SwePub
Sök i SwePub databas

  Utökad sökning

Träfflista för sökning "WFRF:(Ågerstrand Marlene) "

Sökning: WFRF:(Ågerstrand Marlene)

  • Resultat 1-50 av 66
Sortera/gruppera träfflistan
   
NumreringReferensOmslagsbildHitta
1.
  • Beronius, A., et al. (författare)
  • Making the most of expert judgment in hazard and risk assessment of chemicals
  • 2017
  • Ingår i: Toxicology Research. - : Oxford University Press (OUP). - 2045-452X .- 2045-4538. ; 6:5, s. 571-577
  • Tidskriftsartikel (refereegranskat)abstract
    • Evaluation of the reliability and relevance of toxicity and ecotoxicity studies is an integral step in the assessment of the hazards and risks of chemicals. This evaluation is inherently reliant on expert judgment, which often leads to differences between experts' conclusions regarding how individual studies can contribute to the body of evidence. The conclusions of regulatory assessment, such as establishing safe exposure levels for humans and the environment and calculations of margins of exposure, may have large consequences for which chemicals are permitted on the market and their allowed uses. It is therefore important that such assessments are based on all reliable and relevant scientific data, and that assessment principles and assumptions, such as expert judgment, are transparently applied. It is not possible nor desirable to completely eliminate expert judgment from the evaluation of (eco) toxicity studies. However, it is desirable to introduce measures that increase structure and transparency in the evaluation process so as to provide scientifically robust risk assessments that can be used for regulatory decision making. In this article we present results from workshop exercises with Nordic experts to illustrate how experts' evaluations regarding the reliability and relevance of (eco) toxicity studies for risk assessment may vary and discuss methods intended to promote structure and transparency in the evaluation process.
  •  
2.
  • Borchert, Flora, et al. (författare)
  • Characterisation and analysis of key studies used to restrict substances under REACH
  • 2022
  • Ingår i: Environmental Sciences Europe. - : Springer Science and Business Media LLC. - 2190-4707 .- 2190-4715. ; 34:1
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: Understanding how scientifc studies are used in regulatory risk assessments is important since it infuences the outcome of an assessment, and thus the level of protection of human health and the environment. Withinthe REACH legislation (Registration, Evaluation, Authorisation and Restriction of Chemicals, EC Nr. 1907/2006) hazardinformation on clearly defned (eco-)toxicological endpoints are submitted for the registration of substances, and thisinformation is intended for concluding on potential hazards and risk as well as subsequent risk management measures such as restrictions. The present study aimed to (1) characterise key studies used by the European ChemicalsAgency’s Committee for Risk Assessment to restrict hazardous substances; (2) analyse if the REACH registration database provided the key studies used in these restrictions, and (3) investigate potential expert disagreements related tothe use of non-standard studies in the restrictions.Results: Our analysis showed that 58% of the 53 scrutinised key studies were non-standard studies, all available bypaying a fee or through open access. Sixteen (30%) of the key studies were consulted from external sources outsidethe REACH registration database by the Committee for Risk Assessment. Only one study of the 16 external key studieswas a standard study. Further, 9% (5/53) of the key studies used by the Committee for Risk Assessment were inaccessible to third parties, all were standard studies. The uses of non-standard studies were (unsuccessfully) challenged forfve substances during the public consultation.Conclusions: These results suggest that non-standard studies contributed to the identifcation and management ofsubstances of concern, that the REACH registration database may not be sufcient for the identifcation and management of uncontrolled hazards and risks, and that the transparency of the decisions made by the Committee for RiskAssessment was partially hampered due to the use of standard studies inaccessible to third parties.
  •  
3.
  •  
4.
  •  
5.
  • Borchert, Flora, 1993- (författare)
  • Managing chemical risks in the EU : Data use and new approaches for decision-making
  • 2024
  • Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
    • Man-made chemicals benefit our living standards, but exposure to the (most) harmful ones can lead to negative, irreversible effects on human health and the environment. The risk management of harmful chemicals aims to protect human health and the environment from unacceptable risks. Decisions made on management measures are often based on data generated by the chemicals’ producers and/or importers. However, risk management measures have been criticised for not fulfilling their expected purpose, and risk assessors and decision-makers can have different ways of assessing hazards and risks, and hence, can have diverging opinions on the most suitable risk management measures for harmful chemicals. The overall objective of this thesis was to contribute to a better understanding of how information about harmful chemicals put on the EU market are, or could be, used to improve the overall protection of the environment and human health. Two main questions were asked: First, what data are used for the decision-making on chemical risk management under EU regulations? And second, how could available data be used differently through the use of new approaches to improve risk management? The questions were addressed by exploring three risk management procedures in the EU. These were the restriction and authorisation procedures under the REACH Regulation (EC No 1907/2006), as well as the environmental management under the Plant Protection Products Regulation (EC No 1107/2009). First, an analysis of key studies used to restrict substances under the REACH Regulation showed that non-standard studies contribute to risk management decisions, and that the REACH database may not provide sufficient information for adequate hazard identification and risk management (Paper I). Second, data generated in the course of the REACH authorisation procedure should, in theory, provide sufficient and relevant data to implement the essential use concept, a new approach to risk management presented in the EU Chemical Strategy for Sustainability (Paper II). An analysis of applications for authorisation, however, revealed that for approximately one-third of the analysed uses no clear decision could be made on their essentiality when applying the currently suggested essential use criteria (Paper III). Last, a first exploration of the relative risks of insecticides suggests that the more complex higher-tier studies, in particular mesocosm studies, are highly heterogeneous in their design and may not be useful for a systems-based environmental risk assessment that aims to enhance the level of protection of biodiversity on a larger scale. However, as expected, the risk quotients of the investigated substances decreased by adding higher-tier data. The added benefit of performing higher-tier studies could be further explored by investigating the magnitude of decrease of risk quotients (Paper IV). 
  •  
6.
  • Brack, Werner, et al. (författare)
  • Towards the review of the European Union Water Framework Directive : Recommendations for more efficient assessment and management of chemical contamination in European surface water resources
  • 2017
  • Ingår i: Science of the Total Environment. - : Elsevier BV. - 0048-9697 .- 1879-1026. ; 576, s. 720-737
  • Forskningsöversikt (refereegranskat)abstract
    • Water is a vital resource for natural ecosystems and human life, and assuring a high quality of water and protecting it from chemical contamination is a major societal goal in the European Union. The Water Framework Directive (WFD) and its daughter directives are the major body of legislation for the protection and sustainable use of European freshwater resources. The practical implementation of the WFD with regard to chemical pollution has faced some challenges. In support of the upcoming WFD review in 2019 the research project SOLUTIONS and the European monitoring network NORMAN has analyzed these challenges, evaluated the state-of-the-art of the science and suggested possible solutions. We give 10 recommendations to improve monitoring and to strengthen comprehensive prioritization, to foster consistent assessment and to support solution-oriented management of surface waters. The integration of effect-based tools, the application of passive sampling for bioaccumulative chemicals and an integrated strategy for prioritization of contaminants, accounting for knowledge gaps, are seen as important approaches to advance monitoring. Including all relevant chemical contaminants in more holistic chemical status assessment, using effect-based trigger values to address priority mixtures of chemicals, to better consider historical burdens accumulated in sediments and to use models to fill data gaps are recommended for a consistent assessment of contamination. Solution-oriented management should apply a tiered approach in investigative monitoring, to identify toxicity drivers, strengthen consistent legislative frameworks and apply solutions-oriented approaches that explore risk reduction scenarios before and along with risk assessment.
  •  
7.
