Reasoned opinion on the modification of MRLs for spirodiclofen in strawberries bananas, avocado, mango and papaya 1

Transcription

1 EFSA Journal 2012;10(7):2821 REASONED OPINION Reasoned opinion on the modification of MRLs for spirodiclofen in strawberries bananas, avocado, mango and papaya 1 ABSTRACT European Food Safety Authority 2, European Food Safety Authority (EFSA), Parma, Italy In accordance with Article 6 of Regulation (EC) No 396/2005, the Netherlands, herewith referred as the evaluating Member State (EMS), received an application from Bayer S.A.S-Bayer CropScience to modify the existing MRLs for spirodiclofen in strawberries and bananas and set import tolerances for papaya, avocado and mango. The Netherlands proposed to decrease the existing MRL for strawberries from 2 mg/kg to 0.02 mg/kg and to increase the MRL for banana from the limit of quantification 0.02* mg/kg to 0.3mg/kg. In order to accommodate the import of produce, the Netherlands proposed to set the MRL for papaya, mangos and avocados at 1.0 mg/kg. The Netherlands 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. According to EFSA the data are sufficient to derive MRL proposals of 0.3 mg/kg for the proposed use in banana and 1.5 mg/kg to accommodate the reported use in the USA on avocado, noting that the MRL in the country of origin is set at the level of 1 mg/kg. EFSA has some reservations regarding the proposal that the residue trial results for avocado might be extrapolated to propose MRLs on papaya and mango. The intended use on strawberries is not adequately supported by residue data. Based on the risk assessment results, EFSA concludes that the proposed use of spirodiclofen on strawberry, banana, avocado, mango and papaya will not result in consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk. European Food Safety Authority, 2012 KEY WORDS Spirodiclofen, strawberries, bananas, avocado, papaya, mango, MRL application, Regulation (EC) No 396/2005, consumer risk assessment, tetronic acids. 1 On request from European Commission, Question No EFSA-Q , approved on 06 July Correspondence: pesticides.mrl@efsa.europa.eu Suggested citation: European Food Safety Authority; Reasoned opinion on the modification of MRLs for spirodiclofen in strawberries bananas, avocado, mango and papaya. EFSA Journal 2012;10(7):2821. [30 pp.] doi: /j.efsa Available online: European Food Safety Authority, 2012

2 SUMMARY In accordance with Article 6 of Regulation (EC) No 396/2005 3, the Netherlands, herewith referred as the evaluating Member State (EMS), received an application from Bayer S.A.S-Bayer CropScience to modify the existing MRLs for spirodiclofen in strawberries and bananas and set import tolerances for papaya, avocado and mango to accommodate imports from the USA. The Netherlands proposed to decrease the existing MRL for strawberries from 2 mg/kg to 0.02 mg/kg to take into account, the modification of the GAP in the Netherlands. In order to accommodate for the intended use of spirodiclofen, the Netherlands proposed to increase the MRL for banana from the limit of quantification 0.02* mg/kg to 0.3mg/kg. In order to accommodate the import of produce, the Netherlands proposed to set the MRL for papaya, mangos and avocados at 1.0 mg/kg. The Netherlands 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 29 November EFSA bases its assessment on the evaluation report submitted by the EMS, the Draft Assessment Report (DAR) (and its addendum) prepared under Council Directive 91/414/EEC, the Commission Review Report on spirodiclofen, the conclusion on the peer review of the pesticide risk assessment of the active substance spirodiclofen and the JMPR evaluation. The toxicological profile of spirodiclofen was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of mg/kg bw per day. The setting of an ARfD was deemed unnecessary. The metabolism of spirodiclofen in primary crops was investigated in apples, grapes, oranges and lemons (covering fruits and fruiting vegetables). In addition a translocation study in grapefruit was performed. From these studies the peer review concluded that the residue definition for enforcement and risk assessment be established as spirodiclofen (for the uses assessed in the context of the peer review). For the uses assessed in the framework of this application, EFSA concludes that the metabolism of spirodiclofen in primary crops is sufficiently addressed and that the same residue definitions are applicable. EFSA considers that the submitted supervised residue trials are sufficient to derive MRL proposals of 0.3 mg/kg for the proposed use in banana and 1.5 mg/kg to accommodate the reported use in the USA on avocado, noting that the MRL in the country of origin is set at the level of 1 mg/kg. EFSA has some reservations regarding the proposal that the residue trial results for avocado might be extrapolated to propose MRLs to accommodate the reported uses in the USA on papaya and mango. This should be considered further by risk managers. The intended use on strawberries is not adequately supported by residue data. Though the EMS made the case that the use of the active substance before flowering and after harvest represents a no residue situation, EFSA does not accept this case. The case does not address the potential for residues from mulch / soil that will be incurred from application before flowering, being transferred to developing fruit via contact. Also before considering lowering the existing strawberry MRL to the limit of quantification, Member States need to confirm that no other authorised GAPs in the EU or in third countries, requires the existing MRL of 2 mg/kg to be maintained. Studies investigating the nature of spirodiclofen residues in processed commodities were assessed in the peer review. These studies showed that the compound is essentially stable under the conditions of pasteurisation but that it is hydrolysed to spirodiclofen-enol under the processing conditions representative of boiling/cooking and sterilisation. On a provisional basis the residue definitions for processed commodities is defined as parent compound, but should be reconsidered in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005. The available data for processing strawberries were insufficient to derive processing factors, to be included in Annex VI of Regulation (EC) No 396/2005. From field trials on bananas where pulp residues were reported, a peeling factor of 0.1 was derived. 3 Regulation (EC) No 396/2005 of the Parliament and of the Council of 23 February OJ L 70, , p EFSA Journal 2012;10(7):2821 2

