Consumer Risk Assessment with regards to Pesticides in Food

Hermine ReichHermine ReichPesticides Unit Pesticides Unit -- PRAPerPRAPer

Joint conference

1EFSA-Ministry of Agriculture, Forestry and Food

Radenci, 29 August 2009

Overview

European legislation on pesticidesEuropean legislation on pesticides EFSA’s role in the MRL setting process:

kRisk assessmentFirst establishment of temporary MRLsMRL iMRL review programmeRoutine MRL applications

Data collection activities related with pesticideData collection activities related with pesticide residues

Scientific databaseScientific database Monitoring data, Monitoring Report

Risk communication2

Risk communication

European legislation on pesticides

Residues in food/feedResidues in food/feed

Regulation 396/2005

Use of pesticidesDirective on

sustainable use (under preparation)

Pre-marketing approvalDirective 91/414/EEC (will be replaced by Regulation) 3

Regulation 396/2005

Main purpose of the Regulationp p g

Ensure a high level of consumer protection and establish harmonised Community provisionsestablish harmonised Community provisions relating to maximum levels of pesticide residues in or on food and feed of plant and animal originor on food and feed of plant and animal origin

f k d kSeparation of risk assessment and risk management

Defining the role of Member States, EFSA and the European Commission in the MRL setting

4procedure

Regulation 396/2005

European C i iCommission Risk

management

EFSA

Risk communication

Member States

EFSA

Risk

5assessment

Regulation 396/2005

Outline of the content of the Regulation

Establishing harmonised MRLs for all active substances

MRL review programme

Procedures for setting/amending MRLs

Development and maintenance of a scientific MRL databasedatabase

Monitoring of pesticide residues

6

g p

Establishment of harmonised MRLs

European Commission

88 00088 000 proposedproposed

European Commission collected national MRLs

for 280 activefor 280 active88 000 88 000 proposedproposedMRLsMRLs

for 280 active for 280 active substancessubstances

Risk assessment

7Unacceptable risk No consumer risk

Risk assessment

100

umer

Toxicological threshold

re o

f con

su

CN

O N

H2 N

N

H2 N

Expo

sur O

NN

OC

H3 O

N

NNH

2

NH

N

NNH

2

NH

0P ti id A P ti id B

CO

2 CH

3

8

Pesticide Aacceptable

Pesticide Bnot acceptable

Regulation 396/2005Regulation 396/2005Establishing of harmonised EU MRLs for all active

bsubstances

Based on the res lts of EFSA’s risk assessment riskBased on the results of EFSA’s risk assessment, risk managers decided which national MRLs could be included in Annex III of Regulation as temporary EU MRLsin Annex III of Regulation as temporary EU MRLs

MRLs published in Regulation (EC) No 149/2008 and 839/2008

Temporary MRLs entered into force on 1 September 2008

MRLs established nder the pre io s MRL legislationMRLs established under the previous MRL legislation (consolidated list) compiled in Annex II of Regulation 396/2005

9

396/2005

Regulation 396/2005

MRL review programme(linked with Directive 91/414/EEC)(linked with Directive 91/414/EEC)

167 active substances:i l i i A I f inclusion in Annex I of

Directive 91/414 entered into forcebefore 1 September 2008before 1 September 2008

+ 216 active substances:inclusion or non-inclusion in Annex I of

Directive 91/414 enters into force ft 1 S t b 2008

10

after 1 September 2008

MRL review programme:What is requested from EFSA?What is requested from EFSA?

EFSA is required to give:EFSA is required to give:

“… a reasoned opinion based in particular on the relevant assessment report prepared under Directive 91/414/EEC … on:p p / /

(a) Existing MRLs set out in Annex II or III to Regulation 396/2005;

(b) the necessity of setting new MRLs for that active substance, or its inclusion in annex IV to this Regulation;

(c) Specific processing factors as referred to in Article 20(2) of this Regulation that may be needed for that active substance;

(d) MRL hi h th C i i id i l di i A II(d) MRLs which the Commission may consider including in Annex II and/or III and those MRLs which may be deleted

11

MRL review programme

Collection and compilation of scientific data pprovided during the last 30 years to Member States and European Commission in support of MRL p ppapplications at national or EU level.

Re-evaluation of data according to current scientific standardsstandards.

Establishment of a well structured data base accessible to all Member States and the European Commission.

12

MRL review programme

Close collaboration between Member States, EFSA d h E C i i i !and the European Commission is necessary!

13

Regulation 396/2005

Routine MRL applications for i / di MRLsetting/amending MRLs

If M b S i d h i i idIf a Member State intends to authorise a pesticide and the existing MRL is not sufficient

Member States prepare evaluation report in support of the MRL applicationof the MRL application

Ca 100 applications per year are expected

EFSA is asked to give a reasoned opinion regarding the consumer safety of the proposed MRL within 3

14

t e co su e sa ety o t e p oposed t 3months (in exceptional cases 6 months)

Regulation 396/2005

Development and maintenance of a scientific MRLDevelopment and maintenance of a scientific MRL database

European Commission has established a MRL d b h l ldatabase covering the legal aspects

EFSA has to establish a database covering the technical and scientific aspects of MRLsp

Link between these databases15

Link between these databases

Toxicological reference

l

Residue definition for risk values

(ADI/ARfD)

for risk assessment,

conversion factor

Good Agricultural

Results of PracticeResults of supervised field trialse d t a s

Processing factors

Result of consumer risk

Import tolerance Results of

16

consumer risk assessment

tolerance, CXL ?

Results of monitoring

analysis

Regulation 396/2005Monitoring of pesticide residues

By end of August results of previous year’s controlBy end of August, results of previous year’s control activities have to be submitted to EFSA

h l dEFSA prepares the Annual Report on Pesticide Residues, in particular on the following aspects:

Analysis of the resultsActual consumer exposure assessmentRecommendations for future monitoring programmes

Report has to be submitted to COM by 6 months y(end of February)Publication of Report (including comments from MS

17

Publication of Report (including comments from MS and COM)

Regulation 396/2005

Risk AssessmentRisk Assessment Risk assessmentRisk assessment

MRL settingMRL setting MonitoringMonitoring

W t ti Real occurrence dataWorst case assumptions

Risk assessment based on

Real occurrence dataBetter estimate of consumer

exposureRisk assessment based on

data generated by applicants

Limitations regarding current reporting format

18

Supervised field trials Change of reporting format and data model/XML schema under

preparation

Risk communicationAvoiding of trade barriers

Consumer protection

barriersCommon market-free movement of p

No unacceptable consumer risk

goods, WTO agreement

Guarantee for producers

Compliance with MRL

MRLMRLMinimisation

i i l

Compliance with MRL provisions if

pesticides are used di t l b l principle

ALARA (as low as reasonably

according to labelPrecautionary

principle yachievable)Setting of zero-

tolerance in case of missing data or

19

guncertainties

Safety margins in MRL setting

120

100

80

% o

f AD

I

40

60

ntak

e in

%

20

40In

0

e A

e B

e C

e D

e E

e F

e G

e H

de I

e J

e K

e L

e M

e N

e O e P

e Q

20Pest

icid

e

Pest

icid

e

Pest

icid

e

Pest

icid

e

Pest

icid

e

Pest

icid

e

Pest

icid

e

Pest

icid

e

Pest

icid

Pest

icid

e

Pest

icid

e

Pest

icid

e

Pest

icid

e

Pest

icid

e

Pest

icid

e

Pest

icid

e

Pest

icid

e

MRL is not borderlineMRL is not borderlineMRL is not borderline

between acceptable residue t ti f d dconcentration on food and

immediate consumer health

risk21

risk