Modification of the existing maximum residue level for thiacloprid in honey

Transcription

1 REASONED OPINION APPROVED: 18 February 2016 PUBLISHED: 01 March 2016 doi: /j.efsa Abstract Modification of the existing maximum residue level for thiacloprid in honey European Food Safety Authority (EFSA) In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS), Germany, compiled an application to modify the existing maximum residue level (MRL) for the active substance thiacloprid in honey. Germany proposed to raise the existing MRL from the limit of quantification of 0.05 mg/kg to 0.2 mg/kg. No guidance document for the setting of MRL in honey is currently available at EU level and therefore, in addition to the EMS evaluation, EFSA proposed additional alternative MRL values based on monitoring data. An MRL proposal of 0.2 mg/kg was derived from field trials where honey was collected in hives positioned close to rapeseed plots treated with thiacloprid. In addition MRLs of 0.15 and 0.2 mg/kg were derived considering data from national monitoring programs and the approaches recommended by the Food and Agriculture Organization (FAO). EFSA proposes to risk managers to decide which approach should be taken into account for the setting of an MRL in honey. Adequate analytical enforcement methods are available to control the residues of thiacloprid in honey. Based on the risk assessment results, EFSA concludes that the proposed MRLs of 0.15 or 0.2 mg/kg in honey will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a consumer health risk. European Food Safety Authority, 2016 Keywords: thiacloprid, honey, rape, MRL application, consumer risk assessment Requestor: European Commission Question number: EFSA-Q Correspondence: pesticides.mrl@efsa.europa.eu EFSA Journal 2016;14(3):4418

2 Suggested citation: EFSA (European Food Safety Authority), Reasoned opinion on the modification of the existing maximum residue level for thiacloprid in honey. EFSA Journal 2016;14(3):4418, 21 pp. doi: /j.efsa ISSN: European Food Safety Authority, 2016 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 2016;14(3):4418

3 Summary In accordance with Article 6 of Regulation (EC) No 396/2005, the evaluating Member State (EMS) Germany compiled an application to modify the existing maximum residue level (MRL) for the active substance thiacloprid in honey. In order to account for residues that could occur in honey, Germany proposed to raise the existing MRL from the limit of quantification (LOQ) of 0.05 mg/kg to 0.2 mg/kg. Germany drafted an evaluation report in accordance with Article 8 of Regulation (EC) No 396/2005, which was submitted to the European Commission and forwarded to the European Food Safety Authority (EFSA) on 7 July EFSA bases its assessment on the evaluation report submitted by the EMS, the draft assessment report (DAR) prepared under Council Directive 91/414/EEC, the Commission review report on thiacloprid as well as the conclusions from the EFSA reasoned opinion on the MRL review for thiacloprid according to Article 12 of Regulation (EC) No 396/2005 (here after Article 12 MRL review). In addition, monitoring data from EU national control programmes conducted by several Member States in 2013 were considered by EFSA to propose alternative MRL values for thiacloprid in honey. The toxicological profile of thiacloprid was assessed in the framework of the peer review under Directive 91/414/EEC and the data were sufficient to derive an acceptable daily intake (ADI) of 0.01 mg/kg bw per day and an acute reference dose (ARfD) of 0.03 mg/kg bw. The metabolism of thiacloprid in primary crops was investigated in the fruit, cereal/grass and pulses/oilseeds crop groups following foliar/soil applications. Based on these studies, the plant residue definition for enforcement and risk assessment was confirmed as thiacloprid during the Article 12 MRL review. Specific studies on the nature of the residues in honey are not available and EFSA proposes to apply to honey the residue definition set for plants. The QuEChERS method in combination with HPLC- MS/MS quantification was validated by the EURL for the determination of thiacloprid in honey at the LOQ of 0.02 mg/kg. The EMS based the MRL proposal on a total of eight trials where honey was collected in hives positioned close to rapeseed plots treated with thiacloprid at the full bloom growth stage. Based on residue levels in honey collected 16 to 29 days after the last application, an MRL of 0.2 mg/kg was derived for thiacloprid in honey. However, an agreed guidance document on the setting of MRL in honey is not available at EU level and therefore, EFSA proposed alternative MRL values based on monitoring data. Honey was included by several EU member states in their 2013 national control programs. Based on a total of 562 samples from EU origin analysed for thiacloprid residues, MRL proposals of 0.15 and 0.2 mg/kg were derived by EFSA, considering the approaches recommended by the Food and Agriculture Organization (FAO). EFSA proposes to risk managers to decide which of these different approaches should be finally considered for the setting of an MRL in honey. Specific studies to assess the magnitude of thiacloprid residues during the processing of honey were not provided and are not requested as the total theoretical maximum daily intake (TMDI) is less than 10 % of the ADI. The investigation of nature and magnitude of thiacloprid residues in rotational crops and in livestock commodities is of no relevance. The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). In the framework of the Article 12 MRL review, a comprehensive long-term exposure assessment was performed for thiacloprid, taking into account the existing uses at the EU level and the acceptable CXLs. EFSA updated this risk assessment with the median residue levels (STMR) in honey derived from the field trials. The acute exposure assessment was performed only with regard to honey and taking into account the highest MRL proposal of 0.2 mg/kg. A long-term consumer intake concern was not identified for any of the European diets incorporated in the EFSA PRIMo. The highest chronic intake was estimated to be 33 % of the ADI (DE child), the contribution of residues in honey to the total consumer exposure representing less than 0.1 % of the ADI. An acute consumer risk was not identified in relation to the MRL proposals for honey as the highest acute intake was estimated to be 1 % of the ARfD. EFSA concludes that the setting of an MRL of 0.15 or 0.2 mg/kg for thiacloprid in honey will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a concern for public health. 3 EFSA Journal 2016;14(3):4418

