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Transparency within REACH?: Regulatory risk assessment of industrial chemicals
Stockholm University, Faculty of Science, Department of Environmental Science and Analytical Chemistry. Stockholm University.ORCID iD: 0000-0002-4371-2847
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 [en]
REACH, chemicals legislation, risk assessment, hazard assessment, transparency
National Category
Environmental Sciences
Research subject
Applied Environmental Science
Identifiers
URN: urn:nbn:se:su:diva-158580ISBN: 978-91-7797-392-8 (print)ISBN: 978-91-7797-393-5 (electronic)OAI: oai:DiVA.org:su-158580DiVA, id: diva2:1237680
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
List of papers
1. Transparency of chemical risk assessment data under REACH
Open this publication in new window or tab >>Transparency of chemical risk assessment data under REACH
2016 (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.

National Category
Chemical Sciences Earth and Related Environmental Sciences
Research subject
Applied Environmental Science
Identifiers
urn:nbn:se:su:diva-139341 (URN)10.1039/c6em00389c (DOI)000391429000005 ()27819710 (PubMedID)
Available from: 2017-02-08 Created: 2017-02-06 Last updated: 2018-08-09Bibliographically approved
2. Reliability and relevance evaluations of REACH data
Open this publication in new window or tab >>Reliability and relevance evaluations of REACH data
(English)Manuscript (preprint) (Other academic)
Abstract [en]

Regulatory authorities rely on risk and hazard assessments performed under REACH for identifying chemicals of concern and take action. Therefore, these assessments must be systematic and transparent. This study investigates how registrants evaluate and report data evaluations under REACH and the procedures established by the European Chemicals Agency (ECHA) to support these data evaluations. Data on the endpoint repeated dose toxicity were retrieved from the REACH registration database for 60 substances. An analysis of these data shows that the system for registrants to evaluate data and report these evaluations is neither systematic nor transparent. First, the current framework focuses on reliability, but overlooks the equally important aspect of relevance, as well as how reliability and relevance are combined for determining the adequacy of individual studies. Reliability and relevance aspects are also confused in the ECHA guidance for read-across. Second, justifications for reliability evaluations were mainly based on studies complying with GLP and test guidelines, following the Klimisch method. This may result in GLP and guideline studies being considered reliable by default and discounting non-GLP and non-test guideline data. Third, the reported rationales for reliability were frequently vague, confusing and lacking information necessary for transparency. Fourth, insufficient documentation of a study was sometimes used as a reason for judging data unreliable. Poor reporting merely affects the possibility to evaluate reliability and should be distinguished from methodological deficiencies. Consequently, ECHA is urged to improve the procedures and guidance for registrants to evaluate data under REACH to achieve systematic and transparent chemical risk assessments.

National Category
Earth and Related Environmental Sciences
Research subject
Applied Environmental Science
Identifiers
urn:nbn:se:su:diva-158577 (URN)
Available from: 2018-08-09 Created: 2018-08-09 Last updated: 2018-08-09Bibliographically approved
3. Improving structure and transparency in reliability evaluations of data under REACH – suggestions for a systematic method
Open this publication in new window or tab >>Improving structure and transparency in reliability evaluations of data under REACH – suggestions for a systematic method
(English)In: Article in journal (Refereed) Accepted
Abstract [en]

The goal of identifying hazardous chemicals registered under the REACH Regulation and taking appropriate risk management measures relies on robust data registrations. However, the current procedures for European chemical manufacturers and importers to evaluate data under REACH neither support systematic evaluations of data nor transparently communicate these assessments. The aim of this study was to explore how using a data evaluation method with predefined criteria for reliability and establishing principles for assigning reliability categories could contribute to more structured and transparent evaluations under REACH. In total, 20 peer-reviewed studies for 15 substances registered under REACH were selected for an in-depth evaluation of reliability with the SciRAP tool. The results show that using a method for study evaluation, with clear criteria for assessing reliability and assigning studies to reliability categories, contributes to more structured and transparent reliability evaluations. Consequently, it is recommended to implement a method for evaluating data under REACH with predefined criteria and fields for documenting and justifying the assessments to increase consistency of data evaluations and transparency.

Keywords
REACH, SciRAP, reliability, risk assessment, data evaluation, transparency
National Category
Earth and Related Environmental Sciences
Research subject
Applied Environmental Science
Identifiers
urn:nbn:se:su:diva-158578 (URN)
Available from: 2018-08-09 Created: 2018-08-09 Last updated: 2018-08-09
4. Study summaries under REACH - How accurately are they reported?
Open this publication in new window or tab >>Study summaries under REACH - How accurately are they reported?
(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
REACH, risk assessment, (robust) study summary, chemicals legislation, transparency
National Category
Earth and Related Environmental Sciences
Research subject
Applied Environmental Science
Identifiers
urn:nbn:se:su:diva-158579 (URN)
Available from: 2018-08-09 Created: 2018-08-09 Last updated: 2018-08-09Bibliographically approved

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