<p>Occupational Exposure Limits (OELs) are used as an important regulatory instrument to protect workers’ health from adverse effects of chemical exposures. The OELs mirror the outcome of the risk assessment and risk management performed by the standard setting actor. In paper I the OELs established by 18 different organisations or national regulatory agencies from the industrialised world were compared. The comparison concerned: (1) what chemicals have been selected and (2) the average level of exposure limits for all chemicals. In paper II the OELs established by 7 different national regulatory agencies of EU member states are compared to those of the European Commission (EC). In addition to the same comparisons as performed in the first study a comparison level was introduced (3) the similarity between the OELs of these EU member states and the OELs recommended by the EC.</p><p>List of OELs were collected through the web-pages of, and e-mail communication with the standard-setting agencies. The selection of agencies was determined by availability of the lists. The database of paper I contains OELs for a total of 1341 substances; of these 25 substances have OELs from all 18 organisations while more than one third of the substances are only regulated by one organisation alone. In paper II this database was narrowed down to the European perspective.  The average level of OELs differs substantially between organisations; the US OSHA exposure limits are (on average) nearly 40 % higher than those of Poland. Also within Europe there was a nearly as large difference. The average level of lists tends to decrease over time, although there are exceptions to this. The similarity index in paper II indicates that the exposure limits of EU member states are converging towards the European Commission’s recommended OELs. These two studies also showed that OELs for the same substance can vary significantly between different standard-setters. The work presented in paper III identifies steps in the risk assessment that could account for these differences. Substances for which the level of OELs vary by a factor of 100 or more were identified and their documentation sought for further scrutiny. Differences in the identification of the critical effect could explain the different level of the OELs for half of the substances. The results reported in paper III also confirm the tendency of older OELs generally being higher. Furthermore, several OELs were more than 30 years old and were based on out-dated knowledge. But the age of the data review could not account for all the differences in data selection, only one fifth of the documents referred to all available key studies. Also the evaluation of the key studies varied significantly.</p>

Health and environmental risks associated with emissions of hazardous chemicals from articles, including everyday consumer products such as clothes and toys, have become widely acknowledged internationally, particularly in the EU. This thesis contributes to new understandings of how these risks are currently managed within the EU and recommends actions for ensuring a safe and sustainable use of chemicals in articles. Paper I provides an overview and comparative analysis of regulatory strategies for managing risks of chemicals in articles in the EU. The in-depth analysis, which is focused on the Toys Safety Directive, the RoHS Directive, and REACH, shows that the legislations differ significantly. Differences include e.g. what criteria are used for the selection of substances to be targeted for regulation, and the kind of requirements and restrictions applied to the selected substances. It is concluded that product-specific directives are important complements to REACH in order to ensure a safe use of chemicals in articles. Paper II evaluates 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). The results show that the majority of the chemicals that are prioritized for phase-out under the WFD or for concentration restrictions in sludge and soil under the SSD are allowed to be used in articles according to REACH. In order to avoid end-of-pipe problems and to increase resource efficiency, it is argued that it is necessary to minimize the input of chemicals identified as hazardous to health or the environment into articles. Paper III aims to clarify what the substitution principle means and how it can reasonably be applied as part of chemical policies. A general definition is proposed that gives equal weight to hazard, functionality and economical considerations, while at the same time recognizing that the aim of the substitution principle is to reduce hazards to human health and the environment. This paper also summarizes major methods to promote and implement the principle, discusses legislative approaches with regard to their ability to promote substitution of hazardous chemicals, and makes proposals for an efficient implementation of the principle. / <p>QC 20121119</p>