4 Therefore, EFSA proposes risk managers to decide which of the three different approaches listed in the table below should be considered for the setting of an MRL in honey. Code (a) Commodity Existing EU MRL Proposed EU MRL Comment/Justification Enforcement residue definition: Thiacloprid (F) Honey and other apiculture products 0.05* 0.2 Field trials 0.2 Monitoring data, FAO spice approach (a): Commodity code number according to Annex I of Regulation (EC) No 396/2005 (*): indicates that the MRL is set at the limit of analytical quantification (LOQ) (F): fat soluble EMRL: extraneous maximum residue limit 0.15 Monitoring data, FAO EMRL approach (99.5th or 99th percentile) 4 EFSA Journal 2016;14(3):4418

5 Table of contents Abstract... 1 Summary... 3 Background... 6 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 Abbreviations Appendix A Good Agricultural Practice (GAPs) Appendix B Pesticide Residue Intake Model (PRIMo) Appendix C Thiacloprid residue levels observed in honey in the 2013 EU national monitoring programs Appendix D Used compound code EFSA Journal 2016;14(3):4418

6 Background Regulation (EC) No 396/ establishes the rules governing the setting of pesticide maximum residue levels (MRLs) at European Union (EU) level. Article 6 of the 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, 2 repealed by Regulation (EC) No 1107/2009, 3 shall submit to a Member State, when appropriate, an application to modify a MRL in accordance with the provisions of Article 7 of the Regulation. Germany, hereafter referred to as the evaluating Member State (EMS), compiled an application to modify the existing MRL for the active substance thiacloprid in honey. This application was notified to the European Commission and the European Food Safety Authority (EFSA) and was subsequently evaluated in accordance with Article 8 of the Regulation. After completion, the evaluation report was submitted to the European Commission and to EFSA on 7 July The application was included in the EFSA Register of Questions with the reference number EFSA-Q and the following subject: Thiacloprid - Modification of existing MRLs in honey (rape) Germany proposed to raise the existing MRL of thiacloprid in honey from the limit of quantification of 0.05 mg/kg to 0.2 mg/kg. EFSA proceeded with the assessment of the application and the evaluation report as required by Article 10 of the Regulation. In accordance with Article 10 of Regulation (EC) No 396/2005, EFSA shall, based on the evaluation report provided by the EMS, provide a reasoned opinion on the risks to the consumer associated with the application. In accordance with Article 11 of the 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 if more detailed evaluations need to be carried out) from the date of receipt of the application. If EFSA requests supplementary information, the time limit laid down shall be suspended until that information has been provided. The active substance and its use pattern Thiacloprid is the ISO common name for (Z)-3-(6-chloro-3-pyridylmethyl)-1,3-thiazolidin-2- ylidenecyanamide (IUPAC). The chemical structure of the active substance is reported in Appendix D. Thiacloprid belongs to the group of neonicotinoids, which are used as insecticides. Thiacloprid was evaluated in the framework of Directive 91/414/EEC with the United Kingdom designated as rapporteur Member State (RMS). It was included in Annex I of this Directive by Directive 2004/99/EC 4 which entered into force on 1 January In accordance with Regulation (EU) No 540/ thiacloprid is approved under Regulation (EC) No 1107/2009, repealing Council Directive 91/414/EEC. The representative uses supporting the Annex I inclusion were uses on various pome fruits, stone fruits, fruiting vegetables, cucurbits and ornamentals. The draft assessment report (DAR) was not peer reviewed by EFSA, therefore no EFSA conclusion is available. The EU MRLs for thiacloprid are established in Annex II of Regulation (EC) No 396/2005. Since the entry into force of this regulation, EFSA has issued a large number of reasoned opinions on the modification of MRLs. The proposals from these reasoned opinions have been considered in the 1 Regulation (EC) No 396/2005 of the 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 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 Directive 2004/99/EC of 1 October 2004 amending Council Directive 91/414/EEC to include acetamiprid and thiacloprid as active substances, OJ L 309, , p Commission Implementing Regulation (EU) No 540/2011 of 23 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 EFSA Journal 2016;14(3):4418

