A substance that will be added to food is subject to premarket approval by FDA unless its use is generally recognized as safe (GRAS) by qualified experts.⁽¹⁾ On April 17, 1997, FDA issued a proposed rule (the GRAS proposal; 62 FR 18938) that would establish a notification procedure whereby any person may notify FDA of a determination by that person that a particular use of a substance is GRAS. Although the proposed notification procedure is not yet final, FDA has already received several notices. As described in the GRAS proposal, the agency is evaluating whether each submitted notice provides a sufficient basis for a GRAS determination and whether information in the notice or otherwise available to FDA raises issues that lead the agency to question whether use of the substance is GRAS. Following this evaluation, FDA replies to the notifier by letter.

In general, FDA's response has been in one of three categories:

1. The agency does not question the basis for the notifier's GRAS determination;
2. The agency concludes that the notice does not provide a sufficient basis for a GRAS determination (e.g., because the notice does not include appropriate data and information or because the available data and information raise questions about the safety of the notified substance); or
3. The response letter states that the agency has, at the notifier's request, ceased to evaluate the GRAS notice.

In the GRAS proposal, FDA announced its intention to maintain an inventory of GRAS notices and the agency's response to those notices. The main page of the Inventory of GRAS Notices lists all notices that FDA has received, describes FDA's response as one of the three general categories described above, and provides a hyperlink to the actual response letter. The table below, which is a separate part of the Inventory of GRAS Notices, lists the notices that FDA received in the year 2001. Importantly, the table below lists all GRAS notices received in the year 2001, regardless of whether the notice is pending at FDA or has come to closure.

The table below:

• Identifies each GRAS notice by a number (GRN No.);
• Identifies the name of the person who made the GRAS determination (notifier), with a hyperlink to the notifier's address;
• Identifies the substance that is the subject of each notice;
• Describes the intended use of the substance;
• Includes the petition number if the substance was originally the subject of a GRAS petition;
• Identifies the statutory basis for the GRAS determination;
• Identifies the date when FDA received the notice;
• Includes the date when the evaluation process came to closure, with a hyperlink to the agency's response to the notice; and
• When applicable, provides a hyperlink to additional correspondence that FDA has issued regarding the GRAS notice.

This table is current as of January 30, 2004. Because all notices in this table have come to closure, FDA does not expect to update this table on a regular basis.

⁽¹⁾In addition, a substance that is used in accordance with a sanction granted prior to September 6, 1958 is not subject to premarket approval.

Foods Home   |   FDA Home   |   Search/Subject Index   |   Disclaimers & Privacy Policy   |   Accessibility/Help

Content last updated by lah on 2004-FEB-09
Hypertext updated by lah/rxm/emw on 2007-AUG-22