EFSA 2008 Annual report on pesticide residues - PAN Europe

EFSA 2008 Annual report on pesticide residues - PAN Europe EFSA 2008 Annual report on pesticide residues - PAN Europe

12.07.2015 Views

<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesThe total number of samples taken in the c<strong>on</strong>text of the nati<strong>on</strong>al programmes in <str<strong>on</strong>g>2008</str<strong>on</strong>g> was 70,143 4 .This includes 67,887 surveillance samples and 2,256 enforcement samples. Compared with theprevious year, this is a decrease by 5.9 %.Nati<strong>on</strong>al programmes cover samples originating from nati<strong>on</strong>al, Community and third countryproducti<strong>on</strong>. The majority of samples taken were produced in <strong>on</strong>e of the <strong>Europe</strong>an <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries(77%), while 20% of the samples were taken from imported c<strong>on</strong>signments or lots. For 3 % of thesamples the origin was not <str<strong>on</strong>g>report</str<strong>on</strong>g>ed. Approximately 200 different unprocessed food commodities wereanalysed for <strong>pesticide</strong> <strong>residues</strong> by all <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries.In <str<strong>on</strong>g>2008</str<strong>on</strong>g> the number of <strong>pesticide</strong>s sought by each country varied from 39 to 679. The total number ofsubstances covered by all <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries was 862.In total, <strong>residues</strong> of 365 different <strong>pesticide</strong>s were found in measurable quantities in fruit andvegetables, while in cereals <strong>residues</strong> of 76 different <strong>pesticide</strong>s were observed. As in previous years, thenumber of different <strong>pesticide</strong> <strong>residues</strong> found in fruit and vegetables in <str<strong>on</strong>g>2008</str<strong>on</strong>g> was higher than thenumber of <strong>pesticide</strong>s found in cereals, which also reflects the greater number of products used in thefruit and vegetables category.96.5% of the surveillance samples analysed were below the legally permitted limits, while 3.5% of thesamples exceeded the MRLs. The overall <str<strong>on</strong>g>report</str<strong>on</strong>g>ed MRL exceedance rate (3.5%) is lower than in theprevious year where 4.2% of the samples were found to exceed the MRLs.A higher incidence of MRL exceedances was also observed in samples imported from third countries(7.6%) than from EU (2.4%).A significantly higher MRL exceedance rate was observed for enforcement samples (10.3%)compared to surveillance samples (3.5%). The former are taken when there are suspici<strong>on</strong>s about thesafety of a product and as a follow-up of violati<strong>on</strong>s found previously.For baby food, the <strong>Europe</strong>an legislati<strong>on</strong> is more restrictive than for other food categories as no morethan 0.01 mg/kg of any single <strong>pesticide</strong> residue is permitted in baby food samples. In <str<strong>on</strong>g>2008</str<strong>on</strong>g>, a total of2,062 surveillance samples of baby food were <str<strong>on</strong>g>report</str<strong>on</strong>g>ed by 25 countries. Quantifiable <strong>residues</strong> abovethe <str<strong>on</strong>g>report</str<strong>on</strong>g>ing level were found in 76 samples, while the MRLs were exceeded <strong>on</strong>ly in 4 samples(0.2%).At EU level no specific MRLs for organic products are established, i.e. the MRLs established forc<strong>on</strong>venti<strong>on</strong>ally produced products apply. In <str<strong>on</strong>g>2008</str<strong>on</strong>g>, the results of a total of 3,131 samples of organicorigin were <str<strong>on</strong>g>report</str<strong>on</strong>g>ed by 22 countries. For organic fruit and vegetables, a lower rate of MRLexceedances (0.9%) in comparis<strong>on</strong> to c<strong>on</strong>venti<strong>on</strong>ally grown fruit and vegetables (3.7%) was found. Itshould be menti<strong>on</strong>ed that EU legislati<strong>on</strong> allows the use of certain active substances in organic foodproducti<strong>on</strong>.C<strong>on</strong>sidering the results of both the nati<strong>on</strong>al and the EU coordinated programmes (includingenforcement samples), the percentage of samples of fruits, vegetables and cereals with multiple<strong>residues</strong> (i.e. single samples which c<strong>on</strong>tain <strong>residues</strong> of more than <strong>on</strong>e <strong>pesticide</strong>) has increased over thetime, from 15% in 1997 to 26% in 2007. In <str<strong>on</strong>g>2008</str<strong>on</strong>g>, <strong>residues</strong> of two or more <strong>pesticide</strong>s were found in27% of the analysed samples of fruits, vegetables and cereals. The highest number of different<strong>pesticide</strong>s in a single sample was 26 in <str<strong>on</strong>g>2008</str<strong>on</strong>g> and was recorded for a table grape sample. Multiple4 This figure also comprises the number of samples taken for the EU coordinated programme since these samples in manycountries were analysed for a wider range of active substances than defined in the coordinated programme and aretherefore bel<strong>on</strong>ging to both programmes, the nati<strong>on</strong>al and the EU coordinated programme.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):16463


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues<strong>residues</strong> in <strong>on</strong>e sample can result from the applicati<strong>on</strong> of different types of <strong>pesticide</strong>s (e.g. insecticides,fungicides and herbicides) to protect the crop against different pests, diseases or other threats havingan impact <strong>on</strong> the quality or yield of crops, from mixing of lots with different treatments,c<strong>on</strong>taminati<strong>on</strong>s, but also from practices which do not respect the principles of good plant protecti<strong>on</strong>practice.The results of the m<strong>on</strong>itoring were used to perform exposure assessments. However, this exercisewas impeded by the fact that aggregated results, rather than results at single chemical determinati<strong>on</strong>level, were provided to <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>. This lack of informati<strong>on</strong> was bridged by introducing c<strong>on</strong>servativeassumpti<strong>on</strong>s in the exposure modelling which bias the results by overestimating the actual c<strong>on</strong>sumerexposure. In order to improve the accuracy of the actual c<strong>on</strong>sumer exposure calculati<strong>on</strong>s with 2009m<strong>on</strong>itoring data, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> has developed and tested a new <strong>pesticide</strong> m<strong>on</strong>itoring <str<strong>on</strong>g>report</str<strong>on</strong>g>ing format.The l<strong>on</strong>g-term exposure assessment was based <strong>on</strong> the residue findings for the food commodities whichare the major c<strong>on</strong>stituents of the human diet. The calculati<strong>on</strong>s dem<strong>on</strong>strated for all except <strong>on</strong>e<strong>pesticide</strong> that even under c<strong>on</strong>servative assumpti<strong>on</strong>s the chr<strong>on</strong>ic (l<strong>on</strong>g-term) exposure does notexceed the toxicologically acceptable limits. For diazin<strong>on</strong> a potential c<strong>on</strong>sumer health risk could notbe excluded in the first tier risk assessment. However, after having performed a more refinedcalculati<strong>on</strong>, taking into account that <strong>residues</strong> are lower in food commodities that are c<strong>on</strong>sumed afterprocessing (i.e. apple juice), <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> c<strong>on</strong>cluded that the l<strong>on</strong>g-term c<strong>on</strong>sumer exposure to diazin<strong>on</strong><strong>residues</strong> is not likely to exceed the Acceptable Daily Intake (ADI). Thus, also for diazin<strong>on</strong> no l<strong>on</strong>gtermc<strong>on</strong>sumer risk is expected. It is noted that the use of diazin<strong>on</strong> is no l<strong>on</strong>ger permitted in the<strong>Europe</strong>an Uni<strong>on</strong>.The assessment of the acute (short-term) c<strong>on</strong>sumer exposure was performed for the nine foodcommodities which were analysed under the EU coordinated m<strong>on</strong>itoring programme. The assessmentwas based <strong>on</strong> worst-case scenarios: the c<strong>on</strong>sumpti<strong>on</strong> data for c<strong>on</strong>sumers who eat a large porti<strong>on</strong> size ofthe food item under c<strong>on</strong>siderati<strong>on</strong> were combined with the highest residue measured in the coordinatedprogramme. In order to accommodate for a possible n<strong>on</strong>-homogeneous distributi<strong>on</strong> of <strong>residues</strong> in ananalysed food lot a variability factor was introduced. Assuming a coincidence of these events (highfood c<strong>on</strong>sumpti<strong>on</strong>, high residue c<strong>on</strong>centrati<strong>on</strong> and inhomogeneous residue distributi<strong>on</strong> in a lot), apotential c<strong>on</strong>sumer risk could not be excluded for 35 <strong>pesticide</strong>/commodity combinati<strong>on</strong>s.The highest potential exceedances of the toxicological reference value was indicated fordimethoate/omethoate <strong>on</strong> potatoes and spinach (10,763% and 2,938% of the ARfD, respectively),methiocarb <strong>on</strong> cucumbers (2,519%), dimethoate/omethoate <strong>on</strong> pears (1,730%) and mthomyl/thiodicarb<strong>on</strong> oranges (1,644%). However, the critical intake events identified in the acute risk assessmentcalculati<strong>on</strong>s were c<strong>on</strong>sidered very unlikely, taking into account the frequency of critical <strong>residues</strong> andthe frequency of extreme c<strong>on</strong>sumpti<strong>on</strong> events. For 11 of the <strong>pesticide</strong>/commodity combinati<strong>on</strong>s forwhich a critical intake situati<strong>on</strong> could not be excluded, risk management acti<strong>on</strong>s have already beentaken by withdrawing authorisati<strong>on</strong>s or by lowering the MRLs.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):16464


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesTABLE OF CONTENTSAbstract .................................................................................................................................................... 1Summary .................................................................................................................................................. 2Table of c<strong>on</strong>tents ...................................................................................................................................... 5Legal basis ................................................................................................................................................ 7Terms of reference .................................................................................................................................... 81. Introducti<strong>on</strong> ................................................................................................................................. 92. Design and background <strong>on</strong> the m<strong>on</strong>itoring programmes ........................................................... 172.1. EU coordinated programme .................................................................................................. 172.1.1. Food commodities analysed ............................................................................................. 172.1.2. Pesticides analysed ........................................................................................................... 202.1.3. Number of samples ........................................................................................................... 232.2. Nati<strong>on</strong>al programmes ............................................................................................................ 262.2.1. Number of samples – nati<strong>on</strong>al programmes ..................................................................... 272.2.2. Pesticides analysed – nati<strong>on</strong>al programmes...................................................................... 312.2.3. Food commodities analysed – nati<strong>on</strong>al programmes ........................................................ 332.2.4. Baby food m<strong>on</strong>itoring ....................................................................................................... 342.2.5. Organic food m<strong>on</strong>itoring .................................................................................................. 362.2.6. Processed-food m<strong>on</strong>itoring ............................................................................................... 382.2.7. Origin of samples .............................................................................................................. 392.3. Quality assurance .................................................................................................................. 413. Results of the EU-coordinated m<strong>on</strong>itoring programme ............................................................. 433.1. Overall results for MRL exceedances ................................................................................... 433.2. Results by country ................................................................................................................ 443.3. Results by food commodity .................................................................................................. 443.4. Results by <strong>pesticide</strong>-commodity combinati<strong>on</strong> ...................................................................... 473.5. Results by <strong>pesticide</strong>s ............................................................................................................. 594. Results of the nati<strong>on</strong>al m<strong>on</strong>itoring programmes ........................................................................ 624.1. Overall results for MRL exceedances ................................................................................... 624.2. MRL exceedance rate over the time...................................................................................... 624.3. Origin of samples exceeding the EC MRLs .......................................................................... 634.4. Results by food commodity .................................................................................................. 664.5. Results by <strong>pesticide</strong>/crop combinati<strong>on</strong>s ................................................................................ 694.5.1. Results for organic samples .............................................................................................. 704.5.2. Results for baby-food samples ......................................................................................... 714.5.3. Results for processed products ......................................................................................... 714.5.4. Results for samples with multiple <strong>residues</strong> ....................................................................... 724.5.5. Reas<strong>on</strong>s for MRL exceedances ......................................................................................... 765. Dietary exposure and dietary risk assessment ........................................................................... 775.1. Model assumpti<strong>on</strong>s for the short-term exposure assessment ................................................ 785.1.1. Residue levels ................................................................................................................... 815.1.2. Processing/peeling factors ................................................................................................ 845.1.3. Acute Reference Dose values (ARfDs) ............................................................................ 845.1.4. Presentati<strong>on</strong> of the results of the short-term c<strong>on</strong>sumer exposure ..................................... 865.1.5. Limitati<strong>on</strong> and uncertainties affecting the short-term exposure assessment ..................... 875.2. Results of the short-term risk assessment ............................................................................. 885.2.1. Pesticide/crop combinati<strong>on</strong> for which a theoretical short-term risk could not be excluded.......................................................................................................................................... 885.2.1.1. Azinphos-methyl ...................................................................................................... 97<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):16465


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues5.2.1.2. Carbaryl ................................................................................................................... 985.2.1.3. Benomyl/carbendazim ........................................................................................... 1015.2.1.4. Chlormequat ........................................................................................................... 1025.2.1.5. Chlorpropham ........................................................................................................ 1035.2.1.6. Chlorpyriphos ........................................................................................................ 1045.2.1.7. Diazin<strong>on</strong> ................................................................................................................. 1055.2.1.8. Dimethoate/omethoate ........................................................................................... 1065.2.1.9. Endosulfan ............................................................................................................. 1085.2.1.10. Imazalil .................................................................................................................. 1105.2.1.11. Lambda-Cyhalothrin .............................................................................................. 1115.2.1.12. Methamidophos ..................................................................................................... 1135.2.1.13. Methiocarb ............................................................................................................. 1145.2.1.14. Methomyl/thiodicarb ............................................................................................. 1145.2.1.15. Oxamyl ................................................................................................................... 1195.2.1.16. Parathi<strong>on</strong> ................................................................................................................ 1215.2.1.17. Procymid<strong>on</strong>e .......................................................................................................... 1225.2.1.18. Tebuc<strong>on</strong>azole ......................................................................................................... 1245.2.2. Pesticide/crop combinati<strong>on</strong>s for which the short-term risk assessment was not c<strong>on</strong>clusive ......................................................................................................................................... 1255.2.2.1. Cypermethrin ......................................................................................................... 1285.2.2.2. Dithiocarbamates ................................................................................................... 1295.2.2.3. Folpet/Captan ......................................................................................................... 1315.2.3. Pesticide/crop combinati<strong>on</strong>s for which the short-term risk assessment could not beperformed ..................................................................................................................................... 1335.3. Model assumpti<strong>on</strong>s for l<strong>on</strong>g-term risk assessment ............................................................. 1335.3.1. Residue levels ................................................................................................................. 1365.3.2. Processing/peeling factors .............................................................................................. 1445.3.3. Acceptable Daily Intake values (ADIs) .......................................................................... 1445.3.4. Presentati<strong>on</strong> of the results of the l<strong>on</strong>g-term c<strong>on</strong>sumer exposure .................................... 1465.3.5. Limitati<strong>on</strong>s and uncertainties affecting the chr<strong>on</strong>ic exposure assessment ...................... 1465.4. Results of the l<strong>on</strong>g-term risk assessment ............................................................................ 1475.4.1. Pesticides for which a chr<strong>on</strong>ic risk could not be excluded ............................................. 1495.4.1.1. Diazin<strong>on</strong> ................................................................................................................. 1495.4.2. Pesticides for which the chr<strong>on</strong>ic risk assessment was not c<strong>on</strong>clusive ............................ 1505.4.2.1. Dimethoate/omethoate ........................................................................................... 1505.4.3. Pesticides for which the chr<strong>on</strong>ic risk assessment could not be performed ..................... 1515.4.3.1. Dichlorvos .............................................................................................................. 1515.4.3.2. Triazoles ................................................................................................................. 151Recommendati<strong>on</strong>s ................................................................................................................................ 153Acknowledgments ................................................................................................................................ 155References ............................................................................................................................................ 156Abbreviati<strong>on</strong>s and special terms used in the <str<strong>on</strong>g>report</str<strong>on</strong>g> .............................................................................. 159Appendices ........................................................................................................................................... 162Appendix I…………………………………………………………………………………………163Appendix II……………………………………………………………………………………….. 167Appendix III………………………………………………………………………………………. 241Appendix IV……………………………………………………………………………………… 275<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):16466


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesLEGAL BASISAccording to the EU legislati<strong>on</strong> in place in <str<strong>on</strong>g>2008</str<strong>on</strong>g>, EU and EEA Member States 5 (Iceland and Norway)had to carry out nati<strong>on</strong>al m<strong>on</strong>itoring programmes <strong>on</strong> <strong>pesticide</strong> <strong>residues</strong> and <str<strong>on</strong>g>report</str<strong>on</strong>g> the results to the<strong>Europe</strong>an Commissi<strong>on</strong> and <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>.General legal provisi<strong>on</strong>s for food inspecti<strong>on</strong>s and m<strong>on</strong>itoring were established by Regulati<strong>on</strong> (EC) No.882/2004 (EC 2004) <strong>on</strong> official c<strong>on</strong>trols performed to ensure the verificati<strong>on</strong> of compliance with feedand food law, animal health and animal welfare.The legal basis for the preparati<strong>on</strong> of this <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> the <strong>pesticide</strong> <strong>residues</strong> is laid down inDirectives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC (EEC 1976; EEC 1986a; EEC1986b; EEC 1990). These directives required Member States to establish nati<strong>on</strong>al c<strong>on</strong>trol programmesand to carry out regular official c<strong>on</strong>trols <strong>on</strong> <strong>pesticide</strong> <strong>residues</strong> in food commodities to checkcompliance with the Maximum Residues Levels (MRLs) for <strong>pesticide</strong> <strong>residues</strong>. Commissi<strong>on</strong>Regulati<strong>on</strong> (EC) No. 645/2000 (EC 2000) provides for detailed implementing rules for the m<strong>on</strong>itoringprovisi<strong>on</strong>s of Directives 86/362/EEC and 90/642/EEC (EEC1986a; EEC1990) <strong>on</strong> <strong>pesticide</strong> MRLs.On 1 September <str<strong>on</strong>g>2008</str<strong>on</strong>g>, Regulati<strong>on</strong> (EC) No. 396/2005 6 <strong>on</strong> maximum residue levels of <strong>pesticide</strong>s in or<strong>on</strong> food and feed of plant and animal origin (EC 2005a) became fully applicable, and the provisi<strong>on</strong>sregarding the m<strong>on</strong>itoring activities in the above-menti<strong>on</strong>ed four directives were replaced by Chapter Vof Regulati<strong>on</strong> (EC) No. 396/2005. According to Article 31 of this regulati<strong>on</strong>, Member States have tosubmit the results of official c<strong>on</strong>trols and other relevant informati<strong>on</strong> to the <strong>Europe</strong>an Commissi<strong>on</strong>, to<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> and to other Member States. With Article 32 the resp<strong>on</strong>sibility for preparing the <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report<strong>on</strong> <strong>pesticide</strong> <strong>residues</strong> was transferred from the <strong>Europe</strong>an Commissi<strong>on</strong> to <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>. This regulati<strong>on</strong> alsoc<strong>on</strong>tains general provisi<strong>on</strong>s regarding the c<strong>on</strong>tent of the <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report.In additi<strong>on</strong> to the general provisi<strong>on</strong>s <strong>on</strong> nati<strong>on</strong>al m<strong>on</strong>itoring programmes as defined in Article 30 ofthe MRL Regulati<strong>on</strong>, the Commissi<strong>on</strong> has recommended that EU Member States and EEA countriesparticipate in a specific EU coordinated m<strong>on</strong>itoring programme. The details of the coordinatedm<strong>on</strong>itoring programme for <str<strong>on</strong>g>2008</str<strong>on</strong>g> have been established in Commissi<strong>on</strong> Recommendati<strong>on</strong> <str<strong>on</strong>g>2008</str<strong>on</strong>g>/103/EC(EC <str<strong>on</strong>g>2008</str<strong>on</strong>g>a).The results of the analysis of samples taken during the previous year under the nati<strong>on</strong>al andcoordinated Community m<strong>on</strong>itoring programme had to be submitted to the <strong>Europe</strong>an Commissi<strong>on</strong> bythe end of August 2009. All 27 EU Member States and two EEA States submitted the results of the<str<strong>on</strong>g>2008</str<strong>on</strong>g> m<strong>on</strong>itoring programme electr<strong>on</strong>ically to <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> between 10 July and 30 October 2009.5 Liechtenstein, an EFTA State previously <str<strong>on</strong>g>report</str<strong>on</strong>g>ing its results <strong>on</strong> the m<strong>on</strong>itoring of <strong>pesticide</strong> <strong>residues</strong> to the Commissi<strong>on</strong>,has been exempted from <str<strong>on</strong>g>report</str<strong>on</strong>g>ing obligati<strong>on</strong>s from 2007 due to a change in the EEA agreement c<strong>on</strong>cerning agriculturalissues.6 Regulati<strong>on</strong> (EC) No. 396/2005 of the <strong>Europe</strong>an Parliament and of the Council of 23 February 2005 <strong>on</strong> maximum residuelevels of <strong>pesticide</strong>s in or <strong>on</strong> food and feed of plant and animal origin and amending Council Directive 91/414/EECTextwith EEA relevance. Official Journal L 70, 16.3.2005, p 1-16 (EC 2005a)<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):16467


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesTERMS OF REFERENCEIn accordance with Article 32 of Regulati<strong>on</strong> (EC) No. 396/2005 (EC 2005a), <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> shall submit the<str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> <strong>pesticide</strong> <strong>residues</strong> c<strong>on</strong>cerning the c<strong>on</strong>trol activities carried out in <str<strong>on</strong>g>2008</str<strong>on</strong>g> to theCommissi<strong>on</strong>.The <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report shall at least include the following informati<strong>on</strong>:• An analysis of the result of the c<strong>on</strong>trols <strong>on</strong> <strong>pesticide</strong> <strong>residues</strong> provided by EU Member Statesand EEA States;• A statement of the possible reas<strong>on</strong>s why the MRLs were exceeded, together with anyappropriate observati<strong>on</strong>s regarding risk management opti<strong>on</strong>s;• An analysis of chr<strong>on</strong>ic and acute risks to the health of c<strong>on</strong>sumers from <strong>pesticide</strong> <strong>residues</strong>;• An assessment of c<strong>on</strong>sumer exposure to <strong>pesticide</strong> <strong>residues</strong> based <strong>on</strong> the informati<strong>on</strong> providedunder the first bullet point and any other relevant informati<strong>on</strong> available, including <str<strong>on</strong>g>report</str<strong>on</strong>g>ssubmitted under Directive 96/23/EC (EC 1996b).In additi<strong>on</strong>, the <str<strong>on</strong>g>report</str<strong>on</strong>g> may include an opini<strong>on</strong> <strong>on</strong> the <strong>pesticide</strong>s that should be included in futurem<strong>on</strong>itoring programmes.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):16468


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues1. Introducti<strong>on</strong>The <str<strong>on</strong>g>report</str<strong>on</strong>g> presents the results of the m<strong>on</strong>itoring of <strong>pesticide</strong> <strong>residues</strong> in food commodities sampledduring the calendar year <str<strong>on</strong>g>2008</str<strong>on</strong>g> in the 27 EU Member States and the two EFTA States (Norway andIceland ) who have signed the Agreement <strong>on</strong> the <strong>Europe</strong>an Ec<strong>on</strong>omic Area (EEA agreement).The objective of this <str<strong>on</strong>g>report</str<strong>on</strong>g> is to give an overview of the c<strong>on</strong>trol activities performed by MemberStates and EFTA countries in order to ensure compliance of food with the standards defined byDirective 86/362/EEC, 90/642/EEC (applicable until end of August <str<strong>on</strong>g>2008</str<strong>on</strong>g>) and Regulati<strong>on</strong> (EC) No.396/2005, to summarise the results provided by the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries, to identify critical areas ofc<strong>on</strong>cern regarding sample compliance with MRLs, to assess the actual c<strong>on</strong>sumer exposure to <strong>pesticide</strong><strong>residues</strong> and to perform an analysis of the chr<strong>on</strong>ic and acute risks to c<strong>on</strong>sumer health. Furthermore,this <str<strong>on</strong>g>report</str<strong>on</strong>g> provides some recommendati<strong>on</strong>s for future m<strong>on</strong>itoring plans and activities.<str<strong>on</strong>g>2008</str<strong>on</strong>g> was an important year for the harm<strong>on</strong>isati<strong>on</strong> of the <strong>pesticide</strong> MRL legislati<strong>on</strong> at <strong>Europe</strong>an level.Whereas before 1 September <str<strong>on</strong>g>2008</str<strong>on</strong>g> a mixed system with harm<strong>on</strong>ised Community MRLs for about 250active substances and nati<strong>on</strong>al MRLs for the remaining substances was applicable, when Regulati<strong>on</strong>(EC) No 396/2005 was introduced it harm<strong>on</strong>ised MRLs for all active substances used in plantprotecti<strong>on</strong> products that have the potential to enter the food chain.Due to the changed legal situati<strong>on</strong>, the results of previous m<strong>on</strong>itoring <str<strong>on</strong>g>report</str<strong>on</strong>g>s published by <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> andthe <strong>Europe</strong>an Commissi<strong>on</strong> are not directly comparable with the results <str<strong>on</strong>g>report</str<strong>on</strong>g>ed in this <str<strong>on</strong>g>report</str<strong>on</strong>g>.Therefore, the <str<strong>on</strong>g>2008</str<strong>on</strong>g> m<strong>on</strong>itoring data should be interpreted at with care to understand if a possiblechange of the <strong>pesticide</strong> residue findings should be ascribed to the new harm<strong>on</strong>ised EU legal limits orto other factors. The impact will be best evaluated by assessing future m<strong>on</strong>itoring data, starting fromthe 2009 m<strong>on</strong>itoring results. Finally, when comparing the data and results <str<strong>on</strong>g>report</str<strong>on</strong>g>ed by the differentcountries and for different years, the reader should bear in mind that important changes in the legalframework have been introduced. The comparability is also hampered by other factors, such as scopeof the nati<strong>on</strong>al m<strong>on</strong>itoring programmes, proficiencies of analytical laboratories providing results, thedata validati<strong>on</strong> and recoding 7 .Chapter 2 of the <str<strong>on</strong>g>report</str<strong>on</strong>g> describes the design of the m<strong>on</strong>itoring programmes in place in <strong>Europe</strong>. Inparticular, the difference between the EU coordinated programme and the nati<strong>on</strong>al c<strong>on</strong>trol plans isexplained.The results of the EU coordinated m<strong>on</strong>itoring programme, as established in Commissi<strong>on</strong>Recommendati<strong>on</strong> <str<strong>on</strong>g>2008</str<strong>on</strong>g>/103/EC, are <str<strong>on</strong>g>report</str<strong>on</strong>g>ed in chapter 3 of this <str<strong>on</strong>g>report</str<strong>on</strong>g>.Key figures and results of the nati<strong>on</strong>al c<strong>on</strong>trol programmes are summarised in chapter 4. In thissecti<strong>on</strong> the results of surveillance samples (n<strong>on</strong>-targeted samples) and the results of the nati<strong>on</strong>alenforcement sampling taken under the nati<strong>on</strong>al c<strong>on</strong>trol programmes are <str<strong>on</strong>g>report</str<strong>on</strong>g>ed.In the last secti<strong>on</strong> of the <str<strong>on</strong>g>report</str<strong>on</strong>g> (chapter 5), <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> assessed the dietary exposure of <strong>Europe</strong>anc<strong>on</strong>sumers, based mainly <strong>on</strong> the results of the EU coordinated programme.7 More detailed informati<strong>on</strong> about the results of c<strong>on</strong>trol activities in the individual <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries is available from therespective nati<strong>on</strong>al authorities. The list of web addresses where the results of m<strong>on</strong>itoring plans have been published is<str<strong>on</strong>g>report</str<strong>on</strong>g>ed in Appendix I. It should be noted that up<strong>on</strong> submissi<strong>on</strong> of the data, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> validated the data and recoded thenames of the food and the <strong>pesticide</strong> names <str<strong>on</strong>g>report</str<strong>on</strong>g>ed by the participating countries to make the comparable. If there wereinc<strong>on</strong>sistencies in data from different countries, they were asked for correcti<strong>on</strong>s. Therefore, small differences in the datapublished separately by the nati<strong>on</strong>al authorities and the data <str<strong>on</strong>g>report</str<strong>on</strong>g>ed in the present <str<strong>on</strong>g>report</str<strong>on</strong>g> may occur.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):16469


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesThe reader not familiar with terms and c<strong>on</strong>cepts frequently used in the present <str<strong>on</strong>g>report</str<strong>on</strong>g> (e.g. MRL andsampling strategy) is invited to c<strong>on</strong>sult the background informati<strong>on</strong> secti<strong>on</strong> below.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164610


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesBACKGRUND INFORMATIONThis secti<strong>on</strong> provides explanati<strong>on</strong>s <strong>on</strong> terms frequently used in the present <str<strong>on</strong>g>report</str<strong>on</strong>g>.Authorisati<strong>on</strong> of <strong>pesticide</strong>s/plant protecti<strong>on</strong> productsThe quality and yield of agricultural and horticultural crops is jeopardized by plant diseases andinfestati<strong>on</strong> by pests. In order to protect crops before and after harvest, <strong>pesticide</strong>s 8 are used. Since theactive substances used in <strong>pesticide</strong>s can have harmful effects <strong>on</strong> human health, wildlife and theenvir<strong>on</strong>ment, a strict system of <strong>pesticide</strong> authorisati<strong>on</strong> and c<strong>on</strong>trol of use has been established at EUlevel. In the framework of the authorisati<strong>on</strong> procedure, companies asking for the authorisati<strong>on</strong> ofproducts have to dem<strong>on</strong>strate that with regard to c<strong>on</strong>sumer safety the products do not pose a c<strong>on</strong>sumerhealth risk from <strong>pesticide</strong> <strong>residues</strong> <strong>on</strong> food.Pesticide <strong>residues</strong>Pesticide <strong>residues</strong> are the measurable amounts of the active substances used in plant protecti<strong>on</strong>products, their metabolites and/or breakdown or reacti<strong>on</strong> products resulting from current or formerlyused plant protecti<strong>on</strong> products that can be found <strong>on</strong> harvested crops or in food of animal origin.Pesticide useThe nati<strong>on</strong>ally authorised or registered use of a <strong>pesticide</strong> reflects the safe use of a <strong>pesticide</strong> underactual agricultural c<strong>on</strong>diti<strong>on</strong>s and implies the use of the minimum quantity of <strong>pesticide</strong>s which allowsthe desired effect to be obtained (referred to as the Good Agricultural Practice - GAP). Authorisati<strong>on</strong>sare granted at nati<strong>on</strong>al level, taking into account the local and envir<strong>on</strong>mental c<strong>on</strong>diti<strong>on</strong>s and theoccurrence of pests (and therefore the use of <strong>pesticide</strong>s). MRLs are set for the most critical authorisedGAPs, provided that a c<strong>on</strong>sumer health risk can be excluded for these uses.Residue definiti<strong>on</strong>Active substances applied <strong>on</strong> a crop are not stable, but the molecule applied undergoes to a certainextent a transformati<strong>on</strong> induced by plant enzymes, light, humidity or other envir<strong>on</strong>mental factors.Thus, <strong>on</strong> the harvested food commodity, other chemical molecules than the active substancesoriginally applied may be present. Since not all of these degradati<strong>on</strong> products are harmless, they haveto be taken into account in the c<strong>on</strong>sumer risk assessment. In certain cases, the parent compound (i.e.the substance originally applied <strong>on</strong> the crop) is not found at all in the harvested crops, but <strong>on</strong>ly atypical metabolite which is an indicator of the use of this parent compound. The c<strong>on</strong>cept of residuedefiniti<strong>on</strong> is used to define the active substance used in plant protecti<strong>on</strong> products and its metabolites,degradates, and other transformati<strong>on</strong> products relevant for c<strong>on</strong>sumer exposure (i.e. residue definiti<strong>on</strong>for risk assessment) or to define marker substances allowing a c<strong>on</strong>clusi<strong>on</strong> <strong>on</strong> the use of the activesubstance (i.e. residue definiti<strong>on</strong> for MRL enforcement). For each <strong>pesticide</strong> used <strong>on</strong> food or feedcommodities, the regulatory authorities need to choose which comp<strong>on</strong>ents of the terminal residue <strong>on</strong>the harvested crops are of relevance for setting and enforcing MRLs and for the dietary exposure.Therefore, for each <strong>pesticide</strong>, two residue definiti<strong>on</strong>s are set:Residue definiti<strong>on</strong> for MRL setting /MRL enforcement purposes focuses <strong>on</strong> those analytes which areindicators for the use of the <strong>pesticide</strong> and which can be analysed in routine m<strong>on</strong>itoring, ideally by amulti-residue method.Residue definiti<strong>on</strong> for dietary risk assessment includes the parent compound and its metabolites, whichare significant in term of relative toxicities and which c<strong>on</strong>tribute significantly to c<strong>on</strong>sumer exposure.8 In the <str<strong>on</strong>g>report</str<strong>on</strong>g> the term “<strong>pesticide</strong>” is used as syn<strong>on</strong>ym of “plant protecti<strong>on</strong> product”.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164611


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesMRLMaximum Residue Levels (MRLs) for <strong>pesticide</strong>s are defined as the upper legal levels of a <strong>pesticide</strong>residue c<strong>on</strong>centrati<strong>on</strong> (expressed in mg/kg) in or <strong>on</strong> food or feed which result from authorisedagricultural practices. Food with <strong>residues</strong> of <strong>pesticide</strong>s above the MRL cannot be traded.Hence, MRLs are not necessarily toxicological safety limits, but reflect the use of minimum quantitiesof <strong>pesticide</strong>s to achieve effective plant protecti<strong>on</strong>, applied in such a manner that the amount of residueis the smallest practicable. Before an MRL is established, a risk assessment has to prove that the limitis safe for c<strong>on</strong>sumer health. In the past resp<strong>on</strong>sibility for risk assessment in the MRL setting procedurewas shared between Member States and the <strong>Europe</strong>an Commissi<strong>on</strong>. Since Regulati<strong>on</strong> 396/2005 (EC2005a) became fully applicable <strong>on</strong> 1 September <str<strong>on</strong>g>2008</str<strong>on</strong>g>, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> has become the independent, resp<strong>on</strong>siblebody for the risk assessment and evaluati<strong>on</strong> of each intended new/revised MRL in the framework ofthe MRL setting procedures.In most cases the MRLs are well below the toxicologically acceptable residue levels. If a <strong>pesticide</strong>residue is found <strong>on</strong> a given crop at or below the MRL, then the crop can be c<strong>on</strong>sidered safe forc<strong>on</strong>sumer health. On the other hand, if a residue exceeds the MRL, it is not necessarily true that thec<strong>on</strong>sumer is at risk. In the latter case, an assessment of the expected exposure and a comparis<strong>on</strong> withthe toxicological reference values is necessary to c<strong>on</strong>clude whether the food poses a c<strong>on</strong>sumer healthrisk.MRLs are established for raw commodities of plant or animal origin placed <strong>on</strong> the market, i.e. fresh orfrozen products without processing, in many cases including n<strong>on</strong>-edible parts of the crop such as peel.The descripti<strong>on</strong> of the commodities and the parts of the products to which the MRLs apply can befound in the Annexes of the basic MRL directives (EEC 1976; EEC 1990; EEC 1986a and EEC1986b) and in Annex I to Regulati<strong>on</strong> (EC) No. 396/2005 (EC 2005a).At EU level, harm<strong>on</strong>ized MRLs for <strong>pesticide</strong> <strong>residues</strong> in food applicable for the reference periodJanuary to August <str<strong>on</strong>g>2008</str<strong>on</strong>g> have been established in four basic directives (Council Directive 76/895/EEC(EEC 1976), Council Directive 86/362/EEC (EEC 1986a), Council Directive 86/363/EEC (EEC1986b) and Council Directive 90/642/EEC (EEC 1990)), which cover more than 250 <strong>pesticide</strong>s. Inadditi<strong>on</strong>, for <strong>pesticide</strong>s not covered by the <strong>Europe</strong>an legislati<strong>on</strong> in the reference period until September<str<strong>on</strong>g>2008</str<strong>on</strong>g>, Member States had the possibility to establish MRLs at nati<strong>on</strong>al level. However, not all MemberStates had subsidiary nati<strong>on</strong>al MRL provisi<strong>on</strong>s in place.Starting from September <str<strong>on</strong>g>2008</str<strong>on</strong>g>, EU MRLs have been established by Annexes II and III of Regulati<strong>on</strong>(EC) No. 396/2005 (EC 2005a). This Regulati<strong>on</strong> provides for a harm<strong>on</strong>ised system for the setting ofthe MRL, which apply to all food commodities available in all EU Member States. This Regulati<strong>on</strong>covers about 500 <strong>pesticide</strong>s. For <strong>pesticide</strong>s not explicitly menti<strong>on</strong>ed in Annexes II, III or IV of theRegulati<strong>on</strong>, a default MRL of 0.01 mg/kg is applicable. MRLs are established at the limit ofquantificati<strong>on</strong> (LOQ) if a <strong>pesticide</strong> is not authorised for use <strong>on</strong> a specific crop.For processed or composite food commodities, the MRLs established in the MRL legislati<strong>on</strong> for rawcommodities are applied by taking into account changes in the levels of <strong>pesticide</strong> <strong>residues</strong> caused byprocessing or mixing (processing factors).It should also be menti<strong>on</strong>ed that no specific MRLs for organic products have been established at EUlevel. For these products the same MRLs as for c<strong>on</strong>venti<strong>on</strong>al products apply, but additi<strong>on</strong>al producti<strong>on</strong>and labelling rules have to be respected (EC 1991b).For infant formulae, follow-<strong>on</strong> formulae and for processed cereal-based foods and baby foods forinfants and young children, a default MRL of 0.01 mg/kg is applicable, unless a specific lower MRLhas been set in Directives 91/321/EEC and 96/5/EC (ECC 1991, EC1996a).<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164612


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesMRL exceedanceSince the MRLs are closely linked to the Good Agricultural Practices (GAP), MRLs may be exceededin cases where the GAP was not respected, such as• the use of unauthorised <strong>pesticide</strong>s;• the use of <strong>pesticide</strong>s not authorised for a specific crop;• the use of an authorised <strong>pesticide</strong> <strong>on</strong> a crop for which an authorisati<strong>on</strong> was granted, but not incompliance with the authorised GAP (e.g. higher applicati<strong>on</strong> rate or shorter pre-harvestintervals).For products originating from third countries, the lack of import tolerance at EU level may also be areas<strong>on</strong> for MRL exceedance. Before September <str<strong>on</strong>g>2008</str<strong>on</strong>g>, the lack of harm<strong>on</strong>isati<strong>on</strong> for certain activesubstances which were covered by nati<strong>on</strong>al MRL provisi<strong>on</strong>s was also a reas<strong>on</strong> for exceeding MRLs,although the food was lawfully produced in the Member State of origin.In excepti<strong>on</strong>al cases, MRL exceedance was observed for other reas<strong>on</strong>s, such as:• spray drift from neighbouring treated fields;• c<strong>on</strong>taminati<strong>on</strong> of crops at storage or packaging level;• unfavourable weather c<strong>on</strong>diti<strong>on</strong>s associated with a reduced residue decline rate.Finally, MRLs might be exceeded because the legal limits (MRLs) were set at inappropriate levels.MRLs are derived from relatively small data sets generated in supervised field trials. On rare occasi<strong>on</strong>applicati<strong>on</strong>s at the critical GAP may also lead to values above the MRL. Careful analysis of them<strong>on</strong>itoring data should make it possible to decide if certain MRLs need to be revised.In the c<strong>on</strong>text of this <str<strong>on</strong>g>report</str<strong>on</strong>g> the term MRL exceedance refers to a situati<strong>on</strong> where the legal limit isexceeded numerically, without c<strong>on</strong>sidering measurement uncertainty. Thus, this term should not beunderstood as MRL n<strong>on</strong>-compliance that will have legal repercussi<strong>on</strong>s. See also MRLcompliance/n<strong>on</strong>-compliance.MRL compliance/n<strong>on</strong>-complianceIf the residue level measured in a sample, taking into account the measurement uncertainty, exceedsthe legal MRL, the sample is c<strong>on</strong>sidered as n<strong>on</strong>-compliant and the competent nati<strong>on</strong>al authorities shallapply the sancti<strong>on</strong>s applicable to the infringements. The sancti<strong>on</strong>s must be effective, proporti<strong>on</strong>ate anddissuasive. A sample is compliant with the MRL if the measured value does not exceed the MRL.Threshold residue/threshold MRLSince the MRL is not the toxicological limits, for the purpose of the risk assessment <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> introducedtwo new c<strong>on</strong>cepts: the “threshold residue level” and “threshold MRL”.A threshold residue level is the theoretical, calculated maximum residue in the edible part of the cropwhich would be acceptable from a c<strong>on</strong>sumer safety point of view. The threshold residue gives anintake corresp<strong>on</strong>ding to 100% of the ARfD and it is calculated <strong>on</strong> the basis of the c<strong>on</strong>sumer groupwith the highest c<strong>on</strong>sumpti<strong>on</strong> per unit body weight (i.e. the most critical c<strong>on</strong>sumer) identified am<strong>on</strong>gall the nati<strong>on</strong>al c<strong>on</strong>sumer groups for which c<strong>on</strong>sumpti<strong>on</strong> data are available to <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>. The thresholdMRL is the residue c<strong>on</strong>centrati<strong>on</strong> that refers to the whole commodity, e.g. the unpeeled orange, andwhich gives an intake corresp<strong>on</strong>ding to 100% of the ARfD. For crops that are c<strong>on</strong>sumed in peeledand/or processed form, a peeling factor and/or processing factor has to be applied to the threshold<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164613


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residuesresidue to derive the threshold MRL. If the crop of c<strong>on</strong>cern can be c<strong>on</strong>sumed as a whole without anyprocessing/peeling- the calculated threshold residue and threshold MRL have the same value.Dietary exposure assessment and risk assessmentDietary exposure assessment is the quantitative evaluati<strong>on</strong> of the intake of <strong>pesticide</strong>s via food. In thechr<strong>on</strong>ic and acute risk assessment, the estimated l<strong>on</strong>g-term and short-term dietary exposure, calculatedper kg body weight, is compared with the relevant toxicological reference values, i.e. the acceptabledaily intake (ADI) and the Acute Reference Dose (ARfD), respectively (see “ADI” and “ARfD”above). A c<strong>on</strong>sumer health risk is identified if the estimated dietary exposure to a <strong>pesticide</strong>, taking intoaccount the scientific uncertainties, exceeds the ADI and/or the ARfD.Acceptable Daily Intake (ADI)The Acceptable Daily Intake (ADI) is the estimated amount of substance in food, expressed <strong>on</strong> a bodyweight basis, that can be ingested daily over a lifetime, without appreciable chr<strong>on</strong>ic, l<strong>on</strong>g-term risk toany c<strong>on</strong>sumer. The ADI is set <strong>on</strong> the basis of all known facts at the time of evaluati<strong>on</strong>, taking intoaccount sensitive groups within the populati<strong>on</strong> (e.g. children and the unborn).Acute Reference Dose (ARfD)The Acute Reference Dose (ARfD) is the estimated amount of substance in food, expressed <strong>on</strong> a bodyweight basis, that can be ingested over a short period of time, usually during <strong>on</strong>e day, withoutappreciable risk to the c<strong>on</strong>sumer (Regulati<strong>on</strong> (EC) No. 396/2005 (EC 2005a)). The ARfD is set <strong>on</strong> thebasis of the data produced by appropriate studies and taking into account sensitive groups within thepopulati<strong>on</strong> (e.g. children and the unborn).Analytical methodsThe results of m<strong>on</strong>itoring analysis are str<strong>on</strong>gly influenced by the analytical methods used to analysethe samples. The analytical methods used in <strong>pesticide</strong> residue analysis have to fulfil certain criteriaregarding specificity, sensitivity, precisi<strong>on</strong> accuracy, robustness and linearity which are defined inguidance documents ((EC 2007b), post-registrati<strong>on</strong> guidance document). Also the scope of theanalytical methods (the list of <strong>pesticide</strong>s included in the analytical methods) has an impact <strong>on</strong> thenumber of positive findings in samples analysed. If the analytical method applied is not capable ofdetecting a certain <strong>pesticide</strong> active substance applied to the crop – or its toxicologically relevantmetabolites or break-down products - the sample may be c<strong>on</strong>sidered by mistake to be free of <strong>pesticide</strong><strong>residues</strong>. Additi<strong>on</strong>ally, if the analytical method is not sensitive enough, the <strong>pesticide</strong> will not bedetected in cases where the residue occurs at a low c<strong>on</strong>centrati<strong>on</strong>. Therefore, the results <str<strong>on</strong>g>report</str<strong>on</strong>g>ed by<str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries have to be c<strong>on</strong>sidered in the c<strong>on</strong>text of the analytical methods used.The analytical methods used today to detect and quantify <strong>pesticide</strong> <strong>residues</strong> in food commodities fallinto two general types of method: multi-residue and single-residue methods. Multi-residue methodsare able to analyse a high number of different <strong>pesticide</strong> <strong>residues</strong> in the same sample. However, certain<strong>pesticide</strong>s and metabolites cannot be included in multi-residue methods because of their physicalchemicalproperties (e.g. acidic or polar chemicals). In these cases, single-residue methods have to beapplied. Single-residue methods allow the identificati<strong>on</strong> and quantificati<strong>on</strong> of <strong>on</strong>ly <strong>on</strong>e or a few<strong>pesticide</strong> <strong>residues</strong> in <strong>on</strong>e sample. Since these two types of method require a comparable processingtime per sample, multi-residue methods are usually preferred over single-residue methods, as they aregenerally more efficient in terms of cost/benefit ratio. Single-residue methods are therefore preferablefor samples where previous experience shows that it is likely that <strong>residues</strong> of the <strong>pesticide</strong>s in questi<strong>on</strong>will be found.<strong>Europe</strong>an Reference Laboratory (EURL)The <strong>Europe</strong>an Reference Laboratories (EURLs), in the past called “Community ReferenceLaboratories” - CRLs), are appointed by the <strong>Europe</strong>an Commissi<strong>on</strong>, co-ordinate, train staff, developmethods of analysis and organise tests to evaluate the skills of the different nati<strong>on</strong>al c<strong>on</strong>trol<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164614