7 preparation of EU legislation. The review of the existing MRLs of thiacloprid according to Article 12 of Regulation (EC) No 396/2005 (here after Article 12 MRL review) is finalized and the MRL proposals have been implemented by Commission Regulation (EU) No 2015/ (EFSA, 2014). MRL changes that were reported in the EU legislation after the Article 12 review are summarised in Table 1. Table 1: Overview of the MRL changes after the Article MRL 12 review Procedure (a) Considered by Regulation Remarks Art. 12 (EFSA, 2014) (EU) 2015/1200 Review existing MRL Art. 10 (EFSA, 2015) Not yet implemented (SANTE/11195/2015) Jerusalem artichokes (a): Art. 10: Assessment of MRL application according to Article 6 to 10 of Regulation (EC) No 396/2005 Art. 12: Review of the existing MRLs according to Article 12 of Regulation (EC) No 396/2005 Codex Alimentarius has established maximum residue limits (CXL) for a wide range of commodities, but not for honey. The details of the northern GAP for thiacloprid on oilseed rape taken as reference by the EMS for the setting of an MRL in honey (see section ) are given in Appendix A. Assessment EFSA bases its assessment on the evaluation report submitted by the EMS (Germany, 2015), the DAR prepared under Directive 91/414/EEC (United Kingdom, 2000), the Commission review report on thiacloprid (European Commission, 2004) and the conclusions from EFSA opinion on the review of the existing MRLs for thiacloprid according to Article 12 of Regulation (EC) No 396/2005 (EFSA, 2014). 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 (European Commission, 1996, 1997a g, 2000, 2010a, b, 2011; FAO, 2009; OECD, 2011). In addition, since the control of thiacloprid residues in honey was included in the national monitoring programs by several Member States in 2013, these data were considered by EFSA in order to propose alternative MRL values for thiacloprid in honey. 1. Method of analysis 1.1. Methods for enforcement of residues in food of plant origin During the peer review under Directive 91/414/EEC, an analytical method and its ILV using HPLC-UV detection were evaluated and concluded to be sufficiently validated for the determination of thiacloprid in high water (apple) and high oil (cotton) matrices with an LOQ of 0.02 mg/kg (United Kingdom, 2000). A HPLC-MS/MS method reported in JMPR evaluation was validated for the determination of thiacloprid with an LOQ of 0.02 mg/kg in high water (tomato), high acid (strawberry) and dry/starch (cereal grains) matrices (FAO, 2006). However, a confirmatory method and an ILV are missing. The multi-residue QuEChERS method in combination with HPLC-MS/MS, as described by CEN (2008), is also reported for analysis of thiacloprid only with an LOQ of 0.01 mg/kg in high water, high acid and dry commodities (EURL, 2013). According to the EMS, this QuEChERS method is validated to analyse thiacloprid in sugar containing matrices such as honey (Germany, 2015). 6 Commission Regulation (EU) 2015/1200 of 22 July 2015 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 amidosulfuron, fenhexamid, kresoxim-methyl, thiacloprid and trifloxystrobin in or on certain products 7 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 2016;14(3):4418

8 Therefore, EFSA concludes that enforcement methods are available to control residues of thiacloprid in honey Methods for enforcement of residues in food of animal origin Honey, although produced by bees, from analytical point of view is considered as a plant commodity with high sugar content. Thus the availability of analytical enforcement methods for the determination of thiacloprid in animal commodities was not further investigated in the framework of this application. 2. Mammalian toxicology The toxicological profile of thiacloprid was assessed in the framework of the peer review under Directive 91/414/EEC (European Commission, 2004). The data were sufficient to derive toxicological reference values compiled in Table 2. Table 2: Overview of the toxicological reference values Source Year Value Study Safety factor Thiacloprid ADI EC mg/kg bw per day 2 years, rat 100 ARfD EC mg/kg bw Acute neurotoxicity study in rats Residues 3.1. Nature and magnitude of residues in plant Primary crops Nature of residues During the peer review, the metabolism of thiacloprid was investigated by foliar and soil applications on the fruit (apple, tomato) and pulses/oilseeds (cotton) crop groups (United Kingdom, 2000). An additional study on the cereal/grass crop group using foliar application on wheat was evaluated by the RMS after Annex I inclusion and by the JMPR (FAO, 2006). In all studies, thiacloprid was radiolabelled on methylene position. The characteristics of these studies are summarised in Table 3. Table 3: Summary of the available metabolism studies Group Crop Application Sampling (DAT) (a) Remarks Fruit Apple Foliar: 2x 270 g/ha Fruits: 14 Tomato Foliar: 2x 260 g/ha Fruits: 3, 14 Soil: 2x 130 g/ha Fruits: 3, 14 Pulses/oilseeds Cotton Foliar: 3x 190 g/ha Leaves, seeds: 120 Cereal/Grass Wheat Foliar: 2x 50 g/ha Grain & straw: 21 (FAO, 2006) (a): DAT; days after treatment Based on the available studies, the Article 12 MRL review confirmed the residue definition for enforcement and risk assessment as parent thiacloprid (EFSA, 2014). The current residue definition set in Regulation (EC) No 396/2005 is identical to the residue definition for enforcement derived during the peer review. It should be highlighted that specific residue definitions have not been established for honey as studies on the nature of the residues in honey are not available. Since honey is made mainly from nectar partially modified by hydrolysing enzymes from bees, EFSA proposes to apply to honey the residue definition set for plants. 8 EFSA Journal 2016;14(3):4418