  • Bui, Thuy T., et al. (författare)
  • Applying a modified systematic review and integrated assessment framework (SYRINA) - a case study on triphenyl phosphate
  • 2023
  • Ingår i: Environmental Science. - 2050-7887 .- 2050-7895. ; 26:2, s. 380-399
  • Tidskriftsartikel (refereegranskat)abstract
    • This work presents a case study in applying a systematic review framework (SYRINA) to the identification of chemicals as endocrine disruptors. The suitability and performance of the framework is tested with regard to the widely accepted World Health Organization definition of an endocrine disruptor (ED). The endocrine disrupting potential of triphenyl phosphate (TPP), a well-studied flame retardant reported to exhibit various endocrine related effects was assessed. We followed the 7 steps of the SYRINA framework, articulating the research objective via Populations, Exposures, Comparators, Outcomes (PECO) statements, performed literature search and screening, conducted study evaluation, performed data extraction and summarized and integrated the evidence. Overall, 66 studies, consisting of in vivo, in vitro and epidemiological data, were included. We concluded that triphenyl phosphate could be identified as an ED based on metabolic disruption and reproductive function. We found that the tools used in this case study and the optimizations performed on the framework were suitable to assess properties of EDs. A number of challenges and areas for methodological development in systematic appraisal of evidence relating to endocrine disrupting potential were identified; significant time and effort were needed for the analysis of in vitro mechanistic data in this case study, thus increasing the workload and time needed to perform the systematic review process. Further research and development of this framework with regards to grey literature (non-peer-reviewed literature) search, harmonization of study evaluation methods, more consistent evidence integration approaches and a pre-defined method to assess links between adverse effect and endocrine activity are recommended. It would also be advantageous to conduct more case studies for a chemical with less data than TPP.
  •  
8.
  • Carney Almroth, Bethanie, 1974, et al. (författare)
  • Obstacles to scientific input in global policy.
  • 2023
  • Ingår i: Science (New York, N.Y.). - 1095-9203 .- 0036-8075. ; 380:6649, s. 1021-1022
  • Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)
  •  
9.
  • Cooper, Glinda S., et al. (författare)
  • Study sensitivity : Evaluating the ability to detect effects in systematic reviews of chemical exposures
  • 2016
  • Ingår i: Environment International. - : Elsevier BV. - 0160-4120 .- 1873-6750. ; 92-93, s. 605-610
  • Forskningsöversikt (refereegranskat)abstract
    • A critical step in systematic reviews of potential health hazards is the structured evaluation of the strengths and weaknesses of the included studies; risk of bias is a term often used to represent this process, specifically with respect to the evaluation of systematic errors that can lead to inaccurate (biased) results (i.e. focusing on internal validity). Systematic review methods developed in the clinical medicine arena have been adapted for use in evaluating environmental health hazards; this expansion raises questions about the scope of risk of bias tools and the extent to which they capture the elements that can affect the interpretation of results from environmental and occupational epidemiology studies and in vivo animal toxicology studies, (the studies typically available for assessment of risk of chemicals). One such element, described here as sensitivity, is a measure of the ability of a study to detect a true effect or hazard. This concept is similar to the concept of the sensitivity of an assay; an insensitive study may fail to show a difference that truly exists, leading to a false conclusion of no effect Factors relating to study sensitivity should be evaluated in a systematic manner with the same rigor as the evaluation of other elements within a risk of bias framework. We discuss the importance of this component for the interpretation of individual studies, examine approaches proposed or in use to address it, and describe how it relates to other evaluation components. The evaluation domains contained within a risk of bias tool can include, or can be modified to include, some features relating to study sensitivity; the explicit inclusion of these sensitivity criteria with the same rigor and at the same stage of study evaluation as other bias-related criteria can improve the evaluation process. In some cases, these and other features may be better addressed through a separate sensitivity domain. The combined evaluation of risk of bias and sensitivity can be used to identify the most informative studies, to evaluate the confidence of the findings from individual studies and to identify those study elements that may help to explain heterogeneity across the body of literature.
  •  
10.
  • Dulio, Valeria, et al. (författare)
  • The NORMAN Association and the European Partnership for Chemicals Risk Assessment (PARC) : let’s cooperate!
  • 2020
  • Ingår i: Environmental Sciences Europe. - : Springer. - 2190-4707 .- 2190-4715. ; 32:1
  • Tidskriftsartikel (refereegranskat)abstract
    • The Partnership for Chemicals Risk Assessment (PARC) is currently under development as a joint research and innovation programme to strengthen the scientific basis for chemical risk assessment in the EU. The plan is to bring chemical risk assessors and managers together with scientists to accelerate method development and the production of necessary data and knowledge, and to facilitate the transition to next-generation evidence-based risk assessment, a non-toxic environment and the European Green Deal. The NORMAN Network is an independent, well-established and competent network of more than 80 organisations in the field of emerging substances and has enormous potential to contribute to the implementation of the PARC partnership. NORMAN stands ready to provide expert advice to PARC, drawing on its long experience in the development, harmonisation and testing of advanced tools in relation to chemicals of emerging concern and in support of a European Early Warning System to unravel the risks of contaminants of emerging concern (CECs) and close the gap between research and innovation and regulatory processes. In this commentary we highlight the tools developed by NORMAN that we consider most relevant to supporting the PARC initiative: (i) joint data space and cutting-edge research tools for risk assessment of contaminants of emerging concern; (ii) collaborative European framework to improve data quality and comparability; (iii) advanced data analysis tools for a European early warning system and (iv) support to national and European chemical risk assessment thanks to harnessing, combining and sharing evidence and expertise on CECs. By combining the extensive knowledge and experience of the NORMAN network with the financial and policy-related strengths of the PARC initiative, a large step towards the goal of a non-toxic environment can be taken.
  •  
11.
  • Figuière, Romain, 1995-, et al. (författare)
  • The essential-use concept : a valuable tool to guide decision-making on applications for authorisation under REACH?
  • 2023
  • Ingår i: Environmental Sciences Europe. - : Springer Science and Business Media LLC. - 2190-4707 .- 2190-4715. ; 35
  • Tidskriftsartikel (refereegranskat)abstract
    • Background In 2020, the European Commission published the Chemical Strategy for Sustainability (CSS) in which it aims to increase the level of protection for human health and the environment from hazardous chemicals. Part of the implementation of the CSS will involve a reform of the REACH authorisation and restriction processes. One option for the reform of the authorisation process is to implement the essential-use concept as a tool to guide decision-making on applications for authorisation to make the process more efficient and to align it with societal needs. The purpose of this study is to investigate whether changes in the legal text that defines the authorisation process, and of the amount and type of information that applicants should provide in an application for authorisation, are needed to enable an implementation of the essential-use concept.Results The results suggest that no fundamental changes in the regulatory requirements are needed and that applicants should already provide sufficient and relevant information to the authorities to determine if the use(s) applied for is (are) essential.Conclusions Although the REACH authorisation already provides a legal and practical basis for an implementation of the essential-use concept, the feasibility of the essentiality assessment and its potential to make the decision-making on applications more efficient are highly dependent on the quality of the information provided and the clearness of decision criteria. However, if an applicant successfully demonstrates that the risk related to the use(s) applied for is adequately controlled, it could not be legally justified for the European Commission to refuse an authorisation by arguing that the use(s) applied for is (are) non-essential.
  •  
12.
  • Ford, Alex T., et al. (författare)
  • The Role of Behavioral Ecotoxicology in Environmental Protection
  • 2021
  • Ingår i: Environmental Science and Technology. - : American Chemical Society (ACS). - 0013-936X .- 1520-5851. ; 55:9, s. 5620-5628
  • Tidskriftsartikel (refereegranskat)abstract
    • For decades, we have known that chemicals affect human and wildlife behavior. Moreover, due to recent technological and computational advances, scientists are now increasingly aware that a wide variety of contaminants and other environmental stressors adversely affect organismal behavior and subsequent ecological outcomes in terrestrial and aquatic ecosystems. There is also a groundswell of concern that regulatory ecotoxicology does not adequately consider behavior, primarily due to a lack of standardized toxicity methods. This has, in turn, led to the exclusion of many behavioral ecotoxicology studies from chemical risk assessments. To improve understanding of the challenges and opportunities for behavioral ecotoxicology within regulatory toxicology/risk assessment, a unique workshop with international representatives from the fields of behavioral ecology, ecotoxicology, regulatory (eco)toxicology, neurotoxicology, test standardization, and risk assessment resulted in the formation of consensus perspectives and recommendations, which promise to serve as a roadmap to advance interfaces among the basic and translational sciences, and regulatory practices.
