Dietary Risk Assessment of Pesticide Residues in Food

1
Dietary Risk Assessment of Pesticide Residues in
Food
Hermine Reich, European Food Safety Authority
Doing Business with the EU New EU Legislation on
Pesticides Residues in Fruit and Vegetables
Bangkok 26 March 2009
2
Dietary risk assessment of pesticide residues in
food

• Pesticide Risk Assessment Peer Review (PRAPeR)
  MRLs

3
Overview

• EFSAs mandate and tasks
• Concept of Risk Analysis
• Risk Assessment in the process of setting
  maximum residue levels (MRLs) for pesticides on
  food

4
What EFSA does
Mission

• EFSA is the keystone of EU risk assessment
  regarding food and feed safety. In close
  co-operation with national authorities and in
  open consultation with its stakeholders, EFSA
  provides independent scientific advice and clear
  communication on existing and emerging risks

5
Scientific Panels

• Animal health and welfare (AHAW)
• Food additives and nutrient sources (ANS)
• Biological hazards (BIOHAZ)
• Food contact materials, enzymes, flavourings
  (CEF)

• Contaminants (CONTAM)
• Feed additives (FEEDAP)
• Genetically modified organisms (GMO)
• Nutrition (NDA)
• Plant health (PLH)
• Plant protection products (PPR)

6
EFSA in Parma/Italy
EFSAs operational seat
EFSAs Official seat Palazzo Ducale
7
Risk analysis concept
Risk Management Policy based
Risk Assessment Science based
Risk AssessmentScience based
Risk Communication Interactive exchange of
information and opinions concerning risks
Source WHO/FAO 1997
Need for close cooperation between risk assessor
and risk manager
8
Risk Assessment

• Scientifically based process consisting of four
  steps
• Hazard identification
• Hazard characterisation
• Exposure assessment
• Risk characterisation

9
MRL setting procedure
GAP Good Agricultural practice
10
Good Agricultural Practice
Which active substance is used on which crop,
against which pest or desease, with which
application rate, what timing of application,
number of applications, which application
technique, which interval between
treatments, field or glasshouse, what is the
pre-harvest interval (PHI)
11
MRL setting procedure
Hazard identification and characterisation
GAP Good Agricultural practice
12
Hazard quantification
effect
Control group
Dose (logaritmic scale)
13
Toxicological reference values
SF
SF
Extrapolation from most sensitive animal species
to humans
Sensitivity of different subgroups of the
population
SF Safety factors
14
Toxicological reference values

• Acceptable daily intakeADI
• is the estimate of the amount of substances in
  food, expressed on a body weight basis, that can
  be ingested daily over a lifetime, without
  appreciable risk to consumers.
• Expressed in mg/kg body weight/day

• Acute Reference DoseARfD
• is the estimate of the amount of substance in
  food, expressed on a body weight basis, that can
  be ingested over a short period of time, usually
  during one day, without appreciable risk to the
  consumer.
• Expressed in mg/kg body weight

15
MRL setting procedure
Exposure assessment
Hazard characterisation
GAP Good Agricultural practice
16
Consumer exposure
Exposure assessment
17
Occurrence of residues in food
18
MS
MS
MS
Collection of food consumption data from
MSDevelopment of a model for exposure assessment
Unit weights
Chronic diets
Acute diets
Chronic model Calculation for all diet sets
Acute model Identification of critical European
consumer for each commodity
19
EFSA Model for pesticide consumer risk assessment
Long term dietary intake data(average
consumption data)
Short term dietary intake data(97.5th
percentile consumption data)
PRIMo Pesticide Residues Intake Model
20
Chronic exposure

• Assumptions
• All food consumed is treated with the pesticide
  according to the authorised or intended uses
• Lifetime exposure

21
Consumer exposure
100
Intake (mg/kg body weight /day)
0
Pesticide A
Pesticide B
22
MRL setting procedure
Risk characterisation
Exposure assessment
Hazard characterisation
GAP Good Agricultural practice
23
Risk characterisation
24
Consumer risk?
?
Toxicological threshold values
100
?
Intake (in of the toxicological threshold value
0
Pesticide A acceptable
Pesticide B not acceptable
25
Decision on MRLs

• Based on the recommendations given in the
  reasoned opinions issued by EFSA, the European
  Commission will prepare the Regulations regarding
  the setting, modification or deletion of MRLs
• Member States vote on the Regulation in the
  Standing Committee on Food Chain and Animal
  Health
• Publication of the Regulation in the Official
  Journal

26
Risk communication
Avoiding of trade barriers Common market- free
movement of goods, WTO agreement
Consumer protection No unacceptable consumer risk
Guarantee for producers Compliance with MRL
provisions if pesticides are used according to
label (GAP)
Minimisation principle ALARA (as low as
reasonably achievable)
Precautionary principle Setting of zero-tolerance
in case of missing data or uncertainties
27
MRL setting policy
Minimisation principle ALARA (as low as
reasonably achievable)
No EU GAP No Codex MRLNo request for import
tolerance
28
MRL setting policy
Precautionary principle Setting of zero-tolerance
in case of missing data or uncertainties
Insufficient data
Default value 0,01 mg/kg
GAP or import tolerance requested
29
MRLs are established

• on the basis of a GAP,
• if supporting dossier sufficient addressed all
  data requirements,
• expected residues do not pose a consumer health
  risk.

30
MRL is not borderline
between acceptable residue concentration on food
and
immediate consumer health risk
31
THANK YOU
Hermine ReichTel 39 0521 036 662Email
hermine.reich_at_efsa.europa.eu