Towards an animal-free human health assessment: Starting from the current regulatory needs

Abstract

Societal concern for animal welfare and scientific concerns about the predictive power of animal models for the human situation are driving forces for the development of animal-free approaches for the safety testing of chemicals. A paradigm shift towards an assessment of human health risks that is fully based on animal-free approaches is not foreseen within the next decades. To accelerate the use of animal-free innovations (in vitro experiments, in silico methods, etc.) in the EU, it has multiple advantages to simultaneously work towards a new risk assessment paradigm and to aim the development of animal- free methods at better meeting current regulatory needs. To achieve this, a multi-stakeholder collaboration is needed already in the development phase, where regulators can inform on the regulatory needs and the criteria for acceptance. As a first step, the present paper discusses what information is needed within the context of four areas of chemical safety assessment in the EU: 1) classification, labelling and packaging, 2) the derivation of health-based guidance values and product limits, 3) risk assessments of exposure situations of concern and 4) addressing specific topics of societal concern. Further agreements on the level of detail and uncertainty, robustness, predictive value, reproducibility and validation are a prerequisite to develop tools that can be trusted and that will be legally binding.