  •  
13.
  • Hanson, M. L., et al. (författare)
  • How we can make ecotoxicology more valuable to environmental protection
  • 2017
  • Ingår i: Science of the Total Environment. - : Elsevier BV. - 0048-9697 .- 1879-1026. ; 578, s. 228-235
  • Tidskriftsartikel (refereegranskat)abstract
    • There is increasing awareness that the value of peer-reviewed scientific literature is not consistent, resulting in a growing desire to improve the practice and reporting of studies. This is especially important in the field of ecotoxicology, where regulatory decisions can be partly based on data from the peer-reviewed literature, with wide-reaching implications for environmental protection. Our objective is to improve the reporting of ecotoxicology studies so that they can be appropriately utilized in a fair and transparent fashion, based on their reliability and relevance. We propose a series of nine reporting requirements, followed by a set of recommendations for adoption by the ecotoxicology community. These reporting requirements will provide clarity on the the test chemical, experimental design and conditions, chemical identification, test organisms, exposure confirmation, measurable endpoints, how data are presented, data availability and statistical analysis. Providing these specific details will allow for a fuller assessment of the reliability and relevance of the studies, including limitations. Recommendations for the implementation of these reporting requirements are provided herein for practitioners, journals, reviewers, regulators, stakeholders, funders, and professional societies. If applied, our recommendations will improve the quality of ecotoxicology studies and their value to environmental protection.
  •  
14.
  • Hartmann, Nanna B., et al. (författare)
  • NanoCRED : A transparent framework to assess the regulatory adequacy of ecotoxicity data for nanomaterials - Relevance and reliability revisited
  • 2017
  • Ingår i: NanoImpact. - : Elsevier BV. - 2452-0748. ; 6, s. 81-89
  • Tidskriftsartikel (refereegranskat)abstract
    • Environmental hazard and risk assessment serve as the basis for regulatory decisions to protect the environment from unintentional adverse effects of chemical substances including nanomaterials. This process requires reliable and relevant environmental hazard data upon which classification and labelling can be based and Predicted No-Effect Concentration (PNEC) values can be estimated. In a regulatory context ecotoxicological data is often recommended to be generated according to accepted and validated test guidelines, preferably also following Good Laboratory Practice. However, engineered nanomaterials are known to behave very differently in ecotoxicity tests compared to the conventional soluble chemicals, for which most guidelines were developed. Therefore non-guideline tests, or tests following modified test guidelines, can provide valuable information and should not per se be considered less adequate for regulatory use. Here we propose a framework for reliability and relevance evaluation of ecotoxicity data for nanomaterials that take into account the challenges and characterisation requirements associated with testing of these substances. The nanoCRED evaluation criteria, and accompanying guidance, were developed to be used in combination with those developed through the ‘Criteria for Reporting and Evaluating Ecotoxicity Data (CRED)’ project. This approach can accommodate all types of nanomaterials, all types of aquatic ecotoxicity studies, and qualitative as well as quantitative data evaluation requirements. Furthermore, it is practically feasible to implement and directly applicable in European as well as international regulatory frameworks.
  •  
15.
  • Ingre-Khans, Ellen, et al. (författare)
  • Improving structure and transparency in reliability evaluations of data under REACH : suggestions for a systematic method
  • 2020
  • Ingår i: Human and Ecological Risk Assessment. - : Informa UK Limited. - 1080-7039 .- 1549-7860. ; 26:1, s. 212-241
  • Tidskriftsartikel (refereegranskat)abstract
    • The goal of identifying hazardous chemicals registered under the Registration, Evaluation, Authorization and restriction of CHemicals (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.
  •  
16.
  • Ingre-Khans, Ellen, et al. (författare)
  • Reliability and relevance evaluations of REACH data
  • 2019
  • Ingår i: Toxicology Research. - 2045-452X .- 2045-4538. ; 8:1, s. 46-56
  • Tidskriftsartikel (refereegranskat)abstract
    • Regulatory authorities rely on hazard and risk assessments performed under REACH for identifying chemicals of concern and to 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 risk assessments.
  •  
17.
  • Ingre-Khans, Ellen, et al. (författare)
  • Toxicity studies used in registration, evaluation, authorisation and restriction of chemicals (REACH) : How accurately are they reported?
  • 2019
  • Ingår i: Integrated Environmental Assessment and Management. - : Wiley. - 1551-3777 .- 1551-3793. ; 15:3, s. 458-469
  • Tidskriftsartikel (refereegranskat)abstract
    • Toxicity studies on chemicals registered under the European Union's Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation are provided as summaries instead of as a full study report. Because the registration data are used by regulatory agencies to identify chemicals of concern, the study summaries must accurately reflect the information in studies. A “study summary” should include sufficient information on the objectives, methods, results, and conclusions in the full study report in order for the relevance of the study to be determined. Sometimes a “robust study summary” is required, which should contain more detailed information to enable an independent assessment of the study. The aim of the present investigation is to examine how well published toxicity papers were reflected in study summaries submitted by registrants under REACH. Summaries of 20 published studies (peer‐reviewed studies, including 1 abstract) were examined and broad categories of various types of observed differences were derived. The extent to which information in the published studies was reported, as well as how accurately the information was reflected, varied. How accurately the information was reflected also varied. Differences between the published studies and the summaries 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 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 scrutinize 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 thorough examination and fully independent assessment.
  •  
18.
  • Ingre-Khans, Ellen, et al. (författare)
  • Transparency of chemical risk assessment data under REACH
  • 2016
  • Ingår i: Environmental Science: Pocesses & Impacts. - : Royal Society of Chemistry (RSC). - 2050-7887 .- 2050-7895. ; 18:12, s. 1508-1518
  • Tidskriftsartikel (refereegranskat)abstract
    • 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.
  •  
19.
  • Ingre-Khans, Ellen, 1983- (författare)
  • Transparency within REACH? : Regulatory risk assessment of industrial chemicals
  • 2018
  • Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
    • 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.
  •  
20.
  • Kase, Robert, et al. (författare)
  • Criteria for Reporting and Evaluating ecotoxicity Data (CRED) : comparison and perception of the Klimisch and CRED methods for evaluating reliability and relevance of ecotoxicity studies
  • 2016
  • Ingår i: Environmental Sciences Europe. - : Springer Science and Business Media LLC. - 2190-4707 .- 2190-4715. ; 28
  • Tidskriftsartikel (refereegranskat)abstract
    • BACKGROUND: The regulatory evaluation of ecotoxicity studies for environmental risk and/or hazard assessment of chemicals is often performed using the method established by Klimisch and colleagues in 1997. The method was, at that time, an important step toward improved evaluation of study reliability, but lately it has been criticized for lack of detail and guidance, and for not ensuring sufficient consistency among risk assessors.RESULTS: A new evaluation method was thus developed: Criteria for Reporting and Evaluating ecotoxicity Data (CRED). The CRED evaluation method aims at strengthening consistency and transparency of hazard and risk assessment of chemicals by providing criteria and guidance for reliability and relevance evaluation of aquatic ecotoxicity studies. A two-phased ring test was conducted to compare and characterize the differences between the CRED and Klimisch evaluation methods. A total of 75 risk assessors from 12 countries participated. Results show that the CRED evaluation method provides a more detailed and transparent evaluation of reliability and relevance than the Klimisch method. Ring test participants perceived it to be less dependent on expert judgement, more accurate and consistent, and practical regarding the use of criteria and time needed for performing an evaluation.CONCLUSIONS: We conclude that the CRED evaluation method is a suitable replacement for the Klimisch method, and that its use may contribute to an improved harmonization of hazard and risk assessments of chemicals across different regulatory frameworks.
  •  
21.
