An article published on June 24, 2016 in the Science for Environment Policy news alert of the European Commission’s (EC) Directorate General for Environment (DG Environment) draws attention to a review focusing on the use of evidence evaluation methods in European frameworks for chemical risk assessment. The review was written by Marlene Agerstrand and Anna Beronius from the Department of Environmental Science and Analytical Chemistry (ACES), Stockholm University, Sweden, and published on December 9, 2015 in the peer-reviewed journal Environment International.
The scientists asked whether the two common methods for assessment of whole data sets (as opposed to focusing on a single study) – weight-of-evidence (WoE) evaluation and systematic review (SR) – are being promoted by European Union’s (EU) legislation for chemical risk assessment, and if sufficient guidance on how to perform these processes is available. Nine EU regulatory frameworks were scrutinized: Industrial chemicals (REACH), plant protection products, biocides, cosmetics, human pharmaceuticals in the environment, veterinary pharmaceuticals in the environment, contaminants in food, water framework directive, and regulation on classification, labeling and packaging.
The use of WoE and/or SR is at least mentioned by seven out of nine frameworks evaluated (either in the legislation or in the accompanying guidance documents). Only two directives, those dealing with pharmaceuticals in the environment, do not mention these methods at all. Thus, systematic evaluation of all scientific evidence is indeed promoted by most of the European regulatory frameworks for chemicals.
In five out of nine frameworks evaluated, some guidance on how to carry out WoE evaluation or SR can also be found. However, the specifics and level of detail differ greatly between the frameworks. Furthermore, none of the frameworks were judged by the authors to provide sufficient guidance information to enable “robust and reproducible” applications of WoE evaluation or SR.
Clear guidance may greatly contribute to increasing the transparency and credibility of the risk assessment procedures relying on incorporation of all scientific evidence available, which gain more and more importance in the era of increased reliance on non-animal methods for toxicity evaluation. Hence, the authors call for an urgent development of such guidance. Furthermore, they recommend that the guidance be developed jointly by different EU agencies dealing with chemicals, such as the European Food Safety Authority (EFSA), the European Chemicals Agency (ECHA), and the European Medicines Agency (EMA), as this may facilitate a more efficient exchange of risk assessments performed for the same chemical within different regulatory frameworks.
EC Science for Environment Policy (June 24, 2016). “Chemicals risk assessment: evidence-evaluation methods analysed for nine EU regulations.” (pdf)
Agerstrand, M. and Beronius, A. (2016). “Weight of evidence evaluation and systematic review in EU chemical risk assessment: Foundation is laid but guidance is needed.” Environment International 92-93: 590-596.