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

Transcription

1 REASONED OPINION APPROVED: 06 November 2015 PUBLISHED: 16 November 2015 doi: /j.efsa Review of the existing maximum residue levels for deltamethrin according to Article 12 of Regulation (EC) No 396/2005 Abstract European Food Safety Authority (EFSA) According to Article 12 of Regulation (EC) No 396/2005, the European Food Safety Authority (EFSA) has reviewed the maximum residue levels (MRLs) currently established at European level for the pesticide active substance deltamethrin. In order to assess the occurrence of deltamethrin residues in plants, processed commodities, rotational crops and livestock, EFSA considered the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission, as well as the European authorisations reported by Member States (incl. the supporting residues data). Based on the assessment of the available data, MRL proposals were derived and a consumer risk assessment was carried out. Some information required by the regulatory framework was found to be missing and a possible acute risk to consumers was identified. Hence, the consumer risk assessment is considered indicative only, most MRL proposals derived by EFSA still require further consideration by risk managers and measures for reduction of the consumer exposure should also be considered. European Food Safety Authority, 2015 Keywords: deltamethrin, MRL review, Regulation (EC) No 396/2005, consumer risk assessment, pyrethroids, insecticide Requestor: European Commission Question number: EFSA-Q Correspondence: pesticides.mrl@efsa.europa.eu EFSA Journal 2015;13(11):4309

2 Acknowledgement: EFSA wishes to thank the rapporteur Member State Sweden for the preparatory work on this scientific output. Suggested citation: EFSA (European Food Safety Authority), Reasoned opinion on the review of the existing maximum residue levels for deltamethrin according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2015;13(11):4309, 104 pp. doi: /j.efsa ISSN: European Food Safety Authority, 2015 Reproduction is authorised provided the source is acknowledged. The EFSA Journal is a publication of the European Food Safety Authority, an agency of the European Union. 2 EFSA Journal 2015;13(11):4309

3 Summary Deltamethrin was included in Annex I to Directive 91/414/EEC on 1 November 2003 by Commission Directive 2003/5/EC, and has been deemed to be approved under Regulation (EC) No 1107/2009, in accordance with Commission Implementing Regulation (EU) No 540/2011, as amended by Commission Implementing Regulation (EU) No 541/2011. As the active substance was approved before the entry into force of Regulation (EC) No 396/2005 on 2 September 2008, EFSA is required to provide a reasoned opinion on the review of the existing maximum residue levels (MRLs) for that active substance in compliance with Article 12(2) of the aforementioned regulation. In order to collect the relevant pesticide residues data, EFSA asked Sweden, as the designated rapporteur Member State (RMS), to complete the Pesticide Residues Overview File (PROFile) and to prepare a supporting evaluation report. The PROFile and evaluation report provided by the RMS were made available to the Member States. A request for additional information was addressed to the Member States in the framework of a completeness check period which was initiated by EFSA on 22 December 2014 and finalised on 3 March After having considered all the information provided, EFSA prepared a completeness check report which was made available to Member States on 10 April Based on the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission and the additional information provided by the RMS and Member States, EFSA prepared in August 2015 a draft reasoned opinion, which was circulated to Member States for consultation via a written procedure. Comments received by 14 September 2015 were considered during the finalisation of this reasoned opinion. The following conclusions are derived. The metabolism of deltamethrin was investigated in apples, tomatoes, cotton seed and leaves, corn. Similar metabolic patterns were observed in these studies and a general residue definition for monitoring is proposed as deltamethrin. A validated analytical method for this residue definition in the four main matrices is available but not fully validated. For complex matrices, such as spices and herbal infusions, a validated analytical method is missing. The risk assessment residue definition was proposed as the sum of deltamethrin and its trans-isomer and alpha R-isomer. Furthermore, based on the results from rotational crops and hydrolysis studies, the proposed residue definitions also apply to rotational crops and processed commodities. The available residue trials allowed EFSA to derive MRL proposals as well as risk assessment values for all crops under assessment, except for figs, cardoons, celery and spices (seeds), where the available data were insufficient to derive tentative MRLs. Considering the data gap identified for methods of analysis, the lack of residue trials investigating simultaneously the residue definitions for monitoring and risk assessment and the missing information on the storage conditions of some samples from dry commodities, all MRL proposals are considered tentative. A tentative conversion factor (CF) of 1.25 has been proposed for risk assessment expect for asparagus. For this crop, a conversion factor of 1 was also derived for risk assessment. Measurable levels of relevant residues are not expected to occur in rotational crops, provided that the active substance is applied in compliance with the reported good agricultural practices (GAPs). Only indicative processing factors could be derived from the available processing trials. Deltamethrin is authorised for use on several crops that might be fed to livestock and the dietary burden calculations exceeded the trigger values for all groups of livestock. The metabolism of deltamethrin was investigated in cows and laying hens. As metabolic pathways are expected to be similar in ruminants and rodents, the results of the cow metabolism study could be extrapolated to pigs. From these studies it was proposed to consider, on a tentative basis, deltamethrin as a sufficient marker for monitoring in livestock commodities. A validated analytical method for enforcement of the proposed residue definition is available but not fully validated. For risk assessment, the residue definition was tentatively proposed as the sum of deltamethrin and its trans-isomer and alpha R- isomer. Available livestock feeding studies were sufficient only for deriving tentative MRLs in all relevant tissues of ruminants, pigs (except for kidney) and hens, as well as milk and eggs. Deltamethrin is also registered for use as a veterinary product in the EU. Within this scope, a residue definition (marker residue) and MRLs for animal products are already established. These MRLs are covered by the residues arising from the use of deltamethrin as plant protection product. Consequently, alignment with legislation on veterinary medicines might be necessary. 3 EFSA Journal 2015;13(11):4309

