herewith referred to as the Evaluating Member State Netherlands (EMS NL), received an application from the company Dow AgroSciences Ltd. to modify the existing MRL for spinosad in banana, watercress, fresh beans with or without pods, maize, sweet corn, potatoes and radish. The EMS NL 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 11 July In order to accommodate for the intended use of spinosad on these crops in southern and/or northern European Member States, it is proposed to raise the existing MRL in banana from 0.02* mg/kg to 2 mg/kg, in radish from 0.02* mg/kg to 0.3 mg/kg and to lower the existing MRLs in watercress, beans (with pods) and maize. In addition, new uses of spinosad (on potatoes and sweet corn) and additional uses (fresh beans (without pods)) have been notified not requiring the raising of the existing EU MRLs for these crops. EFSA is of the 1 On request from the European Commission, Question No EFSA-Q , EFSA-Q , EFSA-Q , issued on 02 September Correspondence: pesticides.mrl@efsa.europa.eu Suggested citation: European Food Safety Authority;. EFSA Journal 2011;9(9):2352. [30 pp.] doi: /j.efsa Available online: European Food Safety Authority, 2011

2 opinion that the risk assessment related to the lowering of an MRL (which would require the review of all the existing spinosad uses) and the notification of additional uses that do not require the modification of the existing MRLs has to be performed within the framework of the MRL review of spinosad according to Article 12 of Regulation (EC) 396/2005 which is currently ongoing. Therefore in this reasoned opinion EFSA will focus only on the MRL applications which require raising of the existing MRLs. Considering that all three applications refer to the modification of the existing MRLs for spinosad, for reasons of efficiency EFSA addressed all MRL applications in one reasoned opinion. EFSA derived the following conclusions based on the submitted evaluation reports prepared by the United Kingdom, Germany and the Netherlands, the draft assessment report (DAR) prepared by the rapporteur Member state (RMS) Netherlands under Directive 91/414/EEC and the JMPR evaluation reports. The toxicological profile of spinosad was assessed in the framework of the peer review under Directive 91/414/EEC in The experts agreed on an ADI value of mg/kg body weight/day. Due to the low toxicity of the active substance the setting of an ARfD was considered not necessary. The plant metabolism of spinosad was investigated in grapes, apples, tomatoes, cabbage, turnips and cotton. From these studies the peer review derived the residue definition for risk assessment and enforcement as spinosad: sum of spinosyn A and D, expressed as spinosad. The same residue definition was established in Regulation (EC) No 396/2005. EFSA therefore concludes that for the crops under consideration, the metabolism is sufficiently elucidated and no further studies are required. However, EFSA would propose to change the wording of the residue definition, taking into account that spinosad is a mixture of the two components, spinosyn A and spinosyn D which have slightly different molecular weights. Thus, the proposed wording for the revised residue definition is spinosad: sum of spinosyn A and spinosyn D. This amendment would not have an impact on the values of the currently established MRLs. The submitted residue data sets indicate that an MRL of 60 mg/kg in parsley, 2 mg/kg in banana and 0.3 mg/kg in radish would be required to support the intended uses of spinosad on these crops. An insufficient number of residue data has been submitted to derive the MRL proposal in raspberries and blackberries. There are adequate analytical methods available to monitor the compliance of the proposed MRLs for spinosad in these crops. The effects of processing on the nature of spinosad residues have not been investigated in the peer review and no new studies have been submitted in the framework of the current MRL applications. However, considering the wide range of authorised uses of spinosad, EFSA is of the opinion that studies investigating the effects of processing on the nature of spinosad residues have to be performed. Specific studies to assess the magnitude of spinosad residues during the processing in the crops under consideration have not been submitted and are also not necessary considering the low contribution of these crops to the total dietary intake. The occurrence of spinosad residues in rotational and/or succeeding crops has been investigated in the framework of the current application since radish and parsley can be grown in a crop rotation. It is concluded that the use of spinosad on parsley and radish at the application rates specified in the intended GAPs is not likely to result in measurable residues of spinosad and/or spinosad related soil degradation products in succeeding or rotational crops. Since the crops under consideration are not normally fed to livestock, the nature and magnitude of spinosad residues in livestock was not assessed in the framework of this application. The consumer risk assessment was performed with revision 2 of the EFSA PRIMo. For the calculation of the chronic exposure, EFSA used the median residue values as derived from the residue trials on banana, parsley and radish. For several crops the median residue values as derived by the JMPR and EFSA Journal 2011;9(9):2352 2

