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ACROPOLIS Scientific Advisory Board. Jacob van Klaveren. Contents. EFSA opinion cumulative risk assessment ACROPOLIS (EU funded project) Data access issues Risk management perspective Scientific sound. Deterministic approaches. Advantage IESTI (PRIMo, WHO) Used world-wide

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Acropolis scientific advisory board

ACROPOLIS Scientific Advisory Board

Jacob van Klaveren

Jacob van Klaveren

Acropolis scientific advisory board


  • EFSA opinion cumulative risk assessment

  • ACROPOLIS (EU funded project)

  • Data access issues

  • Risk management perspective

  • Scientific sound

Jacob van Klaveren

Acropolis scientific advisory board

Deterministic approaches

  • Advantage

    • IESTI (PRIMo, WHO)

    • Used world-wide

    • Easy to understand

  • Disadvantage

    • One food item at the time

    • One chemical at the time

    • Not addressing variability

    • Not addressing uncertainty

    • Validity of assumptions not known?

Jacob van Klaveren

Acropolis scientific advisory board

Different approaches

  • Short-term intake

    • PRIMo model used (case 2 a or other cases)

Exposure = intake critical RAC + background exposure all other RACs and pesticides CAG - background critical RAC

  • Is probabilistic assessment possible and can it be used at theinternational level addressing both acute and chronic toxicity

Jacob van Klaveren

Acropolis scientific advisory board

Probabilistic modeling cumulative exposure

RPF index






99, 99.9, and/or 99.99 percentile

Jacob van Klaveren

A few recommendations efsa opinion
A few recommendations (EFSA opinion)

Common Assessment Group should be the same in Europe

Draft guidelines are published by EFSA

Jacob van Klaveren

Acropolis scientific advisory board

Institutes working on ACROPOLIS

  • National Institute for Public Health and the Environment (RIVM)

  • The Secretary of State for Environment, Food and Rural Affairs (FERA)

  • University of Milano

  • National Research Institute for Food and Nutrition (INRAN)

  • University of Utrecht

  • Chemical Regulation Directorate (CRD or former PSD)

  • National Institute of Public Health (NIPH)

  • Freshfel Europe

  • National Food Administration

  • University of Ghent

  • Wageningen University (Biometris)

Jacob van Klaveren

Aims of eu project acropolis
Aims of EU project ACROPOLIS

  • Improved cumulative exposure assessment and cumulative hazard assessment;

  • New models for aggregated exposureassessment addressing different routes of exposure;

  • Setting up new toxicological testing for identifying possible synergistic effects and developing a strategy for refinement of cumulative assessment groups;

Jacob van Klaveren

Important aims of eu project acropolis
Important aims of EU project ACROPOLIS

  • To integrate cumulative and aggregate risk models integrated in a web-based tool, includingaccessible data for all stakeholders

  • Improving the understanding of cumulative risk assessment methodology of differentstakeholders.

Jacob van Klaveren

Acropolis scientific advisory board

Project management

Jacob van Klaveren

One platform data and model availability
One platform, data and model availability














Data access agreed

Jacob van Klaveren

Data platform and data sharing
Data platform and data sharing

  • One platform compatible and preferable shared with EFSA

  • Data owners are Member States

  • Difficult process for many years

  • We have to manage this carefully

    - user groups

    - confidentiality agreements where needed

  • A lot of energy (National Food Authorities has already become associated partner of ACROPOLIS to be able to perform cumulative assessment in their own country)

Jacob van Klaveren

Influence of uncertainty analyses
Influence of uncertainty analyses





  • Uncertainty in models, data and assumption

  • EFSA guideline (qualitatively and quantitatively)

  • Cooperation RIVM – FERA

Jacob van Klaveren

Wp6 stakeholder involvement
WP6 Stakeholder involvement

  • Is Science (e.g. Margin of Exposure) understandable

  • Stakeholder attitudes towards pesticide risk assessment

  • Is platform in WP5 useful and practical

Jacob van Klaveren

Do we help the risk management
Do we help the risk management?

Risk managers have to deal with views of different stakeholders

Legal obligation (art 14, 396/2005)

Keep it simple

- exceeding ARfD in deterministic = black-white

- variability already difficult to understand

- relevance of variability and uncertainty factors as it is part of new and old approaches

Starting point is scientific correct model!

Jacob van Klaveren

Efsa guideline ppr 4 approaches needed
EFSA guideline PPR, 4 approaches needed

Assessment of actual exposure using monitoring data

acute assessment

chronic assessment

MRL-setting using Field Trial Data or MRL for one crop-pesticides and monitoring data for all other crops

acute assessment (consumer only)

chronic assessment

Public consultation single chemical (summer 2010)

Jacob van Klaveren

Is our concept scientific sound
Is our concept scientific sound?

EFSA request for overview tables

Source EFSA Draft guideline for public consultation (no real data filled in)

Jacob van Klaveren

Exceeding arfd or adi
Exceeding ARfD or ADI

What was the original meaning when ADI was set?

Animal versus human

Include most sensitive person? Variability or sensitivity?

Rest of all uncertainties covered?

Original concept addressed the average consumer only

How much of the concern has been filled up?

variability is well defined in all parameters and included in the model

Uncertainty is identified and included

Sensitive groups are addressed

Jacob van Klaveren

Exceeding arfd or adi1
Exceeding ARfD or ADI

Once (some) concerns in the original concept have been addressed should we then still use uncertainty factor 10 x 10 in the tails of intake distribution?

But new concerns were addressed overtime?

New refinements have been proposed e.g. toxicological effect is only relevant for a certain group. Will we have PRIMo data for that group?

How to link current deterministic approach results with probabilistic approach?

ACROPOLIS will not interfere with Risk Management decision, might provide useful instruments

Jacob van Klaveren

Acropolis scientific advisory board

Dissemination activities

  • Training

  • Stakeholder conferences

  • Understanding and acceptance

    • Variability and uncertainty

    • Precautionary principle and safety factors

    • Understanding and acceptance

    • Desired Level of Protection

Jacob van Klaveren

Acropolis scientific advisory board

Aim for today

  • ACROPOLIS is a contract signed by partners and EU Commission and we are obliged to follow that contract. We want to share were we are and what we do!

  • ACROPOLIS should be useful for risk managers, EFSA, consumers (Greenpeace), trade and industry.

    • Share information on concepts, data and experience

    • We want to have feedback how work fits in with your developments

    • What can be offered from your side

    • How to organize useful exchange

Jacob van Klaveren

Acropolis eu com

Jacob van Klaveren