3 Based on the available information on the nature and rate of decline of residues in soil considered in the framework of the peer review, it was concluded that significant residue levels are unlikely to occur in rotational crops, when the compound is used on strawberries according to the use pattern assessed in FAO, 2009 or the intended use proposed by the EMS. Residues of spirodiclofen in commodities of animal origin were not assessed in the framework of this application, since the fruit crops under consideration, are not normally fed to livestock. The consumer risk assessment was performed with revision 2 of the EFSA Pesticides Residues Intake Model (PRIMo). No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated dietary exposure accounted for up to 54.2 % of the ADI (German child) when there is no change to the existing MRL for strawberries. The contribution of residues in strawberry, banana, avocado, papaya and mango to the total consumer exposure accounted for a maximum of 0.43 % of the ADI (Irish adult). A calculation of acute consumer exposure was not performed, due to the low acute toxicity of the active substance. EFSA concludes that the proposed use of spirodiclofen on strawberry, banana, avocado, mango and papaya will not result in consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk. Thus EFSA proposes to amend the existing MRLs as reported in the summary table. Summary table Code Commodity Existing number (a) EU MRL (mg/kg) Enforcement residue definition: spirodiclofen (F) Proposed EU MRL (mg/kg) Justification for the proposal Banana 0.02* 0.3 The MRL proposal is sufficiently supported by data and no risk for consumers was identified Avocado 0.02* 1.5 or 1 The MRL proposals are sufficiently Mango 0.02* 1.5 or 1 supported by data (with some reservation over the applicability of extrapolating Papaya or 1 trials data results from avocado to mango and papaya). No risk for consumers was identified for the intended uses. Using the OECD MRL calculator a MRL of 1.5 mg/kg is derived whereas the MRL in the country of origin is set at the level of 1 mg/kg. (a): According to Annex I of Regulation (EC) No 396/2005. (*): Indicates that the MRL is set at the limit of analytical quantification. (F): Fat-soluble pesticide. EFSA Journal 2012;10(7):2821 3

4 TABLE OF CONTENTS Abstract... 1 Summary... 2 Table of contents... 4 Background... 5 Terms of reference... 5 The active substance and its use pattern... 6 Assessment Method of analysis Methods for enforcement of residues in food of plant origin Methods for enforcement of residues in food of animal origin Mammalian toxicology Residues 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 Appendices A. Good Agricultural Practice (GAPs) B. Pesticide Residues Intake Model (PRIMo ) C. Existing EU maximum residue levels (MRLs) D. List of metabolites and related structural formula (if applicable) Abbreviations EFSA Journal 2012;10(7):2821 4

5 BACKGROUND Regulation (EC) No 396/ establishes the rules governing the setting of pesticide MRLs at European Union level. Article 6 of that Regulation lays down that any party having a legitimate interest or requesting an authorisation for the use of a plant protection product in accordance with Council Directive 91/414/EEC, 5 repealed by Regulation (EC) No 1107/2009, 6 shall submit to a Member State, when appropriate, an application to set or to modify an MRL or import tolerance, in accordance with the provisions of Article 7 of that Regulation. The Netherlands, hereafter referred to as the evaluating Member State (EMS), received an application from the company Bayer S.A.S.-Bayer CropScience 7 to modify the existing MRLs for spirodiclofen in strawberries and bananas and set import tolerances for papaya avocado and mango. 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 was submitted to the European Commission who forwarded the application, the evaluation report and the supporting dossier to EFSA on 29 November The application was included in the EFSA Register of Questions with the reference number EFSA-Q and the following subject: Spirodiclofen - Application to modify the existing MRLs in various fruits. The Netherlands proposed to lower the existing MRL for spirodiclofen in strawberries from the current MRL of 2.0 mg/kg to 0.02 mg/kg; and to raise the existing MRLs of spirodiclofen in banana from the limit of quantification (0.02* mg/kg) to 0.3 mg/kg, in papaya from 0.03 mg/kg to 1.0 mg/kg and in avocado and mango from the limit of quantification (0.02* mg/kg) to 1 mg/kg. Following a clarification from the EMS on the countries where the intended use on strawberries was being requested, EFSA proceeded with the assessment of the application and the evaluation report 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 29 February Regulation (EC) No 396/2005 of the Parliament and of the Council of 23 February OJ L 70, , p Council Directive 91/414/EEC of 15 July OJ L 230, , p Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October OJ L 309, , p Bayer S.A.S.-Bayer CropScience, Rue Jean-Marie Leclair 16, 69009, Lyon, France. EFSA Journal 2012;10(7):2821 5