3 corresponding to the existing EU MRLs were available and were used to refine the consumer exposure calculations. The input values for apples (pears) and milk were as derived in the framework of the review of spinosad MRLs according to Article 12 of Regulation (EC) No 396/2005. For the remaining commodities of plant and animal origin, the existing MRLs as established in Annex IIIA of Regulation (EC) No 396/2005 were used as input values. The estimated exposure was then compared with the toxicological reference value derived for spinosad. 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 9.9 to 82.7% of the ADI (WHO Cluster diet B). The contribution of residues in the crops under consideration to the total consumer exposure accounted for a maximum of 4.6% of the ADI for banana (SE general population diet), 2.08% of the ADI for parsley (WHO Cluster diet E) and 0.021% of the ADI for radishes (SE general population diet, WHO Cluster diet D). It is noted that the calculation is based on the use of spinosad as a plant protection product and therefore in case a higher MRL is required due to biocide uses of spinosad, the risk assessment has to be recalculated. The acute exposure was not calculated due to the low acute toxicity of the active substance. EFSA concludes that the intended use of spinosad on the crops under consideration 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 (mg/kg) Proposed EC MRL (mg/kg) Justification for the proposal Existing residue definition: Spinosad: sum of spinosyn A and spinosyn D, expressed as spinosad Proposed revised residue definition: Spinosad: sum of spinosyn A and spinosyn D Blackberries 0.3 No proposal No MRL proposal could be derived due to insufficient data Raspberries 0.3 No proposal provided Bananas 0.02* 2 The MRL proposals are Radishes 0.02* 0.3 sufficiently supported by data and no consumer intake concerns have Parsley been identified. (*): Indicates that the MRL is set at the limit of analytical quantification. a according to Annex I of Regulation (EC) No 396/2005 KEY WORDS Spinosad, blackberries, raspberries, bananas, radishes, parsley, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, spinosyn A, spinosyn D EFSA Journal 2011;9(9):2352 3

4 TABLE OF CONTENTS Summary... 1 Table of contents... 4 Background... 5 Terms of reference... 6 The active substance and its use pattern... 7 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 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(9):2352 4

5 BACKGROUND Commission Regulation (EC) No 396/ establishes the rules governing the setting of pesticide MRLs at Community level. Article 6 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 / Regulation (EC) No 1107/2009 5, 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. The United Kingdom, hereafter referred to as the evaluating Member State United Kingdom (EMS UK), received an application from the Horticultural Development Company 6 to modify the existing MRLs for the active substance spinosad in raspberries and blackberries. 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 report of the EMS UK was submitted to the European Commission who forwarded the application, the evaluation report and the supporting dossier to EFSA on 20 January The application was included in the EFSA Register of Questions with the reference number EFSA-Q and the following subject: Spinosad - Application to modify existing MRLs in raspberries and blackberries. The EMS UK proposed the MRL of 0.5 mg/kg in raspberries and blackberries. EFSA then proceeded with the assessment of the application as required by Article 10 of the Regulation. On 25 May 2011 some data requirements were identified, which prevented EFSA to conclude on the consumer risk assessment. An updated evaluation report, addressing those data requirements, was submitted by the EMS UK on 15 August 2011 and taken into consideration by EFSA for finalization of this reasoned opinion. Germany, hereafter referred to as the evaluating Member State Germany (EMS DE), received an application from the LWK NRW Pflanzenschutzdienst 7 to modify the existing MRLs for the active substance spinosad in parsley. 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 report of the EMS DE was submitted to the European Commission who forwarded the application, the evaluation report and the supporting dossier to EFSA on 23 June The application was included in the EFSA Register of Questions with the reference number EFSA-Q and the following subject: Spinosad - Application to modify the existing MRL in parsley. The EMS DE proposed the MRL of 50 mg/kg in parsley. 3 Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February OJ L 70, , p Council Directive 91/414/EEC of 15 July 1991, OJ L 230, , p Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009, , OJ L 309, p Horticultural Development Company, Bradbourne House, ME 19 6DZ, East Malling, United Kingdom 7 LWK NRW, Pflanzenschutzdienst, Siebengebirgstrasse 200, 53229, Bonn, Germany EFSA Journal 2011;9(9):2352 5

6 The Netherlands, hereafter referred to as the evaluating Member State Netherlands (EMS NL), received an application from the company Dow AgroSciences Ltd. 8 to modify the existing MRLs for the active substance spinosad in banana, watercress, fresh beans with or without pods, maize, sweet corn, potatoes and radish. 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 report of the EMS NL was submitted to the European Commission who forwarded the application, the evaluation report and the supporting dossier to EFSA on 11 July The application was included in the EFSA Register of Questions with the reference number EFSA-Q and the following subject: Spinosad - Application to modify the existing MRL in various commodities The EMS proposed the following MRLs: 2 mg/kg in banana, 3 mg/kg in watercress, 0.3 mg/kg in fresh beans with and without pods, 0.02* mg/kg in maize, sweet corn and potatoes and 0.3 mg/kg in radish. Since all MRL applications refer to the use of spinosad, for reasons of efficiency EFSA combined all applications in one reasoned opinion. 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. 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. In this particular case the calculated deadline for providing the reasoned opinion is 15 August 2011 for the MRL application on raspberries and blackberries, 23 September 2011 for the MRL application on parsley and 11 October 2011 for the MRL application on banana, watercress, fresh beans (with or without pods), maize, sweet corn, potatoes and radish. 8 Dow AgroSciences, Estuary Road, PE30 2JD, Kings Lynn, United Kingdom EFSA Journal 2011;9(9):2352 6

