Transitions in the risk assessment regime: prospects from the case of animal-free testing in the cosmetics industry

Abstract

Introduction This thesis examines the transition from animal testing to animal-free methods in risk assessment in the cosmetics industry, specifically focusing on the ban on animal testing in the European sector. It explores how this transition affected the risk assessment regime, how actors responded and the effect on innovation in the industry. Theory This research studies transversal regimes by combining the concept of socio-technical regimes with risk regulation regimes. The study research the structural tensions that arise due to the misalignment of the regimes and how this shaped the transition towards NAMs. It uses institutional logics to characterise socio-technical regimes and identify changes in storylines over time. Methodology The study utilizes desk research to analyse regulatory changes and the context of the transition. A SocioTechnical Configuration Analysis (STCA) was performed to determine the structure of the sociotechnical system and the dominant institutional logics. This was visualised with actor and concept networks, where components were identified in three time periods. Lastly, interviews with industry, scientific, and NGO representatives were conducted to validate and complement the data from STCA. Results The results show that the Cosmetics regulation forbids the use of animal tests where REACH often still requires animal tests and both regulations apply to some substances. It highlights the pivotal role that NGOs played in the development of the animal testing ban. Industry incumbents strategically delayed the transition to animal-free risk assessment methods (NAMs) until they had successfully adapted to the changes, at which point they emerged as pioneers in NAM development. Currently, a cooling phase is reached where an acceleration of the transition seems possible when looking at the industry initiative but where regulators are creating a bottleneck by ordering animal tests on chemical substances that have been used in products for years. Conclusion & discussion The structural tensions that arose due to the misalignment of REACH and the Cosmetics Regulation reduced the effectiveness of the animal testing ban and the implementation of NAMs. This research has shown the need for regulatory alignment for a successful transition and highlights how this impacts the socio-technical regime. Further research into the dynamics of safety assessment could contribute to understanding the transition towards NAMs.