Hazard identification and characterization of leachable chemicals from plastic products – a new PARC project

Hubert Dirven^1,2*Aleksandra Bogusz³Hans Bouwmeester⁴Mathias Busch⁴Guillaume DUFLOS⁵Gunnar Eriksen⁶Margarida Fardilha⁷Daniela Flores-Gomez⁸Nina Franko⁹Laurent Gaté¹⁰Yves Guichard¹⁰Maria João Aleixo Silva¹¹Jorke Kamstra⁸Konstantinos M Kasiotis¹²Sunmi Kim¹³Youngsam Kim¹⁴Elise van der Koogh⁴Susana Loureiro⁷Henriqueta Louro¹¹Kyriaki Machera¹²Raymond Pieters⁸Anastasia Spyropoulou¹²Evangelia N. Tzanetou¹²Catarina Malheiro⁷Tim Ravnjak¹⁵Guillermo Repetto¹⁶Gilles Riviere⁵Chang Seon Ryu¹⁷Evgenia Anna Papadopoulou¹²Konstantinos A. Aliferis¹²Anita Solhaug¹⁸Marija Sollner Dolenc¹⁹Martina Štampar¹⁵Ana M. Tavares¹¹Knut Erik Tollefsen²⁰Célia Ventura¹¹Radoslaw Walkowiak²¹Walter Zobl²⁰Bojana Zegura¹⁵Igor Snapkow²²Dorte Herzke²²

• ¹Norwegian Institute of Public Health (NIPH), Oslo, Norway
• ²Folkehelseinstituttet Omrade for smittevern miljo og helse, Oslo, Norway
• ³Institute of Environmental Protection - National Research Institute, Poland, Warszawa, Poland
• ⁴Wageningen University & Research, Wageningen, Netherlands
• ⁵Anses Laboratoire de Fougeres, Fougères, France
• ⁶Veterinary Institute, Ås Akershus, Norway
• ⁷Universidade de Aveiro, Aveiro, Portugal
• ⁸Universiteit Utrecht, Utrecht, Netherlands
• ⁹Univerza v Ljubljani, Ljubljana, Slovenia
• ¹⁰Institut National de Recherche et de Securite Centre de Lorraine, Vandœuvre-lès-Nancy, France
• ¹¹Instituto Nacional de Saude Doutor Ricardo Jorge, Lisbon, Portugal
• ¹²Mpenakeio Fytopathologiko Institouto, Athens, Greece
• ¹³Korean Research Institute of Chemical Technology, Daejeon, Republic of Korea
• ¹⁴Korea Institute of Science and Technology Europe Forschungsgesellschaft mbH, Saarbrücken, Germany
• ¹⁵Nacionalni institut za biologijo, Ljubljana, Slovenia
• ¹⁶Universidad Pablo de Olavide, Seville, Spain
• ¹⁷Movianto Deutschland GmbH Kist, Kist, Germany
• ¹⁸veterinarinstituttet, Ås, akershus, Norway
• ¹⁹University of Ljubljana, Ljubljana, Slovenia
• ²⁰Norsk Institutt for Vannforskning, Oslo, Norway
• ²¹Institute for Environmental Protection, Warszaw, Poland
• ²²Folkehelseinstituttet Omrade for klima og miljo, Oslo, Norway

A recent study has suggested that plastics may contain more than 16,000 chemicals, including additives, processing aids, starting substances, intermediates and Non-Intentionally Added Substances (NIASs). Plastic chemicals are released throughout the plastic life cycle, from production, use, disposal and recycling. Most of these chemicals have not been studied for potential hazardous properties for humans and in the environment. To refine the risk assessment of these leachable chemicals, additional hazard data are needed. The PlasticLeach project within the EU co-funded Partnership for the Assessment of Risks from Chemicals (PARC) aims to address this data gap by screening several plastic products in daily use. Leachates will be prepared from a number of these plastic items, and these chemical mixtures will be further tested using several test guideline compliant assays and New Approach Methods (NAMs), covering both human health and environmental endpoints. The most toxic leachates will be characterized using a non-targeted analysis pipeline to identify chemicals in the leachate. When single chemicals of concern are identified, these will be further tested to determine hazardous properties and identify the respective potency factors to better understand their specific hazard profiles. A tiered approach for hazard testing will be followed. The experimental work will be complemented by in silico toxicological profiling, using publicly available toxicity databases and tools, including Artificial Intelligence tools that cover both human and environmental endpoints. A comprehensive array of endpoints, including cytotoxicity, endocrine disruption, genotoxicity, immunotoxicity, reproductive toxicity and effects related to ecotoxicity will be evaluated. In this paper, we outline the plastic products to be tested and the battery of assays that will be used to identify hazards relevant to both human health and the environment. Data generated from in silico, in vitro, and in vivo approaches will be reported using standardized formats, stored within a centralized repository, and harmonized to adhere to the FAIR data principles (Findable, Accessible, Interoperable, and Reusable). This integrated strategy will not only advance our understanding of the risks associated with plastic-derived chemicals but will also provide critical support for regulatory decision-making and facilitate the development of safer, and more ecofriendly plastic materials.