Generally Recognized as Safe (GRAS) Notices

This ICR collects information from food manufactures who wish to obtain a determination from FDA that a food additive is generally recognized as safe (GRAS) and therefore not subject to premarket approval requirements. Respondents submit information as provided in agency regulations regarding GRAS notification, including a description of the substance, intended use, previous communications with the agency, contact information, etc. FDA has developed Form 3667 to facilitate its review of information being submitted so that a GRAS determination can be made. Food additives that are not GRAS must obtain premarket approval.

The latest form for Generally Recognized as Safe (GRAS) Notices expires 2022-07-31 and can be found here.

GRAS Notice under 21 CFR Parts 170 and 570

Federal Enterprise Architecture: Health - Consumer Health and Safety

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.