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residueslaboratories. The overall objective of the EURLs is to improve the quality, accuracy and comparabilityof the results from official c<strong>on</strong>trol laboratories.Limit of Quantificati<strong>on</strong> (LOQ)The Limit of Quantificati<strong>on</strong> (LOQ) is the lowest validated residue c<strong>on</strong>centrati<strong>on</strong>, which can bequantified and <str<strong>on</strong>g>report</str<strong>on</strong>g>ed by routine m<strong>on</strong>itoring with validated methods (EC 2009). In the c<strong>on</strong>text of this<str<strong>on</strong>g>report</str<strong>on</strong>g>, when samples are <str<strong>on</strong>g>report</str<strong>on</strong>g>ed as having <strong>residues</strong> below the LOQ it can mean that no <strong>pesticide</strong><strong>residues</strong> occurs or that very low c<strong>on</strong>centrati<strong>on</strong> are present at a level that cannot be quantified withacceptable certainty. In the present <str<strong>on</strong>g>report</str<strong>on</strong>g>, the term Reporting Level (see “Reporting Level” below) isalso used as a syn<strong>on</strong>ym of the LOQ 9 .Reporting Level (RL)The Reporting Level is lowest level at which <strong>residues</strong> will be <str<strong>on</strong>g>report</str<strong>on</strong>g>ed as absolute numbers. It mayrepresent the practical LOQ, or it may be above that level to limit costs. For EU m<strong>on</strong>itoring purposes,where samples for surveys are analysed over a 12-m<strong>on</strong>th period, the same <str<strong>on</strong>g>report</str<strong>on</strong>g>ing limit should beachievable throughout the whole year (EC 2009).Interval of c<strong>on</strong>fidenceSeveral tables show informati<strong>on</strong> <strong>on</strong> frequency (percentage) of e.g. number of samples with <strong>residues</strong>above MRL. The precisi<strong>on</strong> of the value is dependent <strong>on</strong> the sample size. To express the uncertainty ofthe estimati<strong>on</strong>, 95% c<strong>on</strong>fidence intervals were calculated using the Clopper Pears<strong>on</strong> approach with Fdistributi<strong>on</strong> (Johns<strong>on</strong> 2005). The true proporti<strong>on</strong> of samples is most likely equal to the calculatedvalue with 95% c<strong>on</strong>fidence that lies between the upper and lower c<strong>on</strong>fidence limits (UCI and LCI). Itis important to note that when no exceedance of the MRL was observed, there is still the statisticalpossibility that the MRL is exceeded by other samples of the same food commodity. The <strong>on</strong>e-sidedc<strong>on</strong>fidence interval for no observed exceedance describes this possibility.Sampling methodologyTo ensure that a sample taken is representative for a given food lot/c<strong>on</strong>signment, the sampling has tobe performed according to the sampling methodology for the official c<strong>on</strong>trol of <strong>pesticide</strong> <strong>residues</strong>, asestablished by Commissi<strong>on</strong> Directive 2002/63/EC (EC 2002). For most plant products the minimumsize of a laboratory sample is between <strong>on</strong>e or two kilograms of the food item.Sampling strategyThe sampling strategy is the approach used to select the units of the target populati<strong>on</strong> subject toc<strong>on</strong>trol. Implementati<strong>on</strong> of an efficient, targeted sampling strategy would result in a higher percentageof positive findings and n<strong>on</strong>-compliant results. Thus, it is important to stress that, for a correctinterpretati<strong>on</strong> of the results obtained in c<strong>on</strong>trol programmes, informati<strong>on</strong> about the sampling strategyapplied is indispensable. In the <str<strong>on</strong>g>report</str<strong>on</strong>g>, the following terminology has been used to distinguish betweenmore, or less, targeted sampling.Surveillance sampling: samples are collected without any particular suspici<strong>on</strong> towards a particularproducer, c<strong>on</strong>signment, etc. Surveillance samples could be targeted for specific food products andcountries, but the selecti<strong>on</strong> of samples is randomised. The samples taken in the framework of the ECcoordinated programme are c<strong>on</strong>sidered to be surveillance samples.Enforcement sampling: samples are taken if there is suspici<strong>on</strong> about the safety of a product and/or as afollow-up of violati<strong>on</strong>s found previously. The selecti<strong>on</strong> of the samples is not randomised and therefore9In the EU MRL legislati<strong>on</strong>, the term LOD (Limit of Determinati<strong>on</strong>) is used instead of the term of LOQ. However, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>prefers using the term LOQ in order to avoid possible c<strong>on</strong>fusi<strong>on</strong> with the term LOD that is used to indicate the Limit ofDetecti<strong>on</strong>.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164615


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residuescannot be c<strong>on</strong>sidered representative of the food available <strong>on</strong> the <strong>Europe</strong>an market. Follow-up orenforcement sampling is directed to a specific grower/producer or to a specific c<strong>on</strong>signment.Thus, the key difference between surveillance and enforcement sampling is not so much targeting butrandomisati<strong>on</strong> of the selected samples.In Appendix I to the present <str<strong>on</strong>g>report</str<strong>on</strong>g> more details <strong>on</strong> the general sampling strategies applied at nati<strong>on</strong>allevel are <str<strong>on</strong>g>report</str<strong>on</strong>g>ed.Quality assuranceAll laboratories performing analysis of <strong>pesticide</strong> <strong>residues</strong> in food should be accredited to certainstandards (EC 2004). However, until 31 December 2009, these analyses could also be carried out byn<strong>on</strong>-accredited laboratories, provided that the laboratories had initiated the accreditati<strong>on</strong> procedures,and that quality c<strong>on</strong>trol schemes were in place (EC 2005b).Commissi<strong>on</strong> Recommendati<strong>on</strong> <str<strong>on</strong>g>2008</str<strong>on</strong>g>/103/EC (EC <str<strong>on</strong>g>2008</str<strong>on</strong>g>a) requires Member States to provideinformati<strong>on</strong> about the details of accreditati<strong>on</strong> of the laboratories which carry out the analysis for them<strong>on</strong>itoring programme, about the applicati<strong>on</strong> of the EU Quality C<strong>on</strong>trol Procedures for PesticideResidue Analysis (EC 2009) and about their participati<strong>on</strong> in proficiency and ring tests. It also requiresthe <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries c<strong>on</strong>tributing to the m<strong>on</strong>itoring to provide the accreditati<strong>on</strong> certificates.Rapid Alert System for Food and Feed (RASFF)If in c<strong>on</strong>trol activities <strong>pesticide</strong>s are found at a c<strong>on</strong>centrati<strong>on</strong> level of c<strong>on</strong>cern for c<strong>on</strong>sumer health, theRapid Alert System for Food and Feed (RASFF) circulates the informati<strong>on</strong> am<strong>on</strong>g competentauthorities and measures are taken to protect the c<strong>on</strong>sumer. Thus, RASFF is to ensure that urgentnotificati<strong>on</strong>s are sent, received and resp<strong>on</strong>ded to in the shortest time possible by all members of theRASFF (EU Member States, Commissi<strong>on</strong>, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> and Norway, Liechtenstein and Iceland).<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164616


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues2. Design and background <strong>on</strong> the m<strong>on</strong>itoring programmesTo fulfil the requirements of Regulati<strong>on</strong> (EC) No. 882/2004 (EC 2004), EU Member States performofficial c<strong>on</strong>trols to ensure the compliance of feed and food samples with regard to the <strong>pesticide</strong> MRLlegislati<strong>on</strong>.Typically, in each <strong>Europe</strong>an <str<strong>on</strong>g>report</str<strong>on</strong>g>ing country, two m<strong>on</strong>itoring programmes are in place: a nati<strong>on</strong>alc<strong>on</strong>trol/m<strong>on</strong>itoring programme (designed by each country) and a coordinated <strong>Europe</strong>an programmewhich gives clear guidance <strong>on</strong> which specific c<strong>on</strong>trol activities should be performed by the MemberStates.2.1. EU coordinated programmeThe EU coordinated programme aims to provide statistically representative data regarding <strong>pesticide</strong><strong>residues</strong> in food available to <strong>Europe</strong>an c<strong>on</strong>sumers (EC 2005a). The lots sampled should be chosenwithout any particular suspici<strong>on</strong> towards a specific producer and/or c<strong>on</strong>signment. Thus, the resultsobtained in the coordinated programme are c<strong>on</strong>sidered as an indicator for the MRL compliance rate infood placed <strong>on</strong> the <strong>Europe</strong>an comm<strong>on</strong> market and they allow an estimati<strong>on</strong> of the actual c<strong>on</strong>sumerexposure.The establishment of a coordinated community programme was initiated in 1996. Since then, thenumber of participating <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries has increased; in 1996, 15 EU Member States and <strong>on</strong>eEFTA State (Norway) <str<strong>on</strong>g>report</str<strong>on</strong>g>ed their m<strong>on</strong>itoring results, whereas in <str<strong>on</strong>g>2008</str<strong>on</strong>g> the number of participatingcountries was 29: 27 EU Member States and two EFTA countries (Norway and Iceland) who havesigned the Agreement <strong>on</strong> the <strong>Europe</strong>an Ec<strong>on</strong>omic Area (EEA agreement). Over time, the programmewas also extended with regard to the number of samples, the food commodities and the activesubstances to be analysed each m<strong>on</strong>itoring year.The coordinated m<strong>on</strong>itoring programme is laid down in Commissi<strong>on</strong> Recommendati<strong>on</strong> <str<strong>on</strong>g>2008</str<strong>on</strong>g>/103/ECc<strong>on</strong>cerning a coordinated Community m<strong>on</strong>itoring programme for <str<strong>on</strong>g>2008</str<strong>on</strong>g> (EC <str<strong>on</strong>g>2008</str<strong>on</strong>g>a).2.1.1. Food commodities analysedThe major comp<strong>on</strong>ents of the <strong>Europe</strong>an diet are c<strong>on</strong>stituted by 20 to 30 food products. M<strong>on</strong>itoring the<strong>pesticide</strong> <strong>residues</strong> in these commodities should provide a representative basis for estimating theexposure to <strong>pesticide</strong> <strong>residues</strong> in food of <strong>Europe</strong>an c<strong>on</strong>sumers. In view of the resources available atnati<strong>on</strong>al level, participating countries focus <strong>on</strong> the sampling and analysis of eight to nine productseach year, which are tested in a three-year cycle, covering in total the major food items. Foodcommodities to be analysed in <str<strong>on</strong>g>2008</str<strong>on</strong>g>, 2009, and 2010 in the framework of the EU coordinatedprogramme are shown in table 2.1.1-1.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164617


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesTable 2.1.1-1: Food commodities (plant origin) to be m<strong>on</strong>itored in the calendar years <str<strong>on</strong>g>2008</str<strong>on</strong>g>, 2009, and2010 in the framework of the EU coordinated programme (EC <str<strong>on</strong>g>2008</str<strong>on</strong>g>a; EC <str<strong>on</strong>g>2008</str<strong>on</strong>g>b).<str<strong>on</strong>g>2008</str<strong>on</strong>g> 2009 2010Beans without pods (a) Aubergines ApplesCarrots Bananas Head cabbageCucumbers Cauliflower LeekMandarins Grapes LettuceOranges Orange juice (b) Peaches (c)Pears Peas without pods (a) Rye or oatsPotatoes Pepper (sweet) Swine meatRice Wheat StrawberriesSpinach (a)Tomatoes(a): Fresh or frozen(b): For orange juice, <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries should specify the source, e.g. c<strong>on</strong>centrate or fresh fruit(c): Peaches including nectarines and similar hybridsFigure 2.1.1-1 shows the proporti<strong>on</strong> of the food commodities included in the EU coordinated residuem<strong>on</strong>itoring programme for <str<strong>on</strong>g>2008</str<strong>on</strong>g> and the next two years, compared with the total food c<strong>on</strong>sumpti<strong>on</strong> offood items of plant origin. The food c<strong>on</strong>sumpti<strong>on</strong> data were retrieved from nati<strong>on</strong>al food c<strong>on</strong>sumpti<strong>on</strong>surveys either for the whole populati<strong>on</strong>, adults, children or selected c<strong>on</strong>sumer groups (e.g. vegetarians)or other sources of informati<strong>on</strong> suitable to c<strong>on</strong>clude <strong>on</strong> the food habits of the <strong>Europe</strong>an populati<strong>on</strong>such as food balance sheets (e.g. WHO diets). The data regarding the nati<strong>on</strong>al food c<strong>on</strong>sumpti<strong>on</strong> weresubmitted to <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> in the framework of the development of the <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> PRIMo (Pesticide ResidueIntake Model) and the details of the diet in each Member State can be found in the <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> <str<strong>on</strong>g>report</str<strong>on</strong>g> <strong>on</strong>temporary MRLs (<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> 2007). It should be noted that not all participating countries had submittedfood c<strong>on</strong>sumpti<strong>on</strong> data to <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> at that time and therefore are not represented in the graph.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164618


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesDK adultES adultFI adultFR allIE adultIT adultLT adultNL allPL allPT allSE all P90UK adultUK vegetarianWHO <strong>Europe</strong>WHO cluster BWHO cluster DWHO cluster EWHO cluster FDE childDK childES childFR infantFR toddlerIT kidsNL childUK toddlerUK infant0% 20% 40% 60% 80% 100%EU coor.pgm. <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coor.pgm. 2009 EU coor.pgm. 2010 Other plant originFigure 2.1.1-1: C<strong>on</strong>tributi<strong>on</strong> of the commodities covered by the coordinated m<strong>on</strong>itoring programmes to the totalfood intake (excluding products of animal origin and sugar beet).DK adultES adultFI adultFR allIE adultIT adultLT adultNL allPL allPT allSE all P90UK AdultUK vegetarianWHO <strong>Europe</strong>WHO Cluster BWHO cluster DWHO cluster EWHO Cluster FDE childDK childES childFR infantFR toddlerIT childNL childUK ToddlerUK Infant0% 10% 20% 30% 40% 50% 60%Oranges Mandarins PearsPotatoes Carrots CucumbersSpinach Beans (without pods) RiceFigure 2.1.1-2: C<strong>on</strong>tributi<strong>on</strong> of the commodities covered by the coordinated m<strong>on</strong>itoring programme <str<strong>on</strong>g>2008</str<strong>on</strong>g> to thetotal food intake (excluding products of animal origin and sugar beet).<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164619


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesFigure 2.1.1-2 shows the individual c<strong>on</strong>tributi<strong>on</strong>s of the food items included in the <str<strong>on</strong>g>2008</str<strong>on</strong>g> programmefor the same <strong>Europe</strong>an diets.From the c<strong>on</strong>sumpti<strong>on</strong> figures available it is noted that the nine crops selected for the <str<strong>on</strong>g>2008</str<strong>on</strong>g> m<strong>on</strong>itoringprogramme represented 15% to 50% of the total dietary daily intake of products of plant origin,whereas the total c<strong>on</strong>tributi<strong>on</strong> of the crops to be m<strong>on</strong>itored in <str<strong>on</strong>g>2008</str<strong>on</strong>g>, 2009 and 2010 ranged from 39%to 95% of the diets. These data dem<strong>on</strong>strate that the food items selected are representative of the totalfood c<strong>on</strong>sumpti<strong>on</strong> of <strong>Europe</strong>an c<strong>on</strong>sumers and can therefore be used for assessing dietary exposure to<strong>pesticide</strong> <strong>residues</strong> via food.2.1.2. Pesticides analysedThe list of the 78 <strong>pesticide</strong>s (including the relevant metabolites as specified in the residue definiti<strong>on</strong>)which was recommended to be analysed in <str<strong>on</strong>g>2008</str<strong>on</strong>g> in the EU coordinated programme is <str<strong>on</strong>g>report</str<strong>on</strong>g>ed inTable 2.1.2-1. This list has been extended substantially since the start of the coordinated m<strong>on</strong>itoringprogramme in 1996, as it has integrated the findings of nati<strong>on</strong>al c<strong>on</strong>trol programmes, RASFFnotificati<strong>on</strong>s and toxicological profiles of <strong>pesticide</strong>s. The number of <strong>pesticide</strong>s included has increasedfrom nine in 1996 to the 78 included in <str<strong>on</strong>g>2008</str<strong>on</strong>g> (Figure 2.1.2-1).It should be noted that for 65 <strong>pesticide</strong>s analysed in <str<strong>on</strong>g>2008</str<strong>on</strong>g>, harm<strong>on</strong>ised EU MRLs were already in place<strong>on</strong> 1 January <str<strong>on</strong>g>2008</str<strong>on</strong>g>. For the remaining 13 active substances, nati<strong>on</strong>al MRL provisi<strong>on</strong>s were applicableuntil the end of August <str<strong>on</strong>g>2008</str<strong>on</strong>g>. From 1 September <str<strong>on</strong>g>2008</str<strong>on</strong>g>, with the establishment of Annex II and III ofRegulati<strong>on</strong> 396/2005, fully harm<strong>on</strong>ised EU MRLs apply to all <strong>pesticide</strong>s.Number of <strong>pesticide</strong>s9080706050403020100787155 554741 423620 20 201391996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 <str<strong>on</strong>g>2008</str<strong>on</strong>g>Sampling yearFigure 2.1.2-1: Number of <strong>pesticide</strong>s (residue definiti<strong>on</strong>s) included in the EU coordinated m<strong>on</strong>itoringprogramme 1996-<str<strong>on</strong>g>2008</str<strong>on</strong>g>.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164620


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesTable 2.1.2-1: List of <strong>pesticide</strong>s (residue definiti<strong>on</strong> for m<strong>on</strong>itoring) included in the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EUcoordinated m<strong>on</strong>itoring programme.PesticideResidue definiti<strong>on</strong> according to Regulati<strong>on</strong> 396/2005 <strong>on</strong>EU-MRLs (a)EU MRL in place<strong>on</strong> 01/01/<str<strong>on</strong>g>2008</str<strong>on</strong>g>?(y/n)AcephateyAcetamipridAldicarbSum of aldicarb, its sulfoxide and its sulf<strong>on</strong>e, expressed asaldicarbAzinphos-methylyAzoxystrobinyBifenthrinyBromopropylateyBupirimatenBuprofezinnCaptan (b)yCarbarylyCarbendazim and Sum of benomyl and carbendazim expressed as carbendazimybenomylClofentezineyChlormequat (c)yChlorothal<strong>on</strong>ilyChlorpropham Chlorpropham and 3-chloroaniline, expressed as Chlorpropham yChlorpyrifosyChlorpyrifos-methylyCypermethrin Cypermethrin including other mixtures of c<strong>on</strong>stituent isomers(sum of isomers)yCyprodinilnDeltamethrin (cisdeltamethrin)yDiazin<strong>on</strong>yDichlofluanidyDichlorvosyDicofol Sum of p, p' and o,p' isomers yDimethoate and Sum of dimethoate and omethoate, expressed as dimethoateyomethoateDiphenylamineyDithiocarbamates Including maneb, mancozeb, metiram, propineb, thiram andyziram (expressed as CS 2 ) (d)EndosulfanSum of alpha- and beta-isomers and endosulfan-sulphate,expressed as endosulfanyFenarimolyFenhexamidyFenitrothi<strong>on</strong>yFludiox<strong>on</strong>ilnFlusilazoleyFolpet (b)yHexac<strong>on</strong>azoleyHexythiazoxyImazalilyImidaclopridnIndoxacarb Sum of the isomers S and R yIprodi<strong>on</strong>eyIprovalicarbyKresoxim-methylyLambda-cyhalothrinyMalathi<strong>on</strong> Sum of malathi<strong>on</strong> and malaox<strong>on</strong> expressed as malathi<strong>on</strong> yyy<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164621


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesPesticideMepanipyrimMepiquat (c)MetalaxylMethamidophosMethidathi<strong>on</strong>MethiocarbMethomyl andthiodicarbMyclobutanilOxamylOxydemet<strong>on</strong>-methylParathi<strong>on</strong>Penc<strong>on</strong>azolePhosal<strong>on</strong>ePirimicarbResidue definiti<strong>on</strong> according to Regulati<strong>on</strong> 396/2005 <strong>on</strong>EU-MRLs (a)Mepanipyrim and its metabolite (2-anilino-4-(2-hydroxypropyl)-6-methylpyrimidine,) expressed as mepanipyrimMetalaxyl including other mixtures of c<strong>on</strong>stituent isomersincluding metalaxyl-M (sum of isomers)Sum of methiocarb and methiocarb sulfoxide and sulf<strong>on</strong>e,expressed as methiocarbSum of methomyl and thiodicarb expressed as methomylSum of oxydemet<strong>on</strong>-methyl and demet<strong>on</strong>-S-methylsulf<strong>on</strong>eexpressed as oxydemet<strong>on</strong>-methylSum of pirimicarb and desmethyl pirimicarb expressed aspirimicarbEU MRL in place<strong>on</strong> 01/01/<str<strong>on</strong>g>2008</str<strong>on</strong>g>?(y/n)nPirimiphos-methylyProchloraz Sum of prochloraz and its metabolites c<strong>on</strong>taining the 2,4,6-ytrichlorophenol moiety expressed as prochlorazProcymid<strong>on</strong>eyProfenofosyPropargitenPyrethrinsyPyrimethanilyPyriproxyfennQuinoxyfenySpiroxamineyTebuc<strong>on</strong>azolenTebufenozidenThiabendazoleyThiophanate-methylyTolclofos-methylnTolylfluanid Sum of tolylfluanid and dimethylaminosulfo-toluidide expressedyas tolylfluanidTriadimef<strong>on</strong> Sum of triadimef<strong>on</strong> and triadimenol yTrifloxystrobinyVinclozolin Sum of vinclozolin and all metabolites c<strong>on</strong>taining the 3,5-ydichloraniniline moiety, expressed as vinclozolin(a): If not specifically menti<strong>on</strong>ed the residue definiti<strong>on</strong> comprises the parent compound <strong>on</strong>ly.(b): MRL was set as sum of captan and folpet until 1 September <str<strong>on</strong>g>2008</str<strong>on</strong>g>. From that time the MRLs were separate for pomefruit, tomatoes and certain others.(c): Chlormequat and mepiquat should be analysed in carrots, fruiting vegetables (cucumbers) and pears <strong>on</strong>ly.(d) In September <str<strong>on</strong>g>2008</str<strong>on</strong>g> the residue definiti<strong>on</strong> for dithiocarbamates (maneb group) changed from maneb, mancozeb,metiram, propineb and zineb expressed as CS 2 to Dithiocarbamates (dithiocarbamates expressed as CS 2 , includingmaneb, mancozeb, metiram, propineb, thiram and ziram).yyyynyyyyyyyn<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164622


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesComparing the data submitted by the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries with the Recommendati<strong>on</strong>, it becomesevident that some Member States did not analyse the requested <strong>pesticide</strong>s in all samples. 13 <strong>pesticide</strong>swere analysed in less than 50% of the samples, 30 in less than 60% of the samples. These are mainlysubstances which can <strong>on</strong>ly be analysed with single-residue methods and are c<strong>on</strong>sidered to be veryresource c<strong>on</strong>suming. However, it should be noted that in <str<strong>on</strong>g>2008</str<strong>on</strong>g> participati<strong>on</strong> in the EU coordinatedprogramme was not yet mandatory.2.1.3. Number of samplesThe M<strong>on</strong>itoring Recommendati<strong>on</strong> (EC <str<strong>on</strong>g>2008</str<strong>on</strong>g>a) indicates the minimum number of samples to beanalysed in the framework of the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated programme, varying from 12 or 15 to 93samples per product depending <strong>on</strong> the populati<strong>on</strong> of the Member State 10 . Table 2.1.3-1 gives anoverview of the number of samples requested and the actual number of samples taken by each<str<strong>on</strong>g>report</str<strong>on</strong>g>ing country for each commodity.A total number of 11,610 samples of nine different commodities were analysed in the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EUcoordinated <strong>pesticide</strong> m<strong>on</strong>itoring programme (Figure 2.1.3-1).Denmark; 445Portugal; 462Spain; 537Poland; 409Finland; 365Sweden; 380Norway; 362 Slovenia; 318Belgium; 292Ireland; 283Bulgaria; 278Cyprus; 262Czech Republic; 254Greece; 215Hungary; 150Est<strong>on</strong>ia; 121Lithuania; 114Slovakia; 112Austria; 103Latvia; 100Luxembourg; 96Germany; 729Malta; 77Iceland; 46Italy; 1747Romania; 796Netherlands; 808France; 813United Kingdom; 936Figure 2.1.3-1: Number of surveillance samples in <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated programme taken by <str<strong>on</strong>g>report</str<strong>on</strong>g>ing10 The number of samples to be analysed was derived <strong>on</strong> the basis of a binomial probability distributi<strong>on</strong>, which estimated thatthe examinati<strong>on</strong> of 642 samples allows with a certainty of more than 99 %, the detecti<strong>on</strong> of a sample c<strong>on</strong>taining <strong>pesticide</strong><strong>residues</strong> above the limit of determinati<strong>on</strong> (LOD), provided that not less than 1 % of products of plant origin c<strong>on</strong>tain<strong>residues</strong> above that limit. According to Recommendati<strong>on</strong> <str<strong>on</strong>g>2008</str<strong>on</strong>g>/10//EC the collecti<strong>on</strong> of these samples should beapporti<strong>on</strong>ed between Member States <strong>on</strong> the basis of populati<strong>on</strong> and c<strong>on</strong>sumer numbers, with a minimum of 12 samples perproduct and per year.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164623


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residuescountries. Total number of samples: 11,610<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164624


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesTable 2.1.3-1: Number of samples taken by each <str<strong>on</strong>g>report</str<strong>on</strong>g>ing country for the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated programme by commodity.Country Minimum number of Beans Carrots Cucumber Mandarins Oranges Pears Potatoes Rice Spinachsamples percommoditywithoutpods****Austria 12/15* 0 15 15 2 13 16 15 15 12Belgium 12/15* 1 52 21 25 56 42 61 4 30Bulgaria 12/15* 15 48 59 15 16 16 67 15 27Cyprus 12/15* 0 33 30 13 18 29 79 28 32Czech Republic 12/15* 24 38 44 15 27 35 27 24 20Denmark 12/15* 0 55 51 51 85 61 75 28 39Est<strong>on</strong>ia 12/15* 2 21 12 14 0 13 34 12 13Finland 12/15* 4 39 48 54 92 31 35 39 23France 66 2 126 70 80 99 95 155 115 71Germany 93 0 105 94 106 0 121 113 88 102Greece 12/15* 22 27 26 18 25 26 25 23 23Hungary 12/15* 13 15 13 15 18 24 24 13 15Iceland Not specified 0 11 15 9 0 11 0 0 0Ireland 12/15* 15 33 14 59 45 37 47 17 16Italy 65 123 197 104 189 272 343 290 153 76Latvia 12/15* 11 15 15 0 10 15 14 13 7Lithuania 12/15* 16 15 17 5 12 13 13 13 10Luxembourg 12/15* 0 12 12 5 10 13 13 20 11Malta 12/15* 3 13 7 0 15 8 19 0 12Netherlands 17 0 93 149 135 184 91 66 36 54Norway Not specified 0 85 46 32 57 49 46 25 22Poland 45 47 49 50 11 40 50 61 50 51Portugal 12/15* 58 64 51 17 50 54 57 56 55Romania 17 0 89 103 38 142 90 200 68 66Slovakia 12/15* 0 15 14 4 13 18 17 15 16Slovenia 12/15* 8 47 55 13 23 52 84 15 21Spain 45 16 96 69 22 68 110 70 38 48Sweden 12/15* 1 26 29 61 65 62 46 65 25United Kingdom 66 0 96 96 24 95 144 301 72 108Total 381 1530 1329 1032 1550 1669 2054 1060 1005*: The minimum of 12 samples has to be taken if a single residue method has to be applied. Otherwise (i.e. multi residue methods) 15 samples are the minimum.**: The minimum number of samples refers to the sum of mandarins and oranges.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164625


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesIt was noted that for beans without pods, 17 <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries did not <str<strong>on</strong>g>report</str<strong>on</strong>g> the number of samplesas specified in the M<strong>on</strong>itoring Recommendati<strong>on</strong>, probably because this food commodity is notavailable in these countries. <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> therefore recommends replacing beans without pods with analternative food commodity comm<strong>on</strong>ly available in all <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries and which is relevantregarding the food c<strong>on</strong>sumpti<strong>on</strong>. As an alternative product green beans with pods are proposed. Forthe other food commodities most Member States could comply with the M<strong>on</strong>itoring Recommendati<strong>on</strong>sor they even significantly exceeded the number of samples.The <str<strong>on</strong>g>2008</str<strong>on</strong>g> M<strong>on</strong>itoring Recommendati<strong>on</strong>s (EC <str<strong>on</strong>g>2008</str<strong>on</strong>g>a) proposed a list of food commodities, a list of<strong>pesticide</strong>s to be analysed in these commodities and the number of samples of these commodities to beanalysed by each country. From the actual number of determinati<strong>on</strong>s performed in <str<strong>on</strong>g>2008</str<strong>on</strong>g> it can be seenthat the expected number of determinati<strong>on</strong>s (calculated from the recommended number of substancesand the recommended number of samples taken) has not been achieved (Figure 2.1.3-2). This could becaused by resource limitati<strong>on</strong> in the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries or by analytical difficulties. However, itshould be recalled that participati<strong>on</strong> to the EU coordinated m<strong>on</strong>itoring programme was not yetmandatory in <str<strong>on</strong>g>2008</str<strong>on</strong>g>.SpinachRicePotatoesPearsOrangesMandarinsCucumbersCarrotsBeans (without pods)55%73%7638056%8056073%72%12851370%11780076%7843270%10366270%119340285751561040 50000 100000 150000 200000Number of determinati<strong>on</strong>s <str<strong>on</strong>g>report</str<strong>on</strong>g>edExpected number of determinati<strong>on</strong>sFigure 2.1.3-2: Number of actual determinati<strong>on</strong>s <str<strong>on</strong>g>report</str<strong>on</strong>g>ed as a percentage of the expected number for eachcommodity for the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated programme.2.2. Nati<strong>on</strong>al programmesThe official c<strong>on</strong>trols carried out at nati<strong>on</strong>al level in the framework of the nati<strong>on</strong>al m<strong>on</strong>itoringprogrammes are complementary to the c<strong>on</strong>trol performed in the c<strong>on</strong>text of the EU coordinatedprogramme and are performed to ensure compliance with the provisi<strong>on</strong>s established in food legislati<strong>on</strong>regarding <strong>pesticide</strong> <strong>residues</strong>. Member States and EFTA countries are free to decide <strong>on</strong> the design ofthe nati<strong>on</strong>al m<strong>on</strong>itoring programmes for <strong>pesticide</strong> <strong>residues</strong> in food.In designing their nati<strong>on</strong>al c<strong>on</strong>trol plans, the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries typically take into account thefollowing factors:• Importance of a commodity in nati<strong>on</strong>al food c<strong>on</strong>sumpti<strong>on</strong>;<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164626


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues• Food commodities with high <strong>residues</strong>/n<strong>on</strong>-compliance rate in previous years;• Food c<strong>on</strong>sumed fresh or in processed form;• Balance of organic/c<strong>on</strong>venti<strong>on</strong>al producti<strong>on</strong>;• Origin of food: domestic, EU or third countries;• Sampling at different marketing levels: farm gates, wholesaler, retailer, processing industry,schools or restaurants;• Seas<strong>on</strong>al availability of food commodities;• RASFF notificati<strong>on</strong>s;• Food for sensitive groups of the populati<strong>on</strong>, e.g. baby food;• Geographic representatives for the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing country/cultivati<strong>on</strong> area;• Food produced by producers with n<strong>on</strong>-compliance in the past;• Food commodities not included in the EU coordinated programme.Regarding the <strong>pesticide</strong>s included in the nati<strong>on</strong>al c<strong>on</strong>trol programmes, the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countriesc<strong>on</strong>sider:• Use pattern of <strong>pesticide</strong>s;• Toxicity of the active substances;• Cost of the analysis: single methods /multiple methods;• Capacity of laboratories.More details <strong>on</strong> the design of the nati<strong>on</strong>al m<strong>on</strong>itoring programmes are <str<strong>on</strong>g>report</str<strong>on</strong>g>ed in Appendix II of thecurrent <str<strong>on</strong>g>report</str<strong>on</strong>g>. The number of samples and the analytical scope of the analysis performed by theparticipating countries are str<strong>on</strong>gly determined by nati<strong>on</strong>al budgets. Thus, <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries have tofocus <strong>on</strong> specific aspects which are c<strong>on</strong>sidered most relevant for their nati<strong>on</strong>al c<strong>on</strong>trol activities. Theseresults are of value for c<strong>on</strong>sumer exposure assessment at nati<strong>on</strong>al level; however, due to the variabilityof the programme designs, they should not be used for between-country comparis<strong>on</strong>s at <strong>Europe</strong>anlevel or for exposure assessment for the <strong>Europe</strong>an populati<strong>on</strong>.2.2.1. Number of samples – nati<strong>on</strong>al programmesThe total number of samples taken in the c<strong>on</strong>text of the nati<strong>on</strong>al programmes in <str<strong>on</strong>g>2008</str<strong>on</strong>g> was 70,143 11 .Compared with the previous year, this is a decrease of 5.9 %.In Figure 2.2.1-1 the distributi<strong>on</strong> of the total samples taken am<strong>on</strong>g the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries is displayed.11 This figure also comprises the number samples taken for the EU coordinated programme since in many countries thesesamples were analysed for a wider range of active substances than defined in the coordinated programme and thereforebel<strong>on</strong>g to both programmes, the nati<strong>on</strong>al and the EU coordinated programme.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164627


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesNetherlands;4335United Kingdom;2327Greece; 2496Romania; 3174Hungary; 3584France; 5063Finland; 2083 Denmark; 2048 Austria; 1983Belgium; 1709Poland; 1613Sweden; 1600Norway; 1493Slovenia; 1267Ireland; 1014Bulgaria; 971Czech Republic; 919Slovakia; 894Portugal; 758Lithuania; 527Cyprus; 522Est<strong>on</strong>ia; 316Iceland; 277Luxembourg; 139Latvia; 110Malta; 97Germany; 15683Spain; 6353Italy; 6788Figure 2.2.1-1: Total number of samples taken in <str<strong>on</strong>g>2008</str<strong>on</strong>g> by each <str<strong>on</strong>g>report</str<strong>on</strong>g>ing country (surveillance andenforcement samples of fruit, vegetables, cereals, processed commodities and baby food).The number of samples taken by the participating countries, normalised by the populati<strong>on</strong> is depictedin Figure 2.2.1-2<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164628


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesFigure 2.2.1-2: Number of samples taken in <str<strong>on</strong>g>2008</str<strong>on</strong>g> by each <str<strong>on</strong>g>report</str<strong>on</strong>g>ing country (surveillance andenforcement samples of fruit, vegetables, cereals, processed commodities and baby food) normalised bythe nati<strong>on</strong>al populati<strong>on</strong>.Depending <strong>on</strong> the sampling strategy applied, i.e. the degree of targeting in selecting the samples to beanalysed for <strong>pesticide</strong> <strong>residues</strong>, the nati<strong>on</strong>al programmes are classified as either surveillance orenforcement programmes.In the surveillance programmes, samples are taken without any particular suspici<strong>on</strong> towards aspecific producer and/or c<strong>on</strong>signment. The EU coordinated programme is an example of surveillanceprogramme. However, the nati<strong>on</strong>al surveillance programmes are in most cases more targeted toachieve the objectives defined in the nati<strong>on</strong>al c<strong>on</strong>trol programmes and are therefore already focussed<strong>on</strong> specific pre-selected c<strong>on</strong>signments or lots.In <str<strong>on</strong>g>2008</str<strong>on</strong>g>, the majority of the samples taken are classified as surveillance samples (67,887 samples,96.8% of the total number of samples). Table 2.2.1-1 splits them up into the different product groups.Table 2.2.1-1: Number of surveillance samples (food of animal origin not included).Product Sampling strategy No of samplesBabyfood Surveillance 2062Cereals Surveillance 3931Processed Surveillance 3110Fruit and vegetables Surveillance 58784Total surveillance 67887<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164629


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesThe number of surveillance samples taken and normalised per 100,000 inhabitants varied from 3(Poland) to 88 (Iceland) (Figure 2.2.1-2).Figure 2.2.1-2: Number of surveillance samples of fruit, vegetables, cereals normalised by the nati<strong>on</strong>alpopulati<strong>on</strong> (100,000 inhabitants)In enforcement programmes, the probability of finding samples with positive results or samplesexceeding the legal limits is higher than in surveillance programmes in which, by definiti<strong>on</strong>, theselecti<strong>on</strong> of samples is randomised and not directed towards a specific food sample/c<strong>on</strong>signment of adefined populati<strong>on</strong> of a given crop (e.g. apples). Thus, the key difference between surveillance andenforcement sampling is not so much targeting but randomisati<strong>on</strong> of the selected samples.Surveillance samples could be targeted for specific food products and countries, but the selecti<strong>on</strong> ofsamples is randomised. In enforcement sampling the samples are not taken randomly and thereforecannot be c<strong>on</strong>sidered representative of the food item available in the market place. Typically,enforcement samples are collected if there is a suspici<strong>on</strong> about the safety of a product and/or asfollow-up of violati<strong>on</strong>s found previously. Follow-up or enforcement sampling is directed to a specificgrower/produceror to a specific food c<strong>on</strong>signment.The reader should be aware that because of this difference the results <str<strong>on</strong>g>report</str<strong>on</strong>g>ed by different countries<strong>on</strong> the enforcement sampling cannot directly be compared with the results of surveillance sampling.The total number of enforcement samples taken by all <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries was 2,256 (3.2% of the totalnumber of samples). In Table 2.2.1-1, the breakdown of the total enforcement samples according tothe food products is <str<strong>on</strong>g>report</str<strong>on</strong>g>ed.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164630


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesTable 2.2.1-1: Number of enforcement samples (food of animal origin not included).Product Sampling strategy No of samplesBabyfood Enforcement 7Cereals Enforcement 116Processed Enforcement 112Fruit and vegetables Enforcement 2021Total enforcement 2256The distributi<strong>on</strong> of the enforcement samples over the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries can be found in figure 2.2.1-3.Figure 2.2.1-3: Number of enforcement food samples normalised by the nati<strong>on</strong>al populati<strong>on</strong> (100,000inhabitants)2.2.2. Pesticides analysed – nati<strong>on</strong>al programmesIn <str<strong>on</strong>g>2008</str<strong>on</strong>g>, approximately 500 <strong>pesticide</strong>s were authorised for use as plant protecti<strong>on</strong> products in ECMember States 12 . However, more than 1,000 <strong>pesticide</strong>s can potentially be used as plant protecti<strong>on</strong>products worldwide and may result in <strong>residues</strong> in food traded and c<strong>on</strong>sumed in <strong>Europe</strong>.12 Informati<strong>on</strong> from the <strong>Europe</strong>an Commissi<strong>on</strong> database available at: http://ec.europa.eu/sanco_<strong>pesticide</strong>s/public/index.cfm<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164631


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesIn <str<strong>on</strong>g>2008</str<strong>on</strong>g> the number of <strong>pesticide</strong>s sought 13 by the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries, varied from 39 (Bulgaria) to 679(Germany) (Figure 2.2.2-1). The total number of substances covered by all <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries was862. In 2006 and 2007 the analytical methods used for <strong>pesticide</strong> m<strong>on</strong>itoring covered 769 and 870<strong>pesticide</strong>s, respectively. The slight decrease regarding the number of <strong>pesticide</strong>s sought compared withthe previous year is due to the introducti<strong>on</strong> of the standard coding system for <strong>pesticide</strong> names whichavoided double counting of identical <strong>pesticide</strong>s if <str<strong>on</strong>g>report</str<strong>on</strong>g>ed with different spelling (e.g. names <str<strong>on</strong>g>report</str<strong>on</strong>g>edin different languages).The average number of <strong>pesticide</strong>s sought in 2006, 2007 and <str<strong>on</strong>g>2008</str<strong>on</strong>g> were 209, 218 and 235 respectively(Figure 2.2.2-2).Figure 2.2.2-1: The number of <strong>pesticide</strong>s analysed in <str<strong>on</strong>g>2008</str<strong>on</strong>g> by each <str<strong>on</strong>g>report</str<strong>on</strong>g>ing country (surveillance samples<strong>on</strong>ly). It should be noted that the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries did not analyse all the <strong>pesticide</strong>s indicated in the figures inall samples.13 The number of <strong>pesticide</strong>s sought refers to the residue definiti<strong>on</strong>s (see also glossary). Metabolites or degradati<strong>on</strong> productsincluded in a residue definiti<strong>on</strong> are not counted separately.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164632


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues1000900800769870 862Number of <strong>pesticide</strong>s700600500400300200209 218 235Total number of<strong>pesticide</strong>sAverage numberof <strong>pesticide</strong>s10002006 2007 <str<strong>on</strong>g>2008</str<strong>on</strong>g>Sampling yearFigure 2.2.2-2: Total and average number per country of different <strong>pesticide</strong>s sought in nati<strong>on</strong>al and EU <strong>pesticide</strong>m<strong>on</strong>itoring programmes 2006-<str<strong>on</strong>g>2008</str<strong>on</strong>g>.These figures dem<strong>on</strong>strate that <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries made c<strong>on</strong>siderable progress in expanding theiranalytical capacities, which is an important element in guaranteeing food safety. However, it is als<strong>on</strong>oted that in certain <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries there is still a need to further improve the analytical methodsto ensure that the <strong>pesticide</strong>s used <strong>on</strong> food commodities can be analysed and that the competentnati<strong>on</strong>al authorities are able to enforce the <strong>Europe</strong>an <strong>pesticide</strong> residue legislati<strong>on</strong> properly.2.2.3. Food commodities analysed – nati<strong>on</strong>al programmesThe EU MRL legislati<strong>on</strong> lists about 400 agricultural commodities for which MRLs have beenestablished. The commodities have been classified in ten main food categories. These products andproduct groups refer to unprocessed raw commodities of plant or animal origin which are placed <strong>on</strong>the market. The descripti<strong>on</strong> of the commodities and the parts of the products to which the MRLs applycan be found in the Annexes of the basic MRL directives (EEC 1976; EEC 1990; EEC 1986a and EEC1986b) and in Annex I to Regulati<strong>on</strong> (EC) No. 396/2005 (EC 2005a).In <str<strong>on</strong>g>2008</str<strong>on</strong>g>, approximately 200 different food commodities were analysed for <strong>pesticide</strong> <strong>residues</strong> by all<str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries. The number of different raw commodities sampled by the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries isshown in Figure 2.2.3-1.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164633


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesFigure 2.2.3-1: The number of different raw commodities sampled in the nati<strong>on</strong>al and EU programmes by eachcountry (excluding processed and baby food).2.2.4. Baby food m<strong>on</strong>itoringA general default EC MRL of 0.01 mg/kg is applicable for all <strong>pesticide</strong>s, unless specific MRLs lowerthan 0.01 mg/kg are established under the specific EU legislati<strong>on</strong> (see “Background informati<strong>on</strong>”secti<strong>on</strong>) for baby food (Table 2.2.4-1). Table 2.2.4-2 lists the <strong>pesticide</strong>s which shall not be used inagricultural producti<strong>on</strong> intended for the producti<strong>on</strong> of infant and follow-<strong>on</strong> formulae, processed cerealbasedfoods and baby foods for infants and young children. They are c<strong>on</strong>sidered as not used if their<strong>residues</strong> do not exceed 0.003 mg/kg.Table 2.2.4-1: Substances for which specific MRLs lower than 0.01 mg/kg are established for babyfood.Chemical name of the substanceMRL (mg/kg)Cadusafos 0.006Demet<strong>on</strong>-S-methyl/demet<strong>on</strong>-S-methyl sulf<strong>on</strong>e/oxydemet<strong>on</strong>-methyl (individually or 0.006combined, expressed as demet<strong>on</strong>-S-methyl)Ethoprophos 0.008Fipr<strong>on</strong>il (sum of fipr<strong>on</strong>il and fipr<strong>on</strong>il-desulfinyl, expressed as fipr<strong>on</strong>il) 0.004Propineb/propylenethiourea (sum of propineb and propylenethiourea) 0.006<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164634