9 Magnitude of residues The EMS proposes to derive the MRL for honey from field trials conducted in 2006 and 2007 in Germany, where honey was collected in hives positioned close to rapeseed fields treated with thiacloprid. In addition, since monitoring data from EU national control programs conducted by several Member States in 2013 were available, EFSA derived alternative MRL values for thiacloprid in honey taking into account these data and the approaches recommended by the Food and Agriculture Organization (FAO, 2009). MRL proposal derived from field trials conducted on rapeseed Eight trials conducted during the growing seasons 2006 and 2007 in four locations in Germany were submitted. Thiacloprid was applied on rapeseed once or twice at a rate of 72 g/ha on plots with surfaces in the range of 1.5 ha to 100 ha. The application rate of 72 g/ha was driven by the GAP authorised in Germany on rapeseed (see Appendix A). The last application took place during the full bloom, from BBCH stage 61/63 to 65 (10%/30% to 50% flowers open). Bee hives were placed close to the treated plots ca. 10 days before the last application, except in two situations where hives were positioned far before treatment, during winter and one situation where hives were placed the day after application. Experimental designs are summarised in Table 4. Multiple samples of honey (3 to 6) were collected 16 to 29 days after the last application and analysed for thiacloprid. In each location, the mean value was selected for MRL calculation. Table 4: Summary of the experimental designs and residue levels in honey Location Treatment (a) g/ha BBCH stages dates T1&2 T1 T1/2 T1 T1/2 Hives installation Honey harvest date DAT (day) Plot size (ha) mean level Burscheid /05/06 05/05/06 27/05/ Martfeld /05/06 01/05/06 03/06/ Lensahn /05/06 winter 18/06/ <0.005 Lehrte /05/06 02/05/06 02/06/ Burscheid /04/07 11/04/07 02/04/07 10/05/ Lehrte /03/07 22/04/07-13/05/ Martfeld /04/07 14/04/07 winter 13/05/ Lehnsahn /04/07 30/04/07 01/05/07 25/05/ (a): T1; 1st Treatment T1/2: 1st or 2nd treatment The results indicate no clear relationship between plot size and residue concentration in honey and the largest plot treated (100 ha) resulted in no detected residues in honey. The study holder was asked to provide additional information, but no clear explanation was given and it was suggested that low residues concentrations could have been due to a dilution of honey as bees could have been foraging other melliferous crops in the vicinity of the hives. Based on these data and using the OECD MRL calculator (OECD, 2011), an MRL of 0.2 mg/kg is proposed for thiacloprid in honey (MRL OECD : 0.18/0.2) with a median (STMR) and highest (HR) residue values of 0.06 and 0.08 mg/kg respectively. However, this MRL proposal is driven by various uncertainties: - Relevant information on the experimental designs was missing and has not been provided (e.g. general overview of the experimental sites, information on the surrounding crops ), - Pollen analyses have not performed, to confirm whether the sampled honey results effectively from the foraging on rapeseed, - The 2006 experiments were conducted with a single application and not according to the critical GAP defined for rapeseed with a total of 2 treatments, - The metabolism and detoxification pathways of thiacloprid in bees has not been investigated. 9 EFSA Journal 2016;14(3):4418

10 Moreover, there is no approved guidance available at EU level for the setting of maximum residue limits in honey and therefore, it cannot be concluded whether the experimental conditions (plot size, application full bloom ) are fully appropriate for the setting of MRL in honey. MRL proposal considering the EU national monitoring program EFSA has extracted from the EFSA pesticide residue monitoring database the thiacloprid residue levels observed in honey in the 2013 national monitoring programs conducted in Austria, Cyprus, Germany, Greece, France, Hungary, Ireland, Latvia and Slovakia. In 2013, a total of 667 samples were analysed for thiacloprid, of which 562 from EU origin (84%), 33 (5%) from third countries and 72 (11%) from unknown origin. The vast majority of the EU samples (86%) originated from three Member States; Germany, Hungary and Austria as summarised in Table 5. Table 5: Member State EU sample origins Samples Samples Member State Number (%) Number (%) Germany (DE) Spain (ES) 6 1 Hungary (HU) Latvia (LV) 5 1 Austria (AT) Czech Rep. (CZ) 4 France (FR) 22 4 Romania (RO) 3 Ireland (IE) 12 2 Bulgaria (BG) 2 Cyprus (CY) 10 2 Poland (PL) 1 Greece (EL) 10 2 Belgium (BE) 1 Italy (IT) 6 1 Estonia (EE) 1 2 Considering all sample origins (EU, third countries and unknown), thiacloprid residues were detected in 16% of the honey samples. At EU level thiacloprid residues were present in 94 samples out 562 (17%) in the range of to mg/kg. It is highlighted that thiacloprid was detected in 8 samples out of 36 (22%), claimed to be from organic production. Overview of the number of samples with residues above the limit of quantification is given in Table 6. Individual residue values observed in the samples from EU origin are reported in Appendix C. Table 6: Origin Number of samples with residues above the LOQ and lowest and highest values Total samples Samples >LOQ Residues Number % min. max. EU (organic) EU (conventional) Total EU Third countries (a) Unknown Total (overall) (a): Third countries; Turkey (5), Bosnia (1), USA (1), El Salvador (1), Guatemala (2), Mexico (8), Brazil (2), Chile (1), Argentina (1), New Zealand (1), China (1), unknown (9) Based on these monitoring data and considering the residue levels observed in the samples from EU origin only (562 samples) EFSA derived MRL proposals for honey taking into account the two following methodologies proposed by FAO in its Plant production and Protection Paper 197 (FAO, 2009): - FAO spice approach: The MRL is derived from the calculation of the upper 95th confidence limit for the 95th percentile, considering the samples with detectable residues only. A minimum of values is recommended EFSA Journal 2016;14(3):4418

