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Informationsmöte 7 September 2020 Partnership for the Assessment of Risk from Chemicals (PARC)

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Page 1: Partnership for the Assessment of Risk from Chemicals (PARC)€¦ · •Toxicokinetic modelling, PBK, (Q)IVIVE •Endocrine Disruptors •Mixtures •Nano materials •Human biomonitoring

Informationsmöte 7 September 2020

Partnership for the Assessmentof Risk from Chemicals (PARC)

Page 2: Partnership for the Assessment of Risk from Chemicals (PARC)€¦ · •Toxicokinetic modelling, PBK, (Q)IVIVE •Endocrine Disruptors •Mixtures •Nano materials •Human biomonitoring

• Välkommen

• Horisont Europa

• Bakgrund och syfte för PARC

• Struktur för PARC• Organisation

• Arbetsprogram

• Finansiering

• Vad händer framöver?

• Frågor

Agenda

Page 3: Partnership for the Assessment of Risk from Chemicals (PARC)€¦ · •Toxicokinetic modelling, PBK, (Q)IVIVE •Endocrine Disruptors •Mixtures •Nano materials •Human biomonitoring

Den svenska preliminära PARC-hubben

Myndigheter

• Arbetsmiljöverket

• Folkhälsomyndigheten

• Formas

• Havs och Vattenmyndigheten

• Kemikalieinspektionen

• Livsmedelsverket

• Läkemedelsverket

• Naturvårdsverket

Vetenskapligt stöd vid initial planering

• IMM (KI)

• ACES (SU)

• SWACCS

Page 4: Partnership for the Assessment of Risk from Chemicals (PARC)€¦ · •Toxicokinetic modelling, PBK, (Q)IVIVE •Endocrine Disruptors •Mixtures •Nano materials •Human biomonitoring

Horisont EuropaTherese Woodhill

Formas

Page 5: Partnership for the Assessment of Risk from Chemicals (PARC)€¦ · •Toxicokinetic modelling, PBK, (Q)IVIVE •Endocrine Disruptors •Mixtures •Nano materials •Human biomonitoring
Page 6: Partnership for the Assessment of Risk from Chemicals (PARC)€¦ · •Toxicokinetic modelling, PBK, (Q)IVIVE •Endocrine Disruptors •Mixtures •Nano materials •Human biomonitoring
Page 7: Partnership for the Assessment of Risk from Chemicals (PARC)€¦ · •Toxicokinetic modelling, PBK, (Q)IVIVE •Endocrine Disruptors •Mixtures •Nano materials •Human biomonitoring
Page 8: Partnership for the Assessment of Risk from Chemicals (PARC)€¦ · •Toxicokinetic modelling, PBK, (Q)IVIVE •Endocrine Disruptors •Mixtures •Nano materials •Human biomonitoring
Page 9: Partnership for the Assessment of Risk from Chemicals (PARC)€¦ · •Toxicokinetic modelling, PBK, (Q)IVIVE •Endocrine Disruptors •Mixtures •Nano materials •Human biomonitoring

PARC - bakgrundAnnika Hanberg, professor, ERT

Institutet för miljömedicin, Karolinska Institutet

Annika Hanberg

Page 10: Partnership for the Assessment of Risk from Chemicals (PARC)€¦ · •Toxicokinetic modelling, PBK, (Q)IVIVE •Endocrine Disruptors •Mixtures •Nano materials •Human biomonitoring

Varför ett partnerskap om riskbedömning avkemikalier? Svarar mot politiska prioriteringar: Sustainable Development Goals, Europeiska rådets

slutsatser 2019, Green Deal, Towards a Sustainable Chemicals Policy Strategy …

Riskbedömande myndigheter upplever luckor vad gäller kunskap, information ochmetoder

PARC baseras bl a på HBM4EU, EU-TP, mixture projekt, EU-ToxRisk, Safe-by-design

Trots många och stora forskningsprojekt kommer nya lovande metoder inte ända framtill regulatorisk tillämpning

• Behov av (pre)validering och case studies• Behov av långsiktighet

Myndigheter och forskare arbeta tillsammans, inom länder, inom EU, mellan sektorer!

Utgå ifrån myndigheternas prioriteringar!

Kommunikation och utbildning

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Exempel på områden där forskning behöver främja regulatorisk tillämpning

• Non-animal toxicity prediction models –in vitro, in silico, 3R

• Human relevance

• Mode of Action – Adverse Outcome Pathways

• Toxicokinetic modelling, PBK, (Q)IVIVE

• Endocrine Disruptors

• Mixtures

• Nano materials

• Human biomonitoring and biomarkers

• Environmental and multisource monitoring

• Early warning systems

• Exposure modelling

• Integrated approaches to testing and assessment (IATA)

• Use of research data

• Transparency and trust – communication

• Education and training

Page 12: Partnership for the Assessment of Risk from Chemicals (PARC)€¦ · •Toxicokinetic modelling, PBK, (Q)IVIVE •Endocrine Disruptors •Mixtures •Nano materials •Human biomonitoring

Syftet med PARC

The purpose of the Partnership is to drive innovation in chemical risk assessment and thereby enable the sustainable use and management of chemicals whilst protecting human health and the environment and contributing to a non-toxic environment by:

• strengthening the scientific basis for chemical risk assessment in the EU, by bringing risk assessors and managers together with scientists to accelerate method development, the generation of necessary data and knowledge, and

• facilitating the transition to next generation evidence-based risk assessment

Page 13: Partnership for the Assessment of Risk from Chemicals (PARC)€¦ · •Toxicokinetic modelling, PBK, (Q)IVIVE •Endocrine Disruptors •Mixtures •Nano materials •Human biomonitoring

