Chemical Pollution and Risks Towards Biodiversity - About the Role of the Precautionary Principle in the EU Chemical Risk Governance

Biodiversity declines faster than at any time in human history and its loss is driven mainly by anthropogenic pressures. Among those pressures, chemical pollution is one main driver for biodiversity loss. Despite this knowledge, the number and volume of global chemicals being produced increase and result in the planetary boundary for so-called novel entities being exceeded. Although the practices of assessing and managing chemicals in Europe and beyond made significant advances, it is widely acknowledged that existing regulatory approaches have not enabled suitable action to reduce risks from most hazardous chemicals. To mitigate current and future ecological impacts from chemicals, a more preventive and precautionary hazard-based approach has been suggested. However, chemicals are regulated under different regulatory frameworks, e.g., as pesticides, industrial chemicals, and pharmaceuticals, with specific ecotoxicological testing requirements, assessment methodologies, and risk management procedures and structures. The overall objective of this study is to assess how five key EU regulations - REACH, the Plant Protection Products Regulation, the Biocidal Product Regulation, the Human Medicinal Products Regulation and the Veterinary Medicinal Products Regulation – acknowledge and integrate uncertainty and different lines of evidence related to impacts on biodiversity in regulatory decision-making of chemicals. Based on that, the study strives to ascertain the role of the precautionary principle within regulatory decision-making processes. For the analysis we apply a conceptual framework based on the Risk Governance concept which describes different phases (pre-assessment, risk assessment, risk evaluation and risk management) of the entire decision-making process, including structures and procedures of handling risks of chemicals in general. The focus of the analysis is the application of the precautionary principle throughout these phases with regard to biodiversity protection. We adopted a mixed methods approach including document analysis, an analysis of five case studies of different regulated substances as well as a focus group with German risk assessors assigned to one of the analysed EU regulations. Based on this analysis, we found a weak understanding of precaution if applied with regard to biodiversity protection. We further identified (i) a lack in using early warning signals and chemical monitoring data in the pre-assessment phase, (ii) improper assessment factors, (iii) strategical use of evidence by industry actors and non-accessibility of additional data in the risk assessment phase, and (iv) missing translation of biodiversity in weighing procedures in the risk management phase. Based on the findings we discuss potential intervention points for further research to strengthen the precautionary action towards better protection of biodiversity within the triple environmental crisis. These are e.g. coherence between biodiversity protection goals and substance regulations; implementation of a weight-of-evidence approach; relation between reliability and reasonable grounds of concern.