4 Chronic and acute consumer exposure resulting from the authorised uses reported in the framework of this review was calculated using revision 2 of the EFSA PRIMo. For those commodities where data were insufficient to derive an MRL, EFSA considered the existing EU MRL for an indicative calculation. The highest chronic exposure was calculated for the WHO Cluster diet B, representing 95% of the acceptable daily intake (ADI). However, an exceedance of the acute reference dose (ARfD) was identified for scarole (1508% of the ARfD), lettuce (464% of the ARfD), spinach (390% of the ARfD), kale (330% of the ARfD), beet leaves (303% of the ARfD), purslane (261% of the ARfD), wheat (259% of the ARfD), rice (170% of the ARfD), tomatoes (145% of the ARfD), barley (130% of the ARfD), maize (121% of the ARfD) and rye (113% of the ARfD). Considering fall-back MRLs for scarole, lettuce, wheat, rice, tomatoes, barley, maize and rye, and disregarding the MRL proposals for spinach, kale, beet leaves and purslane where no fall-back MRL could be identified by EFSA, the highest chronic exposure represented 36% of the ADI (WHO Cluster diet B) and the highest acute exposure amounted to 99% of the ARfD (celery leaves). Apart from the MRLs evaluated in the framework of this review, internationally recommended CXLs have also been established for deltamethrin. Although these CXLs are not adequately supported by data, in particular with regard to the residue definitions for risk assessment, additional calculations of the consumer exposure considering these CXLs were carried out and exceedances of the ARfD were identified for the existing CXLs in scarole (1093% of the ARfD), kale (845% of the ARfD), kohlrabi (626% of the ARfD), witloof (580% of the ARfD), Chinese cabbage (464% of the ARfD), lettuce (336% of the ARfD), spinach (283% of the ARfD), beet leaves (219% of the ARfD), wheat (199% of the ARfD), dry beans (194% of the ARfD), purslane (189% of the ARfD), rice (173% of the ARfD), melons (171% of the ARfD), tomatoes (145% of the ARfD) and watermelons (138% of the ARfD). Excluding these CXLs from the calculation, the highest chronic exposure represented 51% of the ADI (Irish adults) and the highest acute exposure amounted to 100% of the ARfD (barley). 4 EFSA Journal 2015;13(11):4309

5 Table of contents Abstract... 1 Summary... 3 Background... 6 Terms of reference... 7 The active substance and its use pattern... 7 Assessment Residues in plants Nature of residues and methods of analysis in plants Nature of residues in primary crops Nature of residues in rotational crops Nature of residues in processed commodities Methods of analysis in plants Stability of residues in plants Proposed residue definitions in plants Magnitude of residues in plants Magnitude of residues in primary crops Magnitude of residues in rotational crops Magnitude of residues in processed commodities Proposed MRLs Residues in livestock Nature of residues and methods of analysis in livestock Nature of residues in ruminants Nature of residues in poultry Methods of analysis in livestock Stability of residues in livestock Proposed residue definitions in livestock Magnitude of residues in livestock Proposed MRLs Consumer risk assessment Consumer risk assessment without consideration of the existing CXLs Consumer risk assessment with consideration of the existing CXLs Conclusions Recommendations References Abbreviations Appendix A Summary of authorised uses considered for the review of MRLs Appendix B List of end points Appendix C Input values for the exposure calculations Appendix D Decision tree for deriving MRL recommendations Appendix E Used compound code(s) EFSA Journal 2015;13(11):4309