11 - FAO extraneous MRL (EMRL) approach: This approach refers to the chemicals which have been widely used as pesticides, are persistent in the environment for relatively long periods after use has been discontinued and are expected to occur in foods or feeds at levels of sufficient concern to warrant monitoring (FAO, 2009). Since there is no internationally agreed level of acceptable violation rate, specific percentiles are not recommended by JMPR, but it is reported that violation rates of 0.5 to 1% or greater are generally unacceptable. Therefore and based on the entire dataset including values below the LOQs, EFSA derived MRL proposals corresponding to violation rates of 0.5 and 1% (99.5th and 99th percentile respectively). The MRL proposals derived from these two FAO approaches are summarised in Table 7. Table 7: MRL estimations for thiacloprid in honey FAO approach for the setting of MRL in spices Number of samples LOQs 94 Highest residue level mg/kg Lowest residue level mg/kg 95th percentile mg/kg (Rank: 89.3) Upper confidence interval mg/kg (Rank: 93.4) MRL proposal (rounded) 0.2 mg/kg FAO approach for the setting of EMRLs Number of samples 562 Highest residue level mg/kg Lowest residue level <0.001 mg/kg Median residue level (STMR) mg/kg EMRL at 99.5th percentile mg/kg (Rank: EMRL at 99th percentile mg/kg (Rank: 556.4) MRL proposal (rounded) 0.15 mg/kg EMRL at 97.5th percentile mg/kg (Rank: 548.0) EMRL at 95th percentile mg/kg (Rank: 533.9) The storage stability of thiacloprid has been demonstrated for a period of 18 months at -18 C in high water commodities and for a period of 24 months at -20 C in high acid, high oil content matrices as well as in dry commodities (EFSA, 2014). No particular storage stability studies are available for honey. Given the demonstrated stability of thiacloprid over 24 months in the investigated plant matrices and since honey samples from the field trials were stored frozen for a maximum of 2.5 months prior to analysis, EFSA agrees with the EMS proposal to concluded that the residue data are valid with regard to storage stability According to the EMS, the analytical methods used to analyse the residue trial samples have been sufficiently validated and were proven to be fit for the purpose (Germany, 2015). Finally, since no agreed guidance document is currently available at EU level and since it cannot be concluded whether the field trial conditions were fully appropriate for the setting of an MRL in honey, EFSA proposes risk managers to decide which of the three different approaches should be considered for the implementation of an MRL value for honey in the EU legislation: 0.2 mg/kg 0.2 mg/kg 0.15 mg/kg Field trials (OECD calculator) Monitoring data (Spice approach, upper 95th confidence limit, 95th percentile) Monitoring data (EMRL approach, 99.5th and 99th percentile) It is highlighted that all approaches lead to comparable values. Taking into account the entire dataset including samples from EU, third countries and unknown origin, only one value out of 667 exceed the MRL proposals of 0.15 or 0.2 mg/kg (violation rate <0.2%) EFSA Journal 2016;14(3):4418

12 Effect of industrial processing and/or household preparation Standard hydrolysis studies simulating the effect on the nature of thiacloprid residues under processing conditions representative of pasteurisation, boiling and sterilisation were assessed in the conclusion of the peer review (United Kingdom, 2000) and it was concluded that the compound is hydrolytically stable under the representative conditions. Thus, for processed commodities, the same residue definition as for raw agricultural commodities (RAC) is applicable. Specific studies to assess the magnitude of thiacloprid residues during the processing of honey are not necessary as the total theoretical maximum daily intake (TMDI) amounts to less than 10 % of the ADI (European Commission, 1997d) Rotational crops The investigation of nature and magnitude of thiacloprid residues in rotational crops is of no relevance for the MRL application on setting the maximum residue levels of thiacloprid in honey Nature and magnitude of residues in livestock Honey is not a livestock feeding item and the nature and magnitude of thiacloprid residues in livestock was therefore not assessed in the framework of this application. 4. Consumer risk assessment The consumer risk assessment was performed with revision 2 of the EFSA Pesticide Residues Intake Model (PRIMo). This exposure assessment model contains the relevant European food consumption data for different sub-groups of the EU population 8 (EFSA, 2007). In the framework of the review of the existing MRLs for thiacloprid according to Article 12 of Regulation (EC) No 396/2005, a comprehensive long-term exposure assessment was performed taking into account the existing uses at the EU level and the acceptable CXLs (EFSA, 2014). EFSA updated this risk assessment with the median residue levels (STMR) derived from the trials conducted for the determination of residues in honey (see Section ). Additionally, a new MRL proposal for Jerusalem artichokes (EFSA, 2015) was considered in the exposure assessment, although the regulation enforcing this MRL has not been adopted yet. The food commodities for which no uses were reported in the framework of the Article 12 review, were excluded from the exposure calculation, assuming that there is no use of thiacloprid on these crops. The acute exposure assessment was performed only with regard to honey, assuming the consumption of a large portion of the food item as reported in the national food surveys and taking into account the highest MRL proposal of 0.2 mg/kg derived for honey. The input values used for the dietary exposure calculation are summarised in Table 8. The estimated exposure was then compared with the toxicological reference values derived for thiacloprid (see Table 2). The results of the intake calculation are presented in Appendix B of this reasoned opinion. 8 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 2016;14(3):4418

