Current approaches for the assessment of environmental and human health risks due to exposure to chemical substances have served their purpose reasonably well. Nevertheless, the systems in place for different uses of chemicals are faced with various challenges, ranging from a growing number of chemicals to changes in the types of chemicals and materials produced. This has triggered global awareness of the need for a paradigm shift, which in turn has led to the publication of new concepts for chemical risk assessment and explorations of how to translate these concepts into pragmatic approaches. As a result, next-generation risk assessment (NGRA) is generally seen as the way forward. However, incorporating new scientific insights and innovative approaches into hazard and exposure assessments in such a way that regulatory needs are adequately met has appeared to be challenging. The European Partnership for the Assessment of Risks from Chemicals (PARC) has been designed to address various challenges associated with innovating chemical risk assessment. Its overall goal is to consolidate and strengthen the European research and innovation capacity for chemical risk assessment to protect human health and the environment. With around 200 participating organisations from all over Europe, including three European agencies, and a total budget of over 400 million euro, PARC is one of the largest projects of its kind. It has a duration of seven years and is coordinated by ANSES, the French Agency for Food, Environmental and Occupational Health & Safety.

Aristoteles University Thessaloniki Thessaloniki Greece

Austrian Federal Environments Agency Vienna Austria

Department of Public Health University of Naples Federico 2 Naples Italy

European Commission DG Research and Innovation Orban 09 199 1049 Brussels Belgium

European Environment Agency Kongens Nytorv 6 1050 Copenhagen K Denmark

French Agency for Food Environmental and Occupational Health and Safety 94701 Maisons Alfort France

General Chemical State Laboratory of Greece Athens Greece

German Environment Agency Wörlitzer Platz 1 06844 Dessau Germany

German Federal Institute for Risk Assessment Max Dohrn Str 8 10 10589 Berlin Germany

Masaryk Uinversity Recetox Kotlarska 2 61137 Brno Czechia

National Centre for Environmental Health Instituto de Salud Carlos 3 Madrid Spain

National Institute for Health and Environment Bilthoven The Netherlands

National Institute of Health Dr Ricardo Jorge Avenida Padre Cruz 1649 016 Lisbon Portugal

Santé Publique France 12 Rue du Val D'Osne 94415 St Maurice France

School of Geography Earth and Environmental Sciences University of Birmingham Edgbaston Birmingham B15 2TT UK

Swedish Chemicals Agency Vasagatan 12D 172 67 Sundbyberg Sweden

VITO Boeretang 200 2400 Mol Belgium

Zobrazit více v PubMed

Ankley GT, Edwards SW. The adverse outcome pathway: a multifaceted framework supporting 21(st) century toxicology. Curr Opin Toxicol. 2018;9:1–7. doi: 10.1016/j.cotox.2018.03.004. PubMed DOI PMC

Apel P, Rousselle C, Lange R, Sissoko F, Kolossa-Gehring M, Ougier E. Human biomonitoring initiative (HBM4EU) - strategy to derive human biomonitoring guidance values (HBM-GVs) for health risk assessment. Int J Hyg Environ Health. 2020;230:113622. doi: 10.1016/j.ijheh.2020.113622. PubMed DOI

Council NR . Toxicity testing in the 21st century: a vision and a strategy. Washington, DC: The National Academies Press; 2007.

Daston G, Knight DJ, Schwarz M, et al. SEURAT: Safety evaluation ultimately replacing animal testing–recommendations for future research in the field of predictive toxicology. Arch Toxicol. 2015;89(1):15–23. doi: 10.1007/s00204-014-1421-5. PubMed DOI

Den Hond E, Govarts E, Willems H, et al. First steps toward harmonized human biomonitoring in Europe: demonstration project to perform human biomonitoring on a European scale. Environ Health Perspect. 2015;123(3):255–263. doi: 10.1289/ehp.1408616. PubMed DOI PMC

