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

This study has two parts. In the first part, fourteen carcinogen risk assessments of acrylamide made by different expert groups during the years 1976–2002 are compared in terms of their overall conclusions and their use of primary data. In the second part, the public debate on acrylamide and cancer risks and the questioning of the expert risk assessment, that arose as a reaction to the identification of this substance in staple food is discussed. In the first part it is shown that the expert risk assessors concur to a large degree about the assessment of the acrylamide potential to cause cancer. Three risk assessors have concluded that acrylamide is neither carcinogenic to humans nor to animals, while eleven risk assessors have concluded that acrylamide is carcinogenic in animals and is likely to be carcinogenic in humans. The differences in the overall conclusions seem to a large extent be explained by an evolving database. The risk assessors agree considerably on how to interpret and evaluate the available primary data, but the coverage of the available references is low. These results are also compared to those previously published on risk assessments of trichloroethylene. In the second part the arguments used in the public debate to question the expert risk assessment are summarized and it is argued that they are not based on the principles generally accepted in toxicological risk assessment. [Copyright &y& Elsevier]

In 2005 the Swedish Association of the Pharmaceutical Industry (LIF) initiated a national environmental classification and information system for pharmaceuticals. This investigation reports the results from a survey, conducted among the persons involved in the start-up process. The aim of this study is to generate knowledge contributing to the clarification of the motivations, expectations, and intentions underlying the development and implementation of the system. The decision to implement a classification and information system for pharmaceuticals was the result of a combination of several driving forces, mainly political pressure and a possibility to increase the industries'' goodwill, while at the same time keeping the process under the industries'' control. The expected possible effects of the system, other than increased goodwill, are according to this survey assumed to be low. The system offers little guidance for end-users in the substitution of one pharmaceutical for another. One possible reason for this could be that LIF needs to observe the interests of all its members'' and should not affect competition. The affiliation of the involved actors correlates to how these actors view and value the system, but this has not hampered the collaborative process to develop and implement it. [Copyright &y& Elsevier]