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  • 1.
    Agerstrand, Marlene
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Kuester, A.
    Bachmann, J.
    Breitholtz, M.
    Ebert, I.
    Rechenberg, B.
    Ruden, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Reporting and evaluation criteria as means towards a transparent use of ecotoxicity data for environmental risk assessment of pharmaceuticals2011In: Environmental Pollution, ISSN 0269-7491, E-ISSN 1873-6424, Vol. 159, no 10, p. 2487-2492Article in journal (Refereed)
    Abstract [en]

    Ecotoxicity data with high reliability and relevance are needed to guarantee the scientific quality of environmental risk assessments of pharmaceuticals. The main advantages of a more structured approach to data evaluation include increased transparency and predictability of the risk assessment process, and the possibility to use non-standard data. In this collaboration, between the research project MistraPharma and the German Federal Environment Agency, a new set of reporting and evaluation criteria is presented and discussed. The new criteria are based on the approaches in the literature and the OECD reporting requirements, and have been further developed to include both reliability and relevance of test data. Intended users are risk assessors and researchers performing ecotoxicological experiments, but the criteria can also be used for education purposes and in the peer-review process for scientific papers. This approach intends to bridge the gap between the regulator and the scientist's needs and way of work.

  • 2. Beronius, A.
    et al.
    Hanberg, A.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Background paper on the risk assessment of Bisphenol A: Overview of previous risk assessments2010In: The joint FAO/WHO expert meeting to review toxicological and health aspects of bisphenol A, 2010Conference paper (Other academic)
  • 3. Beronius, A.
    et al.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Hanberg, A.
    Improving the transparency of data evaluation in risk assessment of endocrine disrupting compounds-Implications from the bisphenol A case study2011In: Toxicology Letters, ISSN 0378-4274, E-ISSN 1879-3169, Vol. 205, p. S256-S256Article in journal (Other academic)
    Abstract [en]

    The complex biology and toxicology of endocrine disrupting compounds (EDCs) makes toxicity testing as well as evaluation of data for risk assessment difficult. Standardized test guidelines have previously been questioned as to their applicability for evaluating EDC toxicity. However, several guidelines have been updated and enhanced in an effort to better cover EDCs. Also, EDC toxicity is a very active research field and a lot of toxicological data are generated in research studies NOT conducted according to standardized guidelines. Our previous work indicates that differences in how the reliability and relevance of toxicity studies are judged may vary greatly between risk assessments of the same compound and may result in different conclusions about the size and nature of health risks. Further, the process of data evaluation is in many cases in-transparent. The purpose of this on-going study is to contribute to making health risk assessments of EDCs more transparent, systematic, and predictable. The investigation is conducted as a literature study using the EDC bisphenol A (BPA) for a case study. We scrutinize and compare the strengths and weaknesses of both guideline and non-guideline studies evaluating developmental neurotoxicity of BPA. One goal is to further assess the applicability of standardized guidelines in this case. Another aim is to propose improvements in the process of data reporting of non-guideline studies and recommend criteria for the evaluation of data in order to facilitate risk assessment of EDCs.

  • 4. Beronius, Anna
    et al.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Håkansson, Helen
    Hanberg, Annika
    Risk to all or none? A comparative analysis of controversies in the health risk assessment of Bisphenol A2010In: Reproductive Toxicology, ISSN 0890-6238, E-ISSN 1873-1708, Vol. 29, no 2, p. 132-146Article in journal (Refereed)
    Abstract [en]

    Bisphenol A (BPA) is an endocrine disruptor for which health risk assessment has proven controversial. Conclusions regarding health risks of BPA vary between assessments from "there is no risk to any part of the population" to "there is risk to the entire population". We have carried out a literature study investigating what might be the scientific and/or policy-related reasons for these differences. Ten risk assessments for BPA were scrutinized and several factors were compared between assessments, including estimations of exposure levels, identification of critical study and NOAEL, assessment factors and significance attributed to reports of low-dose effects. Differences in conclusions were mainly influenced by the evaluation of low-dose effects and the uncertainties surrounding the significance of these data for health risk assessment. The results illustrate the impact of differences in risk assessment policy and expert judgment on the risk assessment process and highlight the importance of transparency in this process.