  • Kättström, Diana, 1983-, et al. (författare)
  • An analysis of the impact of the new CLP hazard classes on EU chemicals legislation
  • Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
    • The European Union (EU) recently introduced four [MÅ1] new hazard classes to the Classification, Labelling and Packaging (CLP) Regulation (EC) 1272/2008. The classes are endocrine disruption for human health (ED HH) and the environment (ED ENV), persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), and persistent, mobile and toxic (PMT) or very persistent and very mobile (vPvM). This action was a direct consequence of the EU's Chemicals Strategy for Sustainability, which aims at strengthening the protection of human health and the environment, as well as reinforcing the CLP Regulation as the central piece of the chemicals legislation. This study examined the regulatory obligations triggered by these new hazard classes, as well as the existing obligations for endocrine disrupters and PBT/vPvB substances identified in other EU regulations. In addition, we compared the CLP criteria for endocrine disruption and PBT/vPvB to criteria existing in other EU regulations and investigated how these criteria are used in the EU chemicals legislation.  The European Union (EU) recently introduced four new hazard classes to the Classification, Labelling and Packaging (CLP) Regulation (EC) 1272/2008. The classes are endocrine disruption for human health (ED HH) and the environment (ED ENV), persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB), and persistent, mobile and toxic (PMT) or very persistent and very mobile (vPvM). This action was a direct consequence of the EU's Chemicals Strategy for Sustainability, which aims at strengthening the protection of human health and the environment, as well as reinforcing the CLP Regulation as the central piece of the chemicals legislation. This study examined the regulatory obligations triggered by these new hazard classes, as well as the existing obligations for endocrine disrupters and PBT/vPvB substances identified in other EU regulations. In addition, we compared the CLP criteria for endocrine disruption and PBT/vPvB to criteria existing in other EU regulations and investigated how these criteria are used in the EU chemicals legislation.  We found that the implementation of the new hazard classes under the CLP Regulation into existing EU chemicals legislation will require the revision of all regulations that rely on the CLP hazard criteria for risk management. Without revision, the immediate impact of the new hazard classes will only extend to the six regulations and the regulatory obligations they contain, all of which apply to all hazardous substances under the CLP Regulation. Meanwhile, substances with endocrine disrupting and PBT/vPvB properties are already being identified and regulated using criteria from regulations other than the CLP. When comparing the criteria for identification of endocrine disrupters and PBT/vPvB substances across the chemicals legislation, we found that the criteria differed between regulations. The findings aim to support the efficient implementation of the new CLP hazard classes and harmonization of criteria across regulations, in line with the Chemicals Strategy for Sustainability.
  •  
22.
  • Kättström, Diana, 1983-, et al. (författare)
  • Fulfilling the criteria for CLP classification: the implications for substances under the EU chemicals legislation
  • Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
    • The implementation of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) through Regulation (EC) 1272/2008 (CLP) is central to chemical regulation in the European Union (EU). The CLP mandates manufacturers and importers to classify substances and mixtures according to hazard criteria, with notifications submitted to the European Chemicals Agency (ECHA). Substances meeting hazard criteria must be appropriately labelled and packaged to communicate hazards effectively. The CLP establishes hazard classification criteria but does not independently restrict the use of hazardous chemicals. Instead, it serves as a basis for regulatory obligations in other specific regulations. This study investigates the regulatory implications of meeting hazard criteria under the CLP across EU regulations and directives listed in EUCLEF. Results reveal that fulfilling criteria for human health hazard classes triggers regulatory obligations in the highest number of regulations/directives, with carcinogenicity, mutagenicity, and reproductive toxicity (CMR) leading to obligations in 19 of 20 pieces of legislation linked to the CLP. Conversely, physical, environmental, and ozone layer hazards are associated with fewer regulations and directives, resulting in fewer prohibitions.The study underscores the pivotal role of the CLP in EU chemical legislation and the need for coherence and consistency across regulations. While regulatory obligations are primarily aimed at substances meeting hazard criteria, issues with self-classification variability and limitations in harmonized classification processes were observed. Moreover, the complexity of the regulatory structure poses challenges for stakeholders and policymakers, including inconsistencies, compliance difficulties, and the need for frequent revisions. Addressing these challenges is critical for enhancing regulatory effectiveness and ensuring a more coherent and harmonized approach to chemical management in the EU.
  •  
23.
  • Kättström, Diana, 1983- (författare)
  • Inconsistencies and missing links in EU chemicals legislation
  • 2024
  • Doktorsavhandling (övrigt vetenskapligt/konstnärligt)abstract
    • The EU chemicals legislation consists of the Regulation on Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) and the Regulation on Classification, Labelling, and Packaging of Substances and Mixtures (CLP), complemented by over fifty regulations and directives regulating specific uses and products. While regulating individual uses may offer a faster and simpler approach to protecting human health and the environment from hazardous chemicals, it can also lead to inconsistencies, such as gaps and overlaps. These inconsistencies may arise for chemicals with multiple uses, each governed by separate legislation.The overall objective of this work was to understand the links between different pieces of EU chemicals legislation, to identify inconsistencies in the regulation of chemicals covered by multiple regulations and, in particular, to explore the implications of these inconsistencies for the protection of human health and the environment. First, we compared how antimicrobial substances are regulated when used in biocidal products compared to cosmetics (Paper I). The risk assessment of cosmetic preservatives focused solely on human health, omitting environmental data and environmental risk assessment. Once granted, the approval of cosmetic preservatives remained valid indefinitely until revoked by the European Commission, with no requirement to update the dossier based on new information. Based on these findings, we examined whether the approved cosmetic preservatives were hazardous to the aquatic environment or persistent, and if so, whether the risks were efficiently managed by REACH (Paper II). The analysis showed that environmental hazards of cosmetic preservatives and other ingredients are overlooked by the Cosmetic Products Regulation and might not be effectively managed by REACH. Next, the linkage between the CLP and other pieces of chemicals legislation was examined, mapping out regulatory obligations, arising from the new CLP hazard classes for endocrine disruption for human health (ED HH), endocrine disruption for the environment (ED ENV), PBT/vPvB, and PMT/vPvM (Papers III and IV). Meeting criteria for human health hazards under the CLP triggered more regulatory obligations across multiple regulations, compared to when fulfilling the criteria for physical or environmental hazards. Implementation of the new CLP hazard classes will require revision of regulations with existing risk management measures connected to the CLP hazard criteria.The results and conclusions of the studies included in this thesis highlight the need for addressing the existing inconsistencies in order to strengthen the protection of human health and the environment. The provided recommendations address the need for harmonisation of the chemicals legislation and more efficient management of hazardous chemicals.
  •  
24.
  • Kättström, Diana, et al. (författare)
  • Out of REACH : environmental hazards of cosmetic preservatives
  • 2024
  • Ingår i: Human and Ecological Risk Assessment. - 1080-7039 .- 1549-7860.
  • Tidskriftsartikel (refereegranskat)abstract
    • The EU Cosmetic Products Regulation requires neither environmental data nor environmental risk assessment for individual ingredients or finished cosmetic products. Instead, it relies on REACH to address environmental risks linked to cosmetic ingredients, including preservatives. We investigated how the environmental risks of cosmetic preservatives are managed by REACH. We identified preservatives of environmental concern and examined if any of these had been selected for Substance Evaluation, proposed for or identified as an SVHC, required authorization or were proposed for, or subject to, restriction under REACH. More than half of the preservatives approved under the Cosmetic Product Regulation, 70 of 137, were identified as being of environmental concern according to the criteria set in this study. Some of the approved preservatives were no longer produced or used in the EU due to their hazardous properties. However, they remained approved and may still enter the EU via the imported products. Our results also indicate that the environmental aspects of cosmetic ingredients, including preservatives, are not efficiently managed by REACH. Besides the known issues in REACH, we identified additional areas in the interface between REACH, CLP and the Cosmetic Products Regulation that call for improvement. Here, we provide practical suggestions in line with the Chemicals Strategy for Sustainability. If implemented, these measures would strengthen the protection of the environment from hazardous cosmetic ingredients.