6 THE ACTIVE SUBSTANCE AND ITS USE PATTERN Spirodiclofen is the ISO common name for 3-(2,4-dichlorophenyl)-2-oxo-1-oxaspiro[4.5]dec-3-en-4- yl 2,2-dimethylbutyrate (IUPAC). The chemical structure of the compound is herewith reported. Cl H 3 C H 3 C CH 3 O O O O Cl Molecular weight: 411.3g/mol Spirodiclofen is a non-systemic acaricide and insecticide belonging to the tetronic acid class. It is currently the only member of this class. Spirodiclofen acts as an insect growth regulator and is fat soluble. Spirodiclofen was evaluated in the framework of Council Directive 91/414/EEC with the Netherlands designated as rapporteur Member State (RMS). It was included in Annex I of this Directive by Commission Directive 2010/25/EU 8 which entered into force on 1 August 2010 for use only as an acaricide or insecticide. In accordance with Commission Implementing Regulation (EU) No 540/ spirodiclofen is approved under Regulation (EC) No 1107/2009, repealing Council Directive 91/414/EEC. The representative uses evaluated in the peer review were spray applications on grape, peach, apricot, nectarine, orange and mandarin to control mites and on apple and pear to control mites and sucking insects. The Draft Assessment Report (DAR) of spirodiclofen has been peer reviewed by EFSA (EFSA, 2009). The EU MRLs for spirodiclofen have been established in Annexes IIIA of Regulation (EC) No 396/2005 (Appendix C). In 2011, CXLs established for a number of commodities by Codex Alimentarius were incorporated into the EU legislation (Regulation (EU) No 520/ The existing EU MRLs for spirodiclofen on avocado, mango and bananas are set at the LOQ of 0.02 mg/kg. The EU values for strawberries and papaya are 2 mg/kg and 0.03 mg/kg respectively. Codex Alimentarius has established CXLs for a wide range of commodities but not for avocado, mango or bananas. The CXLs for strawberries and for papaya are set at the same level as the EU MRLs. The intended GAP for strawberry in the NEU for which modification of the existing MRL is requested refers to spray application at kg as/ha before flowering or after harvest. The intended GAP for bananas in the SEU for which modification of the existing MRL is requested refers to spray application on bananas at kg as/ha and the PHI is 14 days. For the import tolerances in papaya, avocado and mangos GAPs from the USA have been notified. The details of the intended and authorised GAPs for spirodiclofen are given in Appendix A. 8 Commission Directive 2010/25/EU of 18 March 2010 amending Council Directive 91/414/EEC to include penoxsulam, proquinazid and spirodiclofen as active substances. OJ L 69, , p Commission Implementing Regulation (EU) No 540/2011 of 23 May OJ L 153, , p Commission Regulation (EU) No 520/2011 of 25 May 2011, OJ L 140, , p EFSA Journal 2012;10(7):2821 6

7 ASSESSMENT EFSA bases its assessment on the evaluation report submitted by the EMS (the Netherlands, 2011), the Draft Assessment Report (DAR) (and its addendum) prepared under Council Directive 91/414/EEC (the Netherlands, 2004, 2009)], the Commission Review Report on spirodiclofen (EC, 2010), the conclusion on the peer review of the pesticide risk assessment of the active substance spirodiclofen (EFSA, 2009) and the JMPR Evaluation report (FAO, 2009). The assessment is performed in accordance with the legal provisions of the Uniform Principles for the Evaluation and the Authorisation of Plant Protection Products adopted by Commission Regulation (EU) 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, 2010a, 2010b, 2011; OECD, 2011). 1. Method of analysis 1.1. Methods for enforcement of residues in food of plant origin Analytical methods for the determination of spirodiclofen residues in plant commodities were assessed in the DAR and during the peer review under Directive 91/414/EEC (the Netherlands, 2004; EFSA, 2009). Residues in food of plant origin of parent spirodiclofen can be determined with a multi residue method (DFG S19) utilising GC-ECD with confirmation being provided by GC-MSD analysis. The validated LOQ is 0.02 mg/kg in dry matrices, matrices with high water, high acid and high oil content. It should be noted that in orange peel the validate LOQ is higher at 0.1mg/kg. Since the commodities under consideration belong to the group of high water/ high acid and high fat content commodities, EFSA concludes that sufficiently validated analytical methods for enforcing the proposed MRLs for spirodiclofen on strawberry, banana, avocado, papaya and mango are available 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 strawberry, banana, avocado, papaya and mango are normally not fed to livestock. 2. Mammalian toxicology The toxicological profile of the active substance spirodiclofen was assessed in the framework of the peer review under Directive 91/414/EEC (EFSA, 2009). The data were sufficient to derive toxicological reference values for spirodiclofen which are compiled in Table 2-1. Table 2-1: Overview of the toxicological reference values Source Year Value Study relied upon Safety factor Spirodiclofen ADI EFSA mg/kg bw per day ARfD EFSA 2009 not allocated, not required 1 year dog Commission Regulation (EU) No 546/2011 of 10 June OJ L 155, , p EFSA Journal 2012;10(7):2821 7

