title: Weight of evidence evaluation and systematic review in EU chemical risk assessment: Foundation is laid but guidance is needed.
abstract: The aim of this review was to investigate if and how the application of weight of evidence (WoE) evaluation or systematic review (SR) in chemical risk assessment is promoted within different regulatory frameworks in the European Union. Legislative and relevant guidance documents within nine regulatory frameworks were scrutinized and compared. WoE evaluation or SR is promoted in seven of the investigated frameworks but sufficient guidance for how to perform these processes is generally lacking. None of the investigated frameworks give enough guidance for generating robust and reproducible WoE evaluations or SRs. In conclusion, the foundation for use of WoE evaluation and SR is laid in the majority of the investigated frameworks, but there is a need to provide more structured and detailed guidance. In order to make the process of developing guidance as efficient as possible, and to ensure smooth transfer of risk assessment's between frameworks if a chemical is risk assessed both as, for example, a biocide and an industrial chemical, it is recommended that guidance is developed jointly by the European regulatory agencies.
authors.affiliation: Department of Environmental Science and Analytical Chemistry (ACES), Stockholm University, Stockholm, Sweden. Electronic address: marlene.agerstrand@aces.su.se.
authors.forename: Marlene
authors.initials: M
authors.lastname: Ågerstrand
authors.affiliation: Department of Environmental Science and Analytical Chemistry (ACES), Stockholm University, Stockholm, Sweden.
authors.forename: Anna
authors.initials: A
authors.lastname: Beronius
mesh_terms: D004781:Environmental Exposure; D004785:Environmental Pollutants / Q000633:toxicity*; D005062:European Union; D018570:Risk Assessment / Q000379:methods*; D014116:Toxicology / Q000379:methods*
chemical_list: D004785:Environmental Pollutants
keywords: Chemical legislation; Chemical risk assessment; Evidence integration; Systematic review; Weight of evidence