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Chemicals risk assessment: evidence-evaluation methods analysed for nine EU regulations

June 24, 2016

Chemicals risk assessment: evidence-evaluation methods analysed for nine EU regulations

The use of two methods to systematise evidence-evaluation methods is reviewed in nine EU regulations dealing with chemicals risk assessment. The majority of frameworks were found to promote the use of ‘weight of evidence’ or ‘systematic review’-style approaches, but the study found a lack of structured, consistent and detailed guidance for these approaches. The researchers recommend this guidance is developed collaboratively by European regulatory
agencies and points to best practice for this guidance.

Weight-of-evidence (WoE) evaluation and systematic review (SR) are methods (developed in the fields of economics, law and medicine) to summarise, synthesise and interpret a body of evidence to draw conclusions, for example, the relationship between chemical exposure and adverse health effect. These practices are expected to play a more important role than they did in traditional risk-assessment methods, which relied on fewer studies.

For the majority of chemicals on the EU market today, health and environmental risk assessments are performed by the producing or importing company, with guidance from different regulatory frameworks, depending on their intended use. Improving guidance on how to conduct and report WoE or SR would improve the robustness, reproducibility and transparency of assessing the health or environmental risk of a chemical.

The aim of this review was to investigate if either WoE evaluation or SR in chemical risk assessment is promoted within nine different regulatory frameworks set out by the European Commission and implemented by the European Chemicals Agency (ECHA) , the European Food Safety Authority (EFSA), and the European Medicines Agency. Riskassessment documents selected from the most prominent areas within chemical risk assessment in the EU were scrutinised for whether WoE evaluation and SR were promoted and whether there was sufficient guidance for WoE evaluation and SR.

Read more at: "Science for Environment Policy": European Commission DG Environment News Alert Service, edited by SCU, The University of the West of England, Bristol.
http://ec.europa.eu/environment/integration/research/newsalert/pdf/chemicals_risk_assessment_evidence_evaluation_methods_nine_eu_regulations_460na1_en.pdf

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