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Study summaries under REACH - How accurately are they reported?
Stockholm University, Faculty of Science, Department of Environmental Science and Analytical Chemistry.ORCID iD: 0000-0002-4371-2847
Stockholm University, Faculty of Science, Department of Environmental Science and Analytical Chemistry.
Stockholm University, Faculty of Science, Department of Environmental Science and Analytical Chemistry.
(English)Manuscript (preprint) (Other academic)
Abstract [en]

Data on chemicals registered under REACH are provided as summaries instead of a submitted original study report. A “study summary” should include sufficient information on the objectives, methods, results and conclusions in the original report to determine the relevance of the study. Sometimes a “robust study summary” is required, which should contain more detailed information to enable an independent assessment of the study. Since the registration data are used by regulatory agencies to identify chemicals of concern, the study summaries must accurately reflect the information in the original reports. The aim of this study is to examine how well original reports were reflected in study summaries submitted by registrants under REACH. In total, the reporting of 20 study summaries based on peer-reviewed studies as well as one abstract were examined. As seen in this study, it varied to what extent information in the published studies was reported in the study summary as well as how accurately the information was reflected. Differences between the original report and the summary included simple typing errors, unclear and incomplete reporting as well as the omission of information on for example study design, results or interpretation of the results, which in some of the cases could be considered relevant for the risk assessment. This raises concerns regarding the accuracy of study summaries and their use for decision-making. Moreover, the possibility for third parties to independently assess and scrutinise the summaries is limited. Considering that we rely on REACH registration data for chemical safety, all data used for risk assessment should be accessible for examination and independent assessment.

Keywords [en]
REACH, risk assessment, (robust) study summary, chemicals legislation, transparency
National Category
Earth and Related Environmental Sciences
Research subject
Applied Environmental Science
Identifiers
URN: urn:nbn:se:su:diva-158579OAI: oai:DiVA.org:su-158579DiVA, id: diva2:1237655
Available from: 2018-08-09 Created: 2018-08-09 Last updated: 2018-08-09Bibliographically approved
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Ingre-Khans, EllenÅgerstrand, MarleneRudén, Christina
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