PARC NORMAN ANSES - European Partnership for the Assessment of Risks from Chemicals 02/12/2020 - THE NORMAN NETWORK
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European Partnership for the
Assessment of Risks from
Chemicals
PARC
Horizon Europe candidate Partnership
NORMAN
12th General Assemby
02/12/2020
ANSES
European Partnership for the Assessment of Risks from Chemicals – NORMAN General Assembly 2 December 2020
What is a Horizon Europe Partnership
Co-Construction European Commission/Member State
European Partnership for the Assessment of Risks from Chemicals – NORMAN General Assembly 2 December 2020
Context for the PARC proposal
Challenges: Risk assessment agencies and Opportunity: Horizon Europe
regulatory bodies and associated research A partnership to boost research and innovation
community in the EU are confronted with in support of chemical risk assessment
Øpersistent science-regulatory gap
Responding to policy priorities:
Øgaps in knowledge of and information on hazards,
SDGs, 2019 Council Conclusions, Green Deal, Towards a
Øoccurrence and exposures to chemicals and mixtures Sustainable Chemicals Policy Strategy …
Øscattered and non-accessible evidence Requirement:
Øscreening, testing and assessment methods to be A joint research and innovation roadmap set by risk
developed, validated and taken-up assessors & managers in consultation with academia,
Øduplication of efforts and inefficient use of resources association, industry and other stakeholders
Øinsufficient risk communication
Worked on it with a Steering Group (Sept 2019-Nov 2020):
25 countries: AT, BE, CH, CY, CZ, DE, DK, EE, ES, FI, FR, GR,
HR, HU, IS, IT, LV, LU, NL, NO, PL, PT, SE, SI, SK
And ECHA, EEA, EFSA, JRC,
DG R&I, DG SANTE, DG ENV, DG GROW & others
Concept paper published early June 2020:
Provides an overview of the context, objectives and expected impacts and the planned implementation
with the suggested structure, activities and governance
European Partnership for the Assessment of Risks from Chemicals – NORMAN General Assembly 2 December 2020
Setting the scene European Partnership for the Assessment of Risks from Chemicals – NORMAN General Assembly 2 December 2020
Concept paper European Partnership for the Assessment of Risks from Chemicals – NORMAN General Assembly 2 December 2020
Description of the objectives-oriented organisation European Partnership for the Assessment of Risks from Chemicals – NORMAN General Assembly 2 December 2020
Key Performance Indicators European Partnership for the Assessment of Risks from Chemicals – NORMAN General Assembly 2 December 2020
Prioritisation process
2 Surveys: PARC / HBM4EU
• Online survey on priorities for work on
22 June- chemical risk assessment Survey on PARC priorities
18 Sept • 156 entries
Survey on substances for human biomonitoring
• 21 Sept – present proposed process to the • 36 entries
21 Sept interim WP leaders Supporting
2020 WPs
•Q1. Overall knowledge needs
WP4
Monitoring •Q2. Priorities for monitoring & exposure
Oct/Nov • Analysis by interim WP leaders
and exposure
WP5 Hazard
2020 assessment
•Q3. Priorities for hazard assessment Implications
for WP7 on
WP6
Innovation in
•Q4. Priorities for innovation in chemical data and WP9
• Consult interim Country Board, EU Board, regulatory RA
risk assessment
on capacity
Nov/Dec Grant Signatory Board WP8 building
2020 Concepts & •Q5. Priorities for new concepts and tools
toolboxes
Supporting
•Q6. Additional priorities and references
WPs
European Partnership for the Assessment of Risks from Chemicals – NORMAN General Assembly 2 December 2020
Objectives-oriented structure European Partnership for the Assessment of Risks from Chemicals – NORMAN General Assembly 2 December 2020
WP4: Monitoring and exposure
Interim WPL: UBA (DE), SpF(FR)
Interim Team: VITO (BE), ISCIII (ES), AU (DK), INERIS(FR), EEA (EU), INRAE (FR), VU-EH
(NL), MUI (AT), EFSA (EU)
4.1 Human • Alignment and harmonisation of HBM programmes
Biomonitoring
4.2 Environmental and • Multiple sources, chemical fates and environmental exposure pathways of
multisource chemicals
monitoring • Long term and life cycle stages associated exposure
• Environmental monitoring in support of the regulatory framework
4.3 Innovative • Non-targeted screening and emerging chemicals
methods and tools for • Characterise mixtures for exposure assessment
monitoring and • Link exposure and health related information
surveys
• Relevance
• Needs
• Activity planning
• Costs
European Partnership for the Assessment of Risks from Chemicals – NORMAN General Assembly 2 December 2020WP5: Hazard assessment
