Browsing by Author "Rousselle, Christophe"
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- Harmonized human biomonitoring in European children, teenagers and adults: EU-wide exposure data of 11 chemical substance groups from the HBM4EU Aligned Studies (2014-2021)Publication . Govarts, Eva; Gilles, Liese; Rodriguez Martin, Laura; Santonen, Tiina; Apel, Petra; Alvito, Paula; Anastasi, Elena; Andersen, Helle Raun; Andersson, Anna-Maria; Andryskova, Lenka; ANTIGNAC, Jean-Philippe; Rüther, Maria; Sarigiannis, Denis; Silva, Maria João; Šlejkovec, Zdenka; Snoj Tratnik, Janja; Stajnko, Anja; Szigeti, Tamas; Tarazona, Jose; Thomsen, Cathrine; Tkalec, Žiga; Trnovec, Tomas; Tolonen, Hanna; Uhl, Maria; Van Nieuwenhuyse, An; Vasco, Elsa; Verheyen, Veerle J.; Viegas, Susana; Vinggaard, Anne Marie; Vogel, Nina; Vorkamp, Katrin; Wasowicz, Wojciech; Wimmerova, Sona; Weber, Till; Woutersen, Marjolijn; Zimmermann, Philipp; Zvonar, Martin; Koch, Holger; Kolossa-Gehring, Marike; Esteban López, Marta; Castano, Argelia; Stewart, Lorraine; Sepai, Ovnair; Appenzeller, Brice; Schoeters, Greta; Barbone, Fabio; Barnett-Itzhaki, Zohar; Barouki, Robert; Berman, Tamar; Bil, Wieneke; Borges, Teresa; Buekers, Jurgen; Cañas-Portilla, Ana; Covaci, Adrian; Csako, Zsofia; Den Hond, Elly; Dvorakova, Darina; Fabelova, Lucia; Fletcher, Tony; Frederiksen, Hanne; Gabriel, Catherine; Ganzleben, Catherine; Göen, Thomas; Halldorsson, Thorhallur; Haug, Line Småstuen; Horvat, Milena; Huuskonen, Pasi; Imboden, Medea; Jagodic Hudobivnik, Marta; Janasik, Beata; Janev Holcer, Natasa; Karakitsios, Spyros; Katsonouri, Andromachi; Klanova, Jana; Kokaraki, Venetia; Kold Jensen, Tina; Koponen, Jani; Laeremans, Michelle; Laguzzi, Federica; Lange, Rosa; Lemke, Nora; Lignell, Sanna; Lindroos, Anna Karin; Lobo Vicente, Joana; Luijten, Mirjam; Makris, Konstantinos C.; Mazej, Darja; Melymuk, Lisa; Meslin, Matthieu; Mol, Hans; Montazeri, Parisa; Murawski, Aline; Namorado, Sónia; Niemann, Lars; Nübler, Stefanie; Nunes, Baltazar; Olafsdottir, Kristin; Palkovicova Murinova, Lubica; Papaioannou, Nafsika; Pedraza-Diaz, Susana; Piler, Pavel; Plichta, Veronika; Poteser, Michael; Probst-Hensch, Nicole; Rambaud, Loic; Rauscher-Gabernig, Elke; Rausova, Katarina; Remy, Sylvie; Riou, Margaux; Rosolen, Valentina; Rousselle, ChristopheAbstract: As one of the core elements of the European Human Biomonitoring Initiative (HBM4EU) a human biomonitoring (HBM) survey was conducted in 23 countries to generate EU-wide comparable HBM data. This survey has built on existing HBM capacity in Europe by aligning national or regional HBM studies, referred to as the HBM4EU Aligned Studies. The HBM4EU Aligned Studies included a total of 10,795 participants of three age groups: (i) 3,576 children aged 6–12 years, (ii) 3,117 teenagers aged 12–18 years and (iii) 4,102 young adults aged 20–39 years. The participants were recruited between 2014 and 2021 in 11–12 countries per age group, geographically distributed across Europe. Depending on the age group, internal exposure to phthalates and the substitute DINCH, halogenated and organophosphorus flame retardants, per- and polyfluoroalkyl substances (PFASs), cadmium, bisphenols, polycyclic aromatic hydrocarbons (PAHs), arsenic species, acrylamide, mycotoxins (deoxynivalenol (total DON)), benzophenones and selected pesticides was assessed by measuring substance specific biomarkers subjected to stringent quality control programs for chemical analysis. For substance groups analyzed in different age groups higher average exposure levels were observed in the youngest age group, i.e., phthalates/DINCH in children versus teenagers, acrylamide and pesticides in children versus adults, benzophenones in teenagers versus adults. Many biomarkers in