6 Background Regulation (EC) No 396/ establishes the rules governing the setting and the review of pesticide maximum residue levels (MRLs) at European level. Article 12(2) of that regulation stipulates that EFSA shall provide, within 12 months from the date of the inclusion or non-inclusion of an active substance in Annex I to Directive 91/414/EEC 2 a reasoned opinion on the review of the existing MRLs for that active substance. As deltamethrin was included in Annex I to Council Directive 91/414/EEC on 1 November 2003 by means of Commission Directive 2003/5/EC, 3 and has been deemed to be approved under Regulation (EC) No 1107/2009, 4 in accordance with Commission Implementing Regulation (EU) No 540/2011, 5 as amended by Commission Implementing Regulation (EU) No 541/2011, 6 EFSA initiated the review of all existing MRLs for that active substance. According to the legal provisions, EFSA shall base its reasoned opinion in particular on the relevant assessment report prepared under Directive 91/414/EEC. It should be noted, however, that in the framework of Directive 91/414/EEC only a few representative uses are evaluated, while MRLs set out in Regulation (EC) No 396/2005 should accommodate all uses authorised within the EU, and uses authorised in third countries that have a significant impact on international trade. The information included in the assessment report prepared under Directive 91/414/EEC is therefore insufficient for the assessment of all existing MRLs for a given active substance. In order to gain an overview of the pesticide residues data that have been considered for the setting of the existing MRLs, EFSA developed the Pesticide Residues Overview File (PROFile). The PROFile is an inventory of all pesticide residues data relevant to the risk assessment and MRL setting for a given active substance. This includes data on: the nature and magnitude of residues in primary crops; the nature and magnitude of residues in processed commodities; the nature and magnitude of residues in rotational crops; the nature and magnitude of residues in livestock commodities and; the analytical methods for enforcement of the proposed MRLs. Sweden, the designated rapporteur Member State (RMS) in the framework of Directive 91/414/EEC, was asked to complete the PROFile for deltamethrin and to prepare a supporting evaluation report. The PROFile and the supporting evaluation report were submitted to EFSA on 22 January 2009 (Sweden, 2009). Sweden submitted revised versions of the Evaluation report to EFSA (last revised version of 2 March 2015) and made available to the Member States. A request for additional information was addressed to the Member States in the framework of a completeness check period which was initiated by EFSA on 22 December 2014 and finalised on 2 March Additional evaluation reports were submitted by Austria, Belgium, Czech Republic, France, Italy, Netherlands, Spain, Sweden, United Kingdom and after having considered all the information provided by RMS and Member States, EFSA prepared a completeness check report which was made available to all Member States on 10 April Further clarifications were sought from Member States via a written procedure in April Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC. OJ L 70, , p Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market. OJ L 230, , p Repealed by Regulation (EC) No 1107/ Commission Directive 2003/5/EC of 10 January 2003 amending Council Directive 91/414/EEC to include deltamethrin as active substance. OJ L 8, , p Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. OJ L 309, , p Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances. OJ L 153, , p Commission Implementing Regulation (EU) No 541/2011 of 1 June 2011 amending Implementing Regulation (EU) No 540/2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards the list of approved active substances. OJ L 153, , p EFSA Journal 2015;13(11):4309

7 Based on the conclusions derived in the framework of Directive 91/414/EEC, the MRLs established by the Codex Alimentarius Commission and the additional information provided by the Member States, EFSA prepared in August 2015 a draft reasoned opinion, which was submitted to Member States for commenting via a written procedure. All comments received by 14 September 2015 were considered by EFSA during the finalisation of the reasoned opinion. The evaluation reports submitted by the RMS (Sweden, 2009, 2015), and the evaluation reports submitted by the Member States Austria, Belgium, Czech Republic, France, Italy, Netherlands, Spain, United Kingdom (Austria, 2015; Belgium, 2015; Czech Republic, 2015; France, 2015; Italy, 2015; Netherlands, 2015; Spain, 2015; United Kingdom, 2015) are considered as supporting documents to this reasoned opinion and, thus, are made publicly available. In addition, key supporting documents to this reasoned opinion are the completeness check report (EFSA, 2015a) and the Member States consultation report (EFSA, 2015b). These reports are developed to address all issues raised in the course of the review, from the initial completeness check to the reasoned opinion. Considering the importance of the completeness check and consultation report, all documents are considered as background documents to this reasoned opinion and, thus, are made publicly available. For the sake of transparency also the chronic and acute exposure calculations for all crops reported in the framework of this review performed using the EFSA Pesticide Residues Intake Model (PRIMo) are made publicly available. Terms of reference According to Article 12 of Regulation (EC) No 396/2005, EFSA shall provide a reasoned opinion on: the inclusion of the active substance in Annex IV to the Regulation, when appropriate; the necessity of setting new MRLs for the active substance or deleting/modifying existing MRLs set out in Annex II or III of the Regulation; the inclusion of the recommended MRLs in Annex II or III to the Regulation; the setting of specific processing factors as referred to in Article 20(2) of the Regulation. The active substance and its use pattern Deltamethrin is the ISO common name for (S)-α-cyano-3-phenoxybenzyl (1R,3R)-3-(2,2-dibromovinyl)-2,2-dimethylcyclopropanecarboxylate (IUPAC). Deltamethrin contains 3 chiral carbons in different positions and may have 7 other potential stereoisomers. For this reason, deltamethrin ([1R, cis, alpha-s]-isomer) is often referred to as cis-deltamethrin. In the framework of this assessment, deltamethrin refers to the specific isomer unless specified otherwise. Deltamethrin is a non-systemic insecticide belonging to the chemical class of pyrethroids. It prevents the transmission of nervous impulses in harmful organisms thereby disrupting their nervous system. It is used to control many species of insects, in particular Lepidoptera, Coleoptera and Homoptera in a wide range of crops. Deltamethrin is also used topically for the control of ectoparasites in cattle and sheep. Deltamethrin is considered as fat-soluble (log Pow = 4.6). The chemical structure of the active substance and its main metabolites are reported in Appendix E. Deltamethrin was evaluated in the framework of Directive 91/414/EEC with Sweden designated as rapporteur Member State (RMS). The representative uses supported for the peer review process were foliar applications as insecticide on a large number of crops (including roots and tuber vegetables, fruits and fruiting vegetables, leafy vegetables and oilseeds) and post-harvest uses on pulses, potatoes and cereals. Following the peer review, a decision on inclusion of the active substance in Annex I to Directive 91/414/EEC was published by means of Commission Directive 2003/5/EC, which entered into force on 1 November According to Regulation (EU) No 540/2011, deltamethrin is deemed to have been approved under Regulation (EC) No 1107/2009. This approval is restricted to 7 EFSA Journal 2015;13(11):4309