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesTable 2.2.4.-2: Substances which shall not be used in agricultural producti<strong>on</strong> intended for theproducti<strong>on</strong> of infant formulae and follow-<strong>on</strong> formulae use as baby food.Chemical name of the substance (residue definiti<strong>on</strong>)Aldrin and dieldrin, expressed as dieldrinDisulfot<strong>on</strong> (sum of disulfot<strong>on</strong>, disulfot<strong>on</strong> sulfoxide and disulfot<strong>on</strong> sulf<strong>on</strong>e expressed as disulfot<strong>on</strong>)EndrinFensulfothi<strong>on</strong> (sum of fensulfothi<strong>on</strong>, its oxygen analogue and their sulf<strong>on</strong>es, expressed as fensulfothi<strong>on</strong>)Fentin, expressed as triphenyltin cati<strong>on</strong>Haloxyfop (sum of haloxyfop, its salts and esters including c<strong>on</strong>jugates, expressed as haloxyfop)Heptachlor and trans-heptachlor epoxide, expressed as heptachlorHexachlorobenzeneNitrofenOmethoateTerbufos (sum of terbufos, its sulfoxide and sulf<strong>on</strong>e, expressed as terbufos)In <str<strong>on</strong>g>2008</str<strong>on</strong>g>, a total of 2,062 surveillance samples of baby food were <str<strong>on</strong>g>report</str<strong>on</strong>g>ed by 25 countries (Figure2.2.4-2). Three countries did not include any baby food samples in the c<strong>on</strong>trol programme althoughthe <strong>Europe</strong>an m<strong>on</strong>itoring recommendati<strong>on</strong>s recommended that each Member State should take at leastten samples.Figure 2.2.4-2: Number of baby food samples (total baby food, i.e. infant formulae, fruit based baby foodand cereal based baby food) normalised by the nati<strong>on</strong>al populati<strong>on</strong> (100,000 inhabitants)<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164635


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues2.2.5. Organic food m<strong>on</strong>itoringAt EU level no specific MRLs for organic products have been established, but Council Regulati<strong>on</strong>(EEC) No. 2092/91 <strong>on</strong> organic producti<strong>on</strong> of agricultural products (EC 1991b) defines specificlabelling provisi<strong>on</strong>s and producti<strong>on</strong> methods which entail significant restricti<strong>on</strong>s <strong>on</strong> the use of<strong>pesticide</strong>s which may have detrimental effects <strong>on</strong> the envir<strong>on</strong>ment or result in the presence of <strong>residues</strong>in agricultural products. The products listed in Table 2.2.5-1 may <strong>on</strong>ly be used in cases of immediatethreat to the crop, provided that the products are used in accordance with the provisi<strong>on</strong>s established atMember State level.Table 2.2.5-1: Pesticides that can be used in organic farmingGroup Name Descripti<strong>on</strong>, compositi<strong>on</strong>al requirement,c<strong>on</strong>diti<strong>on</strong>s for useI. Substances of crop or animal originAzadirachtin extracted fromInsecticideAzadirachta indica (Neem tree)Beeswax (a)Pruning agentGelatineInsecticideHydrolysed proteins (a)Attractant, <strong>on</strong>ly in authorized applicati<strong>on</strong>s in combinati<strong>on</strong>with other appropriate products of this listLecithinFungicidePlant oils (e.g. mint oil, pine oil, Insecticide, acaricide, fungicide and sprout inhibitorcaraway oil).Pyrethrins extracted fromInsecticideChrysanthemum cinerariaefoliumQuassia extracted from QuassiaamaraRoten<strong>on</strong>e extracted from Derris spp.and L<strong>on</strong>chocarpu sspp. and Terphrosiaspp.Insecticide, repellentInsecticideII. Micro-organisms used for biological pest and disease c<strong>on</strong>trolMicro-organisms (bacteria, viruses andfungi)IIa. Substances produced by micro-organismsSpinosadInsecticide. Only where measures are taken to minimize therisk to key parasitoids and to minimize the risk ofdevelopment of resistanceIII. Substances to be used in traps and/or dispensersDiamm<strong>on</strong>ium phosphate (a)Attractant, <strong>on</strong>ly in trapsPherom<strong>on</strong>esAttractant; sexual behaviour disrupter; <strong>on</strong>ly in traps anddispensersPyrethroids (<strong>on</strong>ly deltamethrin or Insecticide; <strong>on</strong>ly in traps with specific attractants; <strong>on</strong>lylambdacyhalothrin)against Bactrocera oleae and Ceratitis capitata Wied.IIIa. Preparati<strong>on</strong>s to be surface-spread between cultivated plantsFerric phosphate (ir<strong>on</strong> (III)Molluscicideorthophosphate)IV. Other substances from traditi<strong>on</strong>al use in organic farmingCopper in the form of copperFungicide. Up to 6 kg copper per ha per year. For perennialhydroxide, copper oxychloride, crops, Member States may, by derogati<strong>on</strong> from the(tribasic) copper sulphate, cuprous previous paragraph, provide that the 6 kg copper limit canoxide,copper octanoatebe exceeded in a given year provided that the averagequantity actually used over a 5-year period c<strong>on</strong>sisting ofthat year and of the four preceding years does not exceed 6kgEthylene (a)Degreening bananas, kiwis and kakis; Degreening of citrusfruit <strong>on</strong>ly as part of a strategy for the preventi<strong>on</strong> of fruit fly<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164636


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesGroup Name Descripti<strong>on</strong>, compositi<strong>on</strong>al requirement,c<strong>on</strong>diti<strong>on</strong>s for usedamage in citrus; Flower inducti<strong>on</strong> of pineapple; sproutinginhibiti<strong>on</strong> in potatoes and <strong>on</strong>i<strong>on</strong>sFatty acid potassium salt (soft soap) InsecticidePotassium aluminium (aluminium Preventi<strong>on</strong> of ripening of bananassulphate) (Kalinite) (a)Lime sulphur (calcium polysulphide) Fungicide, insecticide, acaricideParaffin oilInsecticide, acaricideMineral oilsInsecticide, fungicide; <strong>on</strong>ly in fruit trees, vines, olive treesand tropical crops (e.g. bananas)Quartz sand (a)RepellentSulphurFungicide, acaricide, repellent7. Other substancesCalcium hydroxideFungicide. Only in fruit trees, including nurseries, toc<strong>on</strong>trol Nectria galligenaPotassium bicarb<strong>on</strong>ateFungicide(a): In some countries the product is not categorized as a plant protecti<strong>on</strong> product.The <strong>Europe</strong>an Commissi<strong>on</strong> recommended taking at least <strong>on</strong>e sample originating from organic farmingof beans (fresh or frozen, without pod) carrots, cucumbers, oranges or mandarins, pears, potatoes, riceand spinach (i.e. the products covered by the coordinated programme). The percentage of samples oforganic farming should reflect the market share of organic produce in each Member State.In <str<strong>on</strong>g>2008</str<strong>on</strong>g>, a total of 3,131 samples of organic origin were taken by a total of 22 countries (Table 2.2.5-2and Figure 2.2.5-1).Table 2.2.5-2: Number of samples of the nati<strong>on</strong>al and EU coordinated m<strong>on</strong>itoring programmes for<strong>pesticide</strong> <strong>residues</strong> in organic food (surveillance and enforcement samples) in <str<strong>on</strong>g>2008</str<strong>on</strong>g>ProductNumber of samples analysedBaby food 150Cereals 335Processed food 167Fruit and vegetables 2479Total 3131<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164637


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesFigure 2.2.5-1: Number of organic food samples normalised by the nati<strong>on</strong>al populati<strong>on</strong> (100,000inhabitants) and <str<strong>on</strong>g>report</str<strong>on</strong>g>ed in the framework of Regulati<strong>on</strong> (EC) No 396/2005.In some of the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries the producti<strong>on</strong> type was not recorded in the nati<strong>on</strong>al datamanagement systems used to handle the sample informati<strong>on</strong> 14 . Therefore it is assumed that moresamples were taken and analysed but could not be <str<strong>on</strong>g>report</str<strong>on</strong>g>ed accordingly.2.2.6. Processed-food m<strong>on</strong>itoringFor processed or composite food commodities, the MRLs established in the MRL legislati<strong>on</strong> for rawcommodities are applicable, taking into account changes in the levels and the nature of <strong>pesticide</strong><strong>residues</strong> caused by processing or mixing (processing factors).Annex VI of Regulati<strong>on</strong> (EC) No 396/2005 (EC 2005a), which will include processing factors forprocessed products, has not yet been established but other sources provide summary informati<strong>on</strong> <strong>on</strong>the fate of <strong>pesticide</strong>s under processing c<strong>on</strong>diti<strong>on</strong>s. These sources can be c<strong>on</strong>sidered to enforce the legalprovisi<strong>on</strong>s in processed food (e.g. a German database developed by the Federal Institute for RiskAssessment 15 ).In <str<strong>on</strong>g>2008</str<strong>on</strong>g>, a total of 3,110 samples of processed products were taken by 23 countries. This is 5% of thetotal surveillance samples. The sampling of processed products in the individual <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries isoutlined in Figure 2.2.6-1.14 Belgium has taken organic food samples but has <str<strong>on</strong>g>report</str<strong>on</strong>g>ed the results of their analysis in the framework of another EUlegislati<strong>on</strong> (i.e. Regulati<strong>on</strong>s EC No 834/2007, 889/<str<strong>on</strong>g>2008</str<strong>on</strong>g> and 1235/<str<strong>on</strong>g>2008</str<strong>on</strong>g>) and not in the framework of Regulati<strong>on</strong> 396/2005.15 The database is available at http://www.bfr.bund.de/cd/579 (BfR compilati<strong>on</strong> of 2009-07-01).<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164638


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesFigure 2.2.6-1: Number of processed food samples normalised by the nati<strong>on</strong>al populati<strong>on</strong> (100,000inhabitants)2.2.7. Origin of samplesNati<strong>on</strong>al programmes cover samples originating from nati<strong>on</strong>al, Community and third countryproducti<strong>on</strong> (Figure 2.2.7-1). The majority of samples taken were produced in <strong>on</strong>e of the <str<strong>on</strong>g>report</str<strong>on</strong>g>ingcountries (77%). 20% of the samples were taken from imported c<strong>on</strong>signments or lots. In 3% of thesamples the origin of the samples was not <str<strong>on</strong>g>report</str<strong>on</strong>g>ed.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164639


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesImported20%Unknown3%EU77%Figure 2.2.7-1: Origin of samples (EU: EU, Iceland and Norway; Imported: third countries); surveillance andenforcement samples of fruit, vegetables, cereals, processed commodities and baby food.The data submitted by the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries dem<strong>on</strong>strate that the ratio of samples with EUprovenience and samples imported from third countries varied significantly; this ratio is affected bythe percentage of imported food c<strong>on</strong>sumed in a specific country (e.g. in the Nordic countries). Inadditi<strong>on</strong>, some countries focus their nati<strong>on</strong>al m<strong>on</strong>itoring programmes <strong>on</strong> domestic producti<strong>on</strong>. Finally,the level of enforcement sampling can affect this value: in the case of e.g. Lithuania, the majority ofimported samples come from enforcement sampling of fruit and vegetables (Figure 2.2.7-2).<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164640


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesFigure 2.2.7-2: Ratio of samples from EU to samples from third countries from surveillance programmesin <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries2.3. Quality assuranceIn accordance with Art. 12 of Regulati<strong>on</strong> 882/2004 (EC 2004), laboratories designated for officialc<strong>on</strong>trols must be accredited to ISO/IEC 17025 (ISO 2005), or make use of the derogati<strong>on</strong> in Art. 18 ofRegulati<strong>on</strong> 2076/2005 (EC 2005b). N<strong>on</strong>-accredited laboratories must, as a minimum, have a qualitysystem as described in document SANCO/3131/2007 (EC 2007b) <strong>on</strong> “Method Validati<strong>on</strong> and QualityC<strong>on</strong>trol Procedures for Pesticide Residues Analysis in Food and Feed”.In <str<strong>on</strong>g>2008</str<strong>on</strong>g>, the majority of countries used accredited laboratories for the m<strong>on</strong>itoring programmes, but inseven countries <strong>on</strong>e or more n<strong>on</strong>-accredited laboratory analysed some or all of the samples (Figure2.3-1).Since the exempti<strong>on</strong> for n<strong>on</strong>-accredited laboratories expired at the end of 2009 (Art. 1 of Regulati<strong>on</strong>(EC) No 2076/2005 (EC 2005b)), it is important that all laboratories c<strong>on</strong>tributing to the EUm<strong>on</strong>itoring programmes make efforts to obtain accreditati<strong>on</strong>.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164641


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesBulgariaFranceGreeceItalyPortugalRomaniaSpain0%0%28%50%49%56%64%68%71%83%78%81%83%98%0% 20% 40% 60% 80% 100%% laboratories accredited % samples analysed accreditedFigure 2.3-1: Status in <str<strong>on</strong>g>2008</str<strong>on</strong>g> for those c<strong>on</strong>tributing countries where not all samples were analysed byaccredited laboratories.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164642


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues3. Results of the EU-coordinated m<strong>on</strong>itoring programme3.1. Overall results for MRL exceedancesThe analysis of the results of the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU-coordinated programme shows that 2.2% of the samplesexceeded the MRL, while 36% of samples had measurable <strong>residues</strong> above the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing level, butbelow or at the MRL. In 62% of the samples no <strong>residues</strong> were measured (Figure 3.1-1).Nomeasurable<strong>residues</strong>62.1%≤ MRL35.7%> MRL2.2%Figure 3.1-1: Overall frequency of samples with and without measurable <strong>residues</strong> in the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinatedprogram (≤MRL: Samples with measurable <strong>residues</strong> below or at the MRL; >MRL: Samples with <strong>residues</strong> abovethe MRL). Total number of samples: 11610The overall <str<strong>on</strong>g>2008</str<strong>on</strong>g> MRL exceedance rate was comparable with the previous year’s rate (2.3%). It isnoted that the percentage of samples without measurable <strong>residues</strong> significantly increased from 52.7%in 2007 to 62.1% in <str<strong>on</strong>g>2008</str<strong>on</strong>g>. However, it should be noted that in the previous m<strong>on</strong>itoring programmedifferent food commodities were sampled and analysed and the MRL exceedance rate is dependent <strong>on</strong>the combinati<strong>on</strong> of crops analysed in the EU programme.In 2005 and <str<strong>on</strong>g>2008</str<strong>on</strong>g> the same food commodities were analysed under the EU coordinated programmes,but the number of <strong>pesticide</strong>s to be m<strong>on</strong>itored increased from 55 in 2005 to 78 in <str<strong>on</strong>g>2008</str<strong>on</strong>g>. A comparis<strong>on</strong>of the results obtained in these two years showed an increase regarding the overall percentage ofsamples without measurable <strong>residues</strong> (58% in 2005 to 62% in <str<strong>on</strong>g>2008</str<strong>on</strong>g>). C<strong>on</strong>sidering the wider scope ofthe m<strong>on</strong>itoring programme and a general improvement in the sensitivity of analytical methods anincrease of the rate of samples with measurable <strong>residues</strong> would be expected. Furthermore, a slightdecrease in the overall MRL exceedance rate from 2.8% in 2005 to 2.2% in <str<strong>on</strong>g>2008</str<strong>on</strong>g> was observed. Apossible explanati<strong>on</strong> of these positive trends is the implementati<strong>on</strong> of the general provisi<strong>on</strong>s of thefood law (Regulati<strong>on</strong> (EC) No. 178/2002) which imposes the resp<strong>on</strong>sibility <strong>on</strong> food business operatorsat all stages of producti<strong>on</strong>, processing and distributi<strong>on</strong> to ensure that food satisfies the legalrequirements by implementing appropriate c<strong>on</strong>trol systems. The lower MRL exceedance rate may alsopartially be ascribed to the new harm<strong>on</strong>ised EU legal limits. However, the impact of the new legal<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164643


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residueslimits <strong>on</strong> the m<strong>on</strong>itoring findings will be best evaluated by assessing future m<strong>on</strong>itoring data, startingfrom the 2009 m<strong>on</strong>itoring results.3.2. Results by countryThe MRL exceedance rate, as <str<strong>on</strong>g>report</str<strong>on</strong>g>ed by each country, is depicted in Figure 3.2-1. It is noted that therates vary greatly am<strong>on</strong>g the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries, ranging from 0% to 12% of the samples analysed.The reas<strong>on</strong> for this significant variati<strong>on</strong> could be ascribed not <strong>on</strong>ly to the difference in the occurrenceof the <strong>residues</strong> measured in the samples taken by the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries, but also to the difference inthe different nati<strong>on</strong>al MRLs applicable in the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries in <str<strong>on</strong>g>2008</str<strong>on</strong>g>, the analytical performancesof the nati<strong>on</strong>al laboratories, and the scope of the analytical methods in the countries (see Figure 2.2.2-1 and Table 2.1.2-1). More details <strong>on</strong> findings <strong>on</strong> the nine commodities analysed in the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EUcoordinated programme are <str<strong>on</strong>g>report</str<strong>on</strong>g>ed in Tables G, H and I of Appendix III.Figure 3.2-1: Rate of MRL-exceeding samples in the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated programme by country.3.3. Results by food commodityNine food commodities were analysed in the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated m<strong>on</strong>itoring programme. Thehighest percentage of samples exceeding the MRL was identified for spinach (6.2%) followed byoranges (3.0%), rice (2.4%), cucumbers (2.1%), mandarins (2.0%), carrots (1.8%), pears (1.6%), beanswithout pods (0.8%) and potatoes (0.5%).<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164644


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesMandarins had the highest percentage of samples with measured <strong>pesticide</strong> <strong>residues</strong> below or at MRLs(78%) followed by 66% of the orange samples and 57% of the pears. Samples of cucumbers, potatoes,spinach, rice, carrots and beans without pods c<strong>on</strong>tained measurable <strong>residues</strong> at or below the MRL lessfrequently (Figure 3.3-1). Furthermore, the proporti<strong>on</strong> of samples with measurable <strong>residues</strong> is higherin fruit crops (67.9%) than vegetables (21.2%). The same was observed with the commodity sampledin the framework of the 2007 EU coordinated programme where other food commodities were tested.Spinach78.5%15.3%6.2%Oranges30.8%66.2%3.0%Rice83.7%13.9%2.4%Cucumbers69.2%28.7%2.1%MandarinsCarrots20.2%84.5%77.8%13.7%2.0%1.8%Pears40.8%57.6%1.6%Beans (without pods)91.1%8.1%0.8%Potatoes78.5%21.0%0.5%0% 20% 40% 60% 80% 100%No measurable <strong>residues</strong>Measurable <strong>residues</strong> below or at the MRLResidues above the MRLFigure 3.3-1: Percentage of samples with no measurable <strong>residues</strong>, with measurable <strong>residues</strong> below or at theMRL and with <strong>residues</strong> above the MRL (nati<strong>on</strong>al or EC MRL) for the nine food commodities analysed in the<str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated m<strong>on</strong>itoring programme. Total number of samples: 11,610.Compared with the results of the 2005 EU coordinated m<strong>on</strong>itoring, where the same food commoditieswere analysed, a general trend is observed towards a higher percentage of samples without detectable<strong>residues</strong>.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164645


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesSpinachOrangesRiceCucumbersMandarinsCarrotsPearsBeans (without pods)Potatoes20%18%31%27%29%41%79%78%84%80%69%69%85%79%64%79%73%91%0% 20% 40% 60% 80% 100%<str<strong>on</strong>g>2008</str<strong>on</strong>g> 2005Figure 3.3-2: Percentage of samples with no measurable <strong>residues</strong> for the nine food commodities analysed in the2005 and <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated m<strong>on</strong>itoring programmes.The increased percentage of samples free of measurable <strong>residues</strong> is surprising since the scope of thecoordinated programme has been extended and analytical methods have been improved with regard totheir sensitivity. Having more active substances in the programme would increase the probability ofpositive findings. More sensitive methods allow detecti<strong>on</strong> of even lower c<strong>on</strong>centrati<strong>on</strong>s of <strong>pesticide</strong><strong>residues</strong> in samples which would not be detectable with less sophisticated analytical methods.The percentage of samples exceeding the MRLs has increased for some commodities (rice, carrots,cucumbers and pears), whereas for spinach, potatoes, oranges and mandarins the percentage ofsamples exceeding the MRLs has decreased. For beans a direct comparis<strong>on</strong> is not possible since in2005 also French beans were sampled. In Figure 3.3-3 the comparis<strong>on</strong> of the MRL exceedanceobserved in 2005 and <str<strong>on</strong>g>2008</str<strong>on</strong>g> is depicted.The increased number of MRL exceedances for rice, carrots, cucumbers and pears seems to bealarming. However, many MRLs have changed between 2005 and <str<strong>on</strong>g>2008</str<strong>on</strong>g> (e.g. significant changes havebeen introduced with the harm<strong>on</strong>isati<strong>on</strong> of MRLs in September <str<strong>on</strong>g>2008</str<strong>on</strong>g>). Therefore the MRL exceedancerate is a relative parameter depending <strong>on</strong> the level of the MRLs established during the referenceperiod. A detailed analysis of the development of the individual 495 MRLs for the 55 <strong>pesticide</strong>/cropcombinati<strong>on</strong>s for which data from 2005 and corresp<strong>on</strong>ding data in <str<strong>on</strong>g>2008</str<strong>on</strong>g> are available would berequired to c<strong>on</strong>clude if the situati<strong>on</strong> has deteriorated since 2005. However, since the individual residuec<strong>on</strong>centrati<strong>on</strong>s measured in 2005 are not available, this analysis is not possible. <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> is of the opini<strong>on</strong>that, instead of the MRL exceedance rates, the results of the exposure assessments are a betterindicator by which to observe trends in human exposure to <strong>pesticide</strong> <strong>residues</strong> (see secti<strong>on</strong> 5).<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164646


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesSpinachOrangesRiceCucumbersMandarinsCarrotsPearsBeans (without pods)Potatoes3.0%1.2%2.4%1.2%2.1%1.9%2.0%2.7%1.8%1.4%1.6%0.8%0.8%0.5%1.2%6.2%6.6%8.4%0.0% 2.0% 4.0% 6.0% 8.0% 10.0%<str<strong>on</strong>g>2008</str<strong>on</strong>g> 2005Figure 3.3-3: Percentage of samples with <strong>residues</strong> above the MRL for the nine food commodities analysed inthe 2005 and <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated m<strong>on</strong>itoring programmes.3.4. Results by <strong>pesticide</strong>-commodity combinati<strong>on</strong>In this secti<strong>on</strong> (Figures 3.4-1 to 3.4-9) more detailed findings for the nine commodities covered by thecoordinated programme are <str<strong>on</strong>g>report</str<strong>on</strong>g>ed. The charts present the percentage of samples c<strong>on</strong>taining <strong>residues</strong>of the 78 <strong>pesticide</strong>s included in the programme: the orange bars relate to the upper scale (0 – 1%) andshow the percentage of samples with <strong>residues</strong> above the MRL. The blue bars relate to the lower scale(0 – 10%) and show the percentage of samples with measurable <strong>residues</strong> above the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing limit, butbelow the MRL. For each commodity, the <strong>pesticide</strong>s found in that commodity are sorted according tothe frequency of samples with residue findings above the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing limit (including samples with<strong>residues</strong> above the quantificati<strong>on</strong> level and above the MRL).It should be noted that not all samples have been analysed for all active substances. For this reas<strong>on</strong>, thesame number of samples with detecti<strong>on</strong> or instances of exceedance can result in different frequencieswithin the same commodity.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164647


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesBeans (without pods)% samples with <strong>residues</strong> above MRL0.0% 0.2% 0.4% 0.6% 0.8% 1.0%AzoxystrobinCyprodinilPyrethrinsDichlofluanidDithiocarbamatesEndosulfan (sum)ThiabendazoleCypermethrin (sum)Procymid<strong>on</strong>eTriadimef<strong>on</strong> (sum)PyrimethanilLambda‐CyhalothrinCaptan/Folpet (sum)Iprodi<strong>on</strong>eChlorpyrifosMalathi<strong>on</strong> (sum)0% 2% 4% 6% 8% 10%% samples with measurable <strong>residues</strong> below or at the MRLFigure 3.4-1: Percentage of samples of beans (without pods) above the MRL (upper scale) or with measurable<strong>residues</strong> below or at the MRL (lower scale) by <strong>pesticide</strong> for the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated programme. Totalnumber of samples: 381.In beans without pods, 16 different <strong>pesticide</strong>s were found in measurable amounts in the 381 samples.The most frequent active substances found were azoxystrobin, cyprodinil and pyrethrins. Onlyprocymid<strong>on</strong>e (two samples) and iprodi<strong>on</strong>e (<strong>on</strong>e sample) were found to exceed the MRL; the MRLs forboth substances are at the LOQ, so no <strong>residues</strong> for these <strong>pesticide</strong>s were found below the MRL.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164648


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesCarrots% samples with <strong>residues</strong> above MRL0.0% 0.2% 0.4% 0.6% 0.8% 1.0%Tebuc<strong>on</strong>azoleIprodi<strong>on</strong>eAzoxystrobinChlorpyrifosTolclofos‐methylDithiocarbamatesPyrimethanilPyrethrinsDimethoate (sum)Chlorothal<strong>on</strong>ilMetalaxyl (sum)Procymid<strong>on</strong>eChlorpyrifos‐methylVinclozolin (sum)Endosulfan (sum)Malathi<strong>on</strong> (sum)Methiocarb (sum)Diazin<strong>on</strong>CaptanMyclobutanilTriadimef<strong>on</strong> (sum)IprovalicarbOxamylMethomyl (sum)TrifloxystrobinThiabendazoleFolpetFludiox<strong>on</strong>ilBuprofezinImazalilMethamidophosCyprodinilKresoxim‐methylChlorpropham (sum)0% 2% 4% 6% 8% 10%% samples with measurable <strong>residues</strong> below or at the MRLFigure 3.4-2: Percentage of samples of carrots above the MRL (upper scale) or with measurable <strong>residues</strong>below or at the MRL (lower scale) by <strong>pesticide</strong> for the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated programme. Total number ofsamples: 1,530.In total, 34 different <strong>pesticide</strong>s were found in 1,530 samples of carrots. The most frequently foundactive substances were tebuc<strong>on</strong>azole, iprodi<strong>on</strong>e and azoxystrobin. MRL exceedances were observedfor eight active substances. Chlorpyrifos (0.7%, 10 samples) and iprodi<strong>on</strong>e (0.6%, 8 samples) showedthe highest rate of exceedance. Exceedances were also found for dimethoate, procymid<strong>on</strong>e,chlorpyriphos-methyl, endosulfan, diazin<strong>on</strong> and folpet (1 – 3 samples each).<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164649


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesCucumbers% samples with <strong>residues</strong> above MRL0.0% 0.2% 0.4% 0.6% 0.8% 1.0%AzoxystrobinChlorothal<strong>on</strong>ilDithiocarbamatesProcymid<strong>on</strong>eMetalaxyl (sum)CyprodinilIprodi<strong>on</strong>eImidaclopridCarbendazim and benomylPyrimethanilTriadimef<strong>on</strong> (sum)Fludiox<strong>on</strong>ilCypermethrin (sum)Methomyl (sum)Endosulfan (sum)BupirimateImazalilMethiocarb (sum)ChlormequatOxamylMyclobutanilFenhexamidAcetamipridIndoxacarbKresoxim‐methylThiophanate‐methylBifenthrinChlorpyrifosVinclozolin (sum)ThiabendazolePirimicarb (sum)Penc<strong>on</strong>azoleDimethoate (sum)SpiroxamineTrifloxystrobinBuprofezinPyrethrinsMethamidophosTolylfluanidTebufenozideChlorpyrifos‐methylClofentezineHexythiazoxMepanipyrimHexac<strong>on</strong>azoleCaptanLambda‐CyhalothrinMalathi<strong>on</strong> (sum)BromopropylatePirimiphos‐methyl0% 2% 4% 6% 8% 10%% samples with measurable <strong>residues</strong> below or at the MRLFigure 3.4-3: Percentage of samples of cucumbers above the MRL (upper scale) or with measurable <strong>residues</strong>below or at the MRL (lower scale) by <strong>pesticide</strong> for the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated programme. Total number ofsamples: 1,329.In total, 50 different <strong>pesticide</strong>s were found in 1,329 cucumber samples. The most frequent foundactive substances were azoxystrobin, chlorothal<strong>on</strong>il and dithiocarbamates. MRL exceedances wereobserved for 14 active substances. The highest rate of exceedance was found forcarbendazim/benomyl and methomyl (0.6%, 5 samples each).<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164650


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesMandarins% samples with <strong>residues</strong> above MRL0.0% 0.2% 0.4% 0.6% 0.8% 1.0%Imazalil72%Chlorpyrifos47%Thiabendazole35%Malathi<strong>on</strong> (sum)21%Pyriproxyfen12%ProchlorazDithiocarbamatesDicofolCarbendazim and benomylHexythiazoxMethidathi<strong>on</strong>ImidaclopridChlorpyrifos‐methylBromopropylateMyclobutanilLambda‐CyhalothrinBuprofezinPyrimethanilPropargitePirimiphos‐methylCarbarylCypermethrin (sum)Endosulfan (sum)AzoxystrobinPhosal<strong>on</strong>eFenitrothi<strong>on</strong>Metalaxyl (sum)Dimethoate (sum)ClofentezineDiphenylamineVinclozolin (sum)Tebuc<strong>on</strong>azoleAzinphos‐methylIprodi<strong>on</strong>eAcetamipridThiophanate‐methylProfenofosCyprodinilChlorpropham (sum)BifenthrinParathi<strong>on</strong>DeltamethrinDiazin<strong>on</strong>Procymid<strong>on</strong>e0% 2% 4% 6% 8% 10%% samples with measurable <strong>residues</strong> below or at the MRLFigure 3.4-4: Percentage of samples of mandarins above the MRL (upper scale) or with measurable <strong>residues</strong>below or at the MRL (lower scale) by <strong>pesticide</strong> for the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated programme. Total number ofsamples: 1,032.In mandarins (1,032 samples) 44 different <strong>pesticide</strong>s were detected – some of these in quite highfrequencies: Imazalil, chlorpyriphos, thiabendazole, malathi<strong>on</strong> and pyriproxyfen were all found inmore than 10% of the samples; imazalil in 72%. Eight different <strong>pesticide</strong>s were found inc<strong>on</strong>centrati<strong>on</strong>s exceeding the MRL. Imazalil was also found to exceed the MRL in eight samples(0.9%) and carbaryl exceeded the MRL in five samples (0.6%).<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164651


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesImazalilThiabendazoleChlorpyrifosMalathi<strong>on</strong> (sum)ImidaclopridProchlorazMethidathi<strong>on</strong>PyriproxyfenBromopropylateDithiocarbamatesDicofolLambda‐CyhalothrinCarbendazim and benomylPirimiphos‐methylPropargiteChlorpyrifos‐methylTrifloxystrobinDiazin<strong>on</strong>Dimethoate (sum)AzoxystrobinMyclobutanilCypermethrin (sum)PyrimethanilProfenofosCarbarylBuprofezinDeltamethrinMetalaxyl (sum)Fenitrothi<strong>on</strong>AcetamipridHexythiazoxPhosal<strong>on</strong>eThiophanate‐methylCaptanFludiox<strong>on</strong>ilIprodi<strong>on</strong>eEndosulfan (sum)Methomyl (sum)Hexac<strong>on</strong>azoleFolpetFenhexamidDiphenylaminePirimicarb (sum)BifenthrinDichlofluanidChlorpropham (sum)Oranges% samples with <strong>residues</strong> above MRL0.0% 0.2% 0.4% 0.6% 0.8% 1.0%70%40%29%0% 2% 4% 6% 8% 10%% samples with measurable <strong>residues</strong> below or at the MRLFigure 3.4-5: Percentage of samples of oranges above the MRL (upper scale) or with measurable <strong>residues</strong>below or at the MRL (lower scale) by <strong>pesticide</strong> for the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated programme. Total number ofsamples: 1,550.In oranges, 46 different <strong>pesticide</strong>s were detected in 1,550 samples analysed - three of these (imazalil,thiabendazole and chlorpyrifos) in more than 10% of the samples. Imazalil was found in 70% of theoranges. 14 different <strong>pesticide</strong>s were found in c<strong>on</strong>centrati<strong>on</strong>s exceeding the MRLs. The highest ratesof exceedance (0.9 – 1.0%) were found for diazin<strong>on</strong> and dimethoate.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164652


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesDithiocarbamatesChlorpyrifosCarbendazim and benomylCaptan/Folpet (sum)ChlormequatDiphenylamineThiabendazoleAzinphos‐methylImazalilIprodi<strong>on</strong>eThiophanate‐methylImidaclopridCyprodinilIndoxacarbTrifloxystrobinFludiox<strong>on</strong>ilAcetamipridTebuc<strong>on</strong>azoleLambda‐CyhalothrinChlorpyrifos‐methylCypermethrin (sum)Malathi<strong>on</strong> (sum)PyrimethanilKresoxim‐methylBifenthrinMethomyl (sum)Procymid<strong>on</strong>eTebufenozideChlorothal<strong>on</strong>ilPhosal<strong>on</strong>eHexythiazoxBuprofezinDeltamethrinBromopropylatePirimicarb (sum)PyrethrinsDichlofluanidDimethoate (sum)Diazin<strong>on</strong>CarbarylPropargiteEndosulfan (sum)Methidathi<strong>on</strong>Chlorpropham (sum)Triadimef<strong>on</strong> (sum)TolylfluanidAcephateMyclobutanilFenitrothi<strong>on</strong>IprovalicarbClofentezineFenarimolDicofolPenc<strong>on</strong>azoleMetalaxyl (sum)Pears% samples with <strong>residues</strong> above MRL0.0% 0.2% 0.4% 0.6% 0.8% 1.0%0% 2% 4% 6% 8% 10%% samples with measurable <strong>residues</strong> below or at the MRLFigure 3.4-6: Percentage of samples of pears above the MRL (upper scale) or with measurable <strong>residues</strong>below or at the MRL (lower scale) by <strong>pesticide</strong> for the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated programme. Total number ofsamples: 1,669.39%17%15%14%13%13%In pears, 55 different <strong>pesticide</strong>s have been detected. The most frequent <strong>pesticide</strong>s weredithiocarbamates, chlorpyrifos and carbendazim (including benomyl). 13 different <strong>pesticide</strong>s werefound in c<strong>on</strong>centrati<strong>on</strong>s exceeding the MRLs. Chlormequat was found to exceed the MRL in foursamples (0.9%). Five samples (0.3%) exceeded the MRL for diazin<strong>on</strong>.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164653


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesPotatoes% samples with <strong>residues</strong> above MRL0.0% 0.2% 0.4% 0.6% 0.8% 1.0%Chlorpropham21%DithiocarbamatesMetalaxyl (sum)ImidaclopridAzoxystrobinChlorpyrifosImazalilThiabendazoleDiphenylamineMalathi<strong>on</strong> (sum)OxamylCarbarylEndosulfan (sum)Methomyl (sum)Methiocarb (sum)MethamidophosVinclozolin (sum)Tebuc<strong>on</strong>azoleDichlofluanidDeltamethrinDimethoate (sum)Fenitrothi<strong>on</strong>Pirimiphos‐methyl0% 2% 4% 6% 8% 10%% samples with measurable <strong>residues</strong> below or at the MRLFigure 3.4-7: Percentage of samples of potatoes above the MRL (upper scale) or with measurable <strong>residues</strong>below or at the MRL (lower scale) by <strong>pesticide</strong> for the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated programme. Total number ofsamples: 2,054.In potatoes, 23 different <strong>pesticide</strong>s were found (2,054 samples). The most frequent <strong>pesticide</strong>s foundwere chlorpropham (in 21% of the samples), dithiocarbamates and metalaxyl. MRL exceedances wereobserved for seven active substances.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164654


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesRice% samples with <strong>residues</strong> above MRL0.0% 0.2% 0.4% 0.6% 0.8% 1.0%Pirimiphos‐methylCarbendazim and benomyl2.2%Tebufenozide1.5%DeltamethrinTebuc<strong>on</strong>azoleImidaclopridAzoxystrobinMalathi<strong>on</strong> (sum)ChlorpyrifosHexac<strong>on</strong>azoleAcetamipridIprodi<strong>on</strong>eProchlorazChlorpyrifos‐methylDithiocarbamatesCypermethrin (sum)BupirimateBuprofezinCyprodinilTriadimef<strong>on</strong> (sum)Metalaxyl (sum)DichlorvosFenitrothi<strong>on</strong>0% 2% 4% 6% 8% 10%% samples with measurable <strong>residues</strong> below or at the MRLFigure 3.4-8: Percentage of samples of rice above the MRL (upper scale) or with measurable <strong>residues</strong> belowor at the MRL (lower scale) by <strong>pesticide</strong> for the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated programme. Total number of samples:1,060.In 1,060 rice samples, 23 different <strong>pesticide</strong>s were observed. The most frequently found <strong>pesticide</strong>swere pirimiphos-methyl, tebufenozide and carbendazim (including benomyl). Seven <strong>pesticide</strong>s werefound in c<strong>on</strong>centrati<strong>on</strong>s exceeding the MRLs. Two of these <strong>pesticide</strong>s (carbendazim/benomyl andtebufenozide) were found to exceed the MRL in 2.2% (12 samples) and 1.5% (5 samples) respectivelyof the samples.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164655


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesSpinach% samples with <strong>residues</strong> above MRL0.0% 0.2% 0.4% 0.6% 0.8% 1.0%Dithiocarbamates4.9%Lambda‐CyhalothrinCypermethrin (sum)DeltamethrinImidaclopridIndoxacarbChlorpyrifosAzoxystrobinMethomyl (sum)1.1%Carbendazim and benomylBifenthrinIprodi<strong>on</strong>ePirimicarb (sum)Endosulfan (sum)Fludiox<strong>on</strong>ilThiabendazoleCaptanDimethoate (sum)PyrethrinsChlorpropham (sum)CyprodinilMetalaxyl (sum)Tolclofos‐methylChlorpyrifos‐methylProcymid<strong>on</strong>ePropargiteMethamidophosDichlofluanidImazalilPyrimethanilChlorothal<strong>on</strong>ilDicofolMalathi<strong>on</strong> (sum)0% 2% 4% 6% 8% 10%% samples with measurable <strong>residues</strong> below or at the MRLFigure 3.4-9: Percentage of samples of spinach above the MRL (upper scale) or with measurable <strong>residues</strong>below or at the MRL (lower scale) by <strong>pesticide</strong> for the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated programme. Total number ofsamples: 1,005.In spinach, 33 different <strong>pesticide</strong>s were detected in 1,005 samples. The most frequent <strong>pesticide</strong>s foundwere the dithiocarbamates, followed by lambda-cyhalothrin, cypermethrin and deltamethrin. 22<strong>pesticide</strong>s were found in c<strong>on</strong>centrati<strong>on</strong>s exceeding the MRL. Dithiocarbamates showed the highest rateof MRL exceedance (4.9%, 25 samples). Also chlorpyrifos, azoxystrobin and methomyl were found toexceed the MRL in more than 0.5% of the samples (0.6 – 1.1 %, 5 – 7 samples).<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164656


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesThe main <strong>pesticide</strong>/crop combinati<strong>on</strong> where findings above the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing level were found mostfrequently, was imazalil/mandarins and oranges (73% and 70%, respectively), chlorpyrifos/mandarinsand oranges (29 and 47%, respectively), dithiocarbamates/pears (39%), thiabendazole/mandarins andoranges (35-40%) and captan/pears (36%) (Table 3.4-1).There were four <strong>pesticide</strong>/crop combinati<strong>on</strong>s with MRL exceedances above 1%. The highestpercentages were found for dithiocarbamates (as carb<strong>on</strong> disulfide, CS 2 ) in spinach, where the MRLwas exceeded in 4.9% of all samples. In spinach methomyl also exceeded the MRL in 1.1% of allsamples. In rice the MRL for carbendazim and tebufenozide was exceeded in 2.2% and 1.5% of allsamples. In spinach, five <strong>pesticide</strong>s exceeded the MRL in more than 0.5 % of the samples (Table 3.4-2).<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164657


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesTable 3.4-1: Most frequent detecti<strong>on</strong>s of particular <strong>pesticide</strong>/commodity combinati<strong>on</strong>s in the<str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated m<strong>on</strong>itoring programme (results over 10%).CommodityPesticide and % samples with detectable<strong>residues</strong>(n<strong>on</strong>e)Background informati<strong>on</strong> <strong>on</strong> theactive substances foundBeans withoutpodsCarrots(n<strong>on</strong>e)Cucumber (n<strong>on</strong>e)Mandarins imazalil (73%), Systemic fungicide used to c<strong>on</strong>trol awide range of fungal or storagediseases in fruit and other crops.chlorpyrifos (47%),thiabendazole (35%),malathi<strong>on</strong> (21%),pyriproxyfen (12%),N<strong>on</strong>-systemic insecticide used toc<strong>on</strong>trol different pests in soil or <strong>on</strong>foliage in fruit and other crops.Systemic fungicide used mainly aspost-harvest treatment for the c<strong>on</strong>trol ofa wide range of different fungi species.N<strong>on</strong>-systemic insecticide and acaricideused <strong>on</strong> a wide rang of crops to protectagainst different pests.Insect growth regulator used to c<strong>on</strong>trolinfestati<strong>on</strong> with insect pests.Oranges imazalil (70%), See mandarinsthiabendazole (40%),See mandarinschlorpyrifos (29%),See mandarinsPears dithiocarbamates (39%), Group of active substances used toc<strong>on</strong>trol fungal diseases in a wide rangeof fruits and other crops.chlorpyrifos (17%),See mandarinscaptan/folpet (14%),Fungicide used to c<strong>on</strong>trol a wide rangeof fungal diseases <strong>on</strong> pome fruit andother crops.chlormequat (14%),Plant growth regulator used in the past<strong>on</strong> pear trees to prevent premature fruitdrop and fruit thinning. Since 1December 2009 <strong>on</strong>ly the use as plantgrowth regulator in cereals and in n<strong>on</strong>ediblecrops may be authorised.diphenylamine (13%),Post-harvest fungicide protectant andscald inhibitor for pome fruit.Potatoes chlorpropham (21%) Used as post-harvest treatment to avoidsprouting of potatoes.Rice(n<strong>on</strong>e)Spinach(n<strong>on</strong>e)<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164658


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesTable 3.4-2: Most frequent MRL exceedances of <strong>pesticide</strong>/commodity combinati<strong>on</strong>s in the<str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated m<strong>on</strong>itoring programme (results over 0.5% <strong>on</strong>ly).CommodityPesticide and % MRL exceedancesBeans without pods Procymid<strong>on</strong>e (0.6%)Carrots Iprodi<strong>on</strong>e (0.6%), chlorpyrifos (0.7%)Cucumber Carbendazim /benomyl (0.6%), methomyl (0.6%)Mandarins Imazalil (0.9%), carbaryl (0.6%)Oranges Dimethoate (1.0%), diazin<strong>on</strong> (0.9%)Pears Chlormequat (0.9%)Potatoes(n<strong>on</strong>e)Rice Carbendazim/benomyl (2.2%), tebufenozide (1.5%), acetamiprid (0.7%),Spinach dithiocarbamates (5%), methomyl (1.1%), chlorpyrifos (0.8%),azoxystrobin (0.6%), iprodi<strong>on</strong>e (0.5%)3.5. Results by <strong>pesticide</strong>sIn the EU coordinated programme <strong>residues</strong> exceeding the MRL were found for 47 different <strong>pesticide</strong>s(Figure 3.5-1). Residues of dithiocarbamates were found most often exceeding the MRL (0.6% ofsamples); all of these samples were spinach (see also Table 3.4-2) originating from EU countries (seeTable 5.2.2-2). Therefore, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> recommends the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries to investigate the reas<strong>on</strong>explaining these findings <strong>on</strong> spinach. Chlormequat (which was <strong>on</strong>ly analysed in carrots, cucumber andpears) exceeded the MRL in 0.4% of these samples, all in pears. Carbendazim/benomyl <strong>residues</strong> aboveMRL were found in cucumbers, pears, rice and spinach (in total 0.3% of all samples). Exceedance ofthe MRL for chlorpyrifos, dimethoate, methomyl, diazin<strong>on</strong>, iprodi<strong>on</strong>e, imazalil and endosulfan wasfound in 0.3 – 0.1% of samples (distributed am<strong>on</strong>g several commodities), while tebufenozide <strong>on</strong>lyexceeded the MRL in rice (0.1% of samples). Carbaryl exceeded the MRL in mandarins, oranges,pears and potatoes (0.1% total). The rates of exceedance for the remaining <strong>pesticide</strong>s were all below0.1%.Measurable <strong>residues</strong> were found for 69 different <strong>pesticide</strong>s out of 78 <strong>pesticide</strong>s included in thecoordinated programme; 47 of them are shown in Figure 3.5-2. The remaining <strong>pesticide</strong>s were eachfound in less than 0.2% of the samples. No positive detecti<strong>on</strong>s were found for folpet, acephate,parathi<strong>on</strong>, dichlorvos, aldicarb (sum), flusilazole, mepiquat, oxydemet<strong>on</strong>-methyl(sum) andquinoxyfen.Chlorpropham (<strong>on</strong>ly <str<strong>on</strong>g>report</str<strong>on</strong>g>ed for potatoes 16 ) was found most frequently (21%). Imazalil hadmeasurable <strong>residues</strong> in 18.3% of the samples; most (17%) were from mandarins and oranges.Chlorpyrifos, captan/folpet, thiabendazole and dithiocarbamates were each found in between 10 - 12%of the samples; chlorpyrifos (8.6%) and thiabendazole (9.3%) mainly in mandarins and oranges, whilecaptan/folpet 17 (12%) and dithiocarbamates (7.6%) were mainly found in pears. Residues ofchlormequat (<strong>on</strong>ly analysed for in carrots, cucumber and pears) were found in 6.4% of these samples,most of which (6.2%) were in pears. Malathi<strong>on</strong>, carbendazim/benomyl, imidacloprid, pyriproxyfenand diphenylamine were each found in 4 – 2 % of samples. Furthermore, 13 <strong>pesticide</strong>s were found in 2– 1% of the samples. 22 <strong>pesticide</strong>s were found in 1 – 0.2% of the samples.16 In other commodities, <strong>residues</strong> of chlorpropham were <str<strong>on</strong>g>report</str<strong>on</strong>g>ed as a sum of chlorpropham and 3-chloroaniline, expressed aschlorpropham according to the residue definiti<strong>on</strong>).17 Captan and folpet was <str<strong>on</strong>g>report</str<strong>on</strong>g>ed as a sum for beans (without pod) and pears <strong>on</strong>ly. For the remaining commodities in the EUprogramme, <strong>residues</strong> of captan and folpet were <str<strong>on</strong>g>report</str<strong>on</strong>g>ed individually.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164659


