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Transparency of chemical risk assessment data under REACH
Stockholm University, Faculty of Science, Department of Environmental Science and Analytical Chemistry.
Stockholm University, Faculty of Science, Department of Environmental Science and Analytical Chemistry.
Stockholm University, Faculty of Science, Department of Environmental Science and Analytical Chemistry.
Number of Authors: 42016 (English)In: Environmental Science: Pocesses & Impacts, ISSN 2050-7887, Vol. 18, no 12, p. 1508-1518Article in journal (Refereed) Published
Abstract [en]

The REACH regulation requires EU manufacturers and importers of substances to register information on the hazard and risk of their substances with the European Chemicals Agency (ECHA). Risk management of the substances is based on the provided information. It is known that conclusions on hazard and risk are influenced by expert judgements as well as potential conflict of interests. Thus, it is important that hazard and risk assessments are transparent and can be evaluated by a third party. The aim of this study is to scrutinize the transparency, i.e. the accessibility and comprehensibility, of information on substances registered under REACH. Data on repeated dose toxicity and hazard assessment conclusions were extracted for 60 substances from the REACH registration database available on the ECHA website. The data were compiled in a database for systematically evaluating the transparency of information related to the conclusions on hazard or risk. In addition, chemical safety reports (CSR) were requested from ECHA for five substances. The transparency of information on the hazard and risk of substances was found to be limited for several reasons. First, certain information was removed due to confidentiality and certain fields were not published because they could contain confidential information although the information had not been claimed confidential. Also, the extent to which registrants reported information varied, and the presentation of some data and certain terminology required further clarification. In addition, the data source for the majority of the key and supporting studies could not be identified due to confidentiality. Since registrants are only required to summarise studies, it cannot be verified whether all relevant information from non-public industry reports have been reported. Lastly, certain information related to the hazard and risk assessment were only reported in the CSR which is only available upon request; a time-consuming and work-intensive process. As information on registered chemicals is currently provided to the public, it is difficult to follow steps that are undertaken in the hazard and risk assessment. This limits the possibility for a third party to evaluate the assessment.

Place, publisher, year, edition, pages
2016. Vol. 18, no 12, p. 1508-1518
National Category
Chemical Sciences Earth and Related Environmental Sciences
Research subject
Applied Environmental Science
Identifiers
URN: urn:nbn:se:su:diva-139341DOI: 10.1039/c6em00389cISI: 000391429000005PubMedID: 27819710OAI: oai:DiVA.org:su-139341DiVA, id: diva2:1072822
Available from: 2017-02-08 Created: 2017-02-06 Last updated: 2018-08-09Bibliographically approved
In thesis
1. Transparency within REACH?: Regulatory risk assessment of industrial chemicals
Open this publication in new window or tab >>Transparency within REACH?: Regulatory risk assessment of industrial chemicals
2018 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Chemicals provide us with many benefits but can also have adverse effects on human health and the environment. Concerns that previous European legislations were not providing adequate protection from chemical risks resulted in a new chemicals legislation – REACH – in 2007. According to REACH, the chemical industry must ensure that risks from chemicals they produce or import at or above one tonne per year can be adequately controlled. Data on the chemicals’ properties and uses, hazards and risks as well as instructions for safely handling the chemicals, must be provided by industry to the European Chemicals Agency (ECHA) before the chemicals are allowed on the European market. The information is used by ECHA and the competent authorities of the Member States to identify chemicals of concern that warrant regulation. Thus, the registered data need to be reliable and relevant as well as transparently reported to ensure that chemicals of concern can be identified. The aim of this thesis was to provide insights into the risk assessments carried out by industry under REACH to contribute to a safer use of chemicals.

The results in this thesis show that information that is used for concluding on hazards and risks of chemicals as well as industry’s conclusions are reported in a semi-transparent manner and therefore difficult for third parties to fully scrutinise and evaluate (paper I). This was in part due to the protection of confidential information as laid down by law but also related to ECHA’s procedures for making information available to the public as well as industry’s reporting. Furthermore, industry is only required under REACH to summarise (eco)toxicity studies that are gathered for the risk assessment. Consequently, data based on industry studies that are not publicly available cannot be scrutinised and independently assessed by third parties. Thus, the system relies on studies being accurately summarised by the registrant although this was not always seen to be the case (paper IV). 

Furthermore, the current framework for industry to evaluate (eco)toxicity studies and report data evaluations under REACH was found to be neither systematic nor transparent (paper II). Studies may not be evaluated based on their inherent scientific quality when the Klimisch method for evaluating data is used, which is the recommended data evaluation method under REACH. Using the Klimisch method may also result in giving less weight to non-standard studies, such as many academic research studies, than studies performed according to standardised test guidelines, although non-standard studies could contribute with important information to the risk assessment. The structure and transparency of data evaluations could be improved by using a framework that has clear criteria and guidance as well as a structured format for reporting data evaluations (paper III). This would support more harmonised and transparent data evaluations and encourage studies to be evaluated according to their inherent scientific quality rather than mere compliance with standardised test guidelines.

The overall objective of this thesis is to contribute to the development of systematic and transparent risk assessments under REACH, which is critical for using chemicals safely.

Place, publisher, year, edition, pages
Stockholm: Department of Environmental Science and Analytical Chemistry, Stockholm University, 2018. p. 43
Keywords
REACH, chemicals legislation, risk assessment, hazard assessment, transparency
National Category
Environmental Sciences
Research subject
Applied Environmental Science
Identifiers
urn:nbn:se:su:diva-158580 (URN)978-91-7797-392-8 (ISBN)978-91-7797-393-5 (ISBN)
Public defence
2018-09-28, De Geersalen, Geovetenskapens hus, Svante Arrhenius väg 14, Stockholm, 10:00 (English)
Opponent
Supervisors
Note

At the time of the doctoral defense, the following papers were unpublished and had a status as follows: Paper 2: Manuscript. Paper 3: Accepted. Paper 4: Manuscript.

Available from: 2018-09-05 Created: 2018-08-09 Last updated: 2018-09-11Bibliographically approved

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