Ellen Fritsche

Ellen Fritsche, MD, is the Director of the Swiss Centre for Applied Human Toxicology (SCAHT) in Basel, Switzerland. For the last >10 years she was a full University Professor at the Heinrich-Heine-University in Düsseldorf, Germany and working group leader of the group ‘Alternative method development for environmental toxicity testing’ at the IUF – Leibniz Research Institute for Environmental Medicine. She is a medical doctor by training and habilitated in environmental toxicology.

NextGen Basel 1

Utilisation of NAMs for Regulatory Applications

The chemical universe is comprised of thousands of compounds that lack sufficient toxicity information for human health. With the current guideline studies, this data gap cannot be closed as the animal-based guideline studies are very resource-intensive concerning time, money and space. Therefore, the US-National Research Council proposed a paradigm shift for toxicological hazard assessment already in 2007 that is based on faster and more cost-efficient in vitro and in silico tools. Since then, the field has experienced tremendous evolution with multiple stakeholders proposing concepts on how to use new approach methodologies (NAMs) for chemical hazard and risk assessment. These include for example APCRA, AFSA, the ASPIS cluster with distinct approaches from ONTOX and RISK-HUNT3R as well as other European projects. Also, for example, the US regulatory agencies and EFSA on the European side have created workplans/roadmaps for implementing in silico and in vitro NAMs into the risk assessment process. All these efforts will contribute to strategies that aim at phasing out animal testing and allow a faster, cheaper and also more human-relevant assessment of the large number of substances in our exposome. Approaches like the one-substance-one-assessment framework of the European Commission supported e.g. by EFSA`s One Health strategy will furthermore strengthen the testing effectiveness by pursuing common environmental and human health strategies.