Interim WPL: ANSES (FR), BfR (DE)
Interim Team: NIPH (NO), VUB (BE), DTU (DK), INSERM (FR), INSA (PT)
Adverse outcomes
(non-genotoxic)
Degradation products PFAS & precursors Substances Carcinogenicity
Genotoxicity
BPA alternatives Endocrine disruption
5.1 Toxicity testing Conduct of 90-d GL studies Conduct of 90-d GL studies
addressing data gaps
Toxins Neurotoxity
with single substances and‚ with toxins; (relevant
of concern DNT
real life‘ mixture; simultan mixtures) simultan analysis
Materials Immunotoxicity
analysis of classical of classical parameters and Reproductive &
parameters and omics omics analysis; simulation. Nano, µ plastics Developmental toxicity
techniques; simulatn. analysis of kinetics nanomaterials Specific organ toxicity
analysis of kinetics
Ecological risks
5.2 Innovative In vitro screening of DBP, co- In vitro screening of toxins,
methods and tools for formulants; cell painting; cell painting; cytotox; HCS, Overarching topics
toxicity testing and cytotox; HCS, reporter reporter genes, enzyme Combinatorial effects/mixtures
modelling genes, enzyme interactions interactions; AOP
Grouping
development
QSAR/Read across
5.3 Regulatory use of In vitro kinetic interactions In vitro kinetic interactions Systems biology
hazard data (in E.g.CYP inhibition+induction E.g. CYP
collaboration with
TK/PBPK
nhibition+induction
6.1) • Relevance
• Needs
• Activity
planning
• Costs
European Partnership for the Assessment of Risks from Chemicals – NORMAN General Assembly 2 December 2020WP6: Innovation in regulatory risk assessment
Interim WPL: RVM (NL), KEMI(SE)
Interim Team: UL-LACDR (NL), Sciensano (BE), VITO (BE), ANSES (FR), EFSA (EU), BPI
(EL), ACES (SE), UNIBAS (CH)
WP6.1 Integrative • Development and testing of IATAs for regulatory purposes
approaches to testing and • Development and/or expansion of (quantitative) Adverse Outcome Pathways
assessment (IATA) • Identification and validation of effect biomarkers
• Development of a workflow for assessing the human relevance of AOPs, as well as the relevance of associated test
methods and tools
• Pre-validation of test methods used in IATA
• Development of computational modelling approaches for integrating outputs from non-animal methods and tools
towards quantitative hazard assessment
• Evaluation of IATAs, using weight of evidence approaches for integrating human data and data from traditional and
novel (test) methods and including characterisation of uncertainty
WP6.2 Integrative • Mixture risk assessment • Linking internal exposure to external aggregate exposure
exposure and risk • Aggregate exposure from different Sources of and vice versa
assessment exposure Routes • Ecological risk assessment
WP6.3 Review of risk • Tools to help enforcement of legislation with focus on articles
assessment methodology • Develop a decision support system
WP6.4 Transposing results • Efficient risk assessment processes
to regulatory risk • Develop regulatory and legally accepted risk assessment and management methods for for chemical mixtures,
assessment methodologies • for articles in circular material flow, complex situations with severe knowledge gaps
• Facilitate the regulatory acceptance and use of new methods
• Research to support the inclusion of new endpoints in chemical regulation to increase the protection of biodiversity,
including the integrity and resilience of ecosystems
European Partnership for the Assessment of Risks from Chemicals – NORMAN General Assembly 2 December 2020WP2: A common science policy agenda
Interim WPL: EEA(EU), EAA (AT)
Interim Team: ANSES (FR), ECHA (EU), EFSA (EU), INSA (PT), BfR (DE), NPHC (HU),
Inserm (FR)
Collaboration with all WPs
• Evaluation and uptake of first • Developement and • Support drafting
survey implementation of a of the 3 year Regular consultations
2.1 Priority setting Drafting the first research and prioritisation strategy strategic agendas
• • Governing Board
innovation agenda • 2022-2024 • Scientific communities
• Develop a process to ensure • Develop a format for dialogue • Stakeholders
the immediate access of risk between
assessors / Managers [Early partnership/regulatory Close collaboration
Warning System] scientists and EU Institutions National Hubs, EUHUb
• Compile existing knowledge • Develop an appointment • Develop
and define data gaps to process for Chemical Leaders workflows to
2.2 Knowledge
addressed (CLs) and New Approach achieve the
management and
• Map list of ongoing activities by Methodologies’ Leaders objectives
uptake into policies
regulatory bodies, OECD work (NAMLs) identified in the
exit strategy