7 THE ACTIVE SUBSTANCE AND ITS USE PATTERN Spinosad is the ISO common name for a mixture of spinosyn A and spinosyn D in a ratio between 95:5 and 50:50. The IUPAC names are as follows: Spinosyn A: (2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-(6-deoxy-2,3,4-tri-O-methyl- -Lmannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy- -D-erythropyranosyloxy)-9-ethyl- 2,3,3a,5a,6,7,9,10, 11,12,13,14,15,16a,16b-hexadecahydro-14-methyl-1H-8-oxacyclododeca[b]asindacene-7,15-dione; Spinosyn D: (2R,3aS,5aR,5bS,9S,13S,14R,16aS,16bR)-2-(6-deoxy-2,3,4-tri-O-methyl- -Lmannopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy- -D-erythropyranosyloxy)-9-ethyl- 2,3,3a,5a,6,7,9,10, 11,12,13,14,15,16a,16b-hexadecahydro-4,14-dimethyl-1H-8-oxacyclododeca[b]asindacene-7,15-dione (CH 3 ) 2 N CH 3 O O O O CH 3 H H O O OCH 3CH3 OCH 3 OCH 3 CH 3 CH 2 O HH H R spinosyn A, R = H- spinosyn D, R = CH 3 - Molecular weight: spinosyn A: , spinosyn D: Spinosad is a natural fermentation product produced by a species of Actinomycetes, Saccharopolyspora spinosa which has insecticidal activity. It acts via contact and ingestion causing paralysis. The biochemical mode of action is explained by activation of the nicotinic acetylcholine receptor. It is used to control Lepidoptera, thrips, flies, beetles and grasshoppers in a wide range of crops. Spinosad may also be used as a biocide on livestock animals for control of lice, and in livestock premises for control of nuisance flies. Spinosad was peer reviewed under Council Directive 91/414/EEC with the Netherlands being the designated Rapporteur Member State (RMS). Spinosad was included in Annex I of this directive by Commission Directive 2007/6/EC 9 which entered into force on 1 February The representative uses evaluated under the peer review were foliar applications on table and wine grapes, peppers, tomatoes, aubergines and ornamentals. Since EFSA was not involved in the peer review, no EFSA conclusion is available for this compound. It is noted that recently by Commission Directive 2010/71/EU 10 spinosad has been included in Annex I of the biocides directive (Directive 98/8/EC 11 ) as product type 18 (products used for the control of 9 Commission Directive 2007/6/EC. OJ L 43, , p Commission Directive 2010/72/EU of 4 November 2010, OJ L 288, , p Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market. OJ L 123, , p.1-62 EFSA Journal 2011;9(9):2352 7

8 arthropods e.g. insects, arachnids and crustaceans). It is also worthwhile mentioning that according to Regulation (EC) No 834/ the use of spinosad is, under certain conditions 13, allowed in organic agriculture. Community MRLs for spinosad have been established for the first time in 2008 with Regulation (EC) No 149/ and Regulation (EC) No 839/ The current MRLs can be found in Appendix C. Recently new MRL proposals of spinosad in herbal infusions were evaluated by EFSA (EFSA, 2010) and the conclusion was that the data are insufficient to propose new MRLs. An overview of the existing EU MRLs, Codex Limits (CXLs) and the MRLs proposed by the evaluating Member States DE, NL and UK in the crops under consideration is presented in the table below: Commodity Raspberries, blackberries Existing EU MRL CXL Proposed MRL by the EMS The EMS The United Kingdom Parsley Germany Banana 0.02* - 2 The Netherlands Watercress 10-3 Beans (with pods) Beans (without pods) Maize * Sweet corn 0.02* 0.01* 0.02* Potatoes 0.02* 0.01* 0.02* Radish 0.02* 0.01* 0.3 According to the evaluation report submitted by the EMS NL, a lowering of EU MRLs is proposed for watercress, beans (with pods) and maize. In addition, uses on potatoes, sweet corn and fresh beans (without pods), not requiring the modification of the existing MRLs, have been assessed. EFSA is of the opinion that the risk assessment related to the lowering of an MRL (which would require the review of all the existing spinosad uses) and the notification of additional uses that do not require the modification of the existing MRLs has to be performed within the framework of the MRL review of spinosad according to Article 12 of Regulation (EC) 396/2005 which is currently at the stage of finalisation. Consequently, in the current reasoned opinion EFSA will focus only on those MRL requests which require raising of the existing EU MRLs (highlighted in bold in the table above). The details of the intended GAPs on the use of spinosad on the crops under consideration are summarised in Appendix A. The GAPs for the crops not assessed in this reasoned opinion are shaded in gray. 12 Council Regulation (EC) No 834/2007. OJ L 189, , p Only if the active substance is produced by strains not genetically modified and only when measures are taken to minimise the risk to key parasitoids and to minimise the risk of development of resistance. 14 Regulation (EC) No 149/2008. OJ L 58, , p Regulation (EC) No 839/2008. OJ L 234, , p EFSA Journal 2011;9(9):2352 8