8 uses as insecticide only. As EFSA was not yet involved in the peer review of deltamethrin, an EFSA Conclusion on this active substance is not available. The EU MRLs for deltamethrin are established in Annexes II and IIIB of Regulation (EC) No 396/2005 and CXLs for deltamethrin were also established by the Codex Alimentarius Commission (CAC). An overview of the MRL changes that occurred since the entry into force of the above mentioned regulation is provided below. Table 1: Overview of the MRL changes since the entry into force of Regulation (EC) No 396/2005 Procedure Legal implementation Remarks MRL application Regulation (EC) No 524/ Modification of existing MRL for deltamethrin in potatoes Implementation of CXLs Regulation (EC) No 441/ CAC 2011 For the purpose of this MRL review, the critical uses of deltamethrin currently authorised within the EU, have been collected by the RMS and reported in the PROFile. The additional GAPs reported by Member States during the completeness check were also considered. The details of the authorised GAPs for deltamethrin are given in Appendix A. MRLs for deltamethrin in products of animal origin, resulting from the use of deltamethrin as a veterinary drug in bovine and ovine livestock (not used for milk production), are also established in the framework of Regulation (EU) N 37/ (EMEA, 2004). Assessment EFSA has based its assessment on the PROFile submitted by the RMS, the evaluation report and its revisions accompanying the PROFile (Sweden, 2009), the draft assessment report (DAR) and its addendum prepared under Council Directive 91/414/EEC (Sweden, 1998, 2002), the review report on deltamethrin (European Commission, 2002), the JMPR Evaluation (FAO, 2002), the previous reasoned opinion on deltamethrin (EFSA, 2010) as well as the evaluation reports submitted during the completeness check (Austria, 2015; Belgium, 2015; Czech Republic, 2015; France, 2015; Italy, 2015; Netherlands, 2015; Spain, 2015; Sweden, 2015; United Kingdom, 2015). The assessment is performed in accordance with the legal provisions of the uniform principles for evaluation and authorisation of plant protection products as set out in Commission Regulation (EU) No 546/ and the currently applicable guidance documents relevant for the consumer risk assessment of pesticide residues (European Commission, 1996, 1997a-g, 2000, 2010a,b, 2011 and OECD, 2011). More detailed information on the available data and on the conclusions derived by EFSA can be retrieved from the list of end points reported in Appendix B. 7 Commission Regulation (EU) No 524/2011 of 26 May 2011 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for biphenyl, deltamethrin, ethofumesate, isopyrazam, propiconazole, pymetrozine, pyrimethanil and tebuconazole in or on certain products. OJ L 142, , p Commission Regulation (EU) No 441/2012 of 24 May 2012 amending Annexes II and III to Regulation (EC) No 396/2005 of the European Parliament and of the Council as regards maximum residue levels for bifenazate, bifenthrin, boscalid, cadusafos, chlorantraniliprole, chlorothalonil, clothianidin, cyproconazole, deltamethrin, dicamba, difenoconazole, dinocap, etoxazole, fenpyroximate, flubendiamide, fludioxonil, glyphosate, metalaxyl-m, meptyldinocap, novaluron, thiamethoxam, and triazophos in or on certain products. OJ L 135, , p Commission Regulation (EU) No 37/2010 of 22 December 2009 on pharmacologically active substances and their classification regarding maximum residue limits in foodstuffs of animal origin. OJ L 15, , p Commission Regulation (EU) No 546/2011 of 10 June 2011 implementing Regulation (EC) No 1107/2009 of the European Parliament and of the Council as regards uniform principles for evaluation and authorisation of plant protection products. OJ L 155, , p EFSA Journal 2015;13(11):4309

