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Chemicals in consumer products: Bridging the gap between academic research and chemicals regulation
Stockholm University, Faculty of Science, Department of Environmental Science and Analytical Chemistry.
2015 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

Exposure to chemicals emitting from consumer products, such as clothes, electronic devices, toys and kitchen-ware, has emerged as an issue of public health and environmental concern. The use of chemicals having endocrine disrupting properties in commercial products is receiving particular attention as low dose exposures of such chemicals have been associated with adverse effects in both human and wildlife populations. Current chemicals regulation has been criticized for not providing adequate protection of human health and the environment with regard to consumer products. The aim of this thesis has been to provide new insights and methods related to the risk assessment and risk management of chemicals in consumer products in order to ensure a safer and more sustainable use.

The comparative analyses of different EU regulatory frameworks targeting the use of chemicals in articles identified a number of shortcomings and inconsistencies in how chemicals in articles are regulated. One main conclusion from Paper I was that product specific rules are important complements to REACH as they can more easily be tailored for certain uses and exposure scenarios. In Paper II it was investigated whether the regulation of chemicals in articles according to REACH is sufficient for meeting EU environmental goals, which include rectifying environmental problems at the source. It was concluded that the prioritization of substances to be targeted by restrictions and other requirements under REACH to a greater extent should take into account substances that have been identified as posing a risk to or via the environment.

With the aim to facilitate the use of all reliable and relevant toxicity information in regulatory health risk assessment of chemicals, a method for systematic and transparent evaluation of non-standard research studies, as well as reporting guidance for such studies, were developed in Paper III. It has for example been emphasized that non-standard research studies can provide valuable information with regard to endocrine disrupting effects. Such effects are not systematically tested for in standardized studies commonly preferred in regulatory risk assessments. In Paper IV, the method for study evaluation proposed in Paper III was combined with recently developed web-based tools that aid summarizing and visualizing toxicity data extracted from several studies. The combined use was found to comprise a promising methodology for identifying reliable and sensitive information from in vivo toxicity studies of relevance to consider in the risk assessment process.

The new methods and tools proposed and evaluated in this thesis will hopefully help improve the use of non-standard studies for risk assessment purposes and thereby strengthen the link between academic research and chemicals policy. In my view, this would be an important step towards improving public health protection with regard to the use of chemicals in consumer products.

Place, publisher, year, edition, pages
Department of Environmental Science and Analytical Chemistry, Stockholm University: Stockholm University, 2015. , 42 p.
Keyword [en]
consumer products, articles, chemicals, chemicals regulation, REACH, risk management, health risk assessment, non-standard toxicity studies, study evaluation, reporting guidance, endocrine disrupting compounds, bisphenol A, low dose effects
National Category
Environmental Sciences
Research subject
Applied Environmental Science
Identifiers
URN: urn:nbn:se:su:diva-120285ISBN: 978-91-7649-244-4 (print)OAI: oai:DiVA.org:su-120285DiVA: diva2:852437
Public defence
2015-10-06, Nordenskiöldsalen, Geovetenskapens hus, Svante Arrhenius väg 12, Stockholm, 10:00 (English)
Opponent
Supervisors
Note

At the time of the doctoral defense, the following paper was unpublished and had a status as follows: Paper 4: Manuscript.

Available from: 2015-09-17 Created: 2015-09-04 Last updated: 2015-09-16Bibliographically approved
List of papers
1. Narrow-and-sharp or broad-and-blunt - Regulations of hazardous chemicals in consumer products in the European Union
Open this publication in new window or tab >>Narrow-and-sharp or broad-and-blunt - Regulations of hazardous chemicals in consumer products in the European Union
2012 (English)In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 62, no 3, 523-531 p.Article in journal (Refereed) Published
Abstract [en]