teenagers and adults varied significantly according to educational attainment, with higher exposure levels of bisphenols, phthalates, benzophenones, PAHs and acrylamide in participants (from households) with lower educational attainment, while teenagers from households with higher educational attainment have higher exposure levels for PFASs and arsenic. In children, a social gradient was only observed for the non-specific pyrethroid metabolite 3-PBA and di-isodecyl phthalate (DiDP), with higher levels in children from households with higher educational attainment. Geographical variations were seen for all exposure biomarkers. For 15 biomarkers, the available health-based HBM guidance values were exceeded with highest exceedance rates for toxicologically relevant arsenic in teenagers (40%), 3-PBA in children (36%), and between 11 and 14% for total DON, Σ (PFOA + PFNA + PFHxS + PFOS), bisphenol S and cadmium. The infrastructure and harmonized approach succeeded in obtaining comparable European wide internal exposure data for a prioritized set of 11 chemical groups. These data serve as a reference for comparison at the global level, provide a baseline to compare the efficacy of the European Commission's chemical strategy for sustainability and will give leverage to national policy makers for the implementation of targeted measures.
- How to use human biomonitoring in chemical risk assessment: Methodological aspects, recommendations, and lessons learned from HBM4EUPublication . Santonen, Tiina; Mahiout, Selma; Alvito, Paula; Apel, Petra; Bessems, Jos; Bil, Wieneke; Borges, Teresa; Bose-O'Reilly, Stephan; Buekers, Jurgen; Cañas Portilla, Ana Isabel; Calvo, Argelia Castaño; de Alba González, Mercedes; Domínguez-Morueco, Noelia; López, Marta Esteban; Falnoga, Ingrid; Gerofke, Antje; Caballero, María del Carmen González; Horvat, Milena; Huuskonen, Pasi; Kadikis, Normunds; Kolossa-Gehring, Marike; Lange, Rosa; Louro, Henriqueta; Martins, Carla; Meslin, Matthieu; Niemann, Lars; Díaz, Susana Pedraza; Plichta, Veronika; Porras, Simo P.; Rousselle, Christophe; Scholten, Bernice; Silva, Maria João; Šlejkovec, Zdenka; Tratnik, Janja Snoj; Joksić, Agnes Šömen; Tarazona, Jose V.; Uhl, Maria; Van Nieuwenhuyse, An; Viegas, Susana; Vinggaard, Anne Marie; Woutersen, Marjolijn; Schoeters, GreetThe need for such information is pressing, as previous research has indicated that regulatory risk assessors generally lack knowledge and experience of the use of HBM data in RA. By recognising this gap in expertise, as well as the added value of incorporating HBM data into RA, this paper aims to support the integration of HBM into regulatory RA. Based on the work of the HBM4EU, we provide examples of different approaches to including HBM in RA and in estimations of the environmental burden of disease (EBoD), the benefits and pitfalls involved, information on the important methodological aspects to consider, and recommendations on how to overcome obstacles. The examples are derived from RAs or EBoD estimations made under the HBM4EU for the following HBM4EU priority substances: acrylamide, o-toluidine of the aniline family, aprotic solvents, arsenic, bisphenols, cadmium, diisocyanates, flame retardants, hexavalent chromium [Cr(VI)], lead, mercury, mixture of per-/polyfluorinated compounds, mixture of pesticides, mixture of phthalates, mycotoxins, polycyclic aromatic hydrocarbons (PAHs), and the UV-filter benzophenone-3. Although the RA and EBoD work presented here is not intended to have direct regulatory implications, the results can be useful for raising awareness of possibly needed policy actions, as newly generated HBM data from HBM4EU on the current exposure of the EU population has been used in many RAs and EBoD estimations.