  • 5.
    Beronius, Anna
    et al.
    Karolinska Inst, Stockholm, Sweden.
    Willighagen, Egon
    Maastricht Univ, Maastricht, Netherlands .
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Hanberg, Annika
    Karolinska Inst, Stockholm, Sweden.
    Factors influencing developmental neurotoxicity study outcome in the bisphenol A case2012In: Toxicology Letters, ISSN 0378-4274, E-ISSN 1879-3169, Vol. 211, p. S128-S129Article in journal (Other academic)
  • 6.
    Ding, Qian
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Malkiewicz, Katarzyna
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Hansson, Sven Ove
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Are the new Chinese chemicals regulations catching up with REACH?2012In: Toxicology Letters, ISSN 0378-4274, E-ISSN 1879-3169Article in journal (Other academic)
  • 7. Eriksson, J.
    et al.
    Gilek, M.Rudén, ChristinaKTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Regulating Chemical Risks: European and Global Challenges2010Collection (editor) (Refereed)
    Abstract [en]

    This important contribution to the scientific understanding of chemical risk regulation offers a coherent, comprehensive and updated multidisciplinary analysis, written by leading experts in toxicology, ecotoxicology, risk analysis, media and communication, law, and political science. The text focuses in particular on the new European REACH regime and its nature, causes and consequences. It examines the regime in the context of the interplay between science and policy, the role of the media, human health, and the environment. Other regulatory systems at both domestic and international levels are also studied, including the UNs Globally Harmonised System (GHS) for chemical labelling, as well as developments in the U.S. In addition, readers will find analyses of a number of new and still largely uncharted regulatory systems, along with in-depth assessments of their complexity and transnational nature.

  • 8.
    Gilek, Michael
    et al.
    Sodertorn Univ, SE-14189 Huddinge, Sweden..
    Eriksson, Johan
    Sodertorn Univ, SE-14189 Huddinge, Sweden..
    Rudén, Christina
    KTH.
    Introduction2010In: Regulating Chemical Risks: European and Global Challenges Introduction, SPRINGER , 2010, p. 1-5Chapter in book (Refereed)
  • 9.
    Hansson, Sven Ove
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Molander, Linda
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    The substitution principle2011In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 59, no 3, p. 454-460Article in journal (Refereed)
    Abstract [en]

    According to the substitution principle, hazardous chemicals should be replaced by less hazardous alternatives. In this paper, the major issues concerning the more precise definition of the principle are analyzed, and a general purpose definition is proposed. It is claimed that the priority between reducing hazard, functionality and economical considerations in the application of the substitution principle is a matter for adjustment in each particular case that cannot be settled beforehand. None of these objectives can have absolute priority over the others, but the substitution principle is aimed at increasing the priority given to the reduction of hazards to human health and the environment. Major methods to promote and implement the principle are summarized, current legislative approaches are discussed, and proposals for efficient implementation are made. It is emphasized that the primary responsibility for avoiding hazardous substances and processes rests with industry.

  • 10.
    Hansson, Sven Ove
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    REACH: What has been achieved and what needs to be done?2010In: Regulating Chemical Risks: European and Global Challenges / [ed] Johan Eriksson, Michael Gilek, and Christina Rudén, Springer, 2010, p. 71-83Chapter in book (Refereed)
  • 11.
    Ingre-Khans, E
    et al.
    Stockholm Univ, Dept Appl Environm Sci ITM.
    Rudén, Christina
    Stockholm Univ, Dept Appl Environm Sci ITM.
    Breitholtz, M
    Stockholm Univ, Dept Appl Environm Sci ITM.
    Chemical risks and consumer products: The toxicity of shoe soles2010In: Ecotoxicology and Environmental Safety, ISSN 0147-6513, E-ISSN 1090-2414, Vol. 73, no 7, p. 1633-1640Article in journal (Refereed)
    Abstract [en]