  •  
25.
  • Kättström, Diana, et al. (författare)
  • Stricter regulation applies to antimicrobial substances when used as biocides compared to cosmetics under current EU legislation
  • 2022
  • Ingår i: Emerging Contaminants. - : Elsevier BV. - 2405-6650 .- 2405-6642. ; 8, s. 229-242
  • Tidskriftsartikel (refereegranskat)abstract
    • Antimicrobial substances are substances that have the ability to kill or slow down the growth of microorganisms such as bacteria, algae and fungi. Exposure of microorganisms to low concentrations of antimicrobial substances may lead to the development of antimicrobial resistance. To protect human health and the environment and to limit resistance, the risks for the release of these substances into the environment should be minimized from all sources. Under the current EU legal framework, some specific uses of antimicrobial substances are strictly regulated whereas others are not. When antimicrobial substances are used as active substances in biocidal products, such as disinfectants, they are regulated by Biocidal Products Regulation. When the same substances are used as preservatives in cosmetic products they fall under Cosmetic Products Regulation. In this paper, we investigated how the regulation of antimicrobial substances differ when used in biocidal products compared to cosmetic products. This was achieved by performing a systematic comparison using document analysis with focus on aims, scope, information requirements, and risk assessment procedures for biocidal active substances and cosmetic preservatives. One of the main differences identified is that no environmental data or environmental risk assessment are required for approval of cosmetic preservatives. In contrast, environmental data and risk assessment for both the active substances and one representative product would be required for the approval of the same substance if used as a biocidal active substance. This means first that a substance not approved for use in biocidal products due to its hazardous environmental properties can still be approved as a cosmetic preservative. And second, the environmental release of antimicrobial substances from cosmetic products remains unassessed and uncontrolled, despite the obvious risks of cosmetic ingredients being emitted into the environment via wastewater. From this, we recommend that an environmental risk assessment is added to the requirements for market approval of cosmetic preservatives to achieve the aim of a high level of protection for the environment as set by several EU regulations. This would be in line with the “one substance – one assessment” approach proposed by the European Commission. While the details of “one substance – one assessment” approach are not decided, it is believed to contribute to more coordinated and transparent chemical safety assessments and enhance interlinking between the regulations.
  •  
26.
  • Lind, Lars, et al. (författare)
  • Uppsala Consensus Statement on Environmental Contaminants and the Global Obesity Epidemic
  • 2016
  • Ingår i: Journal of Environmental Health Perspectives. - : Environmental Health Perspectives. - 0091-6765 .- 1552-9924. ; 124:5, s. A81-A83
  • Tidskriftsartikel (refereegranskat)abstract
    • From the lectures presented at the 2nd International Workshop on Obesity and Environmental Contaminants, which was held in Uppsala, Sweden, on 8–9 October 2015, it became evident that the findings from numerous animal and epidemiological studies are consistent with the hypothesis that environmental contaminants could contribute to the global obesity epidemic. To increase awareness of this important issue among scientists, regulatory agencies, politicians, chemical industry management, and the general public, the authors summarize compelling scientific evidence that supports the hypothesis and discuss actions that could restrict the possible harmful effects of environmental contaminants on obesity.
  •  
27.
  •  
28.
  • Moermond, Caroline T. A., et al. (författare)
  • CRED : CRITERIA FOR REPORTING AND EVALUATING ECOTOXICITY DATA
  • 2016
  • Ingår i: Environmental Toxicology and Chemistry. - : Wiley. - 0730-7268 .- 1552-8618. ; 35:5, s. 1297-1309
  • Tidskriftsartikel (refereegranskat)abstract
    • Predicted-no-effect concentrations (PNECs) and environmental quality standards (EQSs) are derived in a large number of legal frameworks worldwide. When deriving these safe concentrations, it is necessary to evaluate the reliability and relevance of ecotoxicity studies. Such evaluation is often subject to expert judgment, which may introduce bias and decrease consistency when risk assessors evaluate the same study. The Criteria for Reporting and Evaluating Ecotoxicity Data (CRED) project attempts to address this problem. It aims to improve the reproducibility, transparency, and consistency of reliability and relevance evaluations of aquatic ecotoxicity studies among regulatory frameworks, countries, institutes, and individual assessors. In the present study, the CRED evaluation method is presented. It includes a set of 20 reliability and 13 relevance criteria, accompanied by extensive guidance. Risk assessors who participated in the CRED ring test evaluated the CRED evaluation method to be more accurate, applicable, consistent, and transparent than the often-used Klimisch method. The CRED evaluation method is accompanied by reporting recommendations for aquatic ecotoxicity studies, with 50 specific criteria divided into 6 categories: general information, test design, test substance, test organism, exposure conditions, and statistical design and biological response. An ecotoxicity study in which all important information is reported is more likely to be considered for regulatory use, and proper reporting may also help in the peer-review process.
  •  
29.
  • Molander, Linda, et al. (författare)
  • Combining web-based tools for transparent evaluation of data for risk assessment : developmental effects of bisphenol A on the mammary gland as a case study
  • 2017
  • Ingår i: Journal of Applied Toxicology. - : Wiley. - 0260-437X .- 1099-1263. ; 37:3, s. 319-330
  • Tidskriftsartikel (refereegranskat)abstract
    • Different tools have been developed that facilitate systematic and transparent evaluation and handling of toxicity data in the risk assessment process. The present paper sets out to explore the combined use of two web-based tools for study evaluation and identification of reliable data relevant to health risk assessment. For this purpose, a case study was performed using in vivo toxicity studies investigating low-dose effects of bisphenol A on mammary gland development. The reliability of the mammary gland studies was evaluated using the Science in Risk Assessment and Policy (SciRAP) criteria for toxicity studies. The Health Assessment Workspace Collaborative (HAWC) was used for characterizing and visualizing the mammary gland data in terms of type of effects investigated and reported, and the distribution of these effects within the dose interval. It was then investigated whether there was any relationship between study reliability and the type of effects reported and/or their distribution in the dose interval. The combination of the SciRAP and HAWC tools allowed for transparent evaluation and visualization of the studies investigating developmental effects of BPA on the mammary gland. The use of these tools showed that there were no apparent differences in the type of effects and their distribution in the dose interval between the five studies assessed as most reliable and the whole data set. Combining the SciRAP and HAWC tools was found to be a useful approach for evaluating in vivo toxicity studies and identifying reliable and sensitive information relevant to regulatory risk assessment of chemicals. Copyright (c) 2016 John Wiley & Sons, Ltd. The present paper explores the combined use of the Science in Risk Assessment and Policy toxicity study evaluation method and the Health Assessment Workspace Collaborative tools for identification of reliable data relevant to health risk assessment. Combining the Science in Risk Assessment and Policy and Health Assessment Workspace Collaborative tools was found to be a useful and transparent approach for evaluating in vivo toxicity studies and identifying reliable and sensitive information relevant to regulatory risk assessment of chemicals.
  •  
30.
  • Molander, Linda, 1984-, et al. (författare)
  • 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
  • Annan publikation (övrigt vetenskapligt/konstnärligt)abstract
    • 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.  
  •  
31.
  • Molander, Linda, et al. (författare)
  • Science in Risk Assessment and Policy (SciRAP) : An Online Resource for Evaluating and Reporting In Vivo (Eco)Toxicity Studies
  • 2015
  • Ingår i: Human and Ecological Risk Assessment. - : Informa UK Limited. - 1080-7039 .- 1549-7860. ; 21:3, s. 753-762
  • Tidskriftsartikel (refereegranskat)abstract
    • (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.
  •  
32.
  •  
33.