- Human biomonitoring in health risk assessment in Europe: current practices and recommendations for the futurePublication . Louro, Henriqueta; Heinälä, Milla; Bessems, Jos; Buekers, Jurgen; Vermeire, Theo; Woutersen, Marjolijn; van Engelen, Jacqueline; Borges, Teresa; Rousselle, Christophe; Ougier, Eva; Alvito, Paula; Martins, Carla; Assunção, Ricardo; Silva, Maria João; Pronk, Anjoeka; Schaddelee-Scholten, Bernice; Del Carmen Gonzalez, Maria; de Alba, Mercedes; Castaño, Argelia; Viegas, Susana; Humar-Juric, Tatjana; Kononenko, Lijana; Lampen, Alfonso; Vinggaard, Anne Marie; Schoeters, Greet; Kolossa-Gehring, Marike; Santonen, TiinaHuman biomonitoring (HBM) is an important tool to survey the internal exposure of humans which represents the real life chemical body burden to chemicals and/or their metabolites. It results from total exposure to chemical substances from different sources and via different routes. These substances may be regulated under different legislative frameworks on chemicals (e.g., environmental, occupational, food safety etc). In occupational health, HBM has long traditions to control the exposures at workplaces. By providing accurate data on internal exposure, HBM data can improve human health risk assessment (RA) for both the general population and workers. Although the past few years have shown good examples on the use of HBM in the RA of chemicals, there is still quite some work to be done to improve its use in a regulatory RA. Under the scope of the European Human Biomonitoring Initiative (project HBM4EU, 2017-2021), the current study reviews the state-of-the-art of HBM use in chemicals RA with a special focus in Europe, and attempts to identify hurdles and challenges faced by regulators. To gather information on the use of HBM, including the availability of guidance on how to use it in RA, the RA schemes applied by different European or international organizations were analysed. Examples of such use were identified for a few selected groups of chemicals of concern for human health. In addition, we present the results of a survey, aimed at collecting information from national regulatory risk assessors on their day-to-day RA practices, the use of HBM data, and the obstacles and challenges related to their use. The results evidenced and explained some of the current obstacles of using HBM data in RA. These included the lack of HBM guidance values or biomonitoring equivalents (BEs), limited toxicokinetic information to support the interpretation of HBM data and, in the occupational health and safety (OSH) field, the lack of legal enforcement. Therefore, to support the integration of HBM in regulatory RA, we recommend, on one hand, the elaboration of a EU level guidance on the use of HBM in RA and, on the other hand, the continuation of research efforts to integrate HBM with new RA approaches using in vitro/in silico data and Adverse Outcome Pathways (AOPs).
- Innovating in the exposure and risk assessment of chemical contaminants – exploring synergies with the European PARC ProjectPublication . Silva, Maria João; Koutsodimou, Aglaia; Namorado, Sónia; Dessipri, Eugenia; Alygisakis, Nikiforos; Rousselle, Christophe; Sanders, PascalThe prevalence of many human diseases can be drastically reduced through the identification and prevention of environmental risk factors. This fact constitutes a strong incentive to innovate in the exposure and hazard assessment of chemicals, through all available knowledge and technologies, towards a next-generation risk assessment (NGRA). The European Partnership for the Assessment of Risks from Chemicals (PARC, 2022 – 2029) coordinated by the French Agency for Food, Environmental and Occupational Health & Safety (ANSES), brings together around 200 partners from all Europe and three European Agencies, with the common goal of strengthening research and increasing the capacity for innovation in risk assessment, to protect human health and the environment. PARC is organized in three main pillars; i) establishment of a high level network at the interface of science and policy, setting the science-policy agenda and developing synergies collaboration and awareness; ii) implementation of Research & Innovation towards NGRA , comprising the fields of exposure and monitoring, hazard assessment, innovation in regulatory risk assessment and concepts and toolboxes; iii) development of capacities and platforms, to ensure FAIR data production and to develop infrastructures and human capacities. PARC was built on lessons learned and knowledge acquired in other initiatives, e.g., the Human Biomonitoring Initiative for Europe (HBM4EU) but intends to go further and use a more holistic approach through the development of tools and methods that will enable the integration of all sources and routes of exposure to chemical contaminants and by targeting human and environmental health. Several substances groups have been prioritised for study, including heavy metals, bisphenol A analogues, pesticides, and mycotoxins. Taking advantage of established and innovative tools and technologies, PARC also expects to increase the effi ciency of in vitro toxicity testing while reducing the use of animals. The development of Adverse Outcome Pathways will set the biological framework to enable the development of integrated approaches to testing and assessment for regulatory decision-making. This will support the implementation of preventive measures, interventions, or new policies, to better protect public health. To boost its impact, a strategy for the communication and dissemination of PARC outcomes, targeted to diff erent end-users, has been established. Furthermore, PARC offers a unique opportunity to foster synergies and establish effective collaborations with other relevant scientifi c and/or regulatory initiatives at a global level, which will be crucial to maximize the global impact and regulatory acceptance of NGRA.