13 Table 8: Input values for the consumer dietary exposure assessment Commodity Input Chronic exposure assessment Comment Acute exposure assessment Input Comment Risk assessment residue definition: Thiacloprid Honey 0.06 STMR (see Section ) 0.2 Highest MRL proposal Jerusalem artichokes 0.01 STMR (EFSA, 2015) Acute risk assessment undertaken Other plant and STMR Table 4-3 in reasoned opinion on only with regard to honey animal commodities Article 12 MRL review (EFSA, 2014) A long-term consumer intake concern was not identified for any of the European diets incorporated in the EFSA PRIMo. The highest estimated chronic intake accounted for 33 % of the ADI (DE child), the contribution of residues in honey to the total consumer exposure representing less than 0.1 % of the ADI. An acute consumer risk was not identified in relation to the MRL proposals for honey, the highest acute intake for honey was calculated to be 1 % of the ARfD (DE Child). EFSA concludes that setting of an MRL of 0.15 or 0.2 mg/kg in honey will not result in a consumer exposure exceeding the toxicological reference values and therefore is unlikely to pose a concern for public health. Conclusions and recommendations EFSA proposes risk managers to decide which of the three different approaches listed in the table below should be considered for the setting of an MRL in honey. Code (a) Commodity Existing EU MRL Proposed EU MRL Comment/Justification Enforcement residue definition: Thiacloprid (F) Honey and other apiculture products 0.05* 0.2 Field trials 0.2 Monitoring data, FAO spice approach (a): Commodity code number according to Annex I of Regulation (EC) No 396/2005 (*): indicates that the MRL is set at the limit of analytical quantification (LOQ) (F): fat soluble EMRL: extraneous maximum residue limit 0.15 Monitoring data, FAO EMRL approach (99.5th or 99th percentile) 13 EFSA Journal 2016;14(3):4418

14 References Anastassiades M, Lehotay SJ, Stajnbaher D and Schenck FJ, Fast and Easy Mutliresidue Method Employing Acetonitrile Extraction/Partitioning and Dispersive Solid-Phase Extraction for the Determination of Pesticide Residues in Produce. Journal of AOAC International, 86, 22, CEN (European Committee for Standardization), Foods of plant origin Determination of pesticide residues using GC-MS and/or LC-MS/MS following acetonitrile extraction/partitioning and clean-up by dispersive SPE. QuEChERS-method. EN November EFSA (European Food Safety Authority), Reasoned opinion on the potential chronic and acute risk to consumers health arising from proposed temporary EU MRLs. The EFSA Journal 2007, 32r, doi: /j.efsa r EFSA (European Food Safety Authority), Reasoned opinion on the review of the existing maximum residue levels (MRLs) for thiacloprid according to Article 12 of Regulation (EC) No 396/2005. EFSA Journal 2014;12(3):3617, 111 pp, doi: /j.efsa EFSA (European Food Safety Authority), Reasoned opinion on the modification of the existing maximum residue level for thiacloprid in Jerusalem artichokes. EFSA Journal 2015;13(7):4191, 18 pp, doi: /j.efsa European Commission, Appendix G. Livestock Feeding Studies. 7031/VI/95-rev.4. European Commission, 1997a. Appendix A. Metabolism and distribution in plants. 7028/IV/95-rev.3. 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. European Commission, 1997c. Appendix C. Testing of plant protection products in rotational crops. 7524/VI/95-rev.2. European Commission, 1997d. Appendix E. Processing studies. 7035/VI/95-rev.5. European Commission, 1997e. Appendix F. Metabolism and distribution in domestic animals. 7030/VI/95-rev.3. European Commission, 1997f. Appendix H. Storage stability of residue samples. 7032/VI/95-rev.5. European Commission, 1997g. Appendix I. Calculation of maximum residue level and safety intervals. 7039/VI/95. 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. European Commission, Review report for the active substance thiacloprid. Finalised in the Standing Committee on the Food Chain and Animal Health at its meeting on 29 June 2004 in view of the inclusion of thiacloprid in Annex I of Council Directive 91/414/EEC. SANCO/4347/2000 Final, 13 May 2004, 63 pp. 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 European Commission, 2010b. Residue analytical methods. For post-registration control. SANCO/825/00-rev.8.1. European Commission, Appendix D. Guidelines on comparability, extrapolation, group tolerances and data requirements for setting MRLs. 7525/VI/95-rev.9. FAO, (Food and Agriculture Organization of the United Nations), Thiacloprid. 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 Core Expert Group on Pesticide Residues. Residues. FAO Plant Production and Protection Paper 187, EFSA Journal 2016;14(3):4418

15 FAO (Food and Agriculture Organization of the United Nations), Submission and evaluation of pesticide residues data for the estimation of Maximum Residue Levels in food and feed. Pesticide Residues. 2 nd Ed. FAO Plant Production and Protection Paper 197, 264 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 online: Germany, Evaluation report on the modification of MRL for thiacloprid in honey prepared by the evaluating Member State Germany under Article 8 of Regulation (EC) No 396/2005, 1 June 2015, 14 pp. United Kingdom, Draft assessment report on the active substance thiacloprid prepared by the rapporteur Member State United Kingdom in the framework of Council Directive 91/414/EEC, November EFSA Journal 2016;14(3):4418