9 ASSESSMENT EFSA bases its assessment on the evaluation report submitted by the EMS United Kingdom (United Kingdom, 2009, 2011), the EMS Germany (Germany, 2011), the EMS Netherlands (Netherlands, 2011), the Draft Assessment Report (DAR) prepared under Council Directive 91/414/EEC (Netherlands, 2001), the Commission Review Report on spinosad (EC, 2006), the JMPR Evaluation reports (FAO, 2001, 2004), the conclusions from a previous EFSA opinion on spinosad (EFSA, 2010) as well as the draft reasoned opinion on the review of the existing MRLs for spinosad (EFSA, 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 set out in Regulation (EU) No 546/ 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, 2010, 2011; OECD, 2011). 1. Methods of analysis 1.1. Methods for enforcement of residues in food of plant origin The residue definition currently established in Regulation (EC) No 396/2005 is spinosad: sum of spinosyn A and spinosyn D, expressed as spinosad. During the peer review under Directive 91/414/EC, an analytical method using HPLC-UV (DAD) and its ILV were evaluated and validated for the determination of spinosad (sum of spinosyn A and spinosyn D) in plant matrices with an LOQ of 0.01 mg/kg for each component in high water content (tomatoes, apples, peppers) and in high acid content (strawberries, grapes) commodities (The Netherlands, 2001); the combined LOQ is 0.02 mg/kg. Additionally, analytical methods using HPLC-UV or MS detection were evaluated and validated in JMPR report for the determination of spinosad (sum of spinosyn A and spinosyn D) in plant matrices with an LOQ of 0.01 mg/kg for each component in high water content, high acid content, high oil content commodities and dry commodities (FAO, 2001); the combined LOQ is 0.02 mg/kg. The multi-residue QuEChERS method described in the European Standard EN 15662:2008 is also applicable for the determination of spinosad residues in the food commodities of plant origin. The liquid chromatography coupled with tandem mass spectrum detection (LC-MS/MS) analyses spinosad residues in matrices with high water, high acid content and in dry matrices at the individual LOQ of 0.01 mg/kg for spinosyn A and spinosyn D, respectively, resulting in a combined LOQ of 0.02 mg/kg for spinosad (CEN, 2008). EFSA concludes that sufficiently validated analytical methods are available to monitor all compounds included in the enforcement residue definition in the crops under consideration Methods for enforcement of residues in food of animal origin Analytical methods for the determination of residues in food of animal origin are not assessed in the current application, since the crops under consideration are not normally fed to livestock. 16 Commission Regulation (EU) No 546/2011 of 10 June 2011, OJ L 155, , p EFSA Journal 2011;9(9):2352 9

10 2. Mammalian toxicology The toxicological reference values for spinosad were derived at Community level during the peer review under Directive 91/414/EEC (EC, 2006). They are compiled in Table 2-1. Table 2-1. Overview of the toxicological reference values Spinosad Source Year Value Study relied upon Safety factor ADI EC mg/kg bw/d 2 yr rat 100 ARfD EC 2006 Not allocated, not necessary It is noted that the ADI established by the JMPR in 2001 is within the same range (0.02 mg/kg bw/d) and the experts were also of the opinion that the setting of an ARfD is not necessary (FAO, 2001).The slight difference in the toxicological reference values is linked to the different approaches in rounding of the derived values. 3. Residues 3.1. Nature and magnitude of residues in plant Primary crops Nature of residues The metabolism of spinosad was investigated in the peer review (Netherlands, 2001) and by the JMPR (FAO, 2001) in grapes, apples, tomatoes, cabbage, turnips and cotton, representing the crop groups fruit and fruiting vegetables, leafy vegetables, root and tuber vegetables and oil seed/pulses. In all plant metabolism studies, spinosyn A and spinosyn D were tested separately. The basic characteristics of the study design used in the metabolism studies are summarised in Table 3-1. Table 3-1. Overview of the available metabolism studies Crop group Fruits and fruiting vegetables Crop Position of radiolabel Type of appl. Use (F/G) Grapes n.r. foliar G spinosyn A: 0.20 mg /branch spinoyn D: 0.22 mg /branch Apples n.r. foliar n.r. spinosyn A: 1326 mg/tree spinosyn D: 523 mg/tree Application data Rate No Sampling (kg a.s/ha) 1 1, 3, 7, 10, 14, 21 DAT 1 0, 3, 7, 14, DAT 1 0, 3, 7, 14, 28, 42 DAT Remarks Photolysis effect was assessed on day 3 and 7 after treatment. EFSA Journal 2011;9(9):