Chemicals are incorporated into a vast number of consumer products, and it has been recognized that considerable exposures of humans and the environment to chemicals are due to diffuse emissions from everyday products. Different approaches to the management of risks concerning chemicals in products are discussed on the international arena, but no general strategy has yet been adopted. The aim of this study is to investigate how health and environmental risks associated with chemicals in consumer products are currently managed in European Union legislations, mainly by the Toys Directive, the RoHS Directive, and REACH. Significant differences were found between the risk reduction strategies in these legislations, including substance prioritization, type of restrictions and requirements, and information dissemination to consumers. REACH regulates chemicals in products to a limited extent, and via quite complicated processes. Product-specific rules are therefore useful supplements to REACH for regulating chemicals in products. The combined effects of the RoHS and WEEE directives seem to be effective in promoting substitution of substances identified as problematic in electrical and electronic equipment, and it is recommended that the possibility to develop similar systems should be considered also for other product categories.

Keyword
REACH, Toys Safety Directive, RoHS Directive, risk management, consumer products, hazardous chemicals
National Category
Environmental Sciences
Research subject
Applied Environmental Science
Identifiers
urn:nbn:se:su:diva-120330 (URN)10.1016/j.yrtph.2011.11.003 (DOI)000302204100016 ()
Available from: 2015-09-07 Created: 2015-09-07 Last updated: 2017-12-04Bibliographically approved
2. Are chemicals in articles an obstacle for reaching environmental goals?: Missing links in eu chemical management
Open this publication in new window or tab >>Are chemicals in articles an obstacle for reaching environmental goals?: Missing links in eu chemical management
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2012 (English)In: Science of the Total Environment, ISSN 0048-9697, E-ISSN 1879-1026, Vol. 435, 280-289 p.Article in journal (Refereed) Published
Abstract [en]

It is widely acknowledged that the management of risks associated with chemicals in articles needs to be improved. The EU environmental policy states that environmental damage should be rectified at source. It is therefore motivated that the risk management of substances in articles also takes particular consideration to those substances identified as posing a risk in different environmental compartments. The primary aim of the present study was to empirically analyze to what extent the regulation of chemicals in articles under REACH is coherent with the rules concerning chemicals in the Sewage Sludge Directive (SSD) and the Water Framework Directive (WFD). We also analyzed the chemical variation of the organic substances regulated under these legislations in relation to the most heavily used chemicals. The results show that 16 of 24 substances used in or potentially present in articles and regulated by the SSD or the WFD are also identified under REACH either as a substance of very high concern (SVHC) or subject to some restrictions. However, for these substances we conclude that there is limited coherence between the legislations, since the identification as an SVHC does not in itself encompass any use restrictions, and the restrictions in REACH are in many cases limited to a particular use, and thus all other uses are allowed. Only a minor part of chemicals in commerce is regulated and these show a chemical variation that deviates from classical legacy pollutants. This warrants new tools to identify potentially hazardous chemicals in articles. We also noted that chemicals monitored in the environment under the WFD deviate in their chemistry from the ones regulated by REACH. In summary, we argue that to obtain improved resource efficiency and a sustainable development it is necessary to minimize the input of chemicals identified as hazardous to health or the environment into articles.

Keyword
Consumer articles, Priority substances, REACH, The Water Framework Directive, The Sewage Sludge Directive, EU environmental policy
National Category
Environmental Sciences Ecology
Research subject
Applied Environmental Science
Identifiers
urn:nbn:se:su:diva-83990 (URN)10.1016/j.scitotenv.2012.07.021 (DOI)000310396100034 ()
Note

AuthorCount:5;

Available from: 2012-12-17 Created: 2012-12-17 Last updated: 2017-12-06Bibliographically approved
3. Facilitating the use of non-standard in vivo studies in health risk assessment of chemicals: a proposal to improve evaluation criteria and reporting
Open this publication in new window or tab >>Facilitating the use of non-standard in vivo studies in health risk assessment of chemicals: a proposal to improve evaluation criteria and reporting
2014 (English)In: Journal of Applied Toxicology, ISSN 0260-437X, E-ISSN 1099-1263, Vol. 34, no 6, 607-617 p.Article in journal (Refereed) Published
Abstract [en]