16 Abbreviations ADI ARfD BBCH bw CEN CXL DAR EMRL EMS EURL FAO GAP GCPF HPLC HR ISO IUPAC JMPR LOQ MRL MS/MS MW NEU OD OECD PHI PRIMo QuEChERS RAC RMS SCPAFF STMR TMDI UV WHO acceptable daily intake acute reference dose growth stages of mono- and dicotyledonous plants body weight European Committee for Standardization (Comité Européen de Normalisation) Codex maximum residue limit (Codex MRL) draft assessment report extraneous maximum residue limit evaluating Member State EU Reference Laboratory (former Community Reference Laboratory (CRL)) Food and Agriculture Organization of the United Nations good agricultural practice Global Crop Protection Federation (formerly: International Group of National Associations of Manufacturers of Agrochemical Products (GIFAP)) high performance liquid chromatography highest residue International Organisation for Standardization International Union of Pure and Applied Chemistry Joint FAO/WHO Meeting on Pesticide Residues limit of quantification maximum residue level tandem mass spectrometry detector molecular weight northern Europe oil dispersion Organisation for Economic Co-operation and Development pre-harvest interval (EFSA) Pesticide Residues Intake Model Quick, Easy, Cheap, Effective, Rugged, and Safe (analytical method) raw agricultural commodity rapporteur Member State Standing Committee on Plants, Animals, Food and Feed (formerly: Standing Committee on the Food Chain and Animal Health; SCFCAH) supervised trials median residue theoretical maximum daily intake ultra-violet (detector) World Health Organization 16 EFSA Journal 2016;14(3):4418

17 Appendix A Good Agricultural Practice (GAPs) Crop and/or situation (a) MS or NEU/SEU or Country F G or I (b) Pest or group of pests controlled (c) Formulation Application Application rate per treatment type (d-f) conc. a.s. (i) Method kind (f-h) Growth stage & season (j) Number min-max (k) Interval minmax g/hl min-max Water L/ha min-max g/ha min-max PHI (days) (l) Remarks (m) Oilseed rape NEU (DE) F Sucking and biting insect pests OD 240 g/l Spray At infestation days Remarks: (a) For crops, EU or other classifications, e.g. Codex, should be used; where relevant, the usage situation should be described (e.g. fumigation of a structure) (b) Outdoor or field use (F), glasshouse application (G) or indoor application (I) (c) e.g. biting and sucking insects, soil-born insects, foliar fungi, weeds (d) e.g. wettable powder (WP), water soluble granule (WG) (e) GCPF Codes - GIFAP Technical Monograph No 2, 1989 (f) all abbreviations must be explained (g) Method, e.g. high volume spraying, low volume spraying, spreading, dusting, drench (h) Kind, e.g. overall, broadcast, aerial spraying, row, individual plant, between the plants. type of equipment used must be indicated (i) (j) (k) (l) (m) g/kg or µg/l Growth stage at last treatment (Meier U, Growth Stages of mono- and dicotyledonous plants. BBCH Monograph, 2nd Ed., Federal Biological Research Centre of Agriculture and Forestry, Braunschweig, Germany, 2001), including where relevant, information on season at time of application The minimum and maximum number of application possible under practical conditions of use must be provided PHI - minimum pre-harvest interval Remarks may include: Extent of use/economic importance/restrictions 17 EFSA Journal 2016;14(3):4418

18 Appendix B Pesticide Residue Intake Model (PRIMo) Thiachloprid Status of the active substance: Included Code no. LOQ (mg/kg bw): 0,02 proposed LOQ: 0,02 Toxicological end points ADI (mg/kg bw/day): 0,01 ARfD (mg/kg bw): 0,03 Source of ADI: COM Source of ARfD: COM Year of evaluation: 2004 Year of evaluation: 2004 Prepare workbook for refined calculations Undo refined calculations Chronic risk assessment - refined calculations TMDI (range) in % of ADI minimum - maximum 5 33 No of diets exceeding ADI: --- Highest calculated TMDI values in % of ADI MS Diet Highest contributor to MS diet (in % of ADI) Commodity / group of commodities 2nd contributor to MS diet (in % of ADI) Commodity / group of commodities 3rd contributor to MS diet (in % of ADI) Commodity / group of commodities ptmrls at LOQ (in % of ADI) 33 DE child 12,1 Apples 5,9 Herbal infusions (dried) 4,3 Milk and cream, 1,3 29 WHO Cluster diet B 9,8 Olives for oil production 4,5 Tomatoes 2,1 Wheat 1,9 25 NL child 8,8 Milk and cream, 6,3 Apples 1,2 Wheat 1,8 23 FR toddler 11,9 Milk and cream, 2,6 Apples 1,7 Strawberries 1,5 21 UK Infant 11,6 Milk and cream, 2,0 Sugar beet (root) 1,6 Apples 3,2 18 UK Toddler 6,2 Milk and cream, 4,6 Sugar beet (root) 1,7 Apples 5,7 16 FR infant 7,7 Milk and cream, 2,5 Apples 1,3 Strawberries 1,3 15 IE adult 2,5 Tea (dried leaves and stalks, 0,8 Milk and cream, 0,8 Apples 1,6 15 ES child 3,8 Milk and cream, 3,7 Olives for oil production 1,4 Tomatoes 0,6 15 DK child 3,8 Milk and cream, 2,3 Apples 2,3 Cucumbers 1,6 12 SE general population 90th percentile 3,7 Milk and cream, 1,1 Tomatoes 1,1 Apples 1,3 12 WHO regional European diet 1,6 Tomatoes 1,4 Milk and cream, 0,8 Potatoes 1,2 11 WHO cluster diet E 1,0 Wheat 0,9 Milk and cream, 0,9 Olives for oil production 1,6 11 WHO cluster diet D 1,6 Wheat 1,5 Milk and cream, 1,5 Tomatoes 1,4 10 ES adult 2,2 Olives for oil production 1,5 Milk and cream, 1,1 Tomatoes 0,4 9 PT General population 1,3 Olives for oil production 1,3 Tomatoes 1,1 Potatoes 1,9 8 WHO Cluster diet F 1,2 Milk and cream, 1,0 Tomatoes 0,9 Wheat 1,2 8 NL general 2,0 Milk and cream, 1,2 Apples 0,6 Tomatoes 1,0 8 IT kids/toddler 2,1 Tomatoes 1,7 Wheat 0,9 Apples 0,3 7 FR all population 1,0 Olives for oil production 0,8 Wheat 0,8 Milk and cream, 1,2 7 IT adult 1,7 Tomatoes 1,0 Wheat 0,8 Apples 0,2 7 UK vegetarian 1,0 Milk and cream, 0,9 Tea (dried leaves and stalks, 0,9 Tomatoes 1,4 7 LT adult 1,9 Apples 1,2 Milk and cream, 0,9 Tomatoes 1,0 6 DK adult 1,6 Milk and cream, 0,8 Apples 0,6 Tomatoes 0,8 6 UK Adult 1,0 Tea (dried leaves and stalks, 0,9 Milk and cream, 0,8 Sugar beet (root) 1,4 6 PL general population 2,0 Apples 1,3 Tomatoes 0,7 Potatoes 0,9 5 FI adult 1,7 Milk and cream, 0,6 Tomatoes 0,4 Apples 0,5 Conclusion: The estimated Theoretical Maximum Daily Intakes (TMDI), based on ptmrls were below the ADI. A long-term intake of residues of Thiachloprid is unlikely to present a public health concern EFSA Journal 2016;14(3):4418

