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 A GRAS notification is submitted to the FDA consisting of scientific data (toxicology studies, published and unpublished data and a panel of experts with the experience, knowledge and training that review the data to acknowledge that the food substance is safe.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 process for GRAS notification includes:
- conduct a feasibility review to determine if GRAS is possible and appropriate for your ingredient based on evidence supporting safety
- prepare a well organized, detailed and comprehensive GRAS dossier
- organize and coordinate a qualified and excellent expert panel to review your ingredient and come to a conclusion for its safety. The expert panel will sign off on the dossier.
- we prepare and a self-affirmation GRAS dossier for submission to FDA
- Depending on the complexity and novel basis of the ingredient a meeting with FDA may be required
Quality Smart Solutions has the expertise to prepare your GRAS notice and ensure your ingredient meets the safety qualifications for sale in the United States.