To improve data availability in health risk assessment of chemicals and fill information gaps there is a need to facilitate the use of non-standard toxicity studies, i.e. studies not conducted according to any standardized toxicity test guidelines. The purpose of this work was to propose criteria and guidance for the evaluation of reliability and relevance of non-standard in vivo studies, which could be used to facilitate systematic and transparent evaluation of such studies for health risk assessment. Another aim was to propose user friendly guidance for reporting of non-standard studies intended to promote an improvement in reporting of studies that could be of use in risk assessment. Requirements and recommendations for the design and execution of in vivo toxicity studies were identified from The Organisation for Economic Co-operation and Development (OECD) test guidelines, and served as basis for the data evaluation criteria and reporting guidelines. Feedback was also collected from experts within the field of toxicity testing and risk assessment and used to construct a two-tiered framework for study evaluation, as well as refine the reporting guidelines. The proposed framework emphasizes the importance of study relevance and an important aspect is to not completely dismiss studies from health risk assessment based on very strict criteria for reliability. The suggested reporting guidelines provide researchers with a tool to fulfill reporting requirements as stated by regulatory agencies. Together, these resources provide an approach to include all relevant data that may fill information gaps and reduce scientific uncertainty in health risk assessment conclusions, and subsequently also in chemical policy decisions.

Keyword
chemicals, relevance, reliability, study evaluation, reporting guidelines, OECD, Health risk assessment, non-standard studies
National Category
Biological Sciences Pharmacology and Toxicology
Research subject
Applied Environmental Science
Identifiers
urn:nbn:se:su:diva-104117 (URN)10.1002/jat.2991 (DOI)000334955100003 ()
Note

AuthorCount:4;

Available from: 2014-06-03 Created: 2014-06-03 Last updated: 2017-12-05Bibliographically approved
4. Low dose effects of bisphenol A on the developing mammary gland - Combining new web-based tools to identify reliable and relevant data for regulatory risk assessment
Open this publication in new window or tab >>Low dose effects of bisphenol A on the developing mammary gland - Combining new web-based tools to identify reliable and relevant data for regulatory risk assessment
Show others...
(English)Manuscript (preprint) (Other academic)
Abstract [en]

Background: Effects on the developing mammary gland have been repeatedly investigated and reported for bisphenol A (BPA) in experimental animals at doses close to or within human exposure range, and highlighted as being of potential concern to human health.

Objective: The present study provides a characterization of in vivo effects of BPA on the developing mammary gland in relation to the temporary tolerable daily intake (t-TDI), recently established by EFSA. The mammary gland data set was also used to explore the combined use of two different web-based tools for identifying sensitive and reliable data for risk assessment purposes.

Methods: The Health Assessment Workspace Collaborative (HAWC) was used for characterizing the mammary gland data in terms of type of effects investigated and reported and the distribution of these effects within the low dose range. The reliability of the mammary gland studies was evaluated using the Science in Risk Assessment and Policy (SciRAP) criteria. The results from HAWC and SciRAP were then combined to investigate whether there would be a shift in the type of effects reported and/or their distribution in the dose interval when considering only the studies judged as most reliable.

Results: No clear relationship could be identified between the reliability of the studies as assessed according to the SciRAP criteria and the type of mammary gland effects reported or their distribution within the low dose range, respectively.

Conclusions: The combined use of the HAWC and SciRAP tools would comprise a useful methodology for identifying reliable and sensitive information from in vivo toxicity studies of relevance to consider in the regulatory risk assessment process.  

Keyword
bisphenol A, mammary gland, low dose effects, reliability evaluation, health risk assessment, SciRAP, HAWC
National Category
Environmental Sciences Environmental Health and Occupational Health
Research subject
Applied Environmental Science
Identifiers
urn:nbn:se:su:diva-120328 (URN)
Available from: 2015-09-07 Created: 2015-09-07 Last updated: 2016-01-29Bibliographically approved

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