9 1. Residues in plants 1.1. Nature of residues and methods of analysis in plants Nature of residues in primary crops The metabolism of deltamethrin in primary crops was investigated in the framework of the peer review (Sweden, 1998, 2002). The same studies have been considered in the JMPR Evaluation of deltamethrin (FAO, 2002). The metabolism of deltamethrin in primary crops following foliar treatment has been investigated in fruits and fruiting vegetables (apples and tomatoes), pulses and oilseeds (cotton seed and leaves) and cereals (corn). Deltamethrin was the predominant compound in all the crops tested accounting for up 77% total radioactive residue (TRR) (forage corn). In the studies analysing for the single isomers (apples, corn and cotton), the alpha-r-isomer and the trans-isomer accounted for up 34% TRR (apple) and for up to 19% TRR (apples), respectively. In all crops investigated, residues of metabolite 3-phenoxybenzylaldehyde (mpb aldehyde) were found but their levels were never relevant compared to parent and its isomers. In the study on cotton investigating translocation, hydroponic and soil treatments resulted in a significant root uptake while, after foliar treatment, only a limited translocation throughout the plant was observed. After local applications on cotton leaves, deltamethrin was degraded to its trans-isomer more rapidly under field conditions than under glasshouse conditions. No studies investigating the metabolism of deltamethrin following post-harvest treatment are available. However, considering the similar metabolic pathway of deltamethrin observed in all crops investigated, it can be assumed that, when applied in post-harvest treatments, deltamethrin will not undergo a more extensive metabolism. EFSA therefore concludes that no additional metabolism studies are required to support post-harvest treatments Nature of residues in rotational crops Most of the crops under consideration may be grown in rotation. According to the soil degradation studies evaluated in the framework of the peer review, period required for 90 percent dissipation (DT 90 ) value of deltamethrin is expected to range between 30 and 390 days which is higher than the trigger value of 100 days (European Commission, 2002). According to the European guidelines on rotational crops (European Commission, 1997b), further investigation of residues in rotational crops is relevant. The metabolism of deltamethrin in rotational crops carrots, lettuce, barley - has been evaluated during the peer review (Sweden, 1998). One confined rotational crop study investigating the nature of residues following different plant-back intervals is available. Following treatment of a bare soil at kg a.s./ha, residues in rotational crops at harvest were generally found to be below 0.01 mg eq/kg, except in barley straw and foliage where residues amounted to and mg eq/kg, respectively. Consequently, considering the overdosing factor of the confined study (86N), no significant residues are expected in crops grown in rotation and a specific residue definition for rotational crops is not required Nature of residues in processed commodities The effect of processing on the nature of deltamethrin was investigated in the framework of the peer review (Sweden, 2002). Studies were conducted simulating representative hydrolytic conditions for pasteurisation (20 minutes at 90 C, ph 4), boiling/brewing/baking (60 minutes at 100 C, ph 5) and sterilisation (20 minutes at 120 C, ph 6). Under simulated pasteurisation and brewing, baking and boiling, deltamethrin is stable and only small quantities (0.9 to 5.2% of applied radioactivity) of the plant metabolite 3-phenoxybenzylaldehyde (mpb aldehyde) were detected. Following sterilisation process, deltamethrin represented 21-48% of the applied radioactivity (AR) and it was degraded mainly into two metabolites: mpb aldehyde (59-75% of the AR) and (1R,3R)-3-(2,2-dibromovinyl)- 9 EFSA Journal 2015;13(11):4309

10 2,2-dimethyl-cyclopropanecarboxylic acid (Br 2 CA) (39-47% of AR). During the peer review these two substances were considered well known plant metabolites with no toxicological relevance. Although their toxicological relevance may be reconsidered during the renewal of the approval of the active substance, the conclusions derived during the initial peer review were applied in the framework of this MRL review. It is also noted that in the hydrolysis studies, residues were always reported as deltamethrin and it is not clear if the analytical method used analysed for the sum of all isomers Methods of analysis in plants During the peer review under Directive 91/414/EEC, an analytical method using GC-ECD, was evaluated for the determination of deltamethrin in plant matrices with a limit of quantification (LOQ) of 0.02 mg/kg in high water content, high fat content, acidic and dry commodities. According to the current guideline, the method is not considered highly specific and a confirmatory method is still required. Independent laboratory validation (ILV) data are available for the determination of deltamethrin in high water content, high fat content and acidic commodities but not for dry commodities (Sweden, 2002; European Commission, 2002). Consequently, an analytical method fully validated and its ILV is still required for dry commodities. An analytical method for the determination of deltamethrin in complex matrices, such as spices and herbal infusions, is not available and it is still required. Hence it is concluded that there are indications that deltamethrin can be monitored with an LOQ of 0.02 mg/kg in high water content, high fat content, acidic and dry commodities but full validation data are still required (confirmatory method for all the matrices and ILV for dry commodities). A fully validated analytical method for the determination of deltamethrin in spices and herbal infusion is not available and it is still required Stability of residues in plants Storage stability of deltamethrin was demonstrated at -20 C for a period of 24 months in high water content commodities (cabbage and tomatoes) (FAO, 2002) and at -12 C for 30 months in high oil content commodities (cotton seed) and for 9 month in dry commodities (cereals grain) (Sweden, 1998). Storage stability studies on high acid content commodities are not available. However, considering that storage stability in tomatoes (which is borderline between a high water and a high acid content commodity) has been demonstrated for up to 24 months and that in samples from acidic commodities stored for up to 16 months residue levels were not significant different from samples stored for shorter period, a storage stability study on acidic commodities is only desirable Proposed residue definitions in plants The metabolism studies showed that the metabolic pathway is similar in all crop groups investigated. The peer review concluded to establish risk assessment and enforcement residue definition for plant commodities as deltamethrin only. This is in line with the residue definition established in the Regulation (EC) No 396/2005. However, considering that alpha-r isomer and trans- isomer represent approximately 30-40% of the total residue and that information on the toxicity of isomers is not available, EFSA is of the opinion that these two isomers should be included at least in the residue definition for risk assessment. Consequently, EFSA proposes to set the residue definition for enforcement as deltamethrin and the residue definition for risk assessment as the sum of deltamethrin and its alpha-r isomer and trans-isomer. Considering that several crop groups and modes of application were investigated, this residue definition is applicable to all primary crops. Furthermore, based on the results from rotational crops and hydrolysis studies, the proposed residue definition also applies to rotational crops and processed commodities. Analytical methods for enforcement of the proposed residue definitions are available but not fully validated. For complex matrices such as spices and herbal infusions, a fully validated analytical method is missing and it is still required (see also section 1.1.4). EFSA is aware that including the parent compound only in the residue definition requires a stereo-specific analytical method which is usually difficult to implement for routine enforcement of residues. Nevertheless, it is underlined that the same residue definition for enforcement was previously agreed upon by Commission and MSs (currently implemented in legislation) EFSA Journal 2015;13(11):4309