    The European chemicals legislation, REACH, aims to ensure a high level of protection of human health and the environment. However, chemicals included in consumer products are covered only to a very limited extent even though they constitute the main source of chemical emissions. Shoes are large volume products and the overall aim of the present study was to study the ecotoxicological effects of three types of shoe soles and relate these effects to chemical emissions to the aquatic environment. The shoe soles were abraded and leached in water for 29 days and the alga Ceramium tenuicorne and the crustacean Nitocra spinipes were exposed to different concentrations of the leachate. Chemical analyses were performed to determine the chemical contents of the leachate. The main conclusions are that the shoe soles contain substances that are toxic to both test organisms, and that the toxicity is mainly explained by the presence of zinc. The estimated concentration of zinc from shoe soles in storm water runoff is low, but it still contributes to the overall load of chemicals and metals in the environment. The outlined test procedures may, in our view, provide a useful screening tool for assessing the risk that chemicals in consumer articles pose to the environment.

  • 12.
    Molander, Linda
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Beronius, Anna
    Karolinska Inst, Stockholm, Sweden.
    Hanberg, Annika
    Karolinska Inst, Stockholm, Sweden.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Endpoints and dose-response relationships of low-dose studies of Bisphenol A2012In: Toxicology Letters, ISSN 0378-4274, E-ISSN 1879-3169, Vol. 211, p. S130-S130Article in journal (Other academic)
  • 13.
    Molander, Linda
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Breitholtz, M.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Missing links in the regulatory chain controlling life cycle emissions of hazardous chemicals from articles2011In: Toxicology Letters, ISSN 0378-4274, E-ISSN 1879-3169, Vol. 205, p. S243-S243Article in journal (Other academic)
    Abstract [en]

    It is widely acknowledged that the management of risks associated with chemicals in articles, including consumer products, needs to be improved.

    The purpose of the present study is to empirically analyze to what extent European legislations that control emissions of hazardous chemicals from articles during different life cycle phases are coherent or not. To illustrate this, the regulation of a number of case-study chemicals, used in various consumer products and in high volumes, is scrutinized. This analysis identifies missing regulatory links between the rules that are relevant for the use phase and the rules applicable to the waste phase. With the exception of the RoHS directive, a clear connection to the rules for waste is missing in the regulatory system. Clear links are also missing between the rules regulating chemical emissions during the articles’ life cycle and maximum environmental concentration limits set for sludge, soil and surface water. The Waste Directive, the WEEE Directive, and the Water Framework Directive refer to EU environmental and waste policies. These policies state that environmental damage should be rectified at source. The lack of connection between the rules regulating different phases of an article's life cycle makes these objectives difficult to fulfill. These legislative gaps will encourage end-of-pipe solutions, rather than actions to manage the source of the problem. We argue that it is necessary to minimize the input of hazardous chemicals into articles, so that waste and other end-products can be recovered and used without harming human health or the environment.

  • 14.
    Molander, Linda
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Breitholtz, Magnus
    Stockholm University.
    Andersson, Patrik L.
    Umeå University.
    Rybacka, Aleksandra
    Umeå University.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Are chemicals in articles an obstacle for reaching environmental goals? - Missing links in EU chemical management2012In: Science of the Total Environment, ISSN 0048-9697, E-ISSN 1879-1026, Vol. 435, p. 280-289Article in journal (Refereed)
    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.

  • 15.
    Molander, Linda
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Narrow-and-sharp or broad-and-blunt - Regulations of hazardous chemicals in consumer products in the European Union2012In: Regulatory toxicology and pharmacology, ISSN 0273-2300, E-ISSN 1096-0295, Vol. 62, no 3, p. 523-531Article in journal (Refereed)
    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.

  • 16.
    Molander, Linda
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Ågerstrand, Marlene
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    WikiPharma: A database with environmental effect data for pharmaceuticals2010In: Towards sustainable pharmaceuticals in a healthy society, Stockholm: MistraPharma , 2010, p. 98-147Chapter in book (Other academic)
  • 17.
    Roos, Vendela
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Gunnarsson, L.
    Fick, J.
    Larsson, D. G. J.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Prioritising pharmaceuticals for environmental risk assessment: Towards adequate and feasible first-tier selection2012In: Science of the Total Environment, ISSN 0048-9697, E-ISSN 1879-1026, Vol. 421, p. 102-110Article in journal (Refereed)
    Abstract [en]

