GRAS Notification Overview
“GRAS” is an acronym for ‘Generally Recognized As Safe.’ Any substance to be added to a food product in US must obtain a GRAS status before it (the substance) is added to the product. GRAS status is given to proposed use of an ingredient. In general, two separate ways can be adopted to obtain GRAS recognition.
- A GRAS Notification – In GRAS Notification Submission to FDA, the government issues a letter after an assessment.
- Self GRAS Determination – In this method, FDA is not involved. The stakeholder is solely liable for verifying safe use with the review of an expert panel.
A self-determination GRAS dossier follows all of the same steps as a GRAS notification and format with the exception that the dossier is not submitted to the FDA. The majority of GRAS dossiers are self-affirmed. We can help you prepare a self-affirmed GRAS dossier.