11 1.2. Magnitude of residues in plants Magnitude of residues in primary crops To assess the magnitude of deltamethrin residues resulting from the reported GAPs, EFSA considered all residue trials reported by the RMS in its evaluation report (Sweden, 2009), including residue trials evaluated in the framework of the peer review (Sweden, 1998, 2002) or in the framework of a previous MRL application (EFSA, 2010) and additional data submitted during the completeness check (Austria, 2015; Belgium, 2015; Czech Republic, 2015; France, 2015; Italy, 2015; Netherlands, 2015; Spain, 2015; Sweden, 2015; United Kingdom, 2015). Storage conditions for the residue trials considered in this framework were not always reported. Considering that storage stability in high water content and in high oil content commodities was demonstrated for at least 24 months, decline of residues during storage of the trial samples of commodities belonging to these groups is not expected. For the dry commodities for which no information on storage conditions are available, considering that the storage stability was only demonstrated for 9 months, information on the storage conditions of the samples is required in order to confirm the results of the residue trials. The number of residue trials and extrapolations were evaluated in accordance with the European guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs (European Commission, 2011). For asparagus, no residue trials are available. However, according to southern outdoor and indoor GAPs, the active substance is applied approximately one year prior to harvest and no significant uptake of deltamethrin was observed in the available metabolism studies. A no-residue situation is therefore expected for these GAPs and no further residue trials are required. Nevertheless, a different GAP is authorised in northern Europe, for which a no-residue situation could not be confirmed. For this GAP the following data gap has been identified by EFSA: Asparagus: 4 trials compliant with the northern outdoor GAP. Regarding figs, cardoons, celery and spices (seeds), residue trials supporting the authorisations are also not available and a no-residue situation could not be confirmed by EFSA. Therefore, MRL or risk assessment values for these crops could not be derived by EFSA and the following data gaps were identified: Figs: 4 trials compliant with the southern outdoor GAP are required; Cardoons: 4 trials compliant with the southern outdoor GAP are still required. Italy proposed the extrapolation from artichokes (Italy, 2015). Although not foreseen in the current guidance document, due to the morphological similarity between artichokes stems and cardoons, the proposed extrapolation can in principle be considered possible. However, since residue data on the artichoke stems were not available, the extrapolation has not been accepted; Celery: 4 residue trials compliant with the northern outdoor GAP and 4 trials compliant with the indoor GAP are required; Spices (seeds): 4 residue trials compliant with the northern outdoor GAP are required. All required trials should be performed analysing simultaneously residues according to the residue definitions for monitoring and risk assessment. For all other crops, residue trials analysing simultaneously for monitoring and risk assessment residue definitions are not available (except for the indoor GAP on radishes). Moreover, in the summary of the available supervised residue trials, residues were reported as 'deltamethrin' or as 'cis-deltamethrin' and it is not clear whether residues reported as deltamethrin imply the use of an analytical method covering all the isomers. Consequently, for these crops only tentative MRLs and risk assessment values could be derived by EFSA and complete data sets of residue trials analysing simultaneously for monitoring and risk assessment residue definitions are still required Magnitude of residues in rotational crops The results of the confined rotational crop study is confirmed by a field rotational crop study analysing residues in spinach, carrots and radishes planted in soil treated once at 0.12 kg a.s./ha. Considering 11 EFSA Journal 2015;13(11):4309