PARC strukturLina Wendt-Rasch, Kemikalieinspektionen

Linda Linderholm, Naturvårdsverket

Page 14: Partnership for the Assessment of Risk from Chemicals (PARC)€¦ · •Toxicokinetic modelling, PBK, (Q)IVIVE •Endocrine Disruptors •Mixtures •Nano materials •Human biomonitoring

PARC organisation

Country Board

Political guidanceNational risk managers/assessors

e.g. ministries

Programme Owners

EU Board

Political guidanceEU risk managers/assessors

(DG R&I) (DG SANTE) (DG ENV)

(DG GROW) (JRC)

National

Hubs

EU Hub:

DG EMPL

ECHA

EEA

EFSA

EU-OSHA

EMA

Coordinator & Management BoardWork package leaders and the Partnership coordinator

Grant Signatories BoardNational programme managers

e.g. national agencies in charge of risk assessment

and/or funding agencies

Ethics and Data

Protection Board

Bureau of the CB/EUB

Strategy

Operation

Stakeholder Forum

International Board

Linked Third Parties

LTPs

Page 15: Partnership for the Assessment of Risk from Chemicals (PARC)€¦ · •Toxicokinetic modelling, PBK, (Q)IVIVE •Endocrine Disruptors •Mixtures •Nano materials •Human biomonitoring

Arbetsprogram

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Arbetsprogram

Task Leaders Are responsible for managing their tasks and contributing to the development of annual work plans, implementing the work plans and contributing to the financial and technical reporting. They will interact closely with the WP leaders. They are responsible for ensuring that the work is conducted in accordance with the appropriate deadlines and resources, and delivered with high scientific quality.

Work Package Leaders Form together with the Coordinator (ANSES) the Management Board, and are in charge of managing and leading their work package. This includes e.g. drafting the contributions to the annual work plan and ensuring the work as agreed is carried out, overseeing deadlines, quality controlling deliverables and supervising the financial management and reporting for the WP.

Linked Third Parties:Academia and research organisations part of the national networks on research for chemical risk assessment and with established links to the risk assessing institutions

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Interim Workpackage leaders

WP Organisation Country

1 ANSES France

2 EEA

AAE

Europe

Austria

3 GSCL Greece

INSA Portugal

4 SpF France

UBA Germany

5 BfR Germany

ANSES France

6 KEMI Sweden

RIVM the Netherlands

7 VITO Belgium

8 AUTh Greece

9 ISCIII Spain

RECETOX Masaryk Czech Republic

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Finansiering• Partnerskapsprogrammet PARC ska tillgodose riskbedömningsmyndigheternas behov av

forskning. Forskningen kommer att finansieras av EU samt genom motfinansiering från

deltagande länder.

• 15 oktober 2020 förväntas medlemsländerna ge definitivt besked om vilka partnerskap som

de vill delta i.

• Hur en eventuell motfinansiering i så fall skulle kunna se ut i Sverige är inte klart.

• NVs miljöövervakningsanslag används idag för HBM4EU under Horizon. Endast NV och HaV

har idag egna forskningspengar samt miljöövervakningsanslag som eventuellt skulle kunna

motfinansiera de delar i PARC som rör human/environmental monitoring/screening.

• Den preliminära hubben ser att det är väldigt viktigt med transparens och att Sverige kommer

att ha möjlighet att delta i de delar som vi ser är prioriterade.

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Vad händer framöver?

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Vad händer framöver?

Autumn 2020

18 September 2020

15 October 2020

January 2021

Jan - March 2021

Jan – April 2021

April 2021

April – August 2021

Sep – Dec 2021

January 2022

Discussion with interim Work Package (co)leaders and Task Leader candidates to attribute roles

Deadline for responses to the consultation / questionnaires for prioritisation

National commitments for participation in European Partnerships

Launch of the call for the Partnership by the Commission

Preparation of the proposal submission

Verification of documents for LTPs

Submission of the complete proposal

Evaluation by the Commission

Contractual process

Launch of the Partnership and kick off meeting!!!

Roadmap for the next steps

Page 21: Partnership for the Assessment of Risk from Chemicals (PARC)€¦ · •Toxicokinetic modelling, PBK, (Q)IVIVE •Endocrine Disruptors •Mixtures •Nano materials •Human biomonitoring

Nästa steg

• De som är intresserade av att delta på något sätt ska anmäla sig via [email protected]• Inkludera namn, institution/arbetsplats och fullständiga kontaktuppgifter

• Senast 14/9

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Mer information

Concept paper

https://ec.europa.eu/info/files/european-partnership-chemicals-risk-assessment_en

Enkät om prioriteringar inom PARC (senast 18/9)

https://www.hbm4eu.eu/parc_survey/

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Mer informationNominering av ämnen/ämnesgrupper för HBM• Nya nomineringar till lista 3 för HBM4EU, deadline 15 september• Man kan nominera ämnen eller ämnesgrupper och även ämnen som tidigare

varit listade • Vid nominering av enskilt ämne ska vetenskapligt namn, CAS-nummer, EC-

nummer och andra relevanta namn anges• Vid nominering av grupper ska namn och grund för nomineringen anges.• Skickas till [email protected] med cc till [email protected] och

[email protected]• Sverige skickar in EN lista så använd inte den länk som råkat ha skickats ut, det

måste nämligen NV göra.• Max 5 ämnen eller ämnesgrupper kan skickas in från varje part

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Frågor?