11 Crop group Leafy vegetables Root and tuber vegetables Crop Apple leaves Tomatoes Position of radiolabel Type of appl. Use (F/G) n.r. foliar n.r. spinosyn A: 1326 mg per tree spinosyn D: 523 mg per tree 14 C- spinosyn A (uniformly labelled) (97%) and 1% spinosyn B foliar G Spinosyn A: 500 g/ha (total seasonal rate) Cabbage n.r. foliar G spinosyn A: 1.6 kg/ha spinosyn D: 6.2 kg /ha Turnips n.r. foliar F Spinosyn A: 977 mg/l Spinosyn D: 511 mg/l Oilseeds Cotton n.r. foliar n.r. Spinosyn A: 388 g/ha (total rate: 1940 g/ha) Spinosyn D: 200 g/ha (total rate 1000 g/ha). Cotton n.r. foliar n.r. Spinosyn A: 421 g/ha (2104 g/ ha total rate) n.r. not reported in the DAR (Netherlands, 2001) Application data Rate No Sampling (kg a.s/ha) 1 0, 3, 7, 14, 28 DAT 4 3 d after 1 st treatment, 0 and 3 days after final appl. 1 0, 3, 10, 19, 34 DAT 1 0, 10, 24, 48 DAT DAT 5 28 DAT Remarks Photolysis effect was assessed on day 3 and 7 after treatment. Also cabbage roots were analysed Turnip roots and leaves were analysed In addition, a study on rice was submitted in the dossier, but because of several deficiencies the study was not further considered by the RMS. In apples, the unchanged compounds spinosyn A and spinosyn D were found to be the major constituents of the TRR. Similarly, in tomatoes, spinosyn A was identified as the major residue (0 and 3 DAT 65% and 24 % of TRR, respectively). Furthermore, spinosyn B 17 and spinosyn B of D 18 were identified as minor residues after spinosyn A or spinosyn D treatment, respectively, resulting from N- demethylation of the parent compounds. In apples, it could be demonstrated that the degradation of spinosyn A and D is linked to the exposure to light, indicating that photolysis is a major process of degradation. In grapes spinosyn A and D were the major components of TRR (49 DAT: 35% and 22%, respectively) which were mainly located on the surface. In cabbage the major residue components were parent compounds, but it was noticed that a rapid degradation, most likely by photolysis, occurred. Three days after treatment only 10 and 13% of the unchanged compounds were 17 Spinosyn B: 18 Spinosyn B of D: EFSA Journal 2011;9(9):

12 recovered. Several metabolites could be identified (spinosyn B, spinosyn K 19 and spinosyn B of D), in addition numerous polar compounds were observed. In turnip leaves, at 10 DAT the unchanged compounds constituted a minor proportion of the radiolabel, whereas in roots the compounds were more persistent, probably because of the low sun exposure. Several spinosyn related compounds which are products of photolysis were observed in leaves and to a lower extent in roots. In cotton seed and fibre no spinosyn-related compounds could be identified. In fibre the radiolabel was incorporated into cellulose. In the framework of the peer review, the submitted metabolism studies were considered sufficient to derive the following residue definitions for risk assessment and enforcement: Spinosad, sum of spinosyn A and spinosyn D, expressed as spinosad. EFSA notes that the metabolism in the crops for which the MRL requests were submitted is sufficiently elucidated and no further studies are required. Thus, the current residue definition established in Regulation (EC) No 396/2005 can be maintained. However, EFSA recommends rewording the residue definition, taking into account that the parent compound spinosad is a mixture of two compounds which have slightly different molecular weights. The proposed new residue definition therefore should read: Spinosad, sum of spinosyn A and spinosyn D Magnitude of residues 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. a. Raspberries and blackberries In support of the intended outdoor GAP on raspberries and blackberries in the UK the applicant submitted 4 outdoor residue trials on raspberries from Belgium (2007) and 1 outdoor residue trial from Switzerland (2007). The extrapolation of residue data from raspberries to blackberries is proposed. All Belgian trials have been performed by adjusting the application rate for the leaf wall area, assuming that 1 ha contains 0.86 ha (3 trials) to 1.6 ha of leaves (1 trial). No information has been provided on the raspberry cultivation conditions (row width, density of plants per ha/per row, etc.). One trial was overdosed and therefore disregarded by EFSA. The outdoor residue trial from Switzerland was disregarded as the analytical method used to analyse the residue trial samples had not been sufficiently validated. EFSA concludes that the number of submitted residue trials (3 outdoor trials) is not sufficient to propose the MRL in raspberries and to extrapolate the residue data to blackberries. According to EU guidance document 7525/VI/95-rev.9, at least 4 GAP compliant residue trials on raspberries and 4 GAP compliant residue trials on blackberries are required to derive individual MRL proposals in these crops; however, if no residue trials on blackberries are available, 4 GAP compliant residue trials on raspberries are also sufficient to extrapolate the residue data to blackberries (EC, 2011). 19 Spinosyn K: EFSA Journal 2011;9(9):