12 that deltamethrin was applied to a bare soil (interception of active substance by the plants is expected in practice), it can be concluded that residue levels in rotational commodities are not expected to exceed 0.01 mg/kg provided that deltamethrin is used according to the GAPs assessed in the present review Magnitude of residues in processed commodities Studies investigating the magnitude of residues in processed commodities of apples, tomatoes, pulses, sunflower seeds, rape seeds, cotton seed, olive, barley, maize, rice (Sweden, 1998, 2002), potatoes (EFSA, 2010) and strawberries (Italy, 2015) were reported. In these studies, residues were always reported as 'deltamethrin' and it is not clear if an analytical method covering all the isomers has been used. Consequently, no robust processing factors for enforcement and risk assessment could be derived. The processing factors reported in Appendix B should therefore be considered as indicative only. Considering that the processing factor for cooked (unpeeled, boiled) potatoes was tentatively applied in the consumer risk assessment (see section 3), further processing studies analysing simultaneously for monitoring and risk assessment residue definitions and supporting the tentative processing factor are still required Proposed MRLs Consequently, the available data are considered sufficient to derive MRL proposals as well as risk assessment values for all crops under assessment, except for figs, cardoons, celery and spices (seeds), where the available data were insufficient to derive tentative MRLs. Furthermore, considering the data gap identified for methods of analysis, the lack of residue trials investigating simultaneously the residue definitions for monitoring and risk assessment and the missing information on the storage conditions of samples from dry commodities, all MRL proposals are considered tentative. Tentative MRLs were also derived for feed crops (cereal straw, sugar beet tops, clover forage, alfalfa forage and grass) in view of the future need to set MRLs in feed items. In the absence of residue trials analysing simultaneously for monitoring and risk assessment residue definitions, residue data do not allow to derive appropriate conversion factors. Moreover, the available metabolism studies not always analysed parent and isomers independently and cannot be used to derive even tentative CFs, as done for other active substances in previous similar situations. Consequently, in order to perform at least an indicative assessment, EFSA considered the information provided by the RMS and derived from a study conducted by the notifier in the USA. According to this study, results from 263 residue samples showed that the combined contribution of both the transisomer and alpha R-isomer would not exceed 20% of the residue. The comments received from the EURLs during the MSs Consultation, confirmed that these data are in line with the main results from routine analyses. Consequently, for all crops except asparagus, a tentative CF of 1.25 has been proposed for risk assessment. For asparagus, considering that measurable residues are anyhow not expected in this crop, it was possible to derive a conversion factor of 1. Due to the different deficiencies highlighted in the previous sections, the whole assessment is considered tentative only. 2. Residues in livestock Deltamethrin is authorised for use on several crops that might be fed to livestock. Livestock dietary burdens were therefore calculated for different groups of livestock using the agreed European methodology (European Commission, 1996). The input values for all relevant commodities have been selected according to the recommendations of JMPR (FAO, 2009) and are summarised in Appendix C. The calculated dietary burdens for all groups of livestock were found to exceed the trigger value of 0.1 mg/kg DM. Behaviour of residues was therefore assessed in all commodities of animal origin. It is highlighted that for most of the feed items, only tentative MRLs and risk assessment values could be derived. Moreover, residues in cereals straw were derived from trials performed according to a less critical GAP and the animal intake of deltamethrin residues via these commodities may have been underestimated. However, this is not expected to have a major impact on the outcome of the dietary burden considering the high contribution of kale and wheat grain and the conservative conversion factor applied for risk assessment EFSA Journal 2015;13(11):4309

13 2.1. Nature of residues and methods of analysis in livestock Nature of residues in ruminants Metabolism of deltamethrin in ruminants was investigated in the framework of Directive 91/414/EEC (Sweden, 1998, 2002). Cows were dosed for three consecutive days with 10 mg/kg body weight (bw) per day (labelled on both the benzyl- and dimethyl-rings, one cow for each label). Deltamethrin was the major compound in all tissues accounting for up to 90% of the TRR in fat. Metabolites Br2CA and PB acid were present at the same level as parent in liver and kidney (23 and 33% of the TRR, respectively) Nature of residues in poultry Metabolism of deltamethrin in poultry was investigated in the framework of Directive 91/414/EEC (Sweden, 1998, 2002). Hens were dosed for three consecutive days with 5 mg/kg bw per day (also labelled on both rings). In poultry tissues and eggs, deltamethrin was the main compound found (19-65% of the TRR), except in kidney where, apart for deltamethrin (25-28% TRR), metabolites c-br2ca and c/t-cooh-c-br2ca (together 22% TRR), and c-ch2oh-c-br2ca and t-cooh-c-ch2oh-c-br2ca-lactone (together 15-22% TRR) were also identified Methods of analysis in livestock During the peer review under Directive 91/414/EEC, an analytical method using GC-ECD and its ILV, was evaluated for the determination of deltamethrin in food of animal origin with an LOQ of 0.02 mg/kg in milk, meat, fat, liver, kidney and eggs (Sweden, 2002; European Commission, 2002). The method is not considered highly specific. Consequently, a confirmatory method is still required. Hence, there are indications that deltamethrin can be monitored in animal tissues, in milk and eggs at the LOQ of 0.02 mg/kg but a confirmatory method is still required Stability of residues in livestock Storage stability of deltamethrin was demonstrated at -12 C for a period of 11 months in animal tissues and in eggs (FAO, 2000) and at -20 C for 7 months in milk (Sweden, 2002) Proposed residue definitions in livestock Consequently, EFSA proposes on a tentative basis, to define the residue for enforcement as deltamethrin only. For risk assessment, the residue definition is proposed as the sum of deltamethrin and its trans-isomer and alpha R-isomer. As metabolic pathways are expected to be similar in ruminants and rodents, the results of the cow metabolism study could be extrapolated to pigs. It is underlined that animals will not only be exposed to deltamethrin but also to trans-isomer and to alpha R-isomer. Consequently, the metabolism of these isomers in livestock should be investigated as well. According to the information received from the main authorisation holder during the completeness check, residue data on feed items where all 3 isomers of deltamethrin were separately determined, showed that livestock is mainly exposed to deltamethrin and only slightly exposed to the trans-isomer. Moreover, according to the main authorisation holder, since the analytical methods used in the metabolism studies analysed for the sum of isomers, the study was able to take all of them into account. However, since the data were not evaluated by the RMS in a detailed evaluation report, EFSA was not able to verify the reliability of this information. Consequently, further information on the metabolism of trans-deltamethrin and alpha R-deltamethrin in livestock is still required Magnitude of residues in livestock Livestock feeding studies on lactating cows dosed with deltamethrin at and 0.26 mg/kg bw per day during 28 days and on laying hens dosed with a mixture of tralomethrin and deltamethrin (1:1) at 0.093, and mg deltamethrin/kg bw per day during 28 days were evaluated during the peer review (Sweden, 1998, 2002). According to the additional information received during the completeness check, the analytical method used in the livestock feeding studies analyse for the sum of isomers. However, since a detailed evaluation report is not available, EFSA could not verify this 13 EFSA Journal 2015;13(11):4309

