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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?