13 b. Parsley In support of the intended indoor GAP on parsley in Germany, the applicant submitted 10 GAP compliant residue trials on parsley. The residue trials have all been performed in Germany in The number of residue trials is sufficient to derive the MRL proposal. c. Banana In support of the intended outdoor GAP in the SEU the applicant submitted 11 residue trials on bananas (not bagged) which were all performed in Canary Islands (SEU) in Three trials were disregarded as incompliant in terms of application rate, PHI intervals, sample handling (washed before analysis). 8 trials were considered compliant with the intended GAP. In all trials, except one, residue levels were higher at longer PHI intervals (usually 5-7 days).the number of residue trials is sufficient to derive the MRL proposal. d. Radish In support of the intended indoor GAP (seed treatment), the applicant submitted 4 GAP compliant residue trials on radishes. The trials have been performed in the Netherlands in Samples were taken within the PHI interval of days. Two residue trials were designed as residue decline studies, indicating a decline of residue levels when samples taken at the PHI of 30 days. The number of residue trials is sufficient to derive the MRL proposal. The potential degradation of residues during storage of the residue trial samples was also assessed in the framework of the peer review. Storage stabilities of spinosyns A, D were demonstrated for a period of 19 months at -20 C in high water content (pepper) and acidic (grapes, strawberries) commodities (The Netherlands, 2001). The samples of bananas and radish have all been stored not exceeding the period for which the storage stability of spinosad residues was demonstrated. The extracts of raspberries between extraction and analysis were stored for 9 days at 6ºC and afterwards were frozen. The applicant claims that the stability of residues under these storage conditions have been investigated and confirmed; however, no detailed information was provided to EFSA. Half of all the parsley samples from residue trials were stored frozen for up to 30 months prior to analysis, but no indication in the decrease of residue levels was observed as residues in most of these samples were higher than in other samples. EFSA accepted these trials as disregarding them could underestimate the actual residue situation in parsley treated according to the intended GAP. The rest of the parsley samples prior to analysis were stored properly. However, additional storage stability studies, investigating the stability of spinosad residues within longer frozen storage periods are recommended. According to the EMSs, the analytical methods used to analyse supervised residue trial samples have been sufficiently validated and were proven to be fit for purpose. The submitted residue data sets are complete and indicate that an MRL of 60 mg/kg in parsley, 2 mg/kg in banana and 0.3 mg/kg in radish would be required to support the intended uses of spinosad on these crops. An insufficient number of residue data has been submitted to derive the MRL proposal in raspberries and blackberries. EFSA Journal 2011;9(9):

14 Table 3-2. Overview of the available residues trials data Commodity Region (a) Outdoor /Indoor Raspberries blackberries Individual trial results (mg/kg) Enforcement Spinosad, sum of spynosin A and D Risk assessment Spinosad, sum of spynosin A and D Median residue (mg/kg) (b) Highest residue (mg/kg) (c) MRL proposal (mg/kg) NEU Outdoor 0.137; 0.149; 0.200; 0.137; 0.149; 0.200; Insufficient number of residue data submitted. Parsley NEU Indoor 1.0; 4.3; 4.6; 8.0; 9; 11; 11; 15; 21; ; 4.3; 4.6; 8.0; 9; 11; 11; 15; 21; 43 Median CF (d) Comments OECD MRL f =60 R ber =33 R max =48 Banana bagged) (not SEU Outdoor 0.32 e ; 0.53 e ; 0.57; 0.59 e ; 0.64 e ; 0.72 e ; 0.84 e ; 0.85 e 0.32 e ; 0.53 e ; 0.57; 0.59 e ; OECD MRL f = e ; 0.72 e ; 0.84 e ; 0.85 e R ber =1.62 R max =1.19 Radish EU Indoor 0.04; 0.06; 0.09; ; 0.06; 0.09; OECD MRL f =0.3 R ber =0.195 R max =0.21 (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): Residue value higher at a longer PHI interval of 5-7 days (f): The MRL is calculated using the OECD calculator (OECD, 2011). EFSA Journal 2011;9(9):

15 Effect of industrial processing and/or household preparation No studies investigating the effect of processing (pasteurisation, baking, brewing, boiling and sterilisation) on the nature of residues are reported in the DAR (Netherlands, 2001). No new studies have been submitted under the current applications. Considering the wide range of authorised uses of spinosad, EFSA is of the opinion that studies investigating the effects of processing on the nature of spinosad residues have to be performed. Specific studies to assess the magnitude of spinosad residues during the processing in the crops under consideration have not been submitted and are also not necessary considering the low contribution of these crops to the total dietary intake Rotational crops Preliminary considerations Radish and parsley can be grown in an annual crop rotation. A rotational crop study was assessed in the DAR (Netherlands, 2001) where lettuce, radish and wheat seed were sown into a soil that was previously treated with 14 C-spinosyn A at 1.1 kg a.s./ha (treatment 30, 120 and 365 days before sowing). Residue levels in the organic fraction of all samples, except wheat grain and straw were too low for identification (<0.01 mg equiv./kg). In wheat grain and straw spinosyn A was identified at very low levels ( mg/kg and mg/kg, respectively), the major amount of the non-extractable radiolabel has been incorporated into natural compounds such as starch, lignin or glucose sub-units of cellulose. Spinosyn D is expected to show a similar behaviour in rotational crops. It is concluded that the use of spinosad on parsley and radish at the application rates as specified in the intended GAPs is not likely to result in measurable residues of spinosad and/or degradation products in the succeeding and/or rotational crops Nature and magnitude of residues in livestock Since the crops under consideration are not normally fed to livestock, the nature and magnitude of spinosad residues in livestock was not assessed in the framework of this application. 4. Consumer risk assessment The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). This exposure assessment model contains the relevant European food consumption data for different sub-groups of the EU population 20 (EFSA, 2007). For the calculation of the chronic exposure, EFSA used the median residue values as derived from the residue trials on banana, parsley and radish (see Table 3-2). For several crops the median residue values as derived by the JMPR and corresponding to the existing EU MRLs were available and were used to refine the consumer exposure calculations. 20 The calculation of the long-term exposure (chronic exposure) is based on the mean consumption data representative for 22 national diets collected from MS surveys plus 1 regional and 4 cluster diets from the WHO GEMS Food database; for the acute exposure assessment the most critical large portion consumption data from 19 national diets collected from MS surveys is used. The complete list of diets incorporated in EFSA PRIMo is given in its reference section (EFSA, 2007). EFSA Journal 2011;9(9):

