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Environmental exposure to active pharmaceutical ingredients (APIs) can have negative effects on the health of ecosystems and humans. While numerous studies have monitored APIs in rivers, these employ different analytical methods, measure different APIs, and have ignored many of the countries of the world. This makes it difficult to quantify the scale of the problem from a global perspective. Here, we present a global-scale study of API pollution in 258 of the world’s rivers, representing the environmental influence of 471.4 million people across 137 geographic regions. 

Environmental research is detecting ever more pharmaceutical residues in the aquatic environment as analytical methods become increasingly sensitive. The physicochemical properties of some active substances suggest an accumulation in sediment, suspended matter and biota. Hence, these matrices could be interesting alternative matrices for monitoring of pharmaceutical residues in surface waters. Against this background, modern analytical detection methods for different matrices from water to sediment and suspended matter to biota (fish) were developed and published in 2019 (FKZ 3715 67 413). In the current project sampling concepts were combined with retrospective analyses. In this report, the results of the developed methods from investigations of water, sediment, suspended matter and biota samples from different locations and the German environmental specimen bank are presented in terms of occurrence and distribution.

Persistence is a hazard criterion for chemicals enshrined in chemical regulation worldwide. In this paper, we argue that the higher the persistence of a chemical, the greater the emphasis that it should be given in chemicals assessment and decision making. We provide case studies for three classes of highly persistent chemicals (chlorofluorocarbons, polychlorinated biphenyls, and per- and polyfluoroalkyl substances) to exemplify problems unique to highly persistent chemicals, despite their otherwise diverse properties.

Characterizing the degradation behavior of chemicals in the environment is a key component of chemical hazard and risk assessment. Persistence has been successfully characterized for readily and for slowly degradable chemicals using standardized tests, but for the third group of chemicals with intermediate degradability (“middle group”), the assessment is less straightforward. Whether chemicals of this group behave as persistent or not in a given environment depends on environmental factors such as the presence of sorbents that can limit the bioavailability of chemicals. 

For a large part of the active pharmaceutical ingredients (APIs) available on the market, there is no or no comprehensive environmental risk assessment (ERA) existent/available. Existing ERAs are, moreover, treated as commercially/industrial confidential information (CCI) and the information content on the ERAs contained in the Public Assessment Reports is very limited. Thus, neither the public can inform itself sufficient nor environmental authorities can use the ERAs to compile environmental quality standards. Environmental information law, on the other hand, requires the general accessibility of environmental information. Against this background, this investigation examines the following questions in conformity with the environmental information law: Which environmental information on pharmaceuticals is generated in the marketing authorisation?