  • Molander, Linda, et al. (författare)
  • WikiPharma - A freely available, easily accessible, interactive and comprehensive database for environmental effect data for pharmaceuticals
  • 2009
  • Ingår i: Regulatory toxicology and pharmacology. - : Elsevier BV. - 0273-2300 .- 1096-0295. ; 55:3, s. 367-371
  • Tidskriftsartikel (refereegranskat)abstract
    • A significant number of Active Pharmaceutical Ingredients (APIs) have been identified in the environment and in surface waters. Data on the environmental hazards associated with these substances are emerging but are still scarce. We have compiled publicly available ecotoxicity data for APIs into a database called WikiPharma. The use of the database is free of charge. It can be accessed and updated continuously as a "wiki". The aim of WikiPharma is to provide an easily accessible, comprehensive and up-to-date overview of effects caused by pharmaceuticals on non-target organisms. The database currently contains basic information, i.e. substance name, ATC code(s) and pharmaceutical group(s), for 831 APIs representing 35 different drug classes. Effect data have been identified and included for 116 of these substances. These ecotoxicity test data have been extracted from 156 different sources. The development of a comprehensive database on ecological hazard of APIs can facilitate identification of data gaps and promote environmental risk assessment of these substances. The database is available at www.wikipharma.org.
  •  
34.
  • Mueller, L. K., et al. (författare)
  • Policy options to account for multiple chemical pollutants threatening biodiversity
  • 2023
  • Ingår i: Environmental Science: Advances. - : Royal Society of Chemistry (RSC). - 2754-7000. ; 2:2, s. 151-161
  • Forskningsöversikt (refereegranskat)abstract
    • Chemical pollution poses a threat to biodiversity on a global scale. This has been acknowledged in the Post-2020 Global Biodiversity Framework, which proposes to regulate the release of chemicals to the environment and names specific indicators focusing on pesticides, nutrients and plastic waste. We fully welcome the inclusion of these substances but would like to further emphasize that in order to protect biodiversity from hazardous chemicals, the scope of Target 7 should feature a wider range of pollutants that can contribute to biodiversity loss. We propose the inclusion of non-agricultural biocides, per- and polyfluoroalkyl substances (PFASs), toxic metal(loid)s, and endocrine-disrupting chemicals (EDCs). Furthermore, data on emerging pollutants (e.g., rare earth elements, toxic and persistent industrial chemicals, liquid crystal monomers, pharmaceuticals, personal care products) need to be regularly reviewed with the aim to integrate additional pollutants to Target 7 in the case of biodiversity risk. We suggest to amend Target 7 to postulate the aim for the overall reduction of chemical production and emissions, as well as the addition of the aforementioned substance groups of high concern to biodiversity for integration in the Post-2020 Global Biodiversity Framework. We further elaborate on different strategies for the reduction of emissions of hazardous chemicals through chemical simplification and grouping, reduction of chemicals with non-essential use, and innovative synthesis strategies (e.g., “benign-by-design”). In this context, the full life cycle of chemicals (i.e., production, use, and end of life) needs to be considered. Lastly, we propose to set up transparent data inventories, in cooperation with the industry, to inform about the production, transport and emissions of chemicals, which can serve as a basis for indicators related to monitoring the progress towards achieving the goals set under Target 7.
  •  
35.
  • Ramström, Helena, et al. (författare)
  • Pharmaceuticals and Environment : a web-based decision support for considering environmental aspects of medicines in use
  • 2020
  • Ingår i: European Journal of Clinical Pharmacology. - : Springer Science and Business Media LLC. - 0031-6970 .- 1432-1041. ; 76:8, s. 1151-1160
  • Tidskriftsartikel (refereegranskat)abstract
    • Purpose: The database Pharmaceuticals and Environment is a non-commercial, freely available web-based decision support presenting compiled environmental information for pharmaceutical substances. It was developed by Region Stockholm and launched in 2016 at janusinfo.se. The purpose of this paper is to present the database, report on its current use, and reflect on lessons learned from developing and managing the database.Methods: A standard operating procedure describes the work and content of the database, e.g., how information is retrieved, processed, and presented. Google Analytics was used for metrics. Issues related to the database have been discussed and handled by a reference group. The experiences from this work are presented.Results: The database contains environmental hazard and risk information, primarily gathered from regulatory authorities and pharmaceutical companies. There are also assessments comparing substances within some groups of pharmaceuticals. The database is used by the Swedish Drug and Therapeutics Committees to include environmental aspects when recommending pharmaceuticals for health care providers. Page views show that users primarily look for information on commonly used substances, e.g., diclofenac and paracetamol/acetaminophen. Major problems for the development of the database are lack of data, lack of transparency, and discrepancies in the available environmental information.Conclusion: In the absence of an adequate decision support produced by the regulatory authorities, we find the database Pharmaceuticals and Environment to be useful for Swedish Drug and Therapeutics Committees and health care providers, and it is our belief that the information can be valuable also in other settings.
  •  
36.
  •  
37.
  • Rudén, Christina, et al. (författare)
  • Assessing the relevance of ecotoxicological studies for regulatory decision making
  • 2017
  • Ingår i: Integrated Environmental Assessment and Management. - : Wiley. - 1551-3777 .- 1551-3793. ; 13:4, s. 652-663
  • Tidskriftsartikel (refereegranskat)abstract
    • Regulatory policies in many parts of the world recognize either the utility of or the mandate that all available studies be considered in environmental or ecological hazard and risk assessment (ERA) of chemicals, including studies from the peer-reviewed literature. Consequently, a vast array of different studies and data types need to be considered. The first steps in the evaluation process involve determining whether the study is relevant to the ERA and sufficiently reliable. Relevance evaluation is typically performed using existing guidance but involves application of expert judgment by risk assessors. In the present paper, we review published guidance for relevance evaluation and, on the basis of the practical experience within the group of authors, we identify additional aspects and further develop already proposed aspects that should be considered when conducting a relevance assessment for ecotoxicological studies. From a regulatory point of view, the overarching key aspect of relevance concerns the ability to directly or indirectly use the study in ERA with the purpose of addressing specific protection goals and ultimately regulatory decision making. Because ERA schemes are based on the appropriate linking of exposure and effect estimates, important features of ecotoxicological studies relate to exposure relevance and biological relevance. Exposure relevance addresses the representativeness of the test substance, environmental exposure media, and exposure regime. Biological relevance deals with the environmental significance of the test organism and the endpoints selected, the ecological realism of the test conditions simulated in the study, as well as a mechanistic link of treatment-related effects for endpoints to the protection goal identified in the ERA. In addition, uncertainties associated with relevance should be considered in the assessment. A systematic and transparent assessment of relevance is needed for regulatory decision making. The relevance aspects also need to be considered by scientists when designing, performing, and reporting ecotoxicological studies to facilitate their use in ERA. Integr Environ Assess Manag 2017;13:652-663.
  •  
38.
  •  
39.
  •  
40.
  • Schäffer, Andreas, et al. (författare)
  • Conflicts of Interest in the Assessment of Chemicals, Waste, and Pollution
  • 2023
  • Ingår i: Environmental Science and Technology. - 0013-936X .- 1520-5851. ; 57:48, s. 19066-19077
  • Tidskriftsartikel (refereegranskat)abstract
    • Pollution by chemicals and waste impacts human and ecosystem health on regional, national, and global scales, resulting, together with climate change and biodiversity loss, in a triple planetary crisis. Consequently, in 2022, countries agreed to establish an intergovernmental science-policy panel (SPP) on chemicals, waste, and pollution prevention, complementary to the existing intergovernmental science-policy bodies on climate change and biodiversity. To ensure the SPP’s success, it is imperative to protect it from conflicts of interest (COI). Here, we (i) define and review the implications of COI, and its relevance for the management of chemicals, waste, and pollution; (ii) summarize established tactics to manufacture doubt in favor of vested interests, i.e., to counter scientific evidence and/or to promote misleading narratives favorable to financial interests; and (iii) illustrate these with selected examples. This analysis leads to a review of arguments for and against chemical industry representation in the SPP’s work. We further (iv) rebut an assertion voiced by some that the chemical industry should be directly involved in the panel’s work because it possesses data on chemicals essential for the panel’s activities. Finally, (v) we present steps that should be taken to prevent the detrimental impacts of COI in the work of the SPP. In particular, we propose to include an independent auditor’s role in the SPP to ensure that participation and processes follow clear COI rules. Among others, the auditor should evaluate the content of the assessments produced to ensure unbiased representation of information that underpins the SPP’s activities.
