title: White paper on the promotion of an integrated risk assessment concept in European regulatory frameworks for chemicals.
abstract: The vision of a sustainable and safe use of chemicals to protect human health, preserve the environment and maintain the ecosystem requires innovative and more holistic approaches to risk assessment (RA) in order to better inform decision making. Integrated risk assessment (IRA) has been proposed as a solution to current scientific, societal and policy needs. It is defined as the mutual exploitation of environmental risk assessment (ERA) for human health risk assessment (HHRA) and vice versa in order to coherently and more efficiently characterize an overall risk to humans and the environment for better informing the risk analysis process. Extrapolating between species which are relevant for HHRA and ERA requires a detailed understanding of pathways of toxicity/modes of action (MoA) for the various toxicological endpoints. Significant scientific advances, changes in chemical legislation, and increasing environmental consciousness have created a favourable scientific and regulatory environment to develop and promote the concept and vision of IRA. An initial proof of concept is needed to foster the incorporation of IRA approaches into different chemical sectorial regulations and demonstrate their reliability for regulatory purposes. More familiarity and confidence with IRA will ultimately contribute to an overall reduction in in vivo toxicity testing requirements. However, significant progress will only be made if long-term support for MoA-related research is secured. In the short term, further exchange and harmonization of RA terminology, models and methodologies across chemical categories and regulatory agencies will support these efforts. Since societal values, public perceptions and cultural factors are of increasing importance for the acceptance of risk analysis and successful implementation of risk mitigation measures, the integration of socio-economic analysis and socio-behavioural considerations into the risk analysis process may help to produce a more effective risk evaluation and consideration of the risks and benefits associated with the use of chemicals.
authors.affiliation: Swiss Centre for Applied Human Toxicology (SCAHT), University of Basel, Switzerland. Electronic address: martin.wilks@unibas.ch.
authors.forename: M F
authors.initials: MF
authors.lastname: Wilks
authors.affiliation: Swiss Centre for Applied Human Toxicology (SCAHT), University of Basel, Switzerland.
authors.forename: N
authors.initials: N
authors.lastname: Roth
authors.affiliation: Swiss Centre for Applied Human Toxicology (SCAHT), University of Basel, Switzerland.
authors.forename: L
authors.initials: L
authors.lastname: Aicher
authors.affiliation: Faust & Backhaus Environmental Consulting GbR (F+B), Bremen, Germany.
authors.forename: M
authors.initials: M
authors.lastname: Faust
authors.affiliation: Department of Pesticides Control & Phytopharmacy, Benaki Phytopathological Institute (BPI), Athens, Greece.
authors.forename: P
authors.initials: P
authors.lastname: Papadaki
authors.affiliation: OPERA Research Center, Catholic University of the Sacred Heart (UCSC), Piacenza, Italy.
authors.forename: A
authors.initials: A
authors.lastname: Marchis
authors.affiliation: Institute of Agricultural and Environmental Chemistry, Catholic University of the Sacred Heart (UCSC), Piacenza, Italy.
authors.forename: M
authors.initials: M
authors.lastname: Calliera
authors.affiliation: Institute of Environmental Assessment and Water Research, Spanish Council of Scientific Research (CSIC), Barcelona, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Ginebreda
authors.affiliation: French National Institute for Industrial Environment and Risks (INERIS), Parc Technologique Alata, Verneuil-en-Halatte, France.
authors.forename: S
authors.initials: S
authors.lastname: Andres
authors.affiliation: UFZ Department of Ecological Chemistry, Helmholtz Centre for Environmental Research, Leipzig, Germany.
authors.forename: R
authors.initials: R
authors.lastname: Kühne
authors.affiliation: UFZ Department of Ecological Chemistry, Helmholtz Centre for Environmental Research, Leipzig, Germany; Institute for Organic Chemistry, Technical University Bergakademie Freiberg, Germany.
authors.forename: G
authors.initials: G
authors.lastname: Schüürmann
mesh_terms: D004784:Environmental Monitoring / Q000331:legislation & jurisprudence / Q000379:methods*; D058735:Environmental Policy; D004785:Environmental Pollutants / Q000633:toxicity*; D005062:European Union; D015386:Hazardous Substances / Q000633:toxicity; D018570:Risk Assessment / Q000379:methods
chemical_list: D004785:Environmental Pollutants; D015386:Hazardous Substances
keywords: Chemicals; Environmental risk assessment; Human health risk assessment; Integrated risk assessment; Regulatory framework