8 It is noted that the JMPR established an ADI of 0.01 mg/kg bw per day for the compound and also concluded the setting of an ARfD was unnecessary (FAO, 2009). 3. Residues 3.1. Nature and magnitude of residues in plant Primary crops Nature of residues The metabolism of spirodiclofen in primary crops was evaluated by the Netherlands (the Netherlands, 2004) and reviewed by EFSA (EFSA, 2009) in the framework of the peer review under Directive 91/414/EEC. The overview of the available 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 vegetables apples grapes oranges lemons 14 C labelled in the 3- position of the dihydrofur anone ring Application details Method, Rate No/ F or G (a) Interval foliar spray, F foliar spray, F foliar spray, G foliar spray, G kg a.s./ha kg a.s./ha 0.6 kg a.s./ha 0.45 kg a.s./ha (a): Outdoor/field experiment (F) or glasshouse/protected crops/indoor application (G) Sampling 1 84 and 23 DAT 1 84 and 23 DAT DAT 1 21 DAT Remarks Applications in June or August The peer review concluded that the available studies demonstrate that the metabolic pathway was similar in all the fruit investigated. The rate of degradation was low and the majority of the radioactivity remained on the surface of the fruits. Applications early in the growing season led to a relatively higher amount of degradation products and also a higher penetration rate into the fruit flesh than applications close to harvest. However, spirodiclofen was always the predominant component of the terminal residue (34 % TRR (PHI 160 days oranges), 89 % TRR (PHI 84 days apples), 57.6 % TRR (PHI 84 days grapes) for early application and 75 % to 99 % TRR when the PHI was days (late applications)). For the early applications the most predominant metabolite present was 2,4- dichloro-mandelic acid glucoside 12 which accounted for 12.2 % TRR in grapes, 6.1 % TRR in oranges and 4.5 % TRR in apples. The identified metabolites including 2,4-dichloro-mandelic acid glucoside or unidentified resolved components were always < 0.01mg/kg (expressed as parent equivalents for the unidentified fractions). All application rates in the metabolism studies were higher than the intended uses, except for the study on grapes where the dose used was marginally lower than for the intended use on avocado, mango and papaya. In a separate translocation experiment with grapefruit it was shown that less than 0.1% of the radioactivity applied to leaves immediately surrounding the fruits was transported into the fruits. The peer review concluded that the residue definition for enforcement and risk assessment in the crop group fruits and fruiting vegetables is just parent spirodiclofen. The current residue definition set in Regulation (EC) No 396/2005 is identical to the enforcement residue definition derived in the peer 12 2,4-dichloromandelic acid glucoside: see Appendix D EFSA Journal 2012;10(7):2821 8

9 review. Whilst the intended uses in the peer review were for a PHI of 14 days, it is concluded that the available data are sufficient to confirm this residue definition in this crop group, at the longer interval between application and harvest being requested in this application for the use on strawberry. For the uses requested on strawberry, banana, avocado, papaya and mango, EFSA concludes that the metabolism of spirodiclofen is sufficiently addressed and the residue definitions agreed in the peer review are applicable Magnitude of residues In support of the MRL application, the applicant submitted residues trials on banana performed in southern Europe and on avocado performed in north America. a. Strawberry NEU GAP: 1-2 x kg a.s./ha with a minimum 7 day interval, last application BBCH (before flowering) or after harvest. I.e. when fruit are not present. SEU GAP: The applicant has indicated that they have no uses nor envisage intended uses, in southern Europe. Residues trials are not available for this NEU GAP. The EMS proposed this would be a no residue situation, due to the absence of fruit at the time of application and the evidence that spirodiclofen is not systemic and therefore the MRL could be set at the limit of quantification (0.02 mg/kg). However this case does not address the potential for transfer of residues from the ground (mulch: plastic or straw, or soil), to developing fruit via direct contact. This cannot be precluded as the soil DT 90 are up to 43 days for the active substance (EFSA, 2009). Also spirodiclofen is stable to photolysis (EFSA, 2009), so may persist longer than indicated by its soil DT 90, when growing systems that utilise plastic covering / mulching are used. EFSA therefore concludes that positive residues may result as a consequence of this use. EFSA considers some residues trials representing this use would be helpful in clarifying the situation. Also considering that spirodiclofen uses may be authorised in other Member States with a more critical GAP 13, EFSA is of the opinion that before the MRL is lowered, it needs to be confirmed that no other GAPs are authorised, which would require the existing MRL of 2 mg/kg to be maintained. It is noted that the CXL is set at this level of 2 mg/kg based on a Dutch GAP which in the meanwhile has been revoked (indoor and outdoor use, 1-2 applications at a dose rate of up to 0.15 kg/ha, PHI 3 days (FAO, 2009)). b. Banana SEU outdoor GAP: 1 x kg a.s./ha, PHI 14 days In total 4 residue trials on banana from the SEU (Tenerife) were submitted. The trials were carried out in 2004 and The trials were compliant with the GAP in terms of number of applications (1), application rate and the PHI interval. c. Avocado N America outdoor GAP: 1 x kg a.s./ha, PHI 2 days In total 5 independent residue trials on avocado from the USA (California and Florida) were submitted. The trials were carried out in 2007 and The trials were compliant with the GAP in 13 The United Kingdom has a product authorisation (extension of authorisation for a minor use) with a PHI of 3 days. Extension of authorisation No of 2012, extant till 31 July EFSA Journal 2012;10(7):2821 9

