U. S. Food and Drug Administration
Center for Food Safety & Applied Nutrition
Office of Food Additive Safety
Inventory of GRAS Notices
July 2001

GRAS Notices Received in 1998

Information about the Notifier, the Intended Use, and the Basis for the GRAS Determination

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 1998.

List of GRAS Notices Received in 1998

This yearly table:

This table is current as of June 29, 2001. Because all notices in this table have come to closure, FDA does not expect to update this table on a regular basis.

 

GRN No. Notifier Substance Intended Use GRP # Basis Receipt Closure
12 Givaudan Roure Flavors Mesquite wood alcoholic extract Use in several food categories, including alcoholic beverages, as a flavor   Common use in food Dec. 30, 1998 Mar. 11, 1999
11 Bonlac Foods Limited Calcium casein peptone-calcium phosphate Use in chewing gum as a texturizer at a use level of up to 5 percent wt/wt   Scientific procedures Nov. 2, 1998 Jan. 29, 1999
10 Rohm Enzyme Finland Oy Exopeptidase derived from Aspergillus oryzae carrying a gene encoding a leucine aminopeptidase from Aspergillus sojae Use as a food processing aid at a level ranging from 0.2 to 0.8 percent   Scientific procedures Oct. 28, 1998 Jan. 29, 1999
9 Quest International Polyglycerol polyricinoleic acid Use in chocolate as an emulsifier at a level up to 0.3 percent   Scientific procedures Oct. 22, 1998 Mar. 2, 1999
8 Novo Nordisk Pectin esterase derived from Aspergillus oryzae carrying a gene encoding pectin esterase from Aspergillus aculeatus Use in fruit and vegetable products as a processing aid at minimal level needed to accomplish the intended technical effect   Scientific procedures Oct. 14, 1998 Mar. 2, 1999
7 Wyeth Nutritionals International ARASCO (arachidonic acid-rich single-cell oil) and DHASCO (docosahexaenoic acid-rich single-cell oil) as sources of the fatty acids ARA (arachidonic acid) and DHA (docosahexaenoic acid) ARASCO as a source of ARA and DHASCO as a source of DHA in infant formula   Scientific procedures Sept. 1, 1998 Mar. 4, 1999
6 Cytec Industries, Inc. Dioctyl sodium sulfosuccinate Use in carbonated and non-carbonated soft drinks as a wetting agent or solubilizer for flavor emulsion stabilizers at levels up to 10 parts per million of the finished beverage   Scientific procedures Jul. 21, 1998 Dec. 28, 1998
5 Hawaii International Seafood Inc. Tasteless smoke Use in red-meat seafoods such as tuna and salmon to preserve the taste, aroma, and color   Common use in food Apr. 29, 1998 Nov. 9, 1998
4 Ajinomoto USA Transglutaminase from Streptoverticillium mobaraense Use in processed seafood as a crosslinking agent at levels not to exceed 65 parts per million   Scientific procedures Mar. 4, 1998 June 22, 1998
3 Jones Hamilton Co. Sodium bisulfate Use in cake mixes as a pH control agent and a leavening agent at a level of 0.1 to 1.0 percent by weight; use in foods in general as a pH control agent and processing aid at levels not to exceed good manufacturing practices   Scientific procedures Feb. 26, 1998 June 5, 1998
2 United Grain Growers Ltd. Solin oil (low linolenic acid flaxseed oil or low linolenic acid linseed oil) Use as a general purpose cooking, frying, and salad oil; and as an ingredient in margarines, shortenings, and other food products 5G0416 Scientific procedures Feb. 11, 1998 May 27, 1998
1 Archer Daniels Midland Company Soy isoflavone extract Ingredient in performance bars, mature adult meal replacements, and beverages at a level of 25 milligrams per serving   Scientific procedures Feb. 10, 1998 Nov. 3, 1998



(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.


 

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