16 For apples and pears, according to the review of the existing spinosad MRLs which is now ongoing in the framework of Article 12 of Regulation (EC) No 396/2005, the existing MRLs are not supported neither by the existing less critical GAPs in the EU nor by import tolerances and therefore for these crops the new derived median residue values were used as input values (EFSA, 2011). For milk, according to the review of the existing MRLs which is now ongoing in the framework of Article 12 of Regulation (EC) No 396/2005, a lower MRL would be sufficient to account for the carry-over of pesticides residues from feed crops treated with spinosad (EFSA, 2011). The median residue value for the new proposed MRL was used as an input value. For the remaining commodities of plant and animal origin, the existing MRLs as established in Annex IIIA of Regulation (EC) No 396/2005 were used as input values. The model assumptions for the longterm exposure assessment are considered to be rather conservative, assuming that all food items consumed have been treated with the active substance under consideration. In reality, it is not likely that all food consumed will contain residues at the MRL or at levels of the median residue values identified in supervised field trials. However, if this first tier exposure assessment, does not exceed the toxicological reference value for long-term exposure (i.e. the ADI), a consumer health risk can be excluded with a high probability. Acute consumer exposure was not performed as the setting of an ARfD was not considered necessary due to the low acute toxicity of the active substance. The input values used for the dietary exposure calculation are summarized in Table 4-1. Table 4-1: Input values for the consumer dietary exposure assessment Commodity Chronic exposure assessment Acute exposure assessment Input value (mg/kg) Comment Risk assessment residue definition: Spinosad, sum of spynosin A and D Input value (mg/kg) Comment Parsley 10 Median residue Acute consumer exposure was Radish Median residue not performed as the setting of an ARfD was not considered Citrus fruit 0.01 Median residue (edible portion) a (FAO,2001) necessary due to the low acute toxicity of the active Apples, pears 0.05 Median residue (Art.12) b substance. Flowering brassica, head brassica, leafy brassica Lettuce and other salad plants, spinach and similar, wine leaves, water cress, witloof 0.27 Median residue a (FAO,2001) 1.9 Median residue a (FAO,2001) Celery 0.97 Median residue a (FAO,2001) Cereals 0.7 Median residue a (FAO,2004) Swine liver 0.06 Median residue a (FAO,2004) Bovine fat 0.08 Median residue a (FAO,2004) Bovine liver 0.66 Median residue a (FAO,2004) Bovine kidney 0.31 Median residue a (FAO,2004) EFSA Journal 2011;9(9):

17 Commodity Chronic exposure assessment Acute exposure assessment Input value (mg/kg) Comment Sheep, goat fat 0.32 Median residue a (FAO,2004) Sheep, goat liver 0.06 Median residue a (FAO,2004) Sheep, goat kidney 0.03 Median residue a (FAO,2004) Milk 0.02 Median residue (Art.12) c Input value (mg/kg) Comment Other commodities of food and animal origin MRL See Appendix C a The median residue values derived by the JMPR and supports the existing EU MRLs. b This median residue value does not support the existing EU MRL of 1 mg/kg but has been derived in the framework of the MRL review of spinosad (Article 12 of Regulation (EC) No 396/2005)) considering all existing EU uses and import tolerances on apples and pears (EFSA, 2011). The median residue value of 0.05 mg/kg corresponds to a lower MRL proposal of 0.3 mg/kg. CXL is 0.1 mg/kg for apples. c The median residue value does not support the existing EU MRL of 0.5 mg/kg but has been derived in the framework of the MRL review of spinosad (Article 12 of Regulation (EC) No 396/2005) considering the carry-over of spinosad residues from feed crops (EFSA, 2011). The median residue of 0.02 mg/kg value supports a new MRL proposal of 0.2 mg/kg. It is noted that a CXL of 1 mg/kg is established (median residue of 0.65 mg/kg), accommodating the use of spinosad as a biocide in Australia and the USA (FAO, 2011). The estimated exposure was then compared with the toxicological reference values derived for spinosad (see Table 2-1). The results of the intake calculation are presented in Appendix B to this reasoned opinion. 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 9.9 to 82.7% of the ADI (WHO Cluster diet B). The contribution of residues in the crops under consideration to the total consumer exposure accounted for a maximum of 4.6% of the ADI for banana (SE general population diet), 2.08% of the ADI for parsley (WHO Cluster diet E) and 0.021% of the ADI for radishes (SE general population diet, WHO Cluster diet D). It is noted that the calculation is based on the use of spinosad as a plant protection product and therefore, in case a higher MRL is required due to biocide uses of spinosad, the risk assessment has to be recalculated. Acute consumer exposure was not performed as the setting of an ARfD was not considered necessary due to the low acute toxicity of the active substance. EFSA concludes that the intended use of spinosad on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore will not pose a public health concern. EFSA Journal 2011;9(9):

