Substances Generally Recognized as Safe: Notification Procedure

OMB 0910-0342

OMB 0910-0342

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 Substances Generally Recognized as Safe: Notification Procedure expires 2022-07-31 and can be found here.

OMB Details

GRAS Notice under 21 CFR Parts 170 and 570

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form Form FDA 3667GRAS NotificationFillable FileableForm and instruction

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