Occupational Exposure Limits (OELs) are used as an important regulatory instrument to protect workers’ health from adverse effects of chemical exposures. The OELs mirror the outcome of the risk assessment and risk management performed by the standard setting actor. In paper I the OELs established by 18 different organisations or national regulatory agencies from the industrialised world were compared. The comparison concerned: (1) what chemicals have been selected and (2) the average level of exposure limits for all chemicals. In paper II the OELs established by 7 different national regulatory agencies of EU member states are compared to those of the European Commission (EC). In addition to the same comparisons as performed in the first study a comparison level was introduced (3) the similarity between the OELs of these EU member states and the OELs recommended by the EC. List of OELs were collected through the web-pages of, and e-mail communication with the standard-setting agencies. The selection of agencies was determined by availability of the lists. The database of paper I contains OELs for a total of 1341 substances; of these 25 substances have OELs from all 18 organisations while more than one third of the substances are only regulated by one organisation alone. In paper II this database was narrowed down to the European perspective.  The average level of OELs differs substantially between organisations; the US OSHA exposure limits are (on average) nearly 40 % higher than those of Poland. Also within Europe there was a nearly as large difference. The average level of lists tends to decrease over time, although there are exceptions to this. The similarity index in paper II indicates that the exposure limits of EU member states are converging towards the European Commission’s recommended OELs. These two studies also showed that OELs for the same substance can vary significantly between different standard-setters. The work presented in paper III identifies steps in the risk assessment that could account for these differences. Substances for which the level of OELs vary by a factor of 100 or more were identified and their documentation sought for further scrutiny. Differences in the identification of the critical effect could explain the different level of the OELs for half of the substances. The results reported in paper III also confirm the tendency of older OELs generally being higher. Furthermore, several OELs were more than 30 years old and were based on out-dated knowledge. But the age of the data review could not account for all the differences in data selection, only one fifth of the documents referred to all available key studies. Also the evaluation of the key studies varied significantly.

Kemikalier utgör en grundläggande beståndsdel av det senindustriella samhället, och en omfattande produktion av kemikalier brukar allmänt anses som en nödvändig förutsättning för teknisk utveckling och ekonomisk tillväxt. I Sverige ledde miljölarmen om DDT, PCB och kvicksilver på 1960- och 1970-talet till inrättandet av ett system för kemikaliekontroll som brukar framhållas som ett av världens främsta. Avhandlingen undersöker detta kontrollsystem och dess logik. Detta görs genom textanalys av propositioner, statliga utredningar, rapporter från Naturvårdsverket och Kemikalieinspektionen, samt genom intervjuer med anställda på sistnämnda myndigheter. Analysen identifierar kemikaliekontroll i Sverige som ett system genomsyrat av motsättningar, vilka bottnar i en epistemologisk paradox som innebär att ju mer kunskap som ackumuleras om kemikalier, desto mer ökar osäkerheten. Den konstanta ökningen av världens kemikalieproduktion, i kombination med kemikaliers epistemologiska komplexitet, placerar kontrollmyndigheterna i en omöjlig sits. Samtidigt visar avhandlingen att myndigheterna är delaktiga i att upprätthålla detta kontrollsystem som till stor del är ett system av simulerad kontroll. Dels förmedlar kontrollsystemet genom sin blotta existens intrycket av kontroll, och dels fungerar vissa centrala regulatoriska begrepp som signaler om kontroll, trots att de visar sig vara ihåliga. På så vis blir osäkerhet inom kontrollsystemet alltid ett undantag, trots att den är så utbredd. / Chemical substances have become an inextricable feature of the late-industrial society, deemed necessary for the welfare, technological development and economic growth that large parts of the world have come to expect. In Sweden, the identification in the 1960s and 1970s of DDT, PCB and mercury as serious environmental threats led to the establishment of a system of chemicals control which is widely held to be one of the most advanced in the world. The thesisexamines this control system, its possibilities, its problems and its logic, through text analysis of state reports, governmental propositions, the reports of the Swedish Environmental Protection Agency (SEPA) and the Swedish Chemicals Agency (SCA), and interviews with employees at these agencies. The analysis shows chemicals control in Sweden to be a system pervaded with contradictions, which may be explained by an epistemological paradox at its core: that the accumulation of knowledge only serve to increase uncertainty. The constant increase of chemicals production, in combination with the highly unpredictable character of chemicals in the environment, puts the monitoring agencies in an impossible situation, always working against the tide. The thesis also shows, however, that the agencies are themselves an important part of maintaining a system of control that is to a large extent simulated. This in the sense that the system, by its very existence as well as by the circulation of regulatory concepts and principles within it which are in fact without much substance, always signals control, and constitute uncertainty as the exception.