Managing chemical risks in the EU : Data use and new approaches for decision-making

Sammanfattning: 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).