• Guarantee open access and fair • Develop a proposal for
data consistent and coherent
information flow
• Mapping of needs of national • Concept for capacity building • Exit Strategy
hubs & establish a peer to peer
2.3 Sustainalibilty
learning activity process
together with WP9
European Partnership for the Assessment of Risks from Chemicals – NORMAN General Assembly 2 December 2020WP3: Synergies, collaborations and awareness
Interim WPL: INSA (PT), GSCL (EL)
Interim Team: EAA (AT), ECHA (EU), EFSA (EU)
3.1 Stakeholders Set-up of the International Board, Running of the International Board
forum and Stakeholder Forum and nomination of and Stakeholder Forum
international board the PARC Ambassador
3.2 Communication Development of a graphical identity for Establishment of synergies and
and dissemination PARC collaborations with national, EU-
Website and channels in social media level and international activities
Development of a communication and Outreach activities and awareness
dissemination strategy raising
European Partnership for the Assessment of Risks from Chemicals – NORMAN General Assembly 2 December 2020WP8: Concepts and tools
Interim WPL: AUTh (EL)
Interim Team: EMPA (CH), UF2N (IT), RIVM (NL), WR-Bio (NL), KEMI (SE)
8.1 Safe and • Key protection goals and implementation criteria Development of a SSBD assessment toolbox
sustainable • Develop conventions for the terms ‘safe’ and § Describe methods with which critical properties
by design ‘sustainable’ in relation with the key protection goals (such as toxicity, exposure) of chemicals in
function of usage (reparability, reusability,
recyclability)
§ Develop guidelines for the toolbox
implementation, following OECD
recommendations
8.2 Early • Identification of the needs and user requirements for • Development of the computational framework
warning an early warning system to support the early warning system).
system • Enable searches in chemical inventories on their • Develop guidelines for the toobox
potential of being new emerging risk chemicals implementation (OECD recommendations)
(NERC),
• Relevance
• link with development in Non Targeted Screening
• Needs
analysis • Activity
8.3 Development of the toolbox for integrative modeling of Toolbox implementation based on cloud computing planning
Integrative exposure and risk assessment and application programming interfaces (APIs) • Costs
models • Mobility in the environment, accounting for their overall
environmental fate Case studies using the integrative modeling toolbox
• Exposure pathways and routes
• Toxicity potency, using QSARs and other computational methods
developed in WP5
• Identify whether they will be potential NERCs
European Partnership for the Assessment of Risks from Chemicals – NORMAN General Assembly 2 December 2020WP7: FAIR Data
Interim WPL: VITO (BE), TNO (NL)
Interim Team: MU (CZ), EFSA (EU) UU-IRAS (NL), support by JRC, DG ENV
European Partnership for the Assessment of Risks from Chemicals – NORMAN General Assembly 2 December 2020WP9: Capacities and networks
Interim WPL: MU (CZ), ISCIII (ES)
Interim Team:
Capacities Capacity Mapping and Strengthening
Laboratory Networks Cooperation
raining
Standardisation of approaches ¨. x a m ples of t
le
Severa et
to pics o su res (targ
Training Development of templates and questionnaires to identify the training s of ex p
analyse ,
needs and relevant groups of stakeholders beyond the Partnership S)
and NT s of related lth
Collection and management of needs identified in other WPs within analy s e
n ta l a nd hea
me
expert working groups comprising experts from WP 4-8 representatives environ
s,
effect risks,
Implementation of the needs via s es s m ent of analysis
of
as t a n d
emen
• Organisation of (on-line) training activities manag etc
d ata, e of models
• preparation of annual (on-line) training programmes within and beyond ing, u s
modell
Partnership
• development of online materials
• development or adaptation of guidance on training programmes and
harmonisation procedures
• organisation of periodical seminars • Needs by activity
Collaboration with education sector and national hubs • Design Training
programme
Dissemination of training materials and training programmes (in cooperation • Implementation
with WP3) • Monitoring
European Partnership for the Assessment of Risks from Chemicals – NORMAN General Assembly 2 December 2020Link to EU Chemicals Strategy for Sustainability –
published 14/10/2020
Encourage innovation
Promote the development of safe and sustainable
chemicals and materials, clean production processes
and technologies, innovative tools for testing and risk
assessments.