10 terms of number of applications (1), application rate and the PHI interval. The applicant and EMS proposed to use the residues data on avocado, to extrapolate residue levels from avocado to mango and papaya. An extrapolation from avocados to mango and papaya is not explicitly mentioned in the EU guidance document (EC, 2011). This extrapolation could be a possibility for this non systemic substance as the GAP reported is the same for all three crops and they are in the same fruit sub group (miscellaneous fruit, inedible peel large). However, data on the following aspects should have been provided: form and morphology of the different trees when used in commercial production, ratio of mass to fruit surface of the three fruits as harvested, indication of fruit diameter and mass increase rates over the 14 day harvest interval consideration if the different matrix types (avocado - high oil content; mango and papaya - high water content) has an influence of the residue behaviour. The only information available to EFSA is the EMS statement that: All three crops are similar in shape and have a large inedible core: a stone (avocado and mango) or several seeds (papaya). Avocado will generally be the smallest of these three crops and will have the highest residue levels due to its surface/content ratio. With the available information, it is unclear if the extrapolation requested is appropriate. As EFSA s primary mandate is to provide a reasoned opinion on the risks to the consumer, the consumer risk assessment has been completed accepting the extrapolation as proposed by the EMS. It is also noted that in the country of origin (USA) the MRLs for all three crops is set at the level of 1 mg/kg. The results of the residue trials, the related risk assessment input values (highest residue, median residue, conversion factor) and the MRL proposals are summarised in Table 3-2. The storage stability of spirodiclofen in primary crops was investigated in the DAR under Directive 91/414/EEC (the Netherlands, 2004). Residues of spirodiclofen were found to be stable at -18 C for up to 18 months in matrices with high water and high acid content. Additional data showing stability in these matrices for up to 24 months at -18 C and in almond nut meat (high oil content) at -15 C for up to 15.5 months, were presented by the EMS in their evaluation report (the Netherlands, 2011). 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 on banana and avocado are valid with regard to storage stability. According to the EMS, the analytical methods used to analyse the supervised residue trial samples have been sufficiently validated and were proven to be fit for purpose (the Netherlands, 2011). EFSA concludes that the data are sufficient to derive a MRL proposal of 0.3 mg/kg for the intended use on banana in the SEU and of 1.5 mg/kg for the use on avocado. Scientific data are lacking to demonstrate a comparable residue behaviour in avocados, mango and papaya. The possibility to extrapolate an MRL value from avocado to papaya and mango should be considered further by risk managers. The new GAP on strawberry is not supported by residue data. The proposal to lower the MRL is based on the assumption that the new GAP represents a no residue situation. EFSA concludes that this assumption needs to be supported by some residues data, so does not support the proposal to change the MRL for strawberry. Also before lowering the existing strawberry MRL, it would need to be confirmed that no other authorised GAPs in the EU or in a third country, requires the existing MRL of 2 mg/kg to be maintained EFSA Journal 2012;10(7):

11 Table 3-2: Overview of the available residues trials data Setting and modification of MRLs for spirodiclofen in various fruits Commodity Residue region (a) Outdoor /Indoor Individual trial results (mg/kg) Enforcement (spirodiclofen) Risk assessment (spirodiclofen) Median residue (mg/kg) (b) Highest residue (mg/kg) (c) MRL proposal (mg/kg) Median CF (d) Comments (e) Strawberry NEU Outdoor / indoor Avocado mango, papaya Import (USA) No residue trials for the GAP which is the subject of this application. Outdoor 0.05, 0.08, 0.12, 0.15 (f), , 0.08, 0.12, 0.15 (f), Not proposed or 1 - RMS proposed a no residue situation due to the absence of fruit at application. However potential contamination from the ground (mulch or soil) cannot be excluded. 1 R ber = 0.76 R max = MRL OECD = /1.5 MRL in the country of origin is 1 mg/kg Banana SEU Outdoor 0.06, 0.09, 0.1, , 0.09, 0.1, R ber =0.215 R max =0.201 MRL OECD = 0.27/0.3 (a): NEU (Northern and Central Europe), SEU (Southern Europe and Mediterranean), EU (i.e. outdoor use) or Import (country code) (EC, 2011). (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 residue trial. (e): Statistical estimation of MRLs according to the EU methodology (R ber, R max ; EC, 1997g) and unrounded/rounded values according to the OECD methodology (OECD, 2011). (f): The highest values was measured at longer PHIs of 5 and 7 days. (*): Indicates that the MRL is set at the limit of analytical quantification.. EFSA Journal 2012;10(7):

