EU Roadmap on Combined Exposure to Multiple

Chemicals

Bruno Dujardin

Senior Scientific Officer (DATA)

74th Advisory Forum meeting

Parma, Italy, 27-28.11.2019

ConsultationStart

EU Roadmap – Background and timelines

Advisory Forum73rd meeting

Thematic discussion on combined exposure to

multiple chemicals

Activities presented by DE, DK, FI, FR, NL,

ECHA & EFSA

Prepare EU Roadmap in view of harmonising activities at EU level

18-19 Sep 2019

25 Oct 2019

15 Nov 2019

27-28 Nov 2019

Advisory Forum74th meeting

Discussion on the draft EU Roadmap

Possible agreement on the finalisation of the

EU Roadmap

First draft EU Roadmap circulated to interested

Member States

(DE, DK, FI, FR, NL)

ConsultationEnd

Teleconference with DE, DK, FI, FR, NL

Comments integrated in draft EU Roadmap

Scope

Combined exposure to multiple chemicals

Human health risk assessment

Dietary and non-dietary exposure to chemicals

Relevant projects that are generally applicable to chemical risk assessment listed in Annex

Purpose

Enhance cooperation among Member States

Identify opportunities for engagement

From innovation to regulatory framework

EU Roadmap – Scope and purpose

Methods

Tools

Data

Application

Methods development

Tools harmonisation

Data consolidation

Implementation for pesticides

EU Roadmap – Specific sections

Methods development – Key points

EFSA MixTox Guidance Comprehensive overview on available methods

On-going activities on the criteria for grouping chemicals into assessment groups

What else is needed? Explore deviations from the dose-addition model

Develop alternative testing strategies for interaction of chemicals

Explore further integration of additional exposure routes and toxicokinetic models

Collect all ideas at EFSA’s 2020 MixTox Workshop

Explore funding opportunities under Horizon Europe

Methods development – Overview

Grouping criteria

Envisioning of new developments

Elaboration of new developments

(to be defined)

2022 2023 20242020 2021

2020 MixTox

Workshop

Tools harmonisation – Key points

Collaborative platform Open source and modular

Possibility to perform calculations online (not only a repository of codes and data)

User-friendly interface connecting the modules

Connected to relevant input data (where possible)

Priorities1. Compile and harmonise existing tools (e.g. MCRA, Danish mixture calculator,…)

2. Integrate new methodological developments

Identify possible technical solutions

Assess impact on ownership

Explore possibilities to cover costs for computational capacity

Tools harmonisation – Overview

Integration of EuroMix Toolbox into

MCRA

Action plan for a modular and open

source platform

Implementation of a modular and

open source platform

Integration of new modules

2022 2023 20242020 2021

RIVMPartnership

ConsortiumPartnership

Data consolidation – Key points

Data needs for the assessment of multiple chemicals Toxicological endpoints for non-critical effects

Others may emerge from methods development

OpenFoodTox database to be expanded

Generic data needs Toxicity study results in a structured data format (for BMDL modelling)

Updated food consumption data

Processing factors

Use frequency data

Not included in the roadmap

Harmonised terminologies for organs, effects,

modes of action and mechanisms of action

Data model for integration of non-critical

effects in OpenFoodTox

Implementation of a process for the integration

of non-critical effects in OpenFoodTox

2022 2023 20242020 2021

Data consolidation – Overview

Istituto Mario Negri(Italy)

Other data types may be added to the roadmap

(depending on needs and methodological developments)

Pilot assessment for pesticides Retrospective risk assessment

Reference period 2014-2016

10 Population groups

30 Raw primary commodities+ Food for infants and young children

+ Water

High level implementation plan Development of new Cumulative Assessment Groups (CAGs)

Retrospective assessments for existing CAGs (monitoring data, after authorisation)

Prospective assessments for existing CAGs (trial data, prior to authorisation)

More detailed action plan will be agreed with SC PAFF

Implementation pesticides – Key points

Thyroid

•Hypothyroidism

•Effects on C-cells

Nervous system

•Motor division

•AChE inhibition

Implementation pesticides – Overview

Retrospective risk assessment for the

existing CAGs (process development)

Retrospective risk assessment for the

existing CAGs (process

implementation)

Prospective risk assessment for the

existing CAGs (process development)

Prospective risk assessment for the

existing CAGs (process

implementation)

Identification of the target organs

systems for all pesticides

Validation of the screening method for

the elaboration of new CAGs

Implementation of the screening

method for the elaboration of new

CAGs

Establishment of the new CAGs

according to a prioritisation scheme

Retrospective risk assessment for the

new CAGs

Retrosepective process

Planned activities

Batch 1

2022

Batch 2 etc.

Batch 1 Batch 2

2023 20242020 2021

New cumulative assessment

groups

Prospective process

RIVM

DTU(?)

RIVM

Consortiumpartnership

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