Substances Generally Recognized as Safe: Notification Procedure

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.

Latest Forms, Documents, and Supporting Material

Document Name
Form Form FDA 3667 GRAS Notice under 21 CFR Parts 170 and 570 Form
0342 Supporting Statement Final 6-09-2022.docx Supporting Statement A
GRAS Notice under 21 CFR Parts 170 and 570 Form

All Historical Document Collections

202204-0910-014 Approved without change	Extension without change of a currently approved collection	2022-06-09
201907-0910-015 Approved without change	Extension without change of a currently approved collection	2019-07-16
201608-0910-012 Approved without change	Revision of a currently approved collection	2016-08-22
201602-0910-001 Approved without change	Extension without change of a currently approved collection	2016-02-18
201211-0910-010 Approved with change	Revision of a currently approved collection	2012-11-30
201208-0910-009 Improperly submitted and continue	Revision of a currently approved collection	2012-08-30
200905-0910-003 Approved without change	Extension without change of a currently approved collection	2009-05-15
200604-0910-001 Approved without change	Extension without change of a currently approved collection	2006-04-12
200302-0910-001 Approved without change	Extension without change of a currently approved collection	2003-02-05
200003-0910-006 Approved without change	Extension without change of a currently approved collection	2000-03-29
199704-0910-003 Approved without change	New collection (Request for a new OMB Control Number)	1997-04-21

OMB Details

GRAS Notice under 21 CFR Parts 170 and 570

Federal Enterprise Architecture: Health - Consumer Health and Safety

Form Form FDA 3667

GRAS Notification

Fillable Fileable

Form and instruction

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