12 Effect of industrial processing and/or household preparation Setting and modification of MRLs for spirodiclofen in various fruits The effect of processing on the nature of spirodiclofen was investigated in studies reported in the DAR and in the conclusion on the peer review (the Netherlands, 2004; EFSA, 2009). These studies were performed at test conditions representing baking/brewing/boiling and sterilisation (60 minutes at 100 C ph 5; 20 minutes at 120 C, ph 6). The conclusion on the peer review identified that the compound is hydrolysed under these representative processing conditions forming the compound spirodiclofen-enol 14 (at % AR). Under conditions of pasteurisation, representative for fruit processing such as the preparation of juice, wine and sauce (ph 4, 90 C), spirodiclofen was hydrolysed to a lesser extent (spirodiclofen-enol formed at 8.2 % AR). Because in the framework of the peer review the intended use was restricted to fruit crops which were expected to be pasteurised only, spirodiclofen-enol has not been included in the residue definition for enforcement and risk assessment yet. However, the residue definitions may need to be reconsidered in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005, since for fruit jam and preserves (e.g. strawberry jam), processing conditions involving higher temperatures might occur and the formation of significant residues of spirodiclofen-enol is likely. Considering that spirodiclofen-enol was found to have similar toxicological properties to spirodiclofen (EFSA, 2007), the dietary exposure assessment performed for unprocessed fruits would not underestimate the consumer exposure for processed commodities, even if part of the spirodiclofen residues are converted to the degradation product. Some studies investigating the effect of processing on the magnitude of spirodiclofen residues on some processed fruit products were assessed in the DAR and in the conclusion on the peer review prepared under Directive 91/414/EEC for apples, oranges, peaches and grapes (juice production, drying and preserve making) (the Netherlands, 2004; EFSA, 2009). These studies are not discussed further here as they are not relevant for the fruit commodities being considered in this opinion. In the EMS evaluation report (the Netherlands 2011), processing studies on strawberries were reported. Parent spirodiclofen residues were determined in the strawberries after harvest, after washing, following the production of preserve (conditions of industrial practice) and the production of jam (household practices). Parent spirodiclofen residues were reduced to below the LOQ (0.02mg/kg). However, as the results were only available from 2 processing studies and the residues at harvest before processing were relatively low (0.04mg/kg in the field phases of both experiments), reliable processing factors for inclusion in Annex VI of Regulation (EC) No 396/2005 could not be derived. In the available field trials on banana provided with this application (4 trial sites), residues in pulp were determined in addition to residues in whole fruit. Therefore it was possible to derive a peeling factor for bananas to be used in a refined consumer exposure calculation. Whilst the residues in whole fruit were measured at: 0.06, 0.09, 0.1 and 0.11 mg/kg, these residues were below the validated LOQ (0.01 mg/kg in the pertinent analyses). Thus, the median peeling factor is calculated to be Rotational crops Preliminary considerations Strawberries can be grown in rotation with other plants and therefore the possible occurrence of residues in succeeding crops resulting from the use on primary crops has to be assessed. The soil degradation studies demonstrated that spirodiclofen and its soil metabolites exhibit moderate to low persistence. The maximum DT 90 was 43 days for parent spirodiclofen and up to 98 days for the most persistent metabolite BAJ-2740-dihydroxy 15 (EFSA, 2009), which is below the trigger value of 100 days. Thus, no further studies investigating the nature and magnitude of the compound uptake in rotational crops are required (EC, 1997c) (2,4-dichlorophenyl)-4-hydroxy-1-oxaspiro[4.5]dec-3-en-2-one: see Appendix D 15 3-(2,4-dichlorophenyl)-3,4-dihydroxy-1-oxaspiro[4.5]decan-2-one: see Appendix D EFSA Journal 2012;10(7):

13 3.2. Nature and magnitude of residues in livestock Setting and modification of MRLs for spirodiclofen in various fruits Since strawberries, bananas, avocados, papaya and mangos are not normally fed to livestock, the nature and magnitude of spirodiclofen residues in livestock is not assessed in the framework of this application (EC, 1996). EFSA Journal 2012;10(7):

14 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 16 (EFSA, 2007). For the calculation of chronic exposure, EFSA used the median residue value as derived from the residue trials on bananas and avocado (see Table 3-2), the latter was also extrapolated to papaya and mangoes. For bananas the median peeling factor was used to refine the calculation (see section ). For strawberries, the calculation was performed for the scenario maintaining the existing MRL of 2 mg/kg, using the STMR derived by the JMPR in the calculation. In a second scenario, the exposure is calculated with strawberry residues at 0.02 mg/kg, (EMS proposal not supported by EFSA). For the commodities where the CXLs of Codex Alimentarius were taken over in the EU legislation, the STMR values derived by the JMPR are used in the dietary exposure (FAO, 2009). For the remaining commodities of plant and animal origin, the existing MRLs as established in Annexes IIIA of Regulation (EC) No 396/2005 were used as input values. The model assumptions for the long-term exposure assessment are considered to be sufficiently conservative for a first tier exposure assessment, assuming that all food items consumed have been treated with the active substance under consideration. In reality, it is not likely that all food consumed will contain residues at the MRL or at levels 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. A calculation of acute consumer exposure was not performed, due to the low acute toxicity of the active substance. The input values used for the dietary exposure calculation are summarised in Table 4-1. Table 4-1: Input values for the consumer dietary exposure assessment Commodity Chronic exposure assessment Acute exposure assessment Input value (mg/kg) Risk assessment residue definition: spirodiclofen Strawberries Scenario 1: Scenario 2: 0.02 Comment STMR (FAO, 2009) LOQ Avocado, mango, papaya 0.12 Median residue (Table 3.2) Banana 0.01 Median residue (Table 3.2) x peeling factor (0.1) Mandarin, limes and other citrus excluding grapefruit, orange and lemon 0.13 STMR (FAO, 2009) Input value (mg/kg) Not relevant Comment 16 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 2012;10(7):