Embry MR, Bachman AN, Bell DR, et al. Risk assessment in the 21st century: roadmap and matrix. Crit Rev Toxicol. 2014;44(Suppl 3):6–16. doi: 10.3109/10408444.2014.931924. PubMed DOI

Escher SE, Kamp H, Bennekou SH, et al. Towards grouping concepts based on new approach methodologies in chemical hazard assessment: the read-across approach of the EU-ToxRisk project. Arch Toxicol. 2019;93(12):3643–3667. doi: 10.1007/s00204-019-02591-7. PubMed DOI

Esteban Lopez M, Goen T, Mol H, et al. The European human biomonitoring platform - design and implementation of a laboratory quality assurance/quality control (QA/QC) programme for selected priority chemicals. Int J Hyg Environ Health. 2021;234:113740. doi: 10.1016/j.ijheh.2021.113740. PubMed DOI

European Commission (2004) Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC. Off J Eur Union L338/4

European Commission (2006) Regulation (EC) No 1907/2006 of the European Parliament and the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/105/EC and 2000/21/EC. Off J Eur Union L396/1

European Commission (2008) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006. Off J Eur Union L353/1

European Commission (2009a) Regulation (EC) No 1223/2009a of the European Parliament and of the Council of 30 November 2009a on cosmetic products. Off J EUR Union L342/59

European Commission (2009b) Regulation (EC) No 1107/2009b of the European Parliament and of the Council of 21 October 2009b concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC. Off J Eur Union L309/1

European Commission (2020) Communication from the Commission to the European Parliament, The Council, the European Economic and Social Committee and the Committee of the Regions. Chemicals Strategy for Sustainability, Towards a Toxic-Free Environment. COM(2020) 667 final. Available at https://ec.europa.eu/environment/pdf/chemicals/2020/10/Strategy.pdf

European Union (2012) Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 may 2012 concerning the making available on the market and use of biocidal products. Off J Eur Union L167/1

European Union (2016) Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation). Off J Eur Union L119/1

European Union (2020a) The EU's open science policy. https://research-and-innovation.ec.europa.eu/strategy/strategy-2020-2024/our-digital-future/open-science_en

Ganzleben C, Antignac JP, Barouki R, et al. Human biomonitoring as a tool to support chemicals regulation in the European Union. Int J Hyg Environ Health. 2017;220(2 Pt A):94–97. doi: 10.1016/j.ijheh.2017.01.007. PubMed DOI

Gilles L, Govarts E, Rambaud L, et al. HBM4EU combines and harmonises human biomonitoring data across the EU, building on existing capacity - The HBM4EU survey. Int J Hyg Environ Health. 2021;237:113809. doi: 10.1016/j.ijheh.2021.113809. PubMed DOI PMC

Gocht T, Berggren E, Ahr HJ, et al. The SEURAT-1 approach towards animal free human safety assessment. Altex. 2015;32(1):9–24. doi: 10.14573/altex.1408041. PubMed DOI

Jeddi MZ, Hopf NB, Viegas S, et al. Towards a systematic use of effect biomarkers in population and occupational biomonitoring. Environ Int. 2021 doi: 10.1016/j.envint.2020.106257. PubMed DOI

Joas R, Casteleyn L, Biot P, et al. Harmonised human biomonitoring in Europe: activities towards an EU HBM framework. Int J Hyg Environ Health. 2012;215(2):172–175. doi: 10.1016/j.ijheh.2011.08.010. PubMed DOI

Kolossa-Gehring M, Pack LK, Hulck K, Gehring T. HBM4EU from the Coordinator's perspective: lessons learnt from managing a large-scale EU project. Int J Hyg Environ Health. 2023;247:114072. doi: 10.1016/j.ijheh.2022.114072. PubMed DOI

Krebs A, van Vugt-Lussenburg BMA, Waldmann T, et al. The EU-ToxRisk method documentation, data processing and chemical testing pipeline for the regulatory use of new approach methods. Arch Toxicol. 2020;94(7):2435–2461. doi: 10.1007/s00204-020-02802-6. PubMed DOI PMC

