Browsing by Author "Benfenati, Emilio"
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- Developing human biomonitoring as a 21st century toolbox within the European exposure science strategy 2020-2030Publication . Zare Jeddi, Maryam; Hopf, Nancy B.; Louro, Henriqueta; Viegas, Susana; Galea, Karen S.; Pasanen-Kase, Robert; Santonen, Tiina; Mustieles, Vicente; Fernandez, Mariana F.; Verhagen, Hans; Bopp, Stephanie K.; Antignac, Jean Philippe; David, Arthur; Mol, Hans; Barouki, Robert; Audouze, Karine; Duca, Radu-Corneliu; Fantke, Peter; Scheepers, Paul; Ghosh, Manosij; Van Nieuwenhuyse, An; Lobo Vicente, Joana; Trier, Xenia; Rambaud, Loïc; Fillol, Clémence; Denys, Sebastien; Conrad, André; Kolossa-Gehring, Marike; Paini, Alicia; Arnot, Jon; Schulze, Florian; Jones, Kate; Sepai, Ovnair; Ali, Imran; Brennan, Lorraine; Benfenati, Emilio; Cubadda, Francesco; Mantovani, Alberto; Bartonova, Alena; Connolly, Alison; Slobodnik, Jaroslav; Bruinen de Bruin, Yuri; van Klaveren, Jacob; Palmen, Nicole; Dirven, Hubert; Husøy, Trine; Thomsen, Cathrine; Virgolino, Ana; Röösli, Martin; Gant, Tim; von Goetz, Natalie; Bessems, JosHuman biomonitoring (HBM) is a crucial approach for exposure assessment, as emphasised in the European Commission’s Chemicals Strategy for Sustainability (CSS). HBM can help to improve chemical policies in five major key areas: (1) assessing internal and aggregate exposure in different target populations; 2) assessing exposure to chemicals across life stages; (3) assessing combined exposure to multiple chemicals (mixtures); (4) bridging regulatory silos on aggregate exposure; and (5) enhancing the effectiveness of risk management measures. In this strategy paper we propose a vision and a strategy for the use of HBM in chemical regulations and public health policy in Europe and beyond. We outline six strategic objectives and a roadmap to further strengthen HBM approaches and increase their implementation in the regulatory risk assessment of chemicals to enhance our understanding of exposure and health impacts, enabling timely and targeted policy interventions and risk management. These strategic objectives are: 1) further development of sampling strategies and sample preparation; 2) further development of chemical-analytical HBM methods; 3) improving harmonisation throughout the HBM research life cycle; 4) further development of quality control / quality assurance throughout the HBM research life cycle; 5) obtain sustained funding and reinforcement by legislation; and 6) extend target-specific communication with scientists, policymakers, citizens and other stakeholders. HBM approaches are essential in risk assessment to address scientific, regulatory and societal challenges. HBM requires full and strong support from the scientific and regulatory domain to reach its full potential in public and occupational health assessment and in regulatory decision-making.
- 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.
- Towards a systematic use of effect biomarkers in population and occupational biomonitoringPublication . Zare Jeddi, Maryam; Hopf, Nancy B.; Viegas, Susana; Price, Anna Bal; Paini, Alicia; van Thriel, Christoph; Benfenati, Emilio; Ndaw, Sophie; Bessems, Jos; Behnisch, Peter A.; Leng, Gabriele; Duca, Radu-Corneliu; Verhagen, Hans; Cubadda, Francesco; Brennan, Lorraine; Ali, Imran; David, Arthur; Mustieles, Vicente; Fernandez, Mariana F.; Louro, Henriqueta; Pasanen-Kase, RobertEffect biomarkers can be used to elucidate relationships between exposure to environmental chemicals and their mixtures with associated health outcomes, but they are often underused, as underlying biological mechanisms are not understood. We aim to provide an overview of available effect biomarkers for monitoring chemical exposures in the general and occupational populations, and highlight their potential in monitoring humans exposed to chemical mixtures. We also discuss the role of the adverse outcome pathway (AOP) framework and physiologically based kinetic and dynamic (PBK/D) modelling to strengthen the understanding of the biological mechanism of effect biomarkers, and in particular for use in regulatory risk assessments. An interdisciplinary network of experts from the European chapter of the International Society for Exposure Science (ISES Europe) and the Organization for Economic Co-operation and Development (OECD) Occupational Biomonitoring activity of Working Parties of Hazard and Exposure Assessment group worked together to map the conventional framework of biomarkers and provided recommendations for their systematic use. We summarized the key aspects of this work here, and discussed these in three parts. Part I, we inventory available effect biomarkers and promising new biomarkers for the general population based on the H2020 Human Biomonitoring for Europe (HBM4EU) initiative. Part II, we provide an overview AOP and PBK/D modelling use that improved the selection and interpretation of effect biomarkers. Part III, we describe the collected expertise from the OECD Occupational Biomonitoring subtask effect biomarkers in prioritizing relevant mode of actions (MoAs) and suitable effect biomarkers. Furthermore, we propose a tiered risk assessment approach for occupational biomonitoring. Several effect biomarkers, especially for use in occupational settings, are validated. They offer a direct assessment of the overall health risks associated with exposure to chemicals, chemical mixtures and their transformation products. Promising novel effect biomarkers are emerging for biomonitoring of the general population. Efforts are being dedicated to prioritizing molecular and biochemical effect biomarkers that can provide a causal link in exposure-health outcome associations. This mechanistic approach has great potential in improving human health risk assessment. New techniques such as in silico methods (e.g. QSAR, PBK/D modelling) as well as 'omics data will aid this process. Our multidisciplinary review represents a starting point for enhancing the identification of effect biomarkers and their mechanistic pathways following the AOP framework. This may help in prioritizing the effect biomarker implementation as well as defining threshold limits for chemical mixtures in a more structured way. Several ex vivo biomarkers have been proposed to evaluate combined effects including genotoxicity and xeno-estrogenicity. There is a regulatory need to derive effect-based trigger values using the increasing mechanistic knowledge coming from the AOP framework to address adverse health effects due to exposure to chemical mixtures. Such a mechanistic strategy would reduce the fragmentation observed in different regulations. It could also stimulate a harmonized use of effect biomarkers in a more comparable way, in particular for risk assessments to chemical mixtures.