18 CONCLUSIONS AND RECOMMENDATIONS CONCLUSIONS The toxicological profile of spinosad was assessed in the framework of the peer review under Directive 91/414/EEC in The experts agreed on an ADI value of mg/kg body weight/day. Due to the low toxicity of the active substance the setting of an ARfD was considered not necessary. The plant metabolism of spinosad was investigated in grapes, apples, tomatoes, cabbage, turnips and cotton. From these studies the peer review derived the residue definition for risk assessment and enforcement as spinosad: sum of spinosyn A and D, expressed as spinosad. The same residue definition was established in Regulation (EC) No 396/2005. EFSA therefore concludes that for the crops under consideration, the metabolism is sufficiently elucidated and no further studies are required. However, EFSA would propose to change the wording of the residue definition, taking into account that spinosad is a mixture of the two components, spinosyn A and spinosyn D which have slightly different molecular weights. Thus, the proposed wording for the revised residue definition is spinosad: sum of spinosyn A and spinosyn D. This amendment would not have an impact on the values of the currently established MRLs. The submitted residue data sets indicate that an MRL of 60 mg/kg in parsley, 2 mg/kg in banana and 0.3 mg/kg in radish would be required to support the intended uses of spinosad on these crops. An insufficient number of residue data has been submitted to derive the MRL proposal in raspberries and blackberries. There are adequate analytical methods available to monitor the compliance of the proposed MRLs for spinosad in these crops. The effects of processing on the nature of spinosad residues have not been investigated in the peer review and no new studies have been submitted in the framework of the current MRL applications. However, considering the wide range of authorised uses of spinosad, EFSA is of the opinion that studies investigating the effects of processing on the nature of spinosad residues have to be performed. Specific studies to assess the magnitude of spinosad residues during the processing in the crops under consideration have not been submitted and are also not necessary considering the low contribution of these crops to the total dietary intake. The occurrence of spinosad residues in rotational and/or succeeding crops has been investigated in the framework of the current application since radish and parsley can be grown in a crop rotation. It is concluded that the use of spinosad on parsley and radish at the application rates specified in the intended GAPs is not likely to result in measurable residues of spinosad and/or spinosad related soil degradation products in succeeding or rotational crops. Since the crops under consideration are not normally fed to livestock, the nature and magnitude of spinosad residues in livestock was not assessed in the framework of this application. The consumer risk assessment was performed with revision 2 of the EFSA PRIMo. For the calculation of the chronic exposure, EFSA used the median residue values as derived from the residue trials on banana, parsley and radish. For several crops the median residue values as derived by the JMPR and corresponding to the existing EU MRLs were available and were used to refine the consumer exposure calculations. The input values for apples (pears) and milk were as derived in the framework of the review of spinosad MRLs according to Article 12 of Regulation (EC) No 396/2005. For the remaining commodities of plant and animal origin, the existing MRLs as established in Annex IIIA of Regulation (EC) No 396/2005 were used as input values. The estimated exposure was then compared with the toxicological reference value derived for spinosad. EFSA Journal 2011;9(9):

19 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 9.9 to 82.7% of the ADI (WHO Cluster diet B). The contribution of residues in the crops under consideration to the total consumer exposure accounted for a maximum of 4.6% of the ADI for banana (SE general population diet), 2.08% of the ADI for parsley (WHO Cluster diet E) and 0.021% of the ADI for radishes (SE general population diet, WHO Cluster diet D). It is noted that the calculation is based on the use of spinosad as a plant protection product and therefore in case a higher MRL is required due to biocide uses of spinosad, the risk assessment has to be recalculated. The acute exposure was not calculated due to the low acute toxicity of the active substance. EFSA concludes that the intended use of spinosad on the crops under consideration will not result in a consumer exposure exceeding the toxicological reference values and therefore will not pose a public health concern. RECOMMENDATIONS Code Commodity Existing EC number a MRL (mg/kg) Proposed EC MRL (mg/kg) Justification for the proposal Existing residue definition: Spinosad: sum of spinosyn A and spinosyn D, expressed as spinosad Proposed revised residue definition: Spinosad: sum of spinosyn A and spinosyn D Blackberries 0.3 No proposal No MRL proposal could be derived due to insufficient data Raspberries 0.3 No proposal provided Bananas 0.02* 2 The MRL proposals are Radishes 0.02* 0.3 sufficiently supported by data and no consumer intake concerns have Parsley been identified. (*): Indicates that the MRL is set at the limit of analytical quantification. a according to Annex I of Regulation (EC) No 396/2005 REFERENCES CEN (European Committee for Standardization), Foods of plant origin - Determination of pesticide residues using GC-MS and/or LC-MS/MS following acetonitrile extraction/partitioning and clean-up by dispersive SPE. QuEChERS-method. EN EN November EC (European Commission), Appendix G. Livestock Feeding Studies. 7031/VI/95 rev.4. Available from: EC (European Commission), 1997a. Appendix A. Metabolism and distribution in plants. 7028/IV/95- rev.3. Available from: EC (European Commission), 1997b. Appendix B. General recommendations for the design, preparation and realization of residue trials. Annex 2. Classification of (minor) crops not listed in the Appendix of Council Directive 90/642/EEC. 7029/VI/95-rev.6. Available from: EC (European Commission), 1997c. Appendix C. Testing of plant protection products in rotational crops. 7524/VI/95-rev.2. Available from: EFSA Journal 2011;9(9):