Review of EU Novel Food Submissions and US GRAS Petitions to Identify Opportunities for NAMS

The risk assessment of some food substances has been shifting to adoption of a high-throughput, non-animal method strategy for demonstrating safety. These methods, along with new in vitro, in silico and powerful computer modeling tools, are collectively referred to as New Approach Methodologies or NAMs.

This project seeks to review available safety assessments of food substances to identify classes of food substances that have leveraged NAMs data to support a regulatory approval. This will include a review of safety determinations by the U.S. Food and Drug Administration in its publicly available GRAS database, as well as those from the European Food Safety Authority and Health Canada.

Results will highlight food-specific challenges to adopting NAMs as well as knowledge gaps for future regulatory acceptance.