- SCCS Opinion on Biphenyl-2-ol and Sodium 2-biphenylolate used in cosmetic products (CAS/EC No. 90-43-7/201-993-5 and 132-27-4/205-055-6)– SCCS/1669/24Publication . Bernauer, Ulrike; Bodin, Laurent; Chaudhry, Qasim; Coenraads, Pieter Jan; Ezendam, Janine; Gaffet, Eric; Galli, Corrado L.; Panteri, Eirini; Rogiers, Vera; Rousselle, Christophe; Stepnik, Maciej; Vanhaecke, Tamara; Wijnhoven, Susan; Benfenati, Emilio; Corsini, Emanuela; Koutsodimou, Aglaia; Aglaia Koutsodimou; Louro, Henriqueta; Uter, Wolfgang; von Goetz, NatalieHighlights: -o-Phenylphenol (OPP) is safe when used as preservative up to a maximum concentration of 0.2 % in rinse-off cosmetic products; - o-Phenylphenol (OPP) is safe when used as preservative up to a maximum concentration of 0.15 % in leave-on cosmetic products; - Sodium o-Phenylphenate is safe when used as preservative up to a maximum concentration of 0.2 % in rinse-off cosmetic products; - Sodium o-Phenylphenate is safe when used as preservative up to a maximum concentration of 0.15 % in leave-on cosmetic products; - OPP and Sodium o-Phenylphenate, when used together, should not exceed the maximum concentration 0.15 % in leave-on cosmetic products; - OPP and Sodium o-Phenylphenate, when used together, should not exceed the maximum concentration 0.2 % in rinse-off cosmetic products; - Since this safety dossier related to dermally applied products only, the SCCS did not consider oral and inhalation routes; - This assessment did not cover the safety of O-Phenylphenol and Sodium o-Phenylphenate for the environment.
- Scientific Opinion on benzophenone – 4 (CAS No. 4065-45-6, EC No. 223-772-2) used in cosmetics products – SCCS/1660/23Publication . Van Haecke, Tamara; Rogiers, Vera; Scientific Committee on Consumer Safety - SCCS; Bernauer, Ulrike; Bodin, Laurent; Chaudhry, Qasim; Coenraads, Pieter Jan; Ezendam, Janine; Gaffet, Eric; Galli, Corrado L.; Panteri, Eirini; Rogiers, Vera; Rousselle, Christophe; Stepnik, Maciej; Vanhaecke, Tamara; Wijnhoven, Susan; Benfenati, Emilio; Cabaton, Nicolas; Corsini, Emanuela; Koutsodimou, Aglaia; Louro, Henriqueta; Uter, Wolfgang; von Goetz, NatalieHighlights: -BZP-4 is safe when used as UV filter up to a max. conc. of 5 % in sunscreen, all leave-on products (tot. dermal aggregate); -BZP-4 is safe when used as UV filter up to a max. conc. of 5 % in sunscreen, all rinse-off products (tot. dermal aggregate); -Same for lipstick, sunscreen propellant and pump spray (separately or in combination based on determ. aggregated exposure); -BZP-4 use as stabiliser when the product is exposed to light should remain within the conc. of. 5 %, incl. UV-filter use; -This assessment did not cover the safety of Benzophenone-4 for the environment.