  •  
41.
  • Sigmund, G., et al. (författare)
  • Addressing chemical pollution in biodiversity research
  • 2023
  • Ingår i: Global Change Biology. - : Wiley. - 1354-1013 .- 1365-2486. ; 29:12, s. 3240-3255
  • Tidskriftsartikel (refereegranskat)abstract
    • Climate change, biodiversity loss, and chemical pollution are planetary-scale emergencies requiring urgent mitigation actions. As these "triple crises" are deeply interlinked, they need to be tackled in an integrative manner. However, while climate change and biodiversity are often studied together, chemical pollution as a global change factor contributing to worldwide biodiversity loss has received much less attention in biodiversity research so far. Here, we review evidence showing that the multifaceted effects of anthropogenic chemicals in the environment are posing a growing threat to biodiversity and ecosystems. Therefore, failure to account for pollution effects may significantly undermine the success of biodiversity protection efforts. We argue that progress in understanding and counteracting the negative impact of chemical pollution on biodiversity requires collective efforts of scientists from different disciplines, including but not limited to ecology, ecotoxicology, and environmental chemistry. Importantly, recent developments in these fields have now enabled comprehensive studies that could efficiently address the manifold interactions between chemicals and ecosystems. Based on their experience with intricate studies of biodiversity, ecologists are well equipped to embrace the additional challenge of chemical complexity through interdisciplinary collaborations. This offers a unique opportunity to jointly advance a seminal frontier in pollution ecology and facilitate the development of innovative solutions for environmental protection.
  •  
42.
  • Sigmund, Gabriel, et al. (författare)
  • Broaden chemicals scope in biodiversity targets
  • 2022
  • Ingår i: Science. - : American Association for the Advancement of Science (AAAS). - 0036-8075 .- 1095-9203. ; 376:6599, s. 1279-1280
  • Tidskriftsartikel (övrigt vetenskapligt/konstnärligt)
  •  
43.
  • Stone, Vicki, et al. (författare)
  • The Essential Elements of a Risk Governance Framework for Current and Future Nanotechnologies
  • 2018
  • Ingår i: Risk Analysis. - : Wiley. - 0272-4332 .- 1539-6924. ; 38:7, s. 1321-1331
  • Tidskriftsartikel (refereegranskat)abstract
    • Societies worldwide are investing considerable resources into the safe development and use of nanomaterials. Although each of these protective efforts is crucial for governing the risks of nanomaterials, they are insufficient in isolation. What is missing is a more integrative governance approach that goes beyond legislation. Development of this approach must be evidence based and involve key stakeholders to ensure acceptance by end users. The challenge is to develop a framework that coordinates the variety of actors involved in nanotechnology and civil society to facilitate consideration of the complex issues that occur in this rapidly evolving research and development area. Here, we propose three sets of essential elements required to generate an effective risk governance framework for nanomaterials. (1) Advanced tools to facilitate risk-based decision making, including an assessment of the needs of users regarding risk assessment, mitigation, and transfer. (2) An integrated model of predicted human behavior and decision making concerning nanomaterial risks. (3) Legal and other (nano-specific and general) regulatory requirements to ensure compliance and to stimulate proactive approaches to safety. The implementation of such an approach should facilitate and motivate good practice for the various stakeholders to allow the safe and sustainable future development of nanotechnology.
  •  
44.
  • Undeman, Emma, 1981-, et al. (författare)
  • The potential of the EU Water Framework Directive for reducing emissions of pollutants is limited : a case study on river basin specific pollutants in Swedish environmental permitting processes
  • 2022
  • Ingår i: Environmental Sciences Europe. - : Springer Nature. - 2190-4707 .- 2190-4715. ; 34:1
  • Tidskriftsartikel (refereegranskat)abstract
    • River basin specific pollutants (RBSPs) are supposedly a key tool to fulfil the EU’s Water Framework Directive (WFD) goal of good ecological status in all European waterbodies. The RBSPs provide a tool to manage chemical pollution identified as a national priority. An important question is if the costly management related to RBSPs leads to reduced emissions, an issue we investigated here using Sweden as a case. Swedish measures implemented under the WFD mainly rely on environmental permitting and supervision. We, therefore, specifically assessed how RBSPs have influenced permit proceedings in the Land and Environment Court of Appeal, where precedents for judgements in lower courts and authorities is established, during the 2010s. Despite permit-review being an important measure highlighted in the WFD and in Swedish programs of measures, all cases appealed to higher court were initiated by the operators/permit holders. The permissibility of environmentally hazardous activities was not impacted by RBSPs in any instance. Permit conditions addressing RBSPs were discussed in ⁓1% of all environmental cases, mainly resulting in conditions demanding further inquiries regarding emissions and concentrations of a limited number of RBSPs (i.e., metals and nitrogen in the forms of nitrate and ammonia). Open-ended conditions and delegation allowing for updating permit conditions if additional RBSPs are identified were suggested but rejected by court as these conflict with fundamental principles of precision and predictability of permit conditions stated in Swedish and European law. We conclude that RBSPs as management tool has little impact on emissions from activities requiring environmental permits and thereby water quality.
  •  
45.
  • Vandenberg, Laura N., et al. (författare)
  • A proposed framework for the systematic review and integrated assessment (SYRINA) of endocrine disrupting chemicals
  • 2016
  • Ingår i: Environmental Health. - London : BioMed Central (BMC). - 1476-069X. ; 15:1
  • Tidskriftsartikel (refereegranskat)abstract
    • Background: The issue of endocrine disrupting chemicals (EDCs) is receiving wide attention from both the scientific and regulatory communities. Recent analyses of the EDC literature have been criticized for failing to use transparent and objective approaches to draw conclusions about the strength of evidence linking EDC exposures to adverse health or environmental outcomes. Systematic review methodologies are ideal for addressing this issue as they provide transparent and consistent approaches to study selection and evaluation. Objective methods are needed for integrating the multiple streams of evidence (epidemiology, wildlife, laboratory animal, in vitro, and in silico data) that are relevant in assessing EDCs.Methods: We have developed a framework for the systematic review and integrated assessment (SYRINA) of EDC studies. The framework was designed for use with the International Program on Chemical Safety (IPCS) and World Health Organization (WHO) definition of an EDC, which requires appraisal of evidence regarding 1) association between exposure and an adverse effect, 2) association between exposure and endocrine disrupting activity, and 3) a plausible link between the adverse effect and the endocrine disrupting activity.Results: Building from existing methodologies for evaluating and synthesizing evidence, the SYRINA framework includes seven steps: 1) Formulate the problem; 2) Develop the review protocol; 3) Identify relevant evidence; 4) Evaluate evidence from individual studies; 5) Summarize and evaluate each stream of evidence; 6) Integrate evidence across all streams; 7) Draw conclusions, make recommendations, and evaluate uncertainties. The proposed method is tailored to the IPCS/WHO definition of an EDC but offers flexibility for use in the context of other definitions of EDCs.Conclusions: When using the SYRINA framework, the overall objective is to provide the evidence base needed to support decision making, including any action to avoid/minimise potential adverse effects of exposures. This framework allows for the evaluation and synthesis of evidence from multiple evidence streams. Finally, a decision regarding regulatory action is not only dependent on the strength of evidence, but also the consequences of action/inaction, e.g. limited or weak evidence may be sufficient to justify action if consequences are serious or irreversible.
  •  
46.