15 Commodity Chronic exposure assessment Acute exposure assessment Tree nuts excluding almonds Input value (mg/kg) Comment STMR (FAO, 2009) Pome fruit 0.2 STMR (FAO, 2009) Stone fruit STMR (FAO, 2009) Currants 0.04 STMR (FAO, 2009) Tomato 0.08 STMR (FAO, 2009) Pepper 0.08 STMR (FAO, 2009) Hops 11 STMR (FAO, 2009) Input value (mg/kg) Comment Other commodities of plant and animal origin MRL See Appendix C The estimated exposure was then compared with the toxicological reference value derived for spirodiclofen (see Table 2-1). The results of the intake calculation are presented in Appendix B to this reasoned opinion. In scenario 1 no long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated intake values accounted for up to 54.2 % of the ADI (German child). The residues in avocado, banana, mango and papaya contributed insignificantly to the overall dietary intake as they only accounted for 0.43 % of the ADI (Irish adult). The residues in strawberries accounted for a maximum of 0.26 %, of the ADI (French toddler). In scenario 2, replacing the STMR for strawberries with 0.02 mg/kg, the overall exposure is reduced only marginally (to 54.1 %). EFSA therefore concludes that the intended use of spirodiclofen on banana and the import tolerances for avocado, papaya and mango will not result in a consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a public health concern. The lowering of the MRL for strawberries would have a limited impact on overall consumer exposure. EFSA Journal 2012;10(7):

16 CONCLUSIONS AND RECOMMENDATIONS CONCLUSIONS The toxicological profile of spirodiclofen was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an ADI of mg/kg bw per day. The setting of an ARfD was deemed unnecessary. The metabolism of spirodiclofen in primary crops was investigated in apples, grapes, oranges and lemons (covering fruits and fruiting vegetables). In addition a translocation study in grapefruit was performed. From these studies the peer review concluded that the residue definition for enforcement and risk assessment be established as spirodiclofen (for the uses assessed in the context of the peer review). For the uses assessed in the framework of this application, EFSA concludes that the metabolism of spirodiclofen in primary crops is sufficiently addressed and that the same residue definitions are applicable. EFSA considers that the submitted supervised residue trials are sufficient to derive MRL proposals of 0.3 mg/kg for the proposed use in banana and 1.5 mg/kg to accommodate the reported use in the USA on avocado, noting that the MRL in the country of origin is set at the level of 1 mg/kg. EFSA has some reservations regarding the proposal that the residue trial results for avocado might be extrapolated to propose MRLs to accommodate the reported uses in the USA on papaya and mango. This should be considered further by risk managers. The intended use on strawberries is not adequately supported by residue data. Though the EMS made the case that the use of the active substance before flowering and after harvest represents a no residue situation, EFSA does not accept this case. The case does not address the potential for residues from mulch / soil that will be incurred from application before flowering, being transferred to developing fruit via contact. Also before considering lowering the existing strawberry MRL to the limit of quantification, Member States need to confirm that no other authorised GAPs in the EU or in third countries, requires the existing MRL of 2 mg/kg to be maintained. Studies investigating the nature of spirodiclofen residues in processed commodities were assessed in the peer review. These studies showed that the compound is essentially stable under the conditions of pasteurisation but that it is hydrolysed to spirodiclofen-enol under the processing conditions representative of boiling/cooking and sterilisation. On a provisional basis the residue definitions for processed commodities is defined as parent compound, but should be reconsidered in the framework of the MRL review under Article 12 of Regulation (EC) No 396/2005. The available data for processing strawberries were insufficient to derive processing factors, to be included in Annex VI of Regulation (EC) No 396/2005. From field trials on bananas where pulp residues were reported, a peeling factor of 0.1 was derived. Based on the available information on the nature and rate of decline of residues in soil considered in the framework of the peer review, it was concluded that significant residue levels are unlikely to occur in rotational crops, when the compound is used on strawberries according to the use pattern assessed in FAO, 2009 or the intended use proposed by the EMS. Residues of spirodiclofen in commodities of animal origin were not assessed in the framework of this application, since the fruit crops under consideration, are not normally fed to livestock. The consumer risk assessment was performed with revision 2 of the EFSA Pesticides Residues Intake Model (PRIMo). No long-term consumer intake concerns were identified for any of the European diets incorporated in the EFSA PRIMo. The total calculated dietary exposure accounted for up to 54.2 % of the ADI (German child) when there is no change to the existing MRL for strawberries. The contribution of residues in strawberry, banana, avocado, papaya and mango to the total consumer exposure accounted for a maximum of 0.43 % of the ADI (Irish adult). A calculation of acute consumer exposure was not performed, due to the low acute toxicity of the active substance. EFSA Journal 2012;10(7):