• Contribute to the development of EU criteria
Ø Safe and sustainable chemicals (WP8)
Ø Early Warning System (WP8, WP4)
Ø Mixtures assessment factors (WP6, WP8)
Ø Environmental risk assesments (WP6)
• Development of
Ø innovative tools (WP4,5,6, 8)
Ø methodologies that take into account the whole
life cycle of substances, materials
• Development and uptake of methods to generate
information on endocrine disruptors through
screening and testing of substances (WP5, 6)
• Contribute on the methodologies and data (WP5, 7)
European Partnership for the Assessment of Risks from Chemicals – NORMAN General Assembly 2 December 2020Partnership implementation strategies
7-year Description of Action
3-year common 3-year common Common /
exit
strategy strategy strategy
Annual Annual Annual Annual Annual Annual Annual
Work Work Work Work Work Work Work
Plan Plan Plan Plan Plan Plan Plan
European Partnership for the Assessment of Risks from Chemicals – NORMAN General Assembly 2 December 2020Construction process of the Partnership
Sept Oct Nov Dec Jan Feb Mar Apr May June
2020 2020 2020 2020 2021 2021 2021 2021 2021 2021
Description of actions
By WP
SRIA
Challenges Planning of activities Proposal
Identification of challenges to
Targets/Objectives be addressed
Expected outputs 3Y common Strategy
Near future (1-3Y) - Precise
Task and deliverable List of detailed activities
Long term (4-7Y) - General
description Precise work based on WP/T
(similar to the concept paper) related to DoA
1st annual work plan • Consultation GB
• EU Call
• Priorities
• Concept paper • Interim MB
questionnaire
• National commitments • GSB/LTP
• Interim MB SRIA: Strategic Research and
• Steering Group • GB Innovation Agenda
• GSB/LTP WP/T: Worpackage and Tasks
DoA: Description of Action
• GB
European Partnership for the Assessment of Risks from Chemicals – NORMAN General Assembly 2 December 2020Roadmap for the next steps – 2021
1 Dec • First meeting of the GB/GSB to discuss priorities
2020
Dec - • Interim WP co-leaders translate the priorities into the 3-year common strategy and first annual
March work plan for the Partnership
2021
March- • Second meeting of the GB/GSB to adopt the final 3-year common strategy, the 1st annual
April work plan
2021
April • Publication of the Work Programme 2021-2022 by the EC
2021
TBC
• Preparation of the proposal submission: administrative, technical and budgetary data and CA
April- preparation
June
June- • Submission of the complete proposal to the Commission
Aug TBC
Aug-Nov
• Evaluation by the European Commission
TBC
• Contractual process: Verification, signature of the administrative forms, preparation of the
Nov-Dec
2021 Kick-off meeting
Jan 2022 (TBC) : Launch of the Partnership and kick off meeting in France (under French
presidency of the Council of the EU)
European Partnership for the Assessment of Risks from Chemicals – NORMAN General Assembly 2 December 2020Conclusion
Objectives of NORMAN are in line
with PARC objectives.
Joint data space and cutting-edge
research tools for Risk assessment
of contaminants of emerging
concern
Advanced data analysis tools: NORMAN & PARC networks are connected
towards a European Early Warning INERIS
system UBA
◦ Prioritisation of substances and WUR
priority setting AU
Support to national and European SWACCS
chemical risk asessment: MU
harnessing, combining and sharing AUTh
evidence and expertise on CECs BRGM
INRAE
RIVM
…..
European Partnership for the Assessment of Risks from Chemicals – NORMAN General Assembly 2 December 2020Project contact details
Coordination team:
PARC email box: parc@anses.fr
Adrienne Pittman:
adrienne.pittman@anses.fr
Pascal Sanders: pascal.sanders@anses.fr
Philippine de Barbeyrac:
philippine.debarbeyrac@anses.fr
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