NAMs for regulatory use in food safety: Challenges and opportunities

George E. N. Kass

University of Galway, School of Medicine, Pharmacology & Therapeutics, Galway, Ireland and European Food Safety Authority (IT) (retired) 

In Europe, food safety with respect to chemical contaminants and chemicals intentionally added to food mostly rests on the assessment of data derived from in vivo animal toxicity data and using traditional endpoint measurements. Over the past decade substantial e orts have been made both at political level and through major research initiatives to move away from animal studies and to replace them with new types of studies that use in vitro, in silico and in chemico approaches. These are now collectively referred to as New Approach Methodologies or NAMs. NAM-based approaches should allow for a more precise risk assessment as they can be conducted on human-relevant cells and take advantage of contemporary knowledge of mechanisms of chemical induced cell injury and of the pathophysiology of human diseases. However, the uptake of NAMs in regulatory chemical risk assessment has so far been rather limited in Europe, even though risk assessment agencies such as EFSA have pledged that over the coming years, new data request should mainly be of NAM origin. The presentation will provide an overview of the challenges faced by regulators in the implementation of NAMs for regulatory decision making.