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.

(Eco)toxicity studies conducted according to internationally standardized test guidelines are often considered reliable by default and preferred as key evidence in regulatory risk assessment. At the same time regulatory agencies emphasize the use of all relevant (eco)toxicity data in the risk assessment process, including non-standard studies. However, there is a need to facilitate the use of such studies in regulatory risk assessment. Therefore, we propose a framework that facilitates a systematic and transparent evaluation of the reliability and relevance of (eco)toxicity in vivo studies for health and environmental risk assessment. The framework includes specific criteria to guide study evaluation, as well as a color-coding tool developed to aid the application of these criteria. In addition we provide guidance intended for researchers on how to report non-standard studies to ensure that they meet regulatory requirements. The intention of the evaluating and reporting criteria is to increase the usability of all relevant data that may fill information gaps in chemical risk assessments. The framework is publically available online, free of charge, at the Science in Risk Assessment and Policy (SciRAP) website: [GRAPHICS] . The aim of this article is to present the framework and resources available at the SciRAP website.

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.

UV-filters are chemicals with potentially environmental hazardous properties. In the European Union (EU), UV-filters contained in sunscreen products are currently regulated by the Cosmetic Directive (from July 2013 by the Cosmetic Products Regulation). Environmental hazard classifications according to the regulation on classification, labelling and packaging of substances and mixtures (CLP) must be determined for UV-filters contained in industrial chemical products, whereas UV-filters contained in sunscreens are exempted from CLP. In this study we determined the potential environmental hazard classifications of UV-filters and sunscreen products if the CLP regulation was to be required for cosmetic products. Two sunscreen products were evaluated in accordance with the aquatic environmental hazard criteria for mixtures. The results highlight that the inconsistencies in the current EU regulation of UV filters hamper the risk management of environmental hazards of UV filters used in cosmetic products. Almost 50% of the investigated UV-filters approved for use in cosmetic products on the European market according to the current Cosmetic Directive were identified to meet the CLP classification as being hazardous to the aquatic environment. Assuming a worst-case scenario, the two examined sunscreens could both be classified as hazardous to the aquatic environment with long-lasting effects according to CLP classification criteria. Hence, if the CLP regulation was applicable to sunscreen products, both brands could potentially be labelled with the environmental hazard pictogram and associated hazard and precautionary statements. Including cosmetic products, and thereby sunscreens, in the CLP regulation would contribute to a more harmonized and transparent regulation of potentially hazardous substances on the EU market.

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.

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.

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.