    The presence of pharmaceuticals in the aquatic environment, and the concerns for negative effects on aquatic organisms, has gained increasing attention over the last years. As ecotoxicity data are lacking for most active pharmaceutical ingredients (APIs), it is important to identify strategies to prioritise APIs for ecotoxicity testing and environmental monitoring. We have used nine previously proposed prioritisation schemes, both risk- and hazard-based, to rank 582 APIs. The similarities and differences in overall ranking results and input data were compared. Moreover, we analysed how well the methods ranked seven relatively well-studied APIs. It is concluded that the hazard-based methods were more successful in correctly ranking the well-studied APIs, but the fish plasma model, which includes human pharmacological data, also showed a high success rate. The results of the analyses show that the input data availability vary significantly: some data, such as logP, are available for most API while information about environmental concentrations and bioconcentration are still scarce. The results also suggest that the exposure estimates in risk-based methods need to be improved and that the inclusion of effect measures at first-tier prioritisation might underestimate risks. It is proposed that in order to develop an adequate prioritisation scheme, improved data on exposure such as degradation and sewage treatment removal and bioconcentration ability should be further considered. The use of ATC codes may also be useful for the development of a prioritisation scheme that includes the mode of action of pharmaceuticals and, to some extent, mixture effects.

  • 18.
    Rudén, Christina
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Gilek, M.
    Scientific uncertainty and science-policy interactions in the risk assessment of hazardous chemicals2010In: Regulating Chemical Risks: European and Global Challenges, Springer Netherlands, 2010, p. 151-161Chapter in book (Refereed)
    Abstract [en]

    In this chapter relatively recent European Commission risk assessment reports for three potential PBT/vPvB chemicals are used as examples to illustrate scientific uncertainty in the risk assessment process, and how science and policy interact when such uncertainty is handled. The studied risk assessment reports are for pentabromodiphenylether (Penta), octabromodiphenylether (Octa), and decabromodiphenylether (Deca) and the analyses focus on the scientific basis for assessing the risk of potential PBT and vPvB properties as described in these documents. The purpose of this effort is to contribute to a discussion aiming at clarifying the nature of science-policy interactions, and improving the transparency of the risk assessment process.

  • 19.
    Rudén, Christina
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Hansson, Sven Ove
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Registration, Evaluation, and Authorization of Chemicals (REACH) Is but the First Step-How Far Will It Take Us? Six Further Steps to Improve the European Chemicals Legislation2010In: Journal of Environmental Health Perspectives, ISSN 0091-6765, E-ISSN 1552-9924, Vol. 118, no 1, p. 6-10Article in journal (Refereed)
    Abstract [en]

    OBJECTIVES: In this commentary we analyze how much data will in fact be generated within REACH. CONCLUSIONS: We conclude that the data requirements for many end points still have not been determined but depend on prioritization criteria and waiving practices that will be decided in the years to come. We propose six important steps toward an improved REACH: a) Clarify prioritization and waiving criteria. Implement decisions to ensure that sufficient data are obtained to make first hazard assessments of as many substances and end points as possible. b) Increase data requirements. Introduce data requirements similar to those currently required for substances produced or imported in quantities of 10 metric tons/year for substances produced or imported in quantities of >= 1 metric tons/year. c) Develop the tests and approaches needed to satisfy the information requirements taking into account resource limitations and the aim to reduce animal testing. d) Promote substitution of high risk chemicals. Create an effective process for identifying substances of very high concern and for making the appropriate risk management decisions for these substances. e) Address the control of substances incorporated in articles. And f) acknowledge uncertainties. Systematically report lack of data and include this as a basis for risk management.