14 information and it was not possible to derive CFs for risk assessment. Furthermore, the available cow feeding study did not investigate residues in kidney. EFSA is therefore of the opinion that new livestock feeding studies are required; these studies should investigate all relevant tissues and matrices, according to the residue definitions for monitoring and risk assessment simultaneously Proposed MRLs The available data are considered sufficient only for deriving tentative MRLs in all relevant tissues of ruminants, pigs (except for kidney) and hens, as well as milk and eggs. CFs for risk assessment could not be derived. EFSA notes that deltamethrin is registered for use as a veterinary product in the EU. Within this scope, a residue definition (marker residue defined as deltamethrin only) and MRLs for animal products are already established in the framework of Regulation (EU) No 37/2010. These MRLs are covered by the residues arising from the use of deltamethrin as plant protection product. Consequently, alignment of the MRLs established in the framework of the veterinary medicines might be necessary. 3. Consumer risk assessment In the framework of this review, only the uses of deltamethrin reported by the RMS in Appendix A were considered, however the use of deltamethrin was previously also assessed by the JMPR (FAO, 2002). The CXLs, resulting from this assessment by JMPR and adopted by the CAC, are now international recommendations that need to be considered by European risk managers when establishing MRLs. In order to facilitate consideration of these CXLs by risk managers, the consumer exposure was calculated both with and without consideration of the existing CXLs Consumer risk assessment without consideration of the existing CXLs Chronic and acute exposure calculations for all crops reported in the framework of this review were performed using revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo) (EFSA, 2007). Input values for the exposure calculations were derived in compliance with the decision tree reported in Appendix D. Hence, for those commodities where a tentative MRL could be derived by EFSA in the framework of this review, input values were derived according to the internationally agreed methodologies (FAO, 2009). For those commodities where data were insufficient to derive an MRL in section 3, EFSA considered the existing EU MRL for an indicative calculation (multiplied by a general conversion factor of 1.25 for risk assessment, see also section 1.2.4). For potatoes, EFSA also considered a processing factor for cooking (unpeeled and boiled) that was tentatively derived in section All input values included in the exposure calculations are summarised in Appendix C. The exposures calculated were compared with the toxicological reference values for deltamethrin, derived by the European Commission (2002) under Directive 91/414/EEC. The highest chronic exposure was calculated for the WHO Cluster diet B, representing 95% of the ADI. With regard to the acute exposure, however, an exceedance of the ARfD was identified for scarole (1508% of the ARfD), lettuce (464% of the ARfD), spinach (390% of the ARfD), kale (330% of the ARfD), beet leaves (303% of the ARfD), purslane (261% of the ARfD), wheat (259% of the ARfD), rice (170% of the ARfD), tomatoes (145% of the ARfD), barley (130% of the ARfD), maize (121% of the ARfD) and rye (113% of the ARfD). A second exposure calculation was therefore performed, considering fall-back GAPs for scarole, lettuce, wheat, rice, tomatoes, barley, maize and rye. For spinach, kale, beet leaves and purslane, no fall-back GAP could be identified by EFSA. These crops were therefore excluded from this calculation. According to the results of the second calculation, the highest chronic exposure declined to 36% of the ADI for WHO Cluster diet B; the highest acute exposure is then calculated for celery leaves, representing 99% of the ARfD. Based on these calculations, a potential risk to consumers was identified for the most critical GAPs on scarole, lettuce, spinach, kale, beet leaves, purslane, wheat, rice, tomatoes, barley, maize and rye. While for scarole, lettuce, wheat, rice, tomatoes, barley, maize and rye fall-back GAPs may be considered by risk managers in order to reduce the exposure of consumers to an acceptable level, no 14 EFSA Journal 2015;13(11):4309