19 Processed commodities Unprocessed commodities Modification of the existing maximum residue level for thiacloprid in honey Acute risk assessment /children - refined calculations Acute risk assessment / adults / general population - refined calculations The acute risk assessment is based on the ARfD. For each commodity the calculation is based on the highest reported MS consumption per kg bw and the corresponding unit weight from the MS with the critical consumption. If no data on the unit weight was available from that MS an average European unit weight was used for the IESTI calculation. In the IESTI 1 calculation, the variability factors were 10, 7 or 5 (according to JMPR manual 2002), for lettuce a variability factor of 5 was used. In the IESTI 2 calculations, the variability factors of 10 and 7 were replaced by 5. For lettuce the calculation was performed with a variabilty factor of 3. Threshold MRL is the calculated residue level which would leads to an exposure equivalent to 100 % of the ARfD. No of commodities for which ARfD/ADI is exceeded (IESTI 1): No of commodities for which No of commodities for which No of commodities for which ARfD/ADI is --- ARfD/ADI is exceeded (IESTI 2): --- ARfD/ADI is exceeded (IESTI 1): --- exceeded (IESTI 2): --- IESTI 1 *) **) IESTI 2 *) **) IESTI 1 *) **) IESTI 2 *) **) Highest % of ARfD/ADI Commodities ptmrl/ threshold MRL Highest % of ARfD/ADI Commodities ptmrl/ threshold MRL Highest % of ARfD/ADI Commodities ptmrl/ threshold MRL Highest % of ARfD/ADI Commodities ptmrl/ threshold MRL 1 Honey 0,2 / - 1 Honey 0,2 / - 0,4 Honey 0,2 / - 0,4 Honey 0,2 / - No of critical MRLs (IESTI 1) --- No of critical MRLs (IESTI 2) --- No of commodities for which ARfD/ADI is exceeded: Highest % of ARfD/ADI Processed commodities No of commodities for which --- ARfD/ADI is exceeded: --- ***) ***) ptmrl/ ptmrl/ threshold MRL Highest % of Processed threshold MRL ARfD/ADI commodities *) The results of the IESTI calculations are reported for at least 5 commodities. If the ARfD is exceeded for more than 5 commodities, all IESTI values > 90% of ARfD are reported. **) ptmrl: provisional temporary MRL ***) ptmrl: provisional temporary MRL for unprocessed commodity Conclusion: For Thiachloprid IESTI 1 and IESTI 2 were calculated for food commodities for which ptmrls were submitted and for which consumption data are available. No exceedance of the ARfD/ADI was identified for any unprocessed commodity. For processed commodities, no exceedance of the ARfD/ADI was identified EFSA Journal 2016;14(3):4418

20 Appendix C Thiacloprid residue levels observed in honey in the 2013 EU national monitoring programs. Thiacloprid residues in honey and Member state (MS) (a) MS mg/kg MS mg/kg MS mg/kg MS mg/kg AT DE DE DE AT DE DE DE AT DE DE LV AT DE DE LV AT DE DE DE AT DE DE DE DE DE DE AT AT DE DE AT 1x <0.040 AT DE CZ AT 8x <0.020 DE DE DE AT 36x <0.010 DE DE DE CY 10x <0.010 DE AT DE BE 1x <0.010 DE AT DE BG 1x <0.010 AT DE DE CZ 2x <0.010 DE DE DE DE 231x <0.010 DE AT DE DE 38x <0.005 AT DE DE EE 1x <0.005 DE DE DE ES 6x <0.005 DE BG AT EL 10x <0.005 DE CZ AT HU 52x <0.005 DE DE DE FR 21x <0.005 DE DE DE FR 1x <0.001 DE DE DE DE 3x <0.001 AT DE DE HU 21x <0.001 AT DE DE IE 12x <0.001 AT DE DE IT 6x <0.001 DE DE DE LV 3x <0.001 DE AT DE PL 1x <0.001 DE DE DE RO 3x <0.001 (a) : Underlined values : thiacloprid residue level in organic honey 20 EFSA Journal 2016;14(3):4418