  • Whaley, Paul, et al. (författare)
  • Implementing systematic review techniques in chemical risk assessment : Challenges, opportunities and recommendations
  • 2016
  • Ingår i: Environment International. - : Elsevier BV. - 0160-4120 .- 1873-6750. ; 92-93, s. 556-564
  • Forskningsöversikt (refereegranskat)abstract
    • Systematic review (SR) is a rigorous, protocol-driven approach designed to minimise error and bias when summarising the body of research evidence relevant to a specific scientific question. Taking as a comparator the use of SR in synthesising research in healthcare, we argue that SR methods could also pave the way for a step change in the transparency, objectivity and communication of chemical risk assessments (CRA) in Europe and elsewhere. We suggest that current controversies around the safety of certain chemicals are partly due to limitations in current CRA procedures which have contributed to ambiguity about the health risks posed by these substances. We present an overview of how SR methods can be applied to the assessment of risks from chemicals, and indicate how challenges in adapting SR methods from healthcare research to the CRA context might be overcome. Regarding the latter, we report the outcomes from a workshop exploring how to increase uptake of SR methods, attended by experts representing a wide range of fields related to chemical toxicology, risk analysis and SR Priorities which were identified include: the conduct of CRA-focused prototype SRs; the development of a recognised standard of reporting and conduct for SRs in toxicology and CRA; and establishing a network to facilitate research, communication and training in SR methods. We see this paper as a milestone in the creation of a research climate that fosters communication between experts in CRA and SR and facilitates wider uptake of SR methods into CRA.
  •  
47.
  • Ågerstrand, Marlene, et al. (författare)
  • A call for action : Improve reporting of research studies to increase the scientific basis for regulatory decision-making
  • 2018
  • Ingår i: Journal of Applied Toxicology. - : Wiley. - 0260-437X .- 1099-1263. ; 38:5, s. 783-785
  • Tidskriftsartikel (refereegranskat)abstract
    • This is a call for action to scientific journals to introduce reporting requirements for toxicity and ecotoxicity studies. Such reporting requirements will support the use of peer-reviewed research studies in regulatory decision-making. Moreover, this could improve the reliability and reproducibility of published studies in general and make better use of the resources spent in research.
  •  
48.
  • Ågerstrand, Marlene, et al. (författare)
  • An academic researcher's guide to increased impact on regulatory assessment of chemicals
  • 2017
  • Ingår i: Environmental Science. - 2050-7887 .- 2050-7895. ; 19:5, s. 644-655
  • Forskningsöversikt (refereegranskat)abstract
    • The interactions between academic research and regulatory assessment of chemicals may in theory seem straightforward: researchers perform studies, and these studies are used by regulators for decision-making. However, in practice the situation is more complex, and many factors decide a research study's regulatory use. According to several EU chemical legislations, all available and relevant studies can be used in hazard and risk assessment of chemicals. However, in practice, standard tests conducted under GLP and sponsored and provided by industry are predominantly used. Peer-reviewed studies from independent sources are often disregarded or disputed since they often do not comply with regulatory data requirements and quality criteria. To help bridge such a gap, the aim of this paper is to give an overview of the general workings of legislation of chemicals and propose a set of actions to increase the usability of research data. In the end, this may increase the use of academic research for decision-making and ultimately result in more science-based policies. From a policy perspective, useful scientific evidence comprises those studies that are sufficiently reliable and relevant. This is not in contradiction to the aims of research and generally accepted scientific standards.
  •  
49.
  • Ågerstrand, Marlene, et al. (författare)
  • Bad Reporting or Bad Science? : Systematic Data Evaluation as a Means to Improve the Use of Peer-Reviewed Studies in Risk Assessments of Chemicals
  • 2014
  • Ingår i: Human and Ecological Risk Assessment. - : Informa UK Limited. - 1080-7039 .- 1549-7860. ; 20:6, s. 1427-1445
  • Tidskriftsartikel (refereegranskat)abstract
    • In this study we assess the applicability of a set of reliability criteria proposed by angstrom gerstrand etal. This was done by evaluating the reliability of 12 non-standard peer-reviewed ecotoxicity and toxicity studies for Bisphenol A. There was an overall agreement between the evaluator and the authors of the papers regarding the result of the evaluations. This suggests that the criteria offer enough guidance to be a useful and consistent evaluation tool. It provides a transparent and structured approach, and ensures that a minimum and similar set of criteria is used. The evaluation of the peer-reviewed ecotoxicity and toxicity studies concludes that important information is sometimes missing, and therefore the studies do not always meet common regulatory requirements regarding reporting. Whether this is due to insufficient reporting or due to poorly performed studies is not known. To improve the reporting, and thereby promote reliability and reproducibility, researchers, reviewers, and editors are recommended to use the suggested criteria as a guideline. In conclusion, in order to improve the reliability of peer-reviewed studies, and to increase their use in regulatory risk assessments of chemicals, the dialog between regulators, researchers, and editors regarding how to evaluate and report studies needs to be strengthened.
  •  
50.
  •  
Skapa referenser, mejla, bekava och länka
  • Resultat 1-50 av 66
Typ av publikation
tidskriftsartikel (43)
forskningsöversikt (8)
annan publikation (5)
doktorsavhandling (4)
bokkapitel (3)
rapport (1)
visa fler...
konferensbidrag (1)
licentiatavhandling (1)
visa färre...
Typ av innehåll
refereegranskat (47)
övrigt vetenskapligt/konstnärligt (19)
Författare/redaktör
Ågerstrand, Marlene (55)
Rudén, Christina (28)
Beronius, Anna (16)
Scheringer, Martin (4)
Hanberg, Annika (4)
Molander, Linda (4)
visa fler...
Diamond, Miriam L (4)
Borchert, Flora (4)
Schäffer, Andreas (4)
Breitholtz, Magnus (3)
Backhaus, Thomas, 19 ... (3)
Hollert, Henner (3)
Brodin, Tomas (3)
Vandenberg, Laura N. (3)
Ford, Alex T. (3)
Vlahos, Penny (3)
Kase, Robert (3)
Whaley, Paul (3)
Sobek, Anna (2)
Munthe, John (2)
Larsson, D. G. Joaki ... (2)
Bergman, Åke (2)
Wagner, Martin (2)
Rillig, Matthias C. (2)
Vrana, Branislav (2)
Carney Almroth, Beth ... (2)
Suzuki, Noriyuki (2)
Hollender, Juliane (2)
Brack, Werner (2)
Cousins, Ian T. (2)
Bertram, Michael G. (2)
Josefsson, Henrik, D ... (2)
Wester, Misse (2)
Lohmann, Rainer (2)
Gee, David (2)
Heindel, Jerrold J. (2)
Brooks, Bryan W. (2)
Saaristo, Minna (2)
Scheringer, M. (2)
Posthuma, Leo (2)
Dulio, Valeria (2)
Hilscherova, Klara (2)
Allan, Ian (2)
O'Toole, Simon (2)
Ruedel, Heinz (2)
Sengl, Manfred (2)
Rudén, Christina, 19 ... (2)
Moermond, Caroline T ... (2)
Grimalt, Joan O. (2)
Wheeler, James R. (2)
visa färre...
Lärosäte
Stockholms universitet (58)
Kungliga Tekniska Högskolan (13)
Karolinska Institutet (13)
Göteborgs universitet (6)
Sveriges Lantbruksuniversitet (6)
Uppsala universitet (4)
visa fler...
Örebro universitet (2)
Lunds universitet (2)
Umeå universitet (1)
Luleå tekniska universitet (1)
Linköpings universitet (1)
Karlstads universitet (1)
IVL Svenska Miljöinstitutet (1)
visa färre...
Språk
Engelska (66)
Forskningsämne (UKÄ/SCB)
Naturvetenskap (58)
Medicin och hälsovetenskap (12)
Humaniora (9)
Teknik (5)
Samhällsvetenskap (4)
Lantbruksvetenskap (2)

År

Kungliga biblioteket hanterar dina personuppgifter i enlighet med EU:s dataskyddsförordning (2018), GDPR. Läs mer om hur det funkar här.
Så här hanterar KB dina uppgifter vid användning av denna tjänst.

 
pil uppåt Stäng

Kopiera och spara länken för att återkomma till aktuell vy