  • 20.
    Rudén, Christina
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Liljelund, K.Hagerman, H.
    Towards Sustainable Pharmaceuticals in a Healthy Society2010Collection (editor) (Other academic)
  • 21.
    Rudén, Christina
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Ågerstrand, Marlene
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Göransson, M.
    Breitholtz, M.
    Standard and non-standard tests for risk assessment purposes2010In: Towards Sustainable Pharmaceuticals in a Healthy Society / [ed] C Rudén, K Liljelund, H Hagerman, Elanders Sverige AB , 2010Chapter in book (Other academic)
  • 22.
    Schenk, Linda
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Hansson, Sven Ove
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Wester, Misse
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Are occupational exposure limits still an effective tool for chemicals risk management at the work place?2010In: Toxicology Letters, ISSN 0378-4274, E-ISSN 1879-3169, Vol. 196, p. S101-Article in journal (Refereed)
    Abstract [en]

    Chemicals in the occupational setting are well known to pose a variety of health risks to workers, and are accordingly subject to risk management measures. In Sweden, as well as many other countries, occupational exposure limits (OELs) are presented as an important tool for managing chemical risks. However, measurements to ensure compliance with OELs have decreased significantly and the question is to what extent the OELs still perform their function, and through which mechanisms. By performing interviews at a number of different workplaces in Sweden, that handle chemicals, we will try to identify regulatory, social and organizational factors that influence the risk perception and communication at workplaces and also investigate the role played by OELs in these processes. Previous research on risk management at the workplace has often been focused on physical risks or accident prevention. We believe that the management, communication and perception of chemical risks differ significantly in their nature from most physical risks, since exposures to harmful chemicals generally lead to delayed and unpredictable effects and individuals tend to estimate risks with delayed effects lower than if the consequences are immediate.

  • 23.
    Ågerstrand, Marlene
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Breitholtz, M.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Comparison of four different methods for reliability evaluation of ecotoxicity data: A case study of non-standard test dataused in environmental risk assessments of pharmaceutical substances2011In: Environmental Sciences Europe, ISSN 2190-4707, E-ISSN 2190-4715, Vol. 23, no 17Article in journal (Other academic)
  • 24.
    Ågerstrand, Marlene
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Breitholtz, Magnus
    Stockholm Univ, Stockholm, Sweden .
    Hansson, Sven Ove
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Regulatory perspectives on pharmaceuticals in the environment2012In: Toxicology Letters, ISSN 0378-4274, E-ISSN 1879-3169, Vol. 211, p. S31-S31Article in journal (Other academic)
  • 25.
    Ågerstrand, Marlene
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Evaluation of the accuracy and consistency of the Swedish Environmental Classification and Information System for pharmaceuticals2010In: Science of the Total Environment, ISSN 0048-9697, E-ISSN 1879-1026, Vol. 408, no 11, p. 2327-2339Article in journal (Refereed)
    Abstract [en]

    The Swedish environmental and classification system for pharmaceuticals is a voluntary, industry-owned system with the purpose to provide environmental information about active pharmaceutical ingredients in the Swedish market. In this paper we report the results from a detailed evaluation of the accuracy and consistency of the risk assessments conducted within this system. The evaluation focused on the following three aspects: 1) comparison of the companies' risk assessments with the classification system's own guidance document, 2) how the risk assessments are affected if additional effect data is used, and 3) the consistency of different risk assessments for the same pharmaceutical substance. The analyses show that the system's guidance gives no criteria for when to consider a study "long-term" or "short-term", and that this confusion affected the outcome of the risk assessments in some cases. Furthermore, when the system's guidance document is followed and the risk assessment was supplemented with effect data from the open scientific literature, then the risk classification for a substantial number of the evaluated substances was altered. Our analyses also revealed that in some cases risk assessors disagree on the outcome of the assessment for the same active pharmaceutical ingredient. Finally we list some recommendations to improve the classification system. The recommendations include clarifying concepts and instructions in the guidance document, introduction of a standardized way of reporting data to the website, and promotion of use of nonstandard test data when considered the most relevant.

  • 26.
    Ågerstrand, Marlene
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Risk assessment of pharmaceuticals in the environment: The Swedish environmental classification system for pharmaceuticals2011Conference paper (Other academic)
  • 27.
    Ågerstrand, Marlene
    et al.
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    Rudén, Christina
    KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy.
    The Swedish environmental and classification system for pharmaceuticals: An evaluation of the system’s achievements so far2010In: Towards Sustainable Pharmaceuticals in a Healthy Society / [ed] C Rudén, K Liljelund, H Hagerman, Elanders Sverige AB , 2010Chapter in book (Other academic)
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Output format
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  • asciidoc
  • rtf