EU Roadmap on Combined Exposure to Multiple Chemicals 7.pdf · EU Roadmap on Combined Exposure to...
Transcript of EU Roadmap on Combined Exposure to Multiple Chemicals 7.pdf · EU Roadmap on Combined Exposure to...
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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