17 EFSA concludes that the proposed use of spirodiclofen on strawberry, banana, avocado, mango and papaya will not result in consumer exposure exceeding the toxicological reference value and therefore is unlikely to pose a consumer health risk. RECOMMENDATIONS Code Commodity Existing number (a) EU MRL (mg/kg) Enforcement residue definition: spirodiclofen (F) Proposed EU MRL (mg/kg) Justification for the proposal Banana 0.02* 0.3 The MRL proposal is sufficiently supported by data and no risk for consumers was identified Avocado 0.02* 1.5 or 1 The MRL proposals are sufficiently Mango 0.02* 1.5 or 1 supported by data (with some reservation over the applicability of extrapolating Papaya or 1 trials data results from avocado to mango and papaya). No risk for consumers was identified for the intended uses. Using the OECD MRL calculator a MRL of 1.5 mg/kg is derived whereas the MRL in the country of origin is set at the level of 1 mg/kg. (a): According to Annex I of Regulation (EC) No 396/2005. (*): Indicates that the MRL is set at the limit of analytical quantification. (F): Fat-soluble pesticide. EFSA Journal 2012;10(7):

18 REFERENCES 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 realisation of residue trials. Annex 2. Classification of (minor) crops not listed in the Appendix of Council Directive 90/642/EEC. 7029/VI/95-rev.6. Available from: EC (European Commission), 1997c. Appendix C. Testing of plant protection products in rotational crops. 7524/VI/95-rev.2. Available from: EC (European Commission), 1997d. Appendix E. Processing studies. 7035/VI/95-rev.5. Available from: EC (European Commission), 1997e. Appendix F. Metabolism and distribution in domestic animals. 7030/VI/95-rev.3. Available from: EC (European Commission), 1997f. Appendix H. Storage stability of residue samples. 7032/VI/95- rev.5. Available from: EC (European Commission), 1997g. Appendix I. Calculation of maximum residue level and safety intervals. 7039/VI/95. Available from: EC (European Commission), Residue analytical methods. For pre-registration data requirement for Annex II (part A, section 4) and Annex III (part A, section 5 of Directive 91/414). SANCO/3029/99-rev.4. Available from: EC (European Commission), 2010a. Classes to be used for the setting of EU pesticide Maximum Residue Levels (MRLs). SANCO 10634/2010 Rev. 0, finalised in the Standing Committee on the Food Chain and Animal Health at its meeting of March EC (European Commission), 2010b. Residue analytical methods. For post-registration control. SANCO/825/00-rev.8.1. Available from: EC (European Commission), Appendix D. Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs. 7525/VI/95-rev.9. Available from: EC (European Commission), Review report for the active substance spirodiclofen Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 22 January 2010 in view of the inclusion of spirodiclofen in Annex I of Directive 91/414/EEC. SANCO/11076/09 - final, 22 October 2010, 10 pp. EFSA (European Food Safety Authority), Reasoned opinion on the potential chronic and acute risk to consumers health arising from proposed temporary EU MRLs. Available online: EFSA (European Food Safety Authority), Peer review of the pesticide risk assessment of the active substance spirodiclofen. EFSA Scientific Report (2009) 339, 86 pp. FAO (Food and Agriculture Organisation of the United Nations), Spirodiclofen. In: Pesticide residues in food Report of the Joint Meeting of the FAO Panel of Experts on Pesticide Residues in Food and the Environment and the WHO Expert Group on Pesticide Residues. FAO Plant Production and Protection Paper 196, p Meier U, Growth Stages of mono- and dicotyledonous plants. BBCH Monograph, 2 nd Ed., Federal Biological Research Centre of Agriculture and Forest. Braunschweig, Germany. Available from: EFSA Journal 2012;10(7):

19 The Netherlands, Draft Assessment Report (DAR) on the active substance spirodiclofen prepared by the rapporteur Member State The Netherlands in the framework of Directive 91/414/EEC, April The Netherlands, Final addendum to the draft assessment report on the active substance spirodiclofen prepared by the rapporteur Member State the Netherlands in the framework of Council Directive 91/414/EEC, compiled by EFSA, June The Netherlands, Evaluation report Setting and modification of MRLs for spirodiclofen in various fruits prepared by the evaluating Member State the Netherlands under Article 8 of Regulation (EC) No 396/2005, 31 October 2011, 53 pp. OECD (Organisation for Economic Co-operation and Development), OECD MRL Calculator: spreadsheet for single data set and spreadsheet for multiple data set, 2 March In: Pesticide Publications/Publications on Pesticide Residues. Available from: EFSA Journal 2012;10(7):