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GRAS (Generally Regarded as Safe) Notification

GRAS stands for Generally Regarded as Safe.  In the United States, food additives go through a review of their safety by the Center for Food Safety and Applied Nutrition (CFSAN).  A GRAS notification is submitted to the FDA consisting of  scientific data (toxicology studies, published and unpublished data and an optional though recommended panel of experts with the experience, knowledge and training that review the data to acknowledge that the food substance is safe. 

After the FDA reviews the GRAS notice the response will be either a “No Questions” response essentially meaning the FDA has no issues with the GRAS notice and the ingredient meets GRAS status.  A response by the FDA of “No Basis” means the data was not acceptable and GRAS status was not granted for the ingredient.

The FDA’s timeline to review a GRAS notice can take 6 to 8 months.  Including the time to conduct an initial feasibility review, if determined to be favourable, prepare the dossier, expert panel opinion and submission a GRAS notice project can take 12 months and if toxicology  studies are required, an additional 12 months.  

Quality Solutions can assist with a GRAS notification from feasibility to submission and FDA feedback assessment.