What is the difference between the FCC and GRAS?
A GRAS (Generally Recognized as Safe) dossier relates more to safety for intended use. The FCC focuses on specifications and analytical methodology. Unlike a GRAS dossier, there is NO COST for an FCC monograph to be developed and submitted to USP and the Food Ingredients Expert Committee. In fact, USP staff scientists will work closely with monograph sponsors to prepare the document and guide it expeditiously through the public FCC Forum and Food Ingredients Expert Committee decisions. Suppliers with self–determined GRAS’d substances, for example, reference FCC monographs and methods as a third–party, independent source for their customers.
