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Content of the presentation1. Control/monitoring activities in Europe: legal framework2. EFSA Annual Report on Pesticide Residues: main findings3. New EU data collection system
Monitoring of pesticide residuesin food in the EUEU legislation(*) requests EU Member States:• To carry out regular official controls on pesticide residues in food commodities to check compliance with Maximum Residue Levels (MRLs - legal limits)• To establish national monitoring programmes• To participate in a specific EU coordinated monitoring programme (voluntarily until 2008, mandatory from 2009)(*) Regulation (EC) No 396/2005 available at:http://eur-lex.europa.eu/Result.do?T1=V2&T2=2005&T3=396&RechType=RECH_naturel&Submit=Search
Monitoring of pesticides residuein food in the EUEU legislation requests EFSA:• To compile and collate data and all the information provided on the results of the analysis of the samples taken during the previous year (both national and EU monitoring programmes)• To prepare an EU Annual Report(*)(*) The Annual Reports 1996-2006 are available at:http://ec.europa.eu/food/fvo/specialreports/pesticides_index_en.htmThe Annual reports 2007-2009 are published at:http://www.efsa.europa.eu/en/topics/topic/pesticides.htmfood in the EU
The EU Annual ReportThe EU Annual Report provides:• An overview of the results of the controls/monitoring and analysis of findings (e.g. number of pesticide sought and found and MRL exceedances)• Possible reasons for MRL exceedences• Recommendations on pesticides to be covered in future monitoring programmes, on risk management actions• An assessment of the consumer exposure to actual pesticide residues in food
2009 Annual Report on Pesticide Residues(*) No of commodities/ 834 distinct pesticides sought: samples analysed: >300 food items 338 found in vegetables >68.000 samples analyzed 319 found in fruit and nuts >14.000.000 single analytical 93 found in cereals determinations(*) Report available at: http://www.efsa.europa.eu/en/efsajournal/pub/2430.htm
Number of samples analyzed(*) Spain; 1568 Austria; 2071 Poland; 1816 Norway; 1499 Belgium; 2112 Sweden; 1784 Slovenia; 1391 Greece; 2278 Ireland; 1329 Finland; 2286 Czech Republic; 1106 Denmark; 2294 Portugal; 969 Bulgaria; 951 Hungary; 2406 Slovakia; 726 Romania; 3718 Cyprus; 642 Estonia; 397 United Kingdom; Lithuania; 310 3835 Iceland; 300 M alta; 170 Luxembourg; 161 Netherlands; 3891 Latvia; 127 France; 4043 Germany; 16866 Italy; 6932(*) Total number of samples taken in 2009 by each reporting country (surveillance and enforcement samples of fruit,vegetables, cereals, processed commodities and baby food). Total 67,978 samples
Origin of samples analyzed(*) Third Country; 14,937; 22% Unknown; 3,012; 4% EEA; 50,029; 74%(*) Origin of samples (EU: EU27, Iceland and Norway; Imported: countries extra-EU); surveillance and enforcementsamples of fruit, vegetables, cereals, processed commodities and baby food.
Number of food commodities analysed(*)(*) The number of different raw commodities sampled in the 2009 national and EU programmes by each country (excluding processed and babyfood). EU legislation sets MRLs for ca. 400 agricultural commodities. Approrx 200 different raw commodities analysed in 2009.
Number of pesticides sought(*)(*) The number of pesticides analysed in 2009 by each reporting country Total number pesticides sought: 834 Number of authorised pesticides: ca. 500
Samples exceeding the MRLs:trend over the time(*) 2009 97,4% 2,6% 2008 96,5% 3,5% 2007 96,0% 4,0% 2006 95,0% 5,0% 2005 95,0% 5,0% 2004 95,0% 5,0% 2003 94,5% 5,5% 2002 94,5% 5,5% 2001 96,1% 3,9% 2000 95,5% 4,5% 1999 95,7% 4,3% 1998 96,7% 3,3% 1997 96,6% 3,4% 1996 97,0% 3,0% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% No measurable residues detected above MRL Residues detected above MRL(*) MRL compliance rate for samples from the national and EU coordinated pesticide residue programmes 1996-2009. Note that for2008/2009 only surveillance samples are included, while for 1996-2007, enforcement samples are included as well.
Samples exceeding the MRLs by food group(*) Fruit and nuts; Processed 99.0% 1.0% Fruit and nuts; Unprocessed 97.2% 2.8% Vegetables; Processed 95.2% 4.8% Vegetables; Unprocessed 96.8% 3.2% Cereals; Processed 99.2% 0.8% Cereals; Unprocessed 99.0% 1.0% Other plant products; Processed 97.9% 2.1% Other plant products; Unprocessed 95.6% 4.4% Animal products; Processed 99.7% 0.3% Animal products; Unprocessed 99.7% 0.3% Babyfood/Infant formulae; Processed 99.2% 0.8% 80% 100% Below MRL Above MRL(*) MRL compliance rate for surveillance samples in the national programme and the EU coordinated pesticide monitoring programme 2009.
No of samples analysed vs No pesticide sought and found
MRL exceedances: origin of samples(*) Unknown; EU origin; 1,30% 1,50% Imported food; 6,90% (*) Exceedances of EU MRLs according to origin of sample (2009 surveillance samples)
MRL exceedances: origin of samples extra-EU
Risk assessment EU coordinated monitoring programme (in 2009, 138 pesticides analysed in 10 food commodities)Analysis of randomly selected samples in order to collect dataon occurrence of pesticide in fruit, vegetables and cerealsrepresentative for the European market which are appropriateto assess the actual dietary exposure of the Europeanpopulation Acute (short-term) risk assessment Chronic(long-term) risk assessment
Number of pesticides included in the EUmonitoring programme 1996-2009 140 130 120 120 110 Number of pesticides 100 90 78 80 71 70 55 55 60 47 50 41 42 36 40 32 30 20 20 20 13 20 9 10 0 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 Sampling year Food of plant origin Food of animal origin
Food commodities included in the EUmonitoring programme 2009 2010 2011 Aubergines Apples Beans with pods (a) Bananas Head cabbage Carrots Butter Leek Cucumbers Cauliflower Lettuce Poultry meat Egg Milk Liver (d) Orange juice (b) Peaches (c) Oranges or mandarins Peas without pods (a) Rye or oats Pears Peppers (sweet) Strawberries Rice Table grapes Swine meat Potatoes Wheat Tomatoes Spinach (a) (a): Fresh or frozen (b): For orange juice, reporting countries shall specify the source (concentrate or fresh fruits) (c): Peaches including nectarines and similar hybrids (d): bovine and other ruminants, swine and poultry ⇒ Total number of pesticide/crop combinations for which the acute RA is potentially needed:1242.
Results acute RA Total Number of pesticide/crop combinations: 1242 (2009)Out of 256 pesticide/crop combinations for which the acute RA wasperformed, for 32 combinations theoretical exposure exceeded 100% ofthe ARfD: for those the short-term risk could not be excluded
Presentation of the acute RA results(*)(*) Summary of the 2009 results of the short-term consumer risk assessment for the 256 pesticide/crop combinations forwhich the acute RA was performed.
Results acute RABased on the frequency of samples exceeding thethreshold residue level (residue leading to 100% ofARfD) the critical events were classified as:– Exceptional event (<0.1%): 10 out of the 32 combinations– Seldom events (<1%): 22 out of the 32 combinations– Non-seldom event (>1%): none
Presentation of the acute RA resultsSummary of the 2009 results of the short-term consumer risk assessment for the pesticide/crop combinations forwhich a potential consumer risk could not be excluded
Results chronic RAFor 135 pesticides/group of pesticides the calculated TMDI basedon the 27 diets included in the PRiMo model(*) was below the ADI.The estimated chronic exposure did not raise consumer healthconcerns. Total Number of pesticide/group of pesticides: 138 (2009)(*)EFSA Data Model description available at: http://www.efsa.europa.eu/en/supporting/pub/1457.htm
Results chronic RA• For 3 pesticides (carbofuran, diazinon and the dithiocarbamates) a potential chronic risk could not be excluded. However, it is noted that the estimated exposure was affected by uncertainties which are mainly related to the conservative data model assumptions.• Taking into account that pesticide residues are lower in food commodities that are consumed after processing (e.g. in apple juice), EFSA concluded that the long-term consumer exposure to carbofuran, diazinon and dithiocarbamates residues is not likely to exceed the ADI. Thus, also for these three pesticides no long-term consumer risk is expected.
Data collection: new EFSA system (2010)Principles the of EFSA Standard Data Model for data reporting (SSD)(*):• Uses a Generic Structure• Designed for Sample/Determination Level data• Uses a Standard Transmission format• Uses Standard Terminology(*) EFSA Data Model description available at: http://www.efsa.europa.eu/en/supporting/pub/1457.htm
Data collection: EFSA new systemAdditives Contaminants Field 1 Field 2 Field 3 Field 4 Field 5 Field 6 Pesticides
Data collection: new systemThe new data collection system foresees:• Replacement mail sending/receiving system (web interface)• Storing data in a centralised EFSA location (data warehouse)• Development of a database application (to query/import/export data, to avoid typing errors)• Development of a data model (information reported at sample level)• Defined data model elements• Use of standardised terminology for e.g. pesticides and food names• Implementation XML schema for data exchange/transmission
Data collection: new system• EFSA promoted the change of the reporting system in order to make best use of the data generated at country level – Improve comparability of MS results – Facilitate data validation, cleaning and analysis – Improvements in risk assessment – Enable cumulative risk assessment• With the full implementation and national data reporting according to the SSD EFSA has built the largest pesticide residue database with control/monitoring results in Europe.• The data base is fed on yearly basis with information concerning approx. 20 million records.
Monitoring data workflow
Conclusions• A well-established monitoring programme of pesticide residues in food is in place in Europe• Considerable efforts have been made by Member States regarding increasing the scope of analytical methods and increase of samples analysed• In the past, aggregate data were reported by Member States; this, impeded detailed analysis of data and made risk assessment inaccurate.• A new data collection system has been developed/implemented in the EU in 2010.• Pesticide monitoring data collected in EFSA are used to prepare the EFSA Annual Report on pesticide Residues, but also for other purposes and by other services of the Community.
Cumulative Risk Assessment (CRA)• Regulation (EC) 396/2005 on pesticide MRLs emphasizes the importance “to carry out further work to develop a methodology to take into account cumulative and synergistic effects of pesticides”• Consumer exposure to residues of pesticides toxicologically acting with the same mode of action
Cumulative Risk Assessment 2 residues: 10.9% 3 residues: 6.5% 4 residues: 1 residue: 4.1% 20.0% 5 residues: 2.4% 6 residues: No 1.3% measurable 7 residues: residues: 0.6% 53.3% ≥8 residues; 0.9%Number of residues found in individual surveillance samples from the national and EU coordinated pesticide monitoringprogrammes 2008
Cumulative Risk Assessment• In the context of the EU Annual Report, CRA of pesticide residues is not yet performed• At present, no agreed international/European CRA methodology is available. However, EFSA has published a first scientific opinion on the issue (suitability of existing methodologies) and a second opinion is on the way. On the basis of these 2 opinions EFSA will develop an operational tool to address CRA.• In the future, CRA will be also performed for the consumer exposure assessment to actual residues of pesticides measured in food available for the EU consumers