Krewski D, Acosta D, Jr, Andersen M, et al. Toxicity testing in the 21st century: a vision and a strategy. J Toxicol Environ Health B Crit Rev. 2010;13(2–4):51–138. doi: 10.1080/10937404.2010.483176. PubMed DOI PMC

Luijten M, Sprong RC, Rorije E, van der Ven LTM. Prioritization of chemicals in food for risk assessment by integrating exposure estimates and new approach methodologies: a next generation risk assessment case study. Front Toxicol. 2022;4:933197. doi: 10.3389/ftox.2022.933197. PubMed DOI PMC

Mone MJ, Pallocca G, Escher SE, et al. Setting the stage for next-generation risk assessment with non-animal approaches: the EU-ToxRisk project experience. Arch Toxicol. 2020;94(10):3581–3592. doi: 10.1007/s00204-020-02866-4. PubMed DOI PMC

OECD (2018a) Test No. 443: Extended one-generation reproductive toxicity study

OECD (2018b) Users & apos; Handbook supplement to the Guidance Document for developing and assessing Adverse Outcome Pathways. 10.1787/5jlv1m9d1g32-en

OECD (2020) Overview of concepts and available guidance related to integrated Approaches to Testing and Assessment (IATA), OECD Series on Testing and Assessment, No. 329, Environment, Health and Safety, Environment Directorate, OECD. https://www.oecd.org/chemicalsafety/risk-assessment/concepts-and-available-guidance-related-to-integrated-approaches-to-testing-and-assessment.pdf

Pastoor TP, Bachman AN, Bell DR, et al. A 21st century roadmap for human health risk assessment. Crit Rev Toxicol. 2014;44(Suppl 3):1–5. doi: 10.3109/10408444.2014.931923. PubMed DOI

Pourchet M, Debrauwer L, Klanova J, et al. Suspect and non-targeted screening of chemicals of emerging concern for human biomonitoring, environmental health studies and support to risk assessment: from promises to challenges and harmonisation issues. Environ Int. 2020 doi: 10.1016/j.envint.2020.105545. PubMed DOI

Rotter S, Beronius A, Boobis AR, et al. Overview on legislation and scientific approaches for risk assessment of combined exposure to multiple chemicals: the potential EuroMix contribution. Crit Rev Toxicol. 2018;48(9):796–814. doi: 10.1080/10408444.2018.1541964. PubMed DOI

Schuijt LM, Peng FJ, van den Berg SJP, Dingemans MML, Van den Brink PJ. (Eco)toxicological tests for assessing impacts of chemical stress to aquatic ecosystems: facts, challenges, and future. Sci Total Environ. 2021 doi: 10.1016/j.scitotenv.2021.148776. PubMed DOI

Schultes E, Magagna B, Hettne KM, Pergl R, Suchanek M, Kuhn T. Reusable FAIR implementation profiles as accelerators of FAIR convergence. Lect Notes Comput Sc. 2020;12584:138–147. doi: 10.1007/978-3-030-65847-2_13. DOI

Thompson M, Burger K, Kaliyaperumal R, Roos M, Santos LOBD. Making FAIR easy with FAIR tools: from creolization to convergence. Data Intelligence. 2020;2(1–2):87–95. doi: 10.1162/dint_a_00031. DOI

Wilkinson MD, Dumontier M, Aalbersberg IJ, et al. The FAIR guiding principles for scientific data management and stewardship. Sci Data. 2016;3:160018. doi: 10.1038/sdata.2016.18. PubMed DOI PMC

Human biomonitoring of essential and toxic trace elements (heavy metals and metalloids) in urine of children, teenagers, and young adults from a Central European Cohort in the Czech Republic

Adopting Mechanistic Molecular Biology Approaches in Exposome Research for Causal Understanding

New approach methodologies to facilitate and improve the hazard assessment of non-genotoxic carcinogens-a PARC project