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesDithiocarbamatesChlormequatCarbendazim and benomylChlorpyrifosDimethoate (sum)Methomyl (sum)Diazin<strong>on</strong>Iprodi<strong>on</strong>eImazalilEndosulfan (sum)TebufenozideCarbarylOxamylChlorprophamFenitrothi<strong>on</strong>Procymid<strong>on</strong>eAzoxystrobinAcetamipridThiabendazoleChlorpyrifos‐methylCaptanThiophanate‐methylAzinphos‐methylImidaclopridBifenthrinCypermethrin (sum)Methiocarb (sum)FolpetAcephateFludiox<strong>on</strong>ilProfenofosMethamidophosCyprodinilPyrimethanilDicofolMetalaxyl (sum)ClofentezinePyriproxyfenChlorpropham (sum)BuprofezinVinclozolin (sum)DiphenylaminePirimicarb (sum)Lambda‐CyhalothrinChlorothal<strong>on</strong>ilParathi<strong>on</strong>Dichlorvos0.0% 0.1% 0.2% 0.3% 0.4% 0.5% 0.6%Beans (without pods) Carrots Cucumbers Mandarins Oranges Pears Potatoes Rice SpinachFigure 3.5-1: Frequency of samples with measured <strong>residues</strong> above the MRL in the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinatedm<strong>on</strong>itoring programme. C<strong>on</strong>tributi<strong>on</strong>s from each commodity are indicated.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164660


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesChlorprophamImazalilChlorpyrifosCaptan/Folpet (sum)ThiabendazoleDithiocarbamatesChlormequatMalathi<strong>on</strong> (sum)Carbendazim and benomylImidaclopridPyriproxyfenDiphenylamineProchlorazIprodi<strong>on</strong>eAzoxystrobinLambda‐CyhalothrinTebuc<strong>on</strong>azoleMethidathi<strong>on</strong>CyprodinilCypermethrin (sum)Azinphos‐methylBromopropylateDicofolPirimiphos‐methylChlorothal<strong>on</strong>ilThiophanate‐methylIndoxacarbChlorpyrifos‐methylPyrimethanilMetalaxyl (sum)Fludiox<strong>on</strong>ilTrifloxystrobinProcymid<strong>on</strong>eAcetamipridDeltamethrinHexythiazoxMyclobutanilTebufenozidePropargiteBuprofezinMethomyl (sum)BifenthrinKresoxim‐methylTriadimef<strong>on</strong> (sum)Endosulfan (sum)Phosal<strong>on</strong>ePyrethrins0% 5% 10% 15% 20%Beans (without pods) Carrots Cucumbers Mandarins Oranges Pears Potatoes Rice SpinachFigure 3.5-2: Frequency of samples with measurable <strong>residues</strong> below or at MRL (above 0.20 %) in the<str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated m<strong>on</strong>itoring programme. C<strong>on</strong>tributi<strong>on</strong>s from each commodity are indicated.Additi<strong>on</strong>al informati<strong>on</strong> <strong>on</strong> the results <str<strong>on</strong>g>report</str<strong>on</strong>g>ed in Figure 3.5-1 and Figure 3.5-2 can be found inAppendix III (Tables H and I).<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164661


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues4. Results of the nati<strong>on</strong>al m<strong>on</strong>itoring programmesDue to the limitati<strong>on</strong>s of the format used to <str<strong>on</strong>g>report</str<strong>on</strong>g> the <str<strong>on</strong>g>2008</str<strong>on</strong>g> m<strong>on</strong>itoring results, it was not alwayspossible to identify the samples taken in the framework of the nati<strong>on</strong>al programmes or in theframework of the EU coordinated programme. As a c<strong>on</strong>sequence, some of the findings <str<strong>on</strong>g>report</str<strong>on</strong>g>ed in thissecti<strong>on</strong> (e.g. results <strong>on</strong> the multiple <strong>residues</strong>) refer to results of both the nati<strong>on</strong>al and the EUcoordinated c<strong>on</strong>trol activities.4.1. Overall results for MRL exceedances96.5% of the surveillance samples analysed (nati<strong>on</strong>al and EU coordinated programme) were below orat the legal Maximum Residue Levels (MRLs); in 3.5% of the samples the legal limits were exceededfor <strong>on</strong>e or more <strong>pesticide</strong>. It should be noted that for many of the <strong>pesticide</strong>s detected, EU harm<strong>on</strong>isedMRLs had not yet been established in the first part of <str<strong>on</strong>g>2008</str<strong>on</strong>g>. Thus, an MRL exceedance in <strong>on</strong>e<str<strong>on</strong>g>report</str<strong>on</strong>g>ing country did not necessarily represent an exceedance in all others.4.2. MRL exceedance rate over the timeThe overall <str<strong>on</strong>g>report</str<strong>on</strong>g>ed MRL exceedance rate (3.5%) is slightly lower than in the previous year where4.2% of the samples were found to exceed the MRL. Over the last years, the exceedance rate rangedbetween 3.0 and 5.5%.Figure 4.2-1 shows the trend of exceeding/n<strong>on</strong>-exceeding samples from the m<strong>on</strong>itoring <str<strong>on</strong>g>report</str<strong>on</strong>g>s for1996 to <str<strong>on</strong>g>2008</str<strong>on</strong>g>. The figure includes surveillance samples from both the nati<strong>on</strong>al and the EU coordinatedprogramme. For the period 1996-2007 the figure also includes enforcement samples.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164662


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues<str<strong>on</strong>g>2008</str<strong>on</strong>g>20072006200520042003200220012000199919981997199696.5%96.0%95.0%95.0%95.0%94.5%94.5%96.1%95.5%95.7%96.7%96.6%97.0%3.5%4.0%5.0%5.0%5.0%5.5%5.5%3.9%4.5%4.3%3.3%3.4%3.0%0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%No measurable <strong>residues</strong> detected above MRLResidues detected above MRLFigure 4.2-1: MRL compliance rate for samples from the nati<strong>on</strong>al and EU coordinated<strong>pesticide</strong> residue programmes 1996-<str<strong>on</strong>g>2008</str<strong>on</strong>g>. Note that for <str<strong>on</strong>g>2008</str<strong>on</strong>g> <strong>on</strong>ly surveillance samples areincluded, while for 1996-2007, enforcement samples are included as well.Although different factors may influence the observati<strong>on</strong> of MRL exceedances, and this hampers adirect comparis<strong>on</strong>, the percentage with <strong>residues</strong> of samples above the MRL seems to be slightlydeclining. This is a surprising result since the trend to increase the scope of the analytical methods andthe increased sensitivity of analytical methods would be expected to have an effect in the oppositedirecti<strong>on</strong>, i.e. increased detecti<strong>on</strong> of MRL exceedances. The average number of <strong>pesticide</strong>s analysedhas increased from 66 in 1999 to 235 in <str<strong>on</strong>g>2008</str<strong>on</strong>g> and the levels of <str<strong>on</strong>g>report</str<strong>on</strong>g>ing (LOQs) are c<strong>on</strong>stantlymoving towards lower levels. On the other hand, the results from 1996 – 2007 include enforcementsamples (the percentage of enforcement samples and level of targeting is not <str<strong>on</strong>g>report</str<strong>on</strong>g>ed in the previous<str<strong>on</strong>g>report</str<strong>on</strong>g>s) for which the rate of exceedance is expected to be higher than for surveillance samples.4.3. Origin of samples exceeding the EC MRLsThe participating countries also <str<strong>on</strong>g>report</str<strong>on</strong>g>ed the origin of samples in cases where an MRL exceedance wasobserved. For <str<strong>on</strong>g>2008</str<strong>on</strong>g>, the harm<strong>on</strong>ized EC MRLs were exceeded more often for surveillance samples offruit, vegetables and cereals imported from third countries (7.6%) than from the EU (2.4%) (Table 4.3-1 and Figure 4.3-1).<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164663


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesTable 4.3-1: Exceedances of EC MRLs according to origin of sample (surveillance samples of fruit,vegetables and cereals).SampleoriginNumber ofsamplesSamples with EC MRL exceedances LCI a UCI bNumber %EU c 48138 1177 2.4 2.3 2.6Imported 12527 953 7.6 7.1 8.1Unknown 2050 31 1.5 1.0 2.1Total 62715 2161 3.4(a): Lower C<strong>on</strong>fidence Limit (see ”Background informati<strong>on</strong>” secti<strong>on</strong>)(b): Upper C<strong>on</strong>fidence limit(c): Including EEA countriesTable 4.3-2 lists the countries from which the highest number of EC MRL exceeding samples were<str<strong>on</strong>g>report</str<strong>on</strong>g>ed, including also details <strong>on</strong> the imported food products for which MRL exceedances wereobserved most frequently. The results are also presented in a map (Figure 4.3-1). It is noted that in thispresentati<strong>on</strong> the results of the 29 <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries are not included (see also Figure 3.2-1).Table 4.3-2: Imported food products most frequently exceeding the MRLs and countries of originOrigin country Number of EC MRL Food products most frequently exceeding EC MRLexceedancesThailand 206 Peppers, Beans (with pods), BasilTurkey 92 Peppers, Table grapes, PearsColombia 56 Passi<strong>on</strong> fruit, Physalis (Cape gooseberry), SageEgypt 55 Oranges, Strawberries, PomegranateIndia 52 Okra (lady’s fingers), Peppers, PomegranateBrazil 43 Mangoes, Figs, Apples, LimesDominican Republic 43 Beans (with pods), Aubergines (egg plants), CucurbitsIsrael 41 Carrots, Herbs, StrawberriesKenya 35 Beans (with pods), Passi<strong>on</strong> fruit, Peas (with pods)Morocco 34 Peppers, Beans (with pods), TomatoesChina 29 Tea, Grapefruit, Beans (with pods)Chile 20 Peaches, Table grapes, ApplesUnited States 20 Grapefruit, ApplesArgentina 18 Lem<strong>on</strong>s, Apples, PearsCosta Rica 16 Pineapples, Passi<strong>on</strong> fruit, MangoesVietnam 15 Tea, Lychee (Litchi), Celery, HerbsSouth Africa 14 Oranges, Lem<strong>on</strong>s, Passi<strong>on</strong> fruit, PineapplesZimbabwe 14 Passi<strong>on</strong> fruit, Peas (with pods), PeppersSuriname 13 Peppers, Aubergines (egg plants), Celery leavesJordan 12 Peppers, Okra (lady’s fingers), Cucumbers<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164664


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646Figure 4.3-1: Origin of samples imported from third countries exceeding EC MRLs. Samples include all surveillance samples from the <str<strong>on</strong>g>2008</str<strong>on</strong>g>nati<strong>on</strong>al and EU <strong>pesticide</strong> m<strong>on</strong>itoring programmes.65


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues4.4. Results by food commodityFigure 4.4-1 describes the MRL exceedances rate according to the four food categories fruit andvegetables, cereals, processed products and baby food. Most exceedances were found in fruit andvegetables (3.7%) followed by cereals, with 1.5% of samples exceeding the MRL. In processedcommodities the MRL was exceeded in 0.9% of the samples, while <strong>residues</strong> exceeding the MRL werefound in 0.2% of the samples of baby food. Figure 4.4-2 <str<strong>on</strong>g>report</str<strong>on</strong>g>s the MRL exceedance rates for somefruit and vegetables sub-groups.Fruit and vegetablesCerealsProcessedBabyfood96.3%98.5%99.1%99.8%3.7%1.5%0.9%0.2%0% 20% 40% 60% 80% 100%No measurable <strong>residues</strong> detected above MRLResidues detected above MRLFigure 4.4-1: MRL compliance rate for surveillance samples in the nati<strong>on</strong>al programme andthe EU coordinated <strong>pesticide</strong> m<strong>on</strong>itoring programme <str<strong>on</strong>g>2008</str<strong>on</strong>g>.For fruit and vegetables, the MRL exceedance rate was significantly higher for enforcement samples(11.2%) than for surveillance samples (3.7%) (Table 4.4-1 and Table 4.4-2). For the other categoriesno significant difference can be c<strong>on</strong>cluded – mainly due to the low number of enforcement samplesnumbers (overlapping c<strong>on</strong>fidence interval). In total, 231 samples, corresp<strong>on</strong>ding to 10.2 % of allsamples, exceeded the MRL. No exceedance of the MRL was seen for the baby food samples, while 2samples of both the processed and cereals samples exceeded the MRL.In total, <strong>residues</strong> of 365 different <strong>pesticide</strong>s were found in measurable quantities in fruit andvegetables, while in cereals <strong>residues</strong> of 76 different <strong>pesticide</strong>s were observed. As in previous years, thenumber of different <strong>pesticide</strong> <strong>residues</strong> found in fruit and vegetables in <str<strong>on</strong>g>2008</str<strong>on</strong>g> was higher than thenumber of <strong>pesticide</strong>s found in cereals, which also reflects the greater number of products used in thefruit and vegetables category.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164666


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesTable 4.4-1: Summary of the results of the nati<strong>on</strong>al and EU coordinated m<strong>on</strong>itoring programmes(surveillance samples).ProductNumberofsamplesanalysedSamples with <strong>residues</strong>below or at the MRLLCI(a)UCI(b)Samples with <strong>residues</strong>above the MRLNumber % Number %Fruit and 58784 56631 96.3 96.2 96.5 2153 3.7 3.5 3.8vegetablesCereals 3931 3874 98.5 98.1 98.9 57 1.5 1.1 1.9Processed 3110 3083 99.1 98.7 99.4 27 0.9 0.6 1.3productsBaby food 2062 2057 99.8 99.4 99.9 5 0.2 0.1 0.6Total 67887 65645 2242(a): Lower C<strong>on</strong>fidence Limit(b): Upper C<strong>on</strong>fidence limitLCI(a)UCI(b)Table 4.4-2: Summary of the results of the nati<strong>on</strong>al and EU coordinated m<strong>on</strong>itoring programmes(enforcement samples).ProductNumberofsamplesanalysedSamples with <strong>residues</strong>below or at the MRLLCI(a)UCI(b)Samples with <strong>residues</strong>above the MRLNumber % Number %Fruit and 2021 1794 88.8 87.3 90.1 227 11.2 9.9 12.7vegetablesCereals 116 114 98.3 93.9 99.8 2 1.7 0.2 6.1Processed 112 110 98.2 93.7 99.8 2 1.8 0.2 6.3productsBaby food 7 7 100 65.2 100 0 0 0 35Total 2256 2025 231(a): Lower C<strong>on</strong>fidence Limit(b): Upper C<strong>on</strong>fidence LimitIn Figure 4.4-2 a more detailed presentati<strong>on</strong> of the food commodities or commodity groups 18 ispresented, illustrating the MRL exceedance rates observed in the nati<strong>on</strong>al and EU and coordinatedm<strong>on</strong>itoring programmes. The highest percentage of MRL exceedances was identified for herbs, cropsbel<strong>on</strong>ging to the group “miscellaneous fruits with inedible peel, small (e.g. kiwi, lychee and passi<strong>on</strong>fruit), tea and miscellaneous fruit with edible peel (e.g. dates, figs, kumquats).LCI(a)UCI(b)18 The individual commodities bel<strong>on</strong>ging to the groups <str<strong>on</strong>g>report</str<strong>on</strong>g>ed can be found in Annex I of Regulati<strong>on</strong> (EC) No 396/2005.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164667


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesHerbsMisc. fruits with inedible peel, smallTeaLeafy brassicaMiscellaneous fruits with edible peelSpinach and similar (leaves)Legume vegetables, freshMisc. fruits with inedible peel, largePulses, drySmall fruit and berriesTropical root and tuber vegetablesCane fruitTable and Wine grapesStrawberriesSolanaceaSt<strong>on</strong>e fruitLettuce and other salad plantsStem vegetables, freshCitrus fruitPome fruitRoot and tuber vegetablesCucurbits, edible peelFungiTree nuts, shelled or unshelledCucurbits, inedible peelOilseedsBulb vegetablesSweet cornFlowering brassicaCerealsOilfruitsPotatoesHead brassicaWitloofKohlrabi84%91%91%92%93%93%94%95%95%95%95%96%96%96%96%97%97%97%97%97%97%97%97%97%97%98%98%98%98%98%99%99%99%99%100%16%9%9%8%7%7%6%5%5%5%5%4%4%4%4%3%3%3%3%3%3%3%3%3%3%2%2%2%2%2%1%1%1%1%0%0% 20% 40% 60% 80% 100%No measurable <strong>residues</strong> detected above MRLResidues detected above MRLFigure 4.4-2: Percentage compliance with EC MRL for raw commodities (surveillance samplesfrom EU and nati<strong>on</strong>al programmes commodity groups with sample size below 50 excluded)<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164668


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues4.5. Results by <strong>pesticide</strong>/crop combinati<strong>on</strong>sThe 33 <strong>pesticide</strong>/crop combinati<strong>on</strong>s with the highest absolute number of MRL exceedances are shownin Figure 4.5-1 19 . It should be noted however that the number of positive detecti<strong>on</strong>s is biased by thecommodity sampling frequency (e.g. the crops included in the 3-year cycle of the EU programme arethe most frequent samples), the sampling strategies and by the number of <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries testingfor the specific crop/<strong>pesticide</strong> combinati<strong>on</strong>. The chart also illustrates the percentage of these samplesoriginating from third countries.It is noted that peppers and passi<strong>on</strong> fruit are the commodities which are most frequently <str<strong>on</strong>g>report</str<strong>on</strong>g>ed inFigure 4.5-1.19 The <strong>pesticide</strong>/crop combinati<strong>on</strong>s with the highest percentage of MRL exceedances could not be calculated since the<str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries <strong>on</strong>ly submitted the results of <strong>residues</strong> above the quantificati<strong>on</strong> level. The number of analysed samplesof a certain food item which did not c<strong>on</strong>tain measurable residue c<strong>on</strong>centrati<strong>on</strong>s was not <str<strong>on</strong>g>report</str<strong>on</strong>g>ed to <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164669


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesDimethoate (sum)DithiocarbamatesCarbendazim and benomylBoscalidDimethoate (sum)Diazin<strong>on</strong>Dimethoate (sum)FolpetAmitraz (sum)Carbendazim and benomylCarbofuran (sum)ImazalilDimethoate (sum)Methomyl (sum)Methomyl (sum)Phosal<strong>on</strong>ePhosmetCarbendazim and benomylChlorpyrifosChlorpyrifosCypermethrin (sum)ImazalilPendimethalinSpinosadCarbarylChlorpyrifosDiazin<strong>on</strong>DicofolDifenoc<strong>on</strong>azoleDimethoate (sum)DithiocarbamatesOxamylTrifloxystrobinSpinachPeppersStrawberriesOrangesOrangesPeppersTable grapesPearsPassi<strong>on</strong> fruitPeppersLem<strong>on</strong>sApplesBeans (with pods)PeppersApplesPeachesRiceBeans (with pods)CarrotsPassi<strong>on</strong> fruitMandarinsKaleStrawberriesApplesPeppersPeppersCherriesPassi<strong>on</strong> fruitPassi<strong>on</strong> fruitPineapplesPeppersPassi<strong>on</strong> fruitBeans (with pods)0 5 10 15 20 25 30 35 40Samples from third countriesFigure 4.5-1: Pesticide/crop combinati<strong>on</strong>s exceeding the EC MRLs (nati<strong>on</strong>al and EU <strong>pesticide</strong> m<strong>on</strong>itoringcoordinated programmes <str<strong>on</strong>g>2008</str<strong>on</strong>g> (surveillance samples <strong>on</strong>ly)). Proporti<strong>on</strong> of samples originating from thirdcountries is shown besides the total number of samples.4.5.1. Results for organic samplesTotal number of exceedencesData <strong>on</strong> organic food were <strong>on</strong>ly provided by some <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries. Due to deficiencies in the datamanagement system implemented at nati<strong>on</strong>al level, many countries were not able to <str<strong>on</strong>g>report</str<strong>on</strong>g> the results.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164670


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesTable 4.5.1-1: Summary of the results of the nati<strong>on</strong>al and EU coordinated m<strong>on</strong>itoring programmesfor <strong>pesticide</strong>s <strong>residues</strong> in organic food (surveillance and enforcement samples) in <str<strong>on</strong>g>2008</str<strong>on</strong>g>.ProductNumberof samplesanalysedSamples withoutdetected <strong>residues</strong> orn<strong>on</strong>e above the MRLLCL(a)UCL(b)Samples with<strong>residues</strong> above theMRLNumber % Number %Fruit and 2479 2456 99.1 98.6 99.4 23 0.9 0.6 1.4vegetablesCereals 335 330 98.5 96.6 99.5 5 1.5 0.5 3.4Processed 167 167 100 98.2 100 0 0 0 1.8Babyfood 150 148 98.7 95.3 99.8 2 1.3 0.2 4.7Total 3131 3101 30 1.0(a): Lower C<strong>on</strong>fidence Limit(b): Upper C<strong>on</strong>fidence limitLCL(a)UCL(b)For fruit and vegetables, a lower rate of MRL exceedances (0.9%) in comparis<strong>on</strong> to c<strong>on</strong>venti<strong>on</strong>allygrown fruit and vegetables (3.7%) was found (Table 4.4-1 and Table 4.5.1-1). However, whencomparing the rate of exceedances in organic and c<strong>on</strong>venti<strong>on</strong>al products it should be also born in mindthat the results of the organic samples comprise data for surveillance and enforcement sampleswhereas the data for c<strong>on</strong>venti<strong>on</strong>al products <strong>on</strong>ly refers to surveillance samples.Due to the structure of the <str<strong>on</strong>g>report</str<strong>on</strong>g>ed data, no informati<strong>on</strong> is available which <strong>pesticide</strong>s were found inorganic samples (e.g. the <strong>pesticide</strong>s included in Regulati<strong>on</strong> (EEC) No 2092/91, see Table 2.2.5-1).Therefore a further analysis of the reas<strong>on</strong>s explaining the occurrence of <strong>residues</strong> in organic foodand/or MRL exceedances is not possible.In order to gain further knowledge in this area, <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries are encouraged to enable the datamanagement systems to differentiate between organic and c<strong>on</strong>venti<strong>on</strong>al products. A new datacollecti<strong>on</strong> system for <str<strong>on</strong>g>report</str<strong>on</strong>g>ing this informati<strong>on</strong> to <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> is under implementati<strong>on</strong>.4.5.2. Results for baby-food samplesA general default EC MRL of 0.01 mg/kg is applicable for all active substances unless specific MRLslower than 0.01 mg/kg were established in Commissi<strong>on</strong> Directive 2006/141/EC for infant formulaeand follow-<strong>on</strong> formulae and in Commissi<strong>on</strong> Directive 2006/125/EC for processed cereal-based foodsand baby foods for infants and young children. In <str<strong>on</strong>g>2008</str<strong>on</strong>g> 25 countries <str<strong>on</strong>g>report</str<strong>on</strong>g>ed data <strong>on</strong> analysis of babyfood. Overall 2,062 samples were analysed. Residues above the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing level were found in 76samples, while the MRL was exceeded <strong>on</strong>ly in 4 samples (0.2%). The four samples exceeding theMRL were samples of baby food based <strong>on</strong> fruit and vegetables and the measured residue exceedingthe legal limits were boscalid (2 samples), thiabendazole (1 sample) and thiacloprid (1 sample).Due to the limitati<strong>on</strong> of the format used for the data <str<strong>on</strong>g>report</str<strong>on</strong>g>ing, further analysis of the baby food resultscould not be performed.4.5.3. Results for processed productsThe MRLs applicable for processed commodities are based <strong>on</strong> the MRLs established for rawagricultural commodities, taking into account changes in levels of <strong>pesticide</strong> <strong>residues</strong> caused byprocessing or mixing. In <str<strong>on</strong>g>2008</str<strong>on</strong>g>, 23 countries <str<strong>on</strong>g>report</str<strong>on</strong>g>ed data <strong>on</strong> analysis of processed products. A total of3,110 samples were analysed. Residues above the MRL were found in 27 samples (0.9%). It is not<str<strong>on</strong>g>report</str<strong>on</strong>g>ed which processing factors were applied to derive the MRL for processed commodities.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164671


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues4.5.4. Results for samples with multiple <strong>residues</strong>C<strong>on</strong>sidering the results of both the nati<strong>on</strong>al and the EU coordinated programmes in <str<strong>on</strong>g>2008</str<strong>on</strong>g> (includingenforcement samples), <strong>residues</strong> of two or more <strong>pesticide</strong>s were found in 27% of the analysed samplesof fruits, vegetables and cereals (Figure 4.5.4-1). The highest number of different <strong>pesticide</strong>s in a singlesample was 26 in <str<strong>on</strong>g>2008</str<strong>on</strong>g>. The highest number of <strong>pesticide</strong>s detected in <strong>on</strong>e sample has increased in theperiod from 1997 with 8 different <strong>pesticide</strong>s to 29 different <strong>pesticide</strong>s in 2006 (Figure 4.5.4-2). In2007 there was a decrease in the number of different <strong>pesticide</strong>s to 22. In <str<strong>on</strong>g>2008</str<strong>on</strong>g> the number of different<strong>pesticide</strong>s was 26 (found by Germany in a sample of table grapes). Multiple <strong>residues</strong> were <str<strong>on</strong>g>report</str<strong>on</strong>g>ed by28 countries.In <str<strong>on</strong>g>2008</str<strong>on</strong>g>, 344 samples were found to exceed two or more EC MRLs (Table 4.5.4-1). The highestnumber of EC exceedances is 8, measured in peppers. It is noted that in 2007 fewer samples werefound to exceed two or more EC MRLs (158). Also in 2007 the highest number of exceedances in thesame commodity was eight.2 <strong>residues</strong>:10.9%3 <strong>residues</strong>:6.5%1 residue:20.0%Nomeasurable<strong>residues</strong>:53.3%4 <strong>residues</strong>:4.1%5 <strong>residues</strong>:2.4%6 <strong>residues</strong>:1.3%7 <strong>residues</strong>:0.6%≥8 <strong>residues</strong>;0.9%Figure 4.5.4-1: Number of <strong>residues</strong> found in individual surveillance samples from the nati<strong>on</strong>al andEU coordinated <strong>pesticide</strong> m<strong>on</strong>itoring programmes <str<strong>on</strong>g>2008</str<strong>on</strong>g>.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164672


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesNumber of <strong>pesticide</strong>s3530252015105810 10 10 1116 16182329222601997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 <str<strong>on</strong>g>2008</str<strong>on</strong>g>Sampling yearFigure 4.5.4-2: Highest <str<strong>on</strong>g>report</str<strong>on</strong>g>ed number of different <strong>pesticide</strong>s in <strong>on</strong>e sample from 1997 to <str<strong>on</strong>g>2008</str<strong>on</strong>g> in fruit,vegetables and cereals.Table 4.5.4-1: Summary of results for unprocessed samples with multiple EC MRL exceedances.Commodity Number of EC exceedances in <strong>on</strong>e sample Total number of samples2 3 4 5 6 8 with multiple exceedancesPeppers 27 12 11 2 1 1 54Beans (with pods) 26 9 5 1 41Passi<strong>on</strong> fruit 12 5 4 1 22Basil 13 6 2 21Celery leaves 11 2 1 14Strawberries 10 4 14Lettuce 8 4 1 13Spinach 9 2 1 12Okra, lady’s fingers 4 5 9Peaches 9 9Lem<strong>on</strong>s 7 7Tea 3 2 1 1 7Carrots 6 6Aubergines (egg plants) 4 1 5Celery 2 1 2 5Lychee (Litchi) 1 4 5Yams 4 1 5Pomegranate 5 5Tomatoes 3 1 4Rocket, Rucola 4 4Table grapes 4 4Currants (red, black and white) 4 4Parsley 4 4Oranges 4 4Apples 3 1 4Pears 3 3Beet leaves (chard) 2 1 3Apricots 3 3Cucumbers 3 3Pineapples 3 3Spring <strong>on</strong>i<strong>on</strong>s 1 2 3<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164673


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesCommodity Number of EC exceedances in <strong>on</strong>e sample Total number of samples2 3 4 5 6 8 with multiple exceedancesPotatoes 2 2Lamb's lettuce 1 1 2Herbal infusi<strong>on</strong>s (leaves) 1 1 2Grapefruit 2 2Blueberries 2 2Globe artichokes 2 2Peas (with pods) 1 1 2Blackberries 2 2Courgettes 2 2Mangoes 1 1 2Bananas 2 2Asparagus 1 1 2Legume vegetables, fresh 2 2Barley 1 1Cassava 1 1Kale 1 1Gooseberries 1 1Ginger 1 1Garlic 1 1Figs 1 1Alm<strong>on</strong>ds 1 1Beans (dry) 1 1Mandarins 1 1Celeriac 1 1Turnips 1 1Rosemary 1 1Thyme 1 1Table and Wine grapes 1 1Wheat 1 1Raspberries 1 1Walnuts 1 1Multiple <strong>residues</strong> in <strong>on</strong>e sample can result from the applicati<strong>on</strong> of different types of <strong>pesticide</strong>s used toprotect the crop against different pests or diseases, e.g. insecticides, fungicides and herbicides.However, as an <strong>Europe</strong>an database <strong>on</strong> the authorised GAPs and <strong>pesticide</strong> uses is not available it is notpossible to ascertain if multiple <strong>residues</strong> are due to the applicati<strong>on</strong> of different <strong>pesticide</strong>s <strong>on</strong> the samecrop.Another reas<strong>on</strong> for the increasing number of samples with multiple <strong>residues</strong> could be that laboratoriesare improving the sensitivity of analytical methods and increasing the number of substances for whichthe samples are analysed for.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164674


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesTable 4.5.4-2: Percentage of samples (surveillance and enforcement) from the nati<strong>on</strong>al and EUcoordinated <strong>pesticide</strong> m<strong>on</strong>itoring programme <str<strong>on</strong>g>2008</str<strong>on</strong>g> with multiple <strong>residues</strong>.CommodityNumber Percentage of samples with multiple <strong>residues</strong>of 2 3 4 5 More Totalsamplesthan 5Citrus fruit (e.g. oranges, grapefruits andlem<strong>on</strong>s)5505 21.5 15.7 10.6 5.5 3.5 56.9Cane fruit (e.g. blackberries and raspberries) 390 18.2 17.9 9.7 4.9 4.4 55.1Other small fruit and berries (e.g.blueberries/goosberries)687 13.7 12.2 10.9 8.0 9.0 53.9Strawberries 2760 13.6 11.9 10.8 7.6 7.2 51.0Table and Wine grapes 3153 16.8 10.9 7.1 6.1 10.0 50.8Pome fruit (e.g. apples and pears) 6048 15.2 10.6 8.2 5.1 5.8 44.8Lettuce and other salad plants, includingBrassica3214 12.8 9.5 5.7 4.0 5.9 37.8Herbs (e.g. parsley) 800 11.5 9.9 4.3 2.9 4.5 33.0Tea, dried leaves and stalks, fermented orotherwise of Camellia sinensis240 12.9 6.7 3.8 3.3 5.8 32.5St<strong>on</strong>e fruit (e.g. apricots, cherries and peaches) 3933 14.0 7.8 4.3 2.2 2.7 31.0Miscellaneous fruits with inedible peel, large(e.g. banana, mango and papaya)2007 19.0 6.6 1.7 0.4 0.2 27.9Solanacea (e.g. tomatoes, peppers andaubergines)7436 9.6 4.9 2.6 1.5 2.3 21.0Miscellaneous fruits with inedible peel, small(e.g. kiwi, lychee and passi<strong>on</strong> fruit)1180 9.9 3.5 2.1 1.4 1.2 18.1Leafy brassica (e.g. Chinese cabbage and kale) 431 11.1 3.2 1.6 0.5 0.5 16.9Cucurbits, edible peel (e.g. cucumbers andcurgettes)3177 7.9 3.8 1.9 0.8 0.8 15.3Cucurbits, inedible peel (e.g. mel<strong>on</strong>s,pumpkins)996 8.2 4.3 1.3 0.7 0.7 15.3Other root and tuber vegetables except sugarbeet (e.g. beetroot, carrots and radishes)2862 8.2 3.4 1.9 0.7 0.7 14.8Miscellaneous fruits with edible peel (e.g. figs,table olives and dates)300 10.3 2.0 1.0 0.7 0.0 14.0Legume vegetables, fresh (e.g. beans and peas) 2114 7.6 3.2 1.6 0.6 0.9 13.9Stem vegetables, fresh (e.g. fennel, asparagusand celery)1355 6.9 2.9 1.0 0.7 0.4 12.0Head brassica (e.g. head cabbage and Brusselssprouts)973 6.4 2.4 1.4 0.4 0.2 10.8Spinach and similar (leaves) 1315 5.4 2.3 0.9 0.2 0.4 9.2Cereals 3720 6.0 1.7 0.5 0.1 0.1 8.4Witloof 167 7.2 0.0 0.0 0.0 0.0 7.2Tropical root and tuber vegetables (e.g.cassava)226 5.8 0.9 0.0 0.0 0.0 6.6Fungi 476 3.4 0.2 0.0 0.8 1.5 5.9Bulb vegetables (e.g. garlic and <strong>on</strong>i<strong>on</strong>) 953 2.5 1.3 0.8 0.6 0.4 5.7Kohlrabi 81 4.9 0.0 0.0 0.0 0.0 4.9Potatoes 3092 2.7 0.5 0.2 0.0 0.0 3.4Oilseeds (e.g. linseed and sunflower seed) 183 1.6 1.1 0.0 0.0 0.0 2.7Tree nuts (e.g. alm<strong>on</strong>ds and hazelnuts) 166 2.4 0.0 0.0 0.0 0.0 2.4Flowering brassica (e.g. broccoli) 817 1.6 0.4 0.2 0.0 0.0 2.2Pulses, dry (e.g. dry lentils and beans) 267 0.7 0.4 0.4 0.0 0.0 1.5Oilfruits (e.g. olives for oil producti<strong>on</strong>) 409 0.2 0.2 0.0 0.0 0.0 0.5<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164675


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesIn additi<strong>on</strong> to the reas<strong>on</strong>s for multiple <strong>residues</strong> justified by agricultural practices menti<strong>on</strong>edabove, other possible reas<strong>on</strong>s for the occurrence of multiple <strong>residues</strong> are:• mixing of lots which were treated with different <strong>pesticide</strong>s, either during the samplingor in the course of sorting the commodities (e.g. sorting for quality classes);• <strong>residues</strong> resulting from uptake via soil in cases where <strong>pesticide</strong>s have highpersistence in soil;• <strong>residues</strong> resulting from spray drift from neighbouring plots or cross-c<strong>on</strong>taminati<strong>on</strong> inthe processing of the crops (e.g. by washing practices);• c<strong>on</strong>taminati<strong>on</strong> during storage.4.5.5. Reas<strong>on</strong>s for MRL exceedancesIn <str<strong>on</strong>g>2008</str<strong>on</strong>g>, 2,242 samples (including enforcement samples) were found to exceed nati<strong>on</strong>al or EC MRLs.The <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries indicated reas<strong>on</strong>s for MRL exceedances in <strong>on</strong>ly 232 events of MRLexceedance. 173 out of these 232 events were not c<strong>on</strong>sidered useful for evaluating the reas<strong>on</strong>s forMRL exceedances (e.g. “Only omethoate”, “Not known”). The remaining 59 explanati<strong>on</strong>s providedare listed in Table 4.5.5-1. Due to the limited number of <str<strong>on</strong>g>report</str<strong>on</strong>g>ed explanati<strong>on</strong>s, these are notc<strong>on</strong>sidered to be representative for all MRL exceedances <str<strong>on</strong>g>report</str<strong>on</strong>g>ed in <str<strong>on</strong>g>2008</str<strong>on</strong>g>. As a result, generalc<strong>on</strong>clusi<strong>on</strong>s <strong>on</strong> the reas<strong>on</strong>s for MRL exceedances cannot be provided and possible risk managementopti<strong>on</strong>s cannot be formulated. It is therefore recommended that nati<strong>on</strong>al authorities improve the<str<strong>on</strong>g>report</str<strong>on</strong>g>ing of this informati<strong>on</strong>; this may need improvement of the collaborati<strong>on</strong> with nati<strong>on</strong>al authoritiesinvolved in <strong>pesticide</strong> use and m<strong>on</strong>itoring and in the traceability of samples.Since no <strong>Europe</strong>an database <strong>on</strong> the authorised GAPs is available it is not possible to check if some ofthe <str<strong>on</strong>g>report</str<strong>on</strong>g>ed MRL exceedances are related to unauthorised uses.Table 4.5.5-1: Reas<strong>on</strong>s for MRL exceedances as <str<strong>on</strong>g>report</str<strong>on</strong>g>ed by the participating countriesReas<strong>on</strong>s for exceedancesNumber of samplesDifferences in nati<strong>on</strong>al MRLs 1Inadequate or incorrect use of the <strong>pesticide</strong> 16Misuse - no further informati<strong>on</strong> 9Misuse (authorized many years ago) 1Misuse (authorized till recently) 26Misuse (few products available against the pest) 6Total 59<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164676


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues5. Dietary exposure and dietary risk assessmentDietary exposure assessment is defined by Codex Alimentarius as “the qualitative and/or quantitativeevaluati<strong>on</strong> of the likely intake of chemical agents via food as well as exposure from other sources, ifrelevant” (FAO 2006). Exposure is basically a functi<strong>on</strong> of the amount of c<strong>on</strong>sumed food and thec<strong>on</strong>centrati<strong>on</strong> of the chemical (e.g. <strong>pesticide</strong> residue c<strong>on</strong>centrati<strong>on</strong>) and can be expressed by thefollowing equati<strong>on</strong>:Dietary exposure =Σ(residue c<strong>on</strong>centrati<strong>on</strong> food c<strong>on</strong>sumpti<strong>on</strong>)body weightIn the chr<strong>on</strong>ic (l<strong>on</strong>g-term) and acute (short-term) risk assessment, the estimated dietary exposure iscompared to the relevant toxicological reference values, i.e. the acceptable daily intake (ADI) and theAcute Reference Dose (ARfD), respectively (see “Background informati<strong>on</strong>” in Secti<strong>on</strong> 1), which werederived after a full hazard characterisati<strong>on</strong> of the compound.The c<strong>on</strong>sumer is c<strong>on</strong>sidered to be adequately protected if the estimated dietary intake of a <strong>pesticide</strong>residue does not exceed the ADI or the ARfD. The ADI and ARfD are derived after a full hazardcharacterizati<strong>on</strong> of a compound.In the c<strong>on</strong>text of this <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> performs the risk assessment to estimate the actual dietary<strong>pesticide</strong> exposure of the <strong>Europe</strong>an populati<strong>on</strong>. In this case, the residue data used to calculate thec<strong>on</strong>sumer’s exposures are mainly derived from the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU programme, which aims at representingthe actual residue c<strong>on</strong>centrati<strong>on</strong>s in food c<strong>on</strong>sumed by the populati<strong>on</strong>. As the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinatedprogramme <strong>on</strong>ly covered 9 food commodities, residue data for additi<strong>on</strong>al food commodities relevantfor the chr<strong>on</strong>ic exposure assessment were retrieved from the nati<strong>on</strong>al c<strong>on</strong>trol programmes. Since the<str<strong>on</strong>g>2008</str<strong>on</strong>g> residue data were provided by the participating countries in aggregated format, accuratecalculati<strong>on</strong>s <strong>on</strong> the actual dietary exposure could not be performed. Thus, the calculati<strong>on</strong>s should beregarded as an approximate indicati<strong>on</strong> of the actual short-term and l<strong>on</strong>g-term exposure of <strong>Europe</strong>anc<strong>on</strong>sumers <strong>on</strong>ly which is affected by uncertainties.Regulati<strong>on</strong> (EC) No. 396/2005 also requires that for the risk assessment, other relevant data sourcessuch as the <str<strong>on</strong>g>report</str<strong>on</strong>g> submitted under Directive 96/23/EC (EC 1996b) should be taken into account. In2009, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> published the <str<strong>on</strong>g>2008</str<strong>on</strong>g> annual technical <str<strong>on</strong>g>report</str<strong>on</strong>g> <strong>on</strong> the results from m<strong>on</strong>itoring veterinarymedicinal product <strong>residues</strong> and other substances in food of animal origin in the Member States (<str<strong>on</strong>g>EFSA</str<strong>on</strong>g>2010). Some of the substances covered by this technical <str<strong>on</strong>g>report</str<strong>on</strong>g> are substances that may also be used asplant protecti<strong>on</strong> products. If <strong>residues</strong> of these substances occur in food of animal origin, these could bec<strong>on</strong>sidered as an additi<strong>on</strong>al source of exposure for the estimati<strong>on</strong> of c<strong>on</strong>sumer exposure. However,data submitted by Member States under Directive 96/23/EC for products of animal origin could not bec<strong>on</strong>sidered in the present <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report, as in most cases <strong>on</strong>ly the number of samples exceeding ornot exceeding the MRL were <str<strong>on</strong>g>report</str<strong>on</strong>g>ed but not the actual c<strong>on</strong>centrati<strong>on</strong>s of <strong>residues</strong> measured in thesamples. In additi<strong>on</strong>, the data are generated from targeted sampling strategies and therefore are notrepresentative for all products of animal origin available <strong>on</strong> the EU market.As no agreed internati<strong>on</strong>al or <strong>Europe</strong>an methodology for estimating the actual chr<strong>on</strong>ic and acuteexposure to <strong>pesticide</strong> <strong>residues</strong> measured in m<strong>on</strong>itoring activities is available, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> decided to adaptthe risk assessment methodology developed for the pre-regulatory risk assessment <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> 2007). Themodel implements the principle of the WHO methodologies for short-term and l<strong>on</strong>g-term riskassessment. The assumpti<strong>on</strong>s and c<strong>on</strong>siderati<strong>on</strong>s made for the development of the new risk assessmentmethodology are outlined in the next secti<strong>on</strong>s.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> did not perform a Cumulative Risk Assessment (CRA) since an agreed <strong>Europe</strong>an methodologyfor the assessment of the combined effect of mixtures of <strong>pesticide</strong>s in food is not yet available.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164677


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues5.1. Model assumpti<strong>on</strong>s for the short-term exposure assessmentFor the calculati<strong>on</strong> of the short-term intake <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> calculated the Internati<strong>on</strong>al Estimati<strong>on</strong> of ShortTerm Intake (IESTI) as described by JMPR (FAO 2009). The calculati<strong>on</strong> methodology implements thecoincidence of the following events:• A c<strong>on</strong>sumer who eats a large porti<strong>on</strong> size of the food item under c<strong>on</strong>siderati<strong>on</strong> (normally97.5 th percentile of the daily food c<strong>on</strong>sumpti<strong>on</strong> <str<strong>on</strong>g>report</str<strong>on</strong>g>ed in a food surveys, c<strong>on</strong>sidering <strong>on</strong>lypers<strong>on</strong>s who have c<strong>on</strong>sumed the pertinent food item during the reference period) c<strong>on</strong>sumes afood item bel<strong>on</strong>ging to the lot which c<strong>on</strong>tains the highest residue measured (HRM) in thecoordinated programme <str<strong>on</strong>g>2008</str<strong>on</strong>g>.• The HRM is multiplied with a factor (variability factor) which accommodates for potentialinhomogeneous residue distributi<strong>on</strong> am<strong>on</strong>g the individual units in the same lot. Thevariability factors depend <strong>on</strong> the unit size of the food item: for food commodities with a unitweight between 25 and 250 g a factor of 7 is applied 20 (i.e. carrots, mandarins, oranges, pearsand potatoes). The underlying assumpti<strong>on</strong> is that the c<strong>on</strong>sumer may pick out a highlyc<strong>on</strong>taminated unit which c<strong>on</strong>tains the seven-fold <strong>residues</strong> compared with the compositesample which was analysed in a m<strong>on</strong>itoring programme. For food commodities with a unitweight of more than 250 g, a variability factor of 5 is applied (i.e. cucumbers). No variabilityfactor is used for commodities with unit weights less than 25 g (i.e. beans without pods, riceand spinach). It is noted that the model approach used in EU Member States differs from thecurrently used JMPR methodology, which uses a variability factor of 3 for all commoditieswith unit weight greater than 25 g.It should be stressed that the co-occurrence of the above events (i.e. large porti<strong>on</strong> size, highest residuemeasured and inhomogeneous residue distributi<strong>on</strong>) is extremely unlikely. In case the estimatedc<strong>on</strong>sumer exposure based <strong>on</strong> these very c<strong>on</strong>servative assumpti<strong>on</strong>s leads to an exceedance of thetoxicological reference values, the severity of the critical event should take into account the degree ofexceedance (expressed in percent of the ARfD) and the probability that such an event needs to bec<strong>on</strong>sidered. Therefore not <strong>on</strong>ly the degree of exceedance of the ARfD but also the frequency ofsamples found to exceed the threshold is of relevance.A total of 19 nati<strong>on</strong>al diets are included in the <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> model used for estimating the dietary exposure ofc<strong>on</strong>sumers (<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> PRIMo-Pesticide Residue Intake Model) (<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> 2007). Nine of these diets reflectfood c<strong>on</strong>sumpti<strong>on</strong> habits of children, while the remaining ten c<strong>on</strong>cern adult dietary habits.The short-term assessment is carried out separately for each <strong>pesticide</strong>/crop combinati<strong>on</strong> as it isc<strong>on</strong>sidered unlikely that a c<strong>on</strong>sumer will eat two or more different commodities in large porti<strong>on</strong>swithin a short period of time, all of these commodities c<strong>on</strong>taining <strong>residues</strong> of the same <strong>pesticide</strong> at thehighest level. In the framework of this <str<strong>on</strong>g>report</str<strong>on</strong>g> the short-term exposure has been performed for the ninefood commodities included in the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated programme (i.e. beans (without pods), carrots,cucumbers, mandarins, oranges, pears, potatoes, rice and spinach).The acute c<strong>on</strong>sumer health risk is calculated using the following input parameters:• The highest <strong>residues</strong> measured (HRM) identified for each <strong>pesticide</strong>/crop combinati<strong>on</strong> withfindings above the limit of quantificati<strong>on</strong> <str<strong>on</strong>g>report</str<strong>on</strong>g>ed by EEA and Member States (see secti<strong>on</strong>5.1.1).• Processing/peeling factor (see secti<strong>on</strong> 5.1.2)• Large porti<strong>on</strong> food c<strong>on</strong>sumpti<strong>on</strong> data retrieved from the <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> PRIMo (<str<strong>on</strong>g>EFSA</str<strong>on</strong>g>, 2007)20 At present, the choice of the variability factor to be used for the acute risk assessment at <strong>Europe</strong>an level is still underdiscussi<strong>on</strong>. At internati<strong>on</strong>al level a different factor can be applied.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164678


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues• Unit weight for the individual food commodities (retrieved from the <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> PRIMo, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>,2007)• Acute Reference Dose values (see secti<strong>on</strong> 5.1.3)In Figure 5.1-1, the tiered approach used in assessing the acute risk is represented.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164679


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesFigure 5.1-1: Flow chart for the tiered approach used in assessing the potential acute risk.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164680


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues5.1.1. Residue levelsThe IESTI calculati<strong>on</strong>s have been performed with the residue levels <str<strong>on</strong>g>report</str<strong>on</strong>g>ed in Table 5.1.1-1. Emptycells refer to <strong>pesticide</strong>/crop combinati<strong>on</strong>s for which no <strong>residues</strong> above the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing level weremeasured. The m<strong>on</strong>itoring results were <str<strong>on</strong>g>report</str<strong>on</strong>g>ed according to the enforcement residue definiti<strong>on</strong> asdefined in Regulati<strong>on</strong> (EC) No. 396/2005. A re-calculati<strong>on</strong> to the risk assessment residue definiti<strong>on</strong>was not possible because the c<strong>on</strong>versi<strong>on</strong> factors are currently not available.Table 5.1.1-1: Highest residue measured (mg/kg) used as input values for the short-term dietaryexposure calculati<strong>on</strong>s.PesticideBeans(withoutpods)Carrots CucumbersMandarinsOranges Pears Potatoes Rice SpinachAcephate 0.050Acetamiprid 0.190 0.020 0.050 0.091 0.058Aldicarb (sum of aldicarb, itssulfoxide and its sulf<strong>on</strong>e,expressed as aldicarb)Azinphos-methyl 0.130 1.100Azoxystrobin 0.041 0.076 0.200 0.140 0.100 0.030 0.210 0.410Bifenthrin 0.090 0.020 0.015 0.150 0.340Bromopropylate 0.010 0.758 0.680 0.240Bupirimate 0.200 0.010Buprofezin 0.140 0.022 0.079 0.024 0.170 0.011Captan n.n. (1) 0.065 0.027 0.140 n.n. 0.020Captan/Folpet (sum of folpetand captan) (*) 0.100 n.n. n.n. n.n. n.n. 2.900 n.n. n.n. n.n.Carbaryl 0.230 0.515 0.013 0.690Carbendazim/benomyl (sum ofbenomyl and carbendazim0.300 0.260 0.240 1.400 0.040 0.600expressed as carbendazim)Chlormequat (**) n.n. (*) 0.004 n.n. n.n. 1.100 n.n. n.n. n.n.Chlorothal<strong>on</strong>il 0.070 0.510 0.700 8.800Chlorpropham (chlorprophamand 3-chloroaniline, expressed0.020 0.020 0.010 0.067 18.400 0.020as chlorpropham) (***)Chlorpyrifos 0.016 0.800 0.045 0.700 0.350 0.430 3.710 0.140 1.800Chlorpyrifos-methyl 0.067 0.075 0.210 0.110 0.150 0.474 1.500Clofentezine 0.040 0.020 0.010Cypermethrin (cypermethrinincluding other mixtures ofc<strong>on</strong>stituent isomers (sum ofisomers))0.270 0.060 0.150 0.140 0.550 0.010 1.200Cyprodinil 0.106 0.002 0.140 0.042 0.380 0.030 0.570Deltamethrin 0.010 0.022 0.050 0.020 0.900 0.160Diazin<strong>on</strong> 0.170 0.187 0.600 0.140Dichlofluanid 0.040 0.070 0.130 0.020 0.162Dichlorvos 0.030Dicofol (sum of p, p' and o,p'isomers)1.000 0.500 0.070 0.610<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164681


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesPesticideDimethoate (sum ofdimethoate and omethoate,expressed as dimethoate)Beans(withoutpods)Carrots CucumbersMandarinsOranges Pears Potatoes Rice Spinach0.078 0.150 0.018 0.230 0.380 1.400 2.600Diphenylamine 0.020 0.090 7.900 0.002Dithiocarbamates (Includingmaneb, mancozeb, metiram,propineb, thiram and ziram(expressed as CS 2 ))Endosulfan (sum of alpha- andbeta-isomers and endosulfansulphate,expressed asendosulfan)0.080 0.200 0.500 0.600 0.500 2.800 0.300 0.016 6.6000.050 0.060 0.150 0.070 0.540 0.300 0.010 0.250Fenarimol 0.010Fenhexamid 0.060 0.012Fenitrothi<strong>on</strong> 0.100 0.039 0.010 0.050 0.016Fludiox<strong>on</strong>il 0.040 0.060 0.100 0.290 2.600FlusilazoleFolpet 0.030 0.370Hexac<strong>on</strong>azole 0.020 0.013 0.007Hexythiazox 0.010 0.040 0.010 0.040Imazalil 0.010 0.080 14.300 6.600 3.385 0.760 0.280Imidacloprid 0.110 0.240 0.450 0.160 0.040 0.013 0.098Indoxacarb (sum of the0.080 0.070 0.430isomers S and R)Iprodi<strong>on</strong>e 0.030 4.800 0.900 0.190 0.020 10.900 0.018 4.400Iprovalicarb 0.020 0.020Kresoxim-methyl 0.035 0.050 0.070Lambda-Cyhalothrin 0.120 0.020 0.060 0.090 0.050 1.500Malathi<strong>on</strong> (sum of malathi<strong>on</strong>and malaox<strong>on</strong> expressed asmalathi<strong>on</strong>)Mepanipyrim (mepanipyrimand its metabolite (2-anilino-4-(2-hydroxypropyl)-6-methylpyrimidine,) expressed0.030 0.391 0.010 1.600 0.460 0.240 0.390 3.700 0.0200.010as mepanipyrim)Mepiquat n.n. n.n. n.n. n.n. n.n. n.n. n.n. n.n.Metalaxyl (metalaxyl includingother mixtures of c<strong>on</strong>stituentisomers including metalaxyl-M(sum of isomers))0.058 0.339 0.048 0.070 0.030 0.090 0.002 0.074Methamidophos 0.010 0.390 0.010 0.010Methidathi<strong>on</strong> 1.300 1.150 0.025Methiocarb (sum ofmethiocarb and methiocarbsulfoxide and sulf<strong>on</strong>e,expressed as methiocarb)Methomyl (sum of methomyland thiodicarb expressed asmethomyl)0.050 5.600 0.0800.050 0.157 0.310 0.250 0.020 0.190Myclobutanil 0.002 0.040 0.840 0.770 0.003<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164682


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesPesticideBeans(withoutpods)Carrots CucumbersMandarinsOranges Pears Potatoes Rice SpinachOxamyl 0.010 0.180 0.090Oxydemet<strong>on</strong>-methyl (sum ofoxydemet<strong>on</strong>-methyl anddemet<strong>on</strong>-S-methylsulf<strong>on</strong>eexpressed as oxydemet<strong>on</strong>methyl)Parathi<strong>on</strong> 0.160Penc<strong>on</strong>azole 0.091 0.011Phosal<strong>on</strong>e 0.030 0.060 0.290Pirimicarb (sum of pirimicarband desmethyl pirimicarb0.070 0.010 0.034 4.300expressed as pirimicarb)Pirimiphos-methyl 0.068 0.320 0.400 0.020 1.300Prochloraz (sum of prochlorazand its metabolites c<strong>on</strong>tainingthe 2,4,6-trichlorophenolmoiety expressed asprochloraz)6.830 2.980 0.060Procymid<strong>on</strong>e 0.072 0.096 0.960 0.005 0.600 0.670Profenofos 0.040 0.060Propargite 0.344 0.170 0.110 0.120Pyrethrins 0.130 0.120 0.090 0.270 0.290Pyrimethanil 0.010 0.150 0.610 4.100 1.810 0.810 0.220Pyriproxyfen 0.050 0.040QuinoxyfenSpiroxamine 0.020Tebuc<strong>on</strong>azole 0.260 0.200 0.660 0.080 0.520Tebufenozide 0.015 0.170 1.200Thiabendazole 0.020 0.050 0.060 5.260 7.300 2.810 0.450 0.260Thiophanate-methyl 0.100 0.080 0.690 0.720Tolclofos-methyl 0.110 0.000 0.020Tolylfluanid (sum oftolylfluanid anddimethylaminosulfotoluidideexpressed as tolylfluanid)0.039 0.320Triadimef<strong>on</strong> (sum oftriadimef<strong>on</strong> and triadimenol)Trifloxystrobin 0.004 0.010 0.030 0.060Vinclozolin (sum ofvinclozolin and all metabolitesc<strong>on</strong>taining the 3,5-dichloraniniline moiety,expressed as vinclozolin)0.010 0.100 0.082 0.046 0.0700.312 0.156 0.023 0.010(1): n.n. = the analysis of this <strong>pesticide</strong>/crop combinati<strong>on</strong> was not requested.(*): the residue definiti<strong>on</strong> “captan/folpet (sum of folpet and captan)” <strong>on</strong>ly applies to beans (without pods) and pears.(**): the analysis of chlormequat was <strong>on</strong>ly requested in carrots, cucumbers and pears.(***):The residue definiti<strong>on</strong> and the measured <strong>residues</strong> in potatoes refer to chlorpropham <strong>on</strong>ly (parent compound <strong>on</strong>ly).<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164683


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues5.1.2. Processing/peeling factorsFive crops included in the <str<strong>on</strong>g>2008</str<strong>on</strong>g> coordinated m<strong>on</strong>itoring programme (beans (without pods), mandarins,oranges, potatoes and rice) are usually <strong>on</strong>ly c<strong>on</strong>sumed in processed form or after peeling. A possiblereducti<strong>on</strong> or c<strong>on</strong>centrati<strong>on</strong> of the <strong>residues</strong> as a result of peeling and processing should be taken intoaccount in a refined exposure assessment. However, processing/peeling factors are not alwaysavailable.The factors summarised in Table 5.1.2-1 have been selected from the database 21 developed by theFederal Institute for Risk Assessment (BfR), which includes a collecti<strong>on</strong> of processing factors fromannually published <str<strong>on</strong>g>report</str<strong>on</strong>g>s and evaluati<strong>on</strong>s by the FAO/WHO Joint Meeting <strong>on</strong> Pesticide Residues(JMPR), from draft assessment <str<strong>on</strong>g>report</str<strong>on</strong>g>s (DAR) prepared in the <strong>Europe</strong>an Pesticide Risk AssessmentPeer Review programme (PRAPeR) and from residue data which have been submitted within theframework of nati<strong>on</strong>al authorisati<strong>on</strong> procedures. Additi<strong>on</strong>al data c<strong>on</strong>cerning pulp/peel distributi<strong>on</strong>have been provided for BfR by retailers and have been collected within the framework of nati<strong>on</strong>alfood m<strong>on</strong>itoring programmes. If peeling factors were available for oranges they have also beenapplied for mandarins, since a similar distributi<strong>on</strong> of <strong>residues</strong> between pulp and peel can be assumed.In the event that the IESTI calculati<strong>on</strong> in tier 1 exceeded 100% of the ARfD and processing or peelingfactors were available, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> performed a refined risk assessment (2 nd tier).Table 5.1.2-1: Processing and peeling factors applied in the refined IESTI calculati<strong>on</strong>s.Pesticide Crop PF Processed/peeled cropBromopropylate Oranges 0.02 Orange pulpBromopropylate Mandarins 0.02 Orange pulpCarbaryl Oranges 0.47 Orange pulpCarbaryl Mandarins 0.47 Orange pulpCarbendazim/benomyl Oranges 0.20 Orange pulpChlorpropham Potatoes 0.33 Cooked potatoesDeltamethrin Rice 0.15 Rice grain to brown riceDimethoate Oranges 0.14 Orange pulpDithiocarbamates Oranges 0.88 Orange pulpImazalil Oranges 0.05 Orange pulpImazalil Mandarins 0.05 Clementine pulpMethidathi<strong>on</strong> Oranges 0.03 Orange pulpMethidathi<strong>on</strong> Mandarins 0.03 Orange pulpProchloraz Oranges 0.01 Orange pulpProchloraz Mandarins 0.11 Clementine pulp5.1.3. Acute Reference Dose values (ARfDs)In order to perform the risk assessment, the calculated exposure for a certain <strong>pesticide</strong>/cropcombinati<strong>on</strong> was compared with the ARfD value. In Table 5.1.3-1 the ARfD values used for the acuterisk assessment are listed. It should be menti<strong>on</strong>ed that some of the ARfD values were derived recentlyand were not in place in <str<strong>on</strong>g>2008</str<strong>on</strong>g> when the m<strong>on</strong>itoring results were generated.21 The database is available at http://www.bfr.bund.de/cd/579 (BfR compilati<strong>on</strong> of 2009-07-01).<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164684


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesTable 5.1.3-1: ARfD values used for the short-term risk assessmentPesticideARfD(mg/kg bw)ARfDevaluati<strong>on</strong> yearARfDsourceAcephate 0.1 2005 JMPRAcetamiprid 0.1 2004 COMAldicarb 0.003 1995 JMPRAzinphos-methyl 0.01 2005 COMBuprofezin 0.5 <str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Captan (1) 0.3 2009 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Carbaryl 0.01 2006 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Carbendazim (2) 0.02 2007 COMChlormequat (9) 0.07 <str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Chlorothal<strong>on</strong>il 0.6 2006 COMChlorpropham 0.5 2003 COMChlorpyrifos 0.1 2005 COMChlorpyrifos-methyl 0.1 2005 COMCypermethrin (3) 0.04 2004 COMDeltamethrin 0.01 2002 COMDiazin<strong>on</strong> 0.025 2006 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Dichlorvos n.d. (4) 2006 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Dicofol 0.15 2006 DAR (5)Dimethoate 0.01 2006 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Dithiocarbamates (6) 0.08 2004 COMEndosulfan 0.02 1998 JMPRFenarimol 0.02 2007 COMFenitrothi<strong>on</strong> 0.013 2006 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Flusilazole (general populati<strong>on</strong>) 0.02 2007 JMPRFlusilazole (women) 0.005 2007 COMFolpet (1) 0.2 2009 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Hexac<strong>on</strong>azole 0.005 1990 JMPRImazalil 0.05 2010 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Imidacloprid 0.08 <str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Indoxacarb 0.125 2005 COMLambda-cyhalothrin 0.0075 2001 COMMalathi<strong>on</strong> 0.3 2009 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Mepiquat 0.3 <str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Metalaxyl (7) 0.5 2002 COMMethamidophos 0.003 2007 COMMethidathi<strong>on</strong> 0.01 1997 JMPRMethiocarb (aka mercaptodimethur) 0.013 2006 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Methomyl 0.0025 <str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Myclobutanil 0.31 2009 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Omethoate 0.002 2006 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Oxamyl 0.001 2005 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Oxydemet<strong>on</strong>-methyl 0.0015 2006 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Parathi<strong>on</strong> 0.005 2001 ECCOPenc<strong>on</strong>azole 0.5 <str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Phosal<strong>on</strong>e 0.1 2006 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Pirimicarb 0.1 2006 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Pirimiphos-methyl 0.15 2005 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Prochloraz 0.1 2001 JMPR<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164685


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesPesticideARfD(mg/kg bw)ARfDevaluati<strong>on</strong> yearARfDsourceProcymid<strong>on</strong>e 0.012 2007 DAR/COMProfenofos 1 2007 JMPRPropargite 0.03 2007 DARPyrethrins 0.2 2003 JMPRTebuc<strong>on</strong>azole 0.03 <str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Thiodicarb 0.01 2005 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Thiophanate-methyl 0.2 2005 COMTolylfluanid 0.25 2005 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Triadimef<strong>on</strong> (8) 0.05 <str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Vinclozolin 0.06 2006 COM(1) For commodities for which an MRL is established as sum of captan and folpet, the ARfD for folpet is used.(2) ARfD for carbendazim is used for risk assessment of carbendazim and benomyl.(3) ARfD derived for alpha-cypermethrin.(4) <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> could not c<strong>on</strong>clude <strong>on</strong> the ARfD for Dichlorvos due to insufficient data.(5) DAR = Draft Assessment Report prepared in the framework of the active substance peer-review under DirectiveEEC/91/414.(6) The group of dithiocarbamates includes seven <strong>pesticide</strong>s with different toxicological reference values; a group-ARfD isnot available. The <str<strong>on</strong>g>report</str<strong>on</strong>g> ARfD refers to the reference value set for ziram.(7) ARfD for metalaxyl-M.(8) ARfD for triadimenol is used for risk assessment of triadimenol and triadimef<strong>on</strong>.(9) The ARfD for chlormequat chloride derived in the peer review under 91/414/EEC was 0.09 mg/kg. This value wasrecalculated to chlormequat to be comparable with the residue definiti<strong>on</strong> which is expressed as chlormequat (i<strong>on</strong>).5.1.4. Presentati<strong>on</strong> of the results of the short-term c<strong>on</strong>sumer exposureFor each <strong>pesticide</strong>/crop combinati<strong>on</strong> where a highest measured residue was <str<strong>on</strong>g>report</str<strong>on</strong>g>ed (Table 5.1.4-1)the short-term exposure was calculated for all c<strong>on</strong>sumer groups for which food c<strong>on</strong>sumpti<strong>on</strong> data havebeen submitted in the framework of the development of the <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> PRIMo. If an ARfD value has beenestablished for the active substance c<strong>on</strong>cerned, the calculated exposures for the highest residuemeasured were expressed in percent of the ARfD. For each of the eight commodities the results for thedifferent diets are presented in a chart in Appendix IV.In additi<strong>on</strong>, for each food commodity c<strong>on</strong>cerned, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> calculated a theoretical threshold residue levelfor the most critical diet included in the <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> PRIMo. Residues at this threshold level corresp<strong>on</strong>d to100% of the ARfD and are therefore the maximum residue c<strong>on</strong>centrati<strong>on</strong> for which a c<strong>on</strong>sumer riskcan be excluded.Measured residue c<strong>on</strong>centrati<strong>on</strong>s exceeding the calculated theoretical threshold residue level arehighlighted as values which may be of a potential c<strong>on</strong>sumer health c<strong>on</strong>cern. However, the overallc<strong>on</strong>servative assumpti<strong>on</strong> in the assessment should be kept in mind.The results of the acute exposure assessments are <str<strong>on</strong>g>report</str<strong>on</strong>g>ed individually for each <strong>pesticide</strong> in anexposure assessment summary <str<strong>on</strong>g>report</str<strong>on</strong>g>. All the <str<strong>on</strong>g>report</str<strong>on</strong>g>s are presented in Appendix IV. In these <str<strong>on</strong>g>report</str<strong>on</strong>g>s,for each <strong>pesticide</strong>/crop combinati<strong>on</strong> the following informati<strong>on</strong> is <str<strong>on</strong>g>report</str<strong>on</strong>g>ed:• the EC MRL in place <strong>on</strong> 01/01/<str<strong>on</strong>g>2008</str<strong>on</strong>g> (if applicable)• the total number of samples analysed for the given <strong>pesticide</strong>/crop combinati<strong>on</strong>• the percentage of the samples with quantifiable <strong>residues</strong> below or at the MRL (EC or nati<strong>on</strong>alMRL)• the percentage of the samples above the MRL (EC or nati<strong>on</strong>al MRL)<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164686


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues• the identified Highest Residue Measured (HRM)• the number of the nati<strong>on</strong>al diets in which the theoretical threshold residue was exceeded• the maximum acute exposure for the most critical diet represented in the <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> PRIMo,expressed in percent of the ARfD• the most critical diet for which the highest c<strong>on</strong>sumer exposure was calculatedThe percentage of samples with a residue level exceeding the lowest calculated threshold residue istaken as an indicator of the frequency of a potential critical c<strong>on</strong>sumer exposure for each <strong>pesticide</strong>/cropcombinati<strong>on</strong>. If the exceedance of the threshold occurred in less than 0.1% of the samples which wereanalysed for the <strong>pesticide</strong>, the event was c<strong>on</strong>sidered to be excepti<strong>on</strong>al, a frequency of 0.1 to 1% wasc<strong>on</strong>sidered to be a seldom event, and a frequency above 1% was classified as n<strong>on</strong>-seldom.The format used for <str<strong>on</strong>g>report</str<strong>on</strong>g>ing the <str<strong>on</strong>g>2008</str<strong>on</strong>g> m<strong>on</strong>itoring results of the residue analysis required that<str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries submitted the data in an aggregated form; <strong>on</strong>ly the number of samples with residuelevels falling in <strong>on</strong>e of 13 predefined residue classes was <str<strong>on</strong>g>report</str<strong>on</strong>g>ed (e.g. samples with <strong>residues</strong> between0.02 and 0.05 mg/kg, samples with <strong>residues</strong> between 0.05 and 0.10 mg/kg, etc.); the individualmeasured residue c<strong>on</strong>centrati<strong>on</strong>s for the samples were not <str<strong>on</strong>g>report</str<strong>on</strong>g>ed. Therefore, when the number ofsamples exceeding the threshold residue had to be counted it was c<strong>on</strong>sidered the upper or lower boundof the predefined residue classes which was closer to the theoretical threshold residue.5.1.5. Limitati<strong>on</strong> and uncertainties affecting the short-term exposure assessmentThe routine risk assessment methodology, based <strong>on</strong> the IESTI calculati<strong>on</strong>s, c<strong>on</strong>tains several sources ofuncertainty. Due to the complexity of combining all the relevant uncertainty sources, a quantificati<strong>on</strong>of the uncertainty inherent in the risk assessment methodology cannot be achieved.The most important sources of uncertainty are the following:• Inaccuracies related to the c<strong>on</strong>sumpti<strong>on</strong> data - high c<strong>on</strong>sumpti<strong>on</strong> at the 97.5 th percentile of thec<strong>on</strong>sumpti<strong>on</strong> distributi<strong>on</strong>;• Inaccuracies related to the c<strong>on</strong>sumpti<strong>on</strong> data - in some cases the 97.5 th c<strong>on</strong>sumpti<strong>on</strong> valuesrepresent aggregates of c<strong>on</strong>sumpti<strong>on</strong> of all forms of the raw agricultural commodities,therefore appropriate processing factors cannot be applied to the different forms (e.g. orangec<strong>on</strong>sumpti<strong>on</strong> may represent orange flesh and orange juice);• Inaccuracies related to the highest <strong>pesticide</strong> residue levels (HRM) used in the short-term riskassessment;• Inaccuracies related to the applied variability factors.A qualitative estimati<strong>on</strong> of uncertainties and a descripti<strong>on</strong> of the c<strong>on</strong>straints of the model used forassessing potential acute c<strong>on</strong>sumer risks is <str<strong>on</strong>g>report</str<strong>on</strong>g>ed elsewhere (<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> 2009).Not all food lots which were identified by the competent authorities exceeding the MRL legislati<strong>on</strong>have been available to the <strong>Europe</strong>an c<strong>on</strong>sumers. Some of these lots may have been withdrawn by thenati<strong>on</strong>al authorities from the market before being c<strong>on</strong>sumed or may have been rejected at the borderbefore import to the EU. However, since these cases were specifically labelled in the nati<strong>on</strong>al <str<strong>on</strong>g>report</str<strong>on</strong>g>s,they were also used to calculate the c<strong>on</strong>sumer exposure.Overall, it is c<strong>on</strong>cluded that the methodology applied to assess the short-term risk over-estimates theactual dietary exposure and the potential c<strong>on</strong>sumer risk. In future, if the results of the coordinatedm<strong>on</strong>itoring programmes are to be provided in a n<strong>on</strong>-aggregate form, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> will be able to perform<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164687


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residuesmore realistic exposure assessments, applying probabilistic methodologies. However, for the <str<strong>on</strong>g>report</str<strong>on</strong>g>ingyear <str<strong>on</strong>g>2008</str<strong>on</strong>g> such calculati<strong>on</strong>s were not yet possible.5.2. Results of the short-term risk assessmentThe total number of <strong>pesticide</strong>/crop combinati<strong>on</strong>s analysed in the framework of the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EUcoordinated programmes was 697. For 21 active substances or group of substances, no ARfD wasestablished because of the low acute toxicity of the substance. For <strong>on</strong>e <strong>pesticide</strong> (dichlorvos) noreliable ARfD was available. C<strong>on</strong>sequently, for 198 of the <strong>pesticide</strong>/crop combinati<strong>on</strong>s (22<strong>pesticide</strong>s*9 commodities) no short-term risk assessment was performed.The results of the assessment for the remaining 499 <strong>pesticide</strong>/crop combinati<strong>on</strong>s are presented in thefollowing secti<strong>on</strong>. In Figure 5.2-1, a summary of the number of the <strong>pesticide</strong>/crop combinati<strong>on</strong>saccording to the need to carry out the acute risk assessment is presented.Acute riskassessmentwas notneeded: 189Acute riskassessmentwas needed:499Acute riskassessmentcould not beperformed: 9Figure 5.2-1: Summary of the total number of <strong>pesticide</strong>/crop combinati<strong>on</strong>s according tothe need to carry out the acute risk assessmentThe summary <str<strong>on</strong>g>report</str<strong>on</strong>g>s of the IESTI calculati<strong>on</strong>s for the <strong>pesticide</strong>s for which an acute risk assessmentwas performed are <str<strong>on</strong>g>report</str<strong>on</strong>g>ed in Appendix IV to the <str<strong>on</strong>g>report</str<strong>on</strong>g>.For 458 combinati<strong>on</strong>s of the 499 <strong>pesticide</strong>/crop combinati<strong>on</strong>s for which the acute risk assessment wasneeded the estimated exposure was below 100% of the ARfD. Thus, based <strong>on</strong> the current scientificknowledge, for these combinati<strong>on</strong>s short-term c<strong>on</strong>sumer c<strong>on</strong>cerns can be excluded.5.2.1. Pesticide/crop combinati<strong>on</strong> for which a theoretical short-term risk could notbe excludedAccording to the assessment <str<strong>on</strong>g>report</str<strong>on</strong>g>ed in Appendix IV, a theoretical c<strong>on</strong>sumer risk could not beexcluded for the 35 <strong>pesticide</strong>/crop combinati<strong>on</strong>s listed in Table 5.2.1-1. In table 5.2.1-2 additi<strong>on</strong>alinformati<strong>on</strong> and recommendati<strong>on</strong>s to follow up <strong>on</strong> these findings are <str<strong>on</strong>g>report</str<strong>on</strong>g>ed. In nine cases the<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164688


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residuesestimated exposure was less than 150% of the ARfD. Bearing in mind the overall uncertainties andoverall c<strong>on</strong>servatism of the calculati<strong>on</strong>, these events are c<strong>on</strong>sidered as n<strong>on</strong> significant exceedances.For 33 out of the 35 <strong>pesticide</strong>/crop combinati<strong>on</strong>s for which a theoretical c<strong>on</strong>sumer risk could not beexcluded, the potential risk identified was c<strong>on</strong>sidered to be an excepti<strong>on</strong>al or seldom event; for twosingle combinati<strong>on</strong>s (azinphos-methyl/pears and omethoate-dimethoate/oranges) the threshold levelwas exceeded in more than 1% of the samples analysed for this <strong>pesticide</strong>/commodity combinati<strong>on</strong> andthe event was therefore classified as n<strong>on</strong> seldom. Details <strong>on</strong> these findings are <str<strong>on</strong>g>report</str<strong>on</strong>g>ed in thefollowing paragraphs.It is noted that in all cases the most critical sub group of the populati<strong>on</strong> were children.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164689


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesTable 5.2.1-1: Summary results of the short-term risk assessment of the active substances for which an acute risk could not be excluded.Pesticide Crop<str<strong>on</strong>g>2008</str<strong>on</strong>g> MRL(whole crop) (1)mg/kgTotal numberof samplesanalysed% samplesexceedingthe MRL(*)Highest residuemeasured(HRM) mg/kgHighest residuemeasured correctedwith PF (HRMc)mg/kgMaxIESTI(%ARfD)Mostcritical dietThresholdresidue inedibleporti<strong>on</strong> (2)(mg/kg)Numberofsamplesabove thethresholdresidue% samplesabove thethresholdresidueExceedence ofARfD isc<strong>on</strong>sidered"Excepti<strong>on</strong>al"."seldom" or "notseldom" event?(3)Azinphos-methyl Pears 0.5 1441 0.21 1.1 1001.8 DE child 0.110 38 2.64 n<strong>on</strong> seldomCarbaryl Oranges 0.05* 1161 0.17 0.51 0.242 320.9 UK infant 0.075 2 0.17 seldomCarbaryl Potatoes 0.05* 1671 0.12 0.69 1060.9 UK infant 0.065 2 0.12 seldomCarbendazim/Benomyl Pears 0.2 1054 0.28 1.4 637.5 DE child 0.220 3 0.28 seldomChlormequat Pears 0.2 455 0.88 1.1 143.1 DE child 0.770 1 0.22 seldomChlorpropham Potatoes 10 1611 0.06 18.39 6.07 186.7 UK infant 3.251 6 0.37 seldomChlorpyrifos Potatoes 0.05* 1830 0.27 3.71 570.4 UK infant 0.650 1 0.05 excepti<strong>on</strong>alDiazin<strong>on</strong> Oranges 0.01* 1478 0.88 0.6 318.3 UK infant 0.189 2 0.14 seldomDimethoate/omethoate Oranges 0.02* 1355 0.96 0.23 1525.1 UK infant 0.015 16 1.18 n<strong>on</strong> seldomDimethoate/omethoate Pears 0.02* 1421 0.21 0.38 1730.4 DE child 0.022 3 0.21 seldomDimethoate/omethoate Potatoes 0.02* 1758 0.06 1.4 10763.1 UK infant 0.013 1 0.06 excepti<strong>on</strong>alDimethoate/omethoate Carrots 0.02* 1318 0.15 0.078 247.3 UK infant 0.032 2 0.15 seldomDimethoate/omethoate Cucumbers 0.02* 1122 0.18 0.15 438.6 NL child 0.034 2 0.18 seldomDimethoate/omethoate Spinach 0.02* 897 0.33 2.6 2938.2 BE child 0.088 3 0.33 seldomEndosulfan Oranges 0.05* 1323 0.08 0.54 358.1 UK infant 0.151 1 0.08 excepti<strong>on</strong>alEndosulfan Pears 0.3 1441 0.00 0.3 136.6 DE child 0.220 1 0.07 excepti<strong>on</strong>alImazalil Pears 5 1414 0.00 3.385 145.3 NL (GP) 2.329 3 0.21 seldomImazalil Potatoes 5 1500 0.00 0.76 116.9 UK infant 0.650 1 0.07 excepti<strong>on</strong>allambda-Cyhalothrin Oranges 0.1 1212 0.00 0.09 159.1 UK infant 0.057 2 0.17 seldom<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164690


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesPesticide Crop<str<strong>on</strong>g>2008</str<strong>on</strong>g> MRL(whole crop) (1)mg/kgTotal numberof samplesanalysed% samplesexceedingthe MRL(*)Highest residuemeasured(HRM) mg/kgHighest residuemeasured correctedwith PF (HRMc)mg/kgMaxIESTI(%ARfD)Mostcritical dietThresholdresidue inedibleporti<strong>on</strong> (2)(mg/kg)Numberofsamplesabove thethresholdresidue% samplesabove thethresholdresidueExceedence ofARfD isc<strong>on</strong>sidered"Excepti<strong>on</strong>al"."seldom" or "notseldom" event?(3)lambda-Cyhalothrin Spinach 0.5 849 0.12 1.5 452.0 BE child 0.332 5 0.59 seldomMethamidophos Cucumbers 0.01* 1001 0.20 0.39 760.2 NL child 0.051 2 0.20 seldomMethiocarb (akamercaptodimethur)Cucumbers 0.2 761 0.26 5.6 2519.1 NL child 0.222 2 0.26 seldomMethomyl/thiodicarb Oranges 0.5 813 0.00 0.31 1644.5 UK infant 0.019 1 0.12 seldomMethomyl/thiodicarb Pears 0.2 1058 0.09 0.25 910.7 DE child 0.027 7 0.66 seldomMethomyl/thiodicarb Potatoes 0.05* 1193 0.00 0.02 123.0 UK infant 0.016 1 0.08 excepti<strong>on</strong>alMethomyl/thiodicarb Carrots 0.05* 855 0.00 0.05 126.8 UK infant 0.039 1 0.12 seldomMethomyl/thiodicarb Cucumbers 0.05* 806 0.62 0.157 367.3 NL child 0.043 5 0.62 seldomMethomyl/thiodicarb Spinach 0.05 646 1.08 0.19 171.8 BE child 0.111 2 0.31 seldomOxamyl Potatoes 0.01* 1057 0.19 0.09 1383.8 UK infant 0.007 2 0.19 seldomOxamyl Cucumbers 0.02 693 0.29 0.18 1052.6 NL child 0.017 2 0.29 seldomParathi<strong>on</strong> Mandarins 0.05* 914 0.11 0.16 178.1 UK toddler 0.090 1 0.11 seldomProcymid<strong>on</strong>e Pears 1 1538 0.00 0.6 455.4 DE child 0.132 4 0.26 seldomProcymid<strong>on</strong>e Cucumbers 1 1223 0.00 0.96 467.8 NL child 0.205 6 0.49 seldomProcymid<strong>on</strong>e Spinach 0.05* 910 0.11 0.67 126.2 BE child 0.531 1 0.11 seldomTebuc<strong>on</strong>azole Pears 1 1286 0.00 0.66 200.4 DE child 0.329 2 0.16 seldom(1) EC MRL in place 01/01/<str<strong>on</strong>g>2008</str<strong>on</strong>g>; when the MRL figure is followed by an asterisk (*) the MRL is set at the LOQ.(2) The threshold residue is the theoretical calculated residue level that represents the 100% of the ARfD exhausti<strong>on</strong>. This value is calculated singularly for each <strong>pesticide</strong>/crop combinati<strong>on</strong> andfor each diet.(3) See secti<strong>on</strong> 5.1.3 for more details <strong>on</strong> the event classificati<strong>on</strong>.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164691


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesTable 5.2.1-2: Details <strong>on</strong> the MRL exceedances and sample origin for the samples for which a short-term risk could not be excluded.PesticideCropNo samples abovethe thresholdresidueNumber samples ><str<strong>on</strong>g>2008</str<strong>on</strong>g> EC MRLOrigin ofsamples ><str<strong>on</strong>g>2008</str<strong>on</strong>g> ECMRL(1)Pesticideauthorisati<strong>on</strong>status in EU (anycrop) in <str<strong>on</strong>g>2008</str<strong>on</strong>g>(y/n)<str<strong>on</strong>g>2008</str<strong>on</strong>g> ECMRL(wholecrop)mg/kg2010 ECMRL(wholecrop)mg/kgPFmissing?(y/n)ThresholdEC MRL(wholecrop)mg/kg2010ECMRL >thresholdMRL?(y/n)<str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Recommendati<strong>on</strong>sAzinphos-methyl Pears 38 3 2 IT, 1 ZA n 0.50 0.05* n.a. 0.110 n (2) + (3)Carbaryl Oranges 2 2 1 IT, 1US n 0.05* 0.05* n 0.160 n (2) + (3)Carbaryl Potatoes 2 2 2 MT n 0.05* 0.05* y (2) + (3)Carbendazim/BenomylPears 3 3 1 CY, 2 ES n 0.20 0.20 n.a. 0.220 n (3)Chlormequat Pears 1 41BE, 1 NL, 2SIn 0.20 0.10 n.a. 0.770 n (4)Chlorpropham Potatoes 6 1 1 FR y 10.00 10.00 n 9.851 y (4)Chlorpyrifos Potatoes 1 5 1 ES, 4 MT y 0.05* 0.05* y (3) + (5)Diazin<strong>on</strong> Oranges 2 13 12 EG, 1 ES n 0.01* 0.01* y (2) + (3)Dimethoate/omethoate Oranges 16 133 BR, 1 CY, 4EG, 1 ES, 2IT, 2 PTn (omethoate)y (dimethoate)0.02* 0.02* y (6)Dimethoate/omethoate Pears 3 3 1 GR, 2 PTn (omethoate)y (dimethoate)0.02* 0.02* n.a. 0.022 n (3) + (6)Dimethoate/omethoate Potatoes 1 1 1 MTn (omethoate)y (dimethoate)0.02* 0.02* y (3) + (6)Dimethoate/omethoate Carrots 2 2 2 BEn (omethoate)y (dimethoate)0.02* 0.02* n.a. 0.032 n (6)Dimethoate/omethoateCucumbern (omethoate)2 2 1 RO, 1 THsy (dimethoate)0.02* 0.02* n.a. 0.034 n (6)Dimethoate/omethoate Spinach 3 3 2 IT, 1 CYn (omethoate)y (dimethoate)0.02* 0.02* n.a. 0.088 n (3) + (6)Endosulfan Oranges 1 1 1 PT n 0.05* 0.05* y (3)<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164692


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesPesticideCropNo samples abovethe thresholdresidueNumber samples ><str<strong>on</strong>g>2008</str<strong>on</strong>g> EC MRLOrigin ofsamples ><str<strong>on</strong>g>2008</str<strong>on</strong>g> ECMRL(1)Pesticideauthorisati<strong>on</strong>status in EU (anycrop) in <str<strong>on</strong>g>2008</str<strong>on</strong>g>(y/n)<str<strong>on</strong>g>2008</str<strong>on</strong>g> ECMRL(wholecrop)mg/kg2010 ECMRL(wholecrop)mg/kgPFmissing?(y/n)ThresholdEC MRL(wholecrop)mg/kg2010ECMRL >thresholdMRL?(y/n)<str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Recommendati<strong>on</strong>sEndosulfan Pears 1 0y (until 20/06/2007in Greece)0.30 0.05*(a) n.a. 0.220 y (4)Imazalil Pears 3 0 y 5.00 2.00 n.a. 2.329 n (8)Imazalil Potatoes 1 0 y 5.00 3.00 y (7) + (9)lambda-Cyhalothrin Oranges 2 0 y 0.10 0.10 y (9)lambda-Cyhalothrin Spinach 5 1 1 FR y 0.50 0.50 n.a. 0.332 y (7)MethamidophosCucumbers2 2 1 GR, 1SR y (until 01/07/<str<strong>on</strong>g>2008</str<strong>on</strong>g>) 0.01* 0.01* n.a. 0.051 n (2) + (3)MethiocarbCucumbers2 2 2 DO y 0.20 0.20 n.a. 0.222 n (2)Methomyl/thiodicarb Oranges 1 0y (methomyl)n (thiodicarb from 0.50 0.02 y (8) + (10)25/11/<str<strong>on</strong>g>2008</str<strong>on</strong>g>)Methomyl/thiodicarb Pears 7 1 1 ITy (methomyl)n (thiodicarb from 0.20 0.20 n.a. 0.027 y (3) + (7) + (10)25/11/<str<strong>on</strong>g>2008</str<strong>on</strong>g>)Methomyl/thiodicarb Potatoes 1 0y (methomyl)n (thiodicarb from 0.05* 0.05* y (11)25/11/<str<strong>on</strong>g>2008</str<strong>on</strong>g>)Methomyl/thiodicarb Carrots 1 0y (methomyl)n (thiodicarb from25/11/<str<strong>on</strong>g>2008</str<strong>on</strong>g>)0.05* 0.05* n.a. 0.039 y (10)Methomyl/thiodicarbCucumbers5 5 2 IT, 3 NLy (methomyl)n (thiodicarb from25/11/<str<strong>on</strong>g>2008</str<strong>on</strong>g>)0.05* 0.05* n.a. 0.043 y (10)<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164693


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesPesticideCropNo samples abovethe thresholdresidueNumber samples ><str<strong>on</strong>g>2008</str<strong>on</strong>g> EC MRLOrigin ofsamples ><str<strong>on</strong>g>2008</str<strong>on</strong>g> ECMRL(1)Pesticideauthorisati<strong>on</strong>status in EU (anycrop) in <str<strong>on</strong>g>2008</str<strong>on</strong>g>(y/n)<str<strong>on</strong>g>2008</str<strong>on</strong>g> ECMRL(wholecrop)mg/kg2010 ECMRL(wholecrop)mg/kgPFmissing?(y/n)ThresholdEC MRL(wholecrop)mg/kg2010ECMRL >thresholdMRL?(y/n)<str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Recommendati<strong>on</strong>sMethomyl/thiodicarb Spinach 2 7 6 CY, 1 FRy (methomyl)n (thiodicarb from 0.05 0.05 n.a. 0.111 n (10)25/11/<str<strong>on</strong>g>2008</str<strong>on</strong>g>)Oxamyl Potatoes 2 2 2 UK y 0.01* 0.01* y (3) + (7) + (8)OxamylCucumbers2 2 1 HR, 1 IT y 0.02 0.02 n.a. 0.017 y (2) + (3) + (7)Parathi<strong>on</strong> Mandarins 1 1 1 ES n 0.05* 0.05* y (3)Procymid<strong>on</strong>e Pears 4 0 n 1.00 1.00 n.a. 0.132 y (8)Procymid<strong>on</strong>eCucumbery (<strong>on</strong>ly cucumbers6 0sin greenhouse)1.00 1.00 n.a. 0.205 y (8)Procymid<strong>on</strong>e Spinach 1 1 1 FR n 0.05 0.02* n.a. 0.531 n (3)Tebuc<strong>on</strong>azole Pears 2 0 y 1.00 1.00 n.a. 0.329 y (7)(a) The current MRL in place for endosulfan/pear is 0,3 mg/kg; however in the course of the 2010 the current MRL will be lowered to the LOQ of 0.05 mg/kg.(1) The abbreviati<strong>on</strong>s used for the EU Member States are <str<strong>on</strong>g>report</str<strong>on</strong>g>ed in the secti<strong>on</strong> “Abbreviati<strong>on</strong> and special terms used in the <str<strong>on</strong>g>report</str<strong>on</strong>g>”; ZA= South Africa; US = United States; SR =Suriname; DO = Dominican Republic; HR = Croatia; EG = Egypt; TH = Thailand, BR = Brazil.(2) Member State(s) to check the MRL compliance of imported products.(3) Member State(s) to check for possible misuses <strong>on</strong> domestic products.(4) Member State(s) to c<strong>on</strong>tinue m<strong>on</strong>itoring <strong>residues</strong> of this <strong>pesticide</strong>/crop combinati<strong>on</strong>.(5) Member State(s) to check possible c<strong>on</strong>taminati<strong>on</strong>.(6) COM to revise the current EC MRL.(7) Member State(s) to check compliance with new MRL.(8) To set peeling/processing factor.(9) COM to set separate residue definiti<strong>on</strong>s and MRL for methomyl and thiodicarb; Member States to <str<strong>on</strong>g>report</str<strong>on</strong>g> separately <strong>residues</strong> of methomyl/thiodicarb separately.(10) Member State(s) to implement more sensitive analytical methods; COM to revise the current LOQ MRL accordingly.(11) COM to set separate residue definiti<strong>on</strong>s and MRLs for dimethoate and omethoate; Member States to <str<strong>on</strong>g>report</str<strong>on</strong>g> separately the residue levels for dimethoate and omethoate.(12) EURLs to develop more sensitive analytical methods.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164694


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesThe summary of the total <strong>pesticide</strong>/crop combinati<strong>on</strong>s analysed for <strong>pesticide</strong> <strong>residues</strong> according toresults of the acute risk assessment and according to the event classificati<strong>on</strong> is <str<strong>on</strong>g>report</str<strong>on</strong>g>ed in Figure5.2.1-1.Riskassessmentwas notneeded: 189Risk couldnot beexcluded ‐"seldom"events: 27Riskassessmentcould not beperformed: 9Risk couldnot beexcluded ‐"excepti<strong>on</strong>al"events: 6Risk was notidentified:458Risk couldnot beexcluded ‐"n<strong>on</strong>seldom"events: 2Riskassassmentwas notc<strong>on</strong>clusive: 6Figure 5.2.1-1: Breakdown of the total <strong>pesticide</strong>/crop combinati<strong>on</strong>s according to the results of the acute riskassessment and the frequency of the events of c<strong>on</strong>cern. Number of combinati<strong>on</strong>s in each category is indicated.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164695


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesSpinach: 4Carrots: 2 Mandarins: 1Pears: 9Cucumbers:6Potatoes: 7Oranges: 6Figure 5.2.1-2: Number of <strong>pesticide</strong>s in the different commodities for which a potential acute risk could not beexcluded.No exceedances of the ARfD were identified for any <strong>pesticide</strong>s detected in beans (without pods) andrice (Figure 5.2.1-2).Carrots: 3 Mandarins: 1Spinach: 11Cucumbers:19Pears: 62Oranges: 24Potatoes: 14Figure 5.2.1-3: Number of samples per commodity for which a potential acute risk could not be excluded.The commodity with the highest number of samples of c<strong>on</strong>cern in <str<strong>on</strong>g>2008</str<strong>on</strong>g> was pears (62 samples)(Figure 5.2.1-3).In Figure 5.2.1-4 the results of the short-term c<strong>on</strong>sumer risk assessment are summarised. On the x-axis, the maximum IESTI calculated for the most critical diet <strong>on</strong> the basis of the highest residuemeasured (expressed in % of the ARfD) is displayed, whereas <strong>on</strong> the y-axis the frequency of samples<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164696


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesFI adultDK adultIE adultIT adultUK adultLT adultES adultUK vegetarianPL (GP)NL (GP)IT childES childDK childUK 4‐6 yrNL childBE childUK infantUK toddlerDE childAcute exposure: azinphos‐methyl/pears0 200 400 600 800 1 000 1 200Intake in % of the ARfDFigure 5.2.1.1-1: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to azinphos-methyl in pears, expressed as percentof the ARfD.Of the 38 pear samples of c<strong>on</strong>cern, <strong>on</strong>ly three samples exceeded the EC MRL in place in <str<strong>on</strong>g>2008</str<strong>on</strong>g>; two ofthese samples were produced in Italy, <strong>on</strong>e is originating from South Africa.It is noted that EC MRLs were amended in 2007 and in <str<strong>on</strong>g>2008</str<strong>on</strong>g>. The current EC MRL for pears isestablished at the LOQ of 0.05 mg/kg, while in <str<strong>on</strong>g>2008</str<strong>on</strong>g> an EC MRL of 0.5 mg/kg was applicable. Thecurrent EC MRL which is below the threshold EC MRL (0.11 mg/kg) is c<strong>on</strong>sidered protective for the<strong>Europe</strong>an populati<strong>on</strong>. The use of azinphos-methyl is no l<strong>on</strong>ger authorised in <strong>Europe</strong>. Authorisati<strong>on</strong>sfor its use had to be withdrawn by 1 January 2007.Based <strong>on</strong> these findings <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> recommends that Member States check the possible misuse ofazinphos-methyl at nati<strong>on</strong>al level and that m<strong>on</strong>itoring c<strong>on</strong>tinues under the EU coordinated programme.5.2.1.2. CarbarylIn <str<strong>on</strong>g>2008</str<strong>on</strong>g>, two orange and two potato samples exceeded the threshold residue levels calculated for these<strong>pesticide</strong>/crop combinati<strong>on</strong>s.The highest residue measured for oranges exceeded the ARfD in 6 diets included in the <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>calculati<strong>on</strong> model, the maximum value, taking into account a reducti<strong>on</strong> by peeling, was 321% of theARfD (Figure 5.2.1.2-1). For potatoes, the ARfD was exceeded for 14 diets; for 11 diets it wasexceeded significantly (more than 150%). The highest calculated exposure accounted for 1061% of theARfD (Figure 5.2.1.2-2). For potatoes refined IESTI calculati<strong>on</strong> could not be performed as noprocessing factor is yet available.Taking into account the number of orange and potato samples taken in <str<strong>on</strong>g>2008</str<strong>on</strong>g>, the occurrence of theseevents was c<strong>on</strong>sidered seldom.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164698


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesAcute exposure: carbaryl/orangesDK adultIE adultFI adultIT adultPL (GP)ES adultNL (GP)UK adultUK vegetarianIT childES childDK childNL childBE childUK 4‐6 yrDE childUK toddlerUK infant0 50 100 150 200 250 300 350Intake in % of the ARfDFigure 5.2.1.2-1: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to carbaryl in oranges, expressed as percent of theARfD.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):164699


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesAcute exposure: carbaryl/potatoesDK adultIT adultFI adultES adultNL (GP)IE adultLT adultPL (GP)UK adultIT childES childUK vegetarianBE childDE childNL childUK 4‐6 yrUK toddlerUK infant0 200 400 600 800 1 000 1 200Intake in % of the ARfDFigure 5.2.1.2-2: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to carbaryl in potatoes, expressed as percent ofthe ARfD.In <strong>Europe</strong>, the authorizati<strong>on</strong>s for the use of plant protecti<strong>on</strong> products c<strong>on</strong>taining carbaryl had to bewithdrawn by 21 November 2007. Three of the four samples of c<strong>on</strong>cern originated from <strong>Europe</strong> (Italyand Malta), <strong>on</strong>e sample was originating from the US. The EC MRLs, which are set at the LOQ forboth commodities, have not been amended since <str<strong>on</strong>g>2008</str<strong>on</strong>g>.Taking into c<strong>on</strong>siderati<strong>on</strong> that the use of carbaryl was not authorised in <str<strong>on</strong>g>2008</str<strong>on</strong>g>, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> recommends thatMember States check the possible misuse of carbaryl at nati<strong>on</strong>al level.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646100


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues5.2.1.3. Benomyl/carbendazimCarbendazim <strong>residues</strong> posing potential acute risks were found <strong>on</strong>ly in 3 samples of pears; the highestcalculated IESTI accounted for about 637% of the carbendazim ARfD (Figure 5.2.1.3-1). In the shorttermrisk assessment the ARfD set for carbendazim (0.02 mg/kg bw) was used. If the risk assessmentwas performed with the ARfD set for benomyl (0.03 mg/kg bw) the IESTI would still exhaust morethan 100% of the ARfD (425%).The exceedance of the threshold residue levels by these samples represents a seldom event.FI adultDK adultIE adultIT adultUK adultLT adultES adultUK vegetarianPL (GP)NL (GP)IT childES childDK childUK 4‐6 yrNL childBE childUK infantUK toddlerDE childAcute exposure: carbendazim‐benomyl/pears0 100 200 300 400 500 600 700Intake in % of the ARfDFigure 5.2.1.3-1: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to benomyl/carbendazim <strong>residues</strong> in pears,expressed as percent of the ARfD set for carbendazim.It is noted that the three pear samples for which a potential short-term risk could not be excluded werealso found exceeding the EC MRL applicable in <str<strong>on</strong>g>2008</str<strong>on</strong>g> and that these samples have <strong>Europe</strong>an origin(Cyprus and Spain).The use of benomyl has not been authorised in <strong>Europe</strong> since 2002. Since January 2007, the use ofcarbendazim has been restricted for the following crops: cereals, rapeseed, sugar beet and maize. Thepresence of carbendazim <strong>residues</strong> may also result from the use of thiophanate-methyl.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> recommends that Member States check the possible misuse of carbendazim/benomyl at nati<strong>on</strong>allevel and that m<strong>on</strong>itoring of carbendazim c<strong>on</strong>tinue under the coordinated EU programme.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646101


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues5.2.1.4. ChlormequatIn <str<strong>on</strong>g>2008</str<strong>on</strong>g>, a potential acute risk could not be excluded for <strong>on</strong>ly <strong>on</strong>e single sample out of the 455 samplesof pears analysed. This event has been c<strong>on</strong>sidered as seldom and the ARfD was exceeded (143%)(Figure 5.2.1.4-1).Since 1 December 2009, <strong>on</strong>ly uses of chlormequat as a plant growth regulator <strong>on</strong> cereals or n<strong>on</strong>-ediblecrops can been authorised in <strong>Europe</strong>. However, it is known that chlormequat is quite persistent inpears trees and the current <strong>residues</strong> may result from treatments of pear trees which were made severalyears ago (Maas, 2006). For a phase-out period an interim EC MRL has been established which isrevisited at regular intervals; the MRLs in place in <str<strong>on</strong>g>2008</str<strong>on</strong>g> and 2010 were 0.2 and 0.1 mg/kg,respectively.FI adultDK adultIE adultIT adultUK adultLT adultES adultUK vegetarianPL (GP)NL (GP)IT childES childDK childUK 4‐6 yrNL childBE childUK infantUK toddlerDE childAcute exposure: chlormequat/pears0 20 40 60 80 100 120 140 160Intake in % of the ARfDFigure 5.2.1.4-1: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to chlormequat <strong>residues</strong> in pears, expressed aspercent of the ARfD.The single pear sample of c<strong>on</strong>cern was also found exceeding the MRL and originated from the EU(Belgium, Netherlands and Slovenia). <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> recommends c<strong>on</strong>tinued m<strong>on</strong>itoring of chlormequat<strong>residues</strong> in pears in the future m<strong>on</strong>itoring programmes.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646102


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues5.2.1.5. ChlorprophamA potential c<strong>on</strong>sumer risk could not be excluded for six potato samples out of 1,611 samples analysedin <str<strong>on</strong>g>2008</str<strong>on</strong>g>. Therefore, these events were c<strong>on</strong>sidered as seldom. The highest calculated IESTI amounted to187% of the ARfD, taking into account the reducti<strong>on</strong> after cooking. Chlorpropham is typically used in<strong>Europe</strong> for post-harvest treatment of potatoes to suppress sprouting.DK adultIT adultFI adultES adultNL (GP)IE adultLT adultPL (GP)UK adultIT childES childUK vegetarianBE childDE childNL childUK 4‐6 yrUK toddlerUK infantAcute exposure: chlorpropham/potatoes0 50 100 150 200Intake in % of the ARfDFigure 5.2.1.5-1: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to chlorpropham <strong>residues</strong> in potatoes, expressed aspercent of the ARfD.Only <strong>on</strong>e sample originating from France exceeded the EC MRL of 10 mg/kg. However it is noted thatthe threshold MRL (i.e. the theoretical MRL that would corresp<strong>on</strong>d to 100% of the ARfD) is veryclose (9.8 mg/kg) to the current MRL.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> recommends c<strong>on</strong>tinued m<strong>on</strong>itoring of chlorpropham <strong>residues</strong> in potatoes.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646103


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues5.2.1.6. ChlorpyriphosA potential acute risk with regard to chlorpyriphos residue was identified for <strong>on</strong>e potato sample (HRM3.71 mg/kg); the occurrence of this event was c<strong>on</strong>sidered excepti<strong>on</strong>al. The maximum calculated IESTIexhausted up to 570% of the ARfD (figure 5.2.1.6-1). As no processing factor is available for this<strong>pesticide</strong>/crop combinati<strong>on</strong>, a refined intake calculati<strong>on</strong> could not be performed.DK adultIT adultFI adultES adultNL (GP)IE adultLT adultPL (GP)UK adultIT childES childUK vegetarianBE childDE childNL childUK 4‐6 yrUK toddlerUK infantAcute exposure: chlorpyriphos/potatoes0 100 200 300 400 500 600Intake in % of the ARfDFigure 5.2.1.6-1: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to chlorpyriphos <strong>residues</strong> in potatoes, expressed aspercent of the ARfD.The critical potato sample exceeded the EC MRL set at the LOQ of 0.05 mg/kg. The origin of thissample is Malta.Based <strong>on</strong> the above findings <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> recommends c<strong>on</strong>trol of the possible misuse of chlorpyriphos atnati<strong>on</strong>al level and identificati<strong>on</strong> of possible sources of c<strong>on</strong>taminati<strong>on</strong> of stored potatoes.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646104


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues5.2.1.7. Diazin<strong>on</strong>Two orange samples with <strong>residues</strong> exceeding the existing MRL, which is set at the LOQ of 0.01mg/kg, posed a potential acute c<strong>on</strong>sumer risk. The maximum exposure was calculated to be 318% ofthe ARfD (figure 5.2.1.7-1). According to the <str<strong>on</strong>g>2008</str<strong>on</strong>g> data analysis, the findings above the thresholdresidue level can be c<strong>on</strong>sidered as seldom events.DK adultIE adultFI adultIT adultPL (GP)ES adultNL (GP)UK adultUK vegetarianIT childES childDK childNL childBE childUK 4‐6 yrDE childUK toddlerUK infantAcute exposure: diazin<strong>on</strong>/oranges0 50 100 150 200 250 300 350Intake in % of the ARfDFigure 5.2.1.7-1: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to diazin<strong>on</strong> <strong>residues</strong> in oranges, expressed aspercent of the ARfD.In total 13 orange samples found were exceeding the legal limit; <strong>on</strong>e of these samples was produced in<strong>Europe</strong> (Spain), while the remaining 12 samples originated from outside <strong>Europe</strong> (Egypt).The authorisati<strong>on</strong>s for plant protecti<strong>on</strong> products c<strong>on</strong>taining diazin<strong>on</strong> had to be withdrawn by 6December 2007 at <strong>Europe</strong>an level; any period of grace granted by Member States had to expire <strong>on</strong> 6December <str<strong>on</strong>g>2008</str<strong>on</strong>g> at the latest.On the basis of the above findings, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> recommends c<strong>on</strong>tinued m<strong>on</strong>itoring of diazin<strong>on</strong> <strong>residues</strong> inoranges produced within and outside <strong>Europe</strong>.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646105


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues5.2.1.8. Dimethoate/omethoateThe use of dimethoate is authorised in <strong>Europe</strong>, while the use of omethoate has not been authorisedsince 2003. Nevertheless, <strong>residues</strong> of omethoate in food commodities may occur as omethoate is aplant metabolite of dimethoate. The results are <str<strong>on</strong>g>report</str<strong>on</strong>g>ed according to the enforcement residuedefiniti<strong>on</strong>: sum of dimethoate and omethoate, expressed as dimethoate. However, these substanceshave distinct toxicological profiles: the ARfD value derived for dimethoate being five times higherthan the ARfD for omethoate (0.01 mg/kg bw and 0.002 mg/kg body weight, respectively) 22 .Following a c<strong>on</strong>servative approach an indicative exposure assessment was performed, assuming thatthe measured <strong>residues</strong> <strong>on</strong>ly c<strong>on</strong>tain the more toxic compound omethoate. According to thesecalculati<strong>on</strong>s, a theoretical acute risk could not be excluded for several samples: carrots (two samples),cucumbers (two samples), oranges (16 samples), pears (three samples), potatoes (<strong>on</strong>e sample) andspinach (three samples). Except for the orange findings, the potential acute risks identified for thesecrops are c<strong>on</strong>sidered seldom or excepti<strong>on</strong>al events. For oranges, it was c<strong>on</strong>sidered that the 16 samplesabove the residue threshold represent a n<strong>on</strong>-seldom event.The calculated IESTI for these six crops of c<strong>on</strong>cern ranged from 10,763% (potatoes) to 247% (carrots)of the ARfD set for omethoate.Also under the assumpti<strong>on</strong> that the <strong>residues</strong> <str<strong>on</strong>g>report</str<strong>on</strong>g>ed comprised <strong>on</strong>ly the less toxic moleculedimethoate, a theoretical acute risk could not be excluded for pears (<strong>on</strong>e sample), potatoes (<strong>on</strong>esample) and spinach (two samples). In this case, the IESTI calculati<strong>on</strong>s ranged from 2,153% (potatoes)to 346% (pears) of the ARfD established for dimethoate (figure 5.2.1.8-1 to figure 5.2.1.8-3).It is noted that the highest <strong>residues</strong> measured for the crops menti<strong>on</strong>ed exceeded the existing MRLswhich were in all cases established at the LOQ of 0.02 mg/kg.In order to be in a positi<strong>on</strong> to perform a more accurate risk assessment, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> recommends thefollowing:• To establish separate MRLs for dimethoate and omethoate;• To <str<strong>on</strong>g>report</str<strong>on</strong>g> separately the measured residue levels of dimethoate and omethoate;• To amend the residue definiti<strong>on</strong>, taking into account the c<strong>on</strong>clusi<strong>on</strong>s of the peer review ofdimethoate performed in the framework of Directive 91/414/EEC (<str<strong>on</strong>g>EFSA</str<strong>on</strong>g>, 2006b).• To c<strong>on</strong>tinue m<strong>on</strong>itoring of dimethoate and omethoate.22 As the compounds included in the residue definiti<strong>on</strong> for dimethoate/omethaote have additi<strong>on</strong>al effects, but have differenttoxicological potencies, a toxic equivalence factor based approach shall be used for risk assessment. For the acute riskassessment a factor of 6 shall be used for accounting the c<strong>on</strong>tributi<strong>on</strong> of omethoate.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646106


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesFI adultDK adultIE adultIT adultUK adultLT adultES adultUK vegetarianPL (GP)NL (GP)IT childES childDK childUK 4‐6 yrNL childBE childUK infantUK toddlerDE childAcute exposure: dimethoate‐omethoate/pears0 50 100 150 200 250 300 350 400Intake in % of the ARfDFigure 5.2.1.8-1: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to dimethoate/omethoate <strong>residues</strong> in pears,expressed as percent of the ARfD set for dimethoate.DK adultIT adultFI adultES adultNL (GP)IE adultLT adultPL (GP)UK adultIT childES childUK vegetarianBE childDE childNL childUK 4‐6 yrUK toddlerUK infantAcute exposure: dimethoate‐omethoate/potatoes0 500 1 000 1 500 2 000 2 500Intake in % of the ARfDFigure 5.2.1.8-2: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to dimethoate/omethoate <strong>residues</strong> in potatoes,expressed as percent of the ARfD set for dimethoate.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646107


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesAcute exposure: dimethoate‐omethoate/spinachFI adultIE adultDK adultIT adultIT childES adultDK childPL (GP)ES childUK adultUK vegetarianUK toddlerUK infantUK 4‐6 yrNL (GP)DE childNL childBE child0 100 200 300 400 500 600 700Intake in % of the ARfDFigure 5.2.1.8-3: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to dimethoate/omethoate <strong>residues</strong> in spinach,expressed as percent of the ARfD set for dimethoate.5.2.1.9. EndosulfanAccording to the results of the short-term exposure calculati<strong>on</strong>, a potential acute c<strong>on</strong>sumer risk couldnot be excluded for two crops: oranges (<strong>on</strong>e sample) and pears (<strong>on</strong>e sample). The threshold residuelevel exceedances in these two crops were classified as excepti<strong>on</strong>al. The highest IESTI calculated fororange and pear amounted to 358% and 137% of the ARfD (figure 5.2.1.9-1 and figure 5.2.1.9-2). Noprocessing factor is available to refine the short-term exposure calculated for oranges.The orange sample exceeded the EC MRL which was set at the LOQ of 0.05 mg/kg. This sampleoriginated from <strong>Europe</strong> (Portugal). The pear sample for which an acute risk could not be excluded (0.3mg/kg) was found exceeding the EC MRL of 0.3 mg/kg and its origin was not <str<strong>on</strong>g>report</str<strong>on</strong>g>ed. All uses ofplant protecti<strong>on</strong> products c<strong>on</strong>taining endosulfan had to be withdrawn by June 2006. A restricted use ofproducts c<strong>on</strong>taining endosulfan in pears was still permitted in Greece until 30 June 2007. Currently, n<strong>on</strong>ati<strong>on</strong>al authorisati<strong>on</strong>s for products c<strong>on</strong>taining endosulfan are in place.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> recommends revising the current EC MRL set for pears and checking the possible misuse atnati<strong>on</strong>al level of products c<strong>on</strong>taining endosulfan.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646108


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesAcute exposure: endosulfan/orangesDK adultIE adultFI adultIT adultPL (GP)ES adultNL (GP)UK adultUK vegetarianIT childES childDK childNL childBE childUK 4‐6 yrDE childUK toddlerUK infant0 50 100 150 200 250 300 350 400Intake in % of the ARfDFigure 5.2.1.9-1: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to endosulfan <strong>residues</strong> in oranges, expressed aspercent of the ARfD.FI adultDK adultIE adultIT adultUK adultLT adultES adultUK vegetarianPL (GP)NL (GP)IT childES childDK childUK 4‐6 yrNL childBE childUK infantUK toddlerDE childAcute exposure: endosulfan/pears0 20 40 60 80 100 120 140 160Intake in % of the ARfDFigure 5.2.1.9-2: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to endosulfan <strong>residues</strong> in pear, expressed aspercent of the ARfD.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646109


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues5.2.1.10. ImazalilIn <str<strong>on</strong>g>2008</str<strong>on</strong>g>, exceedances of the threshold residue level were identified for three pear and <strong>on</strong>e potatosample; for these samples a potential c<strong>on</strong>sumer risk could not be excluded and the highest IESTIexhausted 617% and 237% of the ARfD, respectively (figure 5.2.1.10-1 and figure 5.2.1.10-2). Theoccurrence of these events of c<strong>on</strong>cern was c<strong>on</strong>sidered seldom for pears and excepti<strong>on</strong>al for potatoes.The IESTI calculated for potato could have been refined if a processing factor for peeled/cookedpotatoes was available.FI adultDK adultIE adultIT adultUK adultLT adultES adultUK vegetarianPL (GP)NL (GP)IT childES childDK childUK 4‐6 yrNL childBE childUK infantUK toddlerDE childAcute exposure: imazalil/pears0 100 200 300 400 500 600 700Intake in % of the ARfDFigure 5.2.1.10-1: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to imazalil <strong>residues</strong> in pears, expressed aspercent of the ARfD.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646110


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesAcute exposure: imazalil/potatoesDK adultIT adultFI adultES adultNL (GP)IE adultLT adultPL (GP)UK adultIT childES childUK vegetarianBE childDE childNL childUK 4‐6 yrUK toddlerUK infant0 50 100 150 200 250Intake in % of the ARfDFigure 5.2.1.10-2: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to imazalil <strong>residues</strong> in potatoes, expressed aspercent of the ARfD.The samples for which potential acute risks were identified did not exceed the EC MRL in place in<str<strong>on</strong>g>2008</str<strong>on</strong>g>. However, these EC MRLs for both pears and potatoes have been lowered recently. It is als<strong>on</strong>oted that in <str<strong>on</strong>g>2008</str<strong>on</strong>g> no ARfD was assigned for imazalil. Since a ARfD established in 2010 the existingMRLs should be reviewed regarding potential acute c<strong>on</strong>sumer health risks.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> recommends the setting of a processing factor for imazalil/cooked potatoes and revisiting theexisting MRLs, taking into account the recently established ARfD.5.2.1.11. Lambda-CyhalothrinIn two orange and five spinach samples the <strong>residues</strong> of lambda-cyhalothrin exceeded the thresholdresidue c<strong>on</strong>centrati<strong>on</strong>. The events in which a potential acute risk could not be excluded werec<strong>on</strong>sidered seldom. The highest IESTI calculated for these two <strong>pesticide</strong>/crop combinati<strong>on</strong>s accountedfor 159% and 452% of the ARfD (figure 5.2.1.11-1 and figure 5.2.1.11-2).The IESTI calculated for oranges could not be refined since a processing factor for this crop is notavailable.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646111


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesAcute exposure: Lambda‐cyhalothrin/orangesDK adultIE adultFI adultIT adultPL (GP)ES adultNL (GP)UK adultUK vegetarianIT childES childDK childNL childBE childUK 4‐6 yrDE childUK toddlerUK infant0 50 100 150 200Intake in % of the ARfDFigure 5.2.1.11-1: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to lambda-cyhalothrin <strong>residues</strong> in oranges,expressed as percent of the ARfD.FI adultIE adultDK adultIT adultIT childES adultDK childPL (GP)ES childUK adultUK vegetarianUK toddlerUK infantUK 4‐6 yrNL (GP)DE childNL childBE childAcute exposure: lambda‐cyhalothrin/spinach0 100 200 300 400 500Intake in % of the ARfDFigure 5.2.1.11-2: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to lambda-cyhalothrin <strong>residues</strong> in spinach,expressed as percent of the ARfD.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646112


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesThe orange samples that posed a potential risk were found to be below the MRL , while of the fivespinach samples of c<strong>on</strong>cern <strong>on</strong>ly <strong>on</strong>e was exceeding the EC MRL in place in <str<strong>on</strong>g>2008</str<strong>on</strong>g>.Plant protecti<strong>on</strong> products c<strong>on</strong>taining lambda-cyhalothrin are authorised in <strong>Europe</strong>. <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> recommendsthat a processing factor for lambda-cyhalothrin be derived and/or that the EC MRLs for oranges andspinach be rec<strong>on</strong>sidered.5.2.1.12. MethamidophosThe use of products c<strong>on</strong>taining metamidophos is no l<strong>on</strong>ger authorised in <strong>Europe</strong>. Nati<strong>on</strong>alauthorisati<strong>on</strong>s had to be withdrawn by 1 st July <str<strong>on</strong>g>2008</str<strong>on</strong>g>. In two samples of cucumbers a potential acutec<strong>on</strong>sumer risk could not be excluded. The occurrence of these residue levels can be c<strong>on</strong>sidered as aseldom event. The highest IESTI calculated for cucumbers exhausted 760% of the ARfD (figure5.2.1.12-1)IE adultES adultPL (GP)FI adultIT adultIT childES childUK adultUK infantUK vegetarianLT adultDK adultNL (GP)UK 4‐6 yrUK toddlerDK childDE childBE childNL childAcute exposure: methamidophos/cucumber0 100 200 300 400 500 600 700 800Intake in % of the ARfDFigure 5.2.1.12-1: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to metamidophos <strong>residues</strong> in cucumbers,expressed as percent of the ARfD.The two samples with highest <strong>residues</strong> measured were also found exceeding the EC MRL; <strong>on</strong>e ofthese samples was produced in <strong>Europe</strong> (Greece) and <strong>on</strong>e originated from outside <strong>Europe</strong> (Suriname).Since the use of metamidophos is no l<strong>on</strong>ger authorised in <strong>Europe</strong>, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> recommends that the MemberStates check the possible misuse of the product c<strong>on</strong>taining metamidophos at nati<strong>on</strong>al level.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646113


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues5.2.1.13. MethiocarbThe use of products c<strong>on</strong>taining Methiocarb is authorised in <strong>Europe</strong>. The two cucumber samples forwhich a potential acute risk could not be excluded can be classified as seldom events. However, thehighest estimated exposure largely exceeded the ARfD (2519%) (figure 5.2.1.13-1)IE adultES adultPL (GP)FI adultIT adultIT childES childUK adultUK infantUK vegetarianLT adultDK adultNL (GP)UK 4‐6 yrUK toddlerDK childDE childBE childNL childAcute exposure: methamidophos/cucumber0 500 1 000 1 500 2 000 2 500 3 000Intake in % of the ARfDFigure 5.2.1.13-1: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to methiocarb <strong>residues</strong> in cucumbers, expressedas percent of the ARfD.The two cucumber samples of c<strong>on</strong>cern were also found to exceed the EC MRL in place in <str<strong>on</strong>g>2008</str<strong>on</strong>g>. Thesesamples were produced outside <strong>Europe</strong> (Dominican Republic). <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> recommends c<strong>on</strong>tinuedm<strong>on</strong>itoring of methiocarb <strong>residues</strong> in cucumbers in future m<strong>on</strong>itoring programmes.5.2.1.14. Methomyl/thiodicarbThe use of methomyl in plant protecti<strong>on</strong> products was authorised in <str<strong>on</strong>g>2008</str<strong>on</strong>g> in <strong>Europe</strong>. Authorisati<strong>on</strong>sfor thiodicarb uses should have been withdrawn by 25 November 2007, with a period of grace until 25November <str<strong>on</strong>g>2008</str<strong>on</strong>g>.The results of the m<strong>on</strong>itoring were <str<strong>on</strong>g>report</str<strong>on</strong>g>ed as “Sum of methomyl and thiodicarb, expressed asmethomyl”.Following a c<strong>on</strong>servative approach, assuming that the measured <strong>residues</strong> comprise <strong>on</strong>ly the more toxiccompound methomyl, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> performed an indicative risk assessment based <strong>on</strong> the ARfD formethomyl. According to these calculati<strong>on</strong>s, a theoretical acute risk could not be excluded for severalsamples: carrots (<strong>on</strong>e sample), cucumbers (five samples), oranges (<strong>on</strong>e sample), pears (seven samples),potatoes (<strong>on</strong>e sample) and spinach (two samples). Except for the potatoes findings, the potential acute<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646114


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residuesrisks identified for these crops are c<strong>on</strong>sidered seldom events. For potatoes, it was c<strong>on</strong>sidered that <strong>on</strong>lythe sample above the residue threshold represents an excepti<strong>on</strong>al event.The calculated IESTI for these six crops of c<strong>on</strong>cern ranged from 123% (potatoes) to 1,645% (oranges)of the ARfD set for methomyl (figure 5.2.1.14-1 to figure 5.2.1.14-6). Processing factors to refine theIESTI calculated for oranges and potatoes were not available.Assuming that the measured <strong>residues</strong> c<strong>on</strong>sist <strong>on</strong>ly of thiodicarb, the calculated exposure exceeded theARfD of thiodicarb (0.01 mg/kg bw, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> 2005) for oranges and pears (411 and 228% of the ARfDset for thiodicarb). For the other commodities, the IESTI calculated was below the ARfD (32%, 92%,31% and 43% of the ARfD for carrots, cucumbers potatoes and spinach).PL (GP)ES adultES childIE adultFI adultIT adultLT adultUK adultDK adultUK vegetarianIT childNL (GP)DK childUK 4‐6 yrDE childNL childUK toddlerBE childUK infantAcute exposure: methomyl‐thiodicarb/carrot0 20 40 60 80 100 120 140Intake in % of the ARfDFigure 5.2.1.14-1: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to methomyl/thiodicarb <strong>residues</strong> in carrots,expressed as percent of the ARfD set for methomyl.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646115


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesIE adultES adultPL (GP)FI adultIT adultIT childES childUK adultUK infantUK vegetarianLT adultDK adultNL (GP)UK 4‐6 yrUK toddlerDK childDE childBE childNL childAcute exposure: methomyl‐thiodicarb/cucumber0 50 100 150 200 250 300 350 400Intake in % of the ARfDFigure 5.2.1.14-2: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to methomyl/thiodicarb <strong>residues</strong> in cucumbers,expressed as percent of the ARfD set for methomyl.DK adultIE adultFI adultIT adultPL (GP)ES adultNL (GP)UK adultUK vegetarianIT childES childDK childNL childBE childUK 4‐6 yrDE childUK toddlerUK infantAcute exposure: methomyl‐thiodicarb/oranges0 500 1 000 1 500 2 000Intake in % of the ARfDFigure 5.2.1.14-3: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to methomyl/thiodicarb <strong>residues</strong> in oranges,expressed as percent of the ARfD set for methomyl.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646116


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesFI adultDK adultIE adultIT adultUK adultLT adultES adultUK vegetarianPL (GP)NL (GP)IT childES childDK childUK 4‐6 yrNL childBE childUK infantUK toddlerDE childAcute exposure: methomyl‐thiodicarb/pears0 200 400 600 800 1 000Intake in % of the ARfDFigure 5.2.1.14-4: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to methomyl/thiodicarb <strong>residues</strong> in pears,expressed as percent of the ARfD set for methomyl.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646117


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesAcute exposure: methomyl‐thiodicarb/potatoesDK adultIT adultFI adultES adultNL (GP)IE adultLT adultPL (GP)UK adultIT childES childUK vegetarianBE childDE childNL childUK 4‐6 yrUK toddlerUK infant0 20 40 60 80 100 120 140Intake in % of the ARfDFigure 5.2.1.14-5: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to methomyl/thiodicarb <strong>residues</strong> in potatoes,expressed as percent of the ARfD set for methomyl.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646118


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesAcute exposure: methomyl‐thiodicarb/spinachFI adultIE adultDK adultIT adultIT childES adultDK childPL (GP)ES childUK adultUK vegetarianUK toddlerUK infantUK 4‐6 yrNL (GP)DE childNL childBE child0 50 100 150 200Intake in % of the ARfDFigure 5.2.1.14-6: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to methomyl/thiodicarb <strong>residues</strong> in spinach,expressed as percent of the ARfD set for methomyl.It is noted that the MRLs in place for oranges and pears (0.5 mg/kg and 0.2 mg/kg, respectively)exceed the calculated threshold values for these crops (0.08 mg/kg and 0.11 mg/kg). For potatoes andcarrots, the identified acute risk was due to measured residue levels (0.02 and 0.05 mg/kg) below or atthe EC MRLs, which are both set at the LOQ (0.05 mg/kg). Since <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> identified potential c<strong>on</strong>sumerrisks related to the MRLs in place in <str<strong>on</strong>g>2008</str<strong>on</strong>g>, it was recommended to lower certain MRLs of c<strong>on</strong>cern.Regulati<strong>on</strong> (EC) No 1097/2009, entering into force <strong>on</strong> 7 June 2010, implements the <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>recommendati<strong>on</strong>s.As a general recommendati<strong>on</strong> <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> proposes the setting of separate EC MRLs for active substanceslike methomyl and thiodicarb for which different toxicological reference values have been established.5.2.1.15. OxamylFor two potato samples and two cucumber samples, the highest <strong>residues</strong> measured exceeded thethreshold residue c<strong>on</strong>centrati<strong>on</strong>. The occurrence of both events was c<strong>on</strong>sidered seldom. The degree ofexceedance of the ARfD is very high, amounting to 1,384% and 1,053% for potatoes and cucumbers,respectively (figure 5.2.1.15-1 and 5.2.1.15-2).<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646119


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesAcute exposure: oxamyl/potatoesDK adultIT adultFI adultES adultNL (GP)IE adultLT adultPL (GP)UK adultIT childES childUK vegetarianBE childDE childNL childUK 4‐6 yrUK toddlerUK infant0 200 400 600 800 1 000 1 200 1 400 1 600Intake in % of the ARfDFigure 5.2.1.15-1: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to oxamyl <strong>residues</strong> in potatoes, expressed aspercent of the ARfD.IE adultES adultPL (GP)FI adultIT adultIT childES childUK adultUK infantUK vegetarianLT adultDK adultNL (GP)UK 4‐6 yrUK toddlerDK childDE childBE childNL childAcute exposure: oxamyl/cucumber0 200 400 600 800 1 000 1 200Intake in % of the ARfDFigure 5.2.1.15-2: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to oxamyl <strong>residues</strong> in cucumbers, expressed aspercent of the ARfD.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646120


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesIn <strong>Europe</strong>, the use of products c<strong>on</strong>taining oxamyl is allowed. All four samples, where a potentialc<strong>on</strong>sumer risk was identified, exceeded the EC MRLs established in September <str<strong>on</strong>g>2008</str<strong>on</strong>g>. However,before this date, nati<strong>on</strong>al MRLs were applicable for oxamyl. It is noted that some of the current MRLsare also established above the threshold residue level.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> recommends c<strong>on</strong>tinuing m<strong>on</strong>itoring <strong>residues</strong> of oxamyl in food commodities in the futurec<strong>on</strong>trol programmes, reviewing the existing EC MRLs for cucumbers and potatoes and developingmore sensitive analytical methods to set MRL at a lower LOQ level.5.2.1.16. Parathi<strong>on</strong>At present, the use of plant protecti<strong>on</strong> products c<strong>on</strong>taining parathi<strong>on</strong> is not authorised in <strong>Europe</strong>.According to the IESTI calculati<strong>on</strong>s, potential intake c<strong>on</strong>cerns were identified for <strong>on</strong>e out of the 914mandarin samples taken (seldom event). In this case, the IESTI exceeded 178% if the ARfD (figure5.2.1.16-1).DK adultFI adultIE adultES adultNL (GP)IT adultUK adultPL (GP)UK vegetarianIT childES childDK childUK infantBE childNL childUK 4‐6 yrDE childUK toddlerAcute exposure: parathi<strong>on</strong>/mandarin0 50 100 150 200Intake in % of the ARfDFigure 5.2.1.16-1: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to parathi<strong>on</strong> <strong>residues</strong> in mandarins, expressed aspercent of the ARfD.It is noted that the mandarin sample of c<strong>on</strong>cern exceeded the EC MRL; the sample originated fromSpain. Therefore, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> recommends c<strong>on</strong>trolling the possible misuse of parathi<strong>on</strong> at nati<strong>on</strong>al level.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646121


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues5.2.1.17. Procymid<strong>on</strong>eSince 1 January 2007, the use of procymid<strong>on</strong>e has been restricted to cucumbers in greenhouses andplums (for processing). Since June <str<strong>on</strong>g>2008</str<strong>on</strong>g> all procymid<strong>on</strong>e uses have been prohibited in <strong>Europe</strong>.The assessment of the acute c<strong>on</strong>sumer exposure indicated a possible acute intake above the thresholdvalue in three crops: cucumbers (six samples), pears (four samples) and spinach (<strong>on</strong>e sample).C<strong>on</strong>sidering the total number of samples taken for each of these crops, it was c<strong>on</strong>sidered that thesamples of c<strong>on</strong>cern are seldom events. The calculated IESTI for these three crops accounted for 468%,455% and 126% of the ARfD (figure 5.2.1.17-1 to figure 5.2.1.17-3).IE adultES adultPL (GP)FI adultIT adultIT childES childUK adultUK infantUK vegetarianLT adultDK adultNL (GP)UK 4‐6 yrUK toddlerDK childDE childBE childNL childAcute exposure: Procymid<strong>on</strong>e/cucumber0 100 200 300 400 500Intake in % of the ARfDFigure 5.2.1.17-1: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to procymid<strong>on</strong>e <strong>residues</strong> in cucumbers,expressed as percent of the ARfD.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646122


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesFI adultDK adultIE adultIT adultUK adultLT adultES adultUK vegetarianPL (GP)NL (GP)IT childES childDK childUK 4‐6 yrNL childBE childUK infantUK toddlerDE childAcute exposure: procymid<strong>on</strong>e/pears0 100 200 300 400 500Intake in % of the ARfDFigure 5.2.1.17-2: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to procymid<strong>on</strong>e <strong>residues</strong> in pears, expressed aspercent of the ARfD.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646123


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesAcute exposure: procymid<strong>on</strong>e/spinachFI adultIE adultDK adultIT adultIT childES adultDK childPL (GP)ES childUK adultUK vegetarianUK toddlerUK infantUK 4‐6 yrNL (GP)DE childNL childBE child0 20 40 60 80 100 120 140Intake in % of the ARfDFigure 5.2.1.17-3: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to procymid<strong>on</strong>e <strong>residues</strong> in spinach, expressedas percent of the ARfD.The spinach sample of c<strong>on</strong>cern was produced in <strong>Europe</strong> (France) and exceeded the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EC MRLs setfor procymid<strong>on</strong>e in this crop.The cucumber and pear samples of c<strong>on</strong>cern were found not exceeding the EC MRL in place in <str<strong>on</strong>g>2008</str<strong>on</strong>g>. Itis noted that the MRLs for procymid<strong>on</strong>e are to be lowered, following advice given by (<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> 2009).The new MRLs will become applicable as from 07 June 2010 (EC 2009).5.2.1.18. Tebuc<strong>on</strong>azoleAccording to the IESTI calculati<strong>on</strong>, potential acute risks to c<strong>on</strong>sumer health could not be excluded for<strong>on</strong>ly two samples of pears out of the 1286 samples analysed. The occurrence of this event wastherefore c<strong>on</strong>sidered as seldom. The calculated exposure accounted for 200% of the ARfD (figure5.2.1.18-1).<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646124


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesFI adultDK adultIE adultIT adultUK adultLT adultES adultUK vegetarianPL (GP)NL (GP)IT childES childDK childUK 4‐6 yrNL childBE childUK infantUK toddlerDE childAcute exposure: tebuc<strong>on</strong>azole/pears0 50 100 150 200 250Intake in % of the ARfDFigure 5.2.1.18-1: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to tebuc<strong>on</strong>azole <strong>residues</strong> in pears, expressed aspercent of the ARfD.EC MRLs for tebuc<strong>on</strong>azole were set for the first time in <str<strong>on</strong>g>2008</str<strong>on</strong>g>, based <strong>on</strong> a risk assessment which wasperformed with a proposed ARfD of 0.1 mg/kg (Denmark, 2007). Since the ARfD has been lowered inthe meantime, the MRLs should be revised accordingly.5.2.2. Pesticide/crop combinati<strong>on</strong>s for which the short-term risk assessment was notc<strong>on</strong>clusiveFor three groups of chemicals - the dithiocarbamates, the cypermethrins, folpet and captan (expressedas sum) - the residue definiti<strong>on</strong> for enforcement includes two or more comp<strong>on</strong>ents for which differenttoxicological reference values have been derived. The c<strong>on</strong>sumer risk assessment is impeded by the factthat the c<strong>on</strong>tributi<strong>on</strong> of the single comp<strong>on</strong>ent to the total measured <strong>residues</strong> was not <str<strong>on</strong>g>report</str<strong>on</strong>g>ed to <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>.Therefore, Two different scenario were calculated. In the first <strong>on</strong>e it was assumed that the measuredresidue refers <strong>on</strong>ly to the comp<strong>on</strong>ent of the residue definiti<strong>on</strong> with the lowest ARfD; in the sec<strong>on</strong>dscenario, the highest ARfD was c<strong>on</strong>sidered. For three group of <strong>pesticide</strong>s (cypermethrins,dithiocarbamates and folpet/captan) in the two calculated scenarios the rate of ARfD exhausti<strong>on</strong> wouldrespectively exceed and not exceeded 100% of the ARfD. As a result, for these groups of substances afinal c<strong>on</strong>clusi<strong>on</strong> <strong>on</strong> the potential health risk related to measured <strong>residues</strong> could not be drawn.Tables 5.2.2-1 and 5.2.2-2 <str<strong>on</strong>g>report</str<strong>on</strong>g> the details and the risk assessment recommendati<strong>on</strong>s for the<strong>pesticide</strong>/crop combinati<strong>on</strong>s for which the short-term risk assessment were not c<strong>on</strong>clusive.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646125


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesTable 5.2.2-1: Summary results of the short-term risk assessment of the active substances for which the short-term risk assessment was not c<strong>on</strong>clusive.Pesticide Crop<str<strong>on</strong>g>2008</str<strong>on</strong>g> MRL(whole crop) (1)mg/kgTotal numberof samplesanalysed% samplesexceedingthe MRLHighest residuemeasured correctedwith PF (HRMc)mg/kgHighest residuemeasured(HRM) mg/kgMaxIESTI(%ARfD)Mostcritical dietThresholdresidue inedibleporti<strong>on</strong>(mg/kg)(2)Numberofsamplesabove thethresholdresidue%samplesabove thethresholdresidueExceedence ofARfD isc<strong>on</strong>sidered"Excepti<strong>on</strong>al"."seldom" or"not seldom"event?(3)Cypermethrin Pears 1 1452 0.55 125.22 DE child 0.439 1 0.07 excepti<strong>on</strong>alDithiocarbamates Oranges 5 375 4.53 1.00 0.884 146.61 UK infant 0.600 3 0.80 seldomDithiocarbamates Potatoes 0.3 584 1.37 0.603 115.90 UK infant 0.520 1 0.17 seldomDithiocarbamates Pears 3 845 0.00 5.63 640.69 DE child 0.880 46 1.54 n<strong>on</strong> seldomDithiocarbamates Spinach 0.05 510 4.90 13.27 374.78 BE child 3.540 4 0.20 seldomFolpet/Captan Pears 3 1238 0.00 2.9 132.05 DE child 2.196 2 0.16 seldom(1) EC MRL in place 01/01/<str<strong>on</strong>g>2008</str<strong>on</strong>g>; when the MRL figure is followed by an asterisk (*) the MRL is set at the LOQ.(2) The threshold residue is the theoretical calculated residue level that represents the 100% of the ARfD exhausti<strong>on</strong>. This value is calculated individually for each <strong>pesticide</strong>/crop combinati<strong>on</strong>and for each diet.(3) See secti<strong>on</strong> 5.1.3 for more details <strong>on</strong> the event classificati<strong>on</strong>.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646126


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesTable 5.2.2-2: Details <strong>on</strong> the MRL exceedances and sample origin for the samples for which the short-term risk assessment was not c<strong>on</strong>clusive.PesticideCropNo samples abovethe thresholdresidueNumber samples ><str<strong>on</strong>g>2008</str<strong>on</strong>g> EC MRLOrigin ofsamples > <str<strong>on</strong>g>2008</str<strong>on</strong>g>EC MRL(1)Pesticideauthorisati<strong>on</strong>status in EU(any crop) in<str<strong>on</strong>g>2008</str<strong>on</strong>g>(y/n)<str<strong>on</strong>g>2008</str<strong>on</strong>g> ECMRL(wholecrop)mg/kg2010 ECMRL(wholecrop)mg/kgPFmissing?(y/n)ThresholdEC MRL(wholecrop)mg/kg2010ECMRL >thresholdMRL?(y/n)<str<strong>on</strong>g>EFSA</str<strong>on</strong>g>recommendati<strong>on</strong>Cypermethrin Pears 1 0 y 1.00 1.00 n.a. 0.439 y (2)Folpet/Captan Pears 2 0 y 3.00 3.00 n.a. 2.196 y (3)Dithiocarbamates Oranges 3 0 5.00 5.00 y (4)Dithiocarbamates Potatoes 1 0 0.30 0.30 y (4)Dithiocarbamates Pears 46 0 3.00 5.00 n.a. 0.880 y (5)Dithiocarbamates Spinach 4 25 1 AT, 1 BE,0.05 0.05 n.a. 3.540 n (6)4 CY, 4 ES, 6 FR,1 IT, 1 PL, 5 PT,2 Unknown(1) AT= Austria; BE = Belgium; CY = Cyprus; ES = Spain; FR = France; IT = Italy; PL = Poland; PT= Portugal.(2) EURL to investigate possible soluti<strong>on</strong>s to distinguish the isomers c<strong>on</strong>tributing to the total cypermethrins measured in food samples.(3) COM to set separate MRLs for pears for folpet and captan; Member State(s) to <str<strong>on</strong>g>report</str<strong>on</strong>g> separately <strong>residues</strong> of folpet and captan in pears.(4) To set a processing/peeling factor for oranges; Member State(s) to analyse the samples with the analytical methods developed specifically for ziram, thiram and propineb when the MRLfor the dithiocarbamets (CS 2 ) is exceeded.(5) Member State(s) to analyse the samples with the analytical methods developed specifically for ziram, thiram and propineb when the MRL for the dithiocarbamets (CS 2 ) is exceeded.(6) Member State(s) to check possible misuses <strong>on</strong> spinach; when the MRL for the dithiocarbamets (CS 2 ) is exceeded to analyse the samples with the analytical methods developed specificallyfor ziram, thiram and propineb.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646127


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues5.2.2.1. CypermethrinThe use of cypermethrin, alpha-cypermethrin and zeta-cypermethrin is authorised in <strong>Europe</strong>. Noauthorisati<strong>on</strong>s are granted for beta-cypermethrin.The residue definiti<strong>on</strong> for enforcement is set to the sum of mixture of c<strong>on</strong>stituent cypermethrinisomers. Therefore, the identity of the measured residue in samples is not known. As a result, theshort-term risk assessment has been initially performed by comparing the estimated exposure to theARfD of alpha-cypermethrin (0.04 mg/kg bw), the isomer with the lowest acute toxicologicalreference value.A potential c<strong>on</strong>sumer risk could not be excluded for <strong>on</strong>e pear sample. The exceedance of the lowestthreshold residue levels was c<strong>on</strong>sidered as excepti<strong>on</strong>al event and the rate of the ARfD exceedance wasslight (125%) (figure 5.2.2.1-1).FI adultDK adultIE adultIT adultUK adultLT adultES adultUK vegetarianPL (GP)NL (GP)IT childES childDK childUK 4‐6 yrNL childBE childUK infantUK toddlerDE childAcute exposure: cypermethrin/pears0 20 40 60 80 100 120 140Intake in % of the ARfDFigure 5.2.2.1-1: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to cypermethrin <strong>residues</strong> in pear, expressed aspercent of the ARfD of alpha-cypermethrin.It should be noted that the pear sample of c<strong>on</strong>cern was not <str<strong>on</strong>g>report</str<strong>on</strong>g>ed to exceed the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EC MRL of 1.0mg/kg. For this <strong>pesticide</strong>/crop combinati<strong>on</strong> a threshold residue c<strong>on</strong>centrati<strong>on</strong> of 0.44 mg/kg has beencalculated which is about the half of the current EC MRL (1.0 mg/kg).If the risk assessment is performed with the ARfD set for zeta-cypermethrin (0.125 mg/kg bw, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>,<str<strong>on</strong>g>2008</str<strong>on</strong>g>), the calculated exposure is well below the ARfD (40%) and therefore a c<strong>on</strong>sumer risk is to beexcluded.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646128


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> recommends that EURLs investigate possible soluti<strong>on</strong>s to distinguish the isomers c<strong>on</strong>tributingto the total measured cypermethrin in food samples and to establish separate residue definiti<strong>on</strong>s.5.2.2.2. DithiocarbamatesThe dithiocarbamates are a group of active substances which have a comparable chemical structure,but which have different toxicological properties. The analytical method used to analyse the samplesfor <strong>residues</strong> resulting from the use of dithiocarbamates determines the residue c<strong>on</strong>centrati<strong>on</strong> of CS 2without identifying the active substance that has been applied to the crop. For the risk assessment<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> used the ARfD value established for ziram, which is the dithiocarbamate compound with thelowest ARfD (0.08 mg/kg bw) and the ARfD for mancozeb (0.6 mg/kg bw), which is thedithiocarbamate which is most comm<strong>on</strong>ly used.Assuming that all CS 2 is due to the use of ziram, the residue values <str<strong>on</strong>g>report</str<strong>on</strong>g>ed as CS 2 were recalculatedto ziram by using the molecular weight c<strong>on</strong>versi<strong>on</strong> factor of 2.01. According to IESTI calculati<strong>on</strong>s, thesamples that gave rise to theoretical acute intake c<strong>on</strong>cerns were three orange samples, <strong>on</strong>e potatosample, forty-six pear samples, and four spinach samples. The eight exceedances were classified asseldom events (figure 5.2.2.2-1 to figure 5.2.2.2-4). The 46 exceedances of the residue threshold inpears were c<strong>on</strong>sidered as n<strong>on</strong> seldom events. It is noted that the EC MRL set for dithiocarbamates inpears was 3 mg/kg in <str<strong>on</strong>g>2008</str<strong>on</strong>g>, while the current MRL is 5 mg/kg. The threshold MRL calculated <strong>on</strong> thebasis of the ARfD set for ziram is 0.88 mg/kg.DK adultIE adultFI adultIT adultPL (GP)ES adultNL (GP)UK adultUK vegetarianIT childES childDK childNL childBE childUK 4‐6 yrDE childUK toddlerUK infantAcute exposure: dithiocarbamate/oranges0 20 40 60 80 100 120 140 160Intake in % of the ARfDFigure 5.2.2.2-1: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to dithiocarbamate <strong>residues</strong> in oranges, expressedas percent of the ARfD set for ziram.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646129


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesFI adultDK adultIE adultIT adultUK adultLT adultES adultUK vegetarianPL (GP)NL (GP)IT childES childDK childUK 4‐6 yrNL childBE childUK infantUK toddlerDE childAcute exposure: dithiocarbamate/pears0 100 200 300 400 500 600 700Intake in % of the ARfDFigure 5.2.2.2-2: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to dithiocarbamate <strong>residues</strong> in pears, expressed aspercent of the ARfD set for ziram.DK adultIT adultFI adultES adultNL (GP)IE adultLT adultPL (GP)UK adultIT childES childUK vegetarianBE childDE childNL childUK 4‐6 yrUK toddlerUK infantAcute exposure: dithiocarbamate/potatoes0 20 40 60 80 100 120 140Intake in % of the ARfDFigure 5.2.2.2-3: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to dithiocarbamate <strong>residues</strong> in potatoes, expressedas percent of the ARfD set for ziram.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646130


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesAcute exposure: dithiocarbamate/spinachFI adultIE adultDK adultIT adultIT childES adultDK childPL (GP)ES childUK adultUK vegetarianUK toddlerUK infantUK 4‐6 yrNL (GP)DE childNL childBE child0 50 100 150 200 250 300 350 400Intake in % of the ARfDFigure 5.2.2.2-4: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to dithiocarbamate <strong>residues</strong> in spinach, expressedas percent of the ARfD set for ziram.Assuming that all CS 2 is due to the use of mancozeb, the residue values <str<strong>on</strong>g>report</str<strong>on</strong>g>ed as CS 2 wererecalculated to mancozeb by using the molecular weight c<strong>on</strong>versi<strong>on</strong> factor of 1.78. According toIESTI calculati<strong>on</strong>s, no samples gave rise to theoretical acute intake c<strong>on</strong>cern. However, a finalc<strong>on</strong>clusi<strong>on</strong> regarding the potential health risk related to the observed CS 2 <strong>residues</strong> cannot be drawn asthe sources of the CS 2 <strong>residues</strong> are unknown and therefore the appropriate toxicological referencevalue could not be identified.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> recommends that the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries do the following; if the total CS 2 measured complieswith the EC MRL, the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries should <str<strong>on</strong>g>report</str<strong>on</strong>g> the total CS 2 (i.e. it is therefore assumed thatthe dithiocarbamates have been applied correctly); if the total CS 2 measured exceeds the EC MRL setfor the dithiocarbamate group, the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries should also analyse the samples with theanalytical methods developed specifically for ziram, thiram and propineb. The residue results shouldbe <str<strong>on</strong>g>report</str<strong>on</strong>g>ed separately for these three <strong>pesticide</strong>s to allow a refined risk assessment.5.2.2.3. Folpet/CaptanThe use of products c<strong>on</strong>taining folpet and captan is authorised in <strong>Europe</strong>. Except for two singlesamples of pears, all the samples analysed for captan and folpet (as sum) c<strong>on</strong>tained <strong>residues</strong> levels forwhich a potential acute c<strong>on</strong>sumer risk could be excluded. The exceedance of the ARfD is c<strong>on</strong>sidered aseldom event.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646131


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesThe residue definiti<strong>on</strong> for certain commodities included in the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated programme (i.e.pears and beans without pods) is set to the sum of folpet and captan. The c<strong>on</strong>tributi<strong>on</strong> of the two single<strong>pesticide</strong>s to the total <strong>residues</strong> measured in the pear sample of c<strong>on</strong>cern was not <str<strong>on</strong>g>report</str<strong>on</strong>g>ed to <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>.Therefore, a potential short-term risk was identified by comparing the highest estimated exposure withthe ARfD set for folpet (0.2 mg/kg bw). The highest IESTI exceeded 132% of the folpet ARfD (figure5.2.2.3-1).FI adultDK adultIE adultIT adultUK adultLT adultES adultUK vegetarianPL (GP)NL (GP)IT childES childDK childUK 4‐6 yrNL childBE childUK infantUK toddlerDE childAcute exposure: captan‐folpet/pears0 20 40 60 80 100 120 140Intake in % of the ARfDFigure 5.2.2.3-1: Acute exposure of the <strong>Europe</strong>an populati<strong>on</strong> to folpet/captan <strong>residues</strong> in pears, expressed aspercent of the ARfD set for captan.The two pear samples of c<strong>on</strong>cern were found not exceeding the EC MRL in place in <str<strong>on</strong>g>2008</str<strong>on</strong>g> (3 mg/kg)but exceeding the lowest residue threshold (2.2 mg/kg), based <strong>on</strong> the assumpti<strong>on</strong> that the measured<strong>residues</strong> of folpet and captan in pears are solely due to the <strong>pesticide</strong> with lower ARfD (folpet).If the short-term exposure is performed with the ARfD of captan (0.3 mg/kg bw), the calculated IESTIdoes not exceed the ARfD. Under this scenario no c<strong>on</strong>sumer risk is identified.It is noted that no potential short-term risks were identified for captan and folpet <strong>residues</strong> measuredseparately in food commodities for which the residue definiti<strong>on</strong> and EC MRLs are set singularly forcaptan and folpet.Due to the uncertainty relating to c<strong>on</strong>tributi<strong>on</strong> of folpet and captan to the total residue measured, ac<strong>on</strong>clusive risk assessment could not be performed. Therefore, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> recommends setting separateMRLs for captan and folpet.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646132


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues5.2.3. Pesticide/crop combinati<strong>on</strong>s for which the short-term risk assessment could not beperformedNo acute (short-term) risk assessment could be performed for dichlorvos because no toxicologicalreference value is available. During the peer-review of this substance in the framework of Directive91/414/EEC (EC 1991a), it was c<strong>on</strong>cluded that due to insufficient informati<strong>on</strong> available no ARfD canbe derived.Dichlorvos is an active substance that is no l<strong>on</strong>ger authorised for use in plant protecti<strong>on</strong> products in<strong>Europe</strong>. Authorisati<strong>on</strong>s for plant protecti<strong>on</strong> products c<strong>on</strong>taining dichlorvos had to be withdrawn by 6December 2007; any period of grace granted by Member States had to expire at the latest byDecember <str<strong>on</strong>g>2008</str<strong>on</strong>g>.It was noted that in the nine food commodities analysed in <str<strong>on</strong>g>2008</str<strong>on</strong>g> measurable <strong>residues</strong> of this substancewere <strong>on</strong>ly quantified in <strong>on</strong>e single sample of rice out of 768 rice samples analysed. In this sample, theresidue measured amounted to 0.03 mg/kg and therefore it exceeded the EC MRL, which corresp<strong>on</strong>dsto the default MRL of 0.01 mg/kg. It is noted that the rice sample of c<strong>on</strong>cern has EU origin (Italy).<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> recommends making efforts to derive toxicological reference values for dichlorvos <strong>on</strong> the basisof the open scientific literature and the available, limited, scientific dossier and studies to allow ac<strong>on</strong>clusi<strong>on</strong> <strong>on</strong> the potential c<strong>on</strong>sumer risks due to dichlorvos <strong>residues</strong> measured in food samples.5.3. Model assumpti<strong>on</strong>s for l<strong>on</strong>g-term risk assessmentThe chr<strong>on</strong>ic or l<strong>on</strong>g-term exposure assesses the average exposure of an individual over their lifetime.Ideally, the l<strong>on</strong>g-term exposure should be calculated by means of probabilistic modelling, using thedistributi<strong>on</strong>s of the individual food c<strong>on</strong>sumpti<strong>on</strong> <str<strong>on</strong>g>report</str<strong>on</strong>g>ed by the resp<strong>on</strong>dents of food surveys and thedistributi<strong>on</strong> of the measured residue c<strong>on</strong>centrati<strong>on</strong> identified in the m<strong>on</strong>itoring programmes. Sincecurrently the necessary input values for such calculati<strong>on</strong>s are not yet available, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> decided tocalculated the l<strong>on</strong>g-term exposure with a deterministic model, analogous to the calculati<strong>on</strong> of theTheoretical Maximum Daily Intake. The TMDI is calculated according to the following equati<strong>on</strong>which was developed for the assessment of the l<strong>on</strong>g-term dietary intake in the framework of settingMRLs (WHO, 1997):TMDI = Σ (MRL i * F i )MRL i :Fi:Maximum residue level for food commodity iFood c<strong>on</strong>sumpti<strong>on</strong> of food commodity iThe modelling of the actual exposure is d<strong>on</strong>e with a deterministic methodology by multiplying aresidue c<strong>on</strong>centrati<strong>on</strong> by an average daily food c<strong>on</strong>sumpti<strong>on</strong> estimated for each commodity for whichfood c<strong>on</strong>sumpti<strong>on</strong> data are available. The MRL that is used in the TMDI calculati<strong>on</strong> has been replacedwith a relevant residue c<strong>on</strong>centrati<strong>on</strong>. If the calculated exposure is below the toxicological referencevalue derived for l<strong>on</strong>g-term exposure, i.e. the Acceptable Daily Intake (ADI, see “Backgroundinformati<strong>on</strong>” secti<strong>on</strong>), the c<strong>on</strong>sumer is c<strong>on</strong>sidered as adequately protected.The following input values are required to calculate the actual exposure:• Residue c<strong>on</strong>centrati<strong>on</strong> to which the c<strong>on</strong>sumer is exposed (see secti<strong>on</strong> 5.3.1)• Processing/peeling factors (see secti<strong>on</strong> 5.3.2)<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646133


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues• Mean food c<strong>on</strong>sumpti<strong>on</strong> from the <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> PRIMo (<str<strong>on</strong>g>EFSA</str<strong>on</strong>g>, 2007). These food c<strong>on</strong>sumpti<strong>on</strong> datawere derived from nati<strong>on</strong>al food surveys. Data for in total 27 diets representing different foodhabits of <strong>Europe</strong>an populati<strong>on</strong> sub-groups, including children are available.As <str<strong>on</strong>g>report</str<strong>on</strong>g>ed in secti<strong>on</strong> 2.1.1, the c<strong>on</strong>tributi<strong>on</strong> of the 9 food commodities m<strong>on</strong>itored in the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EUcoordinated programme represent 15 to 50% of the total dietary daily intake of the <strong>Europe</strong>anc<strong>on</strong>sumers. In order to be more representative for the total intake, the chr<strong>on</strong>ic risk assessment alsoincluded commodities of plant origin that will be included in the coordinated programme in 2009 and2010 (see secti<strong>on</strong> 3.1.1) 23 (EC 2007). With this approach, 40.0% to 95.1% of the total dietary intakewill be represented.If in the first tier assessment a potential chr<strong>on</strong>ic risk could not be excluded <strong>on</strong> the basis of thecalculati<strong>on</strong> performed as described above, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> tried to perform more refined calculati<strong>on</strong>s, takinginto account processing factors. The available processing/peeling factors are <str<strong>on</strong>g>report</str<strong>on</strong>g>ed in secti<strong>on</strong> 5.1.2In Figure 5.3-1 the tiered approach used in assessing the chr<strong>on</strong>ic risk is represented.23 Orange juice has not been included in the exposure calculati<strong>on</strong>s.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646134


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesFigure 5.3-1: Flow chart for the tiered approach used in assessing the chr<strong>on</strong>ic risk.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646135


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues5.3.1. Residue levelsIn order to perform an actual l<strong>on</strong>g-term exposure assessment, a residue c<strong>on</strong>centrati<strong>on</strong> describing thel<strong>on</strong>g-term exposure of c<strong>on</strong>sumers to a certain <strong>pesticide</strong> has to be derived; the calculated mean residuec<strong>on</strong>centrati<strong>on</strong>s derived from the m<strong>on</strong>itoring results are suitable for this purpose. However, a directcalculati<strong>on</strong> of a mean residue c<strong>on</strong>centrati<strong>on</strong> from the <str<strong>on</strong>g>2008</str<strong>on</strong>g> m<strong>on</strong>itoring results <str<strong>on</strong>g>report</str<strong>on</strong>g>ed by MemberStates was not possible since the format currently used for <str<strong>on</strong>g>report</str<strong>on</strong>g>ing the results of the residue analysisrequires that <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries submit the data in an aggregated form; <strong>on</strong>ly the number of sampleswith residue level falling in <strong>on</strong>e of the 13 predefined residue classes are <str<strong>on</strong>g>report</str<strong>on</strong>g>ed (e.g. samples with<strong>residues</strong> between 0.02 and 0.05 mg/kg); the individual measured residue c<strong>on</strong>centrati<strong>on</strong>s for thesamples are not <str<strong>on</strong>g>report</str<strong>on</strong>g>ed.To derive an appropriate input value for the chr<strong>on</strong>ic exposure assessment, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> analysed the datasubmitted in the framework of a pilot project which was launched in 2009 with six Member Statesvolunteering to test the data submissi<strong>on</strong> according to a new format. This new data format wasdeveloped to submit the detailed results obtained in the nati<strong>on</strong>al m<strong>on</strong>itoring laboratories at the level ofthe single chemical determinati<strong>on</strong>, without aggregati<strong>on</strong> of the results. The six Member States wereable to provide <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> with detailed results for about 6 milli<strong>on</strong> chemical determinati<strong>on</strong>s, which relatedto about 27,000 samples. The samples <str<strong>on</strong>g>report</str<strong>on</strong>g>ed in line with the new format accounted for about 40%of the total samples taken by all the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries. The <strong>pesticide</strong> <strong>residues</strong> measured in eachsample allowed investigati<strong>on</strong> of the distributi<strong>on</strong> of the <strong>residues</strong> within each of the 13 predefinedresidue classes. The results submitted for about 700 <strong>pesticide</strong>/crop combinati<strong>on</strong>s dem<strong>on</strong>strated that,with the following calculati<strong>on</strong> methodology, an appropriate descriptor of the mean residue value canbe derived:• For each class in the current <str<strong>on</strong>g>report</str<strong>on</strong>g>ing system the mid-value was determined (e.g. the midvaluefor the class 0.051 to 0.1 mg/kg is 0.0755 mg/kg).• For each sample analysed for a specific <strong>pesticide</strong>/commodity combinati<strong>on</strong> which was <str<strong>on</strong>g>report</str<strong>on</strong>g>edto fall in a specific residue class it was assumed that the real residue was equivalent to thecalculated mid-value of the class.• For the <strong>pesticide</strong>/residue combinati<strong>on</strong>, an overall mean value was calculated, using the midclassvalues derived for the individual samples. However, for samples with <strong>residues</strong> below theLOQ, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> assumed the real value was the LOQ, as informati<strong>on</strong> <strong>on</strong> the use of the <strong>pesticide</strong>c<strong>on</strong>cerned in the specific commodity was not available.• Samples for which the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing levels were not indicated were disregarded.• If for a given <strong>pesticide</strong>/crop combinati<strong>on</strong> no positive findings were <str<strong>on</strong>g>report</str<strong>on</strong>g>ed am<strong>on</strong>g all the<str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries, then the c<strong>on</strong>tributi<strong>on</strong> of these crops to the total dietary intake was notc<strong>on</strong>sidered since a “no use/no residue” situati<strong>on</strong> was assumed.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646136


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesThe usage of the midpoint of each class was c<strong>on</strong>sidered a c<strong>on</strong>servative estimator, but more realisticthan the upper class limit which was used in the chr<strong>on</strong>ic exposure assessment in the 2007 <str<strong>on</strong>g>Annual</str<strong>on</strong>g>Report 24 .The residue values <str<strong>on</strong>g>report</str<strong>on</strong>g>ed according to the residue definiti<strong>on</strong> for enforcement (as in the MRLlegislati<strong>on</strong>) were not recalculated to the residue definiti<strong>on</strong> for risk assessment because no reliablec<strong>on</strong>versi<strong>on</strong> factors are available at the moment.The residue levels used as input values for the calculati<strong>on</strong> of the l<strong>on</strong>g-term exposure are <str<strong>on</strong>g>report</str<strong>on</strong>g>ed inTable 5.3.1-1a and Table 5.3.1-1b. Empty cells refer to <strong>pesticide</strong>/crop combinati<strong>on</strong>s for which allresults were <str<strong>on</strong>g>report</str<strong>on</strong>g>ed to be below the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing level and therefore a no use/no residue situati<strong>on</strong> wasassumed.24 In the 2007 <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report of Pesticide Residues <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> used a different approach (<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> 2009): for each group of sampleswithin a residue class the residue level was c<strong>on</strong>sidered to be the upper bound (e.g. for samples with residue levels fallingin the class “between 0.02 and 0.05 mg/kg” the c<strong>on</strong>centrati<strong>on</strong> level is assumed to be 0.05 mg/kg). The upper bound for n<strong>on</strong>quantifiable residue levels was assumed to corresp<strong>on</strong>d to the LOQ. Hence, the chr<strong>on</strong>ic exposure assessment was performedusing the mean value derived from these “upper bound” c<strong>on</strong>centrati<strong>on</strong> values. This approach was c<strong>on</strong>sidered veryc<strong>on</strong>servative and was overestimating the real exposure.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646137


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesTable 5.3.1-1a: Mean residue level (mg/kg) for the commodities included in the <str<strong>on</strong>g>2008</str<strong>on</strong>g>-2010 EU coordinated programmes used as input values for the l<strong>on</strong>gtermdietary exposure calculati<strong>on</strong>s.Pesticide Apples Aubergines(egg plants)BananasBeans(withoutpods)CarrotsCucumbersHeadcabbageLeek Lettuce Mandarins Oats OrangesCauliflowerAcephateAcetamiprid 0.0072 0.0076 0.0084 0.0168 0.0081 0.0067Azinphos-methyl 0.0590 0.0200 0.0493Azoxystrobin 0.0271 0.0118 0.0190 0.0288 0.0143 0.0166 0.0180 0.0092 0.0717 0.0151 0.0053 0.0166Bifenthrin 0.0129 0.0226 0.0142 0.0131 0.0193 0.0226 0.0153 0.0152Bromopropylate 0.0237 0.0157 0.0255 0.0279Bupirimate 0.0097 0.0150Buprofezin 0.4134 0.0124 0.0130 0.0153 0.0123Captan 0.0625 0.0050 0.0196 0.0343 0.0288 0.0366 0.0313Captan/Folpet sum 0.0536 0.0320 0.0653Carbaryl 0.0259 0.0247 0.0153 0.0050 0.0179 0.0226Carbendazim andbenomyl0.0188 0.0148 0.0346 0.0152 0.0347 0.0281 0.0129 0.0185Chlormequat 0.0170 0.0700Chlorothal<strong>on</strong>il 0.0240 0.0389 0.0177 0.0373 0.0051 0.0249 0.0129 0.0554Chlorpropham(sum)0.0332 0.0066 0.0180 0.0151 0.0147 0.0149Chlorpyrifos 0.0200 0.0072 0.0356 0.0279 0.0194 0.0309 0.0138 0.0214 0.0229 0.0819 0.0317Chlorpyrifosmethyl0.0102 0.0141 0.0141 0.0154 0.1864 0.0169Clofentezine 0.0135 0.0099 0.0103 0.0083Cypermethrin(sum)0.0140 0.0254 0.0353 0.0242 0.0244 0.0138 0.0306 0.0296 0.0292Cyprodinil 0.0259 0.0143 0.0348 0.0193 0.0095 0.0050 0.0126 0.0311 0.0115Deltamethrin 0.0084 0.0233 0.0356 0.0252 0.0227 0.0222 0.0273 0.0215Diazin<strong>on</strong> 0.0187 0.0060 0.0125 0.0078 0.0068 0.0055 0.0091 0.0088Dichlofluanid 0.0447 0.0313 0.0284 0.0156 0.0174Dichlorvos 0.0050 0.0060<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646138


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesPesticide Apples Aubergines(egg plants)BananasBeans(withoutpods)CarrotsCucumbersHeadcabbageLeek Lettuce Mandarins Oats OrangesCauliflowerDicofol 0.0167 0.0430 0.0287Dimethoate (sum) 0.0221 0.0155 0.0178 0.0128 0.0156 0.0137 0.0253 0.0147 0.0101 0.0116Diphenylamine 0.1024 0.0348 0.0301 0.0388 0.0146Dithiocarbamates 0.1306 0.1366 0.1203 0.0780 0.0438 0.1881 0.0866 0.2158 0.2396 0.296 0.1687 0.0883Endosulfan (sum) 0.0068 0.0093 0.0240 0.0182 0.0161 0.0294 0.0162 0.0191FenarimolFenhexamid 0.0277 0.0355 0.0347 0.0162 0.0058 0.1052 0.0168Fenitrothi<strong>on</strong> 0.0126 0.0066 0.0299 0.0131 0.0141Fludiox<strong>on</strong>il 0.0213 0.0098 0.0122 0.0144 0.0215 0.0364 0.0259Flusilazole 0.0050Folpet 0.0154 0.0062 0.0466 0.0826 0.0275Hexac<strong>on</strong>azole 0.0103 0.0072 0.0090Hexythiazox 0.0051 0.0120 0.0107 0.0083Imazalil 0.0366 0.1043 0.0366 0.0323 0.0052 1.2518 1.0343Imidacloprid 0.0279 0.0160 0.0104 0.0052 0.0195 0.0070 0.0102Indoxacarb 0.0177 0.0182 0.0156 0.0180 0.0346 0.0347Iprodi<strong>on</strong>e 0.0251 0.0199 0.0177 0.0387 0.0197 0.0466 0.2744 0.0293 0.0143Iprovalicarb 0.0137 0.0749Kresoxim-methyl 0.0275 0.0169 0.0194 0.0121 0.0053Lambdacyhalothrin0.0102 0.0071 0.0099 0.0148 0.0121 0.0137 0.0147 0.0163 0.0132 0.0123Malathi<strong>on</strong> (sum) 0.0066 0.0155 0.0459 0.0229 0.0050 0.0194 0.0153 0.0512 0.0312Mepanipyrim 0.0102MepiquatMetalaxyl (sum) 0.0193 0.0207 0.0204 0.0347 0.0191 0.0406Methamidophos 0.0046 0.0084 0.0173 0.0167 0.0377Methidathi<strong>on</strong> 0.0335 0.0321 0.0261 0.0313Methiocarb (sum) 0.0529 0.0136 0.0254 0.0364 0.0687Methomyl (sum) 0.0054 0.0187 0.0152 0.0140 0.0071 0.0236 0.0145Myclobutanil 0.0194 0.0173 0.0161 0.0129 0.0300 0.0253 0.0154<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646139


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesPesticide Apples Aubergines(egg plants)BananasBeans(withoutpods)CarrotsCucumbersHeadcabbageLeek Lettuce Mandarins Oats OrangesCauliflowerOxamyl 0.0083 0.0111 0.0095 0.0221Parathi<strong>on</strong> 0.0213Penc<strong>on</strong>azole 0.0230 0.0136Phosal<strong>on</strong>e 0.0205 0.0153 0.0254 0.0310Pirimicarb (sum) 0.0246 0.0170 0.0148 0.0274 0.0208Pirimiphos-methyl 0.0050 0.0243 0.0139 0.0095 0.0332 0.0253 0.0986 0.0258Prochloraz 0.1095 0.0554Procymid<strong>on</strong>e 0.0097 0.0106 0.0146 0.0138 0.0135 0.0212 0.0136 0.0058 0.0574 0.0142Profenofos 0.0097 0.0161 0.0150Propargite 0.0547 0.0067 0.0607 0.0354 0.0356Pyrethrins 0.0379 0.1654 0.2652 0.0860Pyrimethanil 0.0258 0.0164 0.0046 0.0646 0.0307 0.0244 0.0084 0.0145 0.0319 0.0371Pyriproxyfen 0.0051 0.0146 0.0084 0.0079QuinoxyfenSpiroxamine 0.0324 0.0053 0.0335 0.0167 0.0349Tebuc<strong>on</strong>azole 0.0215 0.0156 0.0365 0.0226 0.0348 0.0180 0.0328Tebufenozide 0.0218 0.0078 0.0279Thiabendazole 0.0774 0.0055 0.0829 0.0224 0.0226 0.0201 0.0051 0.3494 0.3765Thiophanatemethyl0.0230 0.0107 0.0191 0.0099Tolclofos-methyl 0.0130 0.0171Tolylfluanid 0.0500 0.0196 0.0671Triadimef<strong>on</strong> (sum) 0.0200 0.0063 0.0601 0.0375 0.0308Trifloxystrobin 0.0117 0.0010 0.0092 0.0082 0.0095 0.0110 0.0084Vinclozolin (sum) 0.0231 0.0178 0.0115 0.0146<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646140


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesTable 5.3.1-1b: Mean residue level (mg/kg) for the commodities included in the 2009-2010 EU coordinated programmes used as input values for the l<strong>on</strong>gtermdietary exposure calculati<strong>on</strong>s. Empty cells refer to <strong>pesticide</strong>/crop combinati<strong>on</strong>s for which <strong>residues</strong> above the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing level were not measured.Pesticides Peaches Pears Peas(withoutpods)TablegrapesTomatoesPeppers Potatoes Rice Rye Spinach StrawberriesAcephate 0.0174 0.0082 0.0052 0.0328Acetamiprid 0.0085 0.0101 0.0095 0.0119 0.0056 0.0054 0.0078Azinphos-methyl 0.0783 0.0325 0.0152 0.0066 0.0239Azoxystrobin 0.0131 0.0318 0.0143 0.0209 0.0150 0.0164 0.0418 0.0263 0.0245 0.0154Bifenthrin 0.0188 0.0161 0.0221 0.0159 0.0261 0.0219 0.0203 0.0052Bromopropylate 0.0185 0.0245 0.0346 0.0194 0.0213Bupirimate 0.0127 0.0126 0.0162 0.0171 0.0159 0.0127Buprofezin 0.0300 0.0167 0.0267 0.0270 0.0318 0.0231 0.0369Captan 0.0248 0.0293 0.0289 0.0526 0.0652 0.0106Captan/Folpet sum 0.0786 0.0626 0.0344 0.0252Carbaryl 0.0262 0.0252 0.0272 0.0209 0.0670 0.0728Carbendazim andbenomyl0.0117 0.0280 0.0050 0.0462 0.0162 0.0115 0.0204 0.0098 0.0090 0.0440 0.0050Chlormequat 0.0304 0.1499 0.0873Chlorothal<strong>on</strong>il 0.0184 0.0465 0.0224 0.0183 0.0301 0.0109 0.0277Chlorpropham(sum)0.0226 0.0180 0.2754 0.0176 0.0347 0.0095Chlorpyrifos 0.0195 0.0271 0.0292 0.0157 0.0178 0.0704 0.0205 0.0253 0.0250 0.0203 0.0305Chlorpyrifosmethyl0.0141 0.0178 0.0162 0.0236 0.0180 0.0163 0.0157 0.0133 0.0180 0.0231Clofentezine 0.0127 0.0162 0.0122Cypermethrin(sum)0.0223 0.0328 0.0331 0.0222 0.0348 0.0290 0.0372 0.0207Cyprodinil 0.0228 0.0180 0.0167 0.0188 0.0092 0.0533 0.0733 0.0195Deltamethrin 0.0217 0.0396 0.0290 0.0204 0.0380 0.0277 0.0315 0.0220 0.0280 0.0513Diazin<strong>on</strong> 0.0105 0.0107 0.0070Wheat<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646141


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesPesticides Peaches Pears Peas(withoutpods)TablegrapesTomatoesPeppers Potatoes Rice Rye Spinach StrawberriesDichlofluanid 0.0151 0.0154 0.0165 0.0235 0.0335Dichlorvos 0.0050 0.0227 0.0363 0.0318Dicofol 0.0065 0.0225 0.0503 0.0220 0.0145 0.0441 0.0477Dimethoate (sum) 0.0158 0.0127 0.0102 0.0141 0.0123 0.0276 0.0161 0.0154 0.0139 0.0269 0.0329Diphenylamine 0.0266 0.1023 0.0160 0.0055 0.0052 0.0349Dithiocarbamates 0.0771 0.2062 0.0656 0.0542 0.0400 0.0966 0.1046 0.1127 0.1287Endosulfan (sum) 0.0168 0.0212 0.0244 0.0173 0.0177 0.0302 0.0296 0.0283 0.0567Fenarimol 0.0154 0.0231 0.0155 0.0108 0.0135Fenhexamid 0.0425 0.0274 0.1040 0.0927 0.0396Fenitrothi<strong>on</strong> 0.0342 0.0127 0.0106 0.0196 0.0099Fludiox<strong>on</strong>il 0.0185 0.0293 0.0153 0.0188 0.0158 0.0456 0.0466 0.0238Flusilazole 0.0278 0.0051 0.0275 0.0133Folpet 0.0153 0.0180 0.0300 0.1824 0.0229Hexac<strong>on</strong>azole 0.0092 0.0130 0.0146 0.0115Hexythiazox 0.0324 0.0117 0.0182 0.0271 0.0223 0.0198Imazalil 0.0470 0.0752 0.0739 0.0198 0.0218 0.0650 0.0532 0.0551Imidacloprid 0.0154 0.0132 0.0205 0.0108 0.0074 0.0084 0.0140 0.0134 0.0142Indoxacarb 0.0205 0.0198 0.0208 0.0215 0.0256 0.0300 0.0198Iprodi<strong>on</strong>e 0.1116 0.0693 0.0113 0.0499 0.0252 0.0251 0.0420 0.0806 0.0363 0.0245Iprovalicarb 0.0123 0.0277Kresoxim-methyl 0.0215 0.0183 0.0230 0.0311 0.0214 0.0081Lambdacyhalothrin0.0159 0.0189 0.0119 0.0200 0.0135 0.0101 0.0093Malathi<strong>on</strong> (sum) 0.0208 0.0306 0.0268 0.0220 0.0329 0.0501 0.0198 0.0324 0.0263 0.0138 0.1721Mepanipyrim 0.0360 0.0106 0.0130Mepiquat 0.0200 0.0067 0.0109Metalaxyl (sum) 0.0331 0.0472 0.0203 0.0180 0.0238 0.0196 0.0314 0.0230 0.0261Methamidophos 0.0055 0.0058 0.0148 0.0131 0.0086 0.0344Methidathi<strong>on</strong> 0.0158 0.0066 0.0150Methiocarb (sum) 0.0499 0.0132 0.0478 0.0488 0.0580Wheat<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646142


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesPesticides Peaches Pears Peas(withoutpods)TablegrapesTomatoesPeppers Potatoes Rice Rye Spinach StrawberriesMethomyl (sum) 0.0227 0.0211 0.0329 0.0118 0.0127 0.0156 0.0123 0.0170Myclobutanil 0.0150 0.0149 0.0164 0.0241 0.0230 0.0191Oxamyl 0.0275 0.0086 0.0078 0.0288Parathi<strong>on</strong> 0.0213Penc<strong>on</strong>azole 0.0193 0.0183 0.0234 0.0246 0.0180 0.0061Phosal<strong>on</strong>e 0.0215 0.0374 0.0134 0.0162Pirimicarb (sum) 0.0348 0.0257 0.0268 0.0031 0.0164 0.0304 0.0349Pirimiphos-methyl 0.0243 0.0134 0.0395 0.0485 0.0292 0.0561Prochloraz 0.0074 0.0216 0.0218 0.0150Procymid<strong>on</strong>e 0.0452 0.0265 0.0202 0.0254 0.0157 0.0272 0.0303 0.0216Profenofos 0.0321 0.0395 0.0106 0.0151Propargite 0.0668 0.0276 0.0160 0.0302 0.0066 0.0506 0.0556Pyrethrins 0.1685 0.0102 0.1412Pyrimethanil 0.0148 0.0457 0.0069 0.0194 0.0180 0.0312 0.0552 0.0212Pyriproxyfen 0.0198 0.0050 0.0175Quinoxyfen 0.0142 0.0119 0.0153Spiroxamine 0.0052 0.0197 0.0350 0.0026Tebuc<strong>on</strong>azole 0.0222 0.0392 0.0309 0.0146 0.0247 0.0736 0.0211 0.0311 0.0650Tebufenozide 0.0107 0.0209 0.0271 0.0254 0.0349Thiabendazole 0.0176 0.0550 0.0264 0.0181 0.0169 0.0350 0.0326 0.0230Thiophanatemethyl0.0365 0.0142 0.0050 0.0752 0.0600 0.0507 0.0657Tolclofos-methyl 0.0150 0.0105 0.0151 0.0151Tolylfluanid 0.0170 0.0671 0.0712 0.0694Triadimef<strong>on</strong> (sum) 0.0315 0.0398 0.0173 0.0318 0.0371 0.0717 0.0333 0.0219 0.0287Trifloxystrobin 0.0084 0.0090 0.0108 0.0157 0.0161 0.0129Vinclozolin (sum) 0.0151 0.0115 0.0119 0.0157 0.0149 0.0163Wheat<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646143


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues5.3.2. Processing/peeling factorsIn case the 1 st tier calculati<strong>on</strong> exceeded the ADI (see Figure 5.3-1), the processing/peeling factors wereapplied to refine the TMDI calculati<strong>on</strong>s. These factors have been selected from the German database 25developed by the Federal Institute for Risk Assessment (BfR), which includes a collecti<strong>on</strong> of processingfactors from annually published <str<strong>on</strong>g>report</str<strong>on</strong>g>s and evaluati<strong>on</strong>s by the FAO/WHO Joint Meeting <strong>on</strong> PesticideResidues (JMPR), from draft assessment <str<strong>on</strong>g>report</str<strong>on</strong>g>s (DAR) prepared in the <strong>Europe</strong>an Pesticide RiskAssessment Peer Review programme (PRAPeR) and from residue data which have been submittedwithin the framework of nati<strong>on</strong>al authorisati<strong>on</strong> procedures. Additi<strong>on</strong>al data c<strong>on</strong>cerning pulp/peeldistributi<strong>on</strong> have been provided to BfR by retailers and have been collected within the framework ofnati<strong>on</strong>al food m<strong>on</strong>itoring programmes.The processing/peeling factors applied to refine the TMDI intake calculati<strong>on</strong> are <str<strong>on</strong>g>report</str<strong>on</strong>g>ed in Table5.3.2-1.Table 5.3.2-1: Processing/peeling factors applied in the refined TMDI calculati<strong>on</strong>s.Pesticide Crop PF Processed cropDithiocarbamates Oranges 0.88 Orange pulpDithiocarbamates Banana 0.02 Banana pulp5.3.3. Acceptable Daily Intake values (ADIs)The l<strong>on</strong>g-term risk assessment requires a comparis<strong>on</strong> between the exposure calculated with the mean<strong>pesticide</strong> residue levels c<strong>on</strong>sumed and the ADI. The list of the ADIs used for the assessment of thechr<strong>on</strong>ic exposure is <str<strong>on</strong>g>report</str<strong>on</strong>g>ed in Table 5.3.3-1.Table 5.3.3-1: ADI values used as input values for the l<strong>on</strong>g-term risk assessmentPesticideADI(mg/kg bw/d)ADI (*)evaluati<strong>on</strong> yearADIsourceAcephate 0.03 2005 JMPRAcetamiprid 0.07 2004 COMAldicarb 0.003 1995 JMPRAzinphos-methyl 0.005 2006 COMAzoxystrobin 0.2 2009 PRAPeRBifenthrin 0.015 <str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Bromopropylate 0.03 1993 JMPRBupirimate 0.05 2007 DARBuprofezin 0.01 <str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Captan 0.1 2009 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Carbaryl 0.0075 2006 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Carbendazim/benomyl (1) 0.02 2007 COMChlormequat (8) 0.031 <str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Chlorothal<strong>on</strong>il 0.015 2006 COMChlorpropham 0.05 2003 COMChlorpyrifos 0.01 2005 COMChlorpyrifos-methyl 0.01 2005 COM25 The database is available at http://www.bfr.bund.de/cd/579 (BfR compilati<strong>on</strong> of 2009-07-01).<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646144


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesPesticideADI(mg/kg bw/d)ADI (*)evaluati<strong>on</strong> yearADIsourceClofentezine 0.02 2009 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Cypermethrin (2) 0.015 2004 COMCyprodinil 0.03 2005 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Deltamethrin 0.01 2002 COMDiazin<strong>on</strong> 0.0002 2006 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Dichlofluanid 0.007 2000 NLDichlorvos n.d. 2006 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Dicofol 0.002 1992 JMPRDimethoate 0.001 2006 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Diphenylamine 0.075 <str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Dithiocarbamates (3) 0.006 2004 COMEndosulfan 0.006 1998 JMPRFenarimol 0.01 2007 COMFenhexamid 0.2 1998 COMFenitrothi<strong>on</strong> 0.005 2006 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Fludiox<strong>on</strong>il 0.37 2007 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Flusilazole (general populati<strong>on</strong>) 0.002 2007 COMFolpet 0.1 2009 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Folpet/Captan 0.1 2009 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Hexac<strong>on</strong>azole 0.005 1990 JMPRHexythiazox 0.03 1991 JMPRImazalil 0.025 1997 COMImidacloprid 0.06 <str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Indoxacarb 0.006 2005 COMIprodi<strong>on</strong>e 0.06 2002 COMIprovalicarb 0.015 2002 COMKresoxim-methyl 0.4 1998 COMlambda-Cyhalothrin 0.005 2001 COMMalathi<strong>on</strong> 0.03 2009 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Mepanipyrim 0.02 2004 COMMepiquat 0.2 <str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Metalaxyl (4) 0.08 2002 COMMethamidophos 0.001 2007 COMMethidathi<strong>on</strong> 0.001 1992 JMPRMethiocarb (aka mercaptodimethur) 0.013 2006 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Methomyl/thiodicarb (5) 0.0025 <str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Myclobutanil 0.025 2009 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Omethoate 0.0003 2006 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Oxamyl 0.001 2005 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Oxydemet<strong>on</strong>-methyl 0.0003 2006 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Parathi<strong>on</strong> 0.006 2001 ECCOPenc<strong>on</strong>azole 0.03 <str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Phosal<strong>on</strong>e 0.01 2006 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Pirimicarb 0.035 2006 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Pirimiphos-methyl 0.004 2005 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Prochloraz 0.01 2001 JMPRProcymid<strong>on</strong>e 0.0028 2007 DAR (6) /COMProfenofos 0.03 2007 JMPRPropargite 0.007 2007 DARPyrethrins 0.04 2003 JMPR<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646145


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesPesticideADI(mg/kg bw/d)ADI (*)evaluati<strong>on</strong> yearADIsourcePyrimethanil 0.17 2006 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Pyriproxyfen 0.1 2009 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Quinoxyfen 0.2 2003 COMSpiroxamine 0.025 1999 COMTebuc<strong>on</strong>azole 0.03 <str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Tebufenozide 0.02 2007 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Thiabendazole 0.1 2001 COMThiophanate-methyl 0.08 2005 COMTolclofos-methyl 0.064 2005 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Tolylfluanid 0.1 2005 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Triadimef<strong>on</strong>/triadimenol (7) 0.03 2004 JMPRTriadimenol 0.05 <str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>Trifloxystrobin 0.1 2003 COMVinclozolin 0.005 2006 COM(*) For the l<strong>on</strong>g-term risk assessment the most recent ADIs available were used. It should be menti<strong>on</strong>ed that some of the ADIvalues were derived recently and were not in place in 2007 when the m<strong>on</strong>itoring results were generated.(1) ADI derived for carbendazim is used for risk assessment of carbendazim and benomyl.(2) ADI derived for alpha-cypermethrin.(3) The group of dithiocarbamates includes seven <strong>pesticide</strong>s with different toxicological reference values: A group-ADI is notavailable. The risk assessment was performed with both the value for ziram which is the lowest ADI and the value formancozeb which is the most comm<strong>on</strong>ly used dithiocarbamate.(4) ADI for metalaxyl-M.(5) ADI derived for methomyl is used for risk assessment of methomyl and thiodicarb.(6) DAR = Draft Assessment Report prepared in the framework of the active substance peer-review under DirectiveEEC/91/414 (re-submissi<strong>on</strong> of the dossier).(7) ADI for triadimenol is used for risk assessment of triadimenol and triadimef<strong>on</strong>.(8) ADI value derived for chlormequat chloride was recalculated by applying a molecular weight correcti<strong>on</strong> factor tochlormequat.5.3.4. Presentati<strong>on</strong> of the results of the l<strong>on</strong>g-term c<strong>on</strong>sumer exposureFor each <strong>pesticide</strong>, the chr<strong>on</strong>ic risk assessment is performed for all 27 diets of the <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> PRIMo model.The results of the TMDI calculati<strong>on</strong> are <str<strong>on</strong>g>report</str<strong>on</strong>g>ed separately for each <strong>pesticide</strong> in an exposure assessmentsummary <str<strong>on</strong>g>report</str<strong>on</strong>g>. The summary <str<strong>on</strong>g>report</str<strong>on</strong>g>s can be found in Appendix IV of this <str<strong>on</strong>g>report</str<strong>on</strong>g>. For each of the 27diets, the three commodities representing the largest proporti<strong>on</strong> of the ADI exhausti<strong>on</strong> are <str<strong>on</strong>g>report</str<strong>on</strong>g>ed,together with the total dietary intake for that commodity as a proporti<strong>on</strong> of the ADI. If the ADI was notexceeded in any diet, a chr<strong>on</strong>ic c<strong>on</strong>sumer risk can be excluded. In additi<strong>on</strong>, a chart is included in thecalculati<strong>on</strong> spreadsheets for each <strong>pesticide</strong> which presents the c<strong>on</strong>tributi<strong>on</strong> of the <strong>residues</strong> <strong>on</strong> individualcrops to the overall dietary exposure in the individual diets included in the <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> PRIMo.5.3.5. Limitati<strong>on</strong>s and uncertainties affecting the chr<strong>on</strong>ic exposure assessmentThe calculati<strong>on</strong> of the modified TMDI is affected by uncertainties related to the following aspects:• Model uncertainties – e.g. the use of the mean “middle class” approach for the <strong>residues</strong> abovethe limit of quantificati<strong>on</strong> and “upper class” for the <strong>residues</strong> below the limit of quantificati<strong>on</strong>• Measurement uncertainty of residue level• Lack of processing/peeling factors• Food c<strong>on</strong>sumpti<strong>on</strong> data: lack of detailed knowledge of c<strong>on</strong>sumpti<strong>on</strong> of processed productsA qualitative estimati<strong>on</strong> of uncertainties and the c<strong>on</strong>straints of the model used for assessing potentialchr<strong>on</strong>ic c<strong>on</strong>sumer risks are <str<strong>on</strong>g>report</str<strong>on</strong>g>ed elsewhere (<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> 2009).<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646146


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesThe methodology applied to assess the l<strong>on</strong>g-term risk, based <strong>on</strong> the modified TMDI calculati<strong>on</strong>s, isexpected to over-estimates the actual dietary exposure and the potential c<strong>on</strong>sumer risk when usingm<strong>on</strong>itoring data.5.4. Results of the l<strong>on</strong>g-term risk assessmentThe <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated m<strong>on</strong>itoring programme included 79 active substances or group of substances.The detailed results of the TMDI calculati<strong>on</strong>s for the substances for which the risk assessment wascarried out are <str<strong>on</strong>g>report</str<strong>on</strong>g>ed separately for each <strong>pesticide</strong> in Appendix IV to this <str<strong>on</strong>g>report</str<strong>on</strong>g>. In Table 5.4-1, thehighest estimated exposure for each <strong>pesticide</strong> assessed, expressed in percent of the ADI, is <str<strong>on</strong>g>report</str<strong>on</strong>g>ed.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646147


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesTable 5.4-1: Summary results of the l<strong>on</strong>g-term risk assessment.PesticideTMDI max(% ADI)Acephate 0.4Acetamiprid 0.2Aldicarb n.a. (*)Azinphos-methyl 16Azoxystrobin 0.3Bifenthrin 2.4Bromopropylate 1.6Bupirimate 0.4Buprofezin 10Captan 1.1Carbaryl 8.5Carbendazim/benomyl (1) 2.5Chlormequat (chloride) 3Chlorothal<strong>on</strong>il 3.2Chlorpropham 1.1Chlorpyrifos 8.1Chlorpyrifos-methyl 4.4Clofentezine 1Cypermethrin (2) 2.9Cyprodinil 1.9Deltamethrin 7.2Diazin<strong>on</strong> 151.2Dichlofluanid 9.8Dichlorvos (3) -Dicofol 14.8Dimethoate/omethoate (4) -Diphenylamine 2Dithiocarbamates (5) 89.2Endosulfan 11.9Fenarimol 0.6Fenhexamid 0.3Fenitrothi<strong>on</strong> 5.5Fludiox<strong>on</strong>il 0.1Flusilazole 5.9Folpet 0.6Folpet/captan (6) 0.8Hexac<strong>on</strong>azole 1.4Hexythiazox 0.6Imazalil 21.6Imidacloprid 0.8PesticideTMDI max(% ADI)Indoxacarb 5.9Iprodi<strong>on</strong>e 1.3Iprovalicarb 0.4Kresoxim-methyl 0.1lambda-Cyhalothrin 5.1Malathi<strong>on</strong> 5.7Mepanipyrim 0.2Mepiquat 0.1Metalaxyl (7) 0.8Methamidophos 17.7Methidathi<strong>on</strong> 56.6Methiocarb (akamercaptodimethur)2.4Methomyl/thiodicarb (8) 9.9Myclobutanil 1.7Oxamyl 14.2Oxydemet<strong>on</strong>-methyl n.a. (*)Parathi<strong>on</strong> 0.6Penc<strong>on</strong>azole 1.2Phosal<strong>on</strong>e 4.3Pirimicarb 1.4Pirimiphos-methyl 17.3Prochloraz 2.9Procymid<strong>on</strong>e 9.7Profenofos 0.4Propargite 14Pyrethrins 2.1Pyrimethanil 0.4Pyriproxyfen 0.1Quinoxyfen 0.0Spiroxamine 2.1Tebuc<strong>on</strong>azole 2.9Tebufenozide 1.8Thiabendazole 2.9Thiophanate-methyl 0.7Tolclofos-methyl 0.1Tolylfluanid 0.8Triadimef<strong>on</strong>/triadimenol (9) 1.8Trifloxystrobin 0.2Vinclozolin 3.1(*) n.a. = no residue measured above the LOQ in all crops.(1) The toxicological reference values used for carbendazim.(2) Toxicological reference values for alpha-cypermethrin.(3) Toxicological reference values not derived as <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> could not c<strong>on</strong>clude <strong>on</strong> the reference values due to insufficient data.(4) Due to the residue definiti<strong>on</strong> set for dimethoate and omethoate and the format used to <str<strong>on</strong>g>report</str<strong>on</strong>g> the residue level data thel<strong>on</strong>g-term exposure assessment was not c<strong>on</strong>clusive.(5) Toxicological reference values for ziram.(6) Toxicological reference values for folpet.(7) Toxicological reference values for metalaxyl-M.(8) Toxicological reference values for methomyl. (9) Toxicological reference values for triadimenol<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646148


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesFor dichlorvos, no ADI was established; therefore, no chr<strong>on</strong>ic risk assessment could be performed forthis substance.For dimethoate and omethoate the chr<strong>on</strong>ic risk assessment is inc<strong>on</strong>clusive (see secti<strong>on</strong> 5.4.2).With the excepti<strong>on</strong> of diazin<strong>on</strong>, for all remaining substances or groups of substances the estimatedexposure was below the ADI value. Based <strong>on</strong> the current scientific knowledge, for these compounds al<strong>on</strong>g-term c<strong>on</strong>sumer health risk can be excluded. Furthermore, it is noted that, for 95% of the 79substances assessed, the estimated exposure accounts for less than 25 % of the ADI and that for two<strong>pesticide</strong>s (aldicarb and oxydemet<strong>on</strong>-methyl) no positive detecti<strong>on</strong>s above the LOQ were measured inany of the crops c<strong>on</strong>cerned.5.4.1. Pesticides for which a chr<strong>on</strong>ic risk could not be excluded5.4.1.1. Diazin<strong>on</strong>The maximum estimated TMDI for diazin<strong>on</strong>, calculated under the assumpti<strong>on</strong>s <str<strong>on</strong>g>report</str<strong>on</strong>g>ed in secti<strong>on</strong> 5.3was equivalent to 151% of the ADI (Figure 5.4.1.1-1); the ADI was exceeded in <strong>on</strong>ly <strong>on</strong>e diet(German child populati<strong>on</strong>).It is noted that the major c<strong>on</strong>tributor to the German child total exposure is due to <strong>residues</strong> of diazin<strong>on</strong>measured in apples and that the intake from apples al<strong>on</strong>e was more than 100% of the ADI (113% ).However, it is also noted that the German apple c<strong>on</strong>sumpti<strong>on</strong> data used for the l<strong>on</strong>g-term exposurecalculati<strong>on</strong> comprise processed and unprocessed apples. 80% of the <str<strong>on</strong>g>report</str<strong>on</strong>g>ed apple c<strong>on</strong>sumpti<strong>on</strong> refersto processed apple products, mainly apple juice (BfR, 2009). Processing studies dem<strong>on</strong>strated that theprocessing of apples to juice significantly reduces the diazin<strong>on</strong> <strong>residues</strong> (processing factors for rawand pasteurised apple juice: 0.02 and 0.01, respectively, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>, 2006). Thus, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> c<strong>on</strong>cludes that thel<strong>on</strong>g-term c<strong>on</strong>sumer exposure to diazin<strong>on</strong> <strong>residues</strong> is not likely to exceed the ADI. Thus, also fordiazin<strong>on</strong>, no l<strong>on</strong>g-term c<strong>on</strong>sumer risk is expected.The authorisati<strong>on</strong>s for plant protecti<strong>on</strong> products c<strong>on</strong>taining diazin<strong>on</strong> had to be withdrawn by 6December 2007 at <strong>Europe</strong>an level. Any period of grace granted by Member States had to expire <strong>on</strong> 6December <str<strong>on</strong>g>2008</str<strong>on</strong>g> at the latest. In December 2007 new, lower EC MRLs entered into force.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646149


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesIntake in % of ADI160.00150.00140.00130.00120.00110.00100.0090.0080.0070.0060.0050.0040.0030.0020.0010.000.00WheatRyeRiceOatsLeekPeas (without pods)Beans (without pods)SpinachLettuceHead cabbageCauliflowerCucumbersAubergines (egg plants)PeppersTomatoesCarrotsPotatoesBananasStrawberriesTable grapesPeachesPearsFigure 5.4.1.1-1 Estimated l<strong>on</strong>g-term exposure (TMDI) for diazin<strong>on</strong>, expressed in percent of thediazin<strong>on</strong> ADI.Due to the change in the authorisati<strong>on</strong> status of products c<strong>on</strong>taining diazin<strong>on</strong> in <strong>Europe</strong> (the use ofdiazin<strong>on</strong> was authorised until December 2007) it is assumed that crops treated legally in 2007 withdiazin<strong>on</strong>, were still <strong>on</strong> the EC market in <str<strong>on</strong>g>2008</str<strong>on</strong>g>. Out of the 1,423 apple samples taken in <str<strong>on</strong>g>2008</str<strong>on</strong>g> innati<strong>on</strong>al c<strong>on</strong>trol programmes, 18 samples c<strong>on</strong>tained quantifiable diazin<strong>on</strong> <strong>residues</strong> above the <str<strong>on</strong>g>report</str<strong>on</strong>g>inglevel. The MRL was exceeded in 13 samples; of these samples, six were of <strong>Europe</strong>an origin. It isexpected that the residue levels of diazin<strong>on</strong> will decrease in 2009 following the restricti<strong>on</strong>s regardingauthorisati<strong>on</strong>. Nevertheless, it is recommended that c<strong>on</strong>trol of diazin<strong>on</strong> <strong>residues</strong> in food commoditiesc<strong>on</strong>tinue.Member States are recommended to check for the possible misuses at nati<strong>on</strong>al level <strong>on</strong> domesticproducts and check if the LOQ MRLs for the imported products are exceeded.ApplesMandarinsOranges5.4.2. Pesticides for which the chr<strong>on</strong>ic risk assessment was not c<strong>on</strong>clusive5.4.2.1. Dimethoate/omethoateAlthough dimethoate and omethoate bel<strong>on</strong>g to the same chemical group, the toxicological propertiesdiffer significantly (dimethoate: 0.001 mg/kg body weight/day; omethoate: 0.0003 mg/kg body weight/day). For a more accurate risk assessment, the residue c<strong>on</strong>centrati<strong>on</strong>s for the two compounds should<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646150


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residuesbe <str<strong>on</strong>g>report</str<strong>on</strong>g>ed separately. In <str<strong>on</strong>g>2008</str<strong>on</strong>g>, the residue c<strong>on</strong>centrati<strong>on</strong>s were <strong>on</strong>ly <str<strong>on</strong>g>report</str<strong>on</strong>g>ed in accordance with theenforcement residue definiti<strong>on</strong> as the sum of the two compounds.On the basis of the data available, the assessment can <strong>on</strong>ly be c<strong>on</strong>sidered to be exploratory and notc<strong>on</strong>clusive.If all <strong>residues</strong> <str<strong>on</strong>g>report</str<strong>on</strong>g>ed are assumed to be dimethoate, 63% of the ADI set for dimethoate wasexhausted. This situati<strong>on</strong> does not represent a potential risk for the c<strong>on</strong>sumer. Alternatively, if allmeasured <strong>residues</strong> were attributed to the more toxic omethoate, the ADI would be exceeded by eightdiets, being the 210% of the omethoate ADI exceeded in the most critical diet; in this case, the mainfood c<strong>on</strong>tributor to the c<strong>on</strong>sumer exposure was apples (89% of the ADI). As this crop can bec<strong>on</strong>sumed unprocessed a refined calculati<strong>on</strong> of the l<strong>on</strong>g-term c<strong>on</strong>sumer exposure could not beperformed by applying a processing factor.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> reiterates the recommendati<strong>on</strong>s derived in paragraph 5.2.1.8 regarding the need to revise theresidue definiti<strong>on</strong> and the format for <str<strong>on</strong>g>report</str<strong>on</strong>g>ing residue results in the framework of the m<strong>on</strong>itoringexercise.5.4.3. Pesticides for which the chr<strong>on</strong>ic risk assessment could not be performed5.4.3.1. DichlorvosThe toxicological assessment of dichlorvos revealed data gaps in the dossier which did not allow forc<strong>on</strong>clusi<strong>on</strong> <strong>on</strong> toxicological reference values for dichlorvos (see secti<strong>on</strong> 7.2.3.1). Therefore, no l<strong>on</strong>gtermrisk assessment could be carried out.It should be noted that, in <strong>Europe</strong>, the authorisati<strong>on</strong> for the use of products c<strong>on</strong>taining dichlorvosshould have been withdrawn by December 2007; any period of grace granted by Member States had toexpire <strong>on</strong> December <str<strong>on</strong>g>2008</str<strong>on</strong>g> at the latest.From the <str<strong>on</strong>g>2008</str<strong>on</strong>g> data available it is noted that quantifiable <strong>residues</strong> have been measured in samples ofseveral food commodities; the majority of these food samples were produced in <strong>Europe</strong>. These resultsindicated that dichlorvos was still used in <strong>Europe</strong> in 2007 and/or <str<strong>on</strong>g>2008</str<strong>on</strong>g>. Based <strong>on</strong> the available data, anexposure of 0.76 µg/kg body weight was calculated for the most critical diet.Therefore, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> recommends making efforts to derive toxicological reference values for dichlorvos<strong>on</strong> the basis of the open scientific literature and the available, limited scientific dossier and studies toallow a c<strong>on</strong>clusi<strong>on</strong> <strong>on</strong> the potential c<strong>on</strong>sumer risks due to dichlorvos <strong>residues</strong> measured in foodsamples.5.4.3.2. TriazolesThe <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated m<strong>on</strong>itoring programme included seven <strong>pesticide</strong>s bel<strong>on</strong>ging to the chemicalclass of triazoles (i.e. flusilazole, hexac<strong>on</strong>azole, myclobutanil, penc<strong>on</strong>azole, tebuc<strong>on</strong>azole, andtriadimenol/triadimef<strong>on</strong>). The use of some of these substances is now no l<strong>on</strong>ger authorised in <strong>Europe</strong>,but the triazole <strong>pesticide</strong>s have been used extensively as a fungicide in many different crops in the pastsince the early 1980’s and many others, which are not included in the EU m<strong>on</strong>itoring programme, arecurrently in use.Based <strong>on</strong> the available informati<strong>on</strong> <strong>on</strong> the plant metabolism of these chemicals (e.g. in the dossierssubmitted for the peer-review of the substances under Directive 91/414/EEC) it is known that triazoles<strong>pesticide</strong>s may be metabolised to four main compounds: 1,2,4-triazole (free acid), triazole alanine(TA), triazole lactic acid and triazole acetic acid (TAA). The formati<strong>on</strong> of these triazole derivative<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646151


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residuesmetabolites (TDMs) is very dependent <strong>on</strong> the substance and <strong>on</strong> the crops treated. Nevertheless, thereare clear indicati<strong>on</strong>s that triazole derivative metabolites are present in plant storage organs (e.g. cerealand oilseed grains) and rotati<strong>on</strong>al crops. From the scientific studies it is also evident that thesemetabolites are not always rapidly degraded and therefore may accumulate in the soil. Triazolemetabolites are also present in animal commodities when livestock is fed with feeding stuff c<strong>on</strong>taining<strong>residues</strong> of triazole compounds. It is noted that, depending <strong>on</strong> the crop, the formati<strong>on</strong> of TDMs is notobserved in harvested crops (e.g. for myclobutanil in apples and grape 26 ) or TDMs account for up to90% of the total <strong>residues</strong>, while the parent compound is almost not present (e.g. penc<strong>on</strong>azole inapple 27 ). As an example, for myclobutanil, (included in the <str<strong>on</strong>g>2008</str<strong>on</strong>g> EU coordinated programme) theresidue level of metabolites TA and TAA account for 51% and 25% of the total <strong>residues</strong> in wheatgrains at harvest, while the residue of the parent compound amount to <strong>on</strong>ly 0.4% of the total <strong>residues</strong>;for penc<strong>on</strong>azole (also included in the EU coordinated programme), the residue level of metabolites TAand TLA account for 23% and 67% of the total <strong>residues</strong> in apple, while no residue of the parent isdetected in harvested apples. From the <str<strong>on</strong>g>2008</str<strong>on</strong>g> m<strong>on</strong>itoring data it is noted that no countries have detected<strong>residues</strong> of myclobutanil (parent compound) above the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing level in cereals in the 613 ricesamples analysed; in fruit and vegetables myclobutanil was analysed in more than 51,000 samples andquantified in about 1,200 samples (2.3% of positive detecti<strong>on</strong>s) 28 .In 2006, an <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> experts meeting c<strong>on</strong>sidered these three metabolites as toxicologically relevant.Toxicological reference values were proposed for 1,2,4-triazole and the TAA (ADI: 0.02 mg/kgbw/day, ARfD: 0.06 mg/kg bw) and for TA (ADI and ARfD: 0.1 mg/kg bw/(day)). Even though thesetoxicological reference values are not as low as for many other <strong>pesticide</strong>s the c<strong>on</strong>sumer may beexposed to a potential risk due to the presence of potentially significant residue levels in foodcommodities.Currently, no EC MRL has been established for the triazole metabolites. An <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> expert meetinghighlighted the difficulty that would be encountered for the setting of the MRLs for the TDMs,because all triazole <strong>pesticide</strong>s need to be c<strong>on</strong>sidered and assessed together. Moreover, residue trialswill most likely not be available for all triazole compounds. However, for the purpose of the actualassessment of the c<strong>on</strong>sumer’s exposure to TDMs in food useful, background informati<strong>on</strong> <strong>on</strong> the actualresidue levels of triazole metabolites from current and past uses can be derived from m<strong>on</strong>itoringprogrammes. For the future actual cumulative exposure assessment these m<strong>on</strong>itoring data will beneeded, as indicated in the draft <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> scientific opini<strong>on</strong> (Guidance <strong>on</strong> the Use of the ProbabilisticMethodology for Modelling Dietary Exposure to Pesticide Residues – Part <strong>on</strong>e: single activesubstances exposure assessment 29 ). Currently, no TDMs are included in the EU coordinatedprogramme, nor Member States analyse for these compounds in the framework of nati<strong>on</strong>al c<strong>on</strong>trolprogrammes. As a result, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> recommends the inclusi<strong>on</strong> in the future EU coordinated m<strong>on</strong>itoringprogrammes the analysis of the triazole metabolites.26 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> C<strong>on</strong>clusi<strong>on</strong> <strong>on</strong> <strong>pesticide</strong> peer-review – peer review of the <strong>pesticide</strong> risk assessment of the active substancemyclobutanil; document available at http://www.efsa.europa.eu/en/scdocs/doc/298r.pdf27 <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> C<strong>on</strong>clusi<strong>on</strong> <strong>on</strong> <strong>pesticide</strong> peer-review – peer review of the <strong>pesticide</strong> risk assessment of the active substancepenc<strong>on</strong>azole; document available athttp://www.efsa.europa.eu/en/scdocs/doc/175r.pdf28 The authorisati<strong>on</strong>s for plant protecti<strong>on</strong> products c<strong>on</strong>taining myclobutanil will have to be withdrawn by 31 December 2010at EU level. Any period of grace granted by Member States will have to expire <strong>on</strong> 31 December 2011 at latest.29 Part two of the <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> scientific opini<strong>on</strong> will cover the multiple active substances exposure assessment, building up <strong>on</strong> themethodology presented in the first part of the <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> opini<strong>on</strong>.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646152


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesRECOMMENDATIONSIn additi<strong>on</strong> to the specific recommendati<strong>on</strong>s listed in Tables 5.2.1-2 and 5.2.2-2, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> derivedrecommendati<strong>on</strong>s to the Commissi<strong>on</strong>, the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries, the EURLs and <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>.On the basis of the analysis and evaluati<strong>on</strong>s of the <str<strong>on</strong>g>2008</str<strong>on</strong>g> m<strong>on</strong>itoring data <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> recommends to the<strong>Europe</strong>an Commissi<strong>on</strong> the following:• To keep included also in the future EU coordinated m<strong>on</strong>itoring programmes the <strong>pesticide</strong>s forwhich a theoretical c<strong>on</strong>sumer risk could not be excluded, could not be performed, or was notc<strong>on</strong>clusive: azinphos-methyl, carbaryl, carbendazim/benomyl, chlormequat, chlorpropham,chlorpyriphos, cypermethrin, diazin<strong>on</strong>, dichlorvos, dimethoate/omethaote, dithiocarbamates,endosulfan, folpet/captan, imazalil, lambda-cyhalothrin, metamidophos, methidathi<strong>on</strong>,methiocarb, methomyl/thiodicarb, oxamyl, parathi<strong>on</strong>, procymid<strong>on</strong>e and tebuc<strong>on</strong>azole;• To include in the future EU coordinated m<strong>on</strong>itoring programmes the analysis of the triazolederivate metabolites: 1,2,4-triazole (free acid), triazole alanine, triazole lactic acid and triazoleacetic acid;• To <str<strong>on</strong>g>report</str<strong>on</strong>g> separately the individual compounds measured in the samples or to change theenforcement residue definiti<strong>on</strong> and establish separate MRLs for the <strong>pesticide</strong>s and metaboliteswhich are included in the same residue definiti<strong>on</strong> and which have different toxicologicalpotencies (e.g. dimethoate/omethoate, folpet/captan and methomyl/thiodicarb);• To amend the current enforcement residue definiti<strong>on</strong>s set for folpet/captan - “Sum of folpetand captan” - in the following crops into the definiti<strong>on</strong> used for the remaining crops (“folpet”and “captan”): pome fruits, strawberries, blackberries, raspberries, currants, gooseberries,tomatoes, beans (with pods), fresh beans (without pods).• To revise the enforcement residue definiti<strong>on</strong>s set for <strong>pesticide</strong> <strong>residues</strong> in baby and infantfood, so that they are in line with the residue definiti<strong>on</strong>s set for the raw commodities as inRegulati<strong>on</strong> (EC) No 396/2005;• To specify in future EU coordinated m<strong>on</strong>itoring regulati<strong>on</strong>s that the analysis of baby-foodsamples shall be performed for all the <strong>pesticide</strong>s listed in the baby-food legislati<strong>on</strong> withspecific MRLs and for all the <strong>pesticide</strong>s listed in Annex I of the m<strong>on</strong>itoring Regulati<strong>on</strong>s;• To replace the sampling of the commodity beans without pods with beans with pods (i.e.green beans/French beans) in the EU coordinated m<strong>on</strong>itoring programmes;• To rec<strong>on</strong>sider the minimum number of samples to be taken under the EU coordinatedprogramme taking into account that the purpose of the EU coordinated programme is not <strong>on</strong>lyto identify the samples above the limit of quantificati<strong>on</strong> 30 but also to assess the c<strong>on</strong>sumerexposure;• To establish a database <strong>on</strong> the authorised GAPs and <strong>pesticide</strong> uses at nati<strong>on</strong>al level.In additi<strong>on</strong>, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> recommends the following to the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries:• To implement the new format developed by <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> for <str<strong>on</strong>g>report</str<strong>on</strong>g>ing the <strong>pesticide</strong> m<strong>on</strong>itoringresults;• To put effort in recording and <str<strong>on</strong>g>report</str<strong>on</strong>g>ing the producti<strong>on</strong> method (e.g. c<strong>on</strong>venti<strong>on</strong>al and organic)of the analysed samples;• To implement more sensitive analytical methods that would allow enforcement of EC MRLsset at specified LOQ; this would also allow the performance of more accurate l<strong>on</strong>g-term30 See recital (3) of Commissi<strong>on</strong> Recommendati<strong>on</strong> <str<strong>on</strong>g>2008</str<strong>on</strong>g>/103/EC (EC <str<strong>on</strong>g>2008</str<strong>on</strong>g>a).<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646153


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residuesc<strong>on</strong>sumer exposure assessment. If MRL LOQs cannot be achieved analytically, this should benotified;• To ensure <strong>pesticide</strong> <strong>residues</strong> are analysed according to the residue definiti<strong>on</strong>s set in the<strong>Europe</strong>an legislati<strong>on</strong>;• To <str<strong>on</strong>g>report</str<strong>on</strong>g> if difficulties are encountered in analysing the sample for the full enforcementresidue definiti<strong>on</strong>. <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>, the Commissi<strong>on</strong>, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> and the EURLs should follow-up <strong>on</strong> suchproblems identified and rec<strong>on</strong>sider the residue definiti<strong>on</strong>s;• To encourage the further investigati<strong>on</strong> and the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing of the possible reas<strong>on</strong>s for the highnumber of multiple residue findings in single samples. In particular, to further investigate ifthe sample characteristics such as origin, producer and varieties are in line with Communitymethods of sampling for the official c<strong>on</strong>trol;• To <str<strong>on</strong>g>report</str<strong>on</strong>g> the possible reas<strong>on</strong>s for the observed EC MRL exceedances; in particular fordithiocarbamate <strong>residues</strong> <strong>on</strong> spinach a high number of MRL exceeding samples was identified.The reas<strong>on</strong> for this problem should be further investigated;• To clearly indicate if, as a c<strong>on</strong>sequence of a sample exceeding the MRLs, the lot was not put<strong>on</strong> the market and therefore was not available for c<strong>on</strong>sumpti<strong>on</strong>;• To ensure that the scope of the analytical methods used is compatible and includes as far aspossible all <strong>residues</strong> included in the EU coordinated programme.Furthermore, the <strong>Europe</strong>an Reference Laboratories (EURLs) are recommended:• To provide the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries with more guidance in implementing analytical methodssufficiently sensitive for checking sample residue levels against the MRLs, in particular LOQMRLs;• To provide the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries with more guidance <strong>on</strong> <str<strong>on</strong>g>report</str<strong>on</strong>g>ing the results of the baby andinfant-food analysis and in the enforcement of the relevant residue definiti<strong>on</strong>s;• To develop and support the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries in implementing an analytical method for theanalysis of the triazole derivate metabolites;• To investigate possible soluti<strong>on</strong>s to identify the isomers of cypermethrin c<strong>on</strong>tributing to thetotal cypermethrin measured in food samples, as requested by the current legal enforcementresidue definiti<strong>on</strong>.Finally, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> is recommended:• To derive tentative toxicological reference values for dichlorvos <strong>on</strong> the basis of open scientificliterature and the available, limited scientific dossier and studies;• To adapt the <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> data model for the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing of the results of the <strong>pesticide</strong> m<strong>on</strong>itoring data.In particular, <str<strong>on</strong>g>report</str<strong>on</strong>g>ing countries should have the possibility to <str<strong>on</strong>g>report</str<strong>on</strong>g> if a lot which was foundto exceed the MRL has been removed from the market before being c<strong>on</strong>sumed (e.g. lotsrejected at the border before import to the EU, lots destroyed);• To develop a methodology for the l<strong>on</strong>g-term risk assessment which will make use of thedetailed results <str<strong>on</strong>g>report</str<strong>on</strong>g>ed by the Member States according to the new <str<strong>on</strong>g>report</str<strong>on</strong>g>ing formatdeveloped by <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>;• To develop a methodology for assessing cumulative exposure;• To investigate possible improvements for the <str<strong>on</strong>g>report</str<strong>on</strong>g>ing of the results of the m<strong>on</strong>itoring of theveterinary medical product <strong>residues</strong> to allow the c<strong>on</strong>siderati<strong>on</strong> of additi<strong>on</strong>al exposure sources;• To establish a database of the c<strong>on</strong>versi<strong>on</strong> factors for the enforcement residue definiti<strong>on</strong>s to therisk assessment residue definiti<strong>on</strong>s.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646154


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesACKNOWLEDGMENTS<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> wishes to thank colleagues and c<strong>on</strong>tact points in the EU Member States and EEA countries forproviding informati<strong>on</strong>, data, comments and clarificati<strong>on</strong>s <strong>on</strong> the <strong>pesticide</strong> m<strong>on</strong>itoring programmes andresults. <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> also wishes to thank colleagues in the <strong>Europe</strong>an Commissi<strong>on</strong> and the <strong>Europe</strong>anReference Laboratories for their collaborati<strong>on</strong>. Finally, <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> acknowledges the technical andscientific support provided by colleagues in the Food Institute of the Technical University of Denmarkwhich assisted <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> in the preparati<strong>on</strong> of this <str<strong>on</strong>g>report</str<strong>on</strong>g>.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646155


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesREFERENCESBfR (Bundesinstitut für Risikobewertung), 2009. BfR-Modell zur Berechnung der Aufnahme v<strong>on</strong>Pflanzenschutzmittel-Rückständen. Informati<strong>on</strong> Nr. 026/2009 des BfR vom 1. Juli 2009.http://www.bfr.bund.de/cd/10196.Codex 1994. Codex Alimentarius, Pesticide Residues in Foodstuffs, Rome 1994, ISBN 92-5-20372271-1; Vol. 2, p. 72.EC 1991a. Council Directive 91/414/EEC of 15 July 1991 c<strong>on</strong>cerning the placing of plant protecti<strong>on</strong>products <strong>on</strong> the market. Official Journal L 230, 19.08.1991, p. 1.EC 1991b. Council Regulati<strong>on</strong> (EEC) N° 2092/91 of 24 June 1991 <strong>on</strong> organic producti<strong>on</strong> ofagricultural products and indicati<strong>on</strong>s referring thereto <strong>on</strong> agricultural products and foodstuffs. OJ L198, 22.07.1991, p. 1.EC 1996a. Commissi<strong>on</strong> Directive 96/5/EC, of 16 February 1996 <strong>on</strong> processed cereal-based foods andbaby foods for infants and young children. OJ L 049 , 28.02.1996, p. 17.EC 1996b. Council Directive 96/23/EC of 29 April 1996 <strong>on</strong> measure to m<strong>on</strong>itor certain substances and<strong>residues</strong> thereof in live animals and animal products and repealing Directives 85/358/EEC and86/469/EEC and Decisi<strong>on</strong>s 89/187/EEC and 91/664/EEC. OJ L 125, 23.5.1996, p. 10.EC 2000. Commissi<strong>on</strong> Regulati<strong>on</strong> (EC) No 645/2000 of 28 March 2000 setting out detailedimplementing rules necessary for the proper functi<strong>on</strong>ing of certain provisi<strong>on</strong>s of Article 7 of CouncilDirective 86/362 and of Article 4 of Council Directive 90/642/EEC c<strong>on</strong>cerning the arrangements form<strong>on</strong>itoring the maximum levels of <strong>pesticide</strong> <strong>residues</strong> in and <strong>on</strong> cereals and products of plant origin,including fruit and vegetables, respectively. OJ L 78, 29.3.2000, p. 7.EC 2002. Commissi<strong>on</strong> Directive 2002/63/EC of 11 July 2002 establishing Community methods ofsampling for the official c<strong>on</strong>trol of <strong>pesticide</strong> <strong>residues</strong> in and <strong>on</strong> products of plant and animal origin andrepealing Directive 79/7000/EEC. OJ L 187, 16.7.2002, p. 30.EC 2003, Commissi<strong>on</strong> Directive 2003/13/EC of 10 February 2003 amending Directive 96/5/EC <strong>on</strong>processed cereal-based foods and baby foods for infants and young children. OJ L 41, 14.2.2003 , p.33.EC 2004. Regulati<strong>on</strong> (EC) No 882/2004 of the <strong>Europe</strong>an Parliament and of the Council of 29 April2004 <strong>on</strong> the official c<strong>on</strong>trols performed to ensure the verificati<strong>on</strong> of compliance with feed and foodlaw, animal health and animal welfare rules. OJ L 191, 28.5.2004, p. 1.EC 2005a. Regulati<strong>on</strong> (EC) No 396/2005 of the <strong>Europe</strong>an Parliament and of the Council of23 February 2005 <strong>on</strong> maximum residue levels of <strong>pesticide</strong>s in or <strong>on</strong> food and feed of plant and animalorigin and amending Council Directive 91/414/EECText with EEA relevance. Official Journal L 70,16.3.2005, p 1-16EC 2005b. Commissi<strong>on</strong> Regulati<strong>on</strong> (EC) No 2076/2005 of 5 December 2005 laying down transiti<strong>on</strong>alarrangements for the implementati<strong>on</strong> of Regulati<strong>on</strong>s (EC) No 853/2004, (EC) No 854/2004 and (EC)No 882/2004 of the <strong>Europe</strong>an Parliament and of the Council and amending Regulati<strong>on</strong>s (EC) No853/2004 and (EC) No 854/2004 (Text with EEA relevance). OJ L 338, 22.12.2005, p. 83.EC 2006a, Commissi<strong>on</strong> Directive 2006/125/EC of 5 December 2006 <strong>on</strong> processed cereal-based foodsand baby foods for infants and young children. OJ L 339, 6.12.2006, p. 16.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646156


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesEC 2006b, Commissi<strong>on</strong> Directive 2006/141/EC of 22 December 2006 <strong>on</strong> infant formulae and follow<strong>on</strong>formulae and amending Directive 1999/21/EC. OJ L401, 30.12.2006, p. 1.EC 2007a. Commissi<strong>on</strong> Recommendati<strong>on</strong> No 2007/225/EC of 3 April 2007 c<strong>on</strong>cerning a coordinatedCommunity m<strong>on</strong>itoring programme for 2007 to ensure compliance with maximum residue levels of<strong>pesticide</strong> <strong>residues</strong> in and or cereals and certain other products of plant origin and nati<strong>on</strong>al m<strong>on</strong>itoringprogrammes for <str<strong>on</strong>g>2008</str<strong>on</strong>g>. OJ L 96, 11.4.2007, p. 21.EC 2007b. Method validati<strong>on</strong> and quality c<strong>on</strong>trol procedures for <strong>pesticide</strong> <strong>residues</strong> analysis in foodand feed. Document No. SANCO/3131/2007.EC <str<strong>on</strong>g>2008</str<strong>on</strong>g>a. Commissi<strong>on</strong> recommendati<strong>on</strong> of 4 February <str<strong>on</strong>g>2008</str<strong>on</strong>g> c<strong>on</strong>cerning a coordinated Communitym<strong>on</strong>itoring programme for <str<strong>on</strong>g>2008</str<strong>on</strong>g> to ensure compliance with maximum levels of <strong>pesticide</strong> <strong>residues</strong> inand <strong>on</strong> cereals and certain other products of plant origin and nati<strong>on</strong>al m<strong>on</strong>itoring programmes for 2009(<str<strong>on</strong>g>2008</str<strong>on</strong>g>/103/EC). OJ L 36, 9.2.<str<strong>on</strong>g>2008</str<strong>on</strong>g>, p. 7.EC <str<strong>on</strong>g>2008</str<strong>on</strong>g>b. Commissi<strong>on</strong> Regulati<strong>on</strong> (EC) No 1213/<str<strong>on</strong>g>2008</str<strong>on</strong>g> of 5 December <str<strong>on</strong>g>2008</str<strong>on</strong>g> c<strong>on</strong>cerning acoordinated multiannual Community c<strong>on</strong>trol programme for 2009, 2010 and 2011 to ensurecompliance with maximum levels of and to assess the c<strong>on</strong>sumer exposure to <strong>pesticide</strong> <strong>residues</strong> in and<strong>on</strong> food of plant and animal origin. OJ L 328, 6.12.<str<strong>on</strong>g>2008</str<strong>on</strong>g>, p. 9.EC <str<strong>on</strong>g>2008</str<strong>on</strong>g>c. Commissi<strong>on</strong> Regulati<strong>on</strong> (EC) No 149/<str<strong>on</strong>g>2008</str<strong>on</strong>g> of 29 January <str<strong>on</strong>g>2008</str<strong>on</strong>g> amending Regulati<strong>on</strong> (EC)No 396/2005 of the <strong>Europe</strong>an Parliament and of the Council by establishing Annexes II, III and IVsetting maximum residue levels for products covered by Annex I thereto. OJ L 58, 1.3.<str<strong>on</strong>g>2008</str<strong>on</strong>g>, p.1.EC 2009. Commissi<strong>on</strong> Regulati<strong>on</strong> (EC) No 1097/2009 of 16 November 2009 amending Annex II toRegulati<strong>on</strong> (EC) No 396/2005 of the <strong>Europe</strong>an Parliament and of the Council as regards maximumresidue levels for dimethoate, etheph<strong>on</strong>, fenamiphos, fenarimol, methamidophos, methomyl,omethoate, oxydemet<strong>on</strong>-methyl, procymid<strong>on</strong>e, thiodicarb and vinclozolin in or <strong>on</strong> certain products. OJL 301 of 17.11.2009, p.6EEC 1976. Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximumlevels for <strong>pesticide</strong> <strong>residues</strong> in and <strong>on</strong> fruit and vegetables. OJ L 340 of 09.12.1976, p.26.EEC 1986a. Council Directive 86/362/EEC of 24 July 1986 <strong>on</strong> the fixing of maximum levels for<strong>pesticide</strong>s <strong>residues</strong> in and <strong>on</strong> cereals. OJ L 221, 7.8.1986, p 37.EEC 1986b. Council Directive 86/363/EEC of 24 July 1986 <strong>on</strong> the fixing of maximum levels for<strong>pesticide</strong>s <strong>residues</strong> in and <strong>on</strong> foodstuffs of animal origin. OJ L 221, 7.8.1986, p 43.EEC 1990. Council Directive 90/642/EEC of 27 November 1990 <strong>on</strong> the fixing of maximum levels for<strong>pesticide</strong>s <strong>residues</strong> in and <strong>on</strong> certain products of plant origin, including fruit and vegetables. OJ L 350,14.12.1990, p 71.EEC 1991. Commissi<strong>on</strong> Directive 91/321/EEC of 14 May 1991 <strong>on</strong> infant formulae and follow-<strong>on</strong>formulae. OJ L 175, 04.07.1991, p. 35.<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> 2006. <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> C<strong>on</strong>clusi<strong>on</strong> regarding the peer review of the <strong>pesticide</strong> risk assessment of the activesubstance diazin<strong>on</strong>; http://www.efsa.europa.eu/en/scdocs/doc/85r.pdf<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> 2007. Reas<strong>on</strong>ed opini<strong>on</strong> <strong>on</strong> the potential chr<strong>on</strong>ic and acute risk to c<strong>on</strong>sumers’ health arisingfrom proposed temporary EU MRLs, 15 March 2007.http://www.efsa.europa.eu/en/scdocs/scdoc/32r.htm (accessed 11. Feb. 2009)<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646157


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> 2009. Reas<strong>on</strong>ed opini<strong>on</strong> of <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> prepared by the Pesticides Unit (PRAPeR) <strong>on</strong> the 2007<str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide Residues. <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Scientific Report (2009) 305, 1-106.http://www.efsa.europa.eu/<str<strong>on</strong>g>EFSA</str<strong>on</strong>g>/efsa_locale-1178620753812_1211902667778.htm (accessed 11.Feb. 2009)<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> 2010. Technical Report of <str<strong>on</strong>g>EFSA</str<strong>on</strong>g>: Report for <str<strong>on</strong>g>2008</str<strong>on</strong>g> <strong>on</strong> the results from the m<strong>on</strong>itoring ofveterinary medical product <strong>residues</strong> and other substances in food of animal origin in the MemberStates. <str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal (2010); 8(4): 1559. http://www.efsa.europa.eu/en/scdocs/scdoc/1559.htmFAO 2006. Pesticide <strong>residues</strong> in food - 2006. Report of the Joint Meeting of the FAO Panel of Experts<strong>on</strong> Pesticide Residues in Food and the Envir<strong>on</strong>ment and WHO the Core Assessment Group. FAOPlant Producti<strong>on</strong> and Protecti<strong>on</strong> Paper, 187, 2006FAO 2009. Pesticide <strong>residues</strong> in food - 2009. Report of the Joint Meeting of the FAO Panel of Experts<strong>on</strong> Pesticide Residues in Food and the Envir<strong>on</strong>ment and WHO the Core Assessment Group. FAOPlant Producti<strong>on</strong> and Protecti<strong>on</strong> Paper, 196, 2009.ISO 2005. General requirements for the competence of testing and calibrati<strong>on</strong> laboratories, ISO/IEC17025:2005.Maas 2006. Maas, F.. Carry-over effects of CCC-applicati<strong>on</strong>s in pear orchards. Acta Hort. (ISHS)727:125-132, 2006.OECD 2009. OECD Envir<strong>on</strong>ment, Health and Safety Publicati<strong>on</strong>s. Series <strong>on</strong> Testing and AssessmentNo. 63. Guidance document <strong>on</strong> the definiti<strong>on</strong> of residue (as revised in 2009).ENV/JM/MONO(2009)30<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646158


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesABBREVIATIONS AND SPECIAL TERMS USED IN THE REPORTATADIARfDBEBGCOMCYCZEURLDARDEEEEEAEECEC<str<strong>on</strong>g>EFSA</str<strong>on</strong>g>EFTAESEUFAOFIFRGAPGPGRHUHRAustriaAcceptable Daily IntakeAcute Reference DoseBelgiumBulgaria<strong>Europe</strong>an Commissi<strong>on</strong>CyprusCzech Republic<strong>Europe</strong>an Reference LaboratoryDraft Assessment ReportGermanyEst<strong>on</strong>ia<strong>Europe</strong>an Ec<strong>on</strong>omic Area<strong>Europe</strong>an Ec<strong>on</strong>omic Community<strong>Europe</strong>an Commissi<strong>on</strong><strong>Europe</strong>an Food Safety Authority<strong>Europe</strong>an Free Trade Associati<strong>on</strong>Spain<strong>Europe</strong>an Uni<strong>on</strong>Food and Agricultural Organizati<strong>on</strong>FinlandFranceGood Agricultural PracticeGeneral Populati<strong>on</strong>GreeceHungaryHighest Residue measured in supervised filed trials<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646159


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesHRMIEIESTIISISO/IECITJMPRLCILOQLTLULVMRLMTNLNOPLPTROSESISKUKPRIMoRASFFTDMThird countriesTMDIHighest Residue Measured in m<strong>on</strong>itoring samplesIrelandInternati<strong>on</strong>al Estimated Short Term IntakeIslandThe Internati<strong>on</strong>al Organizati<strong>on</strong> for Standardizati<strong>on</strong>/ Internati<strong>on</strong>al ElectrotechnicalCommissi<strong>on</strong>ItalyJoint FAO/WHO Meeting <strong>on</strong> Pesticide ResiduesLower C<strong>on</strong>fidence IntervalAnalytical Limit Of Quantificati<strong>on</strong>LithuaniaLuxembourgLatviaMaximum Residue LevelMaltathe NetherlandsNorwayPolandPortugalRomaniaSwedenSloveniaSlovakiathe United KingdomPesticide Residue Intake ModelRapid Alert System for Food and FeedTriazole derivate MetabolitesAny country that is neither a Member State nor a country from the EEATheoretical Maximum Daily Intake<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646160


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesUCIWHOUpper C<strong>on</strong>fidence IntervalWorld Health Organizati<strong>on</strong><str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646161


<str<strong>on</strong>g>2008</str<strong>on</strong>g> <str<strong>on</strong>g>Annual</str<strong>on</strong>g> Report <strong>on</strong> Pesticide ResiduesAPPENDICES<str<strong>on</strong>g>EFSA</str<strong>on</strong>g> Journal 2010; 8(6):1646162

Hooray! Your file is uploaded and ready to be published.

Saved successfully!

Ooh no, something went wrong!