Pesticide residues in food: Monitoring programs in Europe

and EFSA Annual Reports

ECPA IBMA Workshop Parma 26 April 201 2

Content of the presentation

Content of the presentation

1. Control/monitoring activities in Europe: legal framework

2. EFSA Annual Report on Pesticide Residues: main findings

3. New EU data collection system

Monitoring of pesticide residues in food in the EU

EU 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 residue in food in the EU

EU 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.htm The Annual reports 2007-2009 are published at: http://www.efsa.europa.eu/en/topics/topic/pesticides.htm

food in the EU

The EU Annual Report

The 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/ samples analysed: 834 distinct pesticides sought:

>300 food items

>68.000 samples analyzed

>14.000.000 single analytical determinations

338 found in vegetables

319 found in fruit and nuts

93 found in cereals

(*) Report available at: http://www.efsa.europa.eu/en/efsajournal/pub/2430.htm

Number of samples analyzed(*)

(*) 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

Germany; 16866

Italy; 6932

France; 4043

Netherlands; 3891

United Kingdom; 3835

Romania; 3718

Hungary; 2406

Denmark; 2294

Finland; 2286

Greece; 2278

Belgium; 2112Austria; 2071 Poland; 1816

Sweden; 1784

Spain; 1568

Norway; 1499

Slovenia; 1391Ireland; 1329

Czech Republic; 1106

Portugal; 969

Bulgaria; 951

Slovakia; 726Cyprus; 642

Estonia; 397

Lithuania; 310Iceland; 300

Malta; 170Luxembourg; 161

Latvia; 127

Origin of samples analyzed(*)

(*) Origin of samples (EU: EU27, Iceland and Norway; Imported: countries extra-EU); surveillance and enforcement samples of fruit, vegetables, cereals, processed commodities and baby food.

Unknown; 3,012; 4%

Third Country;

14,937; 22%

EEA; 50,029; 74%

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 baby food). 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(*)

(*) MRL compliance rate for samples from the national and EU coordinated pesticide residue programmes 1996-2009. Note that for 2008/2009 only surveillance samples are included, while for 1996-2007, enforcement samples are included as well.

97,0%

96,6%

96,7%

95,7%

95,5%

96,1%

94,5%

94,5%

95,0%

95,0%

95,0%

96,0%

96,5%

97,4%

3,0%

3,4%

3,3%

4,3%

4,5%

3,9%

5,5%

5,5%

5,0%

5,0%

5,0%

4,0%

3,5%

2,6%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

No measurable residues detected above MRL

Residues detected above MRL

Samples exceeding the MRLs by food group(*)

(*) MRL compliance rate for surveillance samples in the national programme and the EU coordinated pesticide monitoring programme 2009.

99.0%

97.2%

95.2%

96.8%

99.2%

99.0%

97.9%

95.6%

99.7%

99.7%

99.2%

1.0%

2.8%

4.8%

3.2%

0.8%

1.0%2.1%

4.4%

0.3%0.3%0.8%

80% 100%

Fruit and nuts; ProcessedFruit and nuts; Unprocessed

Vegetables; ProcessedVegetables; Unprocessed

Cereals; ProcessedCereals; Unprocessed

Other plant products; ProcessedOther plant products; Unprocessed

Animal products; ProcessedAnimal products; Unprocessed

Babyfood/Infant formulae; Processed

Below MRL Above MRL

No of samples analysed vs No pesticide sought and found

MRL exceedances: origin of samples(*)

(*) Exceedances of EU MRLs according to origin of sample (2009 surveillance samples)

EU origin; 1,50%

Imported food; 6,90%

Unknown; 1,30%

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 data on occurrence of pesticide in fruit, vegetables and cereals representative for the European market which are appropriate to assess the actual dietary exposure of the European population

Acute (short-term) risk assessment Chronic(long-term) risk assessment

Number of pesticides included in the EU monitoring programme 1996-2009

9 1320 20 20

3641 42

4755 55

7178

120

32

0102030405060708090

100110120130140

1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009

Sampling year

Num

ber

of p

estic

ides

Food of plant origin Food of animal origin

Food commodities included in the EU monitoring 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

Out of 256 pesticide/crop combinations for which the acute RA was performed, for 32 combinations theoretical exposure exceeded 100% of the ARfD: for those the short-term risk could not be excluded

Total Number of pesticide/crop combinations: 1242 (2009)

Presentation of the acute RA results(*)

(*) Summary of the 2009 results of the short-term consumer risk assessment for the 256 pesticide/crop combinations for which the acute RA was performed.

Results acute RA

Based on the frequency of samples exceeding the threshold residue level (residue leading to 100% of ARfD) 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 results

Summary of the 2009 results of the short-term consumer risk assessment for the pesticide/crop combinations for which a potential consumer risk could not be excluded

Results chronic RA

For 135 pesticides/group of pesticides the calculated TMDI based on the 27 diets included in the PRiMo model(*) was below the ADI. The estimated chronic exposure did not raise consumer health concerns.

(*)EFSA Data Model description available at: http://www.efsa.europa.eu/en/supporting/pub/1457.htm

Total Number of pesticide/group of pesticides: 138 (2009)

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 system

Field 1 Field 2 Field 3 Field 4 Field 5 Field 6

Additives Contaminants

Pesticides

Data collection: new system

The 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.

Thank you!

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

Number of residues found in individual surveillance samples from the national and EU coordinated pesticide monitoring programmes 2008

No measurable

residues: 53.3%

1 residue: 20.0%

2 residues: 10.9% 3 residues:

6.5%

4 residues: 4.1%5 residues:

2.4%6 residues:

1